(77 days)
The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
The Seiko ColorPoint™ Medical Imager and Video Capture systems are designed for medical imaging applications printing color or monochrome images on paper and or film media.
Please note: The provided text is a 510(k) summary for a medical imager and video capture box. It describes the device, its intended use, and its substantial equivalence to a predicate device. It does NOT contain information about acceptance criteria, a specific study designed to prove device performance against those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to performance evaluation.
Therefore, I cannot populate most of the requested fields as the information is not present in the provided document.
Here's what can be extracted and what cannot:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. This is a 510(k) addressing substantial equivalence, not a performance trial against specific criteria. | The document states the device is "substantially equivalent" to its predicate device (ColorPoint™ Model 820 Medical Imager K971760). No specific performance metrics or thresholds are reported. |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. This document does not describe a performance study with a test set. It's a regulatory submission for substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (See above)
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. (See above)
- 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. This device is a medical imager and video capture system, not an AI-powered diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is hardware for producing hard copies of images; it's not an algorithm with standalone performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. (See above – not an AI/algorithm-based device)
- How the ground truth for the training set was established: Not applicable. (See above)
Summary of available information from the document:
- Device Name: Seiko Instruments, ColorPoint™ 1700 Medical Imagers and Video Capture Box (VCX) systems (specifically ColorPoint™ 1720 Medical Imagers and Video Capture Box CX-1000 series).
- Intended Use: Converting electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
- Predicate Device: Seiko Instruments Inc. ColorPoint™ Model 820 Medical Imager (K971760).
- Regulatory Decision: Substantially Equivalent.
- Key Argument for Equivalence: The new device's technological characteristics are similar to the predicate, and it does not contact the patient or control life-sustaining devices. Images are interpreted by a physician, allowing for human intervention. The device complies with voluntary standards and has undergone a hazard analysis classifying potential hazards as MINOR.
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JUN 30 1999
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section
510(k) Summary of Safety and Effectiveness
for Seiko Instruments, ColorPoint™ 1700 Medical Imagers and Video Capture Box (VCX) systems
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
April 7, 1999
Submitter's Information:
Seiko Instruments Inc. Print System Division 8. Nakase 1-chome Mihama-ku Chiba-shi Chiba 261-8507 Japan
Trade Name, Common Name, Classification:
Seiko Instruments, ColorPoint™ 1720 Medical Imagers and Trade Name: Video Capture Box CX-1000 series Common Name: Medical Imager & Video Capture Device Classification Camera, Multiformat Name:
Predicate Device:
| Manufacturer: | Seiko Instruments Inc. |
|---|---|
| Device: | ColorPoint™ Model 820 Medical Image |
| 510(k) Number: | K971760 |
| Date Received: | 05/12/97 |
| Decision Date: | 10/01/97 |
| Decision: | Substantially Equivalent |
| Panel Code device reviewed by: Radiology | |
| Panel Code device classified by: Radiology | |
| Product Code: | LMC |
| Classification: | Class II |
Device Description:
The Seiko ColorPoint™ Medical Imager and Video Capture systems are designed for medical imaging applications printing color or monochrome images on paper and or film media.
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Indications for Use:
The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
Technological Characteristics:
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being printed.
Conclusion:
The 510(k) Pre-Market Notification for the above referenced device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to Seiko Instruments Inc. ColorPoint™ Model 820 Medical Imager K971760.
- The ColorPoint™ system has been and will be manufactured in accordance 1. with the voluntary standards listed in the enclosed voluntary standard survey.
-
- The submission contains the results of a hazard analysis. All potential hazards have been classified as MINOR.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be an abstract representation of an eagle or bird with three curved lines forming its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 30 1999
Seiko Instruments USA., Inc. c/o Herman Oosterwjick Division of Otech, Inc. 2001 East Oakshores Drive Crossroads. TX 76227
RE:
Trade Name: Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series Date: March 31, 1999 Received: April 14, 1999 Classification: II 21 CFR 892.2040 Product Code: 90 LMC
Dear Mr. Oosterwjick:
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 controis provisions of the Act. The general controls provisions of the Actively 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 dass III (Special Controls) or dass 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 Eederal 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) 594-4613. 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,
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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(Indications for Use Form)
K991282 510(k) Number:
Device Name:
Seiko Instruments, ColorPoint™ 1720 Medical Imagers and Video Capture Box CX-1000 series
Indications for Use:
The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Vomit h. Segum
(Optional Format 1-2-96)
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, Division of Radiological Devic 510(k) Number
510(k) for Seiko Instruments, ColorPoint™ 1720 Medical Imagers and Video Capture Box CX-1000 Page 13
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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.