(55 days)
Not Found
No
The summary describes a surgical implant and associated instruments, with no mention of AI or ML capabilities.
Yes.
Device description and intended use state that it is for sacroiliac joint fusion due to specific conditions, which is therapeutic.
No
Explanation: The device is a surgical system for sacroiliac joint fusion, intended for treatment, not for diagnosing conditions.
No
The device description explicitly details physical implants made of titanium alloy and reusable surgical instruments, indicating it is a hardware-based medical device.
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: The description clearly states that the CATAMARAN SI Joint Fusion System is a surgical implant and associated instruments used for fusing the sacroiliac joint within the body. It is a physical device used in a surgical procedure.
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided describes a surgical device used for treatment, not a device used for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Tenon Medical CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis. The CATAMARAN SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the CATAMARAN SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The CATAMARAN SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroillac joint using an inferiorposterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
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)
The subject 510(k) Submission requests MR Conditional Labeling for the CATAMARAN SI Joint Fusion Implant to support use in an MR Environment. MR Compatibility Assessments were performed using FDA Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 20, 2021) and Assessment of Radiofrequency Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices (March 22, 2016). The results of the MR Compatibility testing support the use of the CATAMARAN SI Joint Fusion Implant in an MR Environment as MR Conditional.
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
August 24, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Tenon Medical, Inc. % Susan Noriega Regulatory Affairs, Clinical and Quality Consultant Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K231944
Trade/Device Name: CATAMARAN™ SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: June 30, 2023 Received: June 30, 2023
Dear Susan Noriega:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Eileen
Digitally signed by
Eileen Cadel -S
Date: 2023.08.24
Cadel -S 13:14:07-04'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231944
Device Name CATAMARAN™ SI Joint Fusion System
Indications for Use (Describe)
The Tenon Medical CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY CATAMARAN™ SI Joint Fusion System
l. DATE PREPARED
June 30, 2023
510(k) SUBMITTER II.
Tenon Medical, Inc. 104 Cooper Court Los Gatos, CA 95032 Phone: (408) 649-5760
Contact Person: Susan Noriega, Regulatory, Clinical and Quality Consultant Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Samon, CA 94583 e-mail: snoriega@linceconsulting.com Mobile: 650-793-1966
FDA Establishment Registration No.: 3015425107
lll. DEVICE
| Trade Name of Device: | CATAMARAN™ SI Joint Fusion System |
|---|---|
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3040; Smooth or threaded metallic bone fastener |
| Product Code: | OUR |
IV. PREDICATE DEVICE
| Primary Predicate Device | Manufacturer | Product
Code | 510(k)# | Clearance Date |
|------------------------------------------------|---------------|-----------------|---------|----------------|
| CATAMARAN™ Sacroiliac Joint
Fixation System | Tenon Medical | OUR | K180818 | June 13, 2018 |
V. INDICATIONS FOR USE
The Tenon Medical CATAMARAN™ SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
4
VI. DEVICE DESCRIPTION
The CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis. The CATAMARAN SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the CATAMARAN SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The CATAMARAN SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroillac joint using an inferiorposterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.
SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES VII.
The subject 510(k) Submission requests MR Conditional Labeling for the CATAMARAN SI Joint Fusion Implant to support use in an MR Environment. MR Compatibility Assessments were performed using FDA Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 20, 2021) and Assessment of Radiofrequency Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices (March 22, 2016). The results of the MR Compatibility testing support the use of the CATAMARAN SI Joint Fusion Implant in an MR Environment as MR Conditional.
Design Verification Standards Testing
| MR
Compatibility
Assessment | • ASTM F2052-21 - Standard Test Method for Measurement of Magnetically
Induced Displacement Force on Medical Devices in the Magnetic Resonance
Environment |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • ASTM F2119-13 (17) - Standard Test Method for Evaluation of MR Image
Artifacts from Passive Implants |
| | • ASTM F2182-19e2 - Standard Test Method for Measurement of Radio
Frequency Induced Heating on or Near Passive Implants During Magnetic
Resonance Imaging |
| | • ASTM F2213-17 - Standard Test Method for Measurement of Magnetically
Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| | • ASTM F2503 -20 - Standard Practice for Marking Medical Devices and Other
Items for Safety in the Magnetic Resonance Environment |
5
VIII. SUMMARY OF SUBSTANTIAL EQUIVALENCE
The CATAMARAN SI Joint Fusion System has the same intended use, indications for use, technological characteristics (with minor changes to the instruments and system tray), and principles of operation as compared to the predicate device; the CATAMARAN Sacroiliac Joint Fixation System cleared in K180818.
Any minor differences between the CATAMARAN SI Joint Fusion System and the predicate device do not raise any new types of safety or effectiveness questions, including the MR Compatibility Assessment. Testing demonstrates that the CATAMARAN SI Joint Fusion System meets requirements for its intended clinical use.
IX. CONCLUSION
Based on the similarities in intended use, indications for use and technological characteristics, the subject CATAMARAN SI Joint Fusion System is substantially equivalent to the predicate device.