(26 days)
None
No
The description focuses on standard image processing, volume reconstruction, and a hardware/software interface for navigation systems. There is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a 3D imaging device used to generate intraoperative 3D information, not for treatment.
No
The device is described as a 3D imaging device used to generate intraoperatively generated 3D information of high contrast objects and anatomical structures, specifically for navigation during surgical procedures, rather than for diagnosing conditions.
No
The device description explicitly states that the 3D-navigation interface is a "hardware and software interface" and mentions hardware components within the 3D imaging option.
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 with the 3D Navigation Interface option is an imaging device. It generates 3D images of anatomical structures (bones and joints) within the body using two-dimensional images. It then provides a navigation interface for surgeons to use during procedures.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is purely related to imaging and surgical navigation based on those images.
Therefore, the device falls under the category of medical imaging and surgical navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 3D Navigation Interface Option does not alter the intended use of the cleared Siremobil Iso-C 3D.
The Siremobil Iso-C 3D with the 3D Navigation Interface option is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C. The 3D imaging option of the Siremobil Iso-C 3D contains hardware for the motorized movement of the orbital axis, a 3D workstation and a software package for volume reconstruction from two-dimensional images, 3D post-processing and visualization.
The Siremobil Iso-C 3D with the 3D Navigation Interface option is intended to be used whenever the surgeon benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures (e.g. bones and joints). The Siremobil Iso-C 3D with the 3D Navigation Interface option is designed as a 3D imaging device for conditions such as complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the spine.
Product codes
90IZL
Device Description
The 3D-navigation interface is hardware and software interface between the Siremobil Iso-C 3D and commercially available 3td party navigation systems. The software calculates the navigation matrix required by the external navigation system for the navigation in 3D-image data sets. The matrix is transferred to the navigation system in the DICOM-header of the 3D image data sets.
Mentions image processing
volume reconstruction from two-dimensional images, 3D post-processing and visualization.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
bones and joints, complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the spine.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. 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
510(K) SUMMARY FOR THE 3D NAVIGATION INTERFACE FOR SIREMOBIL ISO-C 3D
Submitted by:
Siemens Medical Solutions USA, Inc. 186 Wood Avenue South Iselin, NJ 08830
July 16, 2002
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. Amy Shaw Hosler Phone: (732) 321-4830 Fax: (732) 321-4841
2. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: CFR Section: Device Classification: Product Code:
3D Navigation Interface for Siremobil Iso-C 3D Accessory to Mobile X-Ray System Radiology 21 CFR §892.1720 Class II 90IZL
3. Substantial Equivalence:
The 3D Navigation Interface option for the Siremobil Iso-C 3D is substantially equivalent to the following devices:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens Siremobil Iso-C | K973598 | 11/10/1997 |
| Siemens Siremobil Iso-C 3D | K003266 | 12/01/2000 |
4. Device Description:
The 3D-navigation interface is hardware and software interface between the Siremobil Iso-C 3D and commercially available 3td party navigation systems. The software calculates the navigation matrix required by the external navigation system for the navigation in 3D-image data sets. The matrix is transferred to the navigation system in the DICOM-header of the 3D image data sets.
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5. Intended Use of the Device:
The 3D Navigation Interface Option does not alter the intended use of the cleared Siremobil Iso-C 3D.
- Summary of Technological Characteristics of the Devices Compared to the 6. Predicate:
The 3D Navigation Interface option does not alter the fundamental scientific technology of the predicate device, Siremobil Iso-C 3D (K003266). The 3Dnavigation interface transfers 3D-image data sets acquired with the Siremobil Iso-C 3D and the navigation matrix to an external navigation system.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 13 2002
Ms. Amy Shaw Hosler Siemens Medical Solutions USA, Inc. 186 Wood Avenue South ISELIN NJ 08830
Re: K022337
Trade/Device Name: 3d Navigation Interface for Siremobil Iso-C 3D Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: July 16, 2002 Received: July 18, 2002
Dear Ms. Hosler:
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,
Henry C. Brigdon
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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INDICATIONS FOR USE
510(k) Number (if known):_ どこ2つ 337 Device Name: 3D navigation interface for Siremobil Iso-C 3D
Indications For Use:
The Siremobil Iso-C 3D with the 3D Navigation Interface option is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C. The 3D imaging option of the Siremobil Iso-C 3D contains hardware for the motorized movement of the orbital axis, a 3D workstation and a software package for volume reconstruction from two-dimensional images, 3D post-processing and visualization.
The Siremobil Iso-C 3D with the 3D Navigation Interface option is intended to be used whenever the surgeon benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures (e.g. bones and joints). The Siremobil Iso-C 3D with the 3D Navigation Interface option is designed as a 3D imaging device for conditions such as complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the spine.
(Please do not write below this line - continue on another page if needed)
==============================================================================================================================================================================
Concurrence of the CDRH, Office of Device Evaluation (ODE)
David G. Anderson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109)