(39 days)
/ This device is intended to be used in the diagnosis of circulatory vascular system.
/ This device is operated and used by the physicians and X-ray technologist.
As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-9400f is the same as that of predicate device of BRANSIST safire (K062360) and DAR-8000f (K052500).
Consequently, the indications for use of DAR-9400f are also the same as that of BRANSIST safire (K062360) and DAR-8000f (K052500) and there are no additional indications.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device named DAR-9400f, an angiographic x-ray system. The letter states that the device is "substantially equivalent" to legally marketed predicate devices.
However, this letter does not contain any information about the acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications that would allow me to answer your specific questions. The letter is an administrative document confirming regulatory clearance based on substantial equivalence, rather than a summary of performance studies.
Therefore, I cannot provide the requested table or answer most of the questions based on the information given. The document does not describe a study that "proves the device meets the acceptance criteria" in the way you're asking, as 510(k) clearance for this type of device often relies on demonstrating equivalence to a predicate device rather than extensive new clinical trials with specific performance metrics and acceptance criteria.
To elaborate on why most of your questions cannot be answered from this document:
- Acceptance criteria and reported device performance: Not present. The letter only states the device is substantially equivalent to predicates.
- Sample size and data provenance: No study details are provided.
- Number of experts and qualifications: No study details are provided.
- Adjudication method: No study details are provided.
- MRMC comparative effectiveness study: No information about such a study is present. This is an X-ray system, not typically an AI-driven interpretive device, so "human readers improve with AI vs without AI assistance" is likely not applicable in the context of this device's 2007 clearance.
- Standalone performance study (algorithm only): Not applicable for an angiographic x-ray system in this context.
- Type of ground truth used: Not applicable, as no performance study details are given.
- Sample size for training set: Not applicable, as this is a hardware system, not an algorithm being trained.
- How ground truth for training set was established: Not applicable.
The "Indications for Use" section (page 21 of the original submission, page 2 of the provided text snippet) briefly mentions:
- "This device is intended to be used in the diagnosis of circulatory vascular system."
- "This device is operated and used by the physicians and X-ray technologist."
It then states that the intended use and indications for use are the same as two predicate devices (BRANSIST safire K062360 and DAR-8000f K052500). This reinforces that the clearance is based on equivalence, not new performance data against specific acceptance criteria.
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Image /page/0/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three wavy lines that resemble a bird or abstract human figures. The seal appears to be from a government agency related to health and human services in the United States.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 3 1 2007
Shimadzu Corporation c/o Mr. Don Karle Shimadzu Medical Systems 20101 South Vermont Ave. TORRANCE CA 90502
Re: K072006
Trade/Device Name: DAR-9400f Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: June 15, 2007 Received: July 23, 2007
Dear Mr. Karle:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written. Three stars are arranged at the bottom of the logo.
Protecting and Promoting Public Health
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Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Notification Submission, DAR-9400f
Page 21
INDICATION FOR USE SECTION XIII:
510(k) Number(if known):
Device Name: DAR-9400f
Indication for use :
/ This device is intended to be used in the diagnosis of circulatory vascular system.
/ This device is operated and used by the physicians and X-ray technologist.
As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-9400f is the same as that of predicate device of BRANSIST safire (K062360) and DAR-8000f (K052500).
Consequently, the indications for use of DAR-9400f are also the same as that of BRANSIST safire (K062360) and DAR-8000f (K052500) and there are no additional indications.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON THE ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescfiption Use (Per21 CFR801.109)
| OR | TWhen Over-The-Counter Use |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K072006 |
§ 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.