The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

Device Description

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (Poly-Tape/Infinity-Lock) is a woven tape made from Polyethylene Terephthalate (PET) also referred to as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market. The Poly-Tape/Infinity-Lock is a permanent implantable device for the reinforcement of soft tissues that are repaired by suture or other fixation devices during soft tissue repair surgery.

AI/ML Overview

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a non-resorbable surgical mesh intended for reinforcing soft tissues during tendon and ligament repair surgery. The provided text outlines the device's characteristics and references performance testing, but does not specify numerical acceptance criteria or provide detailed results from a formal study proving the device meets those criteria.

Here's an analysis based on the provided input, highlighting what's available and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Conceptual, as not explicitly stated in the document)	Reported Device Performance (Summary from text)
Adequate mechanical properties for soft tissue reinforcement.	"The results demonstrate that the Poly-Tape/Infinity-Lock provides adequate mechanical properties for its use in soft tissue reinforcement." (Specific metrics are not provided).
Biocompatibility standards met.	"Biocompatibility Testing" (Result: Successfully completed, but no details on specific tests or thresholds).
Packaging integrity maintained.	"Packaging Testing" (Result: Successfully completed, but no details).
Acceptable levels of endotoxins.	"Xiros conducts routine endotoxin (LAL) batch testing to monitor endotoxin levels." (Implies acceptable levels are maintained, but no specific criteria or results are given).

Note: The document states that "The series of tests, listed above, has been conducted and successfully completed," but it lacks the quantitative acceptance criteria (e.g., minimum tensile strength of X Newtons, maximum elongation of Y %, etc.) and the actual measured performance values that would typically be found in a detailed study report.

2. Sample size used for the test set and the data provenance

The document lists types of performance testing conducted (Suture Retention, Ultimate Strength, Cyclic, Packaging, Biocompatibility), but does not provide details on the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is a physical implant and the testing described is mechanical and biological in nature, not an AI/diagnostic device that requires expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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 information is not applicable as the device is a physical implant and not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a physical implant and not an algorithm.

7. The type of ground truth used

For the mechanical properties (Suture Retention, Ultimate Strength, Cyclic Testing), the "ground truth" would be established by physical measurement standards and engineering principles (e.g., ASTM or ISO standards for material testing).

For biocompatibility, the "ground truth" is established by validated biological tests as defined by ISO 10993 series.

For packaging integrity, the "ground truth" is established by validated packaging test methods (e.g., ASTM standards).

For endotoxin levels, the "ground truth" is established by pharmacopeial methods like the LAL test.

The document states these tests were "successfully completed," implying adherence to established regulatory and scientific standards for "ground truth."

8. The sample size for the training set

This information is not applicable as the device is a physical implant and does not involve a training set as would be used for AI/machine learning.

9. How the ground truth for the training set was established

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

Summary

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December 27, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Xiros Ltd. Steve Curran Compliance Director Springfield House Lane. Whitehouse Lane Leeds. West Yorkshire LS17 7UE United Kingdom

Re: K222978

Trade/Device Name: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: QUW, OWX, FTL Dated: September 28, 2022 Received: September 28, 2022

Dear Steve Curran:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose -S

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Indications for Use (Describe)

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or extra-articular ligaments.

The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary; K222978

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Submitter Information

Submitter:	Xiros, Ltd
Address:	Springfield HouseWhitehouse LaneLeedsWest YorkshireLS19 7UEUK
Telephone:	+44(0)1132387200
Fax:	+44(0)1132387201
Contact:	Dr. Steve Curran
Date Prepared:	September 28, 2022

Device Information

Trade Name:	Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Common Name:	Surgical Mesh
Classification:	Class II
Regulation:	21 CFR 878.3300
Classification Name:	Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement ofLigament
Classification Panel:	Orthopedic
Product Code:	QUW, OWX, FTL

Predicate/Reference Device Information

The Poly-Tape/Infinity Lock Soft Tissue Reinforcement Device described in this submission is substantially equivalent to the following predicate devices:

BioBridge™ Collagen Matrix (K151083) Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K220091) - Reference Device

Device Description

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Intended Use/Indications for Use

Comparison of Principles of Operation & Technological Characteristics

The Poly-Tape device has the same principles of operations as the predicate devices. They are all implants intended for the reinforcement of soft tissues that are repaired by suture or other fixation devices. The devices are used in various surgical procedures where soft tissue reinforcement is needed.

At a high level, the subject and predicate devices are based on the following same technological elements:

Surgical Mesh ●
. Implant shares the load placed on the primary repair and provides a structural scaffold for torn or damaged soft tissue
Provides consistent reinforcement during healing period
may be cut to size to meet the surgeon's preference .

The following technological differences exist between the subject and predicate devices:

Subject device is non-resorbable .

Performance Data

The following performance testing has been completed for the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device:

Suture Retention Testing ●
Ultimate Strength Testing
Cyclic Testing
Packaging Testing
Biocompatibility Testing ●

The series of tests, listed above, has been conducted and successfully completed. The results demonstrate that the Poly-Tape/Infinity-Lock provides adequate mechanical properties for its use in soft tissue reinforcement.

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The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficac6y of the new device in relation to the predicate.

Xiros conducts routine endotoxin (LAL) batch testing to monitor endotoxin levels.

Conclusion

Based on the above information the Poly-Tape/Infinity-Lock is substantially equivalent to soft tissue reinforcement predicate device:

BioBridge™ Collagen Matrix (K151083)

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.