(241 days)
Not Found
No
The device description explicitly states that the recorder performs no cardiac analysis by itself and is intended to be used with separate Holter ECG Analysis Software. There is no mention of AI or ML in the device description or performance studies.
No
The device is a Holter recorder used to record ECG data for diagnostic purposes, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states the device is for patients who may benefit from an ECG recording for symptoms like palpitations or chest pain, or to "judge their current cardiac functionality," which are all diagnostic purposes. While the device itself doesn't perform analysis, it records data essential for diagnosis.
No
The device description explicitly states that the CardioMem® Models CM 4000/CM 4000B are "digital Holter recorders" and mentions physical differences between the models related to battery size and shape, indicating they are hardware devices that record ECG data. While they are used with software for analysis, the devices themselves are not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) outside of the body. The CardioMem® is a Holter recorder that records electrical signals from the body (ECG) on the body.
- The device description explicitly states it performs no cardiac analysis itself. It simply records the data for later analysis by software and a qualified professional. IVDs typically perform some form of analysis on the sample.
- The intended use is for recording ECG data for diagnostic purposes, not for analyzing biological samples.
The CardioMem® is a medical device used for physiological monitoring, specifically for recording electrical activity of the heart. It falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The CardioMem® Models CM 4000/CM 4000B digital Holter recorders are intended to continuously record EGC data. The CardioMem® Models CM 4000/CM 4000B perform no cardiac analysis by themselves and are intended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or health care professional.
The CardioMem® Models CM 4000/CM 4000B are Holter recorders which are indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.
Product codes (comma separated list FDA assigned to the subject device)
MWJ
Device Description
The CardioMem® Models CM 4000/CM 4000B digital Holter recorders are intended to continuously record ECG data. The CM 4000/CM 4000B perform no cardiac analysis by themselves and are intended to be used with a Holter ECG Analysis Software package. The recorder supports the user throughout all phases of recording Holter ECGs, from applying the electrodes and entering patient demographic data up to inspecting the ECG waveforms. The digital recorders CardioMem® Models CM 4000/CM 4000B devices allow a qualified trained physician or health care professional to record the patient's ECG for the long term. The data is then downloaded to a computer containing a Holter ECG Analysis Software package. This data is then reviewed by a qualified health professional or a physician.
The only difference between the two CM 4000 models CM 4000 and CM 4000B is the battery size. The CM 4000 has a AAA battery compartment whereas the CM 4000B has a AA battery compartment, which results in a different shape of the weight of the recorder.
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
qualified trained physician or health care professional
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)
Non-clinical testing that has been conducted include:
a. Electromagnetic compatibility evaluation according to IEC 60601-1-2;
b. Electrical safety test according test to IEC 60601-1
In addition, software validation testing was performed (using a moderate level of software concern) to address the differences between the subject device and predicate device software.
None of the testing demonstrated that the CardioMem® Models CM 4000B brought up any issues of safety or effectiveness.
No clinical testing was performed in order to support safety or effectiveness.
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
510(K) SUMMARY
,
MAR 2 8 2013
This summary of 5/0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is
Submitter's Identification: 1.
GETEMED Medizin- und Informationstechnik AG Oderstrasse 77, 14513 Teltow, Germany Tel: + 49 - 3328 3942 0
Dr. Bert Schadow Contact: Regulatory Affairs Manager GETEMED Medizin- und informationstechnik AG Oderstrasse 77, 14513 Teltow, GERMANY Tel: + 49 - 3328 3942 70 Fax: + 49 - 3328 3942 99
Date Summary Prepared: March 26, 2013
Name of the Device: CardioMem® Models CM 4000/CM 4000B 2.
- Device Classification: Class II, 21 CFR Part 870.2800 3.
-
- Common or Usual Name: Holter Recorder, Product Code MWJ
5. Predicate Device Information:
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| CardioMem® CM 3000 | GETEMED Medizin- und | |
| Informationstechnik AG | K022540 | |
| "Rz153+/ CardioID+" | ||
| CardioMem® CM 3000-12 | ||
| BT | GETEMED Medizin- und | |
| Informationstechnik AG | K063042 |
6. Device Description:
The CardioMem® Models CM 4000/CM 4000B digital Holter recorders are intended to continuously record ECG data. The CM 4000/CM 4000B perform no cardiac analysis by themselves and are intended to be used with a Holter ECG Analysis Software package. The recorder supports the user throughout all phases of recording Holter ECGs, from applying the electrodes and entering patient demographic data up to inspecting the ECG waveforms. The digital recorders CardioMem® Models CM 4000/CM 4000B devices allow a qualified trained physician or health care professional to record the patient's ECG for the long term. The data is then downloaded to a computer containing a Holter ECG Analysis Software package. This data is then reviewed by a qualified health professional or a physician.
The only difference between the two CM 4000 models CM 4000 and CM 4000B is the battery size. The CM 4000 has a AAA battery compartment whereas the CM 4000B has a AA battery compartment, which results in a different shape of the weight of the recorder.
1
7. Intended Use:
The CardioMem® Models CM 4000/CM 4000B digital Holter recorders are intended to continuously record EGC data. The CardioMem® Models CM 4000/CM 4000B perform no cardiac analysis by themselves and are intended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or health care professional.
8. Comparison to Predicate Devices:
CardioMem® Models CM 4000/CM 4000B are substantially equivalent to the Holter recorder CardioMem® CM 3000-12 BT (K063042) from GETEMED Medizin- und Informationstechnik AG and the CardioMem® CM 3000 (K022540) from GETEMED Medizin- und Informationstechnik AG. There have been no changes implemented in the modifications to the CardioMem® Models CM 4000/CM 4000B that impact either the fundamental technology or the indications for use. There were only some incremental changes in the devices to improve the usability, the design and to bring the technical details up-to date.
The user interface was improved to a color display with touch functionality. The removable compact flash storage card was replaced by a non-removable SD card. In the CM 3000, the channel for the pacemaker detection had to be chosen at the beginning of the measurement and was fixed for the whole examination. Now the CM 4000/CM 400B automatically choose the best channel for the detection of the pacemaker pulses during the measurement. The data storage for further analysis is now divided into episodes of duration of about one hour instead of one large streaming file. Generally, there was a process of miniaturization for the complete device, so that it is now smaller and lighter.
Discussion of Non-Clinical Tests Performed for Determination of Substantial ರು. Equivalence are as follows:
Non-clinical testing that has been conducted include:
a. Electromagnetic compatibility evaluation according to IEC 60601-1-2; b. Electrical safety test according test to IEC 60601-1
In addition, software validation testing was performed (using a moderate level of software concern) to address the differences between the subject device and predicate device software.
None of the testing demonstrated that the CardioMem® Models CM 4000B brought up any issues of safety or effectiveness.
Discussion of Clinical Tests Performed: 10.
No clinical testing was performed in order to support safety or effectiveness.
11. Conclusions:
CardioMem® Models CM 4000/CM 4000B are very similar to its predicate devices in intended use, design principle, material, or performance to applicable standards. The main modification is the updated user interface to a color display with touch
2
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functionality. Generally, there was a process of miniaturization for the complete device, so that it is now smaller and lighter.
:
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:
The test results in this submission demonstrated that these small differences do not raise any new questions of safety and effectiveness to the subject device and the subject device is substantially equivalent to the predicate devices. . . .
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2013
Getemed Medizin - und Informationstechnik AG c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K122272
Trade/Device Name: CardioMem® CM 4000/CM 4000 B Regulation Number: 21 CFR 870.2800 Regulation Name: Electrocardiograph, ambulatory (without analysis) Regulatory Class: Class II (two) Product Code: MWJ Dated: March 7, 2013 Received: March 8, 2013
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications . for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Goldstein-Falk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
OwenP.Faris -S
for
Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122272
Device Name: CardioMem® Models CM 4000/CM 4000B
Indications For Use:
The CardioMem® Models CM 4000/CM 4000B are Holter recorders which are indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.03.28
11:35:54 -04'00'
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