ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR

K972927 · Richard Wolf Medical Instruments Corp. · GCJ · Nov 6, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972927
• Device Name: ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Richard Wolf endoscopes for use in plastic surgery are designed to visualize anatomy through natural and man-made openings in body cavities. The endoscopes may be used to visualize subcutaneous tissue when the indicated application is endoscopic cosmetic surgery of the facial and forethead / breast aughertation, and endospopic absominal plasity procedures.

Device Story

Panoview Telescopes are rigid endoscopes used for visualization of anatomy and subcutaneous tissue during plastic and reconstructive surgery. Devices feature 4mm, 7mm, or 10mm diameters; working lengths of 190mm to 300mm; and viewing angles of 0°, 25°, or 50°. Eyepieces are either fixed or detachable. Operated by surgeons in clinical settings, these devices provide direct optical visualization of body cavities and subcutaneous spaces to assist in surgical navigation and procedure performance. They function as passive optical instruments to facilitate minimally invasive surgical access.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Rigid endoscopes with 4mm, 7mm, 10mm diameters; 190mm-300mm lengths; 0°, 25°, 50° viewing directions. Features removable or permanent eyepieces. Passive optical visualization device.

Indications for Use

Indicated for visualization of anatomy and subcutaneous tissue during endoscopic cosmetic and reconstructive plastic surgery procedures, including facial, forehead, breast augmentation, and abdominal plastic surgery.

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

• WECO Endoscopic System w/ Fiber Optic Light (K951519)
• Diamond-View™ Non-Autoclavable Endoscopes, 10mm (K960400)

Reference Devices

• Storz Endoscope
• Snowden-Pencer EndoPlastic™ Scope, 10mm

Submission Summary (Full Text)

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son capitar in la sankar Vernon Hills, Illinois 60064 Phone: [phone] Fax: 847,913,1488

## NOV - 6 1997

| | | | RICHARD WOLF<br>MEDICAL INSTRUMENTS CORPORATION |
|--------------------------------|---------------------------------------------------------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Summary of Safety and Effectiveness | | |
| Submitter: | | | Date of Preparation:<br>August 5, 1997 |
| Company / Institution Name: | Richard Wolf Medical Instruments Corp. | | FDA establishment registration number:<br>14 184 79 |
| Division name (if applicable): | N.A. | | Phone number (include area code):<br>[phone] |
| Street address: | 353 Corporate Woods Parkway | | FAX number (include area code):<br>[phone] |
| City: | Vernon Hills | State / Province: | Illinois |
| Country: | USA | ZIP / Postal Code: | 60061 |
| Contact Name: | Mr. Robert L. Casarsa | | |
| Contact Title: | Quality Assurance Manager | | |
| Trade name: | Panoview Telescopes | Model number: | 8880.401, 8880.431, 8880.402,<br>8880.403, 8933.441, 8933.401,<br>8933.442, 8933.402, 8933.441,<br>8933.421, 8934.442, 8934.422 |
| Common name: | Endoscopes | Classification name: | Laparoscope, Plastic and<br>General Surgery |
| | Information on devices to which substantial equivalence is claimed: | | |

| | 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---------------|----------------------------------------------------|-----------------------------|
| 1 | K951519 | WECO Endoscopic System w/ Fiber Optic<br>Light | Wells Endoscopic<br>Company |
| 2 | | Endoscope | Storz |
| 3 | | EndoPlastic™ Scope, 10mm | Snowden-Pencer |
| 4 | K960400 | Diamond-View™ Non-Autoclavable<br>Endoscopes, 10mm | Snowden-Pencer |
| 5 | | | |

#### 1.0 Description

파

The Richard Wolf Endoscopes have 4mm, 7mm, and 10mm diameters with working lengths ranging from 190mm to 300 mm. They have a viewing direction of 0°, 25°, and 50°. The eyepieces are fixed or detachable, depending upon the specific model.

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ResseS 10/97

#### 2.0 Intended Use

Richard Wolf endoscopes for use in plastic surgery are designed to visualize anatomy through natural and man-made openings in body cavities. The endoscopes may be used to visualize subcutaneous tissue when the indicated application is endoscopic cosmetic surgery of the facial and forethead / breast aughertation, and endospopic absominal plasity procedures.

#### 3.0 Technological Characteristics

· Removable and permanent eyepiece

#### Substantial Equivalence 4.0

The Richard Wolf Endoscopes for plastic surgery are substantially equivalent to:

- Snowden-Pencer .
- · Wells Endoscopy
- Karl Storz
- Storz (USA) .

All devices have the same intended use.

#### 5.0 Performance Data

- 6.0 Clinical Tests None
#### 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.

By: Robert Casaran

Robert L. Casarsa Quality Assurance Manager

Date: Aug 5, 92

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The overall design is simple and clean, with a focus on the text and the symbolic image of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

NOV - 6 1997

Re: K972927 Trade Name: Panoview Telescopes Regulatory Class: II Product Code: GCJ Dated: August 5, 1997 Received: August 8, 1997

Dear Mr. Casarsa:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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 - Mr. Robert L. Casarsa

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

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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≤ 10(k) **Number (if known):**

# 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Endoscopes for Plastic Surgery Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

## Indications for Use:

Richard Wolf endoscopes for use in plastic surgery, are designed to visualize anatomy through natural and recenture well and socked for ass ar processors) may be used to visualize subcuraneous tissue when the indicated application is endoscopic plastic/reconstructive surgery.

Revised 10/31/97

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K972927
510(k) Number

Prescription Use
Per CFR 21 CFR 801.109
OR
1 - 3
Over-The-Counter Use_