Acier Steel Suture is indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.
Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure, and certain orthopedic procedures including cerclage and tendon repair.

Device Description

Acier Steel Suture is a nonabsorbable sterile surgical suture composed of 316L stainless steel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Acier Sutures, which are surgical sutures. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria and performance metrics described in a traditional study report.

Therefore, many of the requested sections regarding a "study that proves the device meets the acceptance criteria" are not applicable in this context. The 510(k) submission primarily relies on demonstrating substantial equivalence through bench testing and comparison to an already approved predicate device.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

Not directly applicable in the format requested for a 510(k) substantial equivalence submission.

The submission states: "Functional bench testing has been conducted on the Acier sutures and the results of the testing verified that the sutures perform as designed, are suitable for their intended use."

While there would have been internal acceptance criteria for the various bench tests, these specific criteria and the detailed performance against them are not provided in the summary document. The general acceptance criterion is that the device performs as designed and is suitable for its intended use, demonstrating substantial equivalence to the predicate.

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

Not explicitly provided for the functional bench testing.

The text mentions "Functional bench testing has been conducted," but does not specify the sample size used for this testing or the provenance of any data (e.g., country of origin, retrospective/prospective). For bench testing, data provenance is less relevant than for clinical studies.

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

Not applicable.

For bench testing of surgical sutures, ground truth is established through engineering and material science principles, manufacturing specifications, and comparison to a predicate device's known characteristics, not typically by human experts establishing a "ground truth" for a test set in the same way as in diagnostic imaging or clinical outcomes studies.

4. Adjudication Method for the Test Set

Not applicable.

Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert reviews to resolve disagreements in interpretations or diagnoses. This is not relevant for bench testing of device performance against engineering specifications.

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 submission is for a surgical suture, not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance metrics are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable.

This device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

Device Specifications and Predicate Equivalence.

For this type of device, the "ground truth" for demonstrating performance is derived from:

Engineering specifications and material properties of the 316L stainless steel.
Performance characteristics (e.g., tensile strength, knot security) demonstrated through bench testing.
Comparison of these characteristics to the predicate device (Ethicon's Ethi-Pack Surgical Stainless Steel Suture; K931271) to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable.

This device is not an AI/ML model, so there is no "training set."

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

Not applicable.

This device is not an AI/ML model, so there is no "training set" or ground truth associated with one.

Summary of 510(k) for Acier Sutures:

The 510(k) submission for Acier Sutures focuses on demonstrating substantial equivalence to a predicate device (Ethicon's Ethi-Pack Surgical Stainless Steel Suture; K931271). This is achieved through:

Intended Use, Design, Composition, Function, Indications, Patient Population, and Performance: The applicant asserts the Acier sutures are substantially equivalent across these parameters.
Bench Testing: Functional bench testing was conducted to verify that the sutures "perform as designed" and are "suitable for their intended use." This testing would have compared the physical and mechanical properties of the Acier sutures to established standards and/or the predicate device. The specific details of the tests, acceptance criteria, and quantitative results are not provided in this summary but would have been part of the full 510(k) submission.
Key Differences: The application states that "Any differences between the Peters Acier sutures and its predicate device do not raise any new issues of safety and effectiveness."

The FDA's clearance letter confirms their review of the 510(k) and their determination that the device is "substantially equivalent" for the stated indications, allowing it to be marketed. The letter also specifies limitations regarding the metal used (316L stainless steel only) and requirements for maintaining documentation on vendor certification, manufacturing/quality control, and sterilization validation.

Summary

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K991073

510(k) Summary CardioThoracic Systems, Inc. Acier Sutures 510(k) Notification K991073

GENERAL INFORMATION

Manufacturer: Peters Pharmaceutical Laboratory 42 Rue Benoit Frachon Bobigny, France 93000

Distributed By:

CardioThoracic Systems, Inc. 10600 North Tantau Avenue Cupertino, California 95014 Est. Registration No. 9027735 Contact Person:

Michael J. Billig Regulatory, Quality, and Clinical Vice President, Research

March 25, 1999 Date Prepared:

DEVICE DESCRIPTION

Classification:	Suture, Nonabsorbable, Steel, Monofilamentand Multifilament Surgical Suture
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Trade Name:

Acier

Generic/Common Name: Surgical Sutures

PREDICATE DEVICES

Ethicon's Ethi-Pack Surgical Stainless Steel Suture; K931271

INTENDED USE

Acier Steel Suture is indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

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PRODUCT DESCRIPTION

Acier Steel Suture is a nonabsorbable sterile surgical suture composed of 316L stainless steel.

SUBSTANTIAL EQUIVALENCE

The Peters Acier sutures are substantially equivalent to the predicate devices (Ethicon's Ethi-Pack Surgical Stainless Steel Suture; K931271) in regards to intended use, design, composition, function, indications, patient population and performance. Any differences between the Peters Acier sutures and its predicate device do not raise any new issues of safety and effectiveness.

Functional bench testing has been conducted on the Acier sutures and the results of the testing verified that the sutures perform as designed, are suitable for their intended use.

SUMMARY

As contained in this 510(k) summary, the Peters Acier sutures are substantially equivalent to the predicate devices identified in that the sutures have the same intended use and are similar in design, composition, function, patient population and performance.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Michael J. Billig Cardio Thoracic Systems, Inc. 10600 N. Tantau Avenue Cupertino, California 95014-0739

K991073 Re: Trade Name: Acier Stainless Steel Suture Regulatory Class: II Product Code: GAQ Dated: June 25, 1999 Received: June 28, 1999

Dear Mr. Billig:

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 will be announced in a future Federal Register notice. 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:

The Acier Surgical Suture is indicated for use in abdominal wound closure, hernia repair, 1. sternal closure, and certain orthopedic procedures including cerclage and tendon repair.
1. This device may not be manufactured from any metal other than 316L stainless steel. 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 Acier 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.

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 registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.

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Page 2 - Mr. Michael J. Billig

Existing major regulations affecting your device 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 device 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 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) 594-4639. 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

Enclosure

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16991073

Page__________________________________________________________________________________________________________________________________________________________________________

K991073 5 10(k) Number (if known): _

Device Name:__________________________________________________________________________________________________________________________________________________________________ STAINLESS 57286 SUNRE

Indications For Use:

Surgical Suture is indicated for use in abdominal wound closure, hernia repair,
the supportunity artheredic procedures including cerclage and tendo Surgical Suture is indicated for use in abdominal wound closure, access of the course,
sternal closure, and certain orthopedic procedures including cerclage and tendon repair.

(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	K991073

Prescription Use(Per 21 CFR 801.109)	X
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OR
Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4495 Stainless steel suture.

(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.