(71 days)
Not Found
No
The description focuses on signal acquisition, filtering, and processing for display and tracking, without mentioning AI/ML algorithms for analysis or interpretation.
No
The device is described as a diagnostic tool for cardiac electrophysiological mapping and provides catheter location information. It primarily amplifies and filters cardiac signal data for processing and display, which are diagnostic functions. While it can deliver pacing stimuli, its primary indicated use is mapping and determining catheter location (diagnostic), not treating a condition.
Yes.
The device's intended use is for cardiac electrophysiological mapping and delivering pacing stimuli, which are diagnostic functions to assess the heart's electrical activity. Additionally, it collects various physiological signals like EP catheter electrodes, EKG, and pressure transducer inputs for processing and display, further indicating its role in diagnosis.
No
The device description explicitly details hardware components like the Signal Acquisition Module (SAM), Arrhythmia Mapping Computer (AMC), and Position Acquisition Module (PAM), which are integral to the system's function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This typically involves testing blood, urine, tissue, etc., outside of the body.
- Device Function: The provided description clearly states the device is used for cardiac electrophysiological mapping and delivering pacing stimuli within the body. It acquires electrical signals directly from the heart and provides location information for catheters used in these procedures.
- Lack of Specimen Testing: There is no mention of the device analyzing or testing any specimens (blood, tissue, etc.) derived from the patient. The inputs are electrical signals and pressure readings from within the body.
Therefore, based on the intended use and device description, this device falls under the category of an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Boston Scientific Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Real-time Position Management (RPMTM) System to provide catheter location information.
The Signal Acquisition Module (SAM) is a component of the RPM™ System and supports the above indication.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
Signal Acquisition Module (SAM): One of three main components of the RPM™ System that includes the Arrhythmia Mapping Computer (AMC) and the Position Acquisition Module (PAM). The SAM is an amplifier that filters cardiac signal data and transfers it to the AMC for processing and display. The SAM collects the following input signals, applies gain and filter settings as programmed through the Mapping System software and transfers them to the computer over the fiber optic data link for further processing and display.
-
- one or more standard EP catheter electrodes (up to 48 catheter inputs)
-
- two pacing inputs from an external pacing stimulator, which the Mapping System software can route to any catheter bipole or unipole
-
- a synch output channel that can be used with pacing stimulators to synchronize pacing inputs
-
- a 12-lead EKG
-
- two pressure transducer inputs
-
- One 64 electrode Constellation™ Catheter or up to 64 individual catheter inputs through bedside Expansion Pods
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use.
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.
Not Found
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
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
K043257/SI
$
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FEB - 3 2005
1. 510(k) Summary
a. General Information
Modified Device Information
| Category: | Comments: |
|---|---|
| Sponsor: | Boston Scientific Corporation |
| 2710 Orchard Parkway | |
| San Jose, Ca 95134 - | |
| Correspondent: | Todd G. Brill |
| Senior Specialist, Regulatory Affairs | |
| Boston Scientific Corporation | |
| 2710 Orchard Parkway | |
| San Jose, Ca 95134 | |
| Contact Information: | E-mail: brillt@bsci.com |
| Phone: (408) 895-3564 | |
| Fax: (408) 895-2202 | |
| Device Common Name: | Signal Acquisition Module (SAM) |
| Device Proprietary Name: | Arrhythmia Mapping System with Real-time |
| Position Management (RPM™) | |
| Device Classification: | 21 CFR §870.1220 |
Predicate Device Information
| Predicate Device: | Arrhythmia Mapping and Tracking System
(K992912) |
|-----------------------------------------|-----------------------------------------------------|
| Predicate Device Manufacturer: | Boston Scientific Corporation |
| Predicate Device Common Name | Signal Acquisition Module (SAM) |
| Predicate Device Classification: | 21 CFR §870.1220 |
| Predicate Device Classification Number: | Class II |
b. Date Summary Prepared
:
January 13, 2005
1
Description of Device C.
Signal Acquisition Module (SAM): One of three main components of the RPM™ System that includes the Arrhythmia Mapping Computer (AMC) and the Position Acquisition Module (PAM). The SAM is an amplifier that filters cardiac signal data and transfers it to the AMC for processing and display. The SAM collects the following input signals, applies gain and filter settings as programmed through the Mapping System software and transfers them to the computer over the fiber optic data link for further processing and display.
-
- one or more standard EP catheter electrodes (up to 48 catheter inputs)
-
- two pacing inputs from an external pacing stimulator, which the Mapping System software can route to any catheter bipole or unipole
-
- a synch output channel that can be used with pacing stimulators to synchronize pacing inputs
-
- a 12-lead EKG
-
- two pressure transducer inputs
-
- One 64 electrode Constellation™ Catheter or up to 64 individual catheter inputs through bedside Expansion Pods
d. Intended Use
The Boston Scientific Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Real-time Position Management (RPMTM) System to provide catheter location information.
The Signal Acquisition Module (SAM) is a component of the RPM™ System and supports the above indication.
Comparison to Predicate Device e.
The Modified Signal Acquisition Module (SAM) has the same intended use as the predicate device and was validated to perform as the original device without the
2
options of choosing a system reference for the catheters. The modified device makes sole use of the Driven Right Leg Reference.
| Table 1 - Comparison of Device Characteristics to Predicate | |||
|---|---|---|---|
| ------------------------------------------------------------- | -- | -- | -- |
| Component | Arrhythmia Mapping and Tracking
System | Real-time Position Management
(RPMTM) |
|---------------------------------------|-------------------------------------------------------------------------|--------------------------------------------|
| | K992912 | K043257 |
| | 64 Channel Signal Processing Unit | 128 Channel Signal Processing Unit: |
| | > 48 Intra-cardiac | > 112 Intra-cardiac |
| | > 12 EKG | > 12 EKG |
| | > System Reference - EKG Input - | > System Reference - Driven Right |
| | 2 Options | Leg |
| | o Catheter Reference | |
| Signal
Acquisition
Module (SAM) | o Right Leg Reference | |
| | > 2 Pressure | > 2 Pressure |
| | > 2 Pacing | > 2 Pacing |
| | > Dynamic Diode - Minimize
Pacing Artifacts | > Dynamic Diode - Removed |
| | > Post Pace Blanking Interval -
Software to support Dynamic
Diode | > Post Pace Blanking Interval -
Removed |
Summary of the Non-clinical Data f.
Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/11 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three curved lines that appear to be flowing or waving. The text is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 3 2005
Boston Scientific Corporation c/o Mr. Todd Brill Senior Specialist, Regulatory Affairs 2710 Orchard Parkway San Jose, CA 95134
Re: K043257
Trade Name: Real-Time Position Management (RPMTM) System Regulation Number: 21 CFR 870.1220 Regulation Name: 21 CFFC 87072220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: DRF Dated: January 12, 2005 Received: January 14, 2005
Dear Mr. Brill:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications felerenced above and nave determined we are and and the marketed in interstate for use stated in the encrosule) to regary manological Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prof to May 20, 1978, the enaordance with the provisions of the Federal Food. Drug. devices that have been reclassified in accordance with as personal application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application and Cosment Act (Act) that do not require approvinces of the general controls provisions of the Act. The You may, mercefore, market the devices, boys requirements for annual registration, listing of
general controls provisions of the Act include requirements for annual registere general controls provisions of the flections and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing may on and divises EDA may be subject to such additional connoits. Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous of events concerning your device in the Federal Register.
4
Page 2 - Mr. Todd Brill
i
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dris issuated on a substition.
that FDA has made a determination that your device complies with other requirements of the Act that IDA has made a colorimiation administered by other Federal agencies. You must of ally rederal statutes and regulanents ancluding, but not limited to: registration and listing (21 Comply with an the Act 31equirements, networks, welling practice requirements as set CFK Part 807), labeling (21 CFR Part 807), good ff applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neeting your device as described in your Section 510(k) This letter witi anow you to oegin mainer of substantial equivalence of your device to a legally premarket notification. The FDA miding of castion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice ion your are (301) 594-4646. Also, please note the regulation entitled, Contact the Office of Companies and (21CFR Part 807.97) you may obtain. Misorallumg by reference to premarkoonsibilities under the Act may be obtained from the Other general mionmation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours, _
B/Zimmerman for
B. Zimmerman, M.D.
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K043257 510(k) Number: Real-time Position Management (RPM™) Device Name: Indications for Use:
The Boston Scientific Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Real-time Positions Management (RPM™) System to provide catheter location information.
Prescription Use (Part 21CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumima
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K0/3257
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