(146 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on data transmission and monitoring, not algorithmic analysis.
No.
The device is used for screening and monitoring heart rhythms, not for treating any condition.
Yes
The device is described as allowing self-testing by patients and healthcare professionals to display and transmit ECG data for monitoring heart rhythm and symptoms suggestive of abnormal heart rhythms, which are diagnostic activities.
No
The device description explicitly mentions "Built-in 1-lead ECG monitor" and the use of an "external patient cable" for 12-lead ECG, indicating the presence of hardware components beyond just software.
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 PMP4 SelfCheck™ ECG is a device that records and transmits electrical signals from the heart (ECG data). It does not analyze samples taken from the body.
- Intended Use: The intended use is for self-testing and professional use to monitor heart rhythm based on electrical activity, not on the analysis of biological samples.
Therefore, while it is a medical device used for diagnosis and monitoring, it falls under the category of a physiological monitoring device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PMP4 SelfCheck™ ECG and Card Guard Heart Screening Service are intended for self-testing by patients and by health care professionals at home and at medical settings. This 12- lead and 1-lead electrocardiogram(ECG), allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server.
Specifically, the PMP4 SelfCheck™ ECG is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:
- Skipped Beats
- Pounding heart (Palpitations)
- Heart Racing or Irregular Pulse
- Lightheadedness or Faintness
- History of Arrhythmias
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
PMP4 SelfCheck™ ECG allows transmitting multiple ECG recordings of 1 or 12-lead to a device (PMP+ or compatible generic PDA or mobile telephone with Bluetooth support) allowing physician to monitor the device output remotely.
Multi-functional Patient Monitor:
- Built-in 1-lead ECG monitor
- 12-lead ECG monitor using an'extemal patient cable
The PMP4 SelfCheck™ ECG user interface incorporates the following controls and signals:
- On/off control button
- SEND control button (optional)
- Fluctuating transmission sound
- Low battery warning
- Low Battery detection and audio warning
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
self-testing by patients and by health care professionals at home and at medical settings.
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
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
3 2005 MAR
Card Guard Scientific Survival Ltd. c/o Ms. Na'ama Oren QA & Regulatory Specialist 2 Pekeris St. P.O.B. 527 Rehovot 76100 ISRAEL
Re: K042254
Trade Name: PMP4 SelfCheck™ ECG Regulation Number: 21 CFR 870.2920 Regulation Name: Transmitters and Receivers, Electrocardiograph, Teleplione Regulatory Class: II (two) Product Code: DXH Dated: December 29,2004 Received: January 03,2005
Dear Ms. Oren:
This letter corrects our substantially equivalent letter of January 13,2005 regarding the incorrect contact person.
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 (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.
1
Page 2 - Ms. Na'ama Oren
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); 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 continue 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Bhimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K042254/S2
Device name: PMP4 SelfCheck™ ECG
The PMP4 SelfCheck™ ECG and Card Guard Heart Screening Service are intended for self-testing by patients and by health care professionals at home and at medical settings. This 12- lead and 1-lead electrocardiogram(ECG), allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server.
Specifically, the PMP4 SelfCheck™ ECG is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:
- Skipped Beats
- Pounding heart (Palpitations) ●
- Heart Racing or Irregular Pulse ●
- Lightheadedness or Faintness ●
- History of Arrhythmias ●
ﮯ Prescription Use AND/OR Over-The-Counter Use V (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
", "l
Page 1 of 1
3
| PMP4 SelfCheck™ ECG | |
|---|---|
| 510(k) Summary of Safety and Effectiveness |
JAN 13 2005
| Submitter: | Card Guard Scientific Survival Ltd., |
|---|---|
| 2 Pekeris St. P.O.B. 527 | |
| Rehovot 76100, Israel | |
| Tel: 972-8-9484000 | |
| Fax: 972-8-9484044 | |
| Contact Person: | Na'ama Oren, |
| QA and Regulatory Specialist | |
| Tel: 972-8-9484045 | |
| E-mail: naamao@eardguard.com | |
| Date Prepared: | December 19.2004 |
Definition 1.
PMP4 SelfCheck™ ECG allows transmitting multiple ECG recordings of 1 or 12-lead to a device (PMP+ or compatible generic PDA or mobile telephone with Bluetooth support) allowing physician to monitor the device output remotely.
Multi-functional Patient Monitor:
- Built-in 1-lead ECG monitor ●
- 12-lead ECG monitor using an'extemal patient cable ●
Intended Use 2.
The PMP4 SelfCheck™ and Card Guard Heart Screening Service are intended for selftesting by patients and by health care professionals at home and at medical settings. This 12- lead and I-lead electrocardiogram (ECG), allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server.
Specifically, the PMP4 SelfCheck™ ECG is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:
- . Skipped Beats
- Pounding heart (Palpitations) ●
- Heart Racing or Irregular Pulse .
- Lightheadedness or Faintness ●
- . History of Arrhythmias
| This document contains proprietary information of
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| --- | 03 | 1 | 5 |
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Image /page/4/Picture/0 description: The image shows the logo for Card Guard. The logo has the words "CARD GUARD" in bold, black letters. Underneath the words is a thin black line, and below that are smaller words that are difficult to read. To the right of the logo is a line graph that resembles an EKG.
Contraindications for Use:
In order to use this service, the patient must be able to perform all of the following:
- Read and understand the User's Manual ●
- Place the PMP4 SelfCheck™ ECG on his/her chest and hold it steadily for at . least 30 seconds.
- Hear the "beeps" for low battery. .
- . Speak and understand English.
- Operate a PDA or cell phone (hand-held devices) ●
- Operate a simple, push-button device.
Due to the possible seriousness of the abnormal heart rhythms that can be associated with these conditions, persons who have been diagnosed with the following conditions should consult their physician before using this service:
- Blockage of the arteries of the heart
- . Heart valve problems
- Heart transplant ●
- Congestive heart failure ●
- Loss of consciousness ●
If the patient has any of these conditions. CG will need to obtain authorization from their physician within 35 days of enrollment in the service.
Warning:
This non- standard 12- lead and 1- lead electrocardiogram (ECG), which is measured using the SelfCheck™ ECG. should not be used for diagnostics in comparison to the standard 12 lead ECG obtained with standard electrode placement. Use of SelfCheck™ ECG with 12-lead cable is by physician prescription only. This device should not be used with pacemakers or implanted defibrillators and cannot predict or diagnose a heart attack or be used for chest pain monitoring. The SelfCheck™ ECG is not a defibrillation proof device.
Need for Signed Physician Agreement (12- lead ECG):
Your agreement indicates you understand that CG (or affiliate) will contact your physician to verify in writing that you are their patient and that they are willing to be contacted in cases where there are clinically significant events involving your care.
Your agreement indicates you understand that ifwritten verification is not received from your physician within 35 days of your cnrollmcnt, you will not be able to utilize any aspects of the CG (or affiliate) service until such verification is reccived by CG (or affiliate).
Your agreement certifies you understand that this scrvice is not a substitute for physician care and that this is only a screening service.
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Image /page/5/Picture/0 description: The image shows the words "CARD GUARD" in bold black letters above the words "Scientific Survival LLC" in smaller, lighter letters. To the right of the words is a line graph that resembles an electrocardiogram (EKG) reading. The EKG line has a sharp peak, a rounded hill, and a flat line.
- Low Battery detection and audio warning .
5. User Interface
The PMP4 SelfCheck™ ECG user interface incorporates the following controls and signals:
- On/off control button
- SEND control button (optional) ●
- Fluctuating transmission sound ●
- Low battery warning
Substantial Equivalence 6.
The substantially equivalence to the following predicate devices is claimed:
| CG-2211 | 1 Lead ECG Transmitter (OTC) | KO12223 | Decision Date 07/28/01 |
|---|---|---|---|
| CG-7100 | 12 Lead Personal ECG Transmitter | K964836 | Decision Date 07128197 |
PMP4 SelfCheck™ ECG is schematically identical to CG-2211 ECG Transmitter K012223, except it includes a 12 Lead option and uses the Bluetooth technology instead of transtelephonic transmission. It is also proposed as a non-prescription device (OTC).
The Intended use is similar: self-testing by patients. Both devices transmit a limited period of heart activity.
The common feature with CG-7100 (K964836) ECG Transmitter is the 12- Lead option. Both, the PMP4 SelfCheck ECG and the CG-7100 should not be used for diagnostics in comparison to the standard 12 lead ECG obtained with standard electrode placement and do not provide quality ECG data. By comparing the safety tests and performance tests of the SelfCheck™ ECG to those of the CG-7100, it can be concluded that its safety and efficacy are not derogated.
Design Controls and Hazard Analysis 7.
The Card Guard's product design proccdure, and QA and QC policy, formalize the design and production process and assure that all respective requirements arc met. In the framework of the Design Controls laboratory testing were conducted to verify and validate the PMP4 SelfCheck™ ECG compliance with all design specifications.
The device biocompatibility was evaluated and found to be satisfactory.
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Image /page/6/Picture/0 description: The image shows the logo for Card Guard. The text "CARD GUARD" is in bold, black letters. Underneath the text is the phrase "More than Survival ITQ" in a smaller font. To the right of the text is a line graph that resembles an EKG.
The device Level of Concern criteria were evaluated and PMP4 SelfCheck™ ECG was characterized as a moderate level of concern system.
The system safety and risk analysis conducted for PMP4 SelfCheck™ ECG provided rigorous design and structural evaluation aimed at revealing potential failures or possible system flaws which could directly or indirectly affect the patient.
8. Conclusions
PMP4 SelfCheck™ ECG constitutes a safe and reliable means for transmitting ECG data. Its material composition and operation present no adverse health effect or safety risks to patients when used as intended.
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