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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Novosyn Quick Absorbable Suture." It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe an AI medical device or a study involving human readers or AI assistance in diagnostic tasks.

Therefore, I cannot extract information related to acceptance criteria and study designs for an AI medical device, as requested in the prompt. The information provided is purely for a traditional surgical suture and its physical and biological performance characteristics.

Specifically, the document does not contain any of the following information relevant to your request:

Acceptance Criteria for an AI device: The document lists acceptance criteria for a physical medical device (suture) based on USP requirements and biocompatibility, not for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
Study that proves the device meets acceptance criteria for AI: The "performance data" section details mechanical testing (diameter, tensile strength, needle attachment) and biocompatibility testing for the suture, which are physical and biological tests, not clinical performance studies for an AI algorithm.
Sample size for test set and data provenance for AI: No such data exists in the document.
Number of experts and their qualifications for AI ground truth: Not applicable.
Adjudication method for AI test set: Not applicable.
MRMC comparative effectiveness study: Not conducted.
Standalone (algorithm-only) performance: Not applicable.
Type of ground truth used for AI: Not applicable.
Sample size for training set for AI: Not applicable.
How ground truth for training set was established for AI: Not applicable.

In summary, this document is entirely about a surgical suture and does not contain the information needed to answer your request about an AI medical device.

Summary

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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 of medical devicerelated 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.

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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,

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

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Indications for Use

510(k) Number (if known) K170661

Device Name Novosyn Quick Absorbable Suture

Indications for Use (Describe)

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)

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

Aesculap Novosyn Quick Absorbable Suture
March 2, 2017

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com
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

INDICATIONS FOR USE

Novosyn Ouick 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.

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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.Novosyn QuickAbsorbable Suture	Primary PredicateAesculap, Inc.Novosyn AbsorbableSuture	Ethicon, Inc.Vicryl Rapide Suture		Aesculap, Inc.Novosyn QuickAbsorbable Suture	Primary PredicateAesculap, Inc.Novosyn AbsorbableSuture	Ethicon, Inc.Vicryl Rapide Suture
K#	Pending	K122734	K962480/K944110	K#	Pending	K122734	K962480/K944110
Indications	Novosyn Quick AbsorbableSuture is indicated for usein general soft tissueapproximation of the skinand mucosa, where onlyshort term wound support(7-10 days) is required.Novosyn Quick suture isnot intended for use inligation in ophthalmic,cardiovascular orneurological procedures.	Novosyn sutures areindicated for use in generalsoft tissue approximationand/or ligation, includinguse in ophthalmicprocedures, but not for usein cardiovascular andneurological tissues.	Vicryl Rapide suture isindicated only for use insuperficial general softtissue approximation of theskin and mucosa, whereonly short term woundsupport (7-10 days) isrequired. Vicryl rapidesuture is not intended foruse in ligation, ophthalmic,cardiovascular orneurological procedures.	Thread length	-45 cm to 150 cm-ligature reels of longerlength	-5 cm to 150 cm-ligature reels of longerlength	-45cm to 135cm
Absorption Type	Short term absorbable	Mid term absorbable	Short term absorbable	Physical:- Diameter- Length- Needle Attachment- Tensile Strength	All characteristics meetUSP Requirements, exceptfor diameter.	All characteristics meetUSP Requirements, exceptfor diameter.	All characteristics meetUSP Requirements, exceptfor diameter.
Absorption	Essentially complete by 42days	Essentially completedbetween 8-10 weeks	Essentially complete by 42days	Needle material	300 stainless steel	300 stainless steel	unknown
Remaining TensileStrength	5 days 50%14 days 0%	2 weeks 75% (6-0 andlarger)2 weeks 56% (7-0 andsmaller)3 weeks 52% (6-0 andlarger)3 weeks 35 % (7-0 andsmaller)4 weeks 23 % (5-0 andlarger)	5 days 50%14 days 0%	Packaging	Foil packaging in a secondouter peel-pack with paperand plastic film	Foil packaging in a secondouter peel-pack with paperand plastic film	unknown
Material	Polyglycolide-co-L-lactid90/10 (PGLA)	Polyglycolide-co-L-lactid90/10 (PGLA)	Polyglactin 910 (glycolicand lactic acid)	Sterilization	Gamma irradiation	Ethylene Oxide (EO)	Ethylene Oxide (EO) orGamma Irradiation
Dyed, Un-dyed	Un-dyed	Un-dyed and Dyed	Un-dyed
Structure	Braided	Braided	Braided
Coating	Polyglycolide-co-L-lactid35/65 + Calcium Stearate	Polyglycolide-co-L-lactid35/65 + Calcium Stearate	Caproloctone / Glycolide +Polyglactin 370(glycolide/lactide) w/Calcium Stearate
Size	6-0 through 2 (variouslengths)with or w/out needlesattached	8-0 through 2 (variouslengths)with or w/out needlesattached	6-0 through 0 (variouslengths)with or w/out needlesattached

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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.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.