(150 days)
The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.
When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.
The LabSystem EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient.
The provided document is a 510(k) Summary for the Bard LabSystem™ PRO EP Recording System, specifically for its V3.1 software. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving device performance against specific acceptance criteria. This type of regulatory submission typically relies on a comparison to existing, legally marketed devices rather than presenting novel performance studies with acceptance criteria, especially for software updates to established systems.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement are not present in this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available in the document. The document does not describe specific acceptance criteria or report quantified device performance metrics (e.g., sensitivity, specificity, accuracy) for the V3.1 software. The submission aims to show "substantial equivalence" to predicate devices, implying that its performance is comparable, but it doesn't present a study with specific targets.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the document. There is no mention of a test set, its sample size, or the provenance of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in the document. Given no test set is described, there's no information on experts establishing ground truth for it.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the document. No information on an adjudication method for a test set is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not available in the document. This device is an EP recording system for acquiring, analyzing, and displaying cardiac electrophysiologic data and 3D electroanatomical maps during electrophysiology procedures. It does not appear to be an AI-driven diagnostic system that assists human readers in the way an MRMC study typically assesses for AI. The document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not available in the document. The device is a "computer and software driven data acquisition and analysis tool" that "facilitate[s] the gathering, display, analysis by a physician." It is inherently designed for use by a physician, not as a standalone, fully autonomous diagnostic algorithm. No standalone performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available in the document. Since no specific performance study or test set is described, there's no information on the type of ground truth used.
8. The sample size for the training set
- Not available in the document. This document does not discuss a training set. The device appears to be a software update for an existing system, and the submission emphasizes regulatory compliance and substantial equivalence rather than a machine learning model's training and validation process.
9. How the ground truth for the training set was established
- Not available in the document. Since no training set is mentioned, there's no information on how its ground truth was established.
Summary of Non-Clinical Testing Section (Relevant to the overall submission but not specific performance metrics):
The document states: "The LabSystem™ PRO EP Recording System is developed and produced in accordance with 21 CFR 820.30 Quality System Regulations. The software product is developed and tested in accordance with the following industry standards." While this indicates quality control and development processes, it doesn't provide specific device performance acceptance criteria or study results against those criteria. The "Summary of Non-Clinical Testing" is a high-level statement about adherence to quality systems and standards, rather than a detailed report of a performance study.
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OCT 0 8 2010
510(k) Summary
510(k) SUMMARY
This 510(k) Summary is provided per the requirements of section 807.92(c).
| Owner Name: | Bard Electrophysiology Division of C.R. Bard, Inc |
|---|---|
| Address: | 55 Technology Drive |
| Lowell, MA 01851 | |
| Phone Number: | 978-323-2348 |
| Fax Number: | 978-323-2222 |
| Contact Person: | Anastasia C. Randall |
| Manager, Regulatory Affairs | |
| Email address: ana.randall@crbard.com | |
| Alternate Contact: | Julie Broderick |
| Director, Regulatory Affairs | |
| PH: 978-323-2220 | |
| FX: 978-323-2222 | |
| Email address: julie.broderick@crbard.com | |
| Date of Summary: | May 10, 2010 |
| Device Trade Name: | LabSystemTM PRO EP Recording System |
| Device Common Name: | Programmable Diagnostic Computer |
| Classification Name: | Programmable Diagnostic Computer |
| Predicate Device(s): | Bard LabSystem PRO EP Recording System(K031000/June 3, 2003) |
510(k) Submission for V3.1 software for the Bard
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Biosense Webster, Inc. CartoMerge Module of the Carto™ XP V8 EP Navigation System (K042999/March 21, 2005)
Device Description:
The LabSystem EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient.
Indications for Use:
The Bard LabSystem EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data. When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.
Comparison to Predicate Devices:
The predicate devices for this 510(k) Premarket Notification are the LabSystem™ PRO EP Recording System (K031000) and the CartoMerge Module of the Carto™ XP V8 Navigation System (K042999).
The Indications for Use for both the LabSystem PRO EP Recording System V3.1 software and the CartoMerge Module of the CartoXP V8 EP Navigation System are
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substantially equivalent as the CartoMerge Module of the CartoXP V8 Navigation System measurements are obtained in the same way as with the Bard LabSystem PRO EP Recording System V3.1 software. The two systems support activation timing, voltage amplitude, frequency measurements and location maps displayed on a segmented cardiac anatomy. Both Systems can acquire, analyze, and display 3D electroanatomical maps, construct maps using intracardiac electrograms with 3D cardiac positions, display color maps registered over patient's 3D cardiac anatomy, display electrical activation maps, display voltage maps, display dominant frequency maps, display location maps, and display user-defined measurement values. The generated electro-anatomical maps may be viewed in 3D on screen.
The hardware, base software and firmware that are currently utilized in the commercialized LabSystem PRO EP Recording System are identical to the LabSystem PRO EP Recording System with V3.1 software.
Summary of Non-Clinical Testing:
The LabSystem™ PRO EP Recording System is developed and produced in accordance with 21 CFR 820.30 Quality System Regulations. The software product is developed and tested in accordance with the following industry standards. Use of the IEEE standards is voluntary.
Substantial Equivalence:
The LabSystem™ PRO EP Recording System, subject of this 510(k), is substantially equivalent to the predicate devices. They have the same Indications for Use, principles of operation, materials of construction and the technological characteristics support a determination of substantial equivalence.
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 0 8 2010
C.R. Bard, Inc. Bard Electrophysiology Division c/o Ms. Anastasia C. Randall Regulatory Affairs Manager 55 Technology Drive Lowell, MA 01851
Re: K101331
Trade/Device Name: LabSystem PRO EP Recording System V3.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 27, 2010 Received: September 28, 2010
Dear Ms. Randall:
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 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. Anastasia C. Randall
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Dana R. Ulmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: LabSystem™ PRO EP Recording System
Indications for Use:
V3.1 software for the LabSystem™ PRO EP Recording System Indication: The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.
When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.
Contraindications: None
× Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
heimer
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number_K10) 331
510(k) Submission for V3.1 software for the Bard LABSYSTEM™ PRO EP Recording System
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§ 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).