DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002

June 8, 2017
Aesculap, Incorporated
Ms. Kathy A. Racosky
Senior Regulatory Affairs Specialist
3773 Corporate Parkway
Center Valley, Pennsylvania 18034

Re: K170661
Trade/Device Name: Novosyn Quick Absorbable Suture
Regulation Number: 21 CFR 878.4493
Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture
Regulatory Class: Class II
Product Code: GAM
Dated: May 10, 2017
Received: May 11, 2017

Dear Ms. Racosky:

We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
it may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must comply
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2 - Ms. Kathy A. Racosky

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the
Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,
y

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director
Division of Surgical Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: January 31, 2017
Indications for Use See PRA Statement below.

510(k) Number (if known)

K170661

Device Name
Novosyn Quick Absorbable Suture

Indications for Use (Describe)

Novosyn Quick Absorbable Suture is indicated for use in general soft tissue approximation of the skin and mucosa, where
only short term wound support (7-10 days) is required. Novosyn Quick suture is not intended for use in ligation in
ophthalmic, cardiovascular or neurological procedures.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
510(k) Summary – K170661 Page 1 of 3

510(k) SUMMARY (as required by 21 CFR 807.92)

Aesculap Novosyn Quick Absorbable Suture

March 2, 2017

COMPANY: Aesculap®, Inc.

3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714
CONTACT: Kathy A. Racosky
610-984-9291 (phone)
610-791-6882 (fax)
[email protected]

TRADE NAME: Novosyn Quick Absorbable Suture

COMMON NAME: Synthetic Polyglycolic Absorbable Suture

CLASSIFICATION: Class II

CLASSIFICATION NAME: Suture, Absorbable, synthetic, Polyglycolic Acid

REGULATION NUMBER: 878.4493

PRODUCT CODE: GAM

PURPOSE FOR PREMARKET NOTIFICATION

The purpose for this submission is to gain marketing clearance for the Novosyn Quick
Absorbable Suture.

PREDICATE DEVICE
• Primary Predicate: Novosyn Absorbable Suture, Aesculap Inc. (K122734)
• Vicryl Rapid Suture, Ethicon Inc. (K962480/K944110)

DEVICE DESCRIPTION
Novosyn Quick is a synthetic absorbable braided surgical suture which is supplied sterile.
Novosyn Quick is composed of a copolymer made from 90% gylcolide and 10% L-lactide
(PGLA). The Novosyn Quick suture is coated with 35/65 poly(glycolide-co-L-lactide) and
calcium stearate. The Novosyn Quick suture is undyed and will be offered in diameters ranging
from USP size 6-0 through 2. It will be available in a variety of cut lengths with or without
needles attached.

INDICATIONS FOR USE

Novosyn Quick Absorbable Suture is indicated for use in general soft tissue approximation of the
skin and mucosa, where only short term wound support (7-10 days) is required. Novosyn Quick
suture is not intended for use in ligation in ophthalmic, cardiovascular or neurological
procedures.
1
510(k) Summary – K170661 Page 2 of 3

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

As established in this submission, the Novosyn Quick suture is a synthetic absorbable braided
surgical suture offered undyed in the same range of diameters and cut lengths that are
substantially equivalent to other predicate devices cleared by FDA. The subject device is shown
to be substantially equivalent and has the same technological characteristics to its predicate
devices through comparison in design, intended use, material composition, function and range of
sizes. The device characteristics comparing the Novosyn Quick Absorbable Suture to the
predicate devices are summarized below.

Aesculap, Inc. Primary Predicate Ethicon, Inc.

Novosyn Quick Aesculap, Inc. Vicryl Rapide Suture
Absorbable Suture Novosyn Absorbable
Suture
K# Pending K122734 K962480/K944110
Indications Novosyn Quick Absorbable Novosyn sutures are Vicryl Rapide suture is
Suture is indicated for use indicated for use in general indicated only for use in
in general soft tissue soft tissue approximation superficial general soft
approximation of the skin and/or ligation, including tissue approximation of the
and mucosa, where only use in ophthalmic skin and mucosa, where
short term wound support procedures, but not for use only short term wound
(7-10 days) is required. in cardiovascular and support (7-10 days) is
Novosyn Quick suture is neurological tissues. required. Vicryl rapide
not intended for use in suture is not intended for
ligation in ophthalmic, use in ligation, ophthalmic,
cardiovascular or cardiovascular or
neurological procedures. neurological procedures.
Absorption Type Short term absorbable Mid term absorbable Short term absorbable
Absorption Essentially complete by 42 Essentially completed Essentially complete by 42
days between 8-10 weeks days
Remaining Tensile 5 days 50% 2 weeks 75% (6-0 and 5 days 50%
Strength 14 days 0% larger) 14 days 0%
2 weeks 56% (7-0 and
smaller)
3 weeks 52% (6-0 and
larger)
3 weeks 35 % (7-0 and
smaller)
4 weeks 23 % (5-0 and
larger)

Material Polyglycolide-co-L-lactid Polyglycolide-co-L-lactid Polyglactin 910 (glycolic

90/10 (PGLA) 90/10 (PGLA) and lactic acid)
Dyed, Un-dyed Un-dyed Un-dyed and Dyed Un-dyed
Structure Braided Braided Braided
Coating Polyglycolide-co-L-lactid Polyglycolide-co-L-lactid Caproloctone / Glycolide +
35/65 + Calcium Stearate 35/65 + Calcium Stearate Polyglactin 370
(glycolide/lactide) w/
Calcium Stearate
Size 6-0 through 2 (various 8-0 through 2 (various 6-0 through 0 (various
lengths) lengths) lengths)
with or w/out needles with or w/out needles with or w/out needles
attached attached attached

2
510(k) Summary – K170661 Page 3 of 3

Aesculap, Inc. Primary Predicate Ethicon, Inc.

Novosyn Quick Aesculap, Inc. Vicryl Rapide Suture
Absorbable Suture Novosyn Absorbable
Suture
K# Pending K122734 K962480/K944110
Thread length -45 cm to 150 cm -5 cm to 150 cm -45cm to 135cm
-ligature reels of longer -ligature reels of longer
length length
Physical:
- Diameter All characteristics meet All characteristics meet All characteristics meet
- Length USP Requirements, except USP Requirements, except USP Requirements, except
- Needle Attachment for diameter. for diameter. for diameter.
- Tensile Strength
Needle material 300 stainless steel 300 stainless steel unknown
Packaging Foil packaging in a second Foil packaging in a second unknown
outer peel-pack with paper outer peel-pack with paper
and plastic film and plastic film
Sterilization Gamma irradiation Ethylene Oxide (EO) Ethylene Oxide (EO) or
Gamma Irradiation

PERFORMANCE DATA
As recommended by the FDA’s Class II Special Control Guidance Document for Surgical
Sutures, including mechanical testing in accordance to USP 39 for synthetic absorbable suture,
biocompatibility testing in accordance to ISO 10993-1, and in vitro as well as in vivo resorption
testing has been performed to demonstrate that the Novosyn Quick Absorbable Suture meets
current performance requirements for synthetic absorbable sutures unless otherwise labeled, and
that Novosyn Quick is substantially equivalent to other predicate devices.

Tests were conducted for diameter, tensile strength, and needle attachment. All specifications
were met apart from diameter. The Novosyn Quick suture is considered an implant device,
tissue/bone contact device of permanent duration (>30 days). Biocompatibility testing within
this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation,
Acute Systemic Toxicity, Hemolysis, Genotoxicity – Chromosomal Aberration and Mouse
Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (6-week).

Testing demonstrated that the device is as safe and as effective as the predicate device. The
subject device is concluded to be substantially equivalent to the predicate device.

The Novosyn Quick Absorbable Suture is blister packed and sterilized by Gamma. Real-time
aging data for the Novosyn Quick Suture has been generated to support this submission.