Bondek Plus Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Device Description

Bondek Plus Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid. The suture material is coated with a copolymer of polycaprolactone and polyglycolic acid.

AI/ML Overview

This document describes the marketing authorization for the BONDEK® PLUS Synthetic Absorbable Surgical Suture. It is a 510(k) Summary of Substantial Equivalence, which means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device.

Key takeaway: This device is a surgical suture, and the acceptance criteria and supporting studies will revolve around its physical properties, biocompatibility, and performance in comparison to existing sutures, rather than accuracy metrics for a diagnostic device.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a specific table detailing "acceptance criteria" and "reported device performance" in the context of typical diagnostic or AI device studies (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence for this surgical suture is based on its similarity in intended use, materials, design, and performance characteristics to predicate devices, and conformance with voluntary performance standards.

Therefore, the "acceptance criteria" are implied to be meeting the requirements of these standards and being comparable to the predicate devices. The "reported device performance" refers to the demonstration of this conformance and comparability.

Acceptance Criteria Category (Implied)	Relevant Standards / Description of Performance Demonstrated (Based on Document)
Intended Use Equivalence	Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures (excluding cardiovascular and neurological procedures), similar to predicate devices.
Material Equivalence	Composed of a homopolymer of glycolic acid, coated with a copolymer of polycaprolactone and polyglycolic acid, similar to predicate devices.
Design Equivalence	Sterile, absorbable, braided multifilament suture, similar to predicate devices.
Biocompatibility	Conformance with ISO 10993-1 Biological Evaluation of Medical Devices. (Implicitly met, no specific performance data given).
Physical Performance (e.g., tensile strength, knot security, absorption profile)	Conformance with U.S.P. Section 1475 - Absorbable Surgical Sutures. (Implicitly met, no specific performance data given).
Labeling Compliance	Conformance with FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA". (Implicitly met).
Manufacturing & Quality Control	Implied adherence to general controls (registration, listing, GMP), and the requirement to maintain documentation regarding vendor certification, manufacturing/QC procedures, and sterilization validation. Any deviations would require new premarket notification.
Regulatory Compliance (Predicate Devices)	Demonstrated substantial equivalence to: - Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending)) - Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198) - Lukens Medical Corp. Lukens® PGA suture (#K965162)

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not mention a specific "test set" in the way one would for diagnostic device studies involving data samples. The evaluation of a surgical suture primarily involves bench testing (to meet physical standards) and biocompatibility testing (often in vitro and in vivo animal studies, or reliance on established material safety).

Sample Size: Not specified in terms of clinical or data samples. The "data" here refers to the results of bench and biocompatibility testing required by the aforementioned standards.
Data Provenance: Not specified. This would typically be from laboratory testing conducted by the manufacturer or accredited labs, and potentially animal studies for biocompatibility, rather than human patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission for a surgical suture. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret medical images or data. For a physical device like a suture, the "ground truth" is established by adherence to recognized engineering, material science, and biological standards through objective testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is not applicable. Adjudication methods are used in studies where multiple human readers or algorithms provide interpretations that need to be reconciled for a definitive "ground truth." This is not how a surgical suture's performance or equivalence is evaluated. Its performance is measured against objective standards.

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

This is not applicable. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for diagnostic AI devices, not for a synthetic absorbable surgical suture.

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

This is not applicable. This question pertains to AI algorithms, which are not part of this medical device (a surgical suture).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this surgical suture, the "ground truth" is defined by:

Voluntary Performance Standards: Such as ISO 10993-1 (biocompatibility) and U.S.P. Section 1475 (physical properties of sutures).
Material Science and Engineering Principles: Ensuring the suture material meets specifications for strength, degradation, and handling characteristics.
Comparability to Predicate Devices: Demonstrating that the new device performs equivalently to existing, legally marketed sutures based on their established performance profiles.

There is no "expert consensus" or "pathology" in the typical sense for establishing performance of the suture itself, although expert surgeons would evaluate its handling characteristics in practice. Outcomes data might be collected in a larger clinical trial for novel claims, but for a 510(k) for a well-understood device type, it's primarily bench and biocompatibility data.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. This device is a physical surgical suture, not an AI or software device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as point 8.

Summary

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EXHIBIT A

510(k) Summary of Substantial Equivalence

BONDEK ® PLUS Synthetic Absorbable Surgical Suture

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 Surgical Products Corp.600 Airport RoadFall River, MA 02720-4740
Contact Person	Mary E. GrayPhone: (508) 677-6512Fax: (508) 677-6663e-mail: mgray@genzyme.com
Device Information
Trade Name:	Bondek® Plus Polyglycolic Acid SyntheticAbsorbable Surgical Suture
Common Name:	Polyglycolic Acid Synthetic AbsorbableSurgical Suture
Classification Name:	Absorbable poly(glycolide/L-lactide)surgical suture (per 21 CFR § 878.4493)

Indications for Use

Device Description

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EXHIBIT A

510(k) Summary of Substantial Equivalence Cont. BONDEK ® PLUS Synthetic Absorbable Surgical Suture

Substantial Equivalence

The Bondek Plus Synthetic Absorbable Surgical Suture is similar in intended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482, #K930378 and #K991191(pending)), Sherwood-Davis & Geck Dexon® PGA Suture (#K972566, #K951352, #K900198), and Lukens Medical Corp. Lukens® PGA suture (#K965162).

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. ISO 10993-1 Biological Evaluation of Medical Deices, U.S.P. Section 1475 - Absorbable Surgical Sutures, and the FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA"

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999 SEP .

Ms. Mary E. Gray, RAC Genzyme Surgical Products Corp. 600 Airport Road Fall River, Massachusetts 02720

Re: K992088

Trade Name: Bondek® Plus Polyglycolic Acid Synthetic Absorbable Suture Regulatory Class: II Product Code(s): GAM Suture, Absorbable, Synthetic, PolyGlycolic Acid (PGA) Dated: June 18, 1999 Received: June 21, 1999

Dear Ms. Gray:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Monday, December 11, 1989 (Vol. 54, No. 236, Pages 50737 and 50738). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

The Polyglycolic acid (PGA) Surgical Sutures are indicated for use in general soft 1. tissue approximation and/or ligation. including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
1. The Polyglycolic acid (PGA) Surgical Sutures may not be manufactured from any material other than homopolymers and copolymers made from glycolide and/or Llactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be sumitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed changes. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacturing of the PGA surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and FDA clearance prior to commercial distribution of the modified device.

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Page 2 - Ms. Mary E. Gray, RAC

The sale, distribution and use of these devices are restricted to prescription use in accordance with 21 CFR 801.109.

The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Witt, Ph.D., M.D.

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

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510(k) Number (if known) Device Name

K992088 Bondek® Plus Synthetic Absorbable Surgical Suture

Indications for Use

Bondek® Plus Synthetic Absorbable Surgical Suture is indicated for use in general soft Bonder Title Byntholio riosofbacts burghthalmic procedures, but not for use in cardiovascular and neurological procedures.

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

(Division Sign-Off)
Division of General Restorative Devices K992088
510(k) Number

Prescription Use X (Per 21 CFR § 801.109)

111

Over-the-Counter Use _

(Optional Format 1-2-96)

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.