(69 days)
This device is intended to be used in the diagnosis of circulatory vascular system. / This device is operated and used by Physicians and X-ray technologist. As mentioned at "Intended Use" in this clearance letter, the intended use of the MH-400 is the same as that of predecessor device MH-31A (K903372).
Not Found
This is an FDA 510(k) clearance letter for the Shimadzu Medical Systems Lateral Angiographic C-arm Support MH-400. This type of letter generally communicates the FDA's decision regarding substantial equivalence to a predicate device and does not typically contain detailed information about acceptance criteria or specific study results that prove a device meets those criteria, especially for a non-AI/software device like an angiographic C-arm support system.
Based on the provided text, I cannot extract the information required in your request for the following reasons:
- Device Type: The device in question, the "Lateral Angiographic C-arm Support MH-400," is a physical medical device (an accessory for an angiographic x-ray system), not an AI/software-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI algorithms (e.g., performance metrics like sensitivity, specificity, F1-score) are not applicable in this context.
- Document Content: This regulatory clearance letter details the administrative aspects of FDA clearance (e.g., substantial equivalence, regulatory class, general controls) and lists the intended use. It does not contain the technical specifications, performance data, clinical study details, or ground truth establishment relevant to an AI-driven device.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These elements are typically found in a 510(k) submission's performance data sections, not in the clearance letter itself.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 9 2003
Mr. Takeshi Ozaki Director, National Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328 Re: K033184 Trade/Device Name: Lateral Angiographic
C-arm Support MH-400 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 IZI Dated: September 16, 2003 Received: October 29, 2003
Dear Mr. Ozaki:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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510(K) Number(if known) : Unknown KO33/84
Device Name: MH-400
Indications For Use :
/ This device is intended to be used in the diagnosis of circulatory vascular system.
/ This device is operated and used by Physicians and X-ray technologist.
As mentioned at "Intended Use" in this clearance letter, the intended use of the MH-400 is the same as that of predecessor device MH-31A (K903372).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use > (Per21CFR801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033184
§ 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.