CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels

K152693 · Boston Scientific Corporation · DRQ · Oct 21, 2015 · Cardiovascular

Device Facts

• Record ID: K152693
• Device Name: CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels
• Applicant: Boston Scientific Corporation
• Product Code: DRQ · Cardiovascular
• Decision Date: Oct 21, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2060
• Device Class: Class 2

Intended 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.

Device Story

Clearsign II Amplifier is a reusable electromedical device; acquires/conditions physiological signals (ECG, pressure) from heart; transmits data to LabSystem PRO EP Recording System for display/recording. Used in EP cath lab by clinicians during diagnostic/therapeutic procedures. Device integrates with EP catheters, surface ECG leads, pressure transducers, stimulators, and RF ablation generators. Output allows clinicians to monitor cardiac electrical activity and pressure during procedures, facilitating clinical decision-making. Firmware update (single line of code) is the primary change from predicate.

Clinical Evidence

Bench testing only. Verification testing performed per 21 CFR 820.30, including CLEARSIGN II ECG Offset Test, firmware version 2.09 verification, and software verification. No new safety or performance issues identified.

Technological Characteristics

Reusable electromedical signal amplifier/conditioner. Available in 40, 80, 120, and 160 channel configurations. Interfaces with LabSystem PRO EP Recording System. Includes embedded firmware (version 2.09).

Indications for Use

Indicated for patients undergoing electrophysiology (EP) diagnostic and therapeutic procedures in an EP cath lab; used with EP catheters, surface ECG leads, pressure transducers, stimulators, and ablation equipment.

Regulatory Classification

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.

Predicate Devices

• CLEARSIGN II Amplifier (K150235)

Reference Devices

• LabSystem Pro (LS PRO) EP Recording System (K141185)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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's<br>Name and<br>Address | Boston Scientific Corporation<br>55 Technology Drive<br>Lowell, MA 01851<br>Phone:<br>978-805-3231<br>Fax:<br>978-805-3281 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and<br>Information | Maylin Truesdell<br>Senior Regulatory Affairs Specialist<br>Phone:<br>978-805-3231<br>Fax:<br>978-805-3281<br>E-mail:<br>[e-mail] |
| Date Prepared | September 09, 2015 |
| Proprietary<br>Name | CLEARSIGN II Amplifier |
| Model<br>Numbers | M00420020210<br>CLEARSIGN II Amplifier, 40 channels<br>M00420020220<br>CLEARSIGN II Amplifier, 80 channels<br>M00400202300<br>CLEARSIGN II Amplifier, 120 channels<br>M00420020240<br>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 |
| Predicate<br>Devices | CLEARSIGN II Amplifier<br>KI50235, cleared April 22, 2015 |
| Device<br>Description | The LabSystem Pro (LS PRO) EP Recording System (K141185) with<br>CLEARSIGN/CLEARSIGN II Amplifier is an integrated system that<br>acquires, displays, records, and measures physiological signals that<br>originate from that heart. The CLEARSIGN II Amplifier is a reusable<br>electromedical device containing hardware and software that acquires,<br>conditions and presents the physiological signal to the LabSystem PRO<br>EP Recording System such that the signals are available for clinical user<br>selection, display and recording. The CLEARSIGN II Amplifier is used in<br>conjunction with the compatible diagnostic electrophysiology (EP)<br>catheters, surface ECG leads, intravascular pressure transducers,<br>intracardiac stimulators, RF ablation generators and cardiac ablation<br>catheters. The CLEARSIGN II Amplifier is intended for use during EP<br>diagnostic and therapeutic procedures in an EP cath lab. |

Confidential

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| Intended Use/<br>Indications for<br>Use | The CLEARSIGN II Amplifier is intended to amplify and condition<br>electrocardiographic signals of biologic origin and pressure transducer<br>input, transmitting this information to a host computer (the LabSystem<br>PRO EP Recording System) that can record and display the information. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of<br>Technological<br>Characteristics | The predicate device for this 510(k) Premarket Notification is the<br>CLEARSIGN II Amplifier KI50235, cleared April 22, 2015. The Indications<br>for Use between the predicate, CLEARSIGN II Amplifier, and the<br>proposed device, CLEARSIGN II Amplifier, are identical. The<br>CLEARSIGN II Amplifier incorporates fundamentally the same<br>technological characteristics as the predicate device. The basic<br>architecture and design of the hardware and software are the same; the<br>only change is a single line of code in the CLEASIGN II firmware.<br>Therefore, the CLEARSIGN II Amplifier is substantially equivalent to the<br>predicate device. |
| Performance<br>Data | Design verification testing was performed to support a determination of<br>substantial equivalence. The CLEARSIGN II Amplifier is developed in<br>accordance with 21 CFR 820.30 Quality System Regulation Design<br>Controls.<br><br>Testing conducted included:<br>• CLEARSIGN II ECG Offset Test<br>• Firmware version 2.09 Verification Testing<br>• Software Verification Testing<br><br>The results of these tests provide reasonable assurance that the<br>proposed device has been designed and tested to assure conformance to<br>the requirements for its intended use. No new safety or performance<br>issues were raised during the device testing. |
| Conclusion | Based on the identical indications for use, substantially equivalent<br>technological characteristics, and safety and performance testing, the<br>CLEARSIGN II Amplifier has been shown to be appropriate for its<br>intended use and is considered to be substantially equivalent to the<br>CLEARSIGN II Amplifier KI50235, cleared April 22, 2015. |