(65 days)
K 132590
K 132590
No
The summary describes a mechanical implant and inserter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The MultiFIX S is a fixation device used to attach soft tissue to bone, making it a surgical implant rather than a device that delivers therapy.
No
The MultiFIX S Knotless Fixation Device is described as an implantable bone anchor used for the fixation of soft tissue to bone, making it a therapeutic device rather than a diagnostic one.
No
The device description clearly states it is a "laser marked PEEK implantable bone anchor with inserter handle," which are physical hardware components.
Based on the provided information, the MultiFIX S Knotless Fixation Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "implantable bone anchor with inserter handle" designed for "arthroscopic and orthopedic procedures." This describes a surgical implant and the tools used to place it.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The MultiFIX S does not perform any such diagnostic testing on biological samples.
The information clearly describes a surgical device used for internal fixation during orthopedic procedures, not a diagnostic tool used on in vitro 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 System (MultiFIX S) is a laser marked PEEK implantable 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 laser marked PEEK implantable 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 irradiation. Both the anchor and inserter are designed for single use only.
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)
Non-Clinical Data: Toxicological testing (Gas and Liquid Chromatography Mass Spectrometry and FTIR), biocompatibility testing (Cytoxicity) and bench testing (anchor pound-in) were performed. All toxicological and biocompatibility testing passed, demonstrating that the material is non-cytotoxic and equivalent to the predicate. Bench testing in bone foam analog confirmed that the laser marking has no impact on implant strength as the implant screw body was able to be successfully delivered sub-cortical at the end of deployment. The test results demonstrate that the proposed 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 device when used in accordance with labeling.
Clinical Data: No clinical or animal data are included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 132590
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.
0
MAY 1 4 2014
510(k) Summary
ArthroCare® Corporation MultiFIX® S Knotless Fixation System
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: | Laura Kasperowicz |
| Sr. Manager, Regulatory Affairs | |
| Phone: 949-585-2406 | |
| Fax: 949-585-2401 | |
| Date Prepared: | March 7, 2014 |
Device Name
| Proprietary Name: | MultiFIX® S Knotless Fixation System |
|---|---|
| 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® S Knotless Fixation System: K 132590 (cleared September 17, 2013)
Description
The MultiFIX S Knotless Fixation System (MultiFIX S) is a laser marked PEEK implantable 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 laser marked PEEK implantable 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 irradiation. Both the anchor and inserter are designed for single use only.
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
1
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
Toxicological testing (Gas and Liquid Chromatography Mass Spectrometry and FTIR), biocompatibility testing (Cytoxicity) and bench testing (anchor pound-in) were performed. All toxicological and biocompatibility testing passed, demonstrating that the material is non-cytotoxic and equivalent to the predicate. Bench testing in bone foam analog confirmed that the laser marking has no impact on implant strength as the implant screw body was able to be successfully delivered sub-cortical at the end of deployment. The test results demonstrate that the proposed 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 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 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 device, the proposed MultiFIX S Knotless Fixation System is substantially equivalent. The minor differences between the proposed MultiFIX S and predicate device do not raise any new questions of safety or effectiveness.
| Comparison of Technological Characteristics | ||
|---|---|---|
| Characteristics | Predicate Device | |
| MultiFIX S | ||
| (K132590) | Proposed Device | |
| MultiFIX S | ||
| Intended Use | Fixation of soft tissue to bone | Same |
| Delivery Method | Arthroscopic and Limited Access | Same |
| How Supplied | Sterile | Same |
| Suture Material | No. 2 UHMWPE Suture | Same |
| Anchor Material | Invibio PEEK Optima® | Invibio PEEK Optima®with laser |
| marking to enhance anchor | ||
| visualization during delivery | ||
| Design Technology | Pound in Anchor with screw | Same |
| Bone Locking | ||
| Mechanism | Interference Fit | |
| (threaded screw) | Same | |
| Suture Locking | ||
| Mechanism | Plug/Cylinder Compression | Same |
| # of Suture Legs | 2, 3 or 4 | Same |
2
| Comparison of Technological Characteristics | ||
|---|---|---|
| Characteristics | Predicate Device | |
| MultiFIX S | ||
| (K132590) | Proposed Device | |
| MultiFIX S | ||
| Diameter of Cortical | ||
| Lock | 5.5 mm & 6.5 mm | Same |
| Anchor Deployed | ||
| Length | 20 to 23 mm | Same |
| Device Length | 291mm | Same |
| Sterilization Method | Irradiation | Same |
| Packaging | Sterile / Thermoform Tray with | |
| Tyvek Lid | Same |
:
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 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" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a human figure embracing or supporting three horizontal lines, which may represent the department's mission to protect and promote the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 14, 2014
ArthroCare® Corporation Mr. Mitchell Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive, Building One Austin, Texas 78735
Re: K140604
Trade/Device Name: MultiFIX® S Knotless Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 18, 2014 Received: April 21, 2014
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 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
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 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 Biometries/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.
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140604
Device Name
MultiFIX® S Knotless Fixation System
Indications for Use (Describe)
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-clavioular separation, rotator cuff repair, capsule shift/capsule-labrai 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
Knec: 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 1
FORM FDA 3881 (1/14)
PSC Pablubing Services (201) 445-6740 PP