(27 days)
Not Found
No
The 510(k) summary describes a mechanical implantable device for soft tissue fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an implantable bone anchor used for fixation of soft tissue to bone in orthopedic procedures, which is a structural rather than therapeutic function.
No
Explanation: The device is described as an implantable bone anchor for fixation of soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an "implantable bone anchor with inserter handle," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of soft tissue to bone" in various anatomical locations (Shoulder, Ankle, Foot, Elbow, Knee). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an "implantable bone anchor with inserter handle." This is a surgical implant and the tools used to place it.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside of the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or repair structures within the body. This device is clearly designed for surgical intervention.
N/A
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, acromioclavicular 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.
Product codes
MBI
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle, Foot, Elbow, Knee
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. No clinical or animal data are included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 1
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
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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 200 |
| Irvine, CA. 92618 | |
| Contact Person: | Laura Kasperowicz |
| Principle Regulatory Affairs Specialist | |
| Phone: 949-585-2406 | |
| Fax: 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.
4
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 Device | |||
| MultiFIX P | ||||
| (K120096) | Proposed Device | |||
| MultiFIX P | ||||
| Intended Use | Fixation of soft tissue to bone | Same | ||
| Delivery Method | Arthroscopic and Limited Access | Same | ||
| How Supplied | Sterile | Same | ||
| Brand Name of Qualified | ||||
| Suture | #2 UHMWPE MagnumWire® Suture | |||
| Thread | #2 UHMWPE MagnumWire® Suture | |||
| Thread and/or UltraBraid® Suture | ||||
| Thread and/or UltraTape® | ||||
| # of Suture Legs | ||||
| (volume of suture qualified) | 2, 3 or 4 Suture Thread Legs | 2, 3 or 4 Suture Thread Legs | ||
| or a maximum of 2 Suture Thread Legs | ||||
| and 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 |