(226 days)
No
The summary describes a physical implant made of PET and focuses on its mechanical properties and biocompatibility. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a reinforcement device for soft tissues during surgical repair, providing mechanical support but not therapeutic treatment to restore normal function or heal the tissue itself.
No
Explanation: The device is a soft tissue reinforcement device intended for use during surgery. It does not measure, analyze, or interpret any biological or medical parameters to diagnose a condition.
No
The device description clearly states it is a woven tape made from Polyethylene Terephthalate (PET), which is a physical material, not software. The performance studies also focus on mechanical properties and biocompatibility, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is a surgical implant intended for the reinforcement of soft tissues during surgery. It is a physical device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
The device is a surgical aid for mechanical support during soft tissue repair, which falls under a different regulatory category than IVDs.
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 soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.
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 or other tendons. 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
FTL, OWX
Device Description
The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device 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. These devices are permanent implants 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
rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons
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:
- 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 Soft Tissue Reinforcement device provide adequate mechanical properties for its use in soft tissue reinforcement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PRO series Bioimplants - PROcuff/PROankle (Formerly OrthAdapt) (K112786), FlexBand Plus (Formerly SPORTMesh)( K192112), Xylos® MacroPorous Surgical Mesh (K111584)
Reference Device(s)
Infinity-Lock (K171680)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
August 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Xiros Ltd Steve Curran Compliance Director Springfield House Lane, Whitehouse Lane Leeds. West Yorkshire LS17 7UE United Kingdom
Re: K220091
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: FTL, OWX Dated: July 26, 2022 Received: July 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, 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
510(k) Number (if known) K220091
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 soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons .
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 or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the bone, provide mechanical strength for the repair.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
VII. 510(k) Summary
510(k) Summary Poly-Tape/Infinity-LockTM 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: | August 26, 2022 |
Device Information
| Trade Name: | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Devic |
|---|---|
| Common Name: | Surgical Mesh |
| Classification: | Class II |
| Regulation: | 21 CFR 878.3300 |
| Classification Name: | Mesh, Surgical, Polymeric |
| Classification Panel: | General Plastic Surgery |
| Product Code: | FTL, OWX |
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:
PRO series Bioimplants - PROcuff/PROankle (Formerly OrthAdapt) (K112786) FlexBand Plus (Formerly SPORTMesh)( K192112) Xylos® MacroPorous Surgical Mesh (K111584)
Infinity-Lock (Reference Device - K171680)
Device Description
The Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device 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. These devices are permanent implants 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 soft tissue repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.
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 or other tendons. 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/Infinity-Lock Soft Tissue Reinforcement 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 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 ●
- Available in multiple sizes and may be cut to size to meet the surgeon's preference ●
- 0 Synthetic Material (not OrthAdapt)
The following technological differences exist between the subject and predicate devices:
- . Subject device is non-resorbable - 2 of the 3 predicates are partially resorbable.
Performance Data
The following performance testing has been completed:
- 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 Soft Tissue Reinforcement device provide adequate mechanical properties for its use in soft tissue reinforcement.
5
Xiros conducts routine endotoxin (LAL) batch testing to monitor endotoxin levels.
The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate.
Conclusion
Based on the above information the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement device is substantially equivalent to soft tissue reinforcement predicate devices:
PRO series Bioimplants - PROcuff/PROankle (Formerly OrthAdapt) (K112786) FlexBand Plus (Formerly SPORTMesh)( K192112) Xylos® MacroPorous Surgical Mesh (K111584)