(30 days)
CLEARSIGN II Amplifier KI50235
No
The description focuses on signal amplification, conditioning, and recording, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is intended to acquire, amplify, condition, and record physiological signals (electrocardiographic signals and pressure transducer input), and is used during diagnostic and therapeutic procedures, but it does not directly provide therapy.
Yes
The device is described as being used during "EP diagnostic and therapeutic procedures" and in conjunction with "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 IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to amplify and condition in vivo (within the body) electrocardiographic signals and pressure transducer input. This information is then transmitted to a system for recording and display. IVDs are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
- Device Description: The device description explicitly states it acquires, conditions, and presents physiological signals that originate from the heart. It is used in conjunction with devices that interact directly with the patient's body (catheters, leads, transducers).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or performing tests on samples taken from the body.
The CLEARSIGN II Amplifier is a medical device used for physiological monitoring during a medical procedure, not for in vitro diagnostic testing of biological samples.
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
DRQ
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
Design verification testing was performed to support a determination of substantial equivalence. The CLEARSIGN II Amplifier is developed in accordance with 21 CFR 820.30 Quality System Regulation Design Controls.
Testing conducted included:
• CLEARSIGN II ECG Offset Test
• Firmware version 2.09 Verification Testing
• Software Verification Testing
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
Not Found
Predicate Device(s)
CLEARSIGN II Amplifier KI50235
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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
2
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
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 | September 09, 2015 |
| Proprietary
Name | CLEARSIGN II Amplifier |
| Model
Numbers | M00420020210
CLEARSIGN II Amplifier, 40 channels
M00420020220
CLEARSIGN II Amplifier, 80 channels
M00400202300
CLEARSIGN II Amplifier, 120 channels
M00420020240
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 II Amplifier
KI50235, cleared April 22, 2015 |
| 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. |
Confidential
4
| 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 II Amplifier KI50235, cleared April 22, 2015. The Indications
for Use between the predicate, CLEARSIGN II 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 change is a single line of code in the CLEASIGN II firmware.
Therefore, the CLEARSIGN II Amplifier is substantially equivalent to the
predicate device. |
| Performance
Data | Design verification testing was performed to support a determination of
substantial equivalence. The CLEARSIGN II Amplifier is developed in
accordance with 21 CFR 820.30 Quality System Regulation Design
Controls.
Testing conducted included:
• CLEARSIGN II ECG Offset Test
• Firmware version 2.09 Verification Testing
• Software Verification Testing
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 identical 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 II Amplifier KI50235, cleared April 22, 2015. |