The AperFix™ Femoral Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.

Device Description

The AperFix Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open anterior cruciate ligament (ACL) 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.

AI/ML Overview

The provided text is a 510(k) summary for the AperFix™ Femoral Implant with Inserter. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process typically relies on comparisons to existing devices and does not usually involve clinical studies to establish novel performance criteria or extensive studies demonstrating device performance against new acceptance criteria.

Based on the provided text:

No specific acceptance criteria and detailed device performance study are described. The document focuses on establishing substantial equivalence to predicate devices, not on proving performance against a specific set of acceptance criteria through a clinical study.
The provided text does not contain information about:
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.

Summary of what is available from the text:

The AperFix™ Femoral Implant with Inserter is seeking 510(k) clearance based on substantial equivalence to predicate devices. The claim of equivalence is based on the device having:

The same intended use.
The same operating principle.
The same basic design.
The same polymer materials.
Equivalent metallic materials.
Same packaging materials and processes.

Therefore, it is not possible to complete the requested table and answer the specific questions about acceptance criteria and performance studies from the provided document. The 510(k) process for this device relies on demonstrating similarity to existing devices, not on a new study proving performance against defined acceptance criteria.

Summary

{0}------------------------------------------------

K073057 pye 1/2

510(k) Summary

AperFix™ Femoral Implant with Inserter

510(k) Summary

Cayenne Medical, Inc. Special 510(k): Device Modification

NOV 27 2007

AperFix™ Femoral Implant with Inserter

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Official Contact:

Representative/Consultant:

Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone +1 (480) 502-3661 Fax +1 (480) 502-3670

Kereshmeh Shahriari

David J. Collette, MD or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone +1 (858) 792-1235 Fax +1 (858) 792-1236

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Product Code: Classification Panel: Reviewing Branch:

AperFix™ Femoral Implant with Inserter Bone screw Screw, fixation, bonc 21 CFR 888.3040 Class II HWC Orthopedic Devices Orthopedic Joint Devices Branch

INTENDED USE

The AperFix™ Femoral Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.

{1}------------------------------------------------

510(k) Summary

AperFix™ Femoral Implant with Inserter

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

The AperFix™ 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 polymer materials,
· incorporates equivalent metallic materials, and
· is packaged using the same materials and processes.

In summary, the AperFix™ Femoral Implant with Inserter described in this submission is, in our opinion, substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The seal also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the emblem.

NOV 2 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cayenne Medical, Inc % PaxMed International, LLC David J. Collette, MD 11234 El Camino Real, Suite 200 San Diego, California 92130

K073054 Re: Trade/Device Name: AperFix™ 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: HWC Dated: October 26, 2007 Received: October 30, 2007

Dear Dr. Collette:

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 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.

{3}------------------------------------------------

Page 2 – David J. Collette, MD

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin inding of substantial equivalence of your device to a legally prematics notification: The Pro intractor 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 rr you deeme speerite and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 270 0120. Thiss, process now more). For questions regarding postmarket surveillance, premance motheation (216) it 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 N. Milburn

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):

K073054

Device Name:

AperFix™ Femoral Implant with Inserter

Indications for Use:

The AperFix™ Femoral Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use $\underset{(21 \text{ CFR } 801 \text{ Subpart C})}{\curvearrowright}$

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Office of Device Evaluation (ODE) CDRH.

Mark H. Wilkinson

Page 1 of

(Division Sign-Off) Division of General, testorative, and Neurological Devaces

510(k) Number K07305

Page 14 of 78

Regulation Number and Section

N/A