DYNACT

K042646 · Siemens Medical Systems, Inc. · IZI · Oct 19, 2004 · Radiology

Device Facts

• Record ID: K042646
• Device Name: DYNACT
• Applicant: Siemens Medical Systems, Inc.
• Product Code: IZI · Radiology
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

DynaCT is an 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. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Device Story

DynaCT is a software option for angiographic C-arm systems; transforms 2D rotational angiography X-ray projections into 3D image volumes. Used in clinical settings by physicians/technicians to improve soft tissue visualization, providing image quality comparable to CT. Output is a 3D reconstruction displayed on the system workstation; assists clinicians in diagnosis, surgical planning, interventional guidance, and treatment monitoring. Benefits include enhanced anatomical detail for complex procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparison to predicate devices.

Technological Characteristics

Software-based 3D reconstruction algorithm for angiographic X-ray systems. Operates on 2D rotational angiography input data. Provides 3D volumetric output. No specific hardware materials or standards cited.

Indications for Use

Indicated for imaging hard and soft tissues and internal body structures for diagnosis, surgical planning, interventional procedures, and treatment follow-up in patients undergoing angiographic X-ray procedures.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Siemens In Space 3D Software Option (K011447)
• Siemens Siremobil Iso C 3D Imaging Option (K003266)

Submission Summary (Full Text)

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# K042646

OCT 1 9 2004

# 510(k) Summary for the Siemens DynaCT

27 September, 2004

This 510(k) summary of safety and effectiveness information is being submitted in ac-Fills STO(with the requirements of SMDA 1990 and 21 CFR §807.92.

Contact Person: 1. Mrs. Ana Ladino Regulatory Submissions Fax: [phone] Phone: [phone]

| 2. | Device Name and Classification: | |
|----|---------------------------------|----------------------------------------|
| | Trade Name: | DynaCT |
| | Classification Name: | Accessory to Angiographic X-Ray System |
| | Classification Panel: | Radiology |
| | CFR Section: | 21 CFR §892.1600 |
| | Device Class: | Class II |
| | Product Code: | 90JAA |

#### Substantial Equivalence: 3.

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

| Device Name | FDA Clearance Number | FDA Clearance Date |
|----------------------------------------------|----------------------|--------------------|
| Siemens In Space 3D Software Option | K011447 | 08/03/01 |
| Siemens Siremobil Iso C 3D Imaging<br>Option | K003266 | 10/18/00 |

In summary, Siemens is of the opinion that DynaCT does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices

000265

September 23rd, 2004

CONFIDENTIAL

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#### 4. Device Description:

The DynaCT is an 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. DynaCT provides extended visualization capability. An increased number of acquired and post processed images results in an improved visualization of soft tissues. This improved visualization is comparable to CT images.

### Intended Use of the Device: ട്.

DynaCT is an 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.

DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

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

The Siemens DynaCT software option of the In Space 3D software package and the Siremobile 3D software allows construction of a three-dimensional model from two dimensional images acquired during rotational angiography.

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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 features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 9 2004

`Mrs. Ana Ladino Technical Specialist Siemens Medical Systems, Inc. · 51 Valley Stream Parkway MALVERN PA 19355

Re: K042646

Trade/Device Name: DynaCT Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 IZI Dated: September 23, 2004 Received: September 28, 2004

· Dear Mrs. Ladino:

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 (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 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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrb/dsmaldsmamain.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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## Indications for Use

| 510(k) Number (if known): | K042646 |
|---------------------------|---------|
| Device Name: | DynaCT |

DynaCT is an x-ray imaging software option, which allows the reconstruction of twodimensional images acquired with a standard angiographic C-arm device into a threedimensional image format.

DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and read. ment follow-up.

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

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

Prescription Use

OR Over-The-Counter Use (Per 21 CFR 801.109)

NancyC brisdon
(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological Devices 510(k) Number