(94 days)
Not Found
No
The document describes a mechanical bone anchor and inserter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests of mechanical properties.
No.
The document describes the MultiFIX S Knotless Fixation Device as a bone anchor used to fix soft tissue to bone during arthroscopic and orthopedic procedures, which is a structural and mechanical function rather than a therapeutic one that treats specific diseases or conditions.
No.
The device is a bone anchor used for fixation of soft tissue to bone during arthroscopic and orthopedic procedures, not for diagnostic purposes.
No
The device description clearly states it is a bone anchor with an inserter handle, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The MultiFIX S Knotless Fixation Device is a bone anchor used for fixing soft tissue to bone within the body during surgical procedures. It is an implantable device used directly on the patient.
The description clearly indicates it's a surgical implant and associated tools, not a device for testing biological samples.
N/A
Intended Use / Indications for Use
The MultiFIX S 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
Product codes
MBI
Device Description
The MultiFIX S Knotless Fixation Device (MultiFIX S) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S 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 S Knotless Fixation System consists of the bone anchor 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.
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 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 S 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 devices when used in accordance with labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like graphic on the left, followed by the word "ArthroCare" in a sans-serif font. A small registered trademark symbol is located to the upper right of the word "Care".
510(k) Summary
JUL 2 9 2013
ArthroCare® Corporation MultiFIX® S 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 |
| Austin, TX 78735 | |
| Contact Person: | Mitchell Dhority |
| Vice President, Regulatory and Clinical Affairs | |
| Phone: 512-358-5995 | |
| Fax: 512-895-1489 | |
| Date Prepared: | April 26, 2013 |
Device Name
| Proprietary Name: | MultiFIX® S 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 Devices
ArthroCare MultiFIX® P Knotless Fixation Device: K120096 (cleared March 27, 2012)
ArthroCare 5.5 mm SpeedScrew® Knotless Fixation Device: K081893 (cleared October 1, 2008)
ArthroCare 6.5 mm SpeedScrew® Knotless Fixation Device: K101448 (cleared June 21, 2010)
Description
The MultiFIX S Knotless Fixation Device (MultiFIX S) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S 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 S Knotless Fixation System consists of the bone anchor 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.
1
Intended Use/Indications For Use
The MultiFIX S 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 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 S 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 devices when used in accordance with labeling.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the MultiFix S performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
As the intended use, operating principle, materials and technological characteristics are comparable to the predicate devices, the MultiFIX S Knotless Fixation System is substantially equivalent. The minor differences between the MultiFix S and predicate devices do not raise any new questions of safety or effectiveness.
| Comparison of Technological Characteristics | |||
|---|---|---|---|
| Characteristics | Proposed Device | ||
| MultiFIX S | Predicate Device | ||
| MultiFIX P | |||
| (K120096) | Predicate Device | ||
| SpeedScrew | |||
| (K081893, K101448) | |||
| Intended Use | Fixation of soft tissue to | ||
| bone | Same | Same | |
| Delivery Method | Arthroscopic and Limited | ||
| Access | Same | Same | |
| How Supplied | Sterile/Irradiation | Same | Same |
| Suture Material | No. 2 UHMWPE Suture | Same | Same |
| Anchor Material | Invibio PEEK Optima® | Same | Same |
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| Comparison of Technological Characteristics | |||
|---|---|---|---|
| Characteristics | Proposed Device | ||
| MultiFIX S | Predicate Device | ||
| MultiFIX P | |||
| (K120096) | Predicate Device | ||
| SpeedScrew | |||
| (K081893, K101448) | |||
| Design Technology | Pound in Anchor with screw | Pound in Anchor with radial | |
| barbs | Screw in Anchor | ||
| Bone Locking Mechanism | Interference Fit | ||
| (threaded screw) | Interference Fit | ||
| (6 barbs) | Interference Fit | ||
| (threaded screw) | |||
| Suture Locking Mechanism | Plug/Cylinder Compression | Same | Same |
| # of Suture Legs | 2. 3 or 4 | 2. 3 or 4 | 2 |
| Diameter of Cortical Lock | 5.5 mm & 6.5 mm | 4.5 mm | 5.5 mm & 6.5 mm |
| Deployed Length | 20 to 23 mm | 14 to 17 mm | 14 to 16 mm |
| Sterilization Method | Irradiation | Same | Same |
| Packaging | Sterile / Thermoform Tray | ||
| with Tyvek Lid | Same | Same |
·
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing, and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is facing to the right. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
ArthroCare Corporation % Mr. Mitchell Dhority Vice President, Regulatory and Clinical Affairs 7000 West William Cannon Drive Austin, Texas 78735
July 29, 2013
Re: K131182
Trade/Device Name: MultiFIX® S 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: May 9, 2013 Received: May 14, 2013
Dear Mr. Dhority:
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 10 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 vour 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
4
Page 2 - Mr. Mitchell Dhority
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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
5
Indications for Use
510(k) Number (if known): K_131182
Device Name: MultiFIX® S Knotless Fixation Device
Indications for Use:
The MultiFIX S 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
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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