(59 days)
Not Found
No
The description focuses on the mechanical design and function of a surgical implant for ligament reconstruction, with no mention of AI or ML capabilities.
Yes
This device is an implantable internal fixation device used for ligament reconstruction, which is a therapeutic procedure aimed at restoring anatomical function.
No
The device is an implant used for internal fixation in ligament reconstruction, not for diagnosis. Its purpose is to anchor soft tissue grafts.
No
The device description clearly describes a physical implant and inserter used in surgical procedures, not a software-only product.
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.
- AperFix AM Femoral Implant Function: The AperFix AM Femoral Implant is a surgical implant designed to be placed inside the body to anchor soft tissue grafts during ligament reconstruction procedures. It is a mechanical device used for fixation, not for analyzing biological samples.
The provided information clearly describes a surgical implant used for mechanical fixation within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AperFix® AM 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 (comma separated list FDA assigned to the subject device)
MBI
Device Description
The AperFix AM 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 device that are the subject of this submission are confined solely to limited to a line extension consisting of a 24 mm (shortened) version of the original 29 mm implant to enable greater flexibility in tendon graft placement within the femur when clinical conditions (i.e. anatomy and/or deformity) preclude use of the original 29 mm device.
The body wedge and wings of the modified 24 mm device differ from those of the original 29 mm device in that the wings are one piece (as opposed to using an assembly of a wedge, two arms, and two pins). In both the 24 mm and 29 mm versions of the AperFix device, the advancing head of the central screw causes lateral deflection of the body as the implant is secured in position. In the subject 24 mm device, the wings engage the wall of the femoral tunnel upon tightening the central screw. In the predicate 29 mm device the arms engage the wall of the femoral tunnel upon tightening the central screw and wedge.
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 was submitted, referenced, or relied upon to demonstrate substantial equivalence. Mechanical testing was performed on the AperFix AM Femoral Implant with Inserter. It was shown that pull-out strength is comparable to the predicate device. Dimensional analysis was performed on the AperFix AM Femoral Implant with Inserter. Product dimensional analysis met the components and product specifications.
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
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510(k) Summary
AperFix® AM Femoral Implant with Inserter
510(k) Summary
OCT 11 2012
Cayenne Medical, Inc. Special 510(k): Device Modification
AperFix® AM Femoral Implant with Inserter
ADMINISTRATIVE INFORMATION
510(k) Number:
Manufacturer Name:
K122463
Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone +1 (480) 502-3661 Fax +1 (480) 502-3670
Kereshmeh Shahriari
September 11, 2012
Official Contact:
510(k) Summary Preparation Date
Predicate Device
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name:
Classification Name:
Product Code: Classification Panel: Reviewing Branch:
INTENDED USE
AperFix® AM Femoral Implant Fastener, Fixation, Nondegradable, Soft tissue Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040 Class II MBI Orthopedic Devices Orthopedic Joint Devices Branch
Cayenne Medical AperFix® Femoral Implant with Inserter, K083612
The AperFix® AM 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.
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510(k) Summary
AperFix® AM Femoral Implant with Inserter
DEVICE DESCRIPTION AND COMPARISON WITH PREDICATE DEVICE
The AperFix AM 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 device that are the subject of this submission are confined solely to limited to a line extension consisting of a 24 mm (shortened) version of the original 29 mm implant to enable greater flexibility in tendon graft placement within the femur when clinical conditions (i.e. anatomy and/or deformity) preclude use of the original 29 mm device.
The body wedge and wings of the modified 24 mm device differ from those of the original 29 mm device in that the wings are one piece (as opposed to using an assembly of a wedge, two arms, and two pins). In both the 24 mm and 29 mm versions of the AperFix device, the advancing head of the central screw causes lateral deflection of the body as the implant is secured in position. In the subject 24 mm device, the wings engage the wall of the femoral tunnel upon tightening the central screw. In the predicate 29 mm device the arms engage the wall of the femoral tunnel upon tightening the central screw and wedge.
NON-CLINICAL TESTING
Non-clinical testing data was submitted, referenced, or relied upon to demonstrate substantial equivalence. Mechanical testing was performed on the AperFix AM Femoral Implant with Inserter. It was shown that pull-out strength is comparable to the predicate device. Dimensional analysis was performed on the AperFix AM Femoral Implant with Inserter. Product dimensional analysis met the components and product specifications.
EQUIVALENCE TO MARKETED PRODUCT
The AperFix® AM 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,
- · incorporates equivalent metallic materials, and
- · is packaged using the same materials and processes.
In summary, the AperFix® AM Femoral Implant with Inserter described in this submission is, in our opinion, substantially equivalent to the predicate devices. 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread, composed of three thick, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cayenne Medical, Incorporated % Ms. Kereshmeh Shahriari Senior Director of Regulatory Affairs, Quality & Compliance 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260
OCT 11 2012
Re: K122463
Trade/Device Name: AperFix® AM 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 10, 2012 Received: September 13, 2012
Dear Ms. Shahriari:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Kereshmeh Shahriari
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Erine Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification
AperFix® AM Femoral Implant with Inserter
Indications for Use
K122463 510(k) Number (if known):
AperFix® AM Femoral Implant with Inserter
Indications for Use:
Device Name:
The AperFix AM Femoral Implant 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)
K. Lount
01
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122463
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