(48 days)
The ImageScape is intended to be used to capture, store and manipulate digital images of the retina taken by fundus camera.
The ImageScape is intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.
The ImageScape consists of: (1) a digital camera; (2) an imaging board; (3) a personal computer; (4) a monitor; and (5) Tomey's Windows-based image processing software. The ImageScape is used during ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp with a fundus camera. Images are transferred to the ImageScape's imaging board, located in the ImageScape's personal computer, and stored in the computer's Random Access memory ("RAM") and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to operate the icons.
The provided 510(k) summary for the Tomey Corporation's ImageScape Digital Retinal Image System (K971685) does not contain information related to specific acceptance criteria or a study proving the device meets such criteria in terms of clinical performance.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: All devices (ImageScape, DFC, Imagenet, ORIMS) are intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.
- Technological Characteristics: Similar components (e.g., Kodak MegaPlus digital camera), storage capabilities (Jaz drive, TIFF format), operating systems (Pentium chip, Windows/Macintosh), and input methods (keyboard, mouse).
- Software Functions: Similar functions for image acquisition, analysis, storage, and retrieval, including manipulation (zoom, invert, flip, rotate, brightness/contrast, sharpen) and enhancement (shadow, edge trace, blur).
- Operational Manner: Used by an ophthalmologist with a slit lamp and fundus camera, preparing the patient using standard ophthalmic procedures, and operating icon-driven interfaces.
- Software Verification and Validation: A statement that "Tomey has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements."
Therefore, many sections of your requested outline will be marked as "Not provided" or "Not applicable" based on the content of the K971685 submission. This is typical for 510(k) submissions demonstrating substantial equivalence for devices like this, where clinical performance studies are often not required if technological characteristics and intended use are similar to legally marketed predicate devices.
Here's the breakdown based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: | Not provided. The submission focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, not on specific clinical performance metrics for the ImageScape. |
| Software Verification & Validation: Device meets system and software specifications and requirements. | Met. "Tomey has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements." |
| Image Acquisition, Storage, Manipulation, Retrieval: Functions comparable to predicate devices. | Met. The ImageScape and predicate devices have "the same software functions: image acquisition, analysis, storage, and retrieval." |
| Image Quality: (Implied, derived from predicate equivalence) | Image transfer and processing does not use data compression, suggesting a focus on preserving image quality. No specific image quality metrics are provided. |
| Safety & Effectiveness: No new issues raised compared to predicate devices. | Met. "Minor differences do not raise any new issues of safety or effectiveness." and "This difference [operating system] does not raise any new issues of safety or effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not provided. This type of information is typically part of a clinical performance study, which was not the primary basis for this 510(k) submission.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. Ground truth establishment for a clinical test set is not part of this substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This device is a digital imaging system, not an AI-powered diagnostic aid that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. The device is described as being operated by an ophthalmologist.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The submission relies on demonstrating functional and technical equivalence to predicate devices, rather than a direct clinical performance study requiring a gold standard ground truth.
8. The sample size for the training set
- Not provided. Given that this is an imaging system and not a machine learning algorithm in the modern sense, a "training set" as concept might not directly apply. The device's software was developed and validated against specifications.
9. How the ground truth for the training set was established
- Not applicable/Not provided. The software verification and validation would have been against predetermined system and software specifications and requirements, as stated in the document. This is distinct from establishing a clinical "ground truth" for a diagnostic algorithm.
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510(k) SUMMARY
JUN 2 4 1997
Tomey Corporation
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tomey Corporation
(617) 864-6488 Phone: Facsimile: (617) 864-6897
Contact Person: Dick Nachman
May 6, 1997 Date Prepared:
Name of Device and Name/Address of Sponsor
ImageScape Digital Retinal Image System
Tomey Corporation 325 Vassar Street, 2nd Floor Cambridge, MA 02139
Common or Usual Name
AC-powered ophthalmic camera with digital imaging system.
Classification Name
AC-powered ophthalmic camera
Predicate Devices
Ophthalmic Imaging Systems -- DFC Digital Imaging System (K918929) Midwest Ophthalmic Instruments -- ORIMS Digital Angiography (952480) Topcon -- Imagenet Digital Imaging System
Intended Use
The ImageScape is intended to be used to capture, store and manipulate digital images of the retina taken by fundus camera.
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Substantial Equivalence
Tomey's ImageScape, Ophthalmic Imaging Systems DFC, Topcon's Imagenet, and Midwest Ophthalmic Instruments ORIMS have the same intended use: to capture, store, and manipulate digital images of the retina taken by a fundus camera. The ImageScape, DFC, Imagenet, and ORIMS digital imaging systems also have substantially equivalent technological characteristics. For instance, the ImageScape and DFC both are supplied with the same Kodak MegaPlus digital camera and 1 gigabyte Jaz drive, and also store the files in a TIFF file format.
The ImageScape and the predicate devices are all operated using personal computers with keyboards and a hand-operated mouse. The ImageScape, DFC, and Imagenet use Pentium chip-based personal computers with Windows-based software. The ImageScape and DFC also have similar storage capabilities and monitors. Minor differences do not raise any new issues of safety or effectiveness because the ImageScape's storage capabilities are superior to the DFC's storage capabilities and do not affect the imaging capabilities of the device.
The ImageScape and the predicate devices have the same software functions: image acquisition, analysis, storage, and retrieval. The ImageScape and ORIMS software have almost identical functions because the ImageScape software was developed to have many of the same functions. The principal difference between the software is the operating system. The ImageScape is based on the Windows 95 operating system and the ORIMS is based on the Macintosh operating system. This difference does not raise any new issues of safety or effectiveness because both systems are icon-driven systems in which the user clicks a mouse on an icon to perform a task. Furthermore, Tomey has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements.
Tomey's ImageScape and the predicate devices are operated in the same manner. The ophthalmologist views the patient's retina through a slit lamp and uses a fundus camera with a digital camera mounted on a C-Mount to capture, store, and manipulate retinal images. The patient is prepared for retinal imaging in accordance with standard ophthalmic procedures and the ophthalmologist operates the joystick to send images to the digital camera in the same manner. For the Tomey System and the predicates, images are captured and manipulated using icon-driven computer interfaces. The systems software for the various devices also permit the ophthalmologist to print images, view images on the monitor, and archive the images on a removable media drive.
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Performance Characteristics
The ImageScape consists of: (1) a digital camera; (2) an imaging board; (3) a personal computer; (4) a monitor; and (5) Tomey's Windows-based image processing software. The ImageScape is used during ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp with a fundus camera. Images are transferred to the ImageScape's imaging board, located in the ImageScape's personal computer, and stored in the computer's Random Access memory ("RAM") and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to operate the icons.
After downloading the images to the Jaz drive, the ophthalmologist can then continue to capture more retinal images or process the images already captured and downloaded on the Jaz drive. To further process the images with the ImageScape software, the ophthalmologist operates the keyboard or mouse. As the software is Windows 95-based, the ophthalmologist can click icons to perform the functions, described in more detail below, for analysis, storage, and retrieval of images. In addition, the ophthalmologist can view the images on the monitor's screen or print them on paper.
The image captured by the digital camera is transferred to the imaging board. The image transfer and processing does not use data compression. The personal computer is an off-the-shelf Performance/VS Pentium Pro computer. The personal computer is loaded with Tomey's Windows-based image processing software that is used to save, display, and store the images. The software permits the user to manipulate and enhance the image. The image can be manipulated by zooming in or out, inverting, flipping, or rotating the image. It also can be manipulated by adjusting the brightness and contrast and sharpening the image. The image can be enhanced by shadow, edge trace, and blur functions. The software has seven image-processing functions: (1) print; (2) extract/delete; (3) save; (4) auto-align; (5) image comparison; (6) animation; and (7) stereo image.
The print function has the option of allowing the user to create a montage window for printing landscape format images. It also permits the user to annotate the images with the patient's name, date, and selected eye. The image is printable to any printer configured to work with Windows 95.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three thick, curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997
Tomey Corporation USA .... c/o Mr. Howard M. Holstein Hogan & Hartson L.L.P. 555 Thirteenth St., N.W. Washington, D.C. 20004
Re: K971685 Trade Name: ImageScape Digital Retinal Image System Regulatory Class: II Product Code: 86 HKI Dated: May 6, 1997 Received: May 7, 1997
Dear Mr. Holstein:
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. Howard M. Holstein
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/dsmamain.html".
Sincerely yours,
A Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K971685 510(k) Number (if known):
ImageScape Device Name:_
Indications For Use:
The ImageScape is intended to capture, store, and manipulate digital images of the retina taken by a fundus camera. ... . . .....
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am Williams
(Division Sign-Off)
Division of Ophthalmic Devices
Division of Ophthalmic Devices
510(k) Number K971685
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.