Monodek™ Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and opthalmic surgery. Monodek suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

Device Description

Monodek Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture is a sterile, monofilament and is provided in a variety of lengths, with or without needles and may be supplied in a variety of cut lengths or on ligating reels.

AI/ML Overview

The provided text describes a 510(k) summary for the Monodek™ Synthetic Absorbable Surgical Suture, which focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through novel studies.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance (beyond meeting USP requirements for sutures except for oversized diameter)
Sample sizes for a test set or data provenance for such a test
Number and qualifications of experts for ground truth establishment
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone algorithm performance
Type of ground truth for a test set
Sample size for a training set
How ground truth for a training set was established

The information provided focuses on regulatory equivalence:

Acceptance Criteria for Substantial Equivalence:

The primary "acceptance criteria" for the device, as presented, are based on demonstrating substantial equivalence to predicate devices and conformance with established standards and guidance documents. These implicitly act as the performance benchmarks.

Acceptance Criteria (Demonstrated Conformance/Equivalence)	Reported Device Performance
Similar in intended use to cleared predicate devices	Indicated for soft tissue approximation, pediatric cardiovascular tissue, and ophthalmic surgery, similar to CP Medical Mono-Dox and Ethicon PDS II.
Similar in materials to cleared predicate devices	Synthetic absorbable suture, similar to CP Medical Mono-Dox and Ethicon PDS II.
Similar in design to cleared predicate devices	Monofilament, available in sizes 6-0 through 0, undyed and dyed, similar to predicate devices.
Similar in performance characteristics to cleared predicate devices	Meets all USP requirements for absorbable surgical sutures, except for oversized diameter. (Implicitly, the performance is considered equivalent due to meeting standards and similarity to predicate devices).
Conformance with ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices	Conformance stated as a basis for substantial equivalence.
Conformance with USP Section XXV - Absorbable Surgical Sutures	The device meets all USP requirements except for oversized diameter. This is explicitly stated.
Conformance with Guidance Document "Guidance for Surgical Suture 510(k)s" (August 10, 2000)	Conformance stated as a basis for substantial equivalence.
Conformance with FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" (December 19, 2002)	Conformance stated as a basis for substantial equivalence.

Study Proving Acceptance Criteria:

The "study" used to demonstrate that the device meets these acceptance criteria is a regulatory submission based on comparison to predicate devices and adherence to established standards.

Study Type: This is not a clinical trial or a performance study in the typical sense of a novel device proving its efficacy or accuracy against specific clinical endpoints. Instead, it is a 510(k) premarket notification demonstrating substantial equivalence to legally marketed predicate devices.
Methodology: The determination of substantial equivalence was based on:
- A detailed device description.
- Performance testing (implied by meeting USP requirements, though specific test results or protocols are not detailed in this summary).
- Conformance with voluntary performance standards (ANSI/AAMI/ISO 10993-1, USP Section XXV).
- Adherence to FDA guidance documents ("Guidance for Surgical Suture 510(k)s" and "Class II Special Controls Guidance Document: Surgical Sutures").

Missing Information (as per your requested categories):

The document does not describe any specific studies that would involve:

Sample sizes for a test set (as there wasn't a separate "test set" in the context of an AI device)
Data provenance
Number of experts or their qualifications for ground truth in a performance study
Adjudication method
MRMC comparative effectiveness study or effect size (as this is a physical medical device, not an AI diagnostic tool)
Standalone performance (not applicable for this type of device)
Type of ground truth (e.g., pathology, outcomes data) for a diagnostic performance study
Sample size for a training set
How ground truth for a training set was established

In summary, for this specific medical device (a surgical suture), the "acceptance criteria" are met by demonstrating broad equivalence to existing, approved products and adherence to industry standards and regulations, rather than through a performance study that measures accuracy or efficacy against a defined ground truth in a test and training set, which would be typical for AI/diagnostic devices.

Summary

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K0 30 212

MAR 2 7 2003

EXHIBIT A 510(k) Summary

Substantial Equivalence

In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule ".... 510(k) Summaries and 510(k) Statements ... " and can be used to provide equivalence summary to anyone requesting it from the Agency.

Manufacturer	Genzyme BiosurgeryA Division of Genzyme Corporation600 Airport RoadFall River, MA 02720-4740
Contact Person	Stephen PagePhone: (508) 677-6543Fax: (508) 677-6663e-mail: Steve.Page@Genzyme.com
Date Prepared	March 21, 2003
Device Information

Trade Name:	Monodek™ Synthetic Absorbable Surgical Suture.
Common Name:	Polydioxanone Absorbable Surgical Sutures.
Classification Name:	Absorbable Polydioxanone Surgical Sutures

Indications for Use

Device Description

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EXHIBIT A

510(k) Summary

Substantial Equivalence

The device is similar in intended use, materials, design, and performance characteristics to the currently cleared CP Medical Mono-Dox Absorbable Surgical Sutures (#K013274) and the currently approved Ethicon PDS II Absorbable Surgical Suture (PMA N18331).

The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXV - Absorbable Surgical Sutures, Guidance Document "Guidance for Surgical Suture 510(k) s" issued on August 10, 2000 and the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA", December 19, 2002

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with a ribbon-like element flowing beneath them.

MAR 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Page Director of Regulatory Affairs Genzyme Biosurgery 600 Airport Road Fall River, Massachusetts 02720-4740

Re: K030212

Monodek™ Synthetic Absorbable Surgical Suture Regulation Number: 878.4840 Regulation Name: Polydioxanone Suture Regulatory Class: II Product Code: NEW Dated: January 16, 2003 Received: January 21, 2003

Dear Mr. Page:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k)

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Page 2 - Mr. Stephen Page

premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K0302/2 Device Name

Monodek Polydioxanone Absorbable Surgical Suture

Indications for Use

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X (Per 21 CFR § 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Meriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030212

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.