(30 days)
Not Found
No
The summary describes a mechanical implant and inserter for ligament reconstruction, with no mention of AI or ML capabilities.
No
The device is a non-absorbable internal fixation device used to anchor tendon grafts during ligament reconstruction, which is a structural or supportive role rather than directly delivering therapeutic agents, energy, or substances to treat or cure a disease.
No
This device is an implantable internal fixation device used in ligament reconstruction to anchor tendon grafts, not to diagnose a condition.
No
The device description clearly states it is a "non-absorbable internal fixation device" and mentions "mechanical testing," indicating it is a physical implant and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the AFX Femoral Implant with Inserter is a non-absorbable internal fixation device used in surgical procedures (ACL, PCL, etc. reconstruction) to anchor tendon grafts within a surgically created femoral tunnel. This is a surgical implant used within the body, not a test performed on a sample outside the body.
The information provided focuses on the mechanical and biological performance of the implant itself, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The AFX® Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
Product codes
MBI
Device Description
The AFX Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment.
The predicate device implant, AFX Femoral Implant with Inserter, was changed to combine two components, wedge and deployment screw, while rounding the top of the deployment screw to allow for easier insertion into the bone. The integration of the wedge with the deployment screw reduces the total number of components in the subject implant. The overall length of the subject implant has also been increased from 24mm to 25mm due to rounding the top of the deployment screw.
The predicate device inserter was also modified to add a red indicator section to clearly indicate when the device is in drive mode and a locking mechanism as a safety feature to prevent the device from being deployed while in load mode. The mechanism within the implant that deploys the implant in both subject and predicate devices is identical.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral tunnel (femur), Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL)
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
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. The results of performance testing and mechanical testing demonstrated that functionality and safety of the subject AFX femoral implant are adequate for its intended use and determination of substantial equivalence to the predicate device. Mechanical testing, cyclic and pull-out, were performed on the subject device and the test results met the predetermined specifications. Testing also showed that the AFX femoral implant ultimate pull-out strength was comparable to that of the predicate device. The results of assessment of biocompatibility, sterilization, pyrogenicity, and shelf-life also demonstrated substantial equivalence to the predicate device.
Clinical testing was not used to establish substantial equivalence to predicate device.
Key Metrics
Mechanical testing, cyclic and pull-out, were performed on the subject device and the test results met the predetermined specifications. Testing also showed that the AFX femoral implant ultimate pull-out strength was comparable to that of the predicate device.
Predicate Device(s)
AFX® Femoral Implant with Inserter (K161033)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cayenne Medical Shima Hashemian QA/RA Associate Director 16597 N 92nd Street Scottsdale, Arizona 85260
Re: K192428
Trade/Device Name: AFX® Femoral Implant with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 3, 2019 Received: September 5, 2019
Dear Ms. Hashemian:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Device Name:
AFX® Femoral Implant with Inserter
Indications for Use:
The AFX Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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51 0(k) Number: K 192428 Date received: September 5, 2019 Special 510(k): Device Modification
510(k) Summary
Cayenne Medical, Inc. Special 510(k): Device Modification
AFX® Femoral Implant with Inserter
ADMINISTRATIVE INFORMATION
Date of summary:
| Manufacturer Name: | Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone +1 (480) 502-3661 Fax +1 (480) 502-3670 |
|---|---|
| Official Contact: | Shima Hashemian 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 shashemian@cayennemedical.com Telephone (480) 458-2196 FAX (480) 502-3670 |
Device Name
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Trade/Proprietary Name: | AFX® Femoral Implant with Inserter |
| Common Name: | Bone screw |
| Predicate device: | AFX® Femoral Implant with Inserter (K161033) |
Device Classification
FDA has classified bone fixation fasteners as Class II devices (21 CFR 888.3040). The product code for Fastener, Fixation, Nondegradable, and Soft Tissue is MBI. These devices are reviewed by Orthopedic Joint Devices Branch.
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INTENDED USE
The AFX® Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
DEVICE DESCRIPTION AND COMPARISON WITH PREDICATE DEVICE
The AFX Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment.
The predicate device implant, AFX Femoral Implant with Inserter, was changed to combine two components, wedge and deployment screw, while rounding the top of the deployment screw to allow for easier insertion into the bone. The integration of the wedge with the deployment screw reduces the total number of components in the subject implant. The overall length of the subject implant has also been increased from 24mm to 25mm due to rounding the top of the deployment screw.
The predicate device inserter was also modified to add a red indicator section to clearly indicate when the device is in drive mode and a locking mechanism as a safety feature to prevent the device from being deployed while in load mode. The mechanism within the implant that deploys the implant in both subject and predicate devices is identical.
NON-CLINICAL TESTING
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. The results of performance testing and mechanical testing demonstrated that functionality and safety of the subject AFX femoral implant are adequate for its intended use and determination of substantial equivalence to the predicate device. Mechanical testing, cyclic and pull-out, were performed on the subject device and the test results met the predetermined specifications. Testing also showed that the AFX femoral implant ultimate pull-out strength was comparable to that of the predicate device. The results of assessment of biocompatibility, sterilization, pyrogenicity, and shelf-life also demonstrated substantial equivalence to the predicate device.
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CLINICAL TESTING
Clinical testing was not used to establish substantial equivalence to predicate device.
EQUIVALENCE TO MARKETED PRODUCT
The modified AFX Femoral Implant with Inserter device has the following similarities to the unmodified predicate device:
- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same polymeric materials, and
- · is packaged using the same materials and processes.
In summary, the AFX Femoral Implant with Inserter described in this submission is, in our opinion, substantially equivalent to the predicate device. The data included in this submission demonstrates substantial equivalence to the predicate device listed above. Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy.