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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CardioMem® Models CM 4000/CM 4000B, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. This is likely because the device is a Holter recorder that doesn't perform cardiac analysis itself. Its primary function is to continuously record ECG data for later evaluation by software and a physician.

Instead of performance metrics, the acceptance criteria are implicitly related to demonstrating substantial equivalence to predicate devices through non-clinical testing and ensuring the device performs its intended function safely and effectively.

Acceptance Criteria (Implicit)	Reported Device Performance
Safety and Effectiveness Equivalence: No new questions of safety or effectiveness compared to predicate devices.	Non-clinical testing (EMC, electrical safety, software validation) demonstrated that the device "brought up no issues of safety or effectiveness."
Intended Use Equivalence: Device meets the same intended use as predicate devices.	Device's intended use is the same as the predicate devices: "continuously record EGC data" for use with an ECG analysis software package.
Design Principle, Material Equivalence: Device remains similar in fundamental design and materials.	"Very similar to its predicate devices in intended use, design principle, material, or performance to applicable standards."
Performance to Applicable Standards: Device complies with relevant industry standards.	Electromagnetic compatibility according to IEC 60601-1-2. Electrical safety according to IEC 60601-1.
Software Validation: Software changes do not introduce new risks or issues.	Software validation testing performed (moderate level of software concern) addressed differences without demonstrating safety/effectiveness issues.
Usability/Design Improvements Don't Compromise Safety/Effectiveness: Incremental changes (color display, touch, battery, miniaturization) should not negatively impact safety/effectiveness.	The "small differences do not raise any new questions of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable / Not explicitly stated for a clinical test set. The provided document emphasizes non-clinical testing.
Data Provenance: The non-clinical testing (Electromagnetic compatibility, Electrical safety, and Software validation) was performed by GETEMED Medizin- und Informationstechnik AG (Germany). The original device name is CardioMem® Models CM 4000/CM 4000B, manufacturer based in Germany. The data is retrospective in the sense that it's reported by the manufacturer for the specific device being submitted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No clinical test set with human ground truth labeling was used as "No clinical testing was performed in order to support safety or effectiveness."

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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

No. This type of study was not conducted. The device is a Holter recorder, not an AI-powered analysis tool. It records data for later use with existing ECG analysis software, which may or may not incorporate AI. The submission focuses on the recorder itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, in spirit, but not in the context of an "algorithm" as typically defined for AI. The "standalone" performance was assessed through the non-clinical tests (EMC, electrical safety, software validation) to ensure the device's hardware and software components function correctly as a standalone recorder. However, it's crucial to reiterate that the device itself performs "no cardiac analysis."

7. The Type of Ground Truth Used

For the non-clinical tests:
- Regulatory Standards: Ground truth was established by relevant international standards for electromagnetic compatibility (IEC 60601-1-2) and electrical safety (IEC 60601-1).
- Software Design Specifications/Requirements: For software validation, the ground truth would be the defined software requirements and specifications.
- Predicate Device Performance: Implicitly, the performance and safety profile of the predicate devices (CardioMem® CM 3000-12 BT and CardioMem® CM 3000) served as a benchmark for "ground truth" concerning acceptable levels of safety and effectiveness for a Holter recorder.

8. The Sample Size for the Training Set

Not applicable. The device is a medical device hardware (Holter recorder) and associated operating software, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no "training set" for this type of device.

Summary

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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.
1. Common or Usual Name: Holter Recorder, Product Code MWJ

5. Predicate Device Information:

Device	Manufacturer	510(k) Number
CardioMem® CM 3000	GETEMED Medizin- undInformationstechnik AG	K022540"Rz153+/ CardioID+"
CardioMem® CM 3000-12BT	GETEMED Medizin- undInformationstechnik AG	K063042

6. Device Description:

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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

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functionality. Generally, there was a process of miniaturization for the complete device, so that it is now smaller and lighter.

、

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

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Indications for Use

510(k) Number (if known): K122272

Device Name: CardioMem® Models CM 4000/CM 4000B

Indications For Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

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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Regulation Number and Section

§ 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).