IMAGE MANAGEMENT SYSTEM

K033870 · Welch Allyn, Inc. · HEX · Mar 12, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033870
• Device Name: IMAGE MANAGEMENT SYSTEM
• Applicant: Welch Allyn, Inc.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Welch Allyn Basic Image Management system is intended to capture, display, save, export, and print images obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Management system are not intended for diagnostic purposes. The provider shall use the image on the colposcope monitor for clinical diagnosis.

Device Story

The Welch Allyn Image Management System captures, displays, saves, exports, and prints video images from a Welch Allyn colposcope. A third-party DV converter connects to the colposcope via S-video, digitizes the signal, and transmits it to a computer via an IEEE 1394B connection (48kHz/16bit/2ch sampling). The system allows clinicians to save images to an electronic file system or import them into an electronic medical record (EMR/EHR). The device is intended for use in clinical settings by healthcare providers. It is not intended for diagnostic purposes; clinicians must rely on the live colposcope monitor for clinical decision-making. The system provides a mechanism for image documentation and reference for future patient visits.

Clinical Evidence

No clinical data. The device relies on bench testing and evaluation to demonstrate that it meets user needs for image capture, display, and export functionality.

Technological Characteristics

System utilizes a third-party DV converter for S-video to IEEE 1394B signal conversion. Sampling frequency: 48kHz/16bit/2ch. Connectivity: IEEE 1394B interface. Software-based image management for storage and export. No image manipulation capabilities. Designed for use with Welch Allyn video colposcope.

Indications for Use

Indicated for use with the Welch Allyn video colposcope to capture, display, save, export, and print images. Not intended for diagnostic purposes; clinical diagnosis must be performed using the colposcope monitor.

Regulatory Classification

Identification

A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

Special Controls

*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• Chili Video, Chili VideoPro (K000411)

Reference Devices

• Welch Allyn Colposcope (K955635)

Submission Summary (Full Text)

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K033870

# "510(k) SUMMARY" Summary of Safety and Effectiveness

MAR 1 2 2004

Submitter's Name & Address: Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, New York 13153

David Klementowski Contact Person & Telephone: [phone]

September 22, 2003 Date Summary Prepared:

Device Name: Classification Name -| Medical Image Digitizer Common/Usual Name - Image Management System Proprietary Name - Image Management System

Predicate Device: Chili Video, Chili VideoPro (510(k) number K000411)

## Device Description:

e Description.
The Welch Allyn Image Management System is intended for use with the Welch The Welch Allyn Integorient by 510(k) number K955635.

This system enables a customer to save an image to the customer's electronic This system enables a odotomer to ours allows the customer to review images file system for future rolerence and visit date. The file image may be imported into or based on patient lacklifer and tiertronic medical record/electronic health record if desired.

The third-party DV Converter attaches to the Welch Allyn Colposcope through an The third-party DV Oonvertor attaches video that the Converter accepts Svideo connection. The Octposed on prected digitizes the image and sends it to through the Ovideo Intended "The IEEE 1394B connection supplies the TO over an iEE_ sampling frequency of 48kHz/16bit/2ch. Minimum 50 framestoos with a requirements to run the software will be specified.

The images captured, displayed, saved, exported, and printed from the Basic The Images capturity, displayer not intended for diagnostic purposes. The image Management byetem and the colposcope monitor for clinical diagnosis.

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## Technological Characteristics:

| Table 1 | | |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Predicate device feature and specification comparison: | | |
| Technological<br>Specification | Welch Allyn Image Management<br>System | Chili Video, Chili VideoPro |
| Intended Use: | Capture, display, export, and print<br>images obtained from the Welch Allyn<br>video colposcope. | Provide the user with a means to<br>capture and digitize image data from a<br>video data stream. |
| Used to grab images from<br>modalities that do not have<br>digital export functions? | Yes - from Welch Allyn colposcope | Yes |
| Can grab single images | Yes | Yes |
| Can grab sequences of<br>images | Yes | Yes |
| Operated by computer<br>keyboard | Yes | Yes |
| Operated by an external<br>device | Yes - Welch Allyn video colposcope | No |
| Single channel color<br>acquisition | N/A | Yes |
| Multi-channel monochrome<br>images | N/A | Yes |
| Various frame grabber boards<br>available | No | Yes |
| Grabbed image can be<br>manipulated | No | No |
| Images can be added to a<br>study | N/A | Yes |
| User enter patient<br>demographic data | No | Yes |
| Images can be stored with<br>demographic data | No | Yes |
| Can be used with any device<br>that has video data stream<br>output | Yes - but labeling indicates it is for use<br>with Welch Allyn video colposcope | Yes |
| User selectable video sources | Yes - but labeling indicates it is for use | Yes |

### Summary of Safety:

This system is safe for both the patient and user. The system is intended to capture, display, save, export, and print images obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Management system are not intended for diagnostic purposes. The provider shall use the image on the colposcope monitor for clinical diagnosis.

with Weich Allyn video colposcope

#### Summary of Effectiveness:

The Welch Allyn Image Management System is effective for its intended use. Testing and evaluation indicate that the system meets the needs of the users of the device.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN... USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right. The profiles are stacked vertically, with the top profile being the largest and the bottom profile being the smallest. The seal appears to be an official emblem, possibly representing a government agency related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2004

Mr. David Klementowski Sr. Manager, Regulatory Affairs Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 SKANEATELES FALLS NY 13153-0220

Re: K033870 Trade/Device Name: Basic Image Management System Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 85 HEX and 90 LMA Dated: December 8, 2003 Received: December 16, 2003

Dear Mr. Klementowski:

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. Ilisting 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 (2) 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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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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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510(k) Number (if known): K033870
Device Name: Basic Image Management System

#### Indications For Use:

The Welch Allyn Basic Image Management system is intended to capture, display, The Welch Allyn Dasto mages obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Imagement system are not intended for diagnostic purposes. The provider shall use the image on the colposcope monitor for clinical diagnosis.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number