H12+ HOLTER RECORDER

K050896 · Mortara Instrument, Inc. · DSH · Aug 24, 2005 · Cardiovascular

Device Facts

• Record ID: K050896
• Device Name: H12+ HOLTER RECORDER
• Applicant: Mortara Instrument, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Aug 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The H12+ Holter recorder is intended to acquire, record and store up to 48 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

Device Story

H12+ Holter recorder captures 12-lead ECG data via 10-lead electrode hookup; stores data on removable Compact Flash card for up to 48 hours. Device features LCD for lead quality check/configuration and keyboard for event markers. Operated by medical professionals in clinical settings. Device performs no onboard analysis; data transferred to Mortara H-Scribe Holter analysis system for processing. H-Scribe provides arrhythmia and ST segment analysis for review by clinicians to assist in diagnosis and therapeutic decision-making.

Clinical Evidence

No clinical data provided. Device is a passive recorder; substantial equivalence is supported by bench testing of recording capabilities and system integration with the H-Scribe analysis platform.

Technological Characteristics

12-lead ECG recorder; 10-lead electrode configuration; 3-channel full disclosure; 12-lead ST segment analysis capability. Storage: removable Compact Flash card. Power: 1x AA battery. Interface: LCD screen, keyboard. Connectivity: Data transfer to H-Scribe system. No onboard cardiac analysis.

Indications for Use

Indicated for clinical use by qualified medical professionals for recording ECG data of adult patients requiring ambulatory (Holter) monitoring up to 48 hours. Uses include evaluation of symptoms suggesting arrhythmia or myocardial ischemia, ST segment changes, pacemaker function, heart rate variability, response to therapeutic interventions, and clinical/epidemiological research. Infant evaluation limited to QRS detection only.

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

• Mortara PR4 Holter analysis Recorder (K9110977)

Reference Devices

• H-Scribe Holter analysis system (K004017)

Submission Summary (Full Text)

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AUG 2 4 2005

# 510(k): Device Summary

# Submitter:

Harlan Van Matre, Manager of Quality Assurance / Regulatory Affairs Mortara Instrument, Inc. 7865 N. 86" Street Milwaukee, WI 53224 [phone] Fax: [phone] Phone: Contact: Harlan Van Matre (see above)

| Trade Name: | H12+ |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Common Name: | Holter Analysis Recorder |
| Classification Name: | Medical Magnetic Tape Recorder (based on classification for original device.)<br>(Per 21 CFR 870.2800) |

### Legally marketed devices to which S. E. is claimed

The H12+ Holter Recorder is a modification of a legally marketed Mortara predicate device.

- Mortara PR4 Holter analysis Recorder (K9110977) ◆
Note: For commercial reasons, Mortara changed the proprietary name from PR 4 to H-12 in 1995 and has continued to distribute the device under the H-12 name. The "new" H12+ is the latest evolution of this Mortara predicate device.

### Description:

The Mortara H12+ is a Holter Recorder designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H12+ recorder. The H12+ utilizes a 10-lead electrode hookup and placement that will result in three channels of full disclosure for arrhythmia analysis and 12-lead ST segment analysis. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The H12+ Holter recorder stores 12 leads continuously for a 24-hour period. A keyboard is available to set up system configuration, to enter patient's ID, to check lead quality during hook-up, and to start the recording. During the recording, the keyboard can be used to enter event markers.

H12+ has a large LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various warning messages for the hook-up technician.

H12+ uses one AA battery, and a removable Compact Flash card as a memory support.

### Intended use:

The H12+ Holter recorder is intended to acquire, record and store up to 48 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

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# Indications for use:

The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.

Holter analysis is appropriate for the indications below:

- Evaluation of adult patients with symptoms suggesting arrhythmia or myocardial ischemia. .
- Evaluation of adult patients for ST segment changes .
- Evaluation of adult patients with pacemakers .
- Reporting of time domain heart rate variability .
- Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or . cardiac surgery.)
- Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients .
- Clinical and epidemiological research studies .
- Infant patient evaluation is limited to QRS detection only .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2005

Mortara Instrument, Inc. c/o Mr. Harlan L. Van Matre Manager, Quality Assurance and Regulatory Affairs 7865 North 86th Street Milwaukee, WI 53224-3431

Re: K050896

Trade Name: H12+ Holter Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Recorder, Magnetic Tape, Medical Regulatory Class: Class II (two) Product Code: DSH Dated: July 5, 2005 Received: July 11, 2005

Dear Mr. Van Matre:

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.

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Page 2 - Mr. Harlan L. Van Matre

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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/dsma/dsmamain.html

Sincerely yours,

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): __ K050896

#### Mortara H12+ Holter Recorder Device Name:

Indications for Use:

The H12+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter system.

The H12+ is indicated for use:

- in a clinical setting, by qualified medical professionals only, for recording ECG . data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 48 hours.
- The H12+ performs no cardiac analysis by itself and is intended to be used with . the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe.

Prescription Use X (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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number. K050896

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