ESSENTIAL SHAVER SYSTEM

K974232 · Gyrus Ent LLC · EQJ · Jan 12, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974232
• Device Name: ESSENTIAL SHAVER SYSTEM
• Applicant: Gyrus Ent LLC
• Product Code: EQJ · Ear, Nose, Throat
• Decision Date: Jan 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4140
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectorny 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 transspehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy, 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 at the cerebellopontine angle.

Device Story

Electrical surgical shaver system; used for cutting/removal of bone and soft tissue in ENT, head/neck, and otoneurologic procedures. Device consists of handpiece and shaver blades/burrs; operates via electric power. Used by surgeons in clinical/OR settings. Provides mechanical tissue/bone resection; output is physical removal of target anatomy. Benefits include expanded surgical utility for diverse procedures including mastoidectomy, rhinoplasty, and acoustic neuroma removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrical surgical shaver; handpiece and burr/blade assembly. Designed to meet UL 2601-1 and IEC 601-1-2 safety standards. Powered by electric source.

Indications for Use

Indicated for patients requiring cutting and removal of bone and soft tissue in ENT, head and neck, and otoneurologic procedures, including mastoidectomy, mastoidotomy, septoplasty, polypectomy, antrostomy, ethmoidectomy, frontal sinus procedures, endoscopic DCR, transsphenoidal procedures, adenoidectomy, laryngeal lesion debulking, tonsillectomy, rhinoplasty, lipo debridement, and acoustic neuroma removal.

Regulatory Classification

Identification

An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.

Predicate Devices

• Xomed XPS System (not specified)
• ESSential Shaver System (K953096)

Reference Devices

• STRAIGHTSHOT (not specified)
• PERFORMA (not specified)
• SKEETER (not specified)

Submission Summary (Full Text)

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# Food and Drug Administration 510(k) Notification - Modified ESSential Shaver System November 11, 1997

Smith & Nephew, Inc.
2925 Appling Rd., Bartlett, TN 38133 U.S.A.
901-373-0200, Toll Free: 1-800-262-3540, Fax: [phone]
For orders and order inquiries: 1-800-238-7538

# 510(k) Summary of Safety and Effectiveness

JAN 12 1998

K974232

| Trade Name: | ESSential® Shaver System<br>Modification to the ESSential® Sinus Shaver System (K953096) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electrical Surgical Shaver |
| Classification Name: | Surgical ENT drill, electric or pneumatic including handpiece and<br>ENT burr/blades |
| Official Contact: | Deborah Arthur<br>Group Manager<br>Regulatory & Quality Assurance<br>Smith & Nephew, INC.<br>ENT Division<br>2925 Appling Road<br>Bartlett, TN 38133 |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Date Prepared: | November 11, 1997 |

The modified ESSential Shaver System is substantially equivalent to the Xomed XPSTM System used with the STRAIGHTSHOT™, PERFORMA™ and SKEETER™ handpieces and the ESSential Shaver System.

The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectorny 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 transspehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy, laryngeal lesion debulking and tonsillectorny. Head and neck procedures would encompass soft

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# Food and Drug Administration 510(k) Notification - Modified ESSential Shaver System November 11, 1997

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 at the cerebellopontine angle.

The modified ESSential Shaver System that is described in this notification has the same technological characteristics, power modality and mode of operation as the originally cleared device. The broadened intended uses are substantially equivalent to the described predicate Xomed device. The modified ESSential Shaver System is designed to meet UL 2601-1 and IEC 601-1-2.

Differences between the modified ESSential Shaver System and the predicate devices should not affect the safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central emblem.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Deborah A. Arthur Group Manager Regulatory & O.A. Smith & Nephew, Inc. ENT Division 2925 Appling Road Barlett, TN 38133

Dear Ms. Arthur:

Re:

K974232 Electrical Surgical Shaver Dated: November 11, 1997 Received: November 12, 1997 Regulatory class: I 21 CFR 874.4140/Procode: 77 EQJ 21 CFR 874.4250/Procode: 77 ERL

JAN 1 2 1998

We have reviewed your Section 510(k) notification of intent to marker the device referenced above and we have decermined 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 that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.

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 predication 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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or - [phone] or at its Internet address http://www.fda.gov/odrhdsmamain.html":- ------------------------------------------------------------------------------------------

Sincerely yours.

Wiliam Yri

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Food and Drug Administration 510(k) Notification - Modified ESSential Shaver System November 11, 1997

510(k) Number: Device Name: ESSential® Shaver System Modification to the ESSential® Sinus Shaver System (K953096)

### Intended Use:

The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectorny 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 transspehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy, 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 at the cerebellopontine angle.

Prescription Use (Per 21 CFR 801.109)

David li. Seymore

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Division Sion off Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number