(273 days)
Not Found
No
The summary describes a mechanical implant and instrument system for ligament repair and reduction, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The "Intended Use" describes the device's purpose as providing "fixation and anatomically reduce two bones or bone portions" for various ligamental and carpal instabilities, which is a mechanical or structural function, not a therapeutic (treating or curing a disease) one. The "Device Description" also indicates it's an "implant and instrument system designed to treat scapholunate ligament ("SLIL") ruptures," which aligns with repair rather than therapy.
No
The device description clearly states it is an "implant and instrument system designed to treat scapholunate ligament ("SLIL") ruptures" and is for fixation and anatomical reduction of bones. This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states that the device is an "implant and instrument system" made from titanium alloy and stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fixation and anatomically reduce two bones or bone portions" and lists specific anatomical sites (scapholunate, lunotriquetral, carpal). This describes a surgical implant and instrument system used in vivo (within the body) for structural support and repair.
- Device Description: The description details implants made from titanium alloy and instruments made from stainless steel. These are materials and components typical of surgical devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is clearly designed for surgical intervention in vivo.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
The RASL system performed substantially equivalently to the predicate devices in all testing modes.
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.
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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
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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
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8. 510(k) Summary
| Applicant: | Radicle Orthopaedics, Inc.
PO Box 7553
New York, NY 10150 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Kapstone Medical LLC
P.O. Box 969
Leicester, NC 28748
Contact Person:
John Kapitan, CEO
Tel: (704) 843-7852
Fax: (704) 831-5316
Email: 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 Repair | |
| System | 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.
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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.