CARDIOMEM CM 3000-12

K051686 · Getemed Medizin- Und Informationstechnik AG · MWJ · Jul 14, 2005 · Cardiovascular

Device Facts

• Record ID: K051686
• Device Name: CARDIOMEM CM 3000-12
• Applicant: Getemed Medizin- Und Informationstechnik AG
• Product Code: MWJ · Cardiovascular
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The CardioMem® CM 3000-12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The CardioMem® CM 3000-12 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 health care professional. Federal law restricts CardioMem® CM 3000-12 to use on order of a physician. This device is available only upon the order of a physician or other licensed medical professional.

Device Story

CM 3000-12 is a digital Holter recorder; captures 12-channel ECG data via 10-lead electrode hookup; stores data continuously for up to 48 hours on removable flash memory card. Device features LCD screen for lead quality check, system configuration, and patient ID entry; includes keypad for event marking. Operated by healthcare technicians in clinical settings; data downloaded to PC for analysis via CardioDay® software (not included). Device performs no onboard analysis or diagnosis. Output used by physicians to assist in diagnosing rhythm patterns; benefits patients by providing long-term cardiac monitoring data.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and efficacy verified through environmental and safety testing, including EMC tests according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-47, and ANSI/AAMI EC 38:1998 standards.

Technological Characteristics

12-channel digital Holter recorder; 10-lead electrode configuration; 1024 samples/sec A/D rate; 12-bit resolution. Storage: removable CompactFlash™ memory card. Power: 1 or 2 AA alkaline batteries. Interface: LCD screen and membrane keypad. Connectivity: PC download via memory card. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-47, ANSI/AAMI EC 38:1998.

Indications for Use

Indicated for patients requiring long-term continuous ECG recording, including those with palpitations, syncope, chest pain, shortness of breath, or those needing monitoring to assess cardiac functionality.

Regulatory Classification

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.

Predicate Devices

• DR180+ Holter recorder (K004007)
• H12+ Holter recorder (K021373)
• CardioID+ (RZ 153+) Holter recorder (K022540)

Submission Summary (Full Text)

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# Abbreviated 510(k) Notification

♥ geter

CardioMem® CM 3000-12

510(k) - Summary

Project ID: 0404H1

Section 16-0001-Rev B

| Submitted By: | getemed AG<br>Oderstr. 59<br>14513 Teltow<br>Germany<br>Tel.: +49 3328 - 3942-0<br>Fax: +49 3328 - 3942-99 | JUL 1 4 2005 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Dr. Bert Schadow<br>Regulatory Affairs Manager | |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AG<br>Oderstr. 59<br>14513 Teltow<br>Germany | |
| Date of Preparation: | 2005-05-25 | |
| Trade Name: | CardioMem® CM 3000-12 Holter recorder | |
| Common Name: | Holter recorder | |
| Classification Name: | Electrocardiograph, ambulatory (without Analysis) | |
| Product Classification: | 21 CFR 870.2800, Class II | |
| Product Code: | MWJ | |
| Legally Marketed Devices: | DR180+ Holter recorder (K004007, NorthEast<br>Monitoring, Inc.)<br>H12+ Holter recorder (K021373, Mortara Instrument<br>Inc.)<br>CardioID+ (RZ 153+) Holter recorder (K022540,<br>Rozinn Electronics. Inc.) | |

## Reason for Submission

510(k) - Summary

Premarket notification (Abbreviated 510(k)) for CardioMem® CM 3000-12, a New Device, seeking authority to market the device under Section 510(k) as a device that is substantially equivalent to the DR180+ Holter recorder (K004007, NorthEast Monitoring, Inc.), the H12+ Holter recorder (K021373, Mortara Instrument, Inc.) and CardioID+ (RZ 153+) Holter recorder (K022540, Rozinn Electronics, Inc.).

## Device Description

The CM 3000-12 is a Holter recorder designed to be used in conjunction with the evaluation software CardioDay® (not included in this 510(k)). This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. The CM 3000-12 acquires, digitizes and stores data to be analyzed by CardioDay". The CM 3000-12 uiliizes a 10-lead electrode
hookup and placement to provide CardioDay® with 12 channels of full disclosure for H 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 3000-12 Holter recorder stores 12 ECG channels continuously for up to 48-hours. A keypad is available to set up system configuration, 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 3000-12 has a LCD screen to allow ECG display during the hook-up, lead

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| Abbreviated 510(k) Notification | <span style="font-size: 1.5em;">●</span> getemed |
|---------------------------------|--------------------------------------------------|
| CardioMem® CM 3000-12 | Project ID: 0404H1 |
| 510(k) - Summary | Section 16-0001-Rev B |

quality check, system configuration and various messages for the hook-up technician. The CM 3000-12 uses one or two AA batteries, and a removable memory card for data storage.

#### Intended use

The CardioMem® CM 3000-12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The CardioMem® CM 3000-12 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 health care professional.

Federal law restricts CardioMem® CM 3000-12 to use on order of a physician.

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

#### Indications for use

The CardioMem® CM 3000-12 is a Holter 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.

## Comparison of Technology Characteristics

The CardioMem® CM 3000-12 Holter recorder, the DR180+ Holter recorder, the H12+ Holter recorder, and the CardiolD+ (RZ153+) Holter recorder have the following technology specifications:

| Specification | Legally Marketed<br>Device<br>DR180+ Holter<br>recorder | Legally Marketed<br>Device<br>H12+ Holter recorder | Legally Marketed<br>Device<br>CardiolD+ (R2153+) | New Device<br>CardioMem<br>CM3000-12 |
|--------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Online data<br>monitoring &<br>alarm | No | No | No | No |
| Patient hookup | 10 ECG electrodes | 10 ECG electrodes | 7 ECG electrodes | 10 ECG electrodes |
| Number of ECG<br>channels derived | 12 | 12 | 3 | 12 |
| ECG lead names | RA, LA, LL, RL, V1, V2,<br>V3, V4, V5, V6 | RA, LA, LL, RL, V1, V2,<br>V3, V4, V5, V6 | Holter configuration per<br>AAMI EC38 | RA, LA, LL, RL, V1, V2,<br>V3, V4, V5, V6 |
| A to D sample rate | 720 samples/sec. | 180 samples/sec. | 1024 samples/sec. | 1024 samples/sec. |
| A to D resolution | 12 bit | 20 bit | 12 bit | 12 bit |
| Pacemaker<br>detection | Yes | Yes | Yes | No |
| Open-Lead<br>detection | not specified | Yes | Yes | Yes |
| Memory type | CompactFlash™<br>Memory Card | CompactFlash™<br>Memory Card | CompactFlash™<br>Memory Card | CompactFlash™<br>Memory Card |
| Data transfer<br>method | Via removable<br>memory card | Via removable<br>memory card | Via removable<br>memory card | Via removable<br>memory card |
| Memory card data<br>format | Standard file system | Standard file system | Standard file system | Standard file system |
| Liquid crystal<br>display (LCD) | Yes | Yes | Yes | Yes |
| Display purpose | Display ECG,<br>check lead quality,<br>input patient ID,<br>display messages | Display ECG,<br>check lead quality,<br>input patient ID,<br>display messages | Display ECG,<br>check lead quality,<br>input patient ID,<br>display messages | Display ECG,<br>check lead quality,<br>input patient ID,<br>display messages |

0404H1-Sec16-0001-RevB-CM3000-12-510k_Summary.doc CONFIDENTIAL AND PROPRIETARY

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| Abbreviated 510(k) Notification | | | | | | |
|---------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------|--|
| CardioMem® CM 3000-12 | | | | Project ID: 0404H1 | | |
| 510(k) - Summary | | | | | Section 16-0001-Rev B | |
| Specification | Legally Marketed<br>Device<br>DR180+ Holter<br>recorder | Legally Marketed<br>Device<br>H12+ Holter recorder | Legally Marketed<br>Device<br>CardiolD+ (RZ153+) | | New Device<br>CardioMem<br>CM 3000-12 | |
| Keyboard | Protected touch keys<br>(membrane) | Protected touch keys<br>(membrane) | Protected touch keys<br>(membrane) | | Protected touch keys<br>(membrane) | |
| System<br>configuration | Check lead quality,<br>input patient ID,<br>recording mode,<br>start recording | Check lead quality,<br>input patient ID,<br>start recording | Check lead quality,<br>input patient ID and<br>name,<br>start recording | | Check lead quality,<br>input patient ID and<br>name,<br>start recording | |
| System<br>configuration<br>method | Per keyboard and LCD<br>display | Per keyboard and LCD<br>display | Per keyboard and LCD<br>display | | Per keyboard and LCD<br>display | |
| Marker button | Yes | Yes | Yes | | Yes | |
| Size | 125 x 70 x 25 mm | 64 x 91 x 25 mm | 108 x 79 x 22 mm | | 108 * 86 * 22 mm | |
| Weight | 142 g (without battery) | 125 g (without battery) | <160 g (without battery) | | <160 g (without battery) | |
| Belt clip / Carrier<br>pouch | not specified | Carrier bag (Pouch) | Carrier bag (Pouch) | | Carrier bag (Pouch) | |
| Battery | 1 or 2 x 1.5 V AA<br>alkaline | 1 x 1.5 V AA alkaline | 1 or 2 x 1.5 V AA<br>alkaline | | 1 or 2 x 1.5 V AA<br>alkaline | |
| Battery check<br>prior to recording | Yes | Yes | Yes | | Yes | |
| External patient<br>cable | Yes | Yes | Yes | | Yes | |
| Record<br>identification<br>procedure | Yes | Yes | Yes | | Yes | |
| ECG channel<br>preview | Yes | Yes | Yes | | Yes | |

#### Conclusion

The CardioMem® CM 3000-12 Holter recorder, the DR180+ Holter recorder, the H12+ Holter recorder, and the CardiolD+ (RZ153+) Holter recorder are intended to store continuously ECG Data for a period of at least 24 hours. The CM 3000-12, the DR180+, the H12+, and the RZ153+ do not analyze the data at the time of the recording. The recorded data of the mentioned recorders are downloaded to a PC for analysis and following evaluation by a trained physician or health care professional.

Quality system regulation 21 CFR 820 (outlined by the FDA) is a basis for the development of the CardioMem® CM 3000-12 Holter recorder. This recorder is safe and effective for the application for which it is intended and has been tested (environmental and safety tests, including EMC (Electromagnetic Compatibility) tests, according to the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-47 and ANSI/AAMI EC 38:1998 standards) to confirm the safety and efficacy of the recorder.

CardioMem® CM 3000-12 is found to be substantially equivalent to the DR180+ Holter recorder (K004007), the H12+ Holter recorder (K021373) and the CardiolD+ (RZ153+) Holter recorder (K022540).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three abstract human figures connected by flowing lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2005

Getemed Medizin-und Informationstechnik AG c/o Ms. Carolann Kotula MDI Consultants Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K051686

CardioMem® CM3000-12 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: June 20, 2005 Received: June 27, 2005

Dear Ms. Kotula:

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

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# Page 2 – Ms. Carolann Kotula

or any Federal statutes and regulations administered by other Federal agencies. You must of any I cuttin statures and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, adomig (Dr CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro hasis (seems (seems ) our device as described in your Section 510(k) I mis letter will anow you to oegill maing of substantial equivalence of your device to a legally prematics notineation: The Pro Pressification 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 If you desire specific acreoliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Iviliouraliums of reference to prour responsibilities under the Act may be obtained from the Other general miormation sturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimman for

Bram D. Zuckerman, M.D. 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):

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CardioMem® CM 3000-12 Device Name:

Indications For Use:

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but not limited to, those with complaints of palpitations, syncope functionslity but for limited to, those with oomplaints of pairms cardiac functionality.

Prescription Use (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)

Blummenston

asion Sign-Off Division of Cardiovascular Devices 510(k) Number

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