(273 days)
The RASL Repair Kit is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
The Radicle Orthopaedics RASL Repair Kit is an implant and instrument system designed to treat scapholunate ligament ("SLIL") ruptures. The RASL Repair Kit implants are made from titanium alloy, Ti-6Al-EV ELI, per ASTM F136. Instruments are made from surgical-grade stainless steel according to ASTM F899. The entire kit is supplied non-sterile. Instruments are meant to be reusable.
The provided document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Radicle Orthopaedics RASL Repair Kit. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, design, material, and performance testing.
This document describes a medical device (a bone fixation fastener) and its performance through physical (mechanical) testing, not an AI/ML-based device that would require the type of studies and criteria (e.g., accuracy, sensitivity, specificity, human reader improvement, ground truth establishment) typically associated with AI/ML evaluation.
Therefore, I cannot extract information to fill out the requested template as it pertains to AI/ML device performance. The information requested, such as 'acceptance criteria based on computational metrics,' 'sample sizes for test and training sets using patient data,' 'number of experts for ground truth,' and 'MRMC studies,' are not applicable to the mechanical testing described in this document.
The document discusses the following types of performance data (mechanical testing):
- Torsional Testing per ASTM F543
- Insertion/Removal and Axial Pullout Testing per ASTM F543
- Assembly Strength Testing
- Static and Fatigue Bending Testing per ASTM F1264
- Corrosion Testing per ASTM F2129
- Wear Debris Testing per ASTM F1877
These tests compare the physical properties and strength of the RASL Repair Kit to its predicate devices (Acumed SLIC Screw Repair System and Zimmer HBS Screw System) to demonstrate substantial equivalence, rather than clinical performance based on patient data and AI algorithms.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Radicle Orthopaedics, Inc. Mr. John Kapitan CEO Kapstone Medical LLC P.O. Box 969 Leicester, North Carolina 28748
Re: K161334
Trade/Device Name: RASL Repair Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 2, 2017 Received: January 3, 2017
Dear Mr. Kapitan:
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
{1}------------------------------------------------
the quality systems (OS) 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
{2}------------------------------------------------
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
RASL Repair Kit
Indications for Use (Describe)
The RASL Repair Kit is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Image /page/2/Picture/11 description: The image contains a black square followed by the words "Prescr" and "Subpa". The text is in a sans-serif font and is aligned to the left. The black square is located to the left of the text.
Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
Over-The-Counter Use (21 CFR 801
{3}------------------------------------------------
8. 510(k) Summary
| Applicant: | Radicle Orthopaedics, Inc.PO Box 7553New York, NY 10150 |
|---|---|
| Official Correspondent: | Kapstone Medical LLCP.O. Box 969Leicester, NC 28748Contact Person:John Kapitan, CEOTel: (704) 843-7852Fax: (704) 831-5316Email: jkapitan@kapstonemedical.com |
| Date Prepared: | January 2, 2017 |
| Common/Usual Name: | Bone Screw |
| Trade Name: | RASL Repair Kit |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21CFR888.3040 |
| Product Code: | HWC |
| Classification: | II |
| Panel: | Orthopedic |
Predicate Devices
The Radicle Orthopaedics RASL Repair Kit is substantially equivalent to the following device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K111608 | Acumed SLIC Screw RepairSystem | Acumed |
| K143165 | Herbert/Whipple Bone Screw | Zimmer |
Description of the Device
The Radicle Orthopaedics RASL Repair Kit is an implant and instrument system designed to treat scapholunate ligament ("SLIL") ruptures. The RASL Repair Kit implants are made from titanium alloy, Ti-6Al-EV ELI, per ASTM F136. Instruments are made from surgical-grade stainless steel according to ASTM F899. The entire kit is supplied non-sterile. Instruments are meant to be reusable.
{4}------------------------------------------------
Indications for Use
The RASL Repair Kit is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
Summary of Technical Similarities and Differences
The Radicle Orthopaedics RASL Repair Kit is substantially equivalent to the Acumed SLIC Screw Repair System (K111608) and the Zimmer HBS Screw System (K143165). The devices have the similar "Indications for Use" and product codes, are available by prescription only, have similar sizes offered and are provided non-sterile.
The devices also all include a larger proximal threaded portion and a smaller distal threaded portion.
The RASL device and the HBS device are both made from titanium alloy while the SLIC screw is made from stainless steel.
The key technical difference between the implants is the allowance for angulation and rotation of the distal and proximal portions of the respective implants. The SLIC screw allows for 15 to 22 degrees of toggle angle and freely rotates while the HBS screw is monolithic in nature, allowing for neither rotation or angulation. The RASL screw allows for free rotation while limiting angulation.
Summary of Performance Data
To characterize the strength of the RASL Repair Kit implants and compare to the predicates, the following testing was performed:
- Torsional Testing per ASTM F543
- Insertion/Removal and Axial Pullout Testing per ASTM F543
- Assembly Strength Testing
- Static and Fatigue Bending Testing per ASTM F1264
- Corrosion Testing per ASTM F2129
- Wear Debris Testing per ASTM F1877
Safety & Effectiveness
The Radicle Orthopaedics RASL Repair Kit is substantially equivalent to the predicate devices. The devices have the same Indications for Use, are available by prescription only, have similar sizes offered and are provided non-sterile. In addition, the RASL system performed substantially equivalently to the predicate devices in all testing modes.
§ 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.