(17 days)
Heartrak ECAT is a hand-held, portable, externally applied, cardiac event recorder; electrocardiograph transmitter.
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.
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.
This document describes a 510(k) premarket notification for the "Heartrak Smart ECAT" cardiac event recorder. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a de novo clinical study with specific acceptance criteria and performance results in the format requested.
Therefore, the information required to fully answer the request (acceptance criteria, specific study results for the device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) is not explicitly provided in this 510(k) summary.
510(k) submissions typically focus on demonstrating that a new device is "substantially equivalent" to an existing legally marketed device (predicate device) in terms of intended use, indications for use, technological characteristics, and safety and effectiveness. They often rely on bench testing, comparison to predicate devices, and sometimes non-clinical performance data rather than extensive human clinical trials with predefined acceptance criteria for AI algorithms.
However, based on the provided text, I can extract information related to the device and its intended function, and highlight what is not present:
Device Description and Intended Use:
The Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. It registers symptomatic and asymptomatic cardiac events (manual or auto-triggered) and uploads recorded ECG data to a receiver for review and analysis by a physician.
The document indicates that the device has "embedded arrhythmia detection algorithms" capable of auto-triggering for events like Bradycardia, Tachycardia, and Atrial Fibrillation. This suggests an AI-like component or automated analysis, but details on its performance are not given as "acceptance criteria" and "reported performance" in the requested tabular format.
Here's an attempt to answer the request based only on the provided text, with clear indications of what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Sensitivity, Specificity for arrhythmia detection) | Reported Device Performance (e.g., Sensitivity, Specificity) |
|---|---|
| NOT PROVIDED IN DOCUMENT | NOT PROVIDED IN DOCUMENT |
| The document focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, not explicit performance metrics for arrhythmia detection algorithms. | See above. No specific performance metrics (e.g., sensitivity, specificity, accuracy) for the embedded arrhythmia detection algorithms are quantified or reported in this 510(k) summary. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- The document mentions data can be "reviewed and analyzed at a physician's office, clinic, or monitoring center," implying expert review as part of the intended use, but not for establishing ground truth in a clinical study context for the device's algorithms.
4. Adjudication method for the test set (e.g., 2+1, 3+1, none)
- Adjudication Method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not mentioned or indicated.
- This type of study is not typically a requirement for 510(k) clearance based on substantial equivalence.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not explicitly described.
- While the device has "embedded arrhythmia detection algorithms," the document does not detail a standalone performance study of these algorithms with metrics like sensitivity and specificity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified for any internal validation of the "embedded arrhythmia detection algorithms."
- The device's output (recorded ECG waveform and ECG parameter data) is intended for "review and analysis at a physician's office, clinic, or monitoring center," which implies human expert interpretation as part of the clinical workflow, but not as the ground truth for evaluating the device's internal algorithms in a study.
8. The sample size for the training set
- Sample Size (Training Set): Not specified.
- Information on a "training set" would typically be relevant if the device involved a machine learning algorithm explicitly described as such, and if a detailed performance study was conducted. This 510(k) summary is for a device with "embedded arrhythmia detection algorithms" but does not delve into the specifics of their development or internal validation datasets.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not specified.
Summary of Missing Information:
This 510(k) submission primarily focuses on demonstrating substantial equivalence of the Heartrak Smart ECAT to predicate devices (Heartrak Smart AF and CG-6108 Arrhythmia ECG Event Recorder) based on functional and technological characteristics (e.g., 3-lead patient cable, continuous monitoring, RF data transmission, auto-triggering for Bradycardia, Tachycardia, Atrial Fibrillation). It does not provide the detailed performance metrics, study designs, sample sizes, or specifics regarding ground truth and expert adjudication that would be expected for a comprehensive evaluation of an AI/algorithm's acceptance criteria and performance as requested.
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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:
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Image /page/1/Picture/0 description: The image shows the logo for Mednet Healthcare Technologies Inc. The word "mednet" is written in bold, black letters. Below the word "mednet" is the phrase "HEALTHCARE TECHNOLOGIES INC." in smaller, black letters. To the right of the word "mednet" is a stylized heart shape.
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 ModelName | Manufacturer | ClassificationName | ProductCode |
|---|---|---|---|---|
| K071130 | Heartrak SmartAF | Universal Medical,Inc | transmitters andreceivers,electrocardiograph,telephone 870.2920 | DXH |
| K060911 | Cg-6108Arrhythmia ECGEvent Recorder | Card Guard ScientificSurvival, Ltd. | transmitters andreceivers,electrocardiograph,telephone870.2920 | 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.
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tel 800.606.5511 ・ fax 800.889.5415 ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.mednethealth.net
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Image /page/2/Picture/0 description: The image shows the logo for Mednet Healthcare Technologies Inc. The word "mednet" is written in bold, black letters. Below the word "mednet" is the phrase "HEALTHCARE TECHNOLOGIES INC." in smaller, black letters. To the right of the word "mednet" is a graphic that looks like two overlapping hearts.
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.
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tel 800.606.5511 · fax 800.889.5415 · 275 Phillips Blvd., Ewing, NJ 08618 · www.medneth.net
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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 EventRecorder (K060911) | Heartrak Smart AF(K071130) | |
|---|---|---|---|
| Intended use | Universal Medical, Inc.Heartrak Smart ECAT is ahand-held, portable, externallyapplied, cardiac eventrecorder; electrocardiographtransmitter. | Card Guard Scientific Survival,Ltd.Intended for use by patients whoexperience transient symptoms thatmay suggest cardiac arrhythmia. | Universal Medical, Inc.Heartrak Smart AF is a hand-held, portable, externallyapplied, cardiac event recorderthat is intended fortranstelephonic use. |
| Indications for use | Heartrak Smart ECAT is awireless ambulatory, multi-channel, continuous ECGevent recorder with embeddedarrhythmia detectionalgorithms. Heartrak SmartECAT registers symptomaticand asymptomatic cardiacevents triggered by a patientmanually or auto-triggered byembedded arrhythmiadetection algorithms. Using | The CG-6108 system is an ArrhythmiaECG Event Recorder designed for self-testing by patients at home and foranalysis by medical professionals at aremote monitoring center.It comprises a chest-worn ECG sensorand a handheld device with aproprietary application, configured toprocess and transmit the ECGrecordings. | Heartrak Smart AF is a hand-held, portable, externallyapplied, cardiac eventrecorder that is intended fortranstelephonic use. Patientcalls a receiving center at thehospital or physicians officefrom the patient's home toplay back the recording.Heartrak Smart AF convertselectrocardiogram (ECG)signals into audio tones which |
el 800.606.5511 ・ fax 800.889.5415 ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.mednethealth.ne
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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 EventRecorder (K060911)Card Guard Scientific Survival, Ltd. | Heartrak Smart AF(K071130) | |
|---|---|---|---|
| Universal Medical, Inc.wireless technology, HeartrakSmart ECAT, when placedwithin range of a compatibleRF receiver, uploads recordedECG waveform and ECGparameter data to the receiver.When data upload is complete,data can be reviewed andanalyzed at a physician'soffice, clinic, or monitoringcenter. | The chest-worn unit includes 3electrodes on a harness and it houses abattery, an ASIC and a Bluetoothtransceiver for the acquisition,recording, and transmission of the ECGsignal. The ECG signals are transmittedvia Bluetooth to the handheld device.When an event is detected, it iswirelessly transmitted to the CGMonitoring Center for professionalanalysis. The handheld device isequipped with shared memory used torecord the signal received from thesensor and to allow pre- and post-processing options through the use ofthis memory in a dual memory loopconfiguration, both running in parallel.One loop is auto-triggered, withprogrammable thresholds, which startsrecording based on specific rhythmsand arrhythmias detected or manuallyactivated by the patient. The second,and longer, recording loop is controlledremotely to provide the physician withmore information, when requested by | Universal Medical, Inc.are transmitted over thetelephone lines.Heartrak Smart AF does notdeliver any energy, administerany drugs, or control apatient's life. Heartrak SmartAF is not a diagnostic tool andperforms no diagnosticfunctions. | |
| Heartrak Smart ECAT doesnot deliver any energy,administer any drugs, makeany diagnosis, or control apatient's life. Heartrak SmartECAT is for prescription useonly. | |||
| Heartrak Smart ECAT | CG-6108 Arrhythmia ECG EventRecorder (K060911)Card Guard Scientific Survival,Ltd. | Heartrak Smart AF(K071130) | |
| Universal Medical, Inc. | Universal Medical, Inc. | ||
| the CG Monitoring Center. | |||
| The handheld device automaticallytransmits the recorded ECG, viacellular link, to the Monitoring Center.When cellular service is unavailable thepatient can transmit via landlinetelephone. | |||
| 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 rangeof a compatible RF receiver, the monitorautomatically uploads recordedECG data to the receiver.) | (When User puts monitor within rangeof a compatible RF receiver, themonitor automatically uploads recordedECG data to the receiver.) | Yes |
| Reset Button | No | No | Yes |
| Unintentional Erase DataProtection | Yes | Unknown | Yes |
| Heartrak Smart ECAT | CG-6108 Arrhythmia ECG EventRecorder (K060911)Card Guard Scientific Survival, Ltd. | Heartrak Smart AF(K071130) | |
| Universal Medical, Inc. | Unknown | Universal Medical, Inc. | |
| Power Loss Data Protection | Yes | Yes | |
| Programming/ConfigurationOptions | Available | ||
| Programmable pre/postrecording 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 toset range for rate) | Yes (configuration option toset range for rate) | Yes (configuration option toset range for rate) |
| Tachycardia | Yes (configuration option toset range for rate) | Yes (configuration option to setrange for rate) | Yes (configuration option toset range for rate) |
| Atrial Fibrillation | Yes | Yes | Yes |
| Auto-Trigger On/OFFCapability | Yes | Unknown | Yes |
| Monitor PhysicalCharacteristics | |||
| Dimensions | 7.4 cm length x 5.3 cm wide x1.8 cm thickWeight with batteries 90 gm | 75 x 58 x 23 mm (max.)Net weight 54 gm | 7.4 cm length x 5.3 cm wide x1.8 cm thickWeight with batteries 90 gm |
| Heartrak Smart ECAT | CG-6108 Arrhythmia ECG EventRecorder (K060911)Card Guard Scientific Survival, Ltd. | Heartrak Smart AF(K071130)Universal Medical, Inc. | |
| Monitor TechnicalCharacteristics | Universal Medical, Inc. | ||
| Transmission Mode(Bluetooth 2.0 SPPProfile) | 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 ElectricalCharacteristics | |||
| Input Impedance | With supplied leads@ 5Hz2 MOhm | With supplied leads20 MOhm | With supplied leads@ 5Hz2 MOhm |
| Differential Input @ AC 15Hz | $\pm$ 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 rechargeablebattery 3.6V | 3.6V AA | AA 1.5V |
| Battery life | 3 days | 10 days | 14 days (1 event recorded andtransmitted each day |
| Monitor EnvironmentalCharacteristics | |||
| Operating temperature | +10 to +40 degrees C | +10 to +40 degrees C | +10 to +40 degrees C |
| Heartrak Smart ECATCLASSES LA CLAIM . CALL . CONSUL . CONTRACT . CONTRACT . CONTRACT | CG-6108 Arrhythmia ECG EvenARecorder (K060911 | leartrak Smart A1074490ਵ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Inc.Medical.ANTIQUE A PROPERTY - A BOLL CO., CALL PROPERTYJniversal '------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Card Guard Scientific Survival,------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ું.વિત્ત1. | .rateIniversal Medical,------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Transport and storagetemperatur | -20 to 65 degrees | -20 to 65 degrees | -20 to 65 degreesBearing Advertising Article |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Relative humid | THE LAND LA PLANE OF LA BECK A LE AND LEWILL BOOK10% to 90%------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 30% to 85% | 10% to 90% |
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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
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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
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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
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.
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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
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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
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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
§ 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).