3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D

K022337 · Siemens Medical Solutions USA, Inc. · IZL · Aug 13, 2002 · Radiology

Device Facts

• Record ID: K022337
• Device Name: 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IZL · Radiology
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Intended Use

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.

Device Story

Hardware/software interface connecting Siremobil Iso-C 3D mobile C-arm to third-party navigation systems; calculates navigation matrix for 3D image data sets; transfers matrix via DICOM header to external navigation system; used intraoperatively by surgeons; provides spatial orientation for surgical navigation; facilitates visualization of complex bone/joint fractures and spinal anatomy; improves surgical accuracy through integration of C-arm 3D data with external navigation platforms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hardware/software interface; utilizes DICOM-header for data transfer; connectivity to third-party navigation systems; operates as an accessory to the Siremobil Iso-C 3D mobile X-ray system.

Indications for Use

Indicated for patients requiring intraoperative 3D imaging of high-contrast objects and anatomical structures, specifically for complex bone or joint fractures of the upper and lower extremities (knee, foot, elbow, hand) and the spine.

Regulatory Classification

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.

Predicate Devices

• Siemens Siremobil Iso-C (K973598)
• Siemens Siremobil Iso-C 3D (K003266)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(K) SUMMARY FOR THE 3D NAVIGATION INTERFACE FOR SIREMOBIL ISO-C 3D

Submitted by:

K022337

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: [phone] Fax: [phone]

#### 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.

{1}------------------------------------------------

### 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.

{2}------------------------------------------------

### 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.

{3}------------------------------------------------

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

### 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)