(33 days)
· This device is intended to be used in Angiography in Hospital with the X-ray devices.. · This device is operated and used by Physicians and X-ray technologist. · The object of this device is total patient populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the DAR-3000B is the same as that of predicate device IDR-1000 (K920720) and DAR-2400-15B/30B (K955395). Consequently, the indications for use of the DAR-3000B are also the same as that of the IDR-1000 (K920720) and DAR-2400-15B/30B (K955395) , and there are no additional indications.
DAR-3000B Digital Subtraction Angiography System
The provided documents (FDA 510(k) clearance letter dated August 8, 1997, and Indications for Use statement for the DAR-3000B Digital Subtraction Angiography System) do not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them.
These documents are primarily concerned with the regulatory clearance of the device based on substantial equivalence to predicate devices (IDR-1000 and DAR-2400-15B/30B). They state that the intended use and indications for use of the DAR-3000B are the same as its predicate devices.
Therefore, it is not possible to provide the requested information, including:
- A table of acceptance criteria and the reported device performance: The documents do not specify any performance metrics or acceptance criteria for the DAR-3000B itself, nor do they report any performance data.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned. This type of study is more common for AI-based devices; this device is a Digital Subtraction Angiography System, which is hardware.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a hardware system.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable, as this is a medical device, not an AI algorithm requiring a training set in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
The clearance is based on the device being "substantially equivalent" to previously cleared devices, implying that its performance is considered comparable without requiring a new, independent clinical study demonstrating specific performance metrics against defined acceptance criteria.
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Image /page/0/Picture/0 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the top of the seal in a circular pattern.
- 8 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Michael Fishback Director, National Service and Regualtory Affairs Shimadzu Medical Systems 20101 South Vermont Avenue Torrance, California 90502-1328
Re:
K973342 DAR-3000B Digital Subtraction Angiography System Dated: August 28, 1997 Received: August 5, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
Dear Mr. Fishback:
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, 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 vou 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 question 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.
hĩ Tiau Yhi
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
Enclosure
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510(K)Submission, DAR-3000B
Page 1 of of
Unknown 510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________
Device Name:____ DAR-3000B
Indications For Use :
· This device is intended to be used in Angiography in Hospital with the X-ray devices..
· This device is operated and used by Physicians and X-ray technologist.
· The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the DAR-3000B is the same as that of predicate device IDR-1000 (K920720) and DAR-2400-15B/30B (K955395).
Consequently, the indications for use of the DAR-3000B are also the same as that of the IDR-1000 (K920720) and DAR-2400-15B/30B (K955395) , and there are no additional indications.
Uhrid C. Leyon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use (Per2TCFR801.109)
OR
Over-The-Counter Use
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.