TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915

K022565 · Stereotaxis, Inc. · JAA · Oct 8, 2002 · Radiology

Device Facts

• Record ID: K022565
• Device Name: TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
• Applicant: Stereotaxis, Inc.
• Product Code: JAA · Radiology
• Decision Date: Oct 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

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.

Device Story

The Telstar Biplane Digital Imaging System (TIS) is a digital fluoroscopic x-ray system used for imaging vascular systems during angiography and electrophysiology procedures. It functions as a stand-alone unit or integrated with a Stereotaxis Magnetic Navigation System. The system utilizes a rotating anode x-ray tube and image intensifier to capture bi-plane fluoroscopic images, which are displayed on quad 15-inch monitors. The device offers multiple operating modes, including standard Fast Scan Fluoro (2x2 binning) and a modified Low Noise, High Sensitivity Fluoro (2x4 binning) mode. Clinicians use the real-time visual output to guide medical devices and monitor vascular anatomy during procedures. The system is intended for use in clinical settings by medical professionals.

Clinical Evidence

No new clinical or preclinical animal performance data were required or necessary to support the modifications; reliance was placed on data provided in the original 510(k) submission (K013484).

Technological Characteristics

Digital fluoroscopic x-ray system; rotating anode x-ray tube; image intensifier; quad 15-inch monitors. Operating modes: Fast Scan Fluoro (2x2 binning) and Low Noise, High Sensitivity Fluoro (2x4 binning). Pulsed fluoro rates: 7.5, 15, 30 pulses/sec. Pulsed cardiac rates: 15, 30 pulses/sec. Compliant with 21 CFR §1020.32.

Indications for Use

Indicated for patients requiring fluoroscopic imaging of vascular systems during vascular angiography and electrophysiology (EP) studies.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Telstar™ Biplane Digital Imaging System (K013484)

Submission Summary (Full Text)

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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<br>(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 [phone]

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 [phone]. 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 [phone] or [phone] 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.