(93 days)
The 3-CCD Digital Camera System provides medical professionals with video capabilities for diagnostic and surgical procedures.
This device is a 3-CCD Digital Camera System utilized for medical applications. The intended use for this device is identical to that of most contemporary surgical video camera systems and accessories. The 3-CCD Digital Camera System has been designed and manufactured to meet the UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 guidelines for electrical safety.
The provided text describes a 3-CCD Digital Camera System. However, it does not include information about acceptance criteria, device performance, or a study proving that the device meets specific criteria related to its diagnostic or surgical capabilities.
The document primarily focuses on:
- Regulatory clearance: FDA clearance (K970605) for the device as "substantially equivalent" to a predicate device (K941919).
- Safety standards: Mention of meeting UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 for electrical safety.
- Intended use: "providing medical professionals with video capabilities for diagnostic and surgical procedures."
Since the document does not contain the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth, or expert qualifications, I cannot populate the table or answer the specific questions.
The document is a regulatory clearance letter and a brief device description, not a performance study report.
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MAY 2 2 1997
of Salely .
CONFIDENTIAL
11970605
Daniel P McGuire General Manager
This device is a 3-CCD Digital Camera System utilized for medical applications. The intended use for this device is identical to that of most contemporary surgical video camera systems and accessories. The 3-CCD Digital Camera System has been designed and manufactured to meet the UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 guidelines for electrical safety. UL (Underwriter's Laboratories) will be utilized to certify that our product either meets or exceeds the necessary standards for safety compliance. The 3-CCD Digital Camera System is comparable to that of other legally marketed video camera systems. The design was based upon a predicate device that was found to be substantially equivalent in 510K (K941919).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Mr. Dave V. Michels Quality Assurance Manager Envision Medical Corporation 749 Ward Drive Santa Barbara, California 93111
Re: K970605 Trade Name: 3-CCD Digital Camera System Regulatory Class: II Product Code: GCJ Dated: May 6, 1997 Received: May 8, 1997
Dear Mr. Michels:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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Page 2 - Mr. Dave V. Michels
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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Image /page/3/Picture/0 description: The image shows the logo for Envision. The logo consists of the word "Envision" in a sans-serif font, with a stylized graphic to the right. The graphic is a circular shape with three horizontal lines extending from the left side, resembling a stylized "E" or a partially formed globe. The logo is in black and white.
January 16, 1997 -
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| 510(k) Number (if known): | K970605 |
|---|---|
| --------------------------- | --------- |
Device Name: 3-CCD Digital Camera System
Indications for Use:
The 3-CCD Digital Camera System provides medical professionals with video capabilities for diagnostic and surgical procedures.
(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. K970605
Prescription Use OR (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
Envision Medical Corporation 749 Ward Drive Santa Barbara, CA 93111 Tel. (805) 967-6000 Fax. (805) 967-2119
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§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.