(29 days)
Not Found
No
The description focuses on a mechanical implant and inserter for surgical fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A therapeutic device is one that treats a disease or condition. This device is a fixation device used to attach soft tissue to bone, which is a surgical aid rather than a therapeutic treatment for a disease.
No
The device is an implantable bone anchor used for fixation of soft tissue to bone during surgical procedures, not for diagnosing medical conditions.
No
The device description explicitly states it is an "implantable bone anchor with inserter handle" and describes physical components and sterilization, indicating it is a hardware device.
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. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "implantable bone anchor with inserter handle." This is a physical implant used during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The MultiFIX S Ultra Knotless Fixation Device is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MultiFIX S Ultra 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 Ultra Knotless Fixation System (MultiFIX S Ultra) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S Ultra is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue. The MultiFIX S Ultra consists of two primary parts: an 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)
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 into a simulated human bone substrate followed by both static and cyclic fatigue testing. Design Verification testing was performed in order to verify the design outputs meet the design inputs. Simulated use testing was performed on the device and accessory devices which will be promoted for use with the MultiFIX S Ultra system in order to affirm safety and effectiveness. The test results demonstrate that the proposed MultiFIX S Ultra 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. All testing demonstrates that the proposed MultiFIX S Ultra performs as intended and has acceptable mechanical properties when used in accordance with the labeling.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
ArthoCare Corporation Ms. Laura Kasperowicz Principle Regulatory Affairs Specialist 15285 Alton Parkway, Suite 200 Irvine, California 92618
Re: K153669
Trade/Device Name: MultiFIX® S Ultra 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: December 18, 2015 Received: December 21, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/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 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,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153669
Device Name MultiFIX S Ultra Knotless Fixation System
Indications for Use (Describe)
The MultiFIX S Ultra 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 shiftleapsulelabral 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
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)
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Image /page/3/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left and the company name "ArthroCare" on the right. The graphic is made up of several curved lines in a maroon color, arranged to create a sense of movement or flow. The text "ArthroCare" is written in a dark gray, sans-serif font, with the registered trademark symbol "®" appearing in superscript next to the word "Care".
510(k) Summary
ArthroCare® Corporation
MultiFIX® S Ultra 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, 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: | December 18, 2015 | |
| Device Name | ||
| Proprietary Name: | MultiFIX® S Ultra 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: K151660 (cleared July 16, 2015)
Descrintion
The MultiFIX S Ultra Knotless Fixation System (MultiFIX S Ultra) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S Ultra is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S Ultra consists of two primary parts: an implantable bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
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Image /page/4/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".
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 Ultra 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 into a simulated human bone substrate followed by both static and cyclic fatigue testing. Design Verification testing was performed in order to verify the design outputs meet the design inputs. Simulated use testing was performed on the device and accessory devices which will be promoted for use with the MultiFIX S Ultra system in order to affirm safety and effectiveness.
The test results demonstrate that the proposed MultiFIX S Ultra 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 Ultra 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 S Ultra Knotless Fixation System is substantially equivalent. The minor differences between the proposed MultiFIX S Ultra 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 circular graphic on the left and the word "ArthroCare" on the right. The circular graphic is made up of several curved red lines. The word "ArthroCare" is written in a dark gray sans-serif font, and there is a registered trademark symbol after the word.
| Comparison of Technological Characteristics | ||
|---|---|---|
| Characteristics | Predicate Device | |
| MultiFIX S | ||
| (K151660) | Proposed Device | |
| MultiFIX S Ultra | ||
| 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 | |
| and/or UltraBraid® Suture Thread and/or | ||
| UltraTape® | Same | |
| # of Suture Legs | 2, 3 or 4 Suture Thread Legs | |
| or a maximum of 2 Suture Thread Legs | ||
| and 2 Suture Tape Legs | 2, 3 or 4 Suture Thread Legs | |
| or a maximum of 4 Suture Tape Legs | ||
| Suture Snare | Single Loop | Dual Loop |
| Anchor Material | Invibio PEEK Optima® with laser marking | Same |
| Design Technology | Pound in Anchor with screw | Same |
| Bone Locking Mechanism | Interference Fit | |
| (threaded screw) | Same | |
| Suture Locking Mechanism | Plug/Cylinder Compression | Same |
| 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 |
| Accessory Devices | ||
| Promoted for use with the | ||
| MultiFIX S System | Insertion Guide with Obturator, Bone | |
| Punch, Anchor Extraction Tool, Reusable | ||
| FirstPass Suture Passer, SmartStitch Suture | ||
| Passer, PerfectPasser Suture Passer | Same and FirstPass® ST Suture Passer |