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 Description

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Modified ESSential Shaver System." This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with detailed performance metrics against specific acceptance criteria. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of why the requested information is absent based on the document's content:

Acceptance Criteria and Reported Device Performance: The document does not list specific acceptance criteria (e.g., precision, accuracy, sensitivity, specificity) for the device's performance in surgical procedures. Instead, it states that the modified system "has the same technological characteristics, power modality and mode of operation as the originally cleared device" and that "Differences between the modified ESSential Shaver System and the predicate devices should not affect the safety or effectiveness." This indicates that the established safety and effectiveness of the existing predicate devices are implicitly the "acceptance criteria."
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): There is no mention of any new clinical or performance studies being conducted with test sets, training sets, human experts, or ground truth data. The 510(k) process for this device relies on demonstrating equivalence to already cleared devices, not on proving new performance metrics through independent studies.

In summary, the document states that the modified ESSential Shaver System is considered substantially equivalent to existing predicate devices based on its technological characteristics, power modality, mode of operation, and its ability to meet UL and IEC standards. It does not provide details of a study that would define and then prove the device meets specific performance acceptance criteria for new clinical uses.

Summary

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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: 901-373-0220
For orders and order inquiries: 1-800-238-7538

510(k) Summary of Safety and Effectiveness

JAN 12 1998

K974232

Trade Name:	ESSential® Shaver SystemModification to the ESSential® Sinus Shaver System (K953096)
Common Name:	Electrical Surgical Shaver
Classification Name:	Surgical ENT drill, electric or pneumatic including handpiece andENT burr/blades
Official Contact:	Deborah ArthurGroup ManagerRegulatory & Quality AssuranceSmith & Nephew, INC.ENT Division2925 Appling RoadBartlett, TN 38133
Telephone:	(901) 373-0200
Telefax:	(901) 373-0242
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.

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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 (301) 594-4613. Additionally, for question 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/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:

Prescription Use (Per 21 CFR 801.109)

David li. Seymore

Division Sign Off

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

Regulation Number and Section

§ 874.4140 Ear, nose, and throat bur.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.