(36 days)
The device is intended for use in all types of endoscopic and endoscopic assisted procedures.
The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.
The Vista Single Chip Video Camera is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The product is a video camera. The system will be supplied as a Vista Single Chip Video Camera Head and a Camera Control Unit (CCU). The device is designed to work with commercially available light sources, V&C mount endoscope couplers and video monitors or head mounted displays.
The provided text describes a 510(k) submission for the Vista Single Chip Video Camera System. It outlines the device's intended use, predicate devices, and compliance with safety standards. However, it does not contain the detailed performance data, acceptance criteria, or study descriptions needed to fully answer your request regarding acceptance criteria and a study proving device conformance.
The "PERFORMANCE DATA" section only lists the standards the device was designed to comply with (IEC 601-1, IEC 601-1-2, UL544) and mentions "Optical Test Data" without providing any details about the tests, their results, or acceptance criteria.
Therefore, for most of your questions, the answer will be that the information is not provided in the given text.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text. |
| (The document only states the device was designed and will be tested in compliance with standards like IEC 601-1, IEC 601-1-2, and UL544, and mentions "Optical Test Data" without details.) | (No specific performance metrics or thresholds are provided.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not provided. This type of device (a video camera) typically relies on objective performance measurements rather than expert consensus on medical image interpretation for its primary safety and effectiveness evaluation for 510(k) purposes.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No, an MRMC study was not described or implied. This type of study is more relevant for diagnostic AI algorithms rather than a medical imaging device itself.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not described in the text. The "Optical Test Data" mentioned could refer to some form of standalone performance, but no details are given. The device is a video camera, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. For a video camera, "ground truth" would likely relate to objective optical and electrical performance characteristics measured against engineering specifications, rather than medical interpretations.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This device is a hardware video camera, not an AI algorithm that undergoes "training."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. The concept of a "training set" and "ground truth" for training does not apply to this type of device.
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MAY < 0 1997
Vista Medical Technologies Westborough MA
510(k) Vista Single Chip Video Camera April 1997
510(K) SUMMARY April 1997
COMPANY NAME AND ADDRESS
Vista Medical Technologies 134 Flanders Road Westborough, MA. 01581
CONTACT PERSON
Martin Newman Director of Regulatory Affairs and Quality Assurance (508) 366-3668 Telephone Fax: (508) 366-1543
DEVICE TRADE NAME
Vista Single Chip Video Camera System
COMMON NAME
Video Camera System
PREDICATE DEVICE
| 1. Device Name:Classification: | OktasEndoscopes and Accessories -21 CFR 876.1500 |
|---|---|
| Manufacturer: | Oktas134 Flanders RdWestborough, MA 01581 |
| 510(k) #: | K946171 |
| 2. Device Name:Classification :Manufacturer: | Olympus OTV-S5 Video SystemEndoscope and AccessoriesOlympusEndoscope DivisionTwo Corporate Center DriveMelville, New York 11747-3157 |
| 510(k) #: | K955404 |
Page 1 of 2
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Vista Medical Technologies Westborough MA
lg 2 of 2
510(k) Notification
Vista Single Chip Video Camera
April 1997
When compared to the predicate devices, the Vista Single Chip Video Camera System does not incorporate any significant change in intended use, method of operation, material or design that could effect the safety or effectiveness of the subject device.
DEVICE DESCRIPTION
The Vista Single Chip Video Camera is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The product is a video camera. The system will be supplied as a Vista Single Chip Video Camera Head and a Camera Control Unit (CCU). The device is designed to work with commercially available light sources, V&C mount endoscope couplers and video monitors or head mounted displays.
INTENDED USE
The device is intended for use in all types of endoscopic and endoscopic assisted procedures.
PERFORMANCE DATA
The Vista Single Chip Video Camera was designed and will be tested in compliance with the requirements of the following standards:
| IEC 601-1 | General Safety Requirements for Medical Electronic Equipment |
|---|---|
| IEC 601-1-2 | Electromagnetic Compatibility Requirements and Tests |
| UL544 | Standard for Safety Medical and Dental Equipment |
| Optical Test Data |
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of a bird in flight. The text is in a simple, sans-serif font and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
20 1997 MAY
Mr. Martin Newman Director of Regulatory Affairs and ... .................. Quality Assurance Vista Medical Technologies, Inc. 134 Flanders Road Westborough, Massachusetts 01581
Re: K971373
Vista Single Chip Video Camera System Dated: May 8, 1997 Received: May 9, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG
Dear Mr. Newman:
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.
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) 594-4616. 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,
William Yin, Ph.D.
Lillian Yin, Ph. Director, Division of Reproduc Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
L.S.A.T.
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Page 1 of 1
510(k) Number (if known): K971373 Vista Single Chip Video Camera System. ---------Device Name: ... . . . . . . . . . .
Indications for Use:
The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter R. Adkins
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
or
510(k) Number K971373
Prescription Use _ / (Per 21 CFR 801.109)
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.