← Product Code [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL) · K992994 # TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; (K992994) _Gyrus Ent LLC · ERL · Nov 23, 1999 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K992994 ## Device Facts - **Applicant:** Gyrus Ent LLC - **Product Code:** [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL.md) - **Decision Date:** Nov 23, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4250 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The Turbo 7000™ System's intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures would include mastoidectomy and mastoidotomy. Sinus applications would embody septoplasty and procedures such as the the removal of of of septal spurs. polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR and trans-sphenoidal procedures. Nasopharyngeal procedures would comprise adenoidectomy, tracheal, laryngeal polyectomy, larvngeal lesion debulking and tonsillectomy. Head and neck procedures would encompass soft tissue shaving, thinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal. Additionally, an irrigation pump will be included as a component of the system to provide irrigant in conjunction with the procedures. ## Device Story Turbo 7000 System is an electrical surgical drill/shaver for ENT, head/neck, and otoneurologic procedures. System consists of a controller unit with an integrated irrigation pump and various handpieces (burrs/blades). Device operates by mechanical cutting/shaving of bone and soft tissue; irrigation pump provides fluid to the surgical site. Used in clinical/surgical settings by physicians. Output is physical tissue/bone removal; healthcare provider uses visual feedback during surgery to guide the instrument. Benefits include precise tissue/bone resection in complex anatomical regions. ## Clinical Evidence No clinical data. Substantial equivalence is based on technological characteristics and intended use compared to predicate devices. ## Technological Characteristics Electrical surgical drill/shaver system. Includes controller unit, handpieces, and integrated irrigation pump. Complies with UL 2601-1, CSA 22.2 No. 601-1-1 (EN 60601-1), IEC 601-1-2 (EN 60601-1-2), and IEC 529 standards. ## 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 - Xomed XPSTM System (with STRAIGHTSHOT™, PERFORMATM and SKEETER™ handpieces) - Modified ESSential Shaver ## 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}------------------------------------------------ Food and Drug Administration 510(k) Notification - The Turbo 7000™ System September 3, 1999 q 2994 NOV 2 3 1999 ppling Rd., Bartlett, TN 38 0200. Toll Free: 1 orders and order inquiri # 510(k) Summary of Safety and Effectiveness | Trade Name: | The Turbo 7000™ System | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Electrical Surgical Drill/Shaver | | Classification Name: | Surgical ENT drill, electric or pneumatic including handpieces and
ENT burr/blades | | Official Contact: | Jeff Cobb
Group Director
Regulatory, Clinical & Quality Assurance
Smith & Nephew, INC.
ENT Division
2925 Appling Road
Bartlett, TN 38133 | | Telephone: | (901) 373-0200 | | Telefax: | (901) 373-0242 | | Date Prepared: | September 3, 1999 | The Turbo 7000™ System is substantially equivalent to the Xomed XPSTM System used with the STRAIGHTSHOT™, PERFORMATM and SKEETER™ handpieces, and the Modified ESSential Shaver. The Turbo 7000 System's intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures would include mastoidectomy and mastoidotomy. Sinus applications would embody septoplasty and procedures such as the the removal of of of septal spurs. polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR and trans-sphenoidal procedures. Nasopharyngeal procedures would comprise adenoidectomy, tracheal, laryngeal polyectomy, larvngeal lesion debulking and tonsillectomy. Head and neck procedures would encompass soft tissue shaving, thinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal. Additionally, an irrigation pump will be included as a component of the system to provide irrigant in conjunction with the procedures. {1}------------------------------------------------ ## Food and Drug Administration 510(k) Notification -- The Turbo 7000™ System September 3, 1999 The Turbo 7000 System that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate devices. The intended uses are substantially equivalent to the described predicate Modified ESSential Shaver System and the Xomed System. The Turbo 7000 System is designed to meet UL 2601-1 including German Deviations and Australian Deviations, CSA 22.2 No. 601-1-1 (EN 60601-1), IEC 601-1-2(EN 60601-1-2) and IEC 529. Differences between the Turbo 7000 System and the predicate devices should not affect the safety or effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure. od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 3 1999 Mr. Jeff Cobb Group Director Regulatory, Clinical & Quality Assurance Smith & Nephew, Inc. ENT Division 2925 Appling Road Bartlett, TN 38133 Re: K992994 Trade Name: The Turbo 7000™ Regulatory Class: II Product Code: 874.4250 Dated: September 3, 1999 Received: September 7, 1999 Dear Cobb: 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 legally marketed predicate devices marketed in interstate commerce pror 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 announcements 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. {3}------------------------------------------------ Page 2 - Mr. Cobb · 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) 594-4613. 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, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Food and Drug Administration 510(k) Notification - The Turbo 7000™ System September 3, 1999 K992994 510(k) Number: Device Name: The Turbo 7000™ System ### Intended Use: The Turbo 7000™ System's intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures would include: - mastoidectomy and ● - mastoidotomy. . Sinus applications would embody: - septoplasty and . - . procedures such as - . the removal of septal spurs, - polypectomy, . - antrostomy, . - ethmoidectomy/sphenoethmoidectomy, . - frontal sinus trephination and irrigation, . - frontal sinus drill out, . - endoscopic DCR and . - trans-spehnoidal procedures. . Nasopharyngeal/Laryngeal procedures would comprise: - adenoidectomy, . - . tracheal, - laryngeal polyectomy, . - laryngeal lesion debulking and . - tonsillectomy. . Head and neck procedures would encompass: - . soft tissue shaving, - rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), . - removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of . the face, and - . acoustic neuroma removal. Additionally, an irrigation pump is integrated into the controller unit to provide irrigant in conjunction with the procedures. **Prescription Use** (Per 21 CFR 801.109) Page 3 (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K99299 K992994 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K992994](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K992994) **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. 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