(63 days)
The MR Endoscopic Video System is intended to digitally generate and display an image captured from a rigid or flexible endoscope during a minimally invasive interventional MR surgical procedure.
The MR Endoscopic Video System consists of a color camera signal processor (PAL or NTSC), camera head, color video monitor and all associated cables. The camera is powered by a 19 volt (PAL) or 15 volt (NTSC) battery pack. The video monitor is powered by a 110 volt AC to 12.5 volt DC medical-grade power supply attached to the end of a 20 foot shielded cable. The camera head attached to endoscopes by a non-conductive snap-lock coupling. The camera is connected to the video monitor via a cable. The endoscopic image can then be displayed to a remotely located video monitor.
The provided document is a 510(k) Premarket Notification for the "MR Endoscopic Video System" from Greatbatch Scientific, dated July 29, 1998. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, electrical safety, and MR safety.
This document does not contain information regarding clinical performance studies with acceptance criteria, human reader performance, or ground truth establishment typically found in submissions for AI/ML-powered medical devices. The device described is an endoscopic video system, which is a display technology, not an AI diagnostic or assistance algorithm.
Therefore, I cannot provide the requested information. The document only states:
Acceptance Criteria/Performance (Implicit):
The device was tested for Electrical Safety and Performance Data (Electromagnetic Compatibility) and MR Safety. It was found to be "acceptable in an interventional MR environment." This implies that the acceptance criteria were met for these safety and basic performance aspects, likely against established electrical safety and MR compatibility standards of the time.
Specific Study Details Not Available:
The document does not detail specific acceptance criteria for image quality, diagnostic accuracy, precision, or other performance metrics that would be relevant for an AI/ML-driven device. There is no mention of:
- Reported device performance values (e.g., sensitivity, specificity).
- Sample sizes for test sets, data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies (AI vs. without AI).
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for training set.
- How ground truth for the training set was established.
This information is absent because the device is a video system, not an AI/ML diagnostic tool.
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Greatbatch Scientific
JUL 2 9 1998
. - -- --
1981856
MR Endoscopic Video System
510(k) Premarket Notification
510(K) SUMMARY MR ENDOSCOPIC VIDEO SYSTEM
| Submitter Name: | Greatbatch Scientifica division of Wilson Greatbatch Ltd. |
|---|---|
| Submitter Address: | 9645 Wehrle DriveClarence, New York 14031-1899 |
| Contact Person: | Gary J. Sfeir, RAC |
| Phone Number: | 716.759.5655 |
| Facsimile Number: | 716.759.5654 |
| Date Prepared: | 22 May 1998 |
| Device Trade Name: | MR Endoscopic Video System |
| Device Common Name: | Color Television Camera System |
| Classification Name: | Camera, Television, Endoscopic |
| Predicate Devices: | Camera:EndocamCorin, U.S.A.Tampa, FLVideo Monitor:Sony PVM-1343MD Color VideoMonitorSony Medical SystemsMontvale, NJ |
| Device Description: | The MR Endoscopic Video System consists of a colorcamera signal processor (PAL or NTSC), camera head,color video monitor and all associated cables. The camera ispowered by a 19 volt (PAL) or 15 volt (NTSC) battery pack.The video monitor is powered by a 110 volt AC to 12.5 voltDC medical-grade power supply attached to the end of a 20foot shielded cable. The camera head attached to endoscopesby a non-conductive snap-lock coupling. The camera isconnected to the video monitor via a cable. The endoscopicimage can then be displayed to a remotely located videomonitor. |
| Intended Use: | To digitally generate and display an image captured from arigid or flexible endoscope during a minimally invasiveinterventional MR surgical procedure. |
SK-9
Gu
class II
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Greatbatch Scientific
Image /page/1/Picture/1 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The text includes 'K481856' followed by 'Pg 2087'. The writing style suggests it could be a reference code, page number, or some other form of identification label.
Device Technological Characteristics and Comparison to Predicate Devices(s): The device technological characteristics are similar in design to the predicate devices.
The devices were tested for Electrical Safety and Performance Data: Electromagnetic Compatibility. They were also tested for MR Safety and were found to be acceptable in an interventional MR environment.
The MR Endoscopic Video System as designed can be safely Conclusion: used in a MR environment.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines or strokes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jul 2 9 1998
Mr. Gary J. Sfeir, RAC Director, Regulatory Affairs Greatbatch Scientific 4100 Barton Road Clarence, NY 14031
Re: K981856
Magna-Cam Camera and Magna-Pix Video Monitor Dated: May 26, 1998 Received: May 27, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FET
Dear Mr. Sfeir:
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 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 requirements, as set forth in the Quality System Regulation (OS) 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 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) 594-4613. 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/dsmaldsmamain.html".
Sincerely you
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 3
INDICATIONS FOR USE
510 (k) Number (if known):
K 981856
Device Name:
MR Endoscopic Video System
Indications For Use:
The MR Endoscopic Video System is intended to digitally generate and display an image captured from a rigid or flexible endoscope during a minimally invasive interventional MR surgical procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
CONCURRENCE OF CDRH; OFFICE OF DEVICE EVALUATION (ODE)
OR...
(Division Sign-Off)
PRESCRIPTION USE _____________________________________________________________________________________________________________________________________________________________
OVER-THE-COUNTER USE
(OPTIONAL FORMAT 1-2-96)
Robert R. Mathis /
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
K98-1451
510(k) Number K 981856
§ 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.