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.

Device Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CLEARSIGN II Amplifier:

This document is a 510(k) Premarket Notification submission for a medical device called the CLEARSIGN II Amplifier. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive novel studies. Therefore, the information provided focuses on comparative testing and adherence to standards rather than traditional clinical trial-style data.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format with corresponding reported device performance metrics in the way one might expect for a new, breakthrough device. Instead, the "acceptance criteria" are implied by adherence to established industry standards and successful completion of specific functional tests. The reported "performance" is that the device met these predefined acceptance criteria.

Acceptance Criteria Category	Specific Standard/Test Example	Reported Device Performance
Electrical Safety	IEC 60601-1, 3rd Edition	All testing met pre-defined acceptance criteria, confirming safety.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 ed3.0 (2007-03) (Emissions and Immunity)	All testing met pre-defined acceptance criteria.
Software Life-cycle	IEC 62304:2006, and FDA guidelines	Software verification and validation (including life-cycle assessment) met pre-defined acceptance criteria.
Risk Management	ISO 14971:2012	Assessment of risk management met pre-defined acceptance criteria, confirming safety.
Packaging/Shipping	ISTA 2A requirements (Drop/ship testing)	All testing met pre-defined acceptance criteria.
Specific Functions (IBP)	IEC 60601-2-34 (Invasive blood pressure function)	All testing met pre-defined acceptance criteria.
Specific Functions (ECG Monitoring)	IEC 60601-2-27 (Electrocardiographic monitoring function)	All testing met pre-defined acceptance criteria.
Environmental	Operational temperature and atmospheric environment testing	All testing met pre-defined acceptance criteria.
System Compatibility	Compatibility with CARTO 3D navigation and mapping system	All testing met pre-defined acceptance criteria.
In Vivo (General Safety)	In vivo animal testing	All testing met pre-defined acceptance criteria.

Sample size used for the test set and the data provenance:
- Sample Size:
  - For bench testing: Not specified in terms of number of units or test iterations beyond "testing per standards."
  - For in vivo testing: "In vivo animal testing" is mentioned, implying a biological sample, but the number of animals or specific experimental design is not detailed.
- Data Provenance: The standard tests (IEC, ISO, etc.) are generally conducted in a controlled laboratory environment. The in vivo animal testing would also be laboratory-based and prospective within the context of the study. The document does not specify a country of origin for the data, but given it's a submission to the FDA (USA), it's likely the testing was conducted in the US or by a facility adhering to US/international standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The studies described are primarily engineering and bench tests against known standards, which typically do not involve human expert adjudication for "ground truth" in the same way clinical image analysis would. For functional tests, "ground truth" is defined by the physical or electrical standards themselves.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and not mentioned for the type of testing described. Adjudication methods are typically used for subjective assessments or when there is ambiguity in defining a "ground truth" from complex clinical data, which is not the nature of the engineering and functional tests reported here.
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:
- No, an MRMC comparative effectiveness study was not done.
- This device is an amplifier for physiological signals (ECG, pressure transducers), transmitting data to a recording system. It is not an AI-powered diagnostic tool that assists human readers in interpreting complex images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "performance" of the device is inherently standalone in the sense that its functional capabilities (amplification, conditioning, signal transmission) are tested against engineering specifications. The device itself is an electromechanical component of a larger system (LabSystem PRO EP Recording System). Its performance in isolation (e.g., signal fidelity, noise reduction) is what would be tested, as described by the various IEC and ISO standards. However, it's not an "algorithm-only" device; it's hardware with embedded software.
- The document implies standalone testing of the amplifier's functionality and its software's performance, but it's within the context of hardware.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is generally defined by established engineering and medical device standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). For functional tests (like invasive blood pressure or ECG monitoring), the 'truth' would be a precisely known input signal that the device is expected to accurately amplify and condition according to its specifications. For electrical safety, the 'truth' is compliance with safety limits. In a sense, the "ground truth" is the specification itself and the ability of the device to meet it.
- The "in vivo animal testing" would likely establish safety and basic physiological signal acquisition capability, with "ground truth" being in vivo physiological signals and the absence of adverse events, observed by qualified veterinary or medical staff.
The sample size for the training set:
- Not applicable and not mentioned. This device is not an AI/ML device that requires a "training set." It is an amplifier, and its design is based on engineering principles and standards, not on learning from a dataset.
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no training set for this type of device.

Summary of Device and Study Context:

The CLEARSIGN II Amplifier is an electromedical device intended to amplify and condition physiological signals (ECG and pressure). The regulatory submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (CLEARSIGN Amplifier, K050006). This means the focus of the studies is to show that the new device has "fundamentally the same technological characteristics" and performs in a safe and effective manner, compliant with current (updated) standards, and does not raise new safety or effectiveness concerns compared to the predicate.

The "studies" performed are primarily:

Bench testing: Verifying compliance with various electrical, electromagnetic, software, functional, and environmental standards (IEC, ISO, ISTA).
In vivo animal testing: Likely for general safety and initial physiological data acquisition demonstration.

These types of studies are standard for regulatory clearance of updates or minor modifications to existing device types and are distinct from multi-center clinical trials or AI validation studies that require extensive human expert review or large annotated datasets.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 22, 2015

Boston Scientific Corporation Maylin Truesdell, Senior Regulatory Affairs Specialist Electrophysiology Division 55 Technology Drive Lowell, MA 01851

Re: K150235

Trade/Device Name: CLEARSIGN II Amplifier, with models 2002021, 2002022, 2002023 and 2002024 Regulatory Number: 21 CFR 870.2060 Regulation Name: Transducer Signal Amplifier and Conditioner Regulatory Class: Class II (Two) Product Code: DRO Dated: March 23, 2015 Received: March 24, 2015

Dear Ms. 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.

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Page 2 - Maylin Truesdell

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 (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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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Attachment 2: Indications for Use Statement

Indications for Use

510(k) Number (if known):K150235___________________

Device Name: CLEARSIGN II Amplifier

Indications for Use:

Contraindications: None

Prescription Use × (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)

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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	January 28, 2015
ProprietaryName	CLEARSIGN II Amplifier
ModelNumbers	2002021 CLEARSIGN II Amplifier, 40 channels2002022 CLEARSIGN II Amplifier, 80 channels2002023 CLEARSIGN II Amplifier, 120 channels2002024 CLEARSIGN 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 (Borealis) AmplifierK050006, cleared May 27, 2005
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.
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 (Borealis) Amplifier, K050006 cleared May 27, 2005. TheIndications for Use between the predicate, CLEARSIGN 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 changes are to bring the equipment to state-of-the-art (specifically,compliance with IEC 60601-1, 3rd Edition), to comply with the EU RoHSDirective, and to implement minor performance improvements. Therefore,the CLEARSIGN II Amplifier is substantially equivalent to the predicatedevice.

CLEARSIGN II Amplifier Attachment 3, Page 1

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Performance Bench testing and in vivo testing were performed to support a determination of substantial equivalence. The CLEARSIGN II Amplifier is Data developed in accordance with 21 CFR 820.30 Quality System Regulation Design Controls. The device was developed and tested in accordance with the following industry standards: . IEC 60601-1, 310 Edition, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance . IEC 60601-1-2 ed3.0 (2007-03). Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests ● IEC 62304:2006, Medical device software - Software life-cycle processes ISO 14971:2012, Medical devices - Application of risk management to ● medical devices Testing conducted included: Electrical safety testing and assessment of risk management, in . accordance with IEC 60601-1, 3rd Edition ● Electro-magnetic compatibility (emissions and immunity) testing, in accordance with IEC 60601-1-2, 300 Edition ● Software verification and validation including software lifecycle assessment per ISO 62304 and FDA quidelines ● Drop/ship testing, per ISTA 2A requirements . Testing of specific functions, including the invasive blood pressure function (per IEC 60601-2-34) and the electrocardiographic monitoring function (per IEC 60601-2-27) . Operational temperature and atmospheric environment testing . Testing for compatibility with the CARTO 3D navigation and mapping system (Biosense Webster, Diamond Bar, CA), as LabSystem PRO is labeled for use with CARTO . In vivo animal testing All testing met pre-defined acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the CLEARSIGN II Amplifier. 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. No new safety or performance issues were raised during the device testing. Conclusion Based on the idential indications for use, substantially equivalent technological characteristics, and safety and performance testing, the CLEARSIGN II Amplifier has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the CLEARSIGN (Borealis) Amplifier as submitted in K050006.

Regulation Number and Section

§ 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).