(142 days)
The device is indicated for producing full-bleed thermal wax prints in various sizes from medical image signal inputs.
Color point 820 PS, 830 Ps and Professional Colorpoint 2 Model 04.
The provided document is a 510(k) clearance letter from the FDA for the Seiko Instruments, Inc. ColorPoint 820PS and 830PS Color Printer. This document specifically states the device is an "Unclassified Procode: 90 LMC" and is intended for "producing full-bleed thermal wax medical image signal inputs."
Based on the content of these documents, it is not possible to provide the requested information about acceptance criteria and a study proving the device meets those criteria. This type of FDA clearance letter does not typically contain detailed performance specifications, clinical study results, or information regarding ground truth and expert reviews for medical devices.
The FDA 510(k) clearance process for unclassified devices like this color printer often relies on substantial equivalence to a predicate device rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics.
Therefore, I cannot populate the table or answer the specific questions about the study from the given text.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of interconnected shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 1997
Tomohiko Sakai Manager Quality Assurance Section Seiko Instruments, Inc. 1-8 Nakse, Mihama-ku Chiba-shi, Chiba-ken 271 Japan
Dear Mr. Sakai:
Re:
K971760 ColorPoint 820PS and 830PS Color Printer Dated: June 28, 1997 Received: July 8, 1997 Regulatory class: Unclassified Procode: 90 LMC
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 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, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/dsmamain.html".
Sincerely yours.
W. Kiau Yu
Lillian Kiau, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (If known): K971760
Device Name: Color point 820 PS, 830 Ps and Professional Colorpoint 2 Model 04.
The device is indicated for producing full-bleed thermal wax The device is andia sizes from medical image signal inputs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of device Evaluation (ODE)
Thind le. Seymm
Division Sign-Off) Division of Reproductive, Abdominal, E Ind Radiological Devic i10(k) Number
Prescription Use
X
(Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.