(182 days)
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.
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.
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.
Here's an analysis of the provided 510(k) summary regarding the Astronomer Plus™ with SLD device, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics. It broadly mentions that "Tests were performed both in vitro and in vivo to confirm further, conformance to several recognized standards is safety and effectiveness."
Without specific numerical targets for performance (e.g., accuracy, precision, sensitivity, specificity for a particular function), a table of acceptance criteria and reported performance cannot be generated from the given text. The submission focuses on substantial equivalence based on intended use and technological characteristics rather than providing a detailed performance study with quantifiable outcomes against pre-defined criteria.
2. Sample Size Used for the Test Set and Data Provenance
The summary does not specify the sample size used for the test set in either in vitro or in vivo testing. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The summary does not mention the use of experts to establish a "ground truth" for a test set, nor does it specify the number or qualifications of any experts involved. The testing appears to be focused on confirming safety and effectiveness primarily through engineering verification and validation against functional requirements of the device itself and its interaction with the Constellation® Catheter, rather than against a clinical ground truth established by expert review.
4. Adjudication Method for the Test Set
Since the summary does not detail the process of establishing ground truth with experts, an adjudication method is not discussed or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The summary does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The device is described as assisting in diagnosis and displaying information, but there's no mention of a study evaluating human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
The device is explicitly described as a "computerized system to assist in the diagnosis" and "provides data to the physician." This indicates a human-in-the-loop system. Therefore, a standalone (algorithm only) performance study would not be applicable or described for this type of device. Its function is inherently assistive to a human operator.
7. Type of Ground Truth Used
The summary does not explicitly define a "ground truth" in the clinical sense (e.g., pathology, outcomes data). The testing performed seems to be geared towards functional verification and validation of the device's ability to display catheter locations, route signals, and document procedures as intended. The "ground truth" in this context would likely be the accurate functioning of the system itself and its sensors, rather than a clinical diagnostic outcome.
8. Sample Size for the Training Set
The summary does not mention a training set or its sample size. Given the device's apparent function of displaying and routing data rather than performing complex AI-driven diagnostic interpretations requiring extensive training data, the concept of a "training set" in the context of machine learning might not be applicable here.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, the method for establishing its ground truth is also not discussed.
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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 ClassificationName(s) | Programmable Diagnostic Computer |
| Predicate DeviceClassification(s) | Class II DQK 21 CFR §870.1425 |
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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
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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.
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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
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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
§ 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).