SIREMOBIL ISO-C 3D

K032280 · Siemens AG · IZL · Sep 10, 2003 · Radiology

Device Facts

• Record ID: K032280
• Device Name: SIREMOBIL ISO-C 3D
• Applicant: Siemens AG
• Product Code: IZL · Radiology
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Intended Use

The Siremobil Iso-C 3D 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 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 entire spine.

Device Story

Mobile isocentric C-arm x-ray system; includes high-frequency generator, x-ray tube, image intensifier, TV camera, and monitor trolley with digital memory. Operates by acquiring series of 2D x-ray images; reconstructs these into 3D image format. Used intraoperatively by surgeons for visualization of high-contrast objects like bones and joints. Provides 3D anatomical information to assist in surgical decision-making for complex fractures of extremities and spine. Benefits patient through improved intraoperative visualization of bone/joint structures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Isocentric mobile C-arm x-ray system. Components: high-frequency generator, x-ray tube, image intensifier, TV camera, film cassette attachment, laser light localizers, electronics cabinet, and monitor trolley. Features digital memory for 3D reconstruction of 2D images. Connectivity includes monitor trolley interface. System is mobile.

Indications for Use

Indicated for intraoperative 3D imaging of high-contrast anatomical structures, specifically complex bone or joint fractures of the upper and lower extremities (knee, foot, elbow, hand) and the entire 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 3D (K003266)
• GE OEC Flexi View 8800 (K003837)
• Philips BV Endura (K010435)

Submission Summary (Full Text)

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KQ32280

SEP 1 0 2003

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

Submitted by:

Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355

July 18, 2003

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: [phone] Fax: [phone]

#### 2. Device Name and Classification:

Trade Name: Classification Name: Classification Panel: CFR Section: Device Classification: Product Code:

Siremobil Iso-C 3D Mobile X-Ray System Radiology 21 CFR §892.1720 Class II 90IZL

#### 3. Substantial Equivalence:

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 | K003266 | 12/01/00 |
| GE OEC Flexi View 8800 | K003837 | 03/12/01 |
| Philips BV Endura | K010435 | 03/12/01 |

#### Device Description: 4.

The Siremobil 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

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acquired with a mobile isocentric C-arm device into a three-dimensional image format.

#### 5. Intended Use of the Device:

The Siremobil Iso-C 3D is intended to be used whenever the surgeon benefits from intraoperatively generated 3D information of high contrast objects (bones and joints). The Siremobil Iso-C 3D focuses on complex bone or joint fractures of the upper and lower extremities (including knee, foot, elbow, hand), and the entire spine.

### Summary of Technological Characteristics of the Devices Compared to the 6. 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 series of two dimensional images acquired with a C-arm imaging device.

Nealie K. Hartman

Nealie Hartman Technical Specialist, Regulatory Submissions Siemens Medical Systems, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2003

Siemens AG % Ms. Nealie Hartman Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K032280

Trade/Device Name: Siremobil Iso-C 3D Mobil X-Ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: July 18, 2003 Received: July 25, 2003

Dear Ms. Hartman:

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 (sec 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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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 the 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" (21CFR Part 807.97) you may obtain. 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,

Nancy C. Brogdon

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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# ATTACHEMENT 2

### INDICATIONS FOR USE

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 to include the entire spine for the Siremobil Iso-C 3D contains no new hardware or software

The Siremobil Iso-C 3D 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 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 entire spine.

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

David A. Seaman

(Division Sign-Off) Division of Reproduct and Radiological Devic 510(k) Numbe Prescription Use (Per 21 CFR 801.109)