VIEW MD OFFICE SYSTEM, MODEL 41066.5540

K071292 · Richard Wolf Medical Instruments Corp. · GCJ · Jul 19, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071292
• Device Name: VIEW MD OFFICE SYSTEM, MODEL 41066.5540
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The View MD Office System is designed to deliver illumination, provide camera use, and display and store images obtained during endoscopic surgical or diagnostic procedures.

Device Story

View MD Office System is a compact, integrated unit combining a 50-watt light source, 1 CCD camera, and LCD monitor. Device provides illumination for endoscopic procedures, captures video/images from the camera, displays them on the integrated monitor, and stores images on a USB memory stick. Used in clinical/office settings by physicians or trained medical staff during endoscopic surgical or diagnostic procedures. Output allows real-time visualization of the surgical site and documentation of findings for clinical decision-making. Benefits include consolidated equipment footprint and simplified image management.

Clinical Evidence

No clinical data. Bench testing only, confirming compliance with IEC 60601-1 and IEC 61000-3-2 / -3, 61000-4-2 / -3 / -4 / -5 / -6 / -8 / -11 standards.

Technological Characteristics

Integrated 50W light source, 1 CCD camera, and LCD monitor. Compact form factor. Connectivity includes USB port for image storage. Electrical safety/EMC testing per IEC 60601-1 and IEC 61000 series.

Indications for Use

Indicated for use during endoscopic surgical or diagnostic procedures to provide illumination, camera functionality, and image display/storage for patients undergoing such procedures.

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

• Light Projector 4251.007 and Endocam Light 5551.107 with Camera Heads 5551.961 (NTSC) and 5551.901 (PAL) (K010033)
• KSEA Medi Pack (K022490)
• Light source 4008, 4046, 4246 (Pre-enactment)
• CCD Endocam Office 5501 (K950502)

Submission Summary (Full Text)

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## JUL 19 2007

K071292

# 13 510(k) Summary of Safety and Effec

| Submitter: | |
|----------------------------------------|----------------------------------------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | IL 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | 04. May 2007 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | ( 847 ) 913 1113 |
| FAX number (include area code): | ( 847 ) 913 0924 |

Product Information:

| Trade name: | View MD Office System |
|----------------------|---------------------------------|
| Model number: | 41066.5540 |
| Common name: | Light Source / Camera / Monitor |
| Classification name: | Light Source |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|------------------|-------------------------------------------------------------------------------------------------------------|-----------------|
| 1. K010033 | 1. Light Projector 4251.007 and Endocam Light 5551.107 with Camera Heads 5551.961 (NTSC) and 5551.901 (PAL) | 1. Richard Wolf |
| 2. K022490 | 2. KSEA Medi Pack | 2. Karl Storz |
| 3. Pre-enactment | 3. Light source 4008, 4046, 4246 | 3. Richard Wolf |
| 4. K950502 | 4. CCD Endocam Office 5501 | 4. Richard Wolf |

### 1.0 Description

2

The View MD Office System is a 50 watt light source, 1 CCD camera, and LCD Monitor with image capture combined into a compact unit.

#### 2.0 Intended Use

The View MD Office System is designed to deliver illumination, provide camera use, and display and store images obtained during endoscopic surgical or diagnostic procedures.

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#### 3.0 Technological Characteristics

- There are no new technological characteristics when the sum of the separate components are compared to the combination device with the exception of the ability to store images on a USB Memory Stick.
#### 4.0 Substantial Equivalence

The View MD Office System is substantially equivalent to separated devices currently sold by Richard Wolf , as well as, the Medi Pack device (K022490) sold by Karl Storz.

#### 5.0 Performance Data

The View MD Office System has been tested to conform to IEC 60601-1 and IEC 61000-3-2 / -3, 61000-4-2 / -3 / -4 / -5 / -6 / -8 / -11.

#### 6.0 Clinical Tests

No clinical test were performed.

#### 7.0 Conclusions Drawn

The device is designed and tested to assure safety and effectiveness when used according to the instructions for use.

By:

Robert Lasso

Robert L. Casarsa

Date: May 4, 2007

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

JUL 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard Wolf Medical Instruments Corp. % Mr. Robert L. Casarsa Quality Assurance Manager 353 Corporate Woods Parkway Vernon Hills, Illinois 60061-3110

Re: K071292

Trade/Device Name: "View MD Office System" 41066.5540 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 4, 2007 Received: May 8, 2007

Dear Mr. Casarsa:

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 does 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 - Mr. Robert L. Casarsa

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Koziagz

Device Name: "View MD Office System" 41066.5540

510(k) Number (if known):

Indications for Use: The "The View MD Office System" is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures

ction 5 Indications for Us

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDF and Neurological De

**510(k) Number** K071243

Prescription use (Part 21 CFR 801 Subpart D)

and / or

Over-The Counter Use (Part 21 CFR 801 Subpart D)

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