(86 days)
The Image Technologies Corporation SteriCam and TroView Imaging System consists of a CCD camera, coupler and a computer-based documentation system. The SteriCam is intended to attach to a standard commercially available endoscope for visualization of body cavities, hollow organs, and canals. The System includes a Coupler-Drape Assembly which is intended to couple the SteriCam to a standard commercially available endoscope. The TroView System is intended to provide documentation/storage of the image in the field of view of the SteriCam.
The Image Technologies Corporation's SteriCam, SteriCam Coupler-Drape and TroView Imaging System consists of a CCD camera, coupler and a computer based documentation system. The SteriCam takes the image that normally would be seen by the naked eye, and displays it on a color monitor. The SteriCam provides imaging through standard commercially available endoscopes and is designed to be used with the sterile SteriCam Coupler-Drape. The Coupler-Drape includes a sterile drape component. The SteriCam is placed within the sterile drape of the Coupler-Drape to prevent contamination in the sterile field. The video signal cable connects the SteriCam to the TroView Documentation System.
The SteriCam Coupler-Drape's distal end attaches to the eyepiece of a conventional endoscope and uses the SteriCam CCD camera to display the image on the computer monitor. The SteriCam Coupler-Drape simply connects the conventional endoscope to the SteriCam. The SteriCam Coupler-Drape is sterile and includes the drape so that the non-sterile SteriCam Camera and cable are covered during the surgical procedures. Although the SteriCam Coupler-Drape attaches to various endoscopes, it is designed to be used only with the SteriCam camera.
The TroView System is a non-sterile reusable unit that is intended to provide real time image displays as well as storage of the image in the field of view of the SteriCam. As the TroView receives and displays the SteriCam digitized video output, the images can be adjusted for brightness, hue, contrast and saturation. The TroView System allows for printing to a dedicated printer or saving the image in to a 1.44 MB 3.5" floppy disk or other storage medium. A software based zoom is also permitted.
A sterile disposable Remote Controller is also offered with the TroView System which permits remote control access to key camera and computer functions. The Remote Controller looks and performs identically to the controller pad located on the faceplate of the computer. The physician is able to place the sterile Remote Controller in the sterile field whereas the faceplate of the computer is non-sterile and situated outside the sterile field.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device Name: Image Technologies Corporation SteriCam, Coupler-Drape and TroView System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Resolution comparable to predicate devices | 3.17 lines per mm |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a "test set" in the context of clinical or image-based evaluation with a defined sample size of distinct images or cases.
- Sample Size: Not specified in terms of number of images, cases, or patients. The testing involved a standard target rather than biological samples.
- Data Provenance: Not applicable in the context of this performance testing, as it used a standardized test target rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The ground truth for resolution testing using a USAF 1951 Test Target is inherent in the design of the target itself (known line pairs per millimeter). No human experts are used to establish this specific ground truth for this type of technical performance measurement.
4. Adjudication Method for the Test Set:
Not applicable. As the testing involved a technical resolution target and not clinical interpretation, there was no need for an adjudication method by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. The document describes a technical performance test, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance test was done for resolution. The "Image Quality testing" performed on the system measures the device's intrinsic resolution capability using a standardized target, independent of human interpretation or interaction beyond operating the device to capture the image.
7. The Type of Ground Truth Used:
The ground truth used for the image quality testing was a standardized physical target (USAF 1951 Test Target designed to MIL-STD-150). The resolution values (lines per mm) are objectively measurable from this target.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. It is an imaging system (camera, coupler, documentation system) for visualization.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As mentioned, this device does not involve an AI/ML algorithm requiring a training set with established ground truth.
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7 1999 .IAN
510(k) Summary Image Technologies Corporation SteriCam, Coupler-Drape and TroView System
1. SPONSOR
Image Technologies Corporation 27 Wormwood Street Boston, MA 02210-1625 Telephone: 617-428-7595 Facsimile: 617-428-7599
Contact Person: Lunn Sawyer
Date Prepared: October 9, 1998
DEVICE NAME 2.
Classification Name: Endoscopes and accessories, 21 CFR 876.1500 TroCam/TroView Endoscopy System Proprietary Name:
3. INTENDED USE
The Image Technologies Corporation's SteriCam, Coupler-Drape and TroView Imaging System consists of a CCD camera, coupler and a computer-based documentation system. The SteriCam is intended to attach to a standard commercially available endoscope for visualization of body cavities, hollow organs, and canals. The SteriCam Coupler is intended to couple the SteriCam to the standard commercially available endoscope. The TroView System is intended to provide documentation/storage of the image in the field of view of the SteriCam camera.
4. DEVICE DESCRIPTION
The Image Technologies Corporation's SteriCam, SteriCam Coupler-Drape and TroView Imaging System consists of a CCD camera, coupler and a computer based documentation system. The SteriCam takes the image that normally would be seen by the naked eye, and displays it on a color monitor. The SteriCam provides
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imaging through standard commercially available endoscopes and is designed to be used with the sterile SteriCam Coupler-Drape. The Coupler-Drape includes a sterile drape component. The SteriCam is placed within the sterile drape of the Coupler-Drape to prevent contamination in the sterile field. The video signal cable connects the SteriCam to the TroView Documentation System.
The SteriCam Coupler-Drape's distal end attaches to the eyepiece of a conventional endoscope and uses the SteriCam CCD camera to display the image on the computer monitor. The SteriCam Coupler-Drape simply connects the conventional endoscope to the SteriCam. The SteriCam Coupler-Drape is sterile and includes the drape so that the non-sterile SteriCam Camera and cable are covered during the surgical procedures. Although the SteriCam Coupler-Drape attaches to various endoscopes, it is designed to be used only with the SteriCam camera.
The TroView System is a non-sterile reusable unit that is intended to provide real time image displays as well as storage of the image in the field of view of the SteriCam. As the TroView receives and displays the SteriCam digitized video output, the images can be adjusted for brightness, hue, contrast and saturation. The TroView System allows for printing to a dedicated printer or saving the image in to a 1.44 MB 3.5" floppy disk or other storage medium. A software based zoom is also permitted.
A sterile disposable Remote Controller is also offered with the TroView System which permits remote control access to key camera and computer functions. The Remote Controller looks and performs identically to the controller pad located on the faceplate of the computer. The physician is able to place the sterile Remote Controller in the sterile field whereas the faceplate of the computer is non-sterile and situated outside the sterile field.
5. PERFORMANCE TESTING
Image Quality testing was performed on the SteriCam, Coupler-Drape, and TroView System using the USAF 1951 Test Target designed to MIL-STD-150. The results showed that the TroView System resulted in a resolution of 3.17 lines per mm, which is comparable to that of the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 JAN
Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
K983567 Re:
Trade Name: Image Technologies SteriCam, Coupler-Drape and TroView Imaging System Regulatory Class: II Product Code: GCJ Dated: October 9, 1998 Received: October 13, 1998
Dear Ms. McNamara-Cullinane:
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 (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 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 - Ms. Mary McNamara-Cullinane, RAC
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,
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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0(k) Number (if known): 1983567
Image Technologies SteriCam, Coupler-Drape and TroView Imaging Device Name: System
Indications For Use:
The Image Technologies Corporation SteriCam and TroView Imaging System consists of a CCD camera, coupler and a computer-based documentation system. The SteriCam is intended to attach to a standard commercially available endoscope for visualization of body cavities, hollow organs, and canals. The System includes a Coupler-Drape Assembly which is intended to couple the SteriCam to a standard commercially available endoscope. The TroView System is intended to provide documentation/storage of the image in the field of view of the SteriCam.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use (Per 21 CFR 801.109) (Division Sign-Off) Division of General Restorative Devices 1983356 510(k) Number
Image Technologies Corporation 510(k) 10/9/98 SteriCam, Coupler-Drape, and TroView System
CONFIDENTIAL
§ 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.