(52 days)
Not Found
No
The summary mentions image processing but does not contain any terms or descriptions indicative of AI or ML technology, such as "AI," "ML," "deep learning," "neural network," or descriptions of training/test sets for algorithmic performance evaluation.
No
The device is described as an imaging system used for diagnosis and guiding procedures, not for treating conditions.
Yes
The intended use explicitly states "diagnosis" as one of its purposes.
No
The device description clearly states it consists of two mobile hardware units: a C-Arm and a Monitor Trolley, which include physical components like an x-ray tube, image intensifier, and monitors. While it mentions an "image processing system," this is part of the larger hardware system, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "x-ray examinations, and in particular, for radioscopy, radiography, and diagnosis dedicated to..." various medical procedures. This involves imaging the inside of the body using x-rays.
- Device Description: The description details a "mobile C-arm specifically designed for x-ray imaging." It describes components like an x-ray tube, image intensifier, and monitors for displaying images.
- Input Imaging Modality: The input modality is explicitly stated as "x-ray."
IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device operates on the patient to produce images of their internal structures.
N/A
Intended Use / Indications for Use
The TCA 5R / 5S C-arm systems are designed for x-ray examinations, and in particular, for radioscopy, radiography, and diagnosis dedicated to: traumatology, pediatrics, simple interventional radiology, pacemaker implantation, operating room procedures, intensive care, and respiratory and skeleton procedures.
Product codes
JAA, IZL
Device Description
The TCA 5R / 5S are mobile C-arms specifically designed for x-ray imaging. The TCA 5R / 5S consists of two mobile units: a C-Arm and a Monitor Trolley which holds one or two monitors, an image processing system and possible accessories. The C-Arm stand supports the highvoltage generator, x-ray controls, and the "C" shaped arm which supports the x-ray tube and the image intensifier. The C-Arm is designed to move in various directions to allow for proper positioning with the patient based on the procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name: | Dornier MedTech America, Inc. |
|---|---|
| Submitter Address: | 1155 Roberts Blvd. |
| Kennesaw, GA 30144 | |
| Contact Person: | Tim Thomas, Vice President |
| Regulatory/ Quality/ Clinical | |
| MAR 09 2007 | |
| Phone Number: | 770-514-6163 |
| Fax Number: | 770-514-6288 |
| Establishment | |
| Registration Number: | 1037955 |
| Date Prepared: | January 12, 2007 |
| Device Trade Name(s): | TCA 5R / 5S |
| Device Common Name: | Fluoroscopic Imaging System or Mobile C-Arm |
| Classification Name: | System, x-ray, fluoroscopic, image-intensified (JAA) |
| System, x-ray, mobile (IZL) | |
| Device Classification: | II (21 CFR Sec. 892.1650 and 892.1720) |
| (Image-intensified fluoroscopic x-ray system / Mobile | |
| x-ray system) | |
| Predicate Device(s): | K992103 - Wuestec Medical Inc. (C-Quest) |
| K002198 - Fluoroscan Imaging Systems (Hologic) | |
| (FlouroScan Profile) | |
| General Device | |
| Description: | The TCA 5R / 5S are mobile C-arms specifically |
| designed for x-ray imaging | |
| Intended Use: | The TCA 5R / 5S C-arm systems are designed for x- |
| ray examinations, and in particular, for radioscopy, | |
| radiography, and diagnosis dedicated to: | |
| traumatology, pediatrics, simple interventional | |
| radiology, pacemaker implantation, operating room | |
| procedures, intensive care, and respiratory and | |
| skeleton procedures. | |
| Technological | |
| Characteristics: | The TCA 5R / 5S consists of two mobile units: a C- |
| Arm and a Monitor Trolley which holds one or two |
1
monitors, an image processing system and possible accessories. The C-Arm stand supports the highvoltage generator, x-ray controls, and the "C" shaped arm which supports the x-ray tube and the image intensifier. The C-Arm is designed to move in various directions to allow for proper positioning with the patient based on the procedure. Additional technological characteristics are provided in Section 10 (Device Description) and Section 11 (Substantial Equivalence)
The TCA 5R / 5S comply with the applicable performance standards listed in Section 8 Performance Data: (Declaration of Conformity)
Based on a comparison to the predicate device determined to be substantially equivalent through the 510(k) premarket notification process, Dornier MedTech America, Inc., concludes that the TCA 5R / 5S are as safe, as effective, and performs as well as other legally marketed C-arm devices.
Conclusion:
2
Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized graphic of three curved lines that resemble a human figure in motion. The lines are thick and black, and they create a sense of movement and energy. The logo is simple and modern, and it is likely used to represent the Department of Health & Human Services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Tim Thomas Vice President, Quality / Regulatory / Clinical Dornier MedTech America, Inc. 1155 Roberts Blvd. KENNESAW GA 30144
MAR 0 9 2007
Re: K070123
Trade/Device Name: TCA 5R / 5S Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: JAA and IZL Dated: January 12, 2007 Received: January 17, 2007
Dear Mr. Thomas:
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/2/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, "FDA" in the middle, and "Centennial" at the bottom. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
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 yours,
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
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
The TCA 5R / 5S C-arm systems are designed for x-ray examinations, and in particular, for radioscopy, radiography, and diagnosis dedicated to: traumatology, pediatrics, simple interventional radiology, pacemaker implantation, operating room procedures, intensive care, and respiratory and skeleton procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070123