(26 days)
Not Found
No
The document explicitly states "The Siremobil Iso-C 3D contains no new hardware or software" and there are no mentions of AI, ML, or related concepts in the provided text. The 3D reconstruction is described as a standard image processing technique.
No
The device is described as a 3D imaging device used for obtaining intraoperative 3D information, which is a diagnostic rather than therapeutic function.
Yes
Explanation: The device is described as a "3D imaging device" used for generating "3D information of high contrast objects and anatomical structures" intraoperatively. This imaging capability provides information about the patient's state, which is characteristic of a diagnostic device.
No
The device description explicitly states it is an "isocentric mobile x-ray C-ram" consisting of various hardware components like an X-ray tube, image intensifier, and monitor trolley. While it includes a 3D imaging option which involves software for reconstruction, the core device is a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Siremobil Iso-C 3D is an imaging device that uses X-rays to create 3D images of the inside of the body. It does not analyze biological samples.
- Intended Use: The intended use is for generating intraoperative 3D information of high contrast objects and anatomical structures within the body. This is a diagnostic imaging function, not an in vitro diagnostic function.
Therefore, the Siremobil Iso-C 3D falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Siremobil Iso-C 3D with extended Indications for Use is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C 3D. The extended Indications for Use include the high contrast objects and anatomical structures of the entire body. The Siremobil Iso-C 3D contains no new hardware or software.
The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.
Product codes
DXO, JAA
Device Description
The Sirernobil Iso-C 3D is an isocentric mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The 3D imaging option allows the reconstruction of two-dimensional images acquired with a mobile isocentric C-arm device into a three-dimensional image format.
Mentions image processing
The 3D imaging option allows the reconstruction of two-dimensional images acquired with a mobile isocentric C-arm device into a three-dimensional image format.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
high contrast objects and anatomical structures of the entire body.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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§ 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.
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K040347
MAR - 9 2004
510(K) SUMMARY FOR THE SIREMOBIL ISO-C 3D
Submitted by:
Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvem, PA 19355
February 10, 2004
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Contact Person:
Ms. Nealie Hartman 51 Valley Stream Parkway Malvern, PA 19355 Phone: (610) 448-1769 Fax: (610) 448-1787
Device Name and Classification: 2.
| Trade Name: | Siremobil Iso-C 3D |
|---|---|
| Classification Name: | Mobile X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1720 |
| Device Classification: | Class II |
| Product Code: | DXO, JAA |
Substantial: Equivalence: 3.
The Siremobil Iso-C 3D is designed for three-dimensional evaluation of data acquired with an isocentric mobile C-arm device. The package is substantially equivalent to the following devices:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens Siremobil Iso-C 3D | K032088 | 09/10/03 |
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4. Device Description:
1040347
The Sirernobil Iso-C 3D is an isocentric mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The 3D imaging option allows the reconstruction of two-dimensional images acquired with a mobile isocentric C-arm device into a three-dimensional image format.
Intended Use of the Device: ડ.
The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.
6. Summary of Technological Characteristics of the Devices Compared to the Predicate:
The Siemens Siremobil Iso-C 3D with extended Indications for Use and the predicate devices allow reconstruction of a three-dimensional model from a scries of two dimensional images acquired with a C-arm imaging device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Vallev Stream Parkway J-15 MALVERN PA 19355
MAY 22 2012
Re: K040347
Trade/Device Name: Siremobil ISO-C 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO and JAA Dated: February 10, 2004 Received: February 12, 2004
Dear Ms. Hartman:
This letter corrects our substantially equivalent letter of November 14, 2011.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse cromb) (ystems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket will anow you to begal manitoling your antial equivalence of your device to a legally marketed notheation. The I Drivening of succion 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 Parts 801 and II you desire specific advice for your avrous ic Device Evaluation and Safety at (301) 796-607), prodoc conceent and the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I ou may other only Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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KOYO347 510(k) Number (if known): Device Name: Siremobil Iso-C 3D
Indications For Use:
The Siremobil Iso-C 3D with extended Indications for Use is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C 3D. The extended Indications for Use include the high contrast objects and anatomical structures of the entire body. The Siremobil Iso-C 3D contains no new hardware or software.
The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.
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Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over-The-Counter Use (Per 21 CFR 801.109) |
|---|---|
| ------------------ | -------------------------------------------------------------------------------------------------------------------------------- |
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K040347 |
|---|---|
| --------------- | --------- |
Simplified 510(k) for Siemens Medical Solution Siremobil Iso-C 3D