(90 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a woven tape for soft tissue reinforcement, with no mention of AI or ML capabilities.
Type: Yes
Explanation: The device is intended for the "reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery," which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a reinforcement device for soft tissues during surgical repair, not for diagnostic purposes.
No
The device description explicitly states it is a woven tape made from Polyethylene Terephthalate (PET) and is a permanent implantable device, indicating it is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the reinforcement of soft tissues during surgery. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a woven tape made from PET, a nonabsorbable material intended as a permanent implantable device. This further confirms its use within the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a patient's condition.
- Using reagents or assays.
The device is a surgical implant designed to provide mechanical support during soft tissue repair, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QUW, OWX, FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, tendon, ligament, rotator cuff, patellar, Achilles, biceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament, extra-articular ligaments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BioBridge™ Collagen Matrix (K151083)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K220091)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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
1
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
2
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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3
510(k) Summary; K222978
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Submitter Information
| Submitter: | Xiros, Ltd |
|---|---|
| Address: | Springfield House |
| Whitehouse Lane | |
| Leeds | |
| West Yorkshire | |
| LS19 7UE | |
| UK | |
| 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 of |
| Ligament | |
| 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
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.
4
Intended Use/Indications for Use
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.
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.
5
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)