(24 days)
No
The device description and performance studies focus on the mechanical properties and surgical technique, with no mention of AI or ML.
No
The device aids in tissue approximation to facilitate healing, but it does not directly treat or cure the condition; rather, it provides mechanical support for the body's natural healing process.
No
Explanation: The device is a surgical suture used for soft tissue approximation and Achilles tendon repair. Its function is to approximate tissues to facilitate healing, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical medical device (sutures/tapes) made of poly(ethylene terephthalate) and describes its physical form and intended use in surgical repair. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The Infinity-Looks are described as surgical sutures (woven tapes) used for soft tissue approximation, specifically Achilles tendon repair. They are implanted directly into the body.
- Intended Use: The intended use is for soft tissue approximation and Achilles tendon repair, which is a surgical procedure performed directly on the patient's body.
The device is a surgical implant, not a device used to test samples taken from the body.
N/A
Intended Use / Indications for Use
The Infinity-Looks are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of the Achilles tendon.
Product codes
GAT
Device Description
The Infinity-Locks are non-absorbable, sterile, poly(ethylene terephthalate) sutures. They are prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Infinity-Locks differ from USP Sutures in being in the form of woven tapes and in exceeding all USP sizes.
The product comprises two sizes of textile implant based on the Neoligaments poly-tape design. The tapes have an integral loop at one end which are used to tie a cowhitch through one end of a ruptured tendon. The tapes have two tails which are then sutured through the separated end (using methods such as the Bunnell technique), thus drawing the two ends together in order to facilitate healing of the tear. One of the tails has a green stripe to aid identification and both taper into a cord to assist with passing through soft tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Achilles tendon
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
Mechanical testing was performed on the modified device and original poly-tape in both knotted and unknotted conditions to determine the ultimate tensile strengths using an internal method, QT010, and following USP 39 NF33:2016 for non-absorbable surgical sutures, where applicable. The modified devices were found to be equivalent or superior in all cases.
Validation was also undertaken by clinicians using cadaveric materials to demonstrate the suitability of the modified device for the intended use which was found to be satisfactory.
The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device variants in relation to the predicate.
Key Metrics
Not Found
Predicate Device(s)
Xiros, Ltd, Poly-Tapes K002172
Reference Device(s)
Teleflex Medical Inc., polyethylene terephthalate suture (Cottony Il green suture polyester) K021019
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2017
Xiros, Ltd Mr. Stephen Seed Springfield House Whitehouse Lane, Leeds LS19 7UE England
Re: K171680
Trade/Device Name: Infinity-Lock 3, Infinity-Lock 5 Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(ethylene terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: June 2, 2017 Received: June 6, 2017
Dear Mr. Seed:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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/ResourcesforYou/Industry/default.htm. 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
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.
Sincerely.
David Krause -S
- for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Infinity-Lock 3 Infinity-Lock 5
Indications for Use (Describe)
The Infinity-Looks are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of the Achilles tendon.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
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SECTION 7. Special 510(k) SUMMARY
In accordance with 21 CFR 807.92, the following information constitutes the Special 510(k) summary for the Infinity-Locks 3 and 5.
1.SUBMITTER INFORMATION
| Submitter`s Name: | Xiros Limited |
|---|---|
| Address: | Springfield House |
| Whitehouse Lane | |
| Leeds LS19 7UE | |
| England | |
| Telephone Number: | +44 (0)1132387200 |
| Fax Number: | +44 (0)113 2387201 |
| Contact Person 1: | Stephen Seed (Compliance Director) |
| Contact Person 2: | Manuela Rodrigues (Principal Regulatory Affairs Associate) |
| Date: | 02 May 2017 |
II. DEVICE IDENTIFICATION
| Name of Device(s): | Infinity-Lock 3
Infinity-Lock 5 |
|-----------------------|-------------------------------------------------|
| Trade Name(s): | Infinity-Lock 3
Infinity-Lock 5 |
| Common or usual name: | Non-absorbable Polyester Surgical Tape |
| Classification Name: | Suture, Non-absorbable, Synthetic, Polyethylene |
| Regulatory Class: | Class II |
| Product Code: | GAT |
| Panel: | General & Plastic Surgery |
III. PREDICATE/UNMODIFIED DEVICE
Predicate: Xiros, Ltd, Poly-Tapes K002172.
This predicate has not been subject to a design related recall.
Reference device: Teleflex Medical Inc., polyethylene terephthalate suture (Cottony Il green suture polyester) K021019.
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IV. DEVICE DESCRIPTION
The Infinity-Locks are non-absorbable, sterile, poly(ethylene terephthalate) sutures. They are prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Infinity-Locks differ from USP Sutures in being in the form of woven tapes and in exceeding all USP sizes.
The product comprises two sizes of textile implant based on the Neoligaments poly-tape design. The tapes have an integral loop at one end which are used to tie a cowhitch through one end of a ruptured tendon. The tapes have two tails which are then sutured through the separated end (using methods such as the Bunnell technique), thus drawing the two ends together in order to facilitate healing of the tear. One of the tails has a green stripe to aid identification and both taper into a cord to assist with passing through soft tissues.
V. INTENDED USE
The Infinity-Locks are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of Achilles tendon.
The device subject to modification (Poly-Tapes) has exactly the same intended use as the modified device. The Poly-Tapes are single use devices intended to be used for soft tissue approximation, including Achilles tendon repair in patients with acute rupture of Achilles tendon.
VI. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The substantial equivalence of the Infinity-Locks is supported by the fact that they have the same intended use and they have common technological characteristics to the Poly-Tapes. The same material is used in the manufacture of the proposed modified device (both are made of polyester). Both Poly-Tapes and Infinity-Locks have the same construction; they are woven from polyester, and have the same performance characteristics in accordance with USP requirements.
The modified device retains all the features of the original poly-tapes but includes some new ones to aid usability. These are the: -
- . Tapered ends that are intended to aid threading which was previously achieved by adding sutures in theatre.
- . Tails that are marked with green weft to aid identification, previously both were plain.
- Addition of an integral loop to make it easier for surgeons to tie a cow hitch knot . when required. The previous device was un-looped and the modified device can be simply un-looped when required.
These minor differences in the design of the Infinity-Lock variants do not bring any new questions of safety and effectiveness in accordance with performance data hence do not constitute a change in the fundamental technological characteristics.
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VII. PERFORMANCE DATA
Mechanical testing was performed on the modified device and original poly-tape in both knotted and unknotted conditions to determine the ultimate tensile strengths using an internal method, QT010, and following USP 39 NF33:2016 for non-absorbable surgical sutures, where applicable. The modified devices were found to be equivalent or superior in all cases.
Validation was also undertaken by clinicians using cadaveric materials to demonstrate the suitability of the modified device for the intended use which was found to be satisfactory.
The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device variants in relation to the predicate.
Summary: Based on the pre-clinical testing performance, the Infinity-Lock 3 and Infinity-Lock 5 are found to have the same safety and effectiveness profile to the predicate device (Poly-Tapes).
VIII.CONCLUSION
Xiros conclude the Infinity-Lock 3 and Infinity-Lock 5 are substantially equivalent to the Poly-Tapes.