(39 days)
No
The summary does not contain any keywords or descriptions related to AI or ML, nor does it mention performance studies or data sets typically associated with such technologies in medical devices.
No
The device is described as being used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used in the diagnosis of circulatory vascular system."
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. While it mentions an "Angiographic x-ray system" as the input modality, it doesn't clarify if the device itself is the software processing the data from this system or if it includes hardware components integrated with or part of the x-ray system. Without a device description, it's impossible to definitively classify it as software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the diagnosis of circulatory vascular system." While diagnosis is a key aspect of IVDs, the method of diagnosis is crucial.
- Input Imaging Modality: The device uses an "Angiographic x-ray system." This indicates the device is involved in imaging the circulatory system, not analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of blood, urine, tissue, or other biological specimens. IVDs are designed to perform tests on these types of samples to provide diagnostic information.
This device appears to be a medical imaging device used for diagnostic purposes, which falls under a different regulatory category than IVDs. The predicate devices listed (BRANSIST safire and DAR-8000f) are also angiographic systems, further supporting this conclusion.
N/A
Intended Use / Indications 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.
Product codes
IZI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
circulatory vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians and X-ray technologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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 |