The syngo Aortic ValveGuide software is an add-on option to InSpace 3D software with an enhanced algorithm to display the aortic root and to visually assist the physician by placing the C-arm in an orthogonal position to the aortic root plane.

The syngo Aortic ValveGuide software is intended for imaging soft tissues (heart) for diagnosis, surgical planning, interventional procedures and treatment follow-up.

This software is also designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)

Device Description

The syngo Aortic ValveGuide software is an add-on to the 510(k) cleared InSpace 3D software and a workflow improvement. This software visually assists the physician in localizing the aortic root plane by exact C-arm adiustment. The Inspace 3D application was originally cleared under Premarket Notification K011447 on 08/03/2001.

syngo Aortic ValveGuide software offers fast and precise 3D image viewing information of the aortic root anatomy during the procedure, thus providing excellent viewing support of the aortic root plane.

This software modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the "syngo Aortic ValveGuide Software" regarding acceptance criteria and study details:

Summary of Acceptance Criteria and Device Performance (Based on Provided Document):

The provided 510(k) summary (K113027) for the syngo Aortic ValveGuide Software is a "Special 510(k) Submission" and largely focuses on demonstrating substantial equivalence to a predicate device (InSpace 3D, K011447) rather than presenting new performance studies with quantitative acceptance criteria. The submission states that the new software is an "add-on" and a "workflow improvement" that does not affect the intended use or alter its fundamental scientific technology.

Therefore, the acceptance criteria and detailed performance reporting typically found in a traditional 510(k) for a novel device are not explicitly present in this document. The "acceptance criteria" in this context are primarily around demonstrating that the new software maintains the safety and effectiveness of the predicate device and that its enhancements achieve the stated workflow improvements without introducing new risks.

Since specific quantitative acceptance criteria and performance data are not provided in this summary, the table below reflects the stated purpose of the software modification as its "performance goal" and the basis for acceptance as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Summary Statements)
Safety and Effectiveness Equivalence to Predicate	"syngo Aortic ValveGuide is intended for similar indications as cleared in the predicate Inspace 3D." "The functionality of syngo Aortic ValveGuide Software is similar to the predicate device."
Workflow Improvement (Enhanced Algorithm for Aortic Root)	"This software visually assists the physician in localizing the aortic root plane by exact C-arm adjustment." "syngo Aortic ValveGuide software offers fast and precise 3D image viewing information of the aortic root anatomy during the procedure, thus providing excellent viewing support of the aortic root plane."
No Alteration of Intended Use or Fundamental Scientific Technology	"This software modification does not affect the intended use of the device nor does it alter its fundamental scientific technology."
Risk Management and Hazard Control	"Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing."
Compliance with Industry Standards and Practices	"Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing."

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

The document is a Special 510(k) focusing on software modifications and equivalence. It does not mention a specific "test set" in the context of a new clinical study with a defined sample size for performance evaluation of the new features. Instead, it relies on the established performance of its predicate device, InSpace 3D. The "verification and validation testing" mentioned typically refers to internal software testing rather than a clinical performance study.

Sample Size (Test Set): Not specified for the new "syngo Aortic ValveGuide" features in this document.
Data Provenance: Not specified for a new test set. The predicate device, InSpace 3D, would have undergone its own clearance process (K011447) which might have involved clinical data, but this is not detailed for the new add-on.

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

Not applicable. The document does not describe a clinical study requiring expert-established ground truth for a test set. The ground truth for the predicate device (InSpace 3D) would have been established at its original clearance (K011447) but is not detailed here for the new add-on.

4. Adjudication Method for the Test Set:

Not applicable, as no specific clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study is not mentioned or described in this document. The submission's focus is on demonstrating substantial equivalence and workflow improvement through technical modification and internal verification/validation, not a direct comparison of reader performance with and without the AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

The syngo Aortic ValveGuide Software is an "add-on to InSpace 3D" and is "not a stand-alone software." The description indicates it "visually assists the physician," implying human-in-the-loop operation. Therefore, a standalone algorithm-only performance study, in the sense of an AI model making independent decisions, is not relevant or described. The "performance" is about how well it assists the physician.

7. The Type of Ground Truth Used:

For the "syngo Aortic ValveGuide Software" specifically, in this Special 510(k), no new clinical ground truth establishment is described. The device is for "imaging soft tissues (heart) for diagnosis, surgical planning, interventional procedures and treatment follow-up" and to "assist physicians in the diagnosis and treatment of vessel malformations." The implicit ground truth for such clinical applications would typically be clinical outcomes, pathology, or expert consensus based on established diagnostic criteria, but this is related to the intended use and predicate device, not a new comparative study for this add-on.

8. The Sample Size for the Training Set:

Not applicable. The document describes a software "add-on" with an "enhanced algorithm" but does not characterize it as a machine learning/AI model requiring a dedicated training set in the modern sense. It refers to "software development, verification and validation testing," which would use internal datasets for testing the software's functionality and accuracy, but not a "training set" for a learning algorithm.

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

Not applicable, as no training set for a machine learning algorithm is mentioned.

Summary

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K113027

Image /page/0/Picture/2 description: The image shows the word "SIEMENS" in a bold, outlined font. The letters are large and evenly spaced, with a thick black outline. A horizontal line is present underneath the word, emphasizing the brand name.

Special 510(k) Submission: Aortic ValveGuide Software

510(k) Summary: syngo Aortic ValveGuide Software

Siemens Medical Systems, Inc. Company: 1 Valley Stream Parkway Malvern, PA 19355

October 7, 2011 Date Prepared:

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. General Information:
  lmporter / Distributor: Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Establishment Registration Number: 2240869

Manufacturing Site: SIEMENS AG Sector Healthcare Siemensstraße 1 D-91301 Forchheim, Germany

Contact Person: 2.

Ms. Patricia D Jones Technical Specialist. Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway G-01 Malvern, PA 19355 Phone: (610) 448 -3536 Fax: (610) 448-1787 Email: patricia.d.jones@siemens.com

Device Name and Classification: 3.

Trade Name:	syngo Aortic ValveGuide Software
Classification Name:	Accessory to Angiographic X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1600
Device Class:	Class II
Product Code:	90JAA & OWB

Legally Marketed Predicate Device 4. InSpace 3D Software Option Trade Name:
Special 510(k) syngo Aortic ValveGuide Software

Siemens Medical Systems, Inc.

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510(k) #: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

K011447 August 3, 2001 Accessory to Angiographic X-Ray System Radiology 21 CFR 8892.1600 Class II 90JAA

5. Device Description:

This software modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.

6. Indication for Use:

The syngo Aortic ValveGuide software is intended for imaging soft tissues (heart) for diagnosis, surgical planning, interventional procedures and treatment follow-up.

This software is also designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)

7. Substantial Equivalence:

The Aortic ValveGuide Software application is substantially equivalent to the commercially available Siemens software application, Inspace 3D. The Inspace 3D software option was described in premarket notification K011447 which received FDA Clearance on August 03, 2001.

The syngo Aortic ValveGuide software is an add-on to InSpace 3D and uses the same hardware and software components as the InSpace 3D software.

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SIEMENS

8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

syngo Aortic ValveGuide is a software add-on to Inspace 3D. The subject device syngo Aortic ValveGuide features the same post processing software, user interface, archiving and communication as the predicate Inspace 3D. The syngo Aortic ValveGuide software is not a stand-alone software. It interfaces with InSpace 3D. syngo Aortic ValveGuide user function keys are integrated into the InSpace 3D task card. The user function is similar to Inspace 3D task card except for an additional activation button for the syngo Aortic ValveGuide software features.

9. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical and radiation hazards. Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.

10. Conclusion as to Substantial Equivalence:

syngo Aortic ValveGuide is intended for similar indications as cleared in the predicate Inspace 3D. The syngo Aortic ValveGuide Software add-on application is designed for use with the Inspace 3D (K011447) and a workflow improvement which helps during visualizing and localizing the aortic root plane by exact C-arm adjustment.

The functionality of syngo Aortic ValveGuide Sotware is similar to the predicate device. It is Siemens opinion, that the syngo Aortic ValveGuide add-on software is substantially equivalent to the Inspace 3D software (K011447).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with three stylized human profiles facing right, overlaid with three horizontal bars that curve upwards. The seal is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Ms. Patricia D. Jones Technical Regulatory Specialist Siemens Medical Solutions, USA, Inc. 51 Valley Stream Parkway MELVERN PA 19355

Re: K113027

Trade/Device Name: syngo Aortic ValveGuide Software Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: November 10. 2011 Received: November 14, 2011

Dear Ms. Jones:

This letter corrects our substantially equivalent letter of November 22, 2011.

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 Mav 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

MAY - 7 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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SIEMENS

Special 510(k) Submission: Aortic ValvaGuide Software

Indications for Use Statement

510(k) Number (if known):

Device Name: syngo Aortic ValveGuide Software

Indications for Use:

The syngo Aortic ValveGuide software is intended for imaging soft tissues (heart) for diagnosis, surgical planning, interventional procedures and treatment follow-up.

This software is also designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Shuhtl D. O'M

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_k113027

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Special 510(k) syngo Aortic ValveGuide Software

Siemens Medical Systems, Inc.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.