CARDIOMEM CM 3000-12BT

K063042 · Getemed Medizin- Und Informationstechnik AG · MWJ · May 30, 2007 · Cardiovascular

Device Facts

• Record ID: K063042
• Device Name: CARDIOMEM CM 3000-12BT
• Applicant: Getemed Medizin- Und Informationstechnik AG
• Product Code: MWJ · Cardiovascular
• Decision Date: May 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

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.

Device Story

Ambulatory Holter recorder; captures 12-channel ECG data via 10-lead electrode hookup; stores data on removable CompactFlash memory card for up to 48 hours. Device features LCD screen for lead quality check/configuration and keypad for patient ID entry and event marking. Includes Bluetooth module for data transmission to CardioDay evaluation software. Operated by healthcare professionals in clinical settings; patient wears device. Device performs no automated diagnosis or interpretation; raw data transferred to PC-based CardioDay software for physician review. Facilitates diagnosis of cardiac rhythm patterns by providing full disclosure ECG data. Benefits patients by enabling long-term cardiac monitoring outside clinical environment.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, hazard analysis, and compliance with international standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-47, and ANSI/AAMI EC 38.

Technological Characteristics

12-channel ambulatory ECG recorder; 10-lead electrode interface; 1024 Hz sampling rate; 12-bit A/D resolution. Storage: CompactFlash memory card. Connectivity: Bluetooth and USB. Power: 1 or 2 AA alkaline batteries. Features: LCD display, membrane keypad, pacemaker pulse detection, open-lead detection. Standards: IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-47, 60601-2-51, ANSI/AAMI EC 38, ISO 14971.

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 cardiac functionality monitoring.

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

• CardioMem CM 3000-12 Holter recorder (K051686)
• CG-7000DX-BT ECG Recorder/Transmitter (K052556)

Reference Devices

• CardioDay (K051471)

Submission Summary (Full Text)

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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 man<br>CardioMem" 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 a<br>510(k) · Summary | Section 16-0001-Rev A |
| | |

#### 510(k) - Summary

| Name and address of the<br>manufacturer and sponsor<br>of the 510(k) submission: | getemed AG<br>Oderstr. 59<br>14513 Teltow<br>Germany<br>Tel.: +49 3328 - 3942-0<br>Fax: +49 3328 - 3942-99 |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Official contact person<br>for all correspondence: | Dr. Bert Schadow<br>Regulatory Affairs Manager<br>E-mail: [e-mail] |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AG<br>Oderstr. 59<br>14513 Teltow<br>Germany |
| 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 and<br>510(k) Numbers: | CardioMem CM 3000-12 Holter recorder<br>K051686 |
| | CG-7000DX-BT ECG Recorder/Transmitter<br>K052556 |

## Description of Device:

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

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

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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 Device<br>CG-7000DX-AT ECG<br>Recorder/Transmitter (K052556) | Legally Marketed Device<br>CardioMem" CM 3000-12<br>(K051686) | New/ Modified Device<br>CardioMem" 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,<br>Device control | 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 |
| Keyboard | Protected touch keys (membrane) | Protected touch keys (membrane) | Protected touch keys (membrane) |
| System configuration | Not specified | Check lead quality,<br>input patient ID and name,<br>start recording | Check lead quality,<br>input patient ID and name,<br>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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| Special 510(k) Notification | <span style="font-size: large;"><b>o getemed</b></span> |
|-----------------------------|---------------------------------------------------------|
| 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

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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 [phone]. 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 [phone] or [phone] 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:

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.

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)

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