(112 days)
No
The description focuses on the mechanical design and materials of the implant and inserter, with no mention of AI or ML capabilities. The modifications are purely structural and material-based.
Yes
The device is an internal fixation device intended for use in tenodesis procedures to anchor soft tissue grafts in reconstructive surgeries for ligaments like the ACL, PCL, MCL, LCL, and MPFL. Its purpose is to facilitate tissue ingrowth and permanent bony attachment, directly treating a medical condition or ailment.
No
Explanation: The device is described as an "internal fixation device" used in "reconstruction" procedures to "anchor tendon grafts." Its function is structural and reconstructive, not for diagnosing medical conditions.
No
The device description clearly details a physical implant and inserter, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (tenodesis) to reconstruct ligaments using soft tissue grafts. This is a surgical implant used in vivo (within the body).
- Device Description: The device is described as a "non-absorbable internal fixation device" used to anchor tendon grafts within a surgically created tunnel. This is a physical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The description of the AFX Femoral Implant does not involve any such testing or analysis of biological samples.
The device is clearly a surgical implant used directly on a patient during a reconstructive procedure.
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.
Modifications to the predicate device, AperFix AM Femoral Implant with Inserter, that are the subject of this submission are confined solely to a line extension consisting of a metal free version of the original 24mm implant.
The screws of the modified 24mm implant differ from that of the original 24mm implant in that the combination of two PEEK screws, compression and deployment, in the modified 24mm implant play the role of the metal central screw in the original 24mm implant. In both the original 24mm and modified 24mm versions of the implant, lateral deflection of the body occurs as the implant is secured in position, however, in the original 24mm implant this occurrence is caused by advancing the head of the metal central screw and in modified 24mm implant this occurrence is caused by advancing the compression screw. In the subject 24 mm device, the unibody engages the wall of the femoral tunnel upon deploying the deployment screw. In the predicate 24 mm device the wings engage the wall of the femoral tunnel upon deploying the central screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, ACL, PCL, MCL, LCL, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included. The results of performance testing, including biocompatibility, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AperFix® AM Femoral Implant with Inserter (K122463)
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three profiles facing to the right, resembling a family or group of people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2016
Cayenne Medical, Inc. Shima Hashemian OA/RA Director 16597 North 92nd Street Scottsdale, Arizona 85260
Re: K161033
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: July 6, 2016 Received: July 8, 2016
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. 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
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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/ResourcesforYou/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,
Vincent J. Devlin -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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K161033
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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510(k) Summary
Cayenne Medical, Inc. Special 510(k): Device Modification
AFX™ Femoral Implant with Inserter
ADMINISTRATIVE INFORMATION
| Date of summary: | 04/01/2016 |
|---|---|
| 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) 502-3661 | |
| 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: | AperFix® AM Femoral Implant with Inserter (K122463) |
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.
Modifications to the predicate device, AperFix AM Femoral Implant with Inserter, that are the subject of this submission are confined solely to a line extension consisting of a metal free version of the original 24mm implant.
The screws of the modified 24mm implant differ from that of the original 24mm implant in that the combination of two PEEK screws, compression and deployment, in the modified 24mm implant play the role of the metal central screw in the original 24mm implant. In both the original 24mm and modified 24mm versions of the implant, lateral deflection of the body occurs as the implant is secured in position, however, in the original 24mm implant this occurrence is caused by advancing the head of the metal central screw and in modified 24mm implant this occurrence is caused by advancing the compression screw. In the subject 24 mm device, the unibody engages the wall of the femoral tunnel upon deploying the deployment screw. In the predicate 24 mm device the wings engage the wall of the femoral tunnel upon deploying the central screw.
NON-CLINICAL TESTING
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included. The results of performance testing, including biocompatibility, 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.
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CLINICAL TESTING
Clinical testing was not used to establish substantial equivalence to predicate device.
EQUIVALENCE TO MARKETED PRODUCT
The AFX Femoral Implant with Inserter has the following similarities to the unmodified predicate devices:
- · 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 does not raise new issues of safety or efficacy.