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 treatment follow-up.

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.

AI/ML Overview

The provided text, a 510(k) Summary for the Siemens DynaCT, does not contain specific information regarding a study with acceptance criteria and reported device performance. The document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use.

Therefore, I cannot provide the requested information in the format given, as the study details, acceptance criteria, ground truth, and other specific performance metrics are not included in the provided text.

The document states: "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." This suggests that the primary method of demonstrating safety and effectiveness was through comparison to existing cleared devices rather than a detailed performance study with explicit acceptance criteria.

Summary

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

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: (610) 448 1787 Phone: (610) 448-1785

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 ImagingOption	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

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

4. Device Description:

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.

{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 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.

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

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 (800) 638-2041 or (301) 443-6597 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

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

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

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
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.(b)
Classification. Class II.