(75 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 a 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: a PEEK 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. The MultiFIX P Knotless Fixation System consists of the 4.5 mm MultiFIX P and associated instruments for implanting the bone anchor.
The MultiFIX™ P Knotless Fixation Device is a bone anchor designed for the fixation of soft tissue to bone.
1. Acceptance Criteria and Reported Device Performance:
The document states that mechanical testing was performed in accordance with the FDA Guidance Document, "Testing Bone Anchor Devices, April 1996." The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to the predicate device, the ArthroCare LabraLock® P Knotless Fixation Device (K061349).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (ArthroCare LabraLock® P Knotless Fixation Device K061349) based on mechanical testing. | "Results indicated substantial equivalence for the proposed device." "The test results demonstrate that the MultiFIX P meets all design, performance, and safety specifications." "All testing demonstrates that the MultiFIX P performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
| Meet all design, performance, and safety specifications. | "The test results demonstrate that the MultiFIX P meets all design, performance, and safety specifications." |
| Acceptable mechanical properties. | "All testing demonstrates that the MultiFIX P performs as intended and has acceptable mechanical properties when used in accordance with its labeling." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size for the test set used in the bench testing. It only states that "side by side bench testing was performed on both the proposed and predicate device."
- Data Provenance: The data is from in vitro testing, specifically "in a simulated human bone substrate." The country of origin is not explicitly stated but is implied to be within the scope of the submitting company, ArthroCare Corporation. This was a retrospective evaluation of the device's mechanical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the study involved mechanical bench testing, not expert-based assessment of medical images or patient outcomes. The "ground truth" was established by objective mechanical measurements against established engineering principles and the performance of a predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable for mechanical bench testing. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for evaluating human reader performance, typically with medical imaging, and is not applicable to the mechanical testing of a bone anchor.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The bench testing evaluated the mechanical performance of the MultiFIX P Knotless Fixation Device (algorithm only, if considering the device's function as an "unassisted" component) against predetermined criteria and the predicate device, independent of human interaction beyond implantation during the test.
7. Type of Ground Truth Used:
The ground truth used was mechanical performance data obtained from laboratory bench testing. This included measurements of static and cyclic fatigue performance against a simulated human bone substrate, with the predicate device serving as a comparative benchmark for substantial equivalence.
8. Sample Size for the Training Set:
This information is not applicable. The device is a mechanical medical device, not an AI/ML algorithm that requires a training set. The "training" in this context would refer to the design and refinement of the physical device, which isn't described in terms of a data-driven training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as in point 8. The device's "ground truth" for its design would be engineering specifications, material properties, and clinical needs, rather than a labeled dataset used for training an algorithm.
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K 12 0096 (.1/2)
MAR 2 7 2012
510(K) SUMMARY
ARTHROCARE CORPORATION MultiFIXTM 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 |
|---|---|
| Address: | 7000 West William Cannon Drive, Bldg 1Austin, TX 78735 |
| Contact Person: | Cheryl FrederickDirector, Regulatory Affairs |
| Date Prepared: | January 11, 2012 |
Device Name
| Proprietary: | MultiFIX™ P Knotless Fixation Device |
|---|---|
| Common: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Classification: | Class II |
| Product Code: | MBI |
| CFR Section: | 21 CFR 888.3040 |
Predicate Device
ArthroCare LabraLock® P Knotless Fixation Device: K061349 (cleared July 14, 2006)
Description
The MultiFIX P Knotless Fixation Device (MultiFIX P) is a 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: a PEEK 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.
The MultiFIX P Knotless Fixation System consists of the 4.5 mm MultiFIX P and associated instruments for implanting the bone anchor. In accordance with the ArthroCare Product Development Process, testing was performed to demonstrate the proposed device is substantially equivalent to the predicate device. 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.
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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 t 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.
Non-Clinical Data
Side by side bench testing was performed on both the proposed and predicate device 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 MultiFIX P 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 MultiFIX P performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
As the device's intended use and technological characteristics are comparable to the predicate device, we believe that the MultiFIX P is substantially equivalent to the predicate LabraLock P Knotless Fixation Device. The minor differences between the MultiFIX P and the predicate device do not raise any new questions of safety or effectiveness. In addition, the materials are well characterized and have been used in other legally marketed devices with similar indications for use.
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ArthoCare Corporation % Ms. Cheryl Frederick Director. Regulatory Affairs 7000 West William Cannon Drive, Building 1 Austin, Texas 78735
MAR 2 7 2012
Re: K120096
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: January 11, 2012 Received: January 12, 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,
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 STATEMENT
510(k) Number: K
Device Name: MultiFIX™ P Knotless Fixation Device
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. t
- . 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR X
Over-The-Counter Use (21 CFR 801 Subpart C)
NO
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DeBell
Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Number K120096
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.