(30 days)
No
The document explicitly states "There are no changes to the fundamental scientific technology of the device nor are there any changes to the intended use." and describes it as a "microprocessor based data acquisition system". There is no mention of AI or ML in the description of the device's functionality or the software changes.
No.
The device is described as a "data acquisition and analysis tool" and an "EP Recording System" used to acquire, display, and store electrophysiologic data. It does not actively deliver therapy or perform therapeutic functions.
Yes
The device is described as an "acquisition and analysis tool" designed to "facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data." It acquires, stores, and displays 3D mapping events, stimulation pacing data, and images of 3D electro-anatomical maps for "review and insertion into the final clinical report." The emphasis on data analysis by a physician and its contribution to a clinical report indicates a diagnostic purpose.
No
The device description explicitly states it is a "microprocessor based data acquisition system" that acquires data via an "amplifier that is connected to the patient via ECG leadwires and catheters," indicating the presence of hardware components beyond just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body). The LabSystem™ EP Laboratory acquires data directly from the patient during an electrophysiology procedure using ECG leadwires and catheters connected to the patient.
- The data acquired is physiological data (ECG, intracardiac, pressure) and digital data from other devices. It is not analyzing biological samples.
- The intended use is to facilitate the gathering, display, analysis by a physician, pace mapping, and storage of cardiac electrophysiologic data. This is focused on monitoring and analyzing electrical activity within the heart in vivo.
The device is a data acquisition and analysis tool used during a medical procedure performed on a patient, not a device that analyzes samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The 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 Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.
Product codes
DQK
Device Description
The V2.7 software for the LabSystem™ PRO EP Recording System is substantially similar to the currently commercialized software (V2.6a) with the difference that the V2.7 software runs on a Microsoft Windows 7 platform as compared to V2.6a which runs on a Windows XP platform. Other than the platform update, there are no changes to the LabSystem PRO EP Recording System software functionality. There are no changes to the fundamental scientific technology of the device nor are there any changes to the intended use.
The LabSystem™ PRO 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 via ECG leadwires and catheters. It does not transmit alarms and does not have arrhythmia detection capabilities.
Mentions image processing
Acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed healthcare practitioner
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)
Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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JUN 0 6 2014 K141185
Page 1 of 5
510(k) SUMMARY
This 510(k) Summary is provided per the requirements of section 807.92(c).
| Owner Name: | Boston Scientific Corporation |
|---|---|
| Address: | 55 Technology Drive |
| Lowell, MA 01851 | |
| Phone Number: | 978-323-2293 |
| Fax Number: | 978-323-2222 |
| Contact Person: | Robin M. Mulvey |
| Regulatory Affairs, Specialist II | |
| Email address: robin.mulvery@bsci.com | |
| Alternate Contact: | Julie Broderick |
| Vice President, Regulatory Affairs | |
| PH: 978-323-2220 | |
| FX: 978-323-2222 | |
| Email address: julie.broderick@bsci.com | |
| Date of Summary: | 2 May 2014 |
| Device Trade Name: | LabSystem™ PRO EP Recording System |
| Device Common Name: Programmable Diagnostic Computer | |
| Classification Name: | Programmable Diagnostic Computer |
| Product Code: | DQK |
| Predicate Device(s): | Bard LabSystem PRO EP Recording System |
| (K031000/June 3, 2003) |
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V2.6 Software for the Bard LabSystem PRO EP Recording System (K113811/April 3, 2012)
Device Description:
The V2.7 software for the LabSystem™ PRO EP Recording System is substantially similar to the currently commercialized software (V2.6a) with the difference that the V2.7 software runs on a Microsoft Windows 7 platform as compared to V2.6a which runs on a Windows XP platform. Other than the platform update, there are no changes to the LabSystem PRO EP Recording System software functionality. There are no changes to the fundamental scientific technology of the device nor are there any changes to the intended use.
The LabSystem™ PRO 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 via ECG leadwires and catheters. It does not transmit alarms and does not have arrhythmia detection capabilities.
Indications for Use:
The 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 Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense
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K141185 Page 3 of 5
Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration
also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.
Comparison to Predicate Devices:
The predicate devices for this 510(k) Premarket Notification are the LabSystem™ PRO EP Recording System (K031000), and the V2.6 Software for the LabSystem PRO EP Recording System (K113811). The Indications for Use between the V2.6 software and the proposed software, V2.7, are identical.
All of these devices are electrophysiology recording systems that are used for the same intended purpose. These systems are intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. The systems acquire signal types which include ECG signals, direct cardiac signals, and pressure recordings. The systems obtain physiological parameters such as diastolic, systolic and mean blood pressure, heart rate and cycle length which are derived from the signal data, displayed and recorded. The systems allow the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data and generate reports on the data. The systems acquire, amplify, display and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The systems do not transmit alarms and do not have arrhythmia detection capabilities.
V2.6 software (K113811) and the proposed V2.7 software have the capability to integrate with the Biosense Webster®, CARTO™ 3 system, to send patient demographics to Biosense Webster® CARTO™ 3, and acquire (from Biosense
3
Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection between the two systems.
The hardware, base software and firmware that are currently utilized in the LabSystem PRO EP Recording System (K031000 and K113811) are substantially equivalent to the base software and firmware for the V2.7 software for the LabSystem PRO EP Recording System.
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.
| IEEE Standard 730-2002 | Software Quality Assurance Plans |
|---|---|
| IEEE Standard 829-2008 | Software Test Documentation |
| IEEE Standard 1012-2012 | Software Verification and Validation Plans |
| IEEE Standard 830-1998 | Software Requirement Specifications |
| IEEE Standard 1008-1987 | Software Unit Testing |
| EN 60601-1-2:2007 | EMC, Radiated emissions and Conducted emissions requirements |
| EN 60601-1:2005 | Patient Leakage current (Section 19, Table IV, Type CF, 50uA) |
| IEC 62304:2006 | Medical Device Software - Software Life Cycle Processes |
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Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System.
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 and principles of operation, and the technological characteristics support a determination of substantial equivalence.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MD 20993-0002
June 6, 2014
Boston Scientific Corp. Ms. Robin Mulvey Regulatory Affairs, Specialist II 55 Technology Drive Lowell, Massachusetts 01851
Re: K141185
Trade/Device Name: LabSystem™ PRO EP Recording System V2.7 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 5, 2014 Received: May 7, 2014
Dear Ms. Mulvey:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Robin Mulvey
the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
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forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K141185
Indications for Use
510(k) Number (if known):
Device Name: LabSystem™ PRO EP Recording System
Indications for Use:
V2.7 software for the LabSystem™ PRO EP Recording System Indication: The 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 Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. I Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.
Contraindications: None
Prescription Use イ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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2 May 2014