KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM

K973430 · Eastman Kodak Company · GCJ · Jul 17, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973430
• Device Name: KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
• Applicant: Eastman Kodak Company
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The camera is intended to digitally capture images for micro-surgery, pathology, micro-biology, ophthalmology and general surgery applications. Upon capturing the image, it is stored in the memory of the PCMCIA Card in the camera. User may utilize the audio function of the camera to record patient, exam or any other pertinent identification information. The Camera is connected to the computer via the high speed serial bus (IEEE 1394) cable interface. The images are viewed, selected and then downloaded using Twain Compliant" Driver for PCs and Adobe Photoshop Plug-in Software for MACINTOSH based systems. The user will be able to annotate and format the images and add information prior to transmission and/or archiving. The camera is capable of both lossy and lossless data compression. The operator is instructed in the manual to utilize only lossless data compression for medical applications.

Device Story

Kodak Pro-Medical Digital Camera System captures digital images for surgical and clinical applications; stores images on internal PCMCIA card; includes audio recording for patient/exam identification. Device connects to PC/Macintosh via IEEE 1394 high-speed serial bus. Users view, select, and download images using TWAIN-compliant drivers or Adobe Photoshop plug-ins. Software allows image annotation, formatting, and data management prior to archiving. Supports lossy and lossless data compression; manual mandates lossless compression for medical use. Operated by clinical staff in surgical or laboratory settings to document procedures and findings; output used for clinical review and record-keeping.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital camera system; IEEE 1394 (FireWire) interface; PCMCIA storage; TWAIN-compliant driver; Adobe Photoshop plug-in software. Supports lossy and lossless data compression algorithms.

Indications for Use

Indicated for digital image capture in micro-surgery, pathology, micro-biology, ophthalmology, and general surgery applications.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 1998

Mr. Paul Schiller · Worldwide Product Manager Eastman Kodak Company 343 State Street Rochester, New York 14650

Re: K973430 Trade Name: Kodak Pro-Medical Digital Camera System Regulatory Class: II Product Code: GCJ Dated: March 12, 1998 Received: March 16, 1998

Dear Mr. Schiller:

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 requirement, 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.

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.

{1}------------------------------------------------

Page 2 - Mr. Paul Schiller

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,
Piollope

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

{2}------------------------------------------------

Page 8 of 11

510(k) Number (if known): __ 973430

Device Name: KODAK Pro-Medical Digital Camera System

Indications For Use:

The camera is intended to digitally capture images for micro-surgery, pathology, micro-biology, ophthalmology and general surgery applications. Upon capturing the image, it is stored in the memory of the PCMCIA Card in the camera. User may utilize the audio function of the camera to record patient, exam or any other pertinent identification information. The Camera is connected to the computer via the high speed serial bus (IEEE 1394) cable interface. The images are viewed, selected and then downloaded using Twain Compliant" Driver for PCs and Adobe Photoshop Plug-in Software for MACINTOSH based systems. The user will be able to annotate and format the images and add information prior to transmission and/or archiving. The camera is capable of both lossy and lossless data compression. The operator is instructed in the manual to utilize only lossless data compression for medical applications.

(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 | |
| 510(k) Number | K973430 |

| Prescription Use | X | OR | Over-The-Counter Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

Pres (Per 21 CFR 801.109)

to the counter 300

(Optional Format 1-2-96)