X-Repair is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. X-Repair is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. X-Repair is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

Device Description

The X-Repair is a bioabsorbable, rectangular, double-layered, flexible, woven surgical mesh manufactured from poly-l-lactic acid (PLLA) fiber. It has locked top and bottom edges and welded ends. It is provided sterile, intended for single use, and labeled non-pyrogenic.

AI/ML Overview

This submission pertains to the X-Repair surgical mesh (K141394). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device (X-Repair, K083307) rather than establishing novel acceptance criteria for a new type of device or an AI/software. Therefore, many of the typical questions for AI/software-based medical devices regarding acceptance criteria, study design, and ground truth are not directly applicable or explicitly stated in this document.

However, I can extract the relevant performance data and study information that is provided for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this surgical mesh, the "acceptance criteria" are implicitly based on demonstrating equivalence to the predicate device's performance regarding mechanical properties and integrity. The document states that the new device has "similar performance characteristics as the predicate device," which serves as the de facto acceptance criterion.

Performance Characteristic	Acceptance Criterion (Implicit)	Reported Device Performance
Tensile Strength	Similar to predicate X-Repair (K083307)	"the subject device has similar performance characteristics as the predicate device"
Suture Pullout Strength	Similar to predicate X-Repair (K083307)	"the subject device has similar performance characteristics as the predicate device"
Package Integrity	Maintains sterile barrier up to 5 years	"adequate for its intended use" and "maintenance of the sterile barrier"
Maintenance of Mechanical Properties	Maintains mechanical properties up to 5 years	"adequate for its intended use" and "maintenance of mechanical properties"

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

The document only states "Bench testing was conducted" to evaluate tensile strength, suture pullout strength, package integrity, and maintenance of mechanical properties.

Sample Size: Not specified.
Data Provenance: Not specified, but generally, bench testing results are generated in a laboratory setting for the specific device being evaluated. It is prospective testing designed to characterize the device.

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

Not applicable in the context of this device. The "ground truth" for physical characteristics like tensile strength and suture pullout strength is determined by standardized engineering tests, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. Physical performance tests do not typically involve adjudication by experts in the same way clinical or imaging studies do.

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

No. This is a traditional medical device (surgical mesh), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

6. If a Standalone Performance Study Was Done

Yes, the bench testing described "evaluated the tensile strength and suture pullout strength of the subject device" and its package integrity and mechanical properties over an extended shelf life. This constitutes a standalone performance evaluation of the device itself.

7. The Type of Ground Truth Used

The ground truth for the bench testing was based on:

Objective measurements of physical properties (tensile strength, suture pullout strength).
Standardized tests for package integrity and material degradation over time.
The "truth" is derived from direct physical measurement outcomes.

8. The Sample Size for the Training Set

Not applicable. This device is not an algorithm that requires a training set.

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

Not applicable. This device is not an algorithm that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird with three profiles of human faces incorporated into its design. The profiles are facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 6, 2014

Synthasome Incorporated Anthony Ratcliffe, Ph.D. President and Chief Executive Officer 3030 Bunker Hill Street, #308 San Diego, California 92109

Re: K141394

Trade/Device Name: X-Repair Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, OWW Dated: July 9, 2014 Received: July 10, 2014

Dear Dr. Ratcliffe:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141394

Device Name X-Repair

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Peter L. Hudson-S

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510(k) SUMMARY

This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87

Establishment Registration Number:	3008008164
Address of Manufacturer:	Synthasome, Inc.3030 Bunker Hill Street, #308San Diego, CA 92109Phone: (858) 490-9400FAX: (858) 490-9404
Contact Person:	Anthony Ratcliffe, PhDPresident and CEO
Date Prepared:	May 15, 2014
Trade or Proprietary Name:	X-Repair
Common or Usual Name:	Surgical mesh
Classification Name:	21 CFR 878.3300, class II, FTL:Mesh, Surgical, Polymeric
Predicate Device Identification:	X-Repair (K083307)

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Device Description:

Intended use and comparison to predicate devices:

X-Repair is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

X-Repair is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

X-Repair is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

"Indications for Use" are identical to the predicate X-Repair (K083307).

"Directions for Use" are identical to the predicate X-Repair (K083307).

Product labels have been modified to reflect the additional sizes and additional part numbers.

Technological characteristics and comparison to predicate devices:

The technological characteristics are identical to the predicate X-Repair (K083307), namely :

Have the same indications for use
Use the same basic technology .
Have equivalent mechanical properties
Incorporate the same basic woven fabric design ●
Use the same PLLA fiber material
Are packaged and sterilized using the same materials and processes .

Minor changes to the predicate comprise additional widths for the device, starting at 4mm up to 40mm (the largest width of the predicate) and additional lengths for the device, starting at 20mm up to 160mm. In addition, the shelf life has been expanded to five (5) years.

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Summary of performance data:

Bench testing was conducted to evaluate the tensile strength and suture pullout strength of the subject device. The results showed that the subject device has similar performance characteristics as the predicate device. In addition, the package integrity was tested to evaluate the maintenance of the sterile barrier and the maintenance of mechanical properties up to five years. The results of performance testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use and do support a determination of substantial equivalence.

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.