3D presentation of segmented anatomic models (e.g., tracheas, bones, vessels, colon, etc.);
navigating interactively through 3D segmented models that represent body cavities (e.g., vessels, colon, spine, lung, etc.);
for viewing the inner surface of organ models (vessels, colon, etc.). Fly Through offers advantages over real endoscopy. For example, Fly Through can be performed within models of organs or blood vessels inaccessible to a real endoscope;
a training tool for surgeons to practice endoscopic procedures;
surgical planning;
feasibility study of an actual endoscopic procedure; and
a 3D positioning and orientation tool for Multiplanar reconstruction, thus assisting diagnosis from Multi-Planar-Reconstructions (MPRs): the Fly Through tool can help the user to position and visualize the 3-dimensional location of the MPR within the segmented dataset.

Device Description

The Siemens Fly Through is a software package that provides 3D, MPR of anatomic structures, and interactive endoscopic views of organs with cavities. By navigating within the 3D imaging data, the user can tour the patient anatomy and make adjustments to provide the best view.

Fly Through can be installed onto medical viewing and post-processing workstations that meet minimum system requirements such as patient database, filming, and networking, 24 bits true color graphics display, realtime polygon rendering graphics, and real-time texture mapping graphics.

AI/ML Overview

This Siemens 510(k) submission (K971717) for the Fly Through Software Package does not contain a study that describes acceptance criteria and how a device meets them. Instead, it focuses on demonstrating substantial equivalence to predicate devices (GE's Navigator and Prominence Workstation) based on shared technological characteristics and intended use.

Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided document.

Here's an overview of what can be gleaned from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The submission does not define specific performance acceptance criteria or report performance against such criteria. The basis for clearance is substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. No specific test set or associated sample size is mentioned. The submission relies on a comparison of technological characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. No ground truth establishment activity for a test set is described.

4. Adjudication Method:

Not Applicable. No adjudication method is mentioned as there is no test set or ground truth establishment process described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable. No MRMC study is mentioned. The submission is focused on demonstrating equivalence in technological characteristics and intended use, not on comparative effectiveness with human readers.

6. Standalone (Algorithm Only) Performance Study:

Not Applicable. The document does not describe a standalone performance study. The focus is on the software's capabilities and its relationship to predicate devices.

7. Type of Ground Truth Used:

Not Applicable. No specific ground truth is mentioned as no performance study is detailed.

8. Sample Size for the Training Set:

Not Applicable. The document does not provide details about a training set for the software, as this filing predates the common practice of detailed AI/ML validation studies. The software is described as a 3D visualization and navigation tool.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. No information is provided regarding a training set or its ground truth establishment.

Summary

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SIEMENS

ATTACHMENT 11

K971717

510(k) Summary

Siemens Fly Through Software Package

May 8, 1997

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

General Information. I.

Establishment

Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, NJ 08830
----------	----------------------------------------------------------------------------

Contact Person:	Kathleen M. RutherfordManager, Regulatory Submissions
(908) 321-4779	phone
(908) 321-4841	fax

Device Name

Fly Through . Trade Name:
PACS software Common Name: .
Classification Name: Picture Archiving and Communication . System (PACS)
- Class II Classification:
- None established under Section 514 Performance Standards: of the Food, Drug, and Cosmetic Act.

Information Supporting Substantial Equivalence Determination. II.

· Device Description:

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SIEMENS

· Intended Use:

The Fly Through application is intended to provide physicians with a training tool, and means to help evaluate from CT or MR datasets the feasibility of conducting actual endoscopic procedures. The application is also intended to assist diagnosis from Multi-Planar-Reconstructions (MPRs): the Fly Through tool can help the user to position and visualize the 3-dimensional location of the MPR within the segmented dataset.

• Technological Characteristics as compared to the Predicate Device:

The Fly Through has the same technological characteristics as GE's Navigator. They both provide the user with 3D and MPR of anatomic structures. They both provide the user with a navigation tool that can be used to view the anatomy in different viewpoints. Siemens Fly Through also provides the MPR is relation to the 3D model thus making it easier for the user to position and visualize the 3-dimensional location of the MPR within the segmented dataset.

The Fly Through has the same technological characteristics as the Prominence Workstation. FT is installed as an option on the Prominence. They share the same segmentation module, patient data, MPR, user interface, filming, and storage. FT has the added ability to show 3D surface shading and tetrahedral models.

• Substantial Equivalence:

Siemens Fly Through is substantially equivalent to the following devices:

1. Advantage Windows 3D with Navigator GE
1. Prominence Workstation (Silhouette) ISG Technologies

Kathleen Rutherford

Kathleen Rutherford Manager, Regulatory Submissions Imaging Systems Group, Siemens Medical Systems

5/8/97
Date

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 1997

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Ave. South Iselin, NJ 08830

Re: K971717

Fly Through (3D CT/MR Reconstruction Software) Dated: August 7, 1997 Received: August 8, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Ms. Rutherford:

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 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). You may, therefore, market the device, subject to the general controls provisions of 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 vou might have under sections 531 through 542 of the Act for devices under 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 vito diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

hTliau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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ATTACHMENT 1

Indications For Use

510(k) Number (if known): _ K9717/7 Device Name:

Indications For Use:

From user specified sets of CT or MR images, Fly Through can be used for

3D presentation of segmented anatomic models (e.g., tracheas, bones, . vessels, colon, etc.);
navigating interactively through 3D segmented models that represent . body cavities (e.g., vessels, colon, spine, lung, etc.);
for viewing the inner surface of organ models (vessels, colon, etc.). Fly ● Through offers advantages over real endoscopy. For example, Fly Through can be performed within models of organs or blood vessels inaccessible to a real endoscope;
a training tool for surgeons to practice endoscopic procedures; .
surgical planning; .
feasibility study of an actual endoscopic procedure; and .
a 3D positioning and orientation tool for Multiplanar reconstruction, thus . assisting diagnosis from Multi-Planar-Reconstructions (MPRs): the Fly Through tool can help the user to position and visualize the 3-dimensional location of the MPR within the segmented dataset.

( please do no write below this line- continue on another page if needed )

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

David A. Segeum
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

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

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

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