AXYALOOP NONABSORBABLE BONE ANCHOR

{0}------------------------------------------------ K060970 page 1/3 ## JUL - 5 2006 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807,92) #### General Company Information | Name: | Axya Medical, Inc. | |----------|--------------------------------------------------| | Contact: | Howard Schrayer<br>Regulatory Affairs Consultant | - Address: 100 Cummings Center Suite 444C Beverly, MA 01915 - Telephone: (978) 232 - 9997 Fax: (978) 232 - 9998 - Date Prepared April 10, 2006 ## General Device Information - Product Name: AxyaLoop™ Nonabsorbable Bone.Anchor - Classification: "Nondegradable soft tissue fixation fastener" Product code: MBI Class II ### Predicate Devices Axya Medical, Inc Bioabsorbable Bone Anchors - 3mm, 5mm and 6.5mm [501(k) Numbers K051983, K041698 and K051250] respectively Innovasive Devices Inc. Nonabsorbable 2.8mm and 3.5mm ROC Suture Bone Fastener [501(k) Number K9634021 ### Description The device described in this submission is designed with a corkscrew style thread and is available in 3.0mm, 5.0mm and 6.5mm diameters, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor is available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Nonabsorbable Bone Anchor is prethreaded with USP polypropylene monofilament, USP nydon, USP braided polyester and USP braided polyethylene suture materials. {1}------------------------------------------------ Page 2 of The Nonabsorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures. ### Intended Use (Indications) The Axya AxyaLoop™ Nonabsorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females #### Substantial Equivalence This submission supports the position that the Axya Nonabsorbable Bone Anchor is substantially equivalent to a number of previously cleared devices, including the the Axya Medical Bioabsorbable bone anchors cleared under 510(k) numbers K051983 (3mm), K041698 (5mm) and K051250 (6.5mm). The material used to fabricate the AxyaLoop™ Nonabsorbable Bone Anchor is the same acetal polymer used in the previously cleared Innovasive Devices Inc. nonabsorbable 2.8mm and 3.5mm ROC Suture Bone Fasteners cleared under 510(k) K963402. The 510(k) Notice contains summaries of in vitro studies that were conducted to evaluate the anchor pull-out strength as specified in the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996). The data presented demonstrate that the anchor pull-out force of the Axya AxyaLoop™ Nonabsorbable Bone Anchor was comparable to that of the predicate devices of similar corkscrew geometry. The failure mode observed for the Axya anchor was predominately the same as that of the predicate anchor. {2}------------------------------------------------ Page 273 The single-patient-use components of the bone anchor system are provided sterile. The suture material and bone anchors are sterilized by a process equivalent to the process used by the original suture manufacturer. ### Conclusions Axya Medical, Inc. believes that the information provided establishes that similar legally marketed have been used for the same clinical applications as the Axya Nonabsorgable Bone Anchor. The materials from which the Axya device is fabricated have an established history of use in medical applications, and devices produced by Axya have been tested in accordance with applicable FDA guidelines. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 5 2006 Axya Medical, Inc. % Mr. Howard L. Schraver Regulatory Affairs Consultant 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915 Re: K060970 Trade/Device Name: AxyaLoop™ Nonabsorbable Bone Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MBI, HWC Dated: June 8, 2006 Received: June 9, 2006 Dear Mr. Schrayer: 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. {4}------------------------------------------------ Page 2 – Mr. Howard L. Schrayer 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 10gally 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may altain other general information on your responsibilities under the Act from the Division of Swall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index html. Sincerely vours. Souleya Buellet Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### INDICATIONS FOR USE 510(k) Number (if known): K060970 Device Name: AxyaLoop™ Nonabsorbable Bone Anchor Indications For Use: The AxyaLoop™ Nonabsorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Uinar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 807 Subpart C) No (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shater: Brelin 510(k) Number K060770