SupraMESH EXTRA™ nylon mesh is an 18" x 18" mesh panel woven from USP size 3-0 SUPRAMID EXTRA® nylon suture (FDA N80-838). The nylon used to manufacture this SUPRAMID EXTRA® nylon suture (FDA N80-838) is nylon 6. The knit description of the SupraMESH EXTRA™ nylon mesh panel is 1 x 1 Tricot stitch mesh.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called SupraMESH EXTRA™. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets a new set of acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in this document.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document asserts "substantial equivalence" based on the predicate device. It doesn't define new acceptance criteria that the SupraMESH EXTRA™ device must meet with new performance data. The "performance" is considered equivalent to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Same indications for use as predicate (K831723, K852011, K831724)	SupraMESH EXTRA™ has the same indications for use.
Raises no new safety/efficiency issues	SupraMESH EXTRA™ raises no new safety/efficiency issues.
Substantially equivalent in design and function to predicate	SupraMESH EXTRA™ stated to be substantially equivalent in design and function.

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

Sample Size for Test Set: Not applicable. This is a substantial equivalence submission, not a study with a test set. There are no new patient data presented to evaluate the device.
Data Provenance: Not applicable for a performance study. K831723, K852011, and K831724 are prior 510(k) notifications for the predicate devices. The current submission relies on the established safety and effectiveness of these predicate devices.

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

Not applicable. No ground truth establishment for a new test set is described.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not mentioned or implied.

6. Standalone Performance Study (Algorithm only without human-in-the-loop):

No. This is not an AI/algorithm device.

7. Type of Ground Truth Used:

The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices (Supramid Extra Surgical Mesh, FDA K831723, K852011, and K831724) based on their prior clearances and regulatory history. The current device is being compared to these, not to raw pathology or outcomes data.

8. Sample Size for the Training Set:

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

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

Not applicable.

In summary: This document is a 510(k) summary for a medical device. It demonstrates substantial equivalence to previously cleared predicate devices rather than presenting the results of a new clinical or performance study against specific acceptance criteria. Therefore, most of the questions related to new performance testing, sample sizes, and expert review do not apply to this type of submission.

Summary

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SEP 1 5 2008

Image /page/0/Picture/1 description: The image shows the text "S. JACKSON, INC." in a bold, outlined font. The letters are large and blocky, with a distinct outline that makes them stand out. The text is arranged horizontally, with each letter evenly spaced.

080216
pg 1 of 2

sutures & Impla 15 Roth Street · P.O. Box 4487 · Alexandria, VA 22303

4.0 SUMMARY OF SAFETY AND EFFECTIVENESS

ADMINISTRATIVE INFORMATON 4.1

SPONSOR IDENTIFICATION 4.11

S. Jackson, Inc. 15 Roth Street Alexandria, VA 22314 Contact Person: Mr. Janko Jackson, President e-mail: supramid@mindspring.com Telephone: 703-370-4900 Fax: 703-370-1679

ESTABLISHMENT REGISTRATION NUMBER: 1111225 4.12

OFFICIAL CONTACT PERSON 4.13

Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin(a)yourFDAconsultant.com Tel: (301) 279 -2899 Fax: (301) 294-0126

4.14 DATE OF PREPARATION OF THIS SUMMARY: January 13, 2008

4.15 PROPRIETARY (TRADE) NAME: SupraMESH EXTRA™

4.16 COMMON NAME: Surgical Mesh
4.17 CLASSIFICATION NAME: Mesh, Surgical, Polymeric
4.18 REGULATION NUMBERS: 21 CFR 878.3300
4.19 PROPOSED REGULATORY CLASS: Class 2
4.20 DEVICE PRODUCT CODES: FTL
4.21 MEDICAL SPECIALTIES: General and Plastic Surgery

Phone (800) 368-5225 and (703)370-4900 · Fax (703) 370-1679

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K080216
pg 20f2

4.2 DESCRIPTION OF THE DEVICE

S. Jackson, Inc. currently manufactures Supramid Extra Surgical Mesh (marketed as SupraMESH®) sterile mesh sheets under FDA K831723, K852011 and K831724. SupraMESH EXTRA™ nylon mesh is substantially equivalent to Supramid Extra Surgical Mesh (marketed as SupraMESH®) FDA K831723. K852011 and K831724 in design and function and shares the same indications for use.

INDICATIONS FOR USE 4.3

SupraMESH EXTRA™ nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.

PREDICATE DEVICES 4.4 Supramid Extra Surgical Mesh (marketed as SupraMESH®) FDA K831723, K852011 and K831724.

SUBSTANTIAL EQUIVALENCE 4.5

SupraMESH EXTRA™ nylon mesh is substantially equivalent to Supramid Extra Surgical Mesh (marketed as SupraMESH®) FDA K831723, K852011 and K831724 with regard to indications for use and safety and effectiveness.

4.6 CONCLUSION

SupraMESH EXTRA™ nylon mesh raises no new safety/efficiency issues and has the same indications for use as the predicate device cited.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an eagle or bird in flight, rendered in black. Surrounding the symbol is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle, framing the central symbol.

SEP 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

S. Jackson, Inc. % Estrin Consulting Group, Inc. Mr. Norman R. Estrin President 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K080216

Trade/Device Name: SupraMESH EXTRA™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: August 21, 2008 Received: August 22, 2008

Dear Mr. Estrin:

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.

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Page 2 - Mr. Norman R. Estrin

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K080216

Indications for Use

510(k) Number (if known): K080216

Device Trade/Proprietary Name: SupraMESH EXTRA™

Indications for Use:

SupraMESH EXTRA™ nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.

Page 1_of_1_

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Kuumy R. Sence FOR M. MELKERSON

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

510(k) Number K080216

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.