SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPES

K974767 · Endoscopy Division · GCJ · Jan 23, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974767
• Device Name: SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPES
• Applicant: Endoscopy Division
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Dyonics® line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic surgical procedures and in endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Dyonics 4mm diameter Arthroscopes/ENT Endoscopes are indicated for use in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate. Dyonics Laparoscopes are indicated for use in laparoscopic surgical procedures to provide illumination and visualization of the surgical site. The 5mm x 300mm Dyonics Laparoscope is also indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels. Dyonics Hysteroscopes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The abrasive cleaning agent is provided as an accessory to the Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes and is intended to be used, when required, to clean the distal surfaces thus maintaining optical integrity and allowing the scopes to perform as per their intended uses.

Device Story

Rigid endoscopes (arthroscopes, ENT endoscopes, laparoscopes, hysteroscopes) used for illumination and visualization of surgical sites during minimally invasive procedures. Device includes an abrasive cleaning agent accessory to maintain optical integrity of distal surfaces. Operated by physicians in clinical/surgical settings. Modification pertains solely to expanded cleaning instructions. No changes to device design, function, or technology.

Clinical Evidence

Bench testing only; biocompatibility and residual chemical analyses performed to validate the safety of the modified cleaning instructions.

Technological Characteristics

Rigid endoscopes; optical illumination and visualization system. Modification involves addition of an abrasive cleaning agent accessory. No changes to materials or core sensing/actuation principles.

Indications for Use

Indicated for patients undergoing diagnostic or operative arthroscopic, laparoscopic, or hysteroscopic procedures; endoscopic examination/treatment of nasal cavities and nasal pharynx; removal of loose bodies/soft tissue in hip joints; and endoscopic surgery of superficial vessels/fascia of lower extremities. Prescription use only.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes

Submission Summary (Full Text)

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### K974767 510(k) Summary Smith & Nephew, Inc., Endoscopy Division Modification - Cleaning Instructions for Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes

# Substantial Equivalence:

The modified cleaning instructions defined in this premarket notification submission have no impact on the designed safety and efficacy of the Dvonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes. This conclusion is supported by the following testing: biocompatibility and residual chemical analyses.

## Predicate Device:

The predicate devices for this submission are the currently marketed Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes.

## Summary of Device Function:

The Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes are used during various minimally invasive endoscopic procedures to illuminate and visualize the surgical site.

## Intended Use of Device:

The Dyonics® Iine of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative atthroscopic surgical procedures and in endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Dyonics 4mm diameter Arthroscopes/ENT Endoscopes are indicated for use in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Dyonics Laparoscopes are indicated for use in laparoscopic surgical procedures to provide illumination and visualization of the surgical site.

The 5mm x 300mm Dyonics Laparoscope is also indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.

Dyonics Hysteroscopes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

## Comparison of Technological Characteristics of Predicate Device:

The basic technologies, design and function of the Smith & Nephew Dyonics Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes are not changed by the expanded cleaning instructions described in this Premarket Notification Submission. The expanded cleaning instructions defined in this submission raise no new issues of safety and effectiveness.

Debrah J. Connor

Deborah J. Connors Regulatory Affairs Specialist

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Image /page/1/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 perimeter. In the center of the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 1998

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

Re: K974767

> Trade Name: Modification - Cleaning Instructions for Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes Regulatory Class: II Product Code: GCJ Dated: December 19, 1997 Received: December 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

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Page 2 - Ms. Connors

devices under the Electronic Product 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 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,

tocoelfo

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number :

Device Name : Modification - Cleaning Instructions for Arthroscopes/ENT Endoscopes, Laparoscopes and Hysteroscopes

Indications for Use :

The Dyonics® line of rigid Arthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic surgical procedures and in endoscopic examination and treatment of the nasal cavities and nasal pharynx. In addition, the Dyonics 4mm diameter Arthroscopes/ENT Endoscopes are indicated for use in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Dyonics Laparoscopes are indicated for use in laparoscopic surgical procedures to provide illumination and visualization of the surgical site.

The 5mm x 300mm Dyonics Laparoscope is also indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.

Dyonics Hysterosocpes are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <img alt="Signature" src="signature.png"/> <div>(Division Sign-Off)</div> <div>Division of General Restorative Devices</div> <div>510(k) Number: K474767</div> </div> |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) <img alt="Prescription Use" src="prescription_use.png"/> | OR Over-the-Counter ____ |

(Optional Format 1-2-96)

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J.C.H.L.D. 23

(R) 749 1443

NO.631 ь:3

p974767 ನ್ನ OR Us e Inclications

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The abrasive cleaning agent is provided as an accessory to the Dyonics Arthroscopes/ENT I he abrastoscopes and Hysteroscopes and is intended to be used, when required, to Ellooscopes, Laparoscopes and Arraces thus maintaining optical integrity and allowing the scopes to perform as per their intended uses.

**Prescription Use**
**(Per 21 CFR 801.109)**

(Divisio Sign-Off) Division of General Restorative 510(k) Number ________________________________________________________________________________________________________________________________________________________________