Monosyn Quick Synthetic Absorbable Surgical Suture is intended for general soft tissue approximation of the skin and mucosa, where only short term wound support (6-7 days) is required. Monosyn Quick suture is not indicated for use in cardiovascular or neurosurgery.

Device Description

Monosyn Quick is an absorbable flexible monofilament suture which is supplied sterile. It is composed of a synthetic polyglycolic acid-based copolymer. The Monosyn Quick suture is undyed and will be offered in diameters ranging from USP size 6-0 through 1. It is uncoated and will be available in a variety of cut lengths with or with out needles attached.

AI/ML Overview

The provided text describes the regulatory filing for a medical device, the Monosyn Quick Synthetic Absorbable Surgical Suture, and outlines the testing performed to demonstrate its substantial equivalence to predicate devices. However, the document does not detail a study proving the device meets "acceptance criteria" in the way one might expect for a diagnostic or AI-driven system. Instead, it focuses on demonstrating compliance with recognized standards and substantial equivalence to existing devices for safety and performance.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission (510(k) for a surgical suture). I will answer the questions based on the closest available information in the document.

Here's a breakdown of the information that can be extracted:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" as defined by specific thresholds for performance metrics. Instead, it refers to compliance with established USP standards for surgical sutures. The performance data is presented as satisfactory and demonstrating equivalence.

Acceptance Criteria Category	Reported Device Performance (Compliance)
USP 39 Monograph for Absorbable Surgical Sutures	Meets requirements
USP 39 <861> Sutures - Diameter	Meets requirements (with labeling for minimal deviation)
USP 39 <881> Tensile Strength	Meets requirements
USP 39 <871> Sutures - Needle Attachment	Meets requirements
ISO 10993-1:2009 (Biocompatibility)	Compliance demonstrated
ISO 10993-5 (In vitro cytotoxicity)	Compliance demonstrated
ISO 10993-6 (Local Effects After Implantation)	Compliance demonstrated
ISO 10993-7 (Ethylene oxide sterilization residuals)	Compliance demonstrated
ISO 10993-10 (Irritation And Skin Sensitization)	Compliance demonstrated
ISO 10993-11 (Systemic Toxicity)	Compliance demonstrated
ISO 11135-1:2007 (EO Sterilization)	Compliance demonstrated
Residual strength and absorption rate	Demonstrates substantial equivalence to predicate devices

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for the mechanical, biocompatibility, or resorption tests. It refers to "testing" and "data generation" but not specific numbers of samples. Data provenance is not mentioned beyond the tests being performed to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable here. Surgical sutures are evaluated against engineering and biological standards, not through expert consensus on qualitative "ground truth" like in AI/diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication is used for establishing ground truth in human-AI studies, not for the evaluation of a physical medical device like a suture.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a surgical suture, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a surgical suture, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" equivalent in this context is the adherence to established industry standards and regulations:

USP (United States Pharmacopeia) 39 Monograph for Absorbable Surgical Sutures: Provides specifications for material, diameter, tensile strength, and other physical properties.
ISO (International Organization for Standardization) 10993 series and 11135-1: Provide standards for biological evaluation (biocompatibility) and sterilization processes for medical devices.
Predicate Device Performance: Comparison to existing legally marketed devices serves as a benchmark for safety and effectiveness.

8. The sample size for the training set

Not applicable. Medical devices like sutures are not "trained" in the machine learning sense. The manufacturing process is established and controlled, but there isn't a "training set" of data in the way an AI model would have one.

9. How the ground truth for the training set was established

Not applicable. As noted above, this device does not utilize machine learning or require a training set with established ground truth in that context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.

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

October 23, 2017

Aesculap®, Inc. Ms. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K171001

Trade/Device Name: Monosyn Quick Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: September 12, 2017 Received: September 13, 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

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801); medical device 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.

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 (DICE) 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 (DICE) 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.

David Krause -S

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

Enclosure

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apple Synggerics Aps 25 25 27 2017 11 20

Expiration Date: January 31, 2017

See PRA Statement below.

Monosyn

510(k) Prematic Metifisetion OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171001

Device Name

Aesculap Monosyn Quick Synthetic Absorbable Surgical Suture

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

Aesculap Monosyn Quick Synthetic Absorbable Surgical Suture September 12, 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:	Monosyn Quick Synthetic Absorbable Surgical Suture
COMMON NAME:	Synthetic Absorbable Surgical Suture
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	Absorbable poly(glycolide/l-lactide) surgical suture
REGULATION NUMBER:	878.4493
PRODUCT CODE:	GAM

PURPOSE FOR PREMARKET NOTIFICATION

The purpose for this submission is to gain marketing clearance for the Monosyn Quick Synthetic Absorbable Surgical Suture.

PREDICATE DEVICE

Primary predicate: Monosyn Synthetic Absorbable Surgical Suture (K011375) .
. Reference predicate: Caprosyn Absorbable Surgical Suture (K032586)

DEVICE DESCRIPTION

INDICATIONS FOR USE

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TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}

As established in this submission, the Monosyn Quick suture is a synthetic absorbable monofilament 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 Monosyn Quick Synthetic Absorbable Surgical Suture to the predicate devices are summarized below.

	Aesculap Inc.Monosyn Quick SyntheticAbsorbable SurgicalSuture	Aesculap, Inc.Monosyn SyntheticAbsorbable SurgicalSuture	United States SurgicalCaprosyn AbsorbableSurgical Suture
K#	Proposed device	K011375	K032586
Indications	Monosyn Quick SyntheticAbsorbable Surgical Sutureis intended for general softtissue approximation of theskin and mucosa, whereonly short term woundsupport (6-7 days) isrequired. Monosyn Quicksuture is not indicated foruse in cardiovascular orneurosurgery.	Monosyn SyntheticAbsorbable Surgical Sutureis indicated for use ingeneral soft tissueapproximation and/orligation, but not for use incardiovascular orneurological surgery.	Caprosyn syntheticabsorbable sutures areindicated for use in generalsoft tissue approximationand/or ligation, includinguse in ophthalmicprocedures, but not for usein cardiovascular orneurological surgery, ormicrosurgery.
Absorption Type	Short term absorbable	Mid term absorbable	Short term absorbable
Absorption	Essentially complete by 56days	Essentially completedbetween 60-90 days	Essentially complete by 56days
Remaining TensileStrength	5 days 60-70%10 days 25-35%	14 days 50%	5 days 60%10 days 20-30%
Material	72% glycolide14% ε-caprolactone14% trimethylene carbonate	72% glycolide14% ε-caprolactone14% trimethylene carbonate	Glycolide, Caprolactone,Trimethylene Carbonateand Lactide
Dyed, Un-dyed	Undyed	Un-dyed and Dyed	Un-dyed and Dyed
Structure	Monofilament	Monofilament	Monofilament
Size	6-0 through 1 (variouslengths) with or w/outneedles attached	5-0 through 1 (variouslengths) with or w/outneedles attached	6-0 through 1 (variouslengths) with or w/outneedles attached
Thread length	-45 cm to 120 cm	-35 cm to 150 cm-ligature reels of longerlength	-18 in to 60 in-ligature reels of longerlength
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.
Needle material	300 or 400 series stainlesssteel	300 or 400 series stainlesssteel	unknown

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	Aesculap Inc.Monosyn Quick SyntheticAbsorbable SurgicalSuture	Aesculap, Inc.Monosyn SyntheticAbsorbable SurgicalSuture	United States SurgicalCaprosyn AbsorbableSurgical Suture
K#	Pending	K011375	K032589
Packaging	Coated cardboard supportin double peel pouch. Innerpouch composed of PET,aluminum foil and LDPElayers. Medical gradepaper and PET/LDPElaminate outer pouch.orOval HDPE support with acoated cardboard lid in asingle pouch composed ofpolyethylene terephthalatepolyester (PETP).orcardboard support fold cardin a single pouch composedof polyethyleneterephthalate polyester(PETP).	Coated cardboard supportin double peel pouch. Innerpouch composed of PET.aluminum foil and LDPElayers. Medical gradepaper and PET/LDPElaminate outer pouch.	unknown
Sterilization	Ethylene Oxide (EO)	Ethylene Oxide (EO)	unknown

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 Monosyn Quick Synthetic Absorbable Surgical Suture meets current performance requirements for synthetic absorbable sutures unless otherwise labeled, and that Monosyn Quick is substantially equivalent to other predicate devices. The test results demonstrate that the Monosyn Quick complies with the following standards:

USP 39 Monograph for Absorbable Surgical Sutures

USP 39 <861> Sutures - Diameter (where diameter deviates minimally from USP requirements, it will be labeled as such)

USP 39 <881> Tensile Strength

USP 39 <871> Sutures - Needle Attachment

ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. (Biocompatibility)

ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity ISO 10993-6 2007, Biological Evaluation Of Medical Devices - Part 6: Tests For Local Effects After Implantation

ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

ISO 10993-10 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

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ISO 10993-11 2006, Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity

ISO 11135-1:2007, Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices

The Monosyn Quick Synthetic Absorbable Surgical Suture is blister packed and sterilized by Ethylene Oxide. Accelerated aging data for the Monosyn Quick has been generated to support this submission.

CONCLUSION:

Non clinical testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices.

In addition, residual strength and absorption rate studies were performed. The results of this testing demonstrates that the Monosyn Quick is substantially equivalent to the predicate devices.

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.