(27 days)
The MultiFIX P Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair.
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Elbow: Tennis elbow repair, biceps tendon attachment.
Knee: Extra-capsular repairs; reattachment of medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
The MultiFIX P Knotless Fixation Device (MultiFIX P) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX P is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX P consists of two primary parts: an implantable bone 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 irradiation. Both the anchor and inserter are designed for single use only.
This document describes the MultiFIX® P Knotless Fixation Device, a medical device for soft tissue to bone fixation. The provided text is a 510(k) submission for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics for a new device's efficacy or diagnostic accuracy.
Therefore, the requested information regarding acceptance criteria and performance data as typically found in studies proving diagnostic or therapeutic effectiveness is not explicitly present in the provided document. The document primarily addresses the substantial equivalence of the proposed device to a previously cleared predicate device based on design, materials, and mechanical properties.
However, I can extract information related to the "study" that was conducted to support the 510(k) submission and the "acceptance criteria" as implied by the comparison to the predicate device.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the proposed device performs "as intended" and has "acceptable mechanical properties" that are "substantially equivalent" to the predicate device. The "reported device performance" is that it met these criteria through bench testing.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Bench Testing) |
|---|---|
| Performs as intended | Met |
| Acceptable mechanical properties | Met |
| Substantially equivalent to the predicate device | Met |
| (Specific mechanical test results are not detailed in this summary, only the conclusion) | (Specific mechanical test results are not detailed in this summary, only the conclusion) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document states "Bench testing was performed on both the proposed and predicate devices," but does not specify the sample size (e.g., number of devices tested) for the bench tests.
- Data Provenance: The data is from non-clinical bench testing. The country of origin is not specified, but the applicant, ArthroCare Corporation, is located in Irvine, California, USA, suggesting the testing likely occurred in the US or a facility affiliated with the company. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for demonstrating substantial equivalence of a bone fixation device in a 510(k) context is typically based on engineering standards, material specifications, and mechanical testing protocols, not expert clinical interpretation of results like in diagnostic imaging studies. The evaluation of mechanical properties is objective.
4. Adjudication method for the test set:
- Not applicable for bench testing of mechanical properties. The assessment is based on quantitative measurements and comparison to predefined engineering specifications and predicate device performance.
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, this is not applicable. The document describes a traditional medical device (bone anchor) and its mechanical testing, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study was performed, and there's no mention of AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used:
- For the bench testing, the "ground truth" for comparison effectively comes from established engineering principles, material science, and the performance characteristics of the legally marketed predicate device (K120096). The tests are designed to confirm that the proposed device behaves within expected mechanical parameters and equivalently to the predicate.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for it.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
ArthroCare Corporation Ms. Laura Kasperowicz Principle Regulatory Affairs Specialist 15285 Alton Parkway, Suite 200 Irvine, California 92618
Re: K151897
Trade/Device Name: MultiFIX® P Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 9, 2015 Received: July 10, 2015
Dear Ms. Kasperowicz,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Laura Kasperowicz
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 yours,
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | K151897 Page 1 of 1Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. | |
|---|---|---|
| 510(k) Number ( if known ) | K151897 | |
| Device Name | MultiFIX P Knotless Fixation Device | |
| Indications for Use (Describe) | The MultiFIX P Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: | |
| Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair. | ||
| Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction. | ||
| Foot: Hallux valgus reconstruction. | ||
| Elbow: Tennis elbow repair, biceps tendon attachment. | ||
| Knee: Extra-capsular repairs; reattachment of medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions. |
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
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Image /page/3/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" on the right. The symbol is made up of several curved lines that are arranged in a circular shape. The word "ArthroCare" is written in a sans-serif font and is in a dark gray color. There is a registered trademark symbol to the right of the word "ArthroCare".
510(k) Summary
ArthroCare® Corporation
MultiFIX® P Knotless Fixation Device
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, a Smith & Nephew Company |
|---|---|
| Address | 15285 Alton Parkway, Suite 200Irvine, CA. 92618 |
| Contact Person: | Laura KasperowiczPrinciple Regulatory Affairs SpecialistPhone: 949-585-2406Fax: 949-585-2401 |
| Date Prepared: | July 9, 2015 |
Device Name
| Proprietary Name: | MultiFIX® P Knotless Fixation Device |
|---|---|
| ------------------- | -------------------------------------- |
| Common Name: | Bone Anchor |
|---|---|
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Product Code: | MBI |
| CFR Section: | 21 CFR 888.3040 |
Predicate Device
MultiFIX® P Knotless Fixation Device: K120096 (cleared March 27, 2012)
Description
The MultiFIX P Knotless Fixation Device (MultiFIX P) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX P is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX P consists of two primary parts: an implantable bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
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The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.
Intended Use/Indications For Use
The MultiFIX P Knotless Fixation Device is indicated for use in fixation of soft tissue to bone.
Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Non-Clinical Data
Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the proposed MultiFIX P meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the proposed MultiFIX P performs as intended and has acceptable mechanical properties when used in accordance with the labeling.
As the intended use, operating principle, materials and technological characteristics are comparable to the predicate device, the proposed MultiFIX P Knotless Fixation Device is substantially equivalent. The minor differences between the proposed MultiFIX P and predicate device do not raise any new questions of safety or effectiveness.
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Image /page/5/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that converge at the center. The word "ArthroCare" is written in a sans-serif font, and there is a registered trademark symbol after the word.
| Comparison of Technological Characteristics | ||||
|---|---|---|---|---|
| Characteristics | Predicate DeviceMultiFIX P(K120096) | Proposed DeviceMultiFIX P | ||
| Intended Use | Fixation of soft tissue to bone | Same | ||
| Delivery Method | Arthroscopic and Limited Access | Same | ||
| How Supplied | Sterile | Same | ||
| Brand Name of QualifiedSuture | #2 UHMWPE MagnumWire® SutureThread | #2 UHMWPE MagnumWire® SutureThread and/or UltraBraid® SutureThread and/or UltraTape® | ||
| # of Suture Legs(volume of suture qualified) | 2, 3 or 4 Suture Thread Legs | 2, 3 or 4 Suture Thread Legsor a maximum of 2 Suture Thread Legsand 2 Suture Tape Legs | ||
| Suture Snare | Single Loop | Same | ||
| Anchor Material | Invibio PEEK Optima® LT1 | Same | ||
| Design Technology | Pound in Anchor | Same | ||
| Bone Locking Mechanism | 6 barbs | Same | ||
| Suture Locking Mechanism | Plug/Cylinder Compression | Same | ||
| Diameter of Cortical Lock | 4.5 mm | Same | ||
| Anchor Deployed Length | 14.5 mm | Same | ||
| Sterilization Method | Irradiation | Same | ||
| Packaging | Sterile / Thermoform Tray with Tyvek Lid | Same |
N/A