DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

K970511 · Smith & Nephew, Inc. · HRX · Aug 12, 1997 · Orthopedic

Device Facts

• Record ID: K970511
• Device Name: DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
• Applicant: Smith & Nephew, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Aug 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS indication is limited to those small blades which are appropriate for the procedure.

Device Story

Disposable endoscopic surgery blades used for resection of soft and osseous tissues. Device connects to control console, motor drive unit, footswitch, and suction system. Surgeon operates device under endoscopic video visualization. Rotary action draws tissue into lateral cutting window; inner blade rotation excises material; suction and irrigation evacuate resected tissue. Modes include forward, reverse, and oscillate with variable speed control. Used in arthroscopy and FESS procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Disposable curved blades with lateral cutting windows. Materials and design consistent with previously cleared Dyonics blades. Operates via motor drive unit with suction and irrigation. Mechanical rotary cutting mechanism.

Indications for Use

Indicated for resection of soft and osseous tissues in large and small articular cavities and FESS. Contraindicated for FESS use: 2.0mm and 2.9mm TurboWhisker and 2.9mm Cutter.

Regulatory Classification

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.

Predicate Devices

• Stryker Endoscopy’s Curved Small Joint/ENT Disposable Blades
• Linvatec Merlin Disposable Arthroscopic Surgery Blade

Submission Summary (Full Text)

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AUG 12 1997 K97051)

510(k) Summary
Smith & Nephew, Inc.
Endoscopy Division
Dyonics Curved Small Joint Disposable Endoscopic Surgery Blades

## Substantial Equivalence:

The Smith & Nephew, Inc., Endoscopy Division Dyonics Curved Small Joint Disposable Endoscopic Surgery Blades are substantially equivalent in intended use, materials, design and function to small joint/ENT curved blades offered by Stryker Endoscopy for use with the Hummer and Hummer II Systems. Dyonics Curved Small Joint Disposable Endoscopic Surgery Blades are also substantially equivalent in intended use, materials, design and function to the Linvatec Merlin line of bendable disposable blades which are intended for use in arthroscopy and FESS procedures. Smith & Nephew, Inc., Endoscopy Division, Stryker Endoscopy and Linvatec provide blunt tip arthroscopic surgery blades in curved configurations. All blades have lateral cutting windows, in various diameters, lengths, and cutting window configurations. All blades are designed to run in conjunction with a control console, motor drive unit, footswitch, and a suction system under endoscopic video visualization.

## Predicate Device:

The predicate devices for this submission are Stryker Endoscopy’s Curved Small Joint/ENT Disposable Blades and the Linvatec Melin Disposable Arthroscopic Surgery Blade.

## Summary of Device Function:

Curved Small Joint Disposable Endoscopic Surgery Blades are utilized in conjunction with a control console, motor drive unit, footswitch and suction to resect soft and osseous tissues as per indications. The blades can be operated in forward, reverse and oscillate modes and at variable speeds controlled by the surgeon. The rotary action coupled with suction draws tissue into the window of the blade where rotation of the inner blade cleanly excises and evacuates the resected material. Irrigation aids in evacuation of resected materials through the blade.

## Intended Use of Device:

The Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS indication is limited to those small blades which are appropriate for the procedure.

## Comparison of Technological Characteristics of Predicate Device:

The basic design and function of the Dyonics line of Curved Small Joint Disposable Endoscopic Surgery Blades is consistent with the Dyonics curved blades designs as described in previous submissions. These designs, function and intended use are substantially equivalent to those for curved small joint/ENT blades marketed by Stryker Endoscopy and the Linvatec Merlin “bendable” arthroscopy blade. The addition of the features defined in this premarket notification submission present no new safety or effectiveness concerns for the device.

Deborah J. Connors
Regulatory Affairs

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Deborah J. Connors
Regulatory Affairs Specialist
Smith & Nephew, Inc., Endoscopy Division
160 Dascomb Road
Andover, Massachusetts 01810

AUG 12 1997

Re: K970511
Trade Name: Dyonics Disposable Endoscopic Surgery Blades
Regulatory Class: II
Product Code: HRX
Dated: May 21, 1997
Received: May 22, 1997

Dear Ms. Connors:

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 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). 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 (QS) 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.

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Page 2 - Ms. Deborah J. Connors

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 [phone]. Additionally, for questions on the promotion 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/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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# Indications for Use Statement

Indications for Use: Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues 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.

Contraindications: The 2.0mm and 2.9mm TurboWhisker® and 2.9mm Cutter are contraindicated for FESS applications.


(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 6970511

Prescription Use ☑
(Per 21 CFR 801.109)