The Telstar™ Biplane Digital Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This xray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System.

Device Description

The Telstar™ Biplane Digital Imaging System [TIS] is a digital fluoroscopic system providing bi-plane fluoroscopic clinical images of both patients and medical devices during conventional and magnetic procedures.

AI/ML Overview

This document (K022565) describes a modification to an existing medical device, the Telstar™ Biplane Digital Imaging System, previously cleared under K013484. The submission focuses on demonstrating substantial equivalence of the modified device to the predicate device, rather than establishing acceptance criteria for a novel device. Therefore, a direct "acceptance criteria" table and a "study that proves the device meets the acceptance criteria" in the typical sense (e.g., performance metrics against a threshold for a new AI algorithm) are not present because the modification does not change the intended use or fundamental scientific technology.

Instead, the submission primarily relies on comparison to the predicate device and compliance with regulatory standards.

Here's a breakdown of the requested information based on the provided text, heavily emphasizing the absence of certain elements due to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this 510(k) is for a modification to an already cleared device (K013484) that does not alter its intended use or fundamental scientific technology, there are no specific numerical acceptance criteria for performance (e.g., sensitivity, specificity, or accuracy) established in this document for the modified device itself.

The "acceptance criteria" in this context are primarily:

The modified device's characteristics remain substantially equivalent to the predicate device.
The modified device complies with relevant regulatory standards.

The table below outlines the comparison of the modified device's characteristics to the predicate device:

Characteristic	Acceptance Criteria (Predicate Device K013484)	Reported Device Performance (Modified TIS)
Imaging	Fluoroscopic	Fluoroscopic
Pulsed fluoro	7.5, 15, 30 pulses/sec	7.5, 15, 30 pulses/sec
Pulsed cardiac	15, 30 pulses/sec	15, 30 pulses/sec
X-ray tube assembly	Rotating anode	Rotating anode
Image intensifier	Yes	Yes
Monitor	Quad 15"	Quad 15"
Operating modes	Fast Scan Fluoro (2x2 binning) only	Fast Scan Fluoro and Low Noise, High Sensitivity Fluoro (2x4 binning)
Frame rate	Same (as predicate)	Same (as predicate)

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the demonstration of substantial equivalence through direct comparison of technical characteristics and the statement that "No new studies were required or necessary to support the modifications." This indicates that the safety and effectiveness established for the predicate device (K013484) are considered applicable to the modified device due to the nature of the changes.

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

Sample Size for the Test Set: Not applicable. No new test set or clinical study was conducted as part of this 510(k) submission for the modified device. The submission states: "Preclinical animal performance data were provided in K013484. No new studies were required or necessary to support the modifications. Clinical performance data were provided in K013484. No new studies were required or necessary to support the modifications."
Data Provenance: Not applicable, as no new data was presented. Any prior data would have originated from the K013484 submission.

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

Not applicable. No new test set or ground truth establishment was performed for this modification.

4. Adjudication Method for the Test Set

Not applicable. No new test set and therefore no adjudication was performed.

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

No. An MRMC comparative effectiveness study was not done. This submission is for a modification to a fluoroscopic imaging system, not an AI-assisted diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No. This device is a fluoroscopic imaging system, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

Not applicable for this modification. For the original device (K013484) to which this is a modification, ground truth for imaging systems typically involves physical testing, phantom studies, and potentially expert assessment of image quality against known anatomical structures or pathologies. However, this specific submission does not detail how ground truth was established for the predicate, and asserts that no new studies were needed for the modification.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware imaging system, not an AI/machine learning algorithm that requires a training set.

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

Not applicable. As this is not an AI/machine learning algorithm, there is no training set or ground truth established in this context.

Summary

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Appendix 1: 510(k) Summary of Safety and Effectiveness OCT 0 8 2002 KO22565

Statement	Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
Device description	The Telstar™ Biplane Digital Imaging System [TIS] is a digital fluoroscopic system providing bi-plane fluoroscopic clinical images of both patients and medical devices during conventional and magnetic procedures.
Intended use	Provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System.
Substantial equivalence	The TIS is a modification of the Telstar™ Biplane Digital Imaging System originally cleared under K013484. The modifications described herein do not affect the intended use of the device or alter the fundamental scientific technology associated with the device.
Technological characteristics	The TIS provides visualization through standard fluoroscopy.

Continued on next page

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Appendix 1: 510(k) Summary of Safety and Effectiveness, Continued

Device comparisons - Imaging	The following clarifies the modifications to the Telstar Biplane Digital Imaging System cleared under K013484.
	Device Characteristics	Current TIS(K013484)	Modified TIS
	Imaging	Fluoroscopic	Fluoroscopic
	Pulsed fluoro	7.5, 15, 30 pulses/sec	7.5, 15, 30 pulses/sec
	Pulsed cardiac	15, 30 pulses/sec	15, 30 pulses/sec
	X-ray tube assembly	Rotating anode	Rotating anode
	Image intensifier	Yes	Yes
	Monitor	Quad 15"	Quad 15"
	Operating modes	Fast Scan Fluoro (2x2 binning) only	Fast Scan Fluoro and Low Noise, High Sensitivity Fluoro (2x4 binning)
	Frame rate	Same	Same
Physical testing	The TIS is designed and tested in compliance with the requirements of 21 CFR §1020.32 (Fluoroscopic Equipment).
Preclinical animal performance data	Preclinical performance data were provided in K013484. No new studies were required or necessary to support the modifications.
Clinical performance data	Clinical performance data were provided in K013484. No new studies were required or necessary to support the modifications.

The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and expectations of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.

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Special 510(k): Telstar Biplane Digital Imaging System Stereotaxis, Inc.

Appendix 1: 510(k) Summary of Safety and Effectiveness, Continued

Contact Peter A. Takes, Ph.D., RAC Director, Clinical & Regulatory Affairs Stereotaxis, Inc. 4041 Forest Park Avenue St. Louis, Missouri 63108 Ph. 314-615-6964 Fax 314-615-6912

August 1, 2002 Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Peter A. Takes, Ph.D., RAC Director, Clinical & Regulatory Affairs Stereotaxis, Inc. 4041 Forest Park Avenue ST LOUIS MO 63108

AUG 2 0 2013

Re: K022565

Trade/Device Name: Telstar Biplane Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: September 6, 2002 Received: September 9, 2002

Dear Dr. Takes:

This letter corrects our substantially equivalent letter of October 8. 2002.

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 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

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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

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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Special 510(k): Telstar Biplane Digital Imaging System Stereotaxis, Inc. ·

August 1, 2002 Page 30

Appendix 2: Statement of Intended Use

Statement

Indications for Use Statement:

510(k) Number: K

Device Name: Telstar™ Biplane Digital Imaging System [TIS]

Indications for Use: The Telstar™ Biplane Digital Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This xray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System.

Prescription Use

Varid a. Seymon

(Division Sign-Off) Division of Reproductive, a and Radiological Device 510(k) Number

The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and expectations of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.

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.