(90 days)
Not Found
Not Found
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 intended for diagnostic imaging to aid in diagnosis, not for treating a condition, which is a characteristic of therapeutic devices.
Yes
The device is described as producing imaging techniques "providing the patient with an adequate diagnosis of their presented condition," which directly indicates a diagnostic purpose.
No
The summary describes a device that produces imaging techniques using an "Image-intensified fluoroscopic x-ray system." This explicitly mentions hardware (an x-ray system), indicating it is not a software-only device.
Based on the provided information, the AMI1200 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "produce imaging techniques required, providing the patient with an adequate diagnosis of their presented condition." This describes a device used for in vivo imaging, meaning it interacts directly with the patient's body to generate images.
- Input Imaging Modality: The input modality is an "Image-intensified fluoroscopic x-ray system." This is a type of medical imaging equipment used on a living patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. The description of the AMI1200 does not mention any interaction with biological specimens.
Therefore, the AMI1200 is a medical imaging device used for diagnostic purposes on the patient, not an in vitro diagnostic device used to test specimens from the patient.
N/A
Intended Use / Indications for Use
The AMI1200 is intended to be used only by licensed practitioners; to produce imaging techniques required, providing the patient with an adequate diagnosis of their presented condition.
Product codes
90 JAA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed practitioners
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 2 2002
Mr. Kevin J. Meuret President Integrity Practice Management, Inc, 1104 Enterprise Drive SIOUX FALLS SD 57106
Re: K022911 Trade/Device Name: AMII200 C-Arm Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: 90 JAA Dated: September 17, 2002 Received: September 23, 2002
Dear Mr. Meuret:
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 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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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snogdon
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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Intended Use Statement
The AMI1200 is intended to be used only by licensed practitioners; to produce imaging techniques required, providing the patient with an adequate diagnosis of their presented condition.
*FDA/GORM/OPE/BMO
SEP 23 2 51 PM '02
RECEIVED
Submitted by:
Kevin J. Meuret, President Integrity Practice Management, Inc.
Submitted on September 18, 2002
Prescription Use
✓
Colin m Pollard
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number