(142 days)
Not Found
No
The description of the "Auto Detect" feature indicates it captures events automatically or when activated by the patient, and stores them for later analysis. There is no mention of the device itself performing any analysis or learning from the data, which would be indicative of AI/ML. The analysis is explicitly stated to occur after the data is downloaded to a separate system.
No.
The device is designed for diagnostic evaluation and monitoring of cardiac events, not for providing therapy or treatment.
Yes
The device is described as being used for "diagnostic evaluation of transient symptoms" in its Event Recorder mode, and for "detection of arrhythmias" and "pacemaker evaluation" in its Holter mode, all of which are diagnostic activities.
No
The device description explicitly mentions "Telaheart DR200/E-a" and "DR200/HE-a" which are described as "Event Recorder" and "Holter and Event Recorder" respectively. These are hardware devices that record and store data, and the summary mentions electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, 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.
- Device Function: The Telaheart Digital Recorder is a device that records electrical activity of the heart (ECG) from the patient's body. It is a medical device used for monitoring and diagnostic evaluation of cardiac arrhythmias and transient symptoms.
- Lack of Sample Analysis: The description explicitly states that "The data obtained during monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring Holter or Event analysis system." This indicates that the device itself is a data acquisition tool, not a system that performs analysis on biological samples.
Therefore, the Telaheart Digital Recorder falls under the category of a medical device used for physiological monitoring and recording, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.
Holter Mode
Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.
Event Recorder
The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone for evaluation.
The device includes the Auto Detect feature which can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically.
Product codes (comma separated list FDA assigned to the subject device)
MWJ, DXH
Device Description
NorthEast Monitoring will offer versions with the Auto Detect feature.
- Telaheart DR200/E-a Event Recorder with Auto Detect feature (using a black background).
- DR200/HE-a Holter and Event Recorder with Auto Detect feature (using white background).
The Auto Detect feature can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically. The device stores the events in memory. There is a display counter for the events and an audible beep to remind the user to transmit the data to the physician.
The data obtained during monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring Holter or Event analysis system. The Holter Analysis Software was cleared by FDA under K930564. The TelePro software was included in the Telaheart 510(k) cleared by FDA under K061293.
The device is not intended to replace real time telemetry monitoring for patient suspected of having life threatening arrhythmias.
The device has the identical hardware as the Telaheart device (cleared by FDA) and is powered by one 1.5 volt AA alkaline battery (MN1500 or the equivalent), one AA rechargeable NiMH (nickel metal hydride) battery, or one AA Eveready Lithium L91 battery. Batteries should not be re-used for a second patient. The batteries are not included; users are instructed to purchase 2 AA batteries.
The device is compatible with standard silver / silver chloride ECG electrodes. Electrodes are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes.
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
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)
The subject device has been subjected to and passed electrical safety and EMC testing requirements.
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
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo with two mountains in the background. In front of the mountains, there is a line graph that resembles an EKG. The mountains and the line graph are black.
NorthEast Monitor
2 Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com
phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837
advancing Holter technology
510(k) Sur
Date Prepared [21 CFR 807.92(a)(1)] December 29, 2006
Submitter's Information [21 CFR 807.92(a)(1)]
MAY 2 5 2007
Contact / Regulatory Consultant: Joseph M. Azary C/o NorthEast Monitoring Inc. 543 Long Hill Avenue Shelton, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor NorthEast Monitoring Inc.
Sponsor / Manufacturer NorthEast Monitoring Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754
FDA establishment registration# 1224919.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade names are:
- Auto Detect .
- Telaheart DR200/HE-a �
- DR200/HE-a .
Device Common, Usual, or Classification Names:
Ambulatory ECG Recorder, Ambulatory Electrocardiograph (without analysis), Telephone electrocardiograph transmitter and receiver
1
510(k) Summary
Pg. 2 of 5
Classification:
Class II, 21 CFR 870.2800, MWJ Class II, 21 CFR 870.2920, DXH
Predicate Device [21 CFR 807.92(a)(3)]
Auto Detect feature compared to Telaheart
The subject device (DR200/HE-a and Telaheart DR200/E-a) is identical to the predicate device (Telaheart) with one difference. The devices have the same indications for use, identical physical and electrical characteristics, and identical materials as the predicate device. The main difference between the subject device and predicate device are as follows:
- The subject device includes the Auto Detect feature. The Auto Detect feature was included in the . software code of the Telaheart, but was not enabled with the Telaheart units distributed.
DR200/HE compared to Heartrak Smart AT
The subject device has the same indications for use as the predicate devices have automatic detection features, are loop memory recorders, and can transmit data via telephone. The differences are as follows:
- . The Heartrak Smart AT uses 2 AA batteries
- . The devices have minor differences dimensionally
- The Heartrak Smart AT is only an event recorder and cannot be used as a Holter Monitor. .
Description of the Device [21 CFR 807.92(a)(4)]
NorthEast Monitoring will offer versions with the Auto Detect feature.
- Telaheart DR200/E-a Event Recorder with Auto Detect feature (using a black background). o
- DR200/HE-a Holter and Event Recorder with Auto Detect feature (using white background). o
The Auto Detect feature can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically. The device stores the events in memory. There is a display counter for the events and an audible beep to remind the user to transmit the data to the physician.
The data obtained during monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring Holter or Event
2
analysis system. The Holter Analysis Software was cleared by FDA under K930564. The TelePro software was included in the Telaheart 510(k) cleared by FDA under K061293.
The device is not intended to replace real time telemetry monitoring for patient suspected of having life threatening arrhythmias.
The device has the identical hardware as the Telaheart device (cleared by FDA) and is powered by one 1.5 volt AA alkaline battery (MN1500 or the equivalent), one AA rechargeable NiMH (nickel metal hydride) battery, or one AA Eveready Lithium L91 battery. Batteries should not be re-used for a second patient. The batteries are not included; users are instructed to purchase 2 AA batteries.
The device is compatible with standard silver / silver chloride ECG electrodes. Electrodes are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes.
| Characteristic | Specification |
|---|---|
| Dimensions | 8.6cm (length) x 6.0cm (width) x 2cm (depth) |
| Weight | 70.9 grams (2.5 oz) without battery |
| 99.3 grams (3.5 oz) with battery | |
| Recording Bandwidth | 0.05 to 70 hertz in 180 samples/sec mode |
| Prefilter Sampling Rate | 720 samples/sec |
| Data Stored | In 180 samples/sec mode, data stored at 180 samples/sec (4 |
| sample average), in 360 samples/sec mode, data stored at 360 | |
| samples/sec (2 sample average), in 720 samples/sec mode, | |
| data stored at 720 samples/sec. | |
| Pacemaker Sensitivity | 2 millivolts |
| Pacemaker Pulse Duration | 150 to 2500 microseconds |
Physical and Electrical Specifications:
Electrical Safety and Electromagnetic Compatibility
The hardware and electrical circuitry has not changed. The subject device conforms to the following standards:
- . IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety
- IEC 60601-1-2-47 Medical Electrical Equipment Part 2 47: Particular Requirements for the � Safety including Essential Performance of Ambulatory Electrocardiographic Systems.
*IEC 60601-2-47 is the equivalent to AAMI / ANSI EC38:1998.
- EN 55022 Class B ITE emissions ●
3
Patient Contacting Materials
The subject device does not make direct contact with the patient. The subject device is used with commercially available electrodes purchased by the customer.
Reprocessing, Cleaning, Disinfection, and Sterilization
The subject device does not make direct contact with the patient and does not require sterilization. The Operator's Manual includes a section on maintenance and care, which includes cleaning and infection control.
Software
The software in the subject device is identical to the software included in the Telaheart device K061293. The only difference is the Auto Detect feature was not enabled in the Telaheart device when it was sold to the public. The Auto Detect feature was not utilized in the Telaheart, but existed in the software code.
Intended Use [21 CFR 807.92(a)(5)]
The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.
Holter Mode
Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.
Event Recorder
The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone for evaluation.
The device includes the Auto Detect feature which can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically.
4
510(k) Summary
pg. 5 of 5
Technological Characteristics [21 CFR 807.92(a)(6)]
NorthEast Monitoring, Inc. believes that the subject device is substantially equivalent to the predicate device.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed electrical safety and EMC testing requirements.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject device is as safe and effective as the predicate devices
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NorthEast Monitoring, Inc. C/O Joseph M. Azary Azary Technologies, LLC 543 Long Hill Avenue Shelton, CT 06484
MAY 2 5 2007
Re: K070014
Trade/Device Name: Auto Detect for Telaheart Regulation Number: 21 CFR 870.2800 Regulation Name: Ambulatory ECG Recorder, Ambulatory Electrocardiograph (without analysis) Regulatory Class: Class II Product Code: MWJ, DXH Dated: May 17, 2007 Received: May 21, 2007
Dear Mr. Azary:
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
6
Page 2 - Mr. Azary
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 Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
B/Zimmerman for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): KO70014
Device Name: Auto Detect for Telaheart
Indications For Use:
The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.
Holter Mode
Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.
Event Recorder
The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once adale is recorded, the data is transmitted via telephone for evaluation.
The device includes the Auto Detect feature which can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more eyents are captured the natient may transmit his/her recordings transtelephonically.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Blummuma Division of Cardiovascular Devices |
| Page 1 of 1 |