Premilene® sutures are indicated for use in all types of general soft tissue approximation and ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Device Description

The subject device is a nonabsorbable, flexible monofilament suture thread which is supplied sterile. It is composed of isotactic polypropylene polymer, and is indicated for soft tissue approximation. It will be offered undyed, and dyed with the FDA approved colorant [Phthalocyaninati(2-)] copper in accordance with Title 21 CFR, §74.3045. It will be available with and without standard needles attached.

AI/ML Overview

The provided text describes the Premilene Nonabsorbable Polypropylene Surgical Suture and its substantial equivalence to predicate devices, focusing on non-clinical testing. This document is a 510(k) summary for a medical device and thus relates to regulatory approval rather than a study proving the device meets specific acceptance criteria in the typical sense of a clinical trial for AI/software devices. The acceptance criteria here are based on physicochemical equivalence to existing devices.

Here's a breakdown of the requested information based only on the provided text, recognizing that many items common in AI/software device studies are not applicable or detailed in this type of submission:

Description of Acceptance Criteria and Proving Device Meets Criteria

The "acceptance criteria" for the Premilene Nonabsorbable Polypropylene Surgical Suture are primarily based on demonstrating substantial equivalence to existing predicate devices (Prolene®, Surgilene®, Sharpoint). This equivalence is established through adherence to USP XXIII standards and comparative non-clinical testing of physical, chemical, and biological properties.

The study proving the device meets these acceptance criteria is presented as a series of non-clinical tests and validations, as summarized in Section G of the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are compliance with specified standards and "device performance" is expressed as meeting these standards and being substantially equivalent to predicates. No specific numerical thresholds or performance metrics (like sensitivity, specificity, etc.) are provided for this type of medical device which is a physical suture.

Acceptance Criteria (Based on Substantial Equivalence to Predicates)	Reported Device Performance
Material Composition: Isotactic polypropylene polymer	Composed of the same material (isotactic form of polyolefin polymer polypropylene).
Colorant: [Phthalocyaninato(2-)] copper, ≤0.5% by suture weight (if dyed)	Offered undyed, and dyed with the same colorant at ≤0.5% by suture weight, in accordance with 21 CFR §74.3045.
Design: Sterile, flexible monofilament thread, various lengths/diameters, with/without needles	Same design as predicate devices; sterile, flexible monofilament thread; offered in variety of lengths and range of diameters conforming to U.S. Pharmacopeia (U.S.P.) XXIII, with or without standard needles attached.
Physical Properties: Conformance to U.S.P. XXIII for nonabsorbable surgical suture, including: - <861> Sutures -- Diameter - <871> Sutures -- Needle Attachment - <881> Tensile Strength - Fiber diameter - Knot pull tensile strength - Straight pull tensile strength - Flexibility - Elongation - Elasticity - Needle attachment strength	Conforms in all respects to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIII for specified parameters. Physical properties are substantially equivalent to predicate devices for all identified parameters.
Manufacturing Process: Same as at least one predicate device	Manufactured in the same manner as at least one predicate device (supplier of finished suture fiber is manufacturer of said predicate suture). Suture fiber has same chemical characteristics, biocompatibility profile, and in vivo performance properties as that predicate device.
Packaging & Sterilization: Same or equivalent manner as predicates	Packaged and sterilized in the same or equivalent manner.
Labeling Claims: Same as predicates (indications, contraindications, warnings, cautions, precautions)	Has the same labeling claims as predicate devices.
Chemical Assays: Identity and purity for finished suture fiber	Testing conducted by manufacturer/supplier included chemical assays for identity and purity.
Biosafety Studies: In vitro and in vivo	Testing conducted by manufacturer/supplier included in vitro and in vivo biosafety studies.
Tensile Strength Retention (in vivo): Over 1 year	One (1) year implant studies in animals to demonstrate retention of tensile strength.
Sterilization Validation & Residues: Validation and evaluation	Sterilization validation and evaluation of sterilant residues performed.
Shelf-life Testing: Stability and integrity over time	Shelf-life testing performed.

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

The text does not specify sample sizes (e.g., number of sutures, animals used) for the non-clinical tests. This information is typically proprietary and contained in the full 510(k) submission, not the summary.

Data Provenance: The tests were conducted by the manufacturer and supplier to Aesculap®. The country of origin for the data is not specified. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate equivalence.

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

Not applicable. The "ground truth" for this type of medical device is established through adherence to recognized pharmacopeial standards (U.S.P. XXIII) and direct comparative physical/chemical testing, not through expert consensus in a diagnostic sense. The experts involved would be quality control engineers, chemists, and materials scientists, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. As this is not a diagnostic device involving interpretation errors, there is no adjudication method in the context of expert review. Test results are objective measurements against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is for evaluating observer performance with diagnostic imaging or similar outputs, which is not relevant to a surgical suture. The effectiveness is demonstrated through mechanical and biological equivalence to predicate devices and adherence to standards.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" consists of established, objective physical, chemical, and biological standards (e.g., U.S.P. XXIII monographs for sutures, recognized chemical and biocompatibility testing protocols, and the established properties of the predicate devices).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. See point 8.

Summary

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MAY 4 1998

VII. 510(k) Summary

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A. Submitted By

R. Stephen Reitzler, RAC, Vice President, Regulatory Affairs Advanced Bioresearch Associates One America Plaza 600 West Broadway, Suite 900 San Diego, California 92101 Telephone: (619) 702-0700

Regulatory Agents for: Aesculap® 1000 Gateway Boulevard South San Francisco, California 94080-7030 Telephone: (650) 876-7000 Contact: Victoria MacKinnon, Manager, Regulatory Affairs Date Prepared: February 11, 1998

B. Device Name

Premilene Polypropylene Surgical Suture Trade or Proprietary Name: Nonabsorbable Polypropylene Surgical Suture Common or Usual Name: Nonabsorbable Polypropylene Surgical Suture Classification Name:

C. Predicate Devices

Prolene® Nonabsorbable Polypropylene Surgical Suture (Ethicon, Inc.) .
Surgilene® Nonabsorbable Polypropylene Surgical Suture (Davis & Geck) ●
Sharpoint Polypropylene Surgical Suture (Sharpoint) .

The subject device is substantially equivalent to predicate devices listed above.

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D. Device Description

E. Intended Use

Premilene Nonabsorbable Polypropylene Surgical Sutures are indicated for use in all types of general soft tissue approximation and ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

F. Comparison to Predicate Devices

The subject Premilene Nonabsorbable Polypropylene Surgical Suture is composed of the same material as are the predicate devices, that being the isotactic form of the polyolefin polymer polypropylene. Further, the subject device is offered undyed, and dyed with the same colorant as are the predicate devices, that being {phthalocyaninato(2-)] copper at a concentration of ≤0.5% by suture weight in accordance with Title 21 CRR, §74.3045.

The subject device has the same design as do the predicate devices, being a sterile, flexible monofilament thread which is offered in a variety of lengths and a range of diameters conforming with the requirements of U.S. Pharmacopeia (U.S.P.) XXIII, and which is offered with or without one of a selection of standard needles attached. Further, as is the case with the predicate devices, the subject device conforms in all respects to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIII, including <861> Sutures -- Diameter, <871> Sutures -- Needle Attachment, and <881> Tensile Strength.

Physical properties of the subject device are substantially equivalent to those of the predicate devices, including fiber diameter, knot pull tensile strength,

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straight pull tensile strength, flexibility, elongation, elasticity, and needle attachment strength.

The subject device is manufactured in the same manner as at least one of the predicate devices, being supplied to Aesculap® by the manufacturer of said predicate suture. As such, the suture fiber from which the subject device is made has the same chemical characteristics, biocompatibility profile, and in vivo performance properties as does that predicate device.

The subject device is packaged and sterilized in the same or equivalent manner, and has the same labeling claims as do the predicate devices, including indications, contraindications, warnings, cautions and precautions.

G. Summary of Non-Clinical Tests

Non-Clinical testing conducted on the subject device to demonstrate its substantial equivalence to predicate devices included physical testing for all parameters identified above, sterilization validation and evaluation of sterilant residues, and shelf-life testing. Testing conducted by the manufacturer and supplier to Aesculap® of the finished suture fiber included chemical assays for identity and purity, testing of physical properties to prove conformance to the requirements of U.S.P., in vitro and in vivo biosafety studies, and one (1) year implant studies in animals to demonstrate retention of tensile strength.

H. Summary of Clinical Tests

(Not applicable)

I. Conclusions of Non-Clinical and Clinical Tests

The results of all testing demonstrated the substantial equivalence, if not superiority, of the subject device to one or more predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1098 MAY

Aesculap c/o Mr. Steve Reitzler, RAC Vice President, Regulatory Affairs Advanced Bioresearch Associates One America Plaza 600 West Broadway, Suite 900 San Diego, California 92101-3302

K980703 Re:

Premilene Nonabsorbable Polypropylene Surgical Suture Dated: February 19, 1998 Received: February 23, 1998

Dear Mr. Reitzler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). 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 device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

1. The Premilene Nonabsorabable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery, and neurological procedures.
1. This device may not be manufactured from any material other than a long chain polyolefin polymer known as polypropylene. 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 manufacture of the Polypropylene 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 Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.

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Page 2 - Mr. Reitzler

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

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

Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) 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 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,

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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Pagc / of l

510(k) Number (if known): K980703

Device Name: Premilene® Nonabsorbable Polypropylene Surgical Suture

Indications For Use:

11:00 .. : : : :

Premilene® sutures are indicated for use in all types of general soft tissue approximation and ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 12980703

メ Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.