(30 days)
The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.
The LabSystem Pro (LS PRO) EP Recording System (K141185) with CLEARSIGN/CLEARSIGN II Amplifier is an integrated system that acquires, displays, records, and measures physiological signals that originate from that heart. The CLEARSIGN II Amplifier is a reusable electromedical device containing hardware and software that acquires, conditions and presents the physiological signal to the LabSystem PRO EP Recording System such that the signals are available for clinical user selection, display and recording. The CLEARSIGN II Amplifier is used in conjunction with the compatible diagnostic electrophysiology (EP) catheters, surface ECG leads, intravascular pressure transducers, intracardiac stimulators, RF ablation generators and cardiac ablation catheters. The CLEARSIGN II Amplifier is intended for use during EP diagnostic and therapeutic procedures in an EP cath lab.
This document is a 510(k) premarket notification for the CLEARSIGN II Amplifier, which is a Transducer Signal Amplifier and Conditioner. The submission seeks to prove substantial equivalence to a previously cleared device, also named CLEARSIGN II Amplifier (K150235).
The device in question (CLEARSIGN II Amplifier) is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.
Acceptance Criteria and Reported Device Performance
The document describes performance data through various verification tests to support a determination of substantial equivalence. While specific quantitative acceptance criteria are not explicitly detailed in a table format, the document states that "No new safety or performance issues were raised during the device testing" and that the testing assures "conformance to the requirements for its intended use."
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from testing type) | Reported Device Performance (Inferred from Conclusion) |
|---|---|
| Accurate ECG Offset Measurement | Passed: "CLEARSIGN II ECG Offset Test" performed without new safety/performance issues. |
| Correct Firmware Functionality (v2.09) | Passed: "Firmware version 2.09 Verification Testing" performed without new safety/performance issues. |
| Software Functionality and Reliability | Passed: "Software Verification Testing" performed without new safety/performance issues. |
| Conformance to Intended Use | Passed: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is verification testing against design specifications, not a clinical study on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The testing described is design verification (engineering tests), not a clinical study requiring expert ground truth for interpretation of medical data.
4. Adjudication Method for the Test Set:
Not applicable. This was design verification testing, not a clinical study with subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on identical indications for use and fundamentally similar technological characteristics to a predicate device, with verification testing ensuring no new safety or performance issues. This is not a study comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, in essence, the "Performance Data" section describes standalone testing of the device's hardware and software components. The "CLEARSIGN II ECG Offset Test," "Firmware version 2.09 Verification Testing," and "Software Verification Testing" evaluate the device's intrinsic functions without a human-in-the-loop performance assessment.
7. Type of Ground Truth Used:
The ground truth used for the verification testing would be the engineering specifications and expected output parameters for the device's functions (e.g., specific voltage levels for ECG amplification, correct processing logic for firmware, proper software operation). It does not involve expert consensus, pathology, or outcomes data in the medical sense, but rather conformance to defined technical requirements.
8. Sample Size for the Training Set:
Not applicable. This device is an amplifier and conditioner, not an AI or machine learning algorithm that requires a training set of data. The "firmware" and "software" mentioned are likely traditional programmed logic, not adaptive learning models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set (for machine learning) is relevant to this device's development or regulatory submission.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2015
Boston Scientific Corporation Maylin Truesdell Senior Regulatory Affairs Specialist 55 Technology Dr. Lowell, Massachusetts 01851
Re: K152693
Trade/Device Name: Clearsign II Amplifier Regulation Number: 21 CFR 870.2060 Regulation Name: Transducer Signal Amplifier and Conditioner Regulatory Class: Class II (Two) Product Code: DRO Dated: September 18, 2015 Received: September 21, 2015
Dear Maylin Truesdell:
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 device
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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 contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for 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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Attachment 2: Indications for Use Statement
Indications for Use
510(k) Number (if known):_K152693
Device Name: CLEARSIGN II Amplifier
Indications for Use:
The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.
Contraindications: None
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Confidential
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Attachment 3: 510(k) Summary
510(k) Summary per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific Corporation55 Technology DriveLowell, MA 01851Phone:978-805-3231Fax:978-805-3281 |
|---|---|
| Contact NameandInformation | Maylin TruesdellSenior Regulatory Affairs SpecialistPhone:978-805-3231Fax:978-805-3281E-mail:maylin.truesdell@bsci.com |
| Date Prepared | September 09, 2015 |
| ProprietaryName | CLEARSIGN II Amplifier |
| ModelNumbers | M00420020210CLEARSIGN II Amplifier, 40 channelsM00420020220CLEARSIGN II Amplifier, 80 channelsM00400202300CLEARSIGN II Amplifier, 120 channelsM00420020240CLEARSIGN II Amplifier, 160 channels |
| Common Name | Transducer Signal Amplifier and Conditioner |
| Product Code | DRQ - Transducer Signal Amplifier and Conditioner |
| Classification | Class II, 21 CFR Part 870.2060 |
| PredicateDevices | CLEARSIGN II AmplifierKI50235, cleared April 22, 2015 |
| DeviceDescription | The LabSystem Pro (LS PRO) EP Recording System (K141185) withCLEARSIGN/CLEARSIGN II Amplifier is an integrated system thatacquires, displays, records, and measures physiological signals thatoriginate from that heart. The CLEARSIGN II Amplifier is a reusableelectromedical device containing hardware and software that acquires,conditions and presents the physiological signal to the LabSystem PROEP Recording System such that the signals are available for clinical userselection, display and recording. The CLEARSIGN II Amplifier is used inconjunction with the compatible diagnostic electrophysiology (EP)catheters, surface ECG leads, intravascular pressure transducers,intracardiac stimulators, RF ablation generators and cardiac ablationcatheters. The CLEARSIGN II Amplifier is intended for use during EPdiagnostic and therapeutic procedures in an EP cath lab. |
Confidential
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| Intended Use/Indications forUse | The CLEARSIGN II Amplifier is intended to amplify and conditionelectrocardiographic signals of biologic origin and pressure transducerinput, transmitting this information to a host computer (the LabSystemPRO EP Recording System) that can record and display the information. |
|---|---|
| Comparison ofTechnologicalCharacteristics | The predicate device for this 510(k) Premarket Notification is theCLEARSIGN II Amplifier KI50235, cleared April 22, 2015. The Indicationsfor Use between the predicate, CLEARSIGN II Amplifier, and theproposed device, CLEARSIGN II Amplifier, are identical. TheCLEARSIGN II Amplifier incorporates fundamentally the sametechnological characteristics as the predicate device. The basicarchitecture and design of the hardware and software are the same; theonly change is a single line of code in the CLEASIGN II firmware.Therefore, the CLEARSIGN II Amplifier is substantially equivalent to thepredicate device. |
| PerformanceData | Design verification testing was performed to support a determination ofsubstantial equivalence. The CLEARSIGN II Amplifier is developed inaccordance with 21 CFR 820.30 Quality System Regulation DesignControls.Testing conducted included:• CLEARSIGN II ECG Offset Test• Firmware version 2.09 Verification Testing• Software Verification TestingThe results of these tests provide reasonable assurance that theproposed device has been designed and tested to assure conformance tothe requirements for its intended use. No new safety or performanceissues were raised during the device testing. |
| Conclusion | Based on the identical indications for use, substantially equivalenttechnological characteristics, and safety and performance testing, theCLEARSIGN II Amplifier has been shown to be appropriate for itsintended use and is considered to be substantially equivalent to theCLEARSIGN II Amplifier KI50235, cleared April 22, 2015. |
§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).