(79 days)
No
The summary describes a system for acquiring, conditioning, and displaying physiological signals. There is no mention of AI or ML in the intended use, device description, or performance studies. The device appears to be a standard signal amplifier and recording system.
No.
The device is intended to amplify and condition electrocardiographic signals for recording and display, not to treat a condition. While it is used during therapeutic procedures, its function is diagnostic/monitoring, not therapeutic.
Yes
The device is described as being used during "EP diagnostic and therapeutic procedures" and in conjunction with "compatible diagnostic electrophysiology (EP) catheters," indicating its role in diagnosis.
No
The device description explicitly states that the CLEARSIGN II Amplifier is a "reusable electromedical device containing hardware and software".
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended to amplify and condition biologic signals (electrocardiographic and pressure transducer input) from the patient's body. It transmits this information for recording and display.
- Device Description: It acquires, displays, records, and measures physiological signals that originate from the heart. It is used in conjunction with devices that interact directly with the patient (catheters, leads, transducers, stimulators, generators).
- Nature of the Input: The input is physiological data directly from the patient, not a sample of human origin (like blood, urine, tissue) that is tested in vitro.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is focused on acquiring and processing real-time physiological signals from a living patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
EP cath lab
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all black, and they are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
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.
1
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
2
Attachment 2: Indications for Use Statement
Indications for Use
510(k) Number (if known):K150235___________________
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 × (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)
3
Attachment 3: 510(k) Summary
510(k) Summary per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
55 Technology Drive
Lowell, MA 01851
Phone: 978-805-3231
Fax: 978-805-3281 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and
Information | Maylin Truesdell
Senior Regulatory Affairs Specialist
Phone: 978-805-3231
Fax: 978-805-3281
E-mail: maylin.truesdell@bsci.com |
| Date Prepared | January 28, 2015 |
| Proprietary
Name | CLEARSIGN II Amplifier |
| Model
Numbers | 2002021 CLEARSIGN II Amplifier, 40 channels
2002022 CLEARSIGN II Amplifier, 80 channels
2002023 CLEARSIGN II Amplifier, 120 channels
2002024 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
Devices | CLEARSIGN (Borealis) Amplifier
K050006, cleared May 27, 2005 |
| 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. |
| Intended Use/
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. |
| Comparison of
Technological
Characteristics | The predicate device for this 510(k) Premarket Notification is the
CLEARSIGN (Borealis) Amplifier, K050006 cleared May 27, 2005. The
Indications for Use between the predicate, CLEARSIGN Amplifier, and the
proposed device, CLEARSIGN II Amplifier, are identical. The
CLEARSIGN II Amplifier incorporates fundamentally the same
technological characteristics as the predicate device. The basic
architecture and design of the hardware and software are the same; the
only changes are to bring the equipment to state-of-the-art (specifically,
compliance with IEC 60601-1, 3rd Edition), to comply with the EU RoHS
Directive, and to implement minor performance improvements. Therefore,
the CLEARSIGN II Amplifier is substantially equivalent to the predicate
device. |
CLEARSIGN II Amplifier Attachment 3, Page 1
4
5
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.