(64 days)
The Infinity-Lock™ Button System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption and as an adjunct in external and intramedullary fixation systems involving plates.
The Infinity-Lock™ Button System is indicated for patients with acromioclavicular separations resulting from disruption to the coracoclavicular ligaments.
The Infinity-Lock™ Button System comprises a permanent implantable 240 mm Tube-Tape and titanium alloy Button together with a disposable cannulated drill bit and guidewire. A coracoid passer, such as the Xiros CCHook, is also required.
This document is a 510(k) Premarket Notification from the FDA regarding the "Infinity-Lock™ Button System," a medical device for bone fixation. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria via a study on its diagnostic performance, as would be the case for an AI/ML medical device.
Therefore, the requested information for acceptance criteria and a study proving the device meets them (especially points 2-9 related to test sets, experts, ground truth, and training sets for an AI/ML device) is not applicable to this submission. This document describes a traditional medical device (implantable system) and its performance is evaluated through mechanical testing against a predicate device.
Here's how to interpret the provided information in the context of your request:
Acceptance Criteria and Reported Device Performance
The document describes performance testing, but not in the framework of diagnostic performance or AI model validation. Instead, it focuses on the equivalence of mechanical properties.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured against Predicate) | Reported Device Performance (Infinity-Lock™ Button System) |
|---|---|
| Ultimate Tensile Strength (UTS) | Not statistically significantly different from AC TightRope™ Repair Kit Titanium (K052776) |
| UTS after fatiguing | Not statistically significantly different from AC TightRope™ Repair Kit Titanium (K052776) |
| Extension after fatiguing | Not statistically significantly different from AC TightRope™ Repair Kit Titanium (K052776) |
| Pyrogenicity testing (LAL testing via Gel Clot method) | Passed (result of <20 EU/device obtained) |
Study that Proves the Device Meets the Acceptance Criteria:
The "study" in this context is a series of pre-clinical mechanical and biological compatibility tests comparing the new device to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. It merely states "The Infinity-Lock™ Button System when tested against the AC TightRope™ Repair Kit Titanium (K052776)..." without detailing the number of units tested.
- Data Provenance: The tests are pre-clinical (laboratory/bench testing) of the physical device components. Data provenance would be from the manufacturer's internal testing facilities, likely in the United Kingdom based on the submitter's address. It is not "retrospective or prospective" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, not a diagnostic AI. "Ground truth" would be established by validated testing methods and equipment, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a human-in-the-loop diagnostic study.
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:
- Not Applicable. This device is an implant, not a diagnostic imaging AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical implant, not an algorithm. The "standalone performance" is its intrinsic mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering/Material Standards: The ground truth for mechanical testing is established by recognized engineering standards and validated test equipment measuring physical properties (e.g., tensile strength, fatigue resistance). For pyrogenicity, it's a biochemical assay standard.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set."
In summary, this 510(k) submission successfully demonstrates "substantial equivalence" for a physical medical device by comparing its mechanical and biological safety properties to a predicate device, rather than through complex clinical or AI performance studies involving human readers and ground truth data.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
April 3, 2018
Xiros Ltd Stephen Seed Compliance Director Springfield House, Whitehouse Lane Leeds, West Yorkshire LS19 7UE United Kingdom
Re: K180243
Trade/Device Name: Infinity-Lock™ Button System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: January 26, 2018 Received: January 29, 2018
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180243
Device Name
Infinity-LockTM Button System
Indications for Use (Describe)
The Infinity-Lock™ Button System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption and as an adjunct in external and intramedullary fixation systems involving plates.
The Infinity-Lock™ Button System is indicated for patients with acromioclavicular separations resulting from disruption to the coracoclavicular ligaments.
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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Image /page/3/Picture/0 description: The image shows the word "XIROS" in a rounded, gray box. The box has rounded corners and a thick gray outline. A thin gray line extends from the upper right corner of the box, suggesting a connection or continuation to something outside the frame. The text "XIROS" is in a bold, sans-serif font and is centered within the box.
510(k) Summary
In accordance with 21 CFR 807.92, the following information constitutes Xiros Ltd. 510(k) summary for the Infinity-Lock™ Button System.
I. SUBMITTER INFORMATION
| Submitter`s Name: | Xiros Limited |
|---|---|
| Address: | Springfield HouseWhitehouse LaneLeeds LS19 7UEUnited Kingdom |
| Telephone Number: | +44 (0)1132387200 |
| Fax Number: | +44 (0)113 2387201 |
| Contact Person: | Stephen Seed (Compliance Director) |
| Date: | 26 January 2018 |
| 510(k) document number: | K180243 |
II. DEVICE IDENTIFICATION
| Name of Device: | Infinity-Lock™ Button System |
|---|---|
| Trade Name: | Infinity-Lock™ Button System |
| Common or usual name: | Button/suture |
| Classification Name: | Washer, bolt nut |
| Regulatory Class: | Class II |
| Product Code: | HTN |
| Regulation: | 888.3030 |
| Panel: | Orthopedic |
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III. PREDICATE DEVICE
AC TightRope™ Repair Kit Titanium (AR-2257) manufactured by Arthrex Inc, K052776. This predicate has not been subject to a design related recall.
Reference device 1. for fixation at the clavicle for essentially the same indications for use; Lockdown™ Acromioclavicular (AC) device, manufactured by Surgicraft (Trading name of Mandaco 569 Limited), K091207.
Reference device 2. for materials in Tube-Tape within the very general scope of the reference device intended use for soft tissue approximation: Infinity-Lock 3, Infinity-Lock 5, manufactured by Xiros Limited, K171680.
Reference device 3. for materials in Button for different intended purpose: SECURE-LOOP, manufactured by Xiros Limited, K151601.
IV. DEVICE DESCRIPTION
The Infinity-Lock™ Button System comprises a permanent implantable 240 mm Tube-Tape and titanium alloy Button together with a disposable cannulated drill bit and guidewire. A coracoid passer, such as the Xiros CCHook, is also required.
V. INDICATIONS FOR USE
The Infinity-Lock™ Button System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption and as an adjunct in external and intramedullary fixation systems involving plates.
The Infinity-Lock™ Button System is indicated for patients with acromioclavicular separations resulting from disruption to the coracoclavicular ligaments.
VI. COMPARISIONS OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Infinity-Lock™ Button System has the same technological characteristics as the predicate device, with respect to intended use (the subject device falls within the scope of the predicate device), labelling, anatomical site, similar basic design consisting of titanium buttons and polymeric sutures and a similar surgical technique using mechanical means to reduce the clavicle to the required position.
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VII. PERFORMANCE DATA
The Infinity-Lock™ Button System when tested against the AC TightRope™ Repair Kit Titanium (K052776) for Ultimate tensile strength (UTS), UTS after fatiguing and extension affer fatiguing, was not statistically significantly different and determined to be substantially equivalent. Pyrogenicity testing was carried out using LAL testing via the Gel Clot method and a pass result of <20 EU/device obtained. The testing demonstrated that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy. 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.
Summary: Based on the pre-clinical testing performance, the Infinity-Lock™ Button System is found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. CONCLUSION
Testing performed demonstrate that the Infinity-Lock™ Button System is substantially equivalent to the AC TightRope™ Repair Kit Titanium.
Xiros therefore conclude the Infinity-Lock™ Button System is substantially equivalent to the AC TightRope™ Repair Kit Titanium manufactured by Arthrex Inc.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.