(67 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard digital fluoroscopic imaging.
No.
The device is described as an imaging system used for diagnosis (fluoroscopic imaging of vascular systems) rather than for direct treatment or therapy.
Yes
The device provides fluoroscopic imaging of vascular systems for applications like vascular angiography and electrophysiology (EP) studies. These are procedures used to visualize internal structures and processes within the body to diagnose medical conditions.
No
The device description explicitly states it is a "digital fluoroscopic system" and an "xray system," indicating it includes hardware components for image acquisition (fluoroscopy).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system provides "fluoroscopic imaging of vascular systems" and is used for "vascular angiography and electrophysiology (EP) studies." This involves imaging the inside of the body using X-rays, which is an in vivo (within the living body) procedure.
- Device Description: The description reinforces this by stating it's a "digital fluoroscopic system providing bi-plane fluoroscopic clinical images of both patients and medical devices during conventional and magnetic procedures." Again, this describes imaging within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
Therefore, the Telstar™ Biplane Digital Imaging System is an in vivo imaging device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JAA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
Vascular systems
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
4
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.