SPEED TRIAD

{0}------------------------------------------------ ### Section 5: 510(k) Summary # APR 0 7 2014 #### Speed Triad™ Product: Submitter Information BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 (210) 677-0355 Fax: Joe W. Soward Contact: Date Prepared: April 3, 2014 Classification name: Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030) | Classification: | Class II · | |--------------------|-------------| | Product Code: | JDR | | Common/Usual Name: | Bone Staple | | Proprietary Name: | Speed Triad | ### Intended Use: The Speed Triad is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. #### Substantial Equivalence: The Speed Triad is substantially equivalent to the predicate BME Speed Shift™ cleared in K124022, predicate OSSplate™ cleared in K993714, labeled as the Memograph® Staple, and predicate K070598 (SmartToe). The K993714 predicate also includes an intended use of fixation of proximal tibial metaphysis osteotomy and fixation of soft tissue to bone (anterior cruciate reconstruction) which is not included in this submission. #### Device Description: The Speed Triad is a nitinol implant that comes in a range of sizes for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis of the hand and foot. The implant is delivered to the operating room in an "open" state in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient temperature and body heat after insertion, and contracts to a "closed" and compressive state. The implants do not require any external heating; they are completely transformed at room temperature. {1}------------------------------------------------ The Speed Triad incorporates design changes from the Speed Shift. The design is changed to include a third leg to provide additional fixation. Importantly, the Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation). A second predicate is used for comparison of mechanical and corrosion properties of the Speed Triad. Because the Speed Triad implants are more similar shaped to the predicate OSSplate implants than the Speed Shift implants, BME has used the OSSplate to show substantial mechanical and corrosion resistance equivalence to a similar-sized implant. The table below summarizes the technological characteristics of the Speed Triad and the predicate devices. | Product<br>Name: | Speed Triad | Predicate<br>Speed Shift<br>(K124022) | Predicate<br>OSSplate (K993714) | |--------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------| | Raw<br>Material: | Nitinol, per ASTM<br>F2063-12 | Nitinol, per ASTM<br>F2063-12 | Nitinol, per ASTM<br>F2063-12 | | Bridge<br>Lengths<br>(mm): | 18, 20, and 25 | 15 and 20 | 15 | | Leg Lengths<br>(mm): | 10, 12, and 15 | 20 | 6, 8, and 10 | | Cross-section<br>Dimensions<br>(mm): | 1.25 x 1.50 (Double<br>Leg)/<br>1.25 x 1.80 (Single Leg) | 1.8 x 2.0 (Leg) | 1.20 x 1.50 (Leg) | | Barbs: | Barbs on the legs | Barbs on the legs | Smooth legs | | Heat Source: | Fully transformed<br>at room temperature | Fully transformed<br>at room temperature | OSSforce electrical<br>heating unit | | Surface<br>Finish: | Mechanical tumbling,<br>acid cleaning, and<br>chemical passivation. | Mechanical tumbling,<br>acid cleaning, and<br>chemical passivation. | Mechanical<br>tumbling only. | | Patient<br>Contacting<br>Materials: | Nitinol<br>Grey PC #5816<br>SS 17-4<br>SS-303 | Nitinol<br>Grey PC #5816<br>SS 17-4<br>SS-303 | Nitinol<br>SS 17-4<br>SS-303 | | Storage: | Sterile packaged stored<br>at room temp until used. | Sterile packaged,<br>stored at room temp<br>until used. | Sterile packaged,<br>stored at room temp<br>until used. | Technological Characteristics Comparison to the Predicate Devices 1 - Predicate SmartToe not shown, but it is a nitinol extremity fixation device used for comparison of corrosion resistance only. {2}------------------------------------------------ #### Performance Bench Testing: Standard ASTM F564-10 (2010) was used to compare the pull-out strength of the Speed Triad to the predicate OSSplate. Specimens of all three sizes of the Speed Triad were used and compared to a comparably sized predicate OSSplate. The results showed that the Speed Triad has substantially equivalent pull-out resistance than the predicate OSSplate implant. Standard ASTM F564-10 (2010) was used to compare the mechanical strength of the new Speed Triad to the predicate OSSplate. Specimens of all three sizes of the Speed Triad were used and compared to a similar sized predicate OSSplate. The results showed that the Speed Triad implants achieved substantially equivalent bending stiffness when compared to the predicate OSSplate. Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new Speed Triad to the predicate OSSplate. We also have used a secondary predicate for corrosion resistance, the SmartToe (K070598). Test results demonstrate the substantially equivalent corrosion resistance of the Speed Triad compared to the predicate OSSplate and SmartToe. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 7, 2014 BioMedical Enterprises, Incorporated Mr. Joe Soward Director, Quality Assurance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245 Re: K133844 Trade/Device Name: Specd TriadTM Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: March 11, 2014 Received: March 14, 2014 Dear Mr. Soward: 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 {4}------------------------------------------------ #### Page 2 - Mr. Joe Soward 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm. Sincerely yours, # Lori A. Wiggins for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Device Name: Speed Triad™ #### Indications for Use The Speed Triad™ is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96) Casey L. Hanley, Ph.D. Division of Orthopedic Devices 4-1