(182 days)
Not Found
No
The description focuses on data management, display of catheter location and orientation, signal routing, and documentation, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as a computerized system to assist in the diagnosis of complex cardiac arrhythmias, and a data management system for creating, maintaining, and reviewing patient files. It explicitly states its purpose is to "assist in the diagnosis," rather than directly treating or mitigating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "to assist in the diagnosis of complex cardiac arrhythmias." The "Device Description" further reinforces this by mentioning the device is "intended for use within a cardiac electrophysiology lab... to assist in the diagnosis of complex cardiac arrhythmias."
No
The device description explicitly states it consists of a workstation running proprietary software and a catheter interface (the Switching & Locating Device), which is a hardware component.
Based on the provided information, the Astronomer Plus™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Astronomer Plus™ Function: The Astronomer Plus™ System works by:
- Displaying the location of catheters within the body during a procedure.
- Routing electrical signals from the body (cardiac electrograms).
- Assisting in the diagnosis of arrhythmias based on these in vivo measurements and catheter locations.
- Lack of Specimen Analysis: The system does not analyze biological specimens outside of the body. It's interacting directly with the patient's cardiac electrical activity and the location of devices within the body.
The Astronomer Plus™ System is clearly designed for use in vivo during a cardiac electrophysiology procedure, not for the in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus™ System can be used to:
- Display the relative location of catheters during cardiac * mapping procedures (used exclusively with the Constellation® Catheter);
- Route externally generated pacing stimuli and transmit * cardiac electrogram (EGM) signals to electrophysiology recorders; and
- Document electrophysiological procedures which make use * of the Constellation® Catheter.
Product codes
DQK
Device Description
This device is a data management system intended for use within a cardiac electrophysiology lab for the creation, maintenance, and review of patient files generated during a typical electrophysiology study to assist in the diagnosis of complex cardiac arrhythmias. The device consists of a workstation running proprietary software, and catheter interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiac electrophysiology lab
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)
Tests were performed both in vitro and in vivo to confirm Further, conformance to several recognized standards is safety and effectiveness. maintained.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003362, K992912, K992968, K001437, K002869
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness
| Category: | Comments |
|---|---|
| Sponsor: | Boston Scientific Corporation |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Correspondent: | Andrea L. Ruth, RAC |
| Senior Associate, Regulatory Affairs | |
| 2710 Orchard Parkway | |
| San Jose, CA 95134 | |
| Contact Numbers: | Phone: 408.895.3625 |
| Pager: 888.509.6375 | |
| Fax: 408.895.2202 |
Table 1 - Sponsor Information
Table 2 - Device Information
| Device Common Name | Programmable Diagnostic Computer |
|---|---|
| Device Proprietary Name | Astronomer PlusTM with SLD |
| Device Classification Name | Programmable Diagnostic Computer |
| Device Classification | Class II DQK 21 CFR §870.1425 |
| Predicate Devices | BSC/EPT Astronomer PlusTM; |
| Cardiac Pathways Arrhythmia Mapping and Tracking System; | |
| Biosense CARTOTM System; | |
| Endocardial Solutions EnSite 3000® System; | |
| Medtronic LocaLisa® Cardiac Navigation System | |
| Predicate Device Reference(s) | K003362; K992912; K992968; K001437; K002869 |
| Predicate Device Classification | |
| Name(s) | Programmable Diagnostic Computer |
| Predicate Device | |
| Classification(s) | Class II DQK 21 CFR §870.1425 |
1
October 5, 2001. Date Summary Was Prepared:
Description of the Device: This device is a data management system intended for use within a cardiac electrophysiology lab for the creation, maintenance, and review of patient files generated during a typical electrophysiology study to assist in the diagnosis of complex cardiac arrhythmias. The device consists of a workstation running proprietary software, and catheter interface.
Intended Use:
The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus System can be used to:
- Display the relative location of catheters during cardiac mapping * procedures (used exclusively with the Constellation® Catheter);
- Route externally generated pacing stimuli and transmit cardiac * electrogram (EGM) signals to electrophysiology recorders; and
-
- To document electrophysiological procedures which make use of the Constellation® Catheter.
The Astronomer Plus System is an accessory for the Technological Characteristics: Constellation Catheter. Its function and intended use are similar to several commercially available systems, such as Cardiac Pathways' Arrhythmia Mapping and Tracking System, Biosense's CARTO® System, and Endocardial Solutions' EnSite 3000. Like these other systems, the Astronomer Plus™ system is comprised of a catheter input box (the Switching & Locating Device) and a Computer, running a proprietary GUI (Astronomer Plus™). The system provides data to the physician obtained from the Constellation Catheter and a Roving (or auxiliary) Catheter (typically a quad catheter). The System has two window displays that simultaneously show: Constellation catheter orientation, roving catheter proximity indication, and user-defined markers. Additionally, the SLD routes signals received from the Constellation and Roving Catheters 1-to-1 to stand-alone EP recorders for acquisition, storage, and display purposes.
Summary of Testing Performed: Tests were performed both in vitro and in vivo to confirm Further, conformance to several recognized standards is safety and effectiveness. maintained.
BOSTON SCIENTIFIC CORPORATION / EP TECHNOLOGIES, INC. ABBREVIATED 510(K) - ASTRONOMER PLUSTM SYSTEM
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 9 2002
Ms. Andrea L. Ruth Senior Associate, Regulatory Affairs Boston Scientific/EP Technologies, Inc. 2710 Orchard Parkway San Jose, CA 95134
Re: K013349
Trade Name: Astronomer Plus™ System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: January 16, 2002 Received: January 18, 2002
Dear Ms. Ruth:
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 such 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.
3
Page 2 - Ms. Andrea L. Ruth
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Oktell
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Intended Use Statement
510(k) Number (if known): 1
Astronomer Plus™ System Device Name:
Indication for Use:
The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus™ System can be used to:
- Display the relative location of catheters during cardiac * mapping procedures (used exclusively with the Constellation® Catheter);
- Route externally generated pacing stimuli and transmit * cardiac electrogram (EGM) signals to electrophysiology recorders; and
- Document electrophysiological procedures which make use * of the Constellation® Catheter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
Over-The-Counter Use_
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number R013349
BOSTON SCIENTIFIC CORPORATION / EP TECHNOLOGIES, INC. Abbreviated 510(k) - Astronomer Plus™ System
Confidential