3D-ANGIO

K984634 · Siemens Medical Corp. · JAK · Mar 12, 1999 · Radiology

Device Facts

• Record ID: K984634
• Device Name: 3D-ANGIO
• Applicant: Siemens Medical Corp.
• Product Code: JAK · Radiology
• Decision Date: Mar 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.

Device Story

3D-Angio is an x-ray imaging software option for standard angiographic C-arm systems. It transforms 2D rotational angiography images into 3D image formats. Used by physicians in clinical settings to visualize vascular structures; assists in diagnosis and treatment planning for vessel malformations like aneurysms, AVMs, and stenoses. Provides 3D anatomical context to support clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based 3D reconstruction algorithm for angiographic X-ray systems. Operates on 2D rotational angiography input data. Standalone software option for integration with existing C-arm hardware.

Indications for Use

Indicated for physicians to assist in the diagnosis and treatment of vessel malformations, including aneurysms, AVMs, and stenoses, specifically in neuro-angiographic cases.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• GE Advantage 3D XR (K974715)

Submission Summary (Full Text)

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K984634

# 510(K) SUMMARY FOR THE 3D-ANGIO SOFTWARE OPTION

Submitted by:

# Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

December 28, 1998

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. Malgorzata Stanek Phone: [phone] Fax: [phone]

#### 2. Device Name and Classification:

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

3D-Angio Accessory to Angiographic X-Ray System Radiology 21 CFR §892.1600 Class I.I. 90JAA

#### 3. Substantial Equivalence:

The 3D-Angio software option is designed for three-dimensional evaluation of data acquired with a standard angiographic C-arm devices. The package is substantially equivalent to the following device:

| Siemens Device Name | FDA Clearance Number | FDA Clearance Date |
|---------------------|----------------------|--------------------|
| GE Advantage 3D XR | K974715 | 7/6/98 |

#### 4. Device Description:

The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.

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

The resulting images of the 3D-Angio package are intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.

Summary of Technological Characteristics of the Devices Compared to the 6. Predicate:

Both the Siemens 3D-Angio software option and GE Advantage 3D XR allow construction of a three-dimensional model from images acquired during rotational angiography.

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Malgorzata Stanek Technical Specialist Siemens Medical Systems, Inc. 186 Wood Ave. South Iselin, NJ 08830

Re:

K984634 3D-Angio (3D Angiographic Accessory) Dated: December 28, 1998 Received: December 30, 1998 Regulatory class: II 21 CFR 892.1600/Procode: 90 JAA

Dear Ms. Stanek:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements; as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CARL T. HART, D.O., M.D.

CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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): | K984634 |
|---------------------------|----------|
| Device Name: | 3D-Angio |

Indications For Use:

The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.

The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.

(Please do not write below this line - continue on another page if needed)

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

Yhind h. Lyan

(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological De 510(k) Number

Prescription Use ✗ OR Over-The-Counter Use **__**
(Per 21 CFR 801.109)