(116 days)
The Smith & Nephew DYONICS Power II Shaver System control unit is indicated for use, when used with appropriate procedure specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
Not Found
This is a 510(k) premarket notification for a medical device (Smith & Nephew DYONICS Power II Shaver System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/ML study is not applicable.
The provided document describes the regulatory classification of the device, its indications for use, and confirms that it has been found substantially equivalent to predicate devices. It does not contain information about performance studies in the context of an AI/ML model.
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Kα62849
A. Device Name (Unmodified):
Device Trade Name Smith & Nephew DYONICS Power II Shaver System
JAN 1 9 2007
Common/Classification Name Arthroscopic Accessory - Shaver Control Unit
B. Submitter Information:
| Company Name | Smith & Nephew, Inc., Endoscopy Division |
|---|---|
| Address | 150 Minuteman Road, Andover, MA, 01810 |
| Contact | Kathleen Burns |
C. Establishment Registration Number(s):
| Owner/Operator Name | Smith & Nephew, Inc. Endoscopy Division |
|---|---|
| Address | 150 Minuteman Road, Andover, MA 01810 |
| Establishment Registration # | ER# 1216828 |
| Owner Operator # | # 1216828 |
| Manufacturing Site | Smith & Nephew, Inc. Endoscopy Division |
| Address | 76 S.Meridian Ave. Oklahoma City, OK 73107 |
| Establishment Registration # | ER# 1643264 |
| Owner Operator # | # 1216828 |
D. Device Classification: Regulation Number and Regulatory Status
The Smith & Nephew DYONICS Shaver System has been classified as Class II. per 21 CFR §888.1100 and 874.4250. The device Procode is HRX, ERL.
E. Performance Standards
There are no known performance standards or special controls promulgated under section 514 of the Act for this device
Smith & Nephew, Inc DYONICS Power II Shaver Sys Page 10 of 324
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Ms. Kathleen Burns Regulatory Specialist 150 Minuteman Road Andover, Massachusetts 01810
JAN 1 9 2007
Re: K062849
Trade/Device Name: Smith & Nephew DYONICS Power II Shaver System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: December 18, 2006 Received: December 20, 2006
Dear Ms. Burns:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Kathleen Burns
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly vours.
for
Mark N. Melkerson
Mark N N. Me Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew DYONICS Power II Shaver System
Indications for Use:
The Smith & Nephew DYONICS Power II Shaver System control unit is indicated for use, when used with appropriate procedure specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number L062849
Smith & Nephew, Inc
DYONICS Power II Shaver Sys
Page 9 of 324
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.