← Product Code [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL) · K964548 # APEX UNIVERSAL DRIVE SYSTEM (K964548) _Linvatec Corp. · ERL · Jan 17, 1997 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K964548 ## Device Facts - **Applicant:** Linvatec Corp. - **Product Code:** [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL.md) - **Decision Date:** Jan 17, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4250 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable. ## Device Story Apex Universal Drive System comprises drive console, micro handpiece, blades/burrs/routers, and foot switches. Used in ENT and reconstructive surgery by surgeons. Device modification involves console software/chip upgrade to increase maximum RPM for forward/reverse and oscillation modes; intended to reduce bur chatter and increase resection rate. System provides mechanical power to surgical accessories for tissue/bone removal. ## Clinical Evidence Bench testing only. ## Technological Characteristics Reusable surgical drive system including console, micro handpiece, and accessories. Energy source: electric/pneumatic. Modification involves firmware/chip upgrade to increase motor speed (RPM). ## Regulatory Identification An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area. ## Predicate Devices - Apex Universal Drive System ([K944476](/device/K944476.md)) - XPS Straightshot Micro Resector System ([K862807](/device/K862807.md), [K954796](/device/K954796.md), [K960856](/device/K960856.md)) - Dyonics EP1 Surgical Drive System ([K954989](/device/K954989.md)) ## 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} K964548 Jan. 17, 1997 11311 Concept Boulevard Largo, Florida 34643 813 399-5334 Fax: 813 399-5264 Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs November 12, 1996 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Spinal System, 510(k) Number 96454B. ## A. Submitter Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 ## B. Company Contact Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs ## C. Device Name Trade Name: Apex™ Universal Drive System Common Name: Drive System Classification Name: Surgical, ENT (electric or pneumatic), including handpiece ## D. Predicate/Legally Marketed Devices Apex™ Universal Drive System Linvatec Corporation XPS™ Straightshot Micro Resector System Xomed Endoscopy Dyonics® EP1 Surgical Drive System Smith and Nephew Endoscopy A Bristol-Myers Squibb Company 21 {1} Summary of Safety and Effectiveness Apex™ Universal Drive System 510(k) # November 12, 1996 Page 2 of 3 ## E. Device Description The Apex Universal Drive system contains a drive console, micro handpiece, blades/burrs/routers and foot switches. The forward/reverse speed is being increased to reduce the incidence of bur chatter. The oscillation speed is being modified to increase the rate of resection. The modification will take place within the drive console power unit software. A computer chip will be upgraded to allow the handpiece to run at a higher maximum rpm in forward/reverse and oscillate mode. ## F. Intended Use The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable. ## G. Substantial Equivalence The Apex Universal Drive System is substantially equivalent in design, function and intended use to the Apex™ Universal Drive System (Linvatec Corporation), XPS™ Straightshot Micro Resector System (Xomed Endoscopy) and Dyonics® EP1 Surgical Drive System (Smith and Nephew Endoscopy). Testing has been done to prove safety and effectiveness of the devices. The similarities/dissimilarities to the predicates are shown in the attached table. 4 {2} Summary of Safety and Effectiveness Apex™ Universal Drive System 510(k) # November 12, 1996 Page 3 of 3 ## CHART OF SIMILARITIES AND DISSIMILARITIES | Company | Device Name | Intended Use | Design | | --- | --- | --- | --- | | NEW PRODUCT Linvatec | Apex™ Universal Drive System | ENT and Reconstructive Surgery | Micro Handpiece Speed Maximum Forward/Reverse: 5,000 rpm Maximum Oscillate: 2,500 rpm | | PREDICTIVE Linvatec 510(k) # K944476 | Apex™ Universal Drive System | ENT and Reconstructive Surgery | Micro Handpiece Speed Maximum Forward/Reverse: 3,500 rpm Maximum Oscillate: 1,500 rpm | | PREDICTIVE Xomed Endoscopy 510(k) # K862807 K954796 K960856 | XPS™ Straightshot™ Micro Resector System | ENT | Handpiece Speed Maximum Forward/Reverse: 6,000 rpm Maximum Oscillate: 3,000 rpm | | PREDICTIVE Smith and Nephew Endoscopy 510(k) # K954989 | Dyonics® EP1 Surgical Drive System | ENT | Handpiece Speed: Maximum Forward/Reverse: 8,000 rpm Maximum Oscillate: 3,000 rpm | --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K964548](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K964548) **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