The CardioMem® CM 3000-12BT is a Hotter recorder which is 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 CM 3000-12BT is a Holler recorder designed to be used in conjunction with the evaluation software GardioDay® (K051471). This recorder is not capable of any diagnosis nor can it provide any interpretation of the clata. The CM 3000-12BT acquires, digitizes and stores data to be analyzed by CardioDay®. The CM 3000-12BT uitlizes a 10-lead electrode hookup and placement to provide CardioDay" with 12 channels of full disclosure for Holler analysis. The cardiac data provided by CardioDay® is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The CM 3000-12BT Holter recorder stores 12 ECG channels continuously for up to 48-hours including the detection of pacemaker pulses. A keyped is available to set up system contiguration, to enter patient's ID and name, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers. The CM 3000-12BT has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hock-up technician. The CM 3000-12BT uses one or two AA batterles, and a removable memory card for data storage.

ECG data and palient data can be Iransmitted via a Bluetooth connection (BT module from Amber wireless GmbH) from the CM 3000-12BT to CardidDay" and also from CardioDay® to the CM 3000-12BT

AI/ML Overview

Here's an analysis of the provided text regarding the CardioMem CM 3000-12BT, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific quantitative acceptance criteria or detailed performance metrics from a test study. Instead, it relies on a comparison to predicate devices and adherence to relevant standards. The "New/Modified Device" column serves as the "reported device performance" in this context, compared against the "Legally Marketed Device" columns.

Specification	Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (CardioMem CM 3000-12BT)
Online data	No	No
Patient hookup	10 ECG electrodes	10 ECG electrodes
Number of ECG channels desired	12	12
ECG lead names	RA, LA, LL, RL, V1, V2, V3, V4, V5, V6	RA, LA, LL, RL, V1, V2, V3, V4, V5, V6
A to D sample rate	1024 samples/sec (from K051686) / 720 samples/sec (from K052556)	1024 samples/sec
A to D resolution	12 bit	12 bit
Pacemaker detection	No (from K051686) / Not specified (from K052556)	Yes
Open-Lead detection	Yes	Yes
Memory type	CompactFlash™ Memory Card	CompactFlash™ Memory Card
Data transfer method	Via removable memory card	Via removable memory card
Online data transfer	Via OptoLink cable OL1000 (from K051686) / Via Bluetooth connection (from K052556)	Via Bluetooth connection or USB connection
Memory card data format	Standard file system	Standard file system
Liquid crystal display (LCD)	Yes	Yes
Display purpose	Display ECG, check lead quality, input patient ID, display messages	Display ECG, check lead quality, input patient ID, display messages
Keyboard	Protected touch keys (membrane)	Protected touch keys (membrane)
System configuration	Check lead quality, input patient ID and name, start recording	Check lead quality, input patient ID and name, start recording
System configuration method	Per keyboard and LCD display	Per keyboard and LCD display
Marker button	Yes	Yes
Size	108 * 66 * 22 mm	108 * 66 * 22 mm
Weight	<160 g (without battery)	<160 g (without battery)
Carrier pouch	Carrier bag (Pouch)	Carrier bag (Pouch)
Battery	1 or 2 x 1.5 V AA alkaline	1 or 2 x 1.5 V AA alkaline
Battery check prior to recording	Yes	Yes
External patient cable	Yes	Yes
Record identification procedure	Yes	Yes
ECG channel	Yes	Yes

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

The document states: "Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness." This implies that there was no specific "test set" of patient data used in a clinical study as would be typical for many medical devices. The evaluation for this 510(k) focused on non-clinical testing and comparison to predicate devices. The data provenance would therefore be from the technical specifications and performance characteristics of the device itself and the predicate devices.

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

Since no clinical testing with a "test set" was performed, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical testing was not required."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is an ECG recorder, not an algorithm that performs analysis. It acquires, digitizes, and stores data to be analyzed by separate evaluation software (CardioDay®) and "trained medical personnel." Therefore, the concept of a "standalone" algorithm performance study is not directly applicable to this device, which is a data acquisition unit. Its performance is related to its ability to accurately record physiological signals. Non-clinical testing focused on this aspect.

7. Type of Ground Truth Used

The ground truth for the device's technical specifications and electrical performance would be established through engineering measurements, laboratory testing, and adherence to established industry standards (e.g., IEC 60601 series, ANSVAAMI EC 38). For example, the A to D sample rate and resolution would be verified against internal specifications and industry benchmarks for Holter recorders.

8. Sample Size for the Training Set

Not applicable. This device is a hardware recorder, not an AI/ML algorithm that requires a training set. The "training" in this context would refer to the device's design, engineering, and manufacturing process.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this hardware device. The device's functionality is based on its engineering design and adherence to technical requirements, which are verified through non-clinical testing against established industry standards.

Summary

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K063042

MAY 3 0 2007

Special 510(k) Notification
and the controlled on the manage of the many of the man more to the comments of the manufactures and the many of the many of the manCardioMem" CM 3000-12BT	Project ID: 0508H1
assessment of the program as and and the program and of the first and the first and any and the manus a510(k) · Summary	Section 16-0001-Rev A

510(k) - Summary

Name and address of themanufacturer and sponsorof the 510(k) submission:	getemed AGOderstr. 5914513 TeltowGermanyTel.: +49 3328 - 3942-0Fax: +49 3328 - 3942-99
Official contact personfor all correspondence:	Dr. Bert SchadowRegulatory Affairs ManagerE-mail: schadow@getemed.de
Manufacturing Facility:	getemed Medizin- und Informationstechnik AGOderstr. 5914513 TeltowGermany
Date of Preparation:	2006-09-22
Device Name / Trade Name:	CardioMem CM 3000-12BT Holter recorder
Generic name of the device:	Electrocardiograph, ambulatory (withou! Analysis)
Classification of new device:	Class II
Classification Panel:	Cardiovascular
Product Code and	MWJ
CFR Regulation Number:	21 CFR 870.2800
Predicate Devices Name and510(k) Numbers:	CardioMem CM 3000-12 Holter recorderK051686
	CG-7000DX-BT ECG Recorder/TransmitterK052556

Description of Device:

ECG data and palient data can be Iransmitted via a Bluetooth connection (BT module from Amber wireless GmbH) from the CM 3000-12BT to CardidDay" and also from CardioDay® to the CM 3000-12BT

0608H1-Sec216-0007-ResvA-C142000-12BT-510k_Summerry.doc

Page 1 x4 3

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Special 510(k) Notification	Image: getemed logo
CardioMem® CM 3000-12BT	Project ID: 0608H1
510(k) - Summary	Section 16-0001-Rev A

Comparison of Device Technological Characteristics to Predicate Device:

The CG-7000DX-BT, the CardleMem® CM 3000-12 Holler recorder, and the CardioMem® CM 3000-12 Holler recorder have the following technology specifications:

Specification	Legally Marketed DeviceCG-7000DX-AT ECGRecorder/Transmitter (K052556)	Legally Marketed DeviceCardioMem" CM 3000-12(K051686)	New/ Modified DeviceCardioMem" CM 3000-12BT
Online data	Yes	No	No
Patient hookup	10 ECG electrodes	10 ECG electrodes	10 ECG electrodes
Number of ECG channels desired	12	12	12
ECG lead names	RA, LA, LL, RL, V1, V2, V3, V4, V5, V6	RA, LA, LL, RL, V1, V2, V3, V4, V5, V6	RA, LA, LL, RL, V1, V2, V3, V4, V5, V6
A to D sample rate	720 samples/sec	1024 samples/sec	1024 samples/sec
A to D resolution	12 bit	12 bit	12 bit
Pacemaker detection	Not specified	No	Yes
Open-Lead detection	Not specified	Yes	Yes
Memory type	Not specified	CompactFlash" Memory Card	CompactFlash" Memory Card
Data transfer method	Via Bluetooth connection	Via removable memory card	Via removable memory card
Online data transfer	Via Bluetooth connection	Via OptoLink cable OL1000	Via Bluetooth connection or USB connection
Memory card data format	Not specified	Standard file system	Standard file system
Liquid crystal display (LCD)	Yes	Yes	Yes
Display purpose	Display ECG,Device control	Display ECG,check lead quality,input patient ID,display messages	Display ECG,check lead quality,input patient ID,display messages
Keyboard	Protected touch keys (membrane)	Protected touch keys (membrane)	Protected touch keys (membrane)
System configuration	Not specified	Check lead quality,input patient ID and name,start recording	Check lead quality,input patient ID and name,start recording
System configuration method	Per keyboard and LCD display	Per keyboard and LCD display	Per keyboard and LCD display
Marker button	No	Yes	Yes
Size	Not specified	108 * 66 * 22 mm	108 * 66 * 22 mm
Weight	Not specified	<160 g (without battery)	<160 g (without battery)
Carrier pouch	Not specified	Carrier bag (Pouch)	Carrier bag (Pouch)
Battery	Not specified	1 or 2 x 1.5 V AA alkaline	1 or 2 x 1.5 V AA alkaline
Battery check prior to recording	Not specified	Yes	Yes
External patient cable	Yes	Yes	Yes
Record identification procedure	Not specified	Yes	Yes
ECG channel	Yes	Yes	Yes

0509H |-5ec16-0001-RevA-CM3000-128T-610k , Sukumary, doc

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・ .

: .

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Special 510(k) Notification	o getemed
CardioMem ® CM 3000-12BT	Project ID: 0608H1
510(k) - Summary	Section 16-0001-Rev A

Intended use:

The CardioMerri" digital Holler recorder is intended to continuously record up to 48 hours of ECG data on a digital flash mamory card. The CardioMem® performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®. The recorded data are downloaded to a PC for analysis and following evaluation by a trained physician or bealth care professional

Federal law restricts CardioMent® to use on order of a physicien.

This device is available only upon the order of a physician or other licensed medical professional.

Non-Clinical Testing:

Varilization and validation test plans were completed in accordance with geternad AG procedures and GMP guidelines. A Hazard Analysis was completed and hazards were ത്തിക്കുന്നു. അമേരിക്കുന്നതിനു

The CardioMem" CM 3000-12BT complies to the following standards:

· IEC 60601-1.

· IEC 6001-1-1.
· IEC (30601-1-2 (EMC),
· IEC 60601-1-4.
IEC 60601-2-47
IEC 60601-2-51 (Part 50.101.2).
ANSVAAMI EC 38.
150 14971.
EN 980,
13Q 15223,
· EN 1041

All system specifications were met and lesting performed to demonstrate substantial equivalence

Clinical Testing:

Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness

Conclusion:

The CardioMem" CM 3000-12BT Holter recorder is substantially equivalent to the predicate device listed in this Summary and the device, as changed, does not raise any new issues of safely and effectiveness.

060841-Sec16-0001-RewA-CV13000-12BT-510K_Summary Soc

Page 3 of 3

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2007

Getemed AG c/o Sid Mathur Senior Regulatory Affairs Specialist MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K063042

Trade/Device Name: CardioMem CM 3000-12BT Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: April 23, 2007 Received: May 3, 2007

Dear Mr. Mathur:

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, EDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mathur

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 agencics. 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 clectronic 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 cquivalence 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,

Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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F. 561 C. - 1000 - 10/1/71 - 1000 - 10/1/71 - 1000 - 10/1/71 - 1000 - 10/1/71 - 1000 - 10/1/71

Indications for Use

510(k) Number (if known):

Cavice Name:

CardioMem® CM 3000-12BT

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpert D) Over-The-Counter Use (21 CFR 801 Subpari C)

(IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __ (

(Division Sign-Off)
Division of Cardiovetoulat payt
510(k) Number Ko6 3017

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).