Artis zee / zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but is not linited to, pedication and obese patients.

Procedures that can be performed with the Artis zee / zeego family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.

Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.

Device Description

The Artis zee / zeego Modular Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. For these models, a new SW version VC14 will be available. The new SW version VC14 will allow additional functionality of currently used applications and is extended with new features (i.e. a wide screen display, a new OR table, and laser light crosshair). SW VC14 also includes an extension of the intended use to surgical angiography, including general surgical use for patients in the OR. The Artis zee / zeego Modular Angiography System with SW VC14 is substantially equivalent to the AXIOM Artis Modular Angiography System VC13 with all its components as described in the Device Description, Section 11 and the Substantial Equivalence Section 12.

AI/ML Overview

This 510(k) submission (K090745) for the Siemens Artis zee / zeego family VC14 is a premarket notification for a modification to an existing device, rather than a submission for a novel device requiring extensive clinical performance studies. Therefore, much of the information typically sought for AI/ML device performance (like specific metrics, MRMC studies, and detailed ground truth establishment for a training set) is not present. The submission focuses on demonstrating substantial equivalence to the predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific performance metrics or acceptance criteria for clinical performance that would typically be seen in a novel device's submission for AI/ML features. Instead, the acceptance criteria are implicitly tied to demonstrating that the modifications to the device (SW VC14, new OR table, wide screen display, laser light crosshair, and extended intended use to surgical angiography) do not compromise safety and effectiveness and maintain substantial equivalence to the predicate device.

Implicit Acceptance Criteria & Reported Performance:

Acceptance Criteria Category	Reported Device Performance
Safety and Effectiveness	"The testing reported in this 510(k) establishes the device is safe and effective for its intended use." (Page 3)
Substantial Equivalence to Predicate Device	"substantially equivalent to the AXIOM Artis Modular Angiography System VC13 with all its components..." (Page 2) and "substantially equivalent to the predicate device." (Page 3)
Functionality of New Features	"The new SW version VC14 will allow additional functionality of currently used applications and is extended with new features (i.e. a wide screen display, a new OR table, and laser light crosshair)." (Page 2)
Instructions for Use & Warnings	"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. Several safety features including visual and audible warnings are incorporated into the system design." (Page 3)
Hazard Minimization (Electrical, Mechanical, Radiation)	"To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing." (Page 3)

The "Performance Data" section states: "Applicable testing was performed to evaluate the modifications to the Artis zee / zeego family. The test results were found to be acceptable as required by the respective test plans and protocols." However, the specific test plans, protocols, and their outcomes (i.e., the actual numerical performance against criteria) are not detailed in this summary. This generally refers to engineering verification and validation testing, not clinical performance studies with specific metrics like sensitivity/specificity for a diagnostic task.

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

Not applicable/Not mentioned. This submission does not describe a clinical test set with patient data for performance evaluation in the context of AI/ML or a diagnostic task. The "testing" mentioned refers to verification and validation of the device modifications.

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

Not applicable/Not mentioned. As there's no clinical test set in the traditional sense for a diagnostic algorithm, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned.

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

No. The document does not describe an MRMC study. This is a 510(k) for device modifications, not a new diagnostic algorithm requiring human-AI comparative effectiveness.

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

No. This device is an angiographic X-ray system, which is a hardware system with software functionality, not a standalone algorithm. The performance evaluation discussed would be related to the system's operational integrity, image quality, and safety, not an algorithm's diagnostic performance.

7. The Type of Ground Truth Used

Not applicable/Not mentioned. For the type of device and submission, "ground truth" as a clinical reference standard is not a central component of the evaluation described. The "truth" would be whether the device functions according to its specifications and safely.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This device does not appear to involve an AI/ML algorithm that requires a "training set" in the context of learning from data to perform a diagnostic or predictive task. It's an imaging system where software updates provide new features and functionality.

9. How the Ground Truth for the Training Set was Established

Not applicable/Not mentioned.

In summary: K090745 is a 510(k) submission for modifications (software version upgrades and minor hardware additions) to an existing "Angiographic X-ray System." It focuses on demonstrating that these modifications do not alter the substantial equivalence to the predicate device (Artis zee, Artis zeego SW VC13) and that the device remains safe and effective for its intended use, which has been slightly expanded to include surgical angiography. The regulatory review for this type of submission primarily involves engineering verification and validation testing, not clinical performance studies with patient cohorts, ground truth, or AI/ML specific metrics.

Summary

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

K090745
Page 1 of 3

JUN 18 2009

SECTION 5 510(K) SUMMARY

FOR

SIEMENS ARTIS ZEE / ZEEGO FAMILY VC14

Submitted by: Siemens AG, Healthcare Sector, USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

March 17, 2009

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.

1. Contact Person:

Mr. Garv Johnson Technical Specialist, Regulatory Affairs Submissions Siemens AG, Healthcare Sector, USA, Inc 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(601) 448-1778 Fax: (610) 448-1787

Device Name and Classification 2.

Product Name:	Artis zee and Artis zeego - Modular Angiographic System
Classification Name:	Angiographic X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1600
Device Class:	Class II
Product Code:	90 IZI

3. Intended Use:

Artis zee / zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to pediatric and obese patients.

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

KC9C745
Page 2 of 3

Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.

The intended use and indications for use of the Artis zee / zeego VC14 have minor changes from its predicate device the Artis zee / zeego VC13, K073290

Device Description: 4.

5. Substantial Equivalence:

The Artis zee / zeego Modular Angiography System SW VC14 is a modification of a legally marketed device and substantial equivalent to Artis zee, Artis zeego SW VC13 as listed below.

510(k) Number	Date of Clearance	Device Name
K073290	February 11th, 2008	Artis zee, Artis zeego Angiographic X-ray Systems

A detailed Substantial Equivalence Comparison is provided in Section 12.

6. Summary of Technological Characteristics of the Principal Device as compared with the Predicate Device:

Artis zee / zeego Modular Angiography System is designed as a set of components (Carm, X-ray tube and housing, flat detector, digital imaging system, collimator, generator etc.) that may be combined into different configurations to provide specialized angiography systems. Many of the components used with Artis zee / zeego are either commercially available with current Siemens systems or include minor modifications to existing components. New or modified features provided with Artis zee/zeego SW VC 14 are provided in the Executive Summary as well as in the Device Description.

{2}------------------------------------------------

KC9C745.
Page 3 of 3

7. 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. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Artis zee / zeego Modular Angiography System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.

Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

Performance Data:

Applicable testing was performed to evaluate the modifications to the Artis zee / zeego family. The test results were found to be acceptable as required by the respective test plans and protocols.

Conclusion:

The testing reported in this 510(k) establishes the device is safe and effective for its intended use and substantially equivalent to the predicate device.

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

Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

JUN 18 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Garv Johnson

Technical Specialist, Regulatory Affairs, Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K090745

Trade/Device Name: Artis zee / zeego Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: June 5, 2009 Received: June 9, 2009

Dear Mr. Johnson:

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 (PMA), it may be subject to 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); medical device reporting (reporting of medical

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

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

SECTION 4 Indications For Use

510(k) Number (if known): 090 745 Device Name: Artis zee / zeego

Indications for Use:

Artis zee / zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not linited to, pedication and obese patients.

Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.

Prescription Use
(Part 21 CFR 801 Subpart D)
C)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart

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

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

HoguhkPh

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices KO90745 510(k) Number

510(k) Artis zeelzeego

Page 4 of 133 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Siemens AG Healthcare Sector

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.