(162 days)
K#043454, K#091696
Not Found
No
The summary describes a standard ECG loop recorder and event monitor with wireless transmission capabilities. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is a monitor used to record and transmit ECG signals for diagnostic purposes, not to treat a condition.
Yes
The device records and transmits ECG signals for "event analysis" or "full disclosure analysis" to help patients experiencing symptoms potentially attributable to cardiac arrhythmia, which falls under diagnostic purposes.
No
The device description explicitly states it is a "pager-sized, handheld or patient worn device" and is comprised of hardware components (CardioPAL SAVI, SAVI Wireless, and an off the shelf cellular phone).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The TelePatch Cardiac Monitor PM750 records and transmits ambulatory ECG signals. This is a measurement of electrical activity of the heart in vivo (within the living body), not an examination of a specimen in vitro.
- Intended Use: The intended use is to monitor patients experiencing symptoms potentially related to cardiac arrhythmia by recording their ECG. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the device falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device is designated as Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
Product codes
DRG, MLO
Device Description
TelePatch Cardiac Monitor PM750 is a small, auto triggered, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG.
The PM750 has two operating modes to allow for event analysis of the recorded ECG or in Holter mode to allow for full disclosure analysis of the recorded ECG.
The device is comprised of the function contained within the CardioPAL SAVI (Model PM410) ECG loop recorder and the SAVI Wireless (Model PM500) event monitor and an off the shelf cellular phone. The device can be used with a break-away lanyard and has interaction with a PC interface cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infants to adults of all ages.
Intended User / Care Setting
Prescribed by physicians
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)
All testing performed on the TelePatch Cardiac Monitor PM750 was derived from the risk assessment which evaluated the effects of the feature changes. Testing included AAMI/ANSI/IEC 60601-1, IEC 60601-1-2, IEC 60812, ISO 14971 and environmental and software validation testing.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Medicomp Inc., TelePatch Cardiac Monitor PM750 testing meets all relevant requirements of the aforementioned tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#043454, K#091696
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 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 a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Medicomp, Inc. % Susan Goldstein-Falk Official Correspondent Mdi Consultants 55 Northern Blvd Great Neck, New York 11021
Re: K161916
Trade/Device Name: TelePatch Cardiac Monitor PM750 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, MLO Dated: November 8, 2016 Received: November 10, 2016
Dear Susan Goldstein-Falk:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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.
Mada Yellman
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161916
Device Name TelePatch Cardiac Monitor PM750
Indications for Use (Describe)
The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device is designated as Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
The assigned 510(k) number is K161916
Submitter's Identification: 1.
Medicomp, Inc. 600 Atlantis Rd. Melbourne FL 32941
Contact: Mr. Sean A. Marcus Tel: 321-676-0100 ext.2150
Date Summary Prepared: December 12, 2016
Name of the Device: 2.
TelePatch Cardiac Monitor PM750
3. Common or Usual Name:
Transmitters and Receivers, Physiological Signal, Radiofrequency
Regulation Number: 21 CFR Part 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: II Product Code: DRG
Electrocardiograph, Ambulatory with Analysis Algorithm
Regulation Number: 21 CFR Part 870.2800 Regulation Name: Electrocardiograph Ambulatory, with Analysis Algorithm Regulatory Class: II Product Code: MLO
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Predicate Device Information: 4.
K#043454, CardioPAL SAVI (Model PM410) Event /Loop Recorder, Medicomp Inc., K#091696, SAVI Wireless (Model PM500) Radiofrequency Physiological Signal Transmitter and Receiver, Medicomp, Inc.
ട. Device Description:
TelePatch Cardiac Monitor PM750 is a small, auto triggered, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG.
The PM750 has two operating modes to allow for event analysis of the recorded ECG or in Holter mode to allow for full disclosure analysis of the recorded ECG.
The device is comprised of the function contained within the CardioPAL SAVI (Model PM410) ECG loop recorder and the SAVI Wireless (Model PM500) event monitor and an off the shelf cellular phone. The device can be used with a break-away lanyard and has interaction with a PC interface cable.
6. Indications for Use:
The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device is designated as Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
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7. Comparison to Predicate Device (Substantial Equivalence):
The following comparison chart outlines similarities and differences between the subject and the predicate device:
| Features | Predicate Device
CardioPAL SAVI
(PM410)
K#043454 | Predicate Device
SAVI Wireless
(PM500)
K#091696 | Subject Device
TelePatch Cardiac
Monitor
(PM750) | Substantially
Equivalent or
Different |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| ECG Storage | 20 Minutes | 30 Days | 30 Days | SE |
| On Board
Analysis | Yes | Yes | Yes | SE |
| ECG Input | 1 Channel 2 Wires
1 Channel 3 Wires
2 Channel 3 Wires
2 Channel 5 Wires | 1 Channel 2 Wires
1 Channel 3 Wires
2 Channel 3 Wires
2 Channel 5 Wires | 1 Channel 3 Wires
1 Channel 5 Wires
2 Channel 3 Wires
2 Channel 5 Wires
1 Channel Electrode Patch
2 Channel Electrode Patch | SE |
| User Interface | Audio Beeper
2 line x 16
Character LCD
3 buttons | Audio Beeper
2 Buttons
Cellular Telephone | Audio Beeper
2 Buttons
Cellular Telephone | SE |
| PC Interface | Trans-telephonic
USB | Cellular Network
Bluetooth
USB | Cellular Network
Bluetooth
USB | SE |
| Case | Plastic | Plastic | Plastic | SE |
| EC38 Type | Type 3 | Type 3 | Type 3 | SE |
| Battery | 1 AA
1 Coin cell | 1 AA | 1 Coin cell
1 Lithium Ion | SE |
| Operating &
Storage Humidity | 10% to 95%,
non-condensing | 10% to 95%,
non-condensing | 10% to 95%,
non-condensing | SE |
| Operating
Temperature | 0°C to 45°C
(32° F to 113° F) | 0°C to 40°C
(32° F to 104° F) | 0°C to 45°C
(32°F to 113°F) | SE |
| Storage
Temperature | -20°C to 65° C
(-4° F to 149° F) | -20°C to 65°C
(-4° F to 149° F) | -15°C to 60°C
(-5°F to 140°F) | SE |
| Atmospheric
Pressure:
Operating | N/A | N/A | 700 hPa to 1060 hPa | SE |
| Atmospheric
Pressure:
Storage/Transport | N/A | N/A | N/A | SE |
| Shipment
Temperature | N/A | N/A | -15°C to 60°C
(-5°F to 140°F) | SE |
| Indications For
Use | The CardioPAL
SAVI event monitor
is a pager-sized,
handheld or patient-
worn device
designed
specifically to
record and transmit
ambulatory ECG
signals. The device
can be worn for
days or weeks, as it
is intended for use
by patients who are
experiencing
symptoms that are
transient and
infrequent in nature. | The SAVI Wireless
PM500 is a pager-
sized, handheld or
patient-worn device
designed specifically
to record and transmit
ambulatory ECG
signals. The device
can be worn for days
or weeks, as it is
intended for use by
patients who are
experiencing
symptoms that are
transient and
infrequent in nature. | The TelePatch Cardiac
Monitor PM750, is a
pager-sized, handheld or
patient worn device
designed specifically to
record and transmit
ambulatory ECG signals.
The device is designated
as Rx only, to be worn by
infants to adults of all
ages. The device can be
worn for days or weeks, as
it is intended for use by
patients who are
experiencing symptoms
that are transient and
infrequent in nature. | SE |
| Target Population | N/A | "System can be used
for infants weighing
less than 10kg" | IFU: "The device is
designated as Rx only, to
be worn by infants to
adults of all ages."
OVERVIEW: "The
TelePatch System can be
worn by users weighing
less than 10kg." | SE |
| Prescription
Designation | CAUTION
NOTICE: "Federal
law restricts the
CardioPAL SAVI
(PM410) to sale by,
or on the order of, a
licensed medical
practitioner." | CAUTION NOTICE:
"Federal law restricts
the SAVI Wireless™
to sale by, or on the
order of, a licensed
medical practitioner." | COVER: "TelePatch is
intended for use as
prescribed by a physician
who wants to follow
cardiac activity."
CAUTION NOTICE:
"Federal law restricts the
TelePatch Cardiac
Monitor PM750 to sale
by, or on the order of, a
licensed medical
practitioner."
IFU: "The device is
designated as Rx only, to
be worn by infants to
adults of all ages. | SE |
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Discussion of Similarities and Differences:
ECG output is unchanged. The technology for wire configurations is unchanged, using offthe-shelf industry standard electrodes for data input via wires as well as an electrode patch with flex circuit for data input.
The current user interface remains the same, using two buttons for user interaction. An off the shelf cellular phone, with graphic LCD, remains the same. The graphical LCD communicates device status to the user in text and graphical icons, as the device does currently. The audio beeper and LED interaction functions equivalently, to provide feedback to the user.
The interface is unchanged. ECG is transmitted via digital cellular network, a Bluetooth interface is used to send ECG to the cellular telephone and configure device parameters. The intent of the USB PC interface has not changed. The USB PC interface is used to download Holter procedures as well as configure device parameters including default options, and software download.
The case size has been changed accommodating deprecated parts, as indicated below. The composition of the case remains plastic.
The requirement of an EC38 type-3 device is unchanged.
Environmental conditions remain substantially equivalent to the predicate devices. Operating and Storage Humidity remains the same, the Operating Temperature in the subject device is safe and effective as the predicate devices. Storage Temperature remains substantially equivalent. Atmospheric Pressure in the predicate devices were not tested to IEC 60601-1-11 as this standard was introduced 4/1/2010. The subject device fell within the acceptable parameters of 700 hPa to 1060 hPa when tested for Atmospheric Pressure Operating conditions. There were no applicable shipment or Storage/Transport Atmospheric Pressure requirements specified for the predicate or subject devices.
The subject device Indications for Use Statement (IFU) has been updated to reflect target population, as suggested in the Premarket Assessment of Pediatric Medical Devices (3/24/14), pg.11, section A: Basic Elements of Labeling, Indications for Use. Additionally, the IFU states the prescription designation as noted in 21 CFR 801.109 (c).
Target population is now presented in the IFU. The acceptable minimum weight requirement of