(15 days)
Not Found
No
The summary describes image reconstruction software without mentioning AI/ML techniques or providing details about training/test data sets typically associated with such technologies in regulatory submissions.
No.
The device is described as assisting in diagnosis, surgical planning, interventional procedures, and treatment follow-up by providing CT-like images, which are diagnostic and procedural aids, not therapeutic interventions.
Yes
The "Intended Use / Indications for Use" states that the device provides CT-like images "to assist the physician in diagnosis."
No
The device is described as a "software option on the Allura Xper product family," which implies it is a component of a larger hardware system (the Allura Xper product family) that performs rotational fluoroscopy. While the software performs the reconstruction and provides images, it is dependent on and integrated with the hardware for image acquisition.
Based on the provided information, the XperCT device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- XperCT's Function: The description clearly states that XperCT is a software option that processes imaging data (rotational fluoroscopy acquisitions) to create CT-like images of internal body structures (bone, soft tissue, etc.). It assists physicians in diagnosis, planning, procedures, and follow-up based on these images.
- No Specimen Analysis: There is no mention of XperCT analyzing any biological specimens taken from the body. Its input is imaging data, not biological samples.
Therefore, XperCT falls under the category of medical imaging software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
XperCT is a software option on the Allura Xper product family intended for imaging bone, soft tissue and other body structures. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
Product codes
IZI
Device Description
XperCT is a software option on the Allura Xper product family. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images.
Mentions image processing
reconstructs 3D volumes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
rotational fluoroscopy acquisitions
Anatomical Site
bone, soft tissue and other body structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
assist the physician
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
Philips Medical Systems Nederland B.V. Veenpluis 4-6, 5684-PC, Best The Netherlands
APR 4 2006
510(k) summary
The following information is submitted in accordance with the requirements of 21CFR 807.92.
ldentification of submitter
| Company: | Phi |
|---|---|
| Registration number: | 121 |
| Contact person: | Lyn |
| Telephone: | (425) |
| Date prepared: | Feb |
lips Medical Systems North America Company 7116 n Harmer 5) 487-7312 ruary 14, 2006
ldentification of manufacturer
| Company: | Philips Medical Systems Nederland B.V. |
|---|---|
| Address: | Veenpluis 4-6, |
| 5684-PC, Best, The Netherlands | |
| Registration number: | 3003768277 |
Device identification
| Trade name: | XperCT |
|---|---|
| Optional to: | "Xper" family of angiography X-ray systems |
| • Allura Xper FD10 |
- · Allura Xper FD20
- · Allura Xper FD10/10
- · Allura Xper FD20/10
Classification names:......................................................................................................................................................... Angiography X-ray system & Stationary X-ray system
Legally marketed device
| Trade name: | DynaCT |
|---|---|
| Manufacturer: | Siemens |
| 510(k) number: | K042646 |
Device description
Device description : ... .................................
XperCT is a software option on the Allura Xper product family. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images.
Intended use
Intended use: ... ... ... ... ... ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
XperCT is a software option on the Allura Xper product family. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
Technological characteristics
Conclusion: ... ... ... ... ... ... ... ... .......
XperCT is substantially equivalent to the currently legally marketed device DynaCT of Siemens, which has been cleared for marketing under K042646. This opinion is based on the following:
- XperCT does not introduce new indications for use, .
- XperCT has the same technological characteristics as the . predicate device,
- XperCT does not introduce new potential hazards or safety . risks.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2006 APR
Philips Medical Systems % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K060749
Trade/Device Name: XperCT Software Option Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: March 16, 2006 Received: March 20, 2006
Dear Mr. Job:
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.
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.
2
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely vours.
V. Nancy C. Bigelow
Nanev C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
.
3
Indications for Use
510(k) Number (if Known):
Device Name: XperCT software option
Indications for Use:
XperCT is a software option on the Allura Xper product family intended for imaging bone, soft tissue and other body structures. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
_____ Prescription Use ______________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Bugdon
(Division Sign-Off)
Division of Reproductive, Abdomina!