← Product Code [HWE](/submissions/SU/subpart-e%E2%80%94surgical-devices/HWE) · K971544 # SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) (K971544) _Synthes (Usa) · HWE · May 28, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K971544 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [HWE](/submissions/SU/subpart-e%E2%80%94surgical-devices/HWE.md) - **Decision Date:** May 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4820 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. ## Device Story Synthes Compact Air Drive II (CAD II) is an air-powered surgical drill used for drilling, reaming, sawing, burring, filing, and screwdriving. Device features 3.2 mm cannulated center for wires/pins; forward/reverse rotation; variable speed (0-900 rpm); 4 Nm max torque; air consumption 250 L/min; air control valve; latex-free double air hose connection; push-button release for attachment exchange. Operated by surgeons/clinical staff in surgical settings. Provides mechanical power for surgical tools to facilitate bone/tissue procedures. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Air-powered surgical drill. Features: 3.2 mm cannulated center, forward/reverse rotation, variable speed (0-900 rpm), 4 Nm max torque, air control valve, latex-free double air hose connection, push-button attachment release. Compatible with various drill bits, shafts, saw blades, and burrs. ## Regulatory Identification Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade. ## Predicate Devices - Synthes Small Air Drill (SAD) - Synthes Universal Air Drill (UAD) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. The logo and the word are the only elements in the image. The word "SYNTHES" appears to be a brand name or company name. K971544 Attachment IX: Summary of Safety and Effectiveness Information Synthes (USA) 1690 Russell Road Paoli, PA 19301 Contact: Sheri L. Musgnung (610) 647-9700 April 1997 Synthes Compact Air Drive II (CAD II) is compared to Synthes Small Air Drill (SAD) and Synthes Universal Air Drill (UAD). The Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. The CAD II accepts a variety of attachments and accessories. The Synthes SAD and UAD is also used for drilling, reaming, burring, and screwdriving functions and accepts a variety of attachments and accessories. Synthes CAD II has a 3.2 mm cannulated center to accept a variety of wires and pins. The other accessories include drill bits, flexible shafts, adapters, saw blades, air hoses, screwdriver shafts, burrs, files, and a cleaning brush. The drill features both forward and reverse rotation with a variable speed of 0 - 900 rpm; maximum torque of 4 Nm; air consumption of 250 liters/minute. and has an air control valve and latex free double air hose connection. The push button release allows for quick exchange of various attachments. Based on the mechanical test results, Synthes CAD II is at least equivalent to the predicate devices. {1}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 8 1997 Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes (USA) -- - - -1690 Russell Road PO Box 1766 Paoli, Pennsylvania 19301 Re: K971544 > Trade Name: Synthes (USA) Compact Air Drive II (CAD II) Regulatory Class: I Product Code: HWE Dated: April 25, 1997 Received: April 28, 1997 Dear Ms. Musgnung: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further ansouncements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ ## Page 2 - Ms. Sheri L. Musgnung This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Colia M. Witten, Ph.D., M.D. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word. SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700 | 1 | | | | |---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation(ODE) | |-----------------------------------------|-------------------------------------------------------| | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | k971544 | | Prescription Use
(Per 21 CFR 801.109) | X | |------------------------------------------|---| |------------------------------------------|---| OR | Over-The-Counter Use | | |----------------------|--| |----------------------|--| --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K971544](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K971544) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com