(176 days)
The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:
- Hip capsule repair
- Acetabular labrum reattachment
The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The SpeedLock HIP is a knotless fixation device: surgical knots are not necessary for the fixation of suture to tissue.
The SpeedLock HIP consists of two primary parts: a PEEK bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The SpeedLock HIP Knotless Fixation System consists of the 3.4 mm SpeedLock HIP anchor and associated instruments for implanting the anchor into bone.
The provided text describes the SpeedLock® HIP Knotless Fixation Implant, a bone anchor device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing, rather than an AI/ML device. Therefore, a direct response to some of the AI/ML-specific questions (like sample sizes for training/test sets, expert adjudication methods, MRMC studies, or multi-reader multi-case studies) is not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical acceptance criteria for various mechanical tests. Instead, it broadly states that the device "meets all design, performance, and safety specifications" and that the "test results demonstrate... substantial equivalence" to predicate devices. The study performed was a comparative bench test.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meets design specifications | Yes |
| Meets performance specifications | Yes |
| Meets safety specifications | Yes |
| Substantially equivalent to predicate devices (Smith & Nephew Bioraptor® Knotless Suture Anchor K071586, Smith & Nephew Knotless Instability Anchor K093428, ArthroCare's SpeedLock Knotless Fixation Device K111044) | Yes, demonstrated through side-by-side bench testing. |
| Performs as intended | Yes |
| Has acceptable mechanical properties | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "side by side bench testing" but does not specify the sample size (number of devices tested) for the proposed device or the predicate devices.
- Sample Size: Not specified.
- Data Provenance: The testing was "in vitro" using a "simulated human bone substrate." This indicates laboratory bench testing, not human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the study involved mechanical bench testing of a physical device, not an AI/ML algorithm requiring expert interpretation of data or images to establish ground truth.
4. Adjudication Method for the Test Set
This question is not applicable for a mechanical bench test. The "ground truth" (or reference standard) for mechanical properties would be derived from the testing equipment and established engineering principles, not expert consensus or adjudication.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a physical medical device (bone anchor), not an AI/ML software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission was established through mechanical testing data (static and cyclic fatigue testing) against pre-defined engineering and performance specifications, and in comparison to the performance of predicate devices. This is based on objective measurements from laboratory equipment, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This question is not applicable. There is no training set mentioned or implied, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for an AI/ML device.
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K120943 #1/2
510(k) Summary
SEP 2 1 2012
ArthroCare® Corporation SpeedLock® HIP Knotless Fixation Implant
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon DriveBuilding OneAustin, TX 78735 |
| Contact Person: | Cheryl FrederickDirector, Regulatory Affairs |
| Date Prepared: | September 17, 2012 |
Device Name
| Proprietary: | SpeedLock® HIP Knotless Fixation Implant |
|---|---|
| Common: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Classification: | Class II |
| Product Code: | MBI |
| CFR Section: | 21 CFR 888.3040 |
Predicate Device-
The SpeedLock HIP Knotless Fixation Implant is substantially equivalent to the Smith & Nephew Bioraptor® Knotless Suture Anchor cleared under K071586 (August 17. 2007) and the Smith & Nephew Knotless Instability Anchor cleared under K093428 (December 17, 2009) as well as to ArthroCare's SpeedLock Knotless Fixation Device cleared under K111044 (August 9, 2011).
Description
The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The SpeedLock HIP is a knotless fixation device: surgical knots are not necessary for the fixation of suture to tissue.
The SpeedLock HIP consists of two primary parts: a PEEK bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The SpeedLock HIP Knotless Fixation System consists of the 3.4 mm SpeedLock HIP anchor and associated instruments for implanting the anchor into bone. In accordance with the ArthroCare Product
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. K120943 #2/2
Development Process, testing was performed to demonstrate the proposed device is substantially equivalent to the predicate devices. This mechanical testing was performed in accordance with the requirements of the FDA Guidance Document, Testing Bone Anchor Devices, April 1996; results indicated substantial equivalence for the proposed device.
Intended Use/Indications For Use
The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:
- I Hip capsule repair
- Acetabular labrum reattachment
Non-Clinical Data
Side by side bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996. This in vitro testing involved insertion of the anchors in a simulated human bone substrate followed by both static and cyclic fatigue testing.
The test results demonstrate that the SpeedLock HIP Knotless Fixation Implant meets all design. performance, and safety specifications. Based on the test results, the proposed device is substantially equivalent to the predicate device
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the SpeedLock HIP Knotless Fixation Implant performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
As the proposed device's intended use and technological characteristics are comparable to the predicate devices, we believe that the SpeedLock HIP Knotless Fixation Implant is substantially equivalent to the Smith & Nephew Bioraptor Knotless Suture Anchor as well as to the ArthroCare SpeedLock Knotless Fixation Device. The minor differences between the SpeedLock HIP and the predicate devices do not raise any new questions of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrocare Corporation % Ms. Cheryl Frederick Director, Regulatory Affairs 7000 West William Cannon Drive, Building 1 Austin, Texas 78735
SEP 21 2012
Re: K120943
Trade/Device Name: SpeedLock® HIP Knotless Fixation Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 7, 2012 Received: September 10, 2012
Dear Ms. Frederick:
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 (reporting of medical device-related 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.
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Page 2 - Ms. Cheryl Frederick
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Not yet assigned K120943
Device Name: SpeedLock® HIP Knotless Fixation Implant
Indications for Use:
The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:
- Hip capsule repair 프
- Acetabular labrum reattachment
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_
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