(17 days)
Not Found
Yes
The device description explicitly mentions "embedded arrhythmia detection algorithms" and the ability to "automatically record asymptomatic, infrequent, or illusive arrhythmia events such as Bradycardia, and Atrial Fibrillation," which strongly suggests the use of algorithms that learn patterns to identify these events, characteristic of ML.
No.
The device is described as a recorder and transmitter of ECG data for analysis and review, explicitly stating it "does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life," which indicates it is not intended for therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life." It is a recorder that provides data to be reviewed and analyzed by a physician, but the device itself does not perform a diagnosis.
No
The device description explicitly states it is a "cardiac event recorder" that "continuously scan[s] and capture[s] ECG signals" and "store[s] up to 30 days of ECG data in its memory." This indicates the device includes hardware components for signal acquisition, processing, and storage, in addition to any software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Heartrak Smart ECAT Function: The Heartrak Smart ECAT is described as a device that records and transmits ECG signals, which are electrical signals from the heart. It does not analyze samples taken from the body. It is applied externally to the body to capture these signals.
- Intended Use: The intended use is to record and transmit cardiac event data for review and analysis by a physician. This is a diagnostic tool, but it operates by measuring physiological signals directly from the body, not by analyzing samples in vitro.
Therefore, the Heartrak Smart ECAT falls under the category of a medical device that measures physiological parameters, not an in vitro diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
Intended Use / Indications for Use
Intended Use:
Heartrak ECAT is a hand-held, portable, externally applied, cardiac event recorder; electrocardiograph transmitter.
Indications for Use:
Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
Heartrak Smart ECAT is a cardiac event recorder that is used to continuously scan and capture ECG signals. Patients can use Heartrak Smart ECAT to capture ECG data both before and after they experience a cardiac symptom. Heartrak Smart ECAT can capture and automatically record asymptomatic, infrequent, or illusive arrhythmia events such as Bradycardia, and Atrial Fibrillation.
Heartrak Smart ECAT can store up to 30 days of ECG data in its memory. The physician can use a compatible wireless device to set event recording times and autotriggering parameters and then upload them to a patient's monitor.
Using wireless technology, Heartrak Smart ECAT, when placed within range (less than 10 meters) of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
The physician is to instruct the patient on the proper use and care of the Heartrak Smart ECAT monitor. Patients should be told to contact their physician if they have any further questions.
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
Not Found
Intended User / Care Setting
physician's office, clinic, or monitoring center.
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)
Not Found
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
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo in black and white. The logo features a stylized heart shape at the top. Below the heart shape, there is a letter 't' in a bold, sans-serif font. Underneath the letter 't', the letters 'INC' are written in smaller font size.
HeartCare
Corporation of America
Cardiac Monitoring Services
Image /page/0/Picture/3 description: The image shows a logo for Universal Medical Incorporated. The logo features a heart shape on the left side, with the words "Universal Medical" stacked on top of each other to the right of the heart. Below the words "Universal Medical" is the word "Incorporated" in a smaller font. The logo is simple and professional, and it is likely used to represent a medical company.
5. 510(k) Summary or 510(k) Statement
DEC 1 5 2008
Date: October 30, 2008
Universal Medical, Inc. Submitter/Owner:
Official Contact Person Authorized by the Submitter:
Mark Job, Third-Party Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313 Telephone: 763 682 4139 FAX: 763 682 4420 Email: mark@markjob.com
cardiac event recorder; electrocardiograph transmitter Device Type:
Device Class: ==============================================================================================================================================================================
Regulation Number 870.2920
Review Panel: Cardiovascular
Basis for the
new design incorporating wireless technology. Submission:
Page 1 of 9
1
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HeartCare
Corporation of America
Cardiac Monitoring Services
Image /page/1/Picture/2 description: The image shows the logo for Universal Medical Incorporated. The logo features a heart shape on the left side, with the words "Universal medical" stacked on top of each other. Below the words, it says "INCORPORATED" in smaller letters. Underneath that, it says "An ISO13485 Certified Company".
rvice bevond the cal
Predicate Devices
Predicate devices for which Universal Medical, Inc. is claiming equivalence:
| 510(k)
Number | Trade or Model
Name | Manufacturer | Classification
Name | Product
Code |
|------------------|---------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------|-----------------|
| K071130 | Heartrak Smart
AF | Universal Medical,
Inc | transmitters and
receivers,
electrocardiograph,
telephone 870.2920 | DXH |
| K060911 | Cg-6108
Arrhythmia ECG
Event Recorder | Card Guard Scientific
Survival, Ltd. | transmitters and
receivers,
electrocardiograph,
telephone
870.2920 | DXH |
Device Description
Heartrak Smart ECAT is a cardiac event recorder that is used to continuously scan and capture ECG signals. Patients can use Heartrak Smart ECAT to capture ECG data both before and after they experience a cardiac symptom. Heartrak Smart ECAT can capture and automatically record asymptomatic, infrequent, or illusive arrhythmia events such as Bradycardia, and Atrial Fibrillation.
Heartrak Smart ECAT can store up to 30 days of ECG data in its memory. The physician can use a compatible wireless device to set event recording times and autotriggering parameters and then upload them to a patient's monitor.
Using wireless technology, Heartrak Smart ECAT, when placed within range (less than 10 meters) of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
The physician is to instruct the patient on the proper use and care of the Heartrak Smart ECAT monitor. Patients should be told to contact their physician if they have any further questions.
Intended Use
Heartrak ECAT is a hand-held, portable, externally applied, cardiac event recorder; electrocardiograph transmitter.
page 2 of 9
tel 800.606.5511 ・ fax 800.889.5415 ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.mednethealth.net
2
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Image /page/2/Picture/2 description: The image shows a logo for HeartCare Corporation of America Cardiac Monitoring Services. The logo is black and white and features the words "HeartCare" in a large, bold font. Below that, in a smaller font, are the words "Corporation of America" and "Cardiac Monitoring Services". To the left of the text is a graphic that resembles a heart rate monitor.
Image /page/2/Picture/3 description: The image shows a logo for Universal Medical Incorporated. The logo features the words "Universal Medical" in a bold, sans-serif font, with the word "Universal" stacked on top of "Medical". Below the words is a thin line, and below that is the word "Incorporated" in smaller letters. The text "An ISO13485 Certified Company" is at the bottom.
Indications for Use
Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.
Page 3 OF 9
tel 800.606.5511 · fax 800.889.5415 · 275 Phillips Blvd., Ewing, NJ 08618 · www.medneth.net
3
mednet
ervice beyond the call
HeartCarporation of Amer
Image /page/3/Picture/2 description: The image shows the logo for Universal Medical Incorporated. The logo has the words "Universal Medical" in a vertical orientation. To the right of the words is the phrase "Incorporated, An ROI Health Company" in a smaller font.
echnological Claracteristics (Subsatial Equivalers) Table)
In the belows the the technologics of Heartel Co. In art ECAT ae subsentially equivalent othe prodicated deviral, L
CG-6108 Arrhythmia ECG Event Recorder (K060911) manufactured by Card Guard Scientific Survival, Ltd. in wireless communication
ble 1 Substantial Equivalency Tabl
| | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event
Recorder (K060911) | Heartrak Smart AF
(K071130) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Universal Medical, Inc.
Heartrak Smart ECAT is a
hand-held, portable, externally
applied, cardiac event
recorder; electrocardiograph
transmitter. | Card Guard Scientific Survival,
Ltd.
Intended for use by patients who
experience transient symptoms that
may suggest cardiac arrhythmia. | Universal Medical, Inc.
Heartrak Smart AF is a hand-
held, portable, externally
applied, cardiac event recorder
that is intended for
transtelephonic use. |
| Indications for use | Heartrak Smart ECAT is a
wireless ambulatory, multi-
channel, continuous ECG
event recorder with embedded
arrhythmia detection
algorithms. Heartrak Smart
ECAT registers symptomatic
and asymptomatic cardiac
events triggered by a patient
manually or auto-triggered by
embedded arrhythmia
detection algorithms. Using | The CG-6108 system is an Arrhythmia
ECG Event Recorder designed for self-
testing by patients at home and for
analysis by medical professionals at a
remote monitoring center.
It comprises a chest-worn ECG sensor
and a handheld device with a
proprietary application, configured to
process and transmit the ECG
recordings. | Heartrak Smart AF is a hand-
held, portable, externally
applied, cardiac event
recorder that is intended for
transtelephonic use. Patient
calls a receiving center at the
hospital or physicians office
from the patient's home to
play back the recording.
Heartrak Smart AF converts
electrocardiogram (ECG)
signals into audio tones which |
el 800.606.5511 ・ fax 800.889.5415 ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.mednethealth.ne
4 OF 9
Page
4
mednét
Image /page/4/Picture/7 description: The image shows the logo for HeartCare, a corporation of America. The text is vertically oriented and stacked on top of each other. Underneath the text is a graphic of a heart rate monitor.
Image /page/4/Picture/2 description: The image shows the logo for Universal Medical. The logo has the words "Universal Medical" stacked vertically. To the right of the words are some smaller words that are illegible.
| Service |
|---|
| beyond |
| the call |
| Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event
Recorder (K060911)
Card Guard Scientific Survival, Ltd. | Heartrak Smart AF
(K071130) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Universal Medical, Inc.
wireless technology, Heartrak
Smart ECAT, when placed
within range of a compatible
RF receiver, uploads recorded
ECG waveform and ECG
parameter data to the receiver.
When data upload is complete,
data can be reviewed and
analyzed at a physician's
office, clinic, or monitoring
center. | The chest-worn unit includes 3
electrodes on a harness and it houses a
battery, an ASIC and a Bluetooth
transceiver for the acquisition,
recording, and transmission of the ECG
signal. The ECG signals are transmitted
via Bluetooth to the handheld device.
When an event is detected, it is
wirelessly transmitted to the CG
Monitoring Center for professional
analysis. The handheld device is
equipped with shared memory used to
record the signal received from the
sensor and to allow pre- and post-
processing options through the use of
this memory in a dual memory loop
configuration, both running in parallel.
One loop is auto-triggered, with
programmable thresholds, which starts
recording based on specific rhythms
and arrhythmias detected or manually
activated by the patient. The second,
and longer, recording loop is controlled
remotely to provide the physician with
more information, when requested by | Universal Medical, Inc.
are transmitted over the
telephone lines.
Heartrak Smart AF does not
deliver any energy, administer
any drugs, or control a
patient's life. Heartrak Smart
AF is not a diagnostic tool and
performs no diagnostic
functions. | |
| Heartrak Smart ECAT does
not deliver any energy,
administer any drugs, make
any diagnosis, or control a
patient's life. Heartrak Smart
ECAT is for prescription use
only. | | | |
| | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event
Recorder (K060911)
Card Guard Scientific Survival,
Ltd. | Heartrak Smart AF
(K071130) |
| | Universal Medical, Inc. | | Universal Medical, Inc. |
| | | the CG Monitoring Center. | |
| | | The handheld device automatically
transmits the recorded ECG, via
cellular link, to the Monitoring Center.
When cellular service is unavailable the
patient can transmit via landline
telephone. | |
| Monitor Features | | | |
| Patient Cable | 3-lead patient cable | 3-lead patient cable | 2-lead patient cable |
| Lead off Detection | Yes | Unknown | No |
| Channel Recording | 3 | 3 | 1 |
| Monitoring Mode | Continuous | Continuous | Loop |
| Data Transmission | Radio Frequency (RF) | Radio Frequency (RF) | Transtelephonic FM |
| Recording Button | Yes | Yes | Yes |
| | No | No | Yes |
| Playback Button | (When User puts monitor within range
of a compatible RF receiver, the monitor
automatically uploads recorded
ECG data to the receiver.) | (When User puts monitor within range
of a compatible RF receiver, the
monitor automatically uploads recorded
ECG data to the receiver.) | Yes |
| Reset Button | No | No | Yes |
| Unintentional Erase Data
Protection | Yes | Unknown | Yes |
| | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event
Recorder (K060911)
Card Guard Scientific Survival, Ltd. | Heartrak Smart AF
(K071130) |
| | Universal Medical, Inc. | Unknown | Universal Medical, Inc. |
| Power Loss Data Protection | Yes | | Yes |
| Programming/Configuration
Options | Available | | |
| Programmable pre/post
recording times | Multiple | Yes | Multiple (Total memory 10 minutes) |
| Number of events | Multiple | Multiple | Multiple |
| Patient Manual Activation | Yes | Yes | Yes |
| Silent Recording | Yes | Unknown | Yes |
| Auto-Triggering | Yes | Yes | Yes |
| Bradycardia | Yes (configuration option to
set range for rate) | Yes (configuration option to
set range for rate) | Yes (configuration option to
set range for rate) |
| Tachycardia | Yes (configuration option to
set range for rate) | Yes (configuration option to set
range for rate) | Yes (configuration option to
set range for rate) |
| Atrial Fibrillation | Yes | Yes | Yes |
| Auto-Trigger On/OFF
Capability | Yes | Unknown | Yes |
| Monitor Physical
Characteristics | | | |
| Dimensions | 7.4 cm length x 5.3 cm wide x
1.8 cm thick
Weight with batteries 90 gm | 75 x 58 x 23 mm (max.)
Net weight 54 gm | 7.4 cm length x 5.3 cm wide x
1.8 cm thick
Weight with batteries 90 gm |
| | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event
Recorder (K060911)
Card Guard Scientific Survival, Ltd. | Heartrak Smart AF
(K071130)
Universal Medical, Inc. |
| Monitor Technical
Characteristics | Universal Medical, Inc. | | |
| Transmission Mode
(Bluetooth 2.0 SPP
Profile) | Yes | Yes | N/A |
| RF transmission range | 10 meters open space | 10 meters open space | N/A |
| Bandwidth | 0.05 - 30 Hz | 60 Hz | 0.05 - 30 Hz |
| Recording Period | 3 channel, 30 days | 1-lead, up to 24 hours | 9 minutes |
| Monitor Electrical
Characteristics | | | |
| Input Impedance | With supplied leads
@ 5Hz
2 MOhm | With supplied leads
20 MOhm | With supplied leads
@ 5Hz
2 MOhm |
| Differential Input @ AC 15
Hz | $\pm$ 3 mV | +5 mVp-p | $\pm$ 3 mV |
| Differential Input Range | DC $\pm$ 250 mV | DC $\pm$ 165 mV | DC $\pm$ 250 mV |
| Common Mode Ratio (CMR) | 60 dB | 60 dB | 60 dB |
| Common Mode Ratio Range
(CMRR) AC + DC | $\pm$ 0.5V | Unknown | $\pm$ 0.5V |
| Monitor Battery | | | |
| Battery type | Internal Li-Ion rechargeable
battery 3.6V | 3.6V AA | AA 1.5V |
| Battery life | 3 days | 10 days | 14 days (1 event recorded and
transmitted each day |
| Monitor Environmental
Characteristics | | | |
| Operating temperature | +10 to +40 degrees C | +10 to +40 degrees C | +10 to +40 degrees C |
| | Heartrak Smart ECAT
CLASSES LA CLAIM . CALL . CONSUL . CONTRACT . CONTRACT . CONTRACT | CG-6108 Arrhythmia ECG Even
A
Recorder (K060911 | leartrak Smart A
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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Inc.
Medical.
ANTIQUE A PROPERTY - A BOLL CO., CALL PROPERTY
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| .
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| Iniversal Medical, |
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| Transport and storage |
| temperatur |
| Bearing Advertising Article |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Relative humid |
| 10% to 90% |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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5
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Image /page/5/Picture/1 description: The image contains two logos, one for HeartCare Corporation of America and one for Universal Medical. The HeartCare logo is on the left and features the word "HeartCare" in large, bold letters, followed by "Corporation of America" in a smaller font. The Universal Medical logo is on the right and features the word "Universal" above the word "Medical".
tel 800.606.5511 • fax 800.889.5415 • 275 Phillips Blvd., Ewing, NJ 08618 • www.mednethealth.ne
6
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Image /page/6/Picture/1 description: The image contains two logos, one for HeartCare and one for Universal Medical. The HeartCare logo includes the text "HeartCare Corporation of America Cardiac Monitoring Services" stacked vertically. The Universal Medical logo includes the text "universal medical" stacked vertically, with smaller text below it.
el 800.606.5511 ・ fax 800.889.5415 ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.medneth.net
Proge
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Image /page/7/Picture/1 description: The image contains two logos, one for HeartCare and one for Universal Medical. The HeartCare logo is vertically oriented and includes the words "HeartCare", "Corporation of America", and "Cardiac Monitoring Services". The Universal Medical logo is also vertically oriented and includes the words "universal medical".
el 800.606.5511 ・ fax 800.889.5415 ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.medneth.net
8
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.
medical HeartCare
:
service beyond the call
tel 800.606.5511 · fax 800.889.5415 · 275 Phillips Blvd., Ewing, NJ 08618 · www.mednethealth.net xvi
Page 9 of 9
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2008
Universal Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K083535
Trade/Device Name: Heartrak Smart ECAT Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: November 26, 2008 Received: November 28, 2008
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
10
Page 2 - Mr. Mark Job
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
D. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
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HeartCare
Corporation of America
Cardiac Monitoring Services
Image /page/11/Picture/2 description: The image shows a logo for Universal Medical Incorporated. The logo features a heart shape on the left side, with the words "universal medical" stacked on top of each other to the right of the heart. Below the words, there is the word "INCORPORATED" and the phrase "An ISO13485 Certified Company".
4. Indications for Use Statement
510(k) Number (if known): K083535
Device Name: Heartrak Smart ECAT
Indications for Use
Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or autotriggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of a compatible RF receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Duna R. Vacher
(Division Sien-Division of Cardiovascular Devices
510(k) Number_K0835 35