(65 days)
The intended use of the ED-3000 is to produce digital copies of radiological film.
The Model ED-3000 is a desk top laser image digitizer intended to produce digital copies of radiological film.
The ED-3000 is a desk top radiographic film digitizer incorporating a laser beam scanned in one direction, a mechanical stage that moves a sheet of film in the orthagonal direction, a light collector and photomutiplier and electronic circuitry for analog-to-digital conversion, system operation and connection to external networks.
The provided text is a 510(k) summary for the Nishimoto Sangyo Elk Laser Film Digitizer, Model ED-3000. It focuses on demonstrating substantial equivalence to a predicate device (Vidar VXR-LS) rather than providing a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Therefore, many of the requested details about acceptance criteria and study design are not present in the provided document. The document describes the device, its intended use, software development practices, hazard analysis, and safety concerns, but it does not include a performance study with acceptance criteria.
Here's a breakdown of the information that can be extracted, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics like accuracy, sensitivity, or specificity. The document focuses on demonstrating substantial equivalence based on technical specifications and functional attributes compared to a predicate device.
- Reported Device Performance: Instead of performance against acceptance criteria, the document provides a table comparing the technical specifications of the ED-3000 to its predicate device, the Vidar VXR-LS. This comparison serves as the primary 'proof' of equivalence for this type of device.
| Characteristic | Elk Model ED-3000 | Vidar VXR-LS (Predicate) |
|---|---|---|
| Film size | 8"x10" - 14"x17" | 8"x10" - 14"x17" |
| Light Source | Laser Diode (670µm) | Laser Diode |
| Resolution (14"x17") | 73/146/293 DPI | 73/146/293 DPI |
| Pixel size (µm) | 320/160/80 | 348/174/87 |
| Pixels | 1024 x 1244 / 2048 x 2488 / 4096 x 4976 | 1022 x 1241 / 2044 x 2482 / 4102 x 4981 |
| Density | 8 bit/10 bit/12 bit | 8 bit (256) grayscale / 12 bit (4096) grayscale |
| Optical Density | 0 | 0.0 ~ 3.6 OD |
| Scan Rate | 155 lines/sec. | 155 Lines/sec. |
| Interface | SCSI-2/TWAIN (Win 95) | SCSI-2 conformance |
2. Sample size used for the test set and the data provenance
- Not provided. The document does not describe a performance study with a test set of data. The submission relies on technical specification comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No test set with ground truth established by experts is mentioned.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set or adjudication method is mentioned.
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
- No. This device is a film digitizer, not an AI-powered diagnostic tool. An MRMC study or AI assistance is not relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is not an algorithmic diagnostic device, but a hardware device for converting analog film to digital images. Its performance is characterized by its technical specifications (resolution, density range, etc.) rather than diagnostic accuracy.
7. The type of ground truth used
- Not applicable/Not provided. Since no performance study is described, no ground truth is mentioned. The "truth" for this device's function would be the accuracy of its digital representation compared to the original physical film, which is implicitly covered by the technical specifications for resolution, pixel size, and optical density.
8. The sample size for the training set
- Not applicable/Not provided. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" in this context is the comparison of technical specifications between the new device (Elk Laser Film Digitizer, Model ED-3000) and its legally marketed predicate device (Vidar, VXR-LS, Laser Film Digitizer, K974315). The acceptance criterion, implicitly, is that the new device's specifications are substantially equivalent to or better than the predicate such that it raises no new questions of safety or effectiveness.
The document explicitly states: "The following product provides functions, which are substantially equivalent to this product. Please note that Nishimoto Sangyo is the Original Equipment Manufacturer (OEM) for the Vidar VXR-LS predicate device." This indicates that the new device is essentially a re-submission of a device for which Nishimoto Sangyo was already the OEM, reinforcing the substantial equivalence argument.
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2/12/99
510(k) Summary
1. Company Identification
Nishimoto Sangyo Co., Ltd. 2-17-4 Yushima Bunkyo, Tokyo, Japan Tel. (03) 3818-1324 Fax (03) 3818-1814 e-mail elkint@ca.mbn.or.jb
2. Official Correspondent
Gary I. Allsebrook Regulatory Affairs
3. Date of Submission
December 7, 1998
4. Device Name
| Classification Name: | Medical image digitizers were evaluated by theRadiology panel and are classified in Class II per21 CFR §892.2040 (proposed). | |
|---|---|---|
| Common/Usual Name: | Laser Film Digitizer | |
| Proprietary Name: | Elk Laser Film Digitizer, Model ED-3000 |
5. Substantial Equivalence
Vidar, VXR-LS, Laser Film Digitizer, K974315
6. Device Description and Intended Use
The ED-3000 is a desk top radiographic film digitizer incorporating a laser beam scanned in one direction, a mechanical stage that moves a sheet of film in the orthagonal direction, a light collector and photomutiplier and electronic circuitry for analog-to-digital conversion, system operation and connection to external networks. The intended use of the ED-3000 is to produce digital copies of radiological film.
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7. Software
Nishimoto Sangyo Co., Ltd. certifies that the ED-3000 software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.
8. Hazard Analysis
.
Hazard analysis on this product has been performed throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:
- Identification of potential hazards, their causes, and their effects; ●
- Development of methodologies to control the occurrence of hazards and to ● constrain their effects; and
- Determine any effect on patient safety and system effectiveness.
The potential hazards associated with this software product are no different than those of other PACS components . These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.
It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".
9. Safety Concerns
The device was submitted and passed the following tests in accordance with the Standard for Medical Electric Equipment (JIS T 1001, T1002 200 edition).
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10. Substantial Equivalence
The following product provides functions, which are substantially equivalent to this product. Please note that Nishimoto Sangyo is the Original Equipment Manufacturer (OEM) for the Vidar VXR-LS predicate device:
| Manufacturer: | Nishimoto Sangyo | Vidar |
|---|---|---|
| Product Name: | Elk Model ED-3000 | VXR-LS |
| 510(k) Number: | K974315 | |
| Film size: | 8"x10" - 14"x17" | 8"x10" - 14"x17" |
| Light Source | Laser Diode (670µm) | Laser Diode |
| Resolution: (14"x17") | ||
| DPI: | 73/146/293 | 73/146/293 |
| Pixel size (µm): | 320/160/80 | 348/174/87 |
| Pixels: | 1024 x 1244/2048 x2488/4096 x 4976 | 1022 x 1241/2044 x2482/4102 x 4981 |
| Density: | 8 bit/10 bit/12 bit | 8 bit (256) grayscale12 bit (4096) grayscale |
| Optical Density: | 0 | 0.0 ~ 3.6 OD |
| Scan Rate: | 155 lines/sec. | 155 Lines/sec. |
| Interface: | SCSI-2/TWAIN (Win 95) | SCSI-2 conformance |
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a stylized emblem. The emblem consists of three abstract human profiles facing right, layered on top of each other, with a wing-like shape above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Nishimoto Sangyo Co., LTD Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116
Re:
:
K984409 Elk Laser Film Digitizer, Model ED-3000 Dated: December 7, 1998 Received: December 9, 1998 Regulatory class: II 21 CFR 892.2030/Procode: 90 LMA
Dear Mr. Allsebrook:
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 legally marketed predicate 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 (QS) 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.
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 vour 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/dsma/dsmamain.html".
Sincerely yours,
S.S.T.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Nishimoto Sangyo Co., Ltd. Elk Laser Film Digitizer, Model Device Name: ED-3000
Indications For Use:
The Model ED-3000 is a desk top laser image digitizer intended to produce digital copies of radiological film.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 901.109)
OR
Over-the-Counter Use_
Yhird A. Glymm
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984409
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.