(76 days)
Not Found
Not Found
No
The summary describes a mechanical interference screw for ACL reconstruction and does not mention any AI or ML components or functionalities.
Yes
The device is used to fix grafts during ACL reconstruction procedures, which is a therapeutic intervention aimed at restoring function.
No
The device, AperFix™ Interference Screw, is an orthopedic implant used for fixation during ACL reconstruction, not for diagnosing medical conditions.
No
The device description clearly states it is a physical interference screw intended for surgical implantation, not a software product.
Based on the provided information, the AperFix™ Interference Screw is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- AperFix™ Function: The AperFix™ Interference Screw is a surgical implant used to fix a bone-patellar tendon-bone graft within the body during ACL reconstruction. It is a mechanical device used for structural support, not for analyzing biological samples.
The description clearly states its purpose is for fixation during a surgical procedure, which is an in vivo (within the body) application.
N/A
Intended Use / Indications for Use
The AperFix™ Interference Screw is intended for use with bone-patellar tendon-bone (BPTB) grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Cayenne Medical AperFix™ Interference Screw is intended for the bone-patellar tendonbone (BPTB) reconstruction of the anterior cruciate ligament (ACL). During an ACL reconstruction procedure, BPTB grafts are fixed to the femur and tibia utilizing the AperFix™ Interference Screw. BPTB grafts are typically harvested from the patient's ipsilateral leg, but cadaveric grafts are also acceptable. The AperFix™ Interference Screw is packaged STERILE. The AperFix™ Interference Screw provides interference fixation of the BPTB graft within the femoral and tibial tunnels.
The AperFix Interference Screw will be supplied sterilization will be accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy.
Mechanical testing was performed on the AperFix Interference Screw. It was shown that pullout strength is significantly higher than that of a predicate interference screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia
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)
Mechanical testing was performed on the AperFix Interference Screw. It was shown that pullout strength is significantly higher than that of a predicate interference screw.
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.
Not Found
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
510(k) Premarket Notification
K073426 (pg 1 of 2)
AperFix
perFix™ Interference Screw
510(k) Summary
Cayenne Medical, Inc. AperFix Interference Screw
ADMINISTRATIVE INFORMATION
Manufacturer Name: Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone (480) 502-3661 FAX (480) 502-3670 Kereshmeh Shahriari Official Contact: 16597 N. 92nd St., Suite 101 Scottsdale, A7. 85260 kshahriari@cayennemedical.com Telephone (480) 502-3661 FAX (480) 502-3670
DEVICE NAME
| Classification Names: | Screw, fixation, bone |
|---|---|
| Trade/Proprietary Name: | AperFix™ Interference Screw |
| Common Name: | Bone screw |
DEVICE CLASSIFICATION
FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for screw, fixation, bone is HWC. These devices are reviewed by the Orthopedic Joint Devices Branch.
.
FEB 19 2008
1
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INTENDED USE
The AperFix™ Interference Screw is intended for use with bone-patellar tendon-bone (BPTB) grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.
DEVICE DESCRIPTION
The Cayenne Medical AperFix™ Interference Screw is intended for the bone-patellar tendonbone (BPTB) reconstruction of the anterior cruciate ligament (ACL). During an ACL reconstruction procedure, BPTB grafts are fixed to the femur and tibia utilizing the AperFix™ Interference Screw. BPTB grafts are typically harvested from the patient's ipsilateral leg, but cadaveric grafts are also acceptable. The AperFix™ Interference Screw is packaged STERILE. The AperFix™ Interference Screw provides interference fixation of the BPTB graft within the femoral and tibial tunnels.
The AperFix Interference Screw will be supplied sterilization will be accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy.
Mechanical testing was performed on the AperFix Interference Screw. It was shown that pullout strength is significantly higher than that of a predicate interference screw.
EQUIVALENCE TO MARKETED PRODUCT
Cavenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the AperFix™ Interference Screw is substantially equivalent in indications and design principles to predicate devices, cach of which has been determined by FDA to be substantially equivalent to preamendment devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
FEB 19 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cayenne Medical, Incorporated % Ms. Kereshmeh Shahriari Directory of Quality Assurance & Regulatory Affairs 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260
Re: K073426 Trade/Device Name: AperFix 1M Interference Screw
Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 4, 2007 Received: December 5, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Ms. Kereshmeh Shahriari
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ |4073426
Device Name: AperFix™ Interference Screw
Indications for Use:
The AperFix™ Interference Screw is intended for use with bone patellar tendon bone (BPTB) grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Mark A. Millkum
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number
Revised Page 15 of 186