DEFIBRILLATOR ANALYZER - DA-2006P

K110192 · Bc Group International, Inc. · DRL · Feb 8, 2011 · Cardiovascular

Device Facts

• Record ID: K110192
• Device Name: DEFIBRILLATOR ANALYZER - DA-2006P
• Applicant: Bc Group International, Inc.
• Product Code: DRL · Cardiovascular
• Decision Date: Feb 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5325
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The DA-2006/DA-2006P are used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output. The DA-2006 tests defibrillators while the DA-2006P additionally tests transcutaneous pacemakers.

Device Story

Microprocessor-based instrument for testing defibrillators and transcutaneous pacemakers; measures energy output and pulse information. Features built-in 50-ohm human body simulation load, 12-lead ECG with arrhythmias, and performance waveforms. Used by trained service technicians in clinical or service environments. Provides analysis of pacer pulse, refractory period, sensitivity, and immunity. Outputs data via 240x64 pixel graphic display, centronics printer port, serial port, oscilloscope output, and high-level ECG output. Enables technicians to verify device compliance with performance specifications, ensuring safe and effective operation of life-critical cardiac equipment.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed compliance with EN61326 (EMC), EN61000-3-2/3 (Harmonic/Flicker), and IEC61010-1 (Safety).

Technological Characteristics

Microprocessor-based instrument; 50-ohm human body simulation load; 12-lead ECG generation; 240x64 pixel graphic display; connectivity via serial/centronics ports; oscilloscope/high-level ECG outputs. Complies with IEC61010-1 and EN61326 standards.

Indications for Use

Indicated for use by trained service technicians to verify performance specifications of manual, semi-automatic, and automatic defibrillators (monophasic/biphasic) and transcutaneous pacemakers.

Regulatory Classification

Identification

A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.

Predicate Devices

• Metron QA-40/45M Defibrillator Tester (K963190)

Submission Summary (Full Text)

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#### 510(k) Summary (As required by 21 CFR 807.92) 5

FEB 8 2011

Date Prepared: November 2, 2010 Submitter's Information:

| Submitter's Name/<br>Address | BC Group International, Inc<br>3081 Elm Point Industrial Drive<br>St. Charles, MO 63301 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/Operator | BC Group International, Inc<br>3081 Elm Point Industrial Drive<br>St. Charles, MO 63301 USA |
| Manufacturing Sites | BC Group International, Inc<br>3081 Elm Point Industrial Drive<br>St. Charles, MO 63301 USA<br>FDA Establishment Registration Number: Pending |

# Submission Contact Information:

| Primary Contact | Name<br>Title<br>Telephone:<br>Fax:<br>Email Address | Mel Roche<br>President<br>(314)-638-3800<br>(314)-638-3200<br>[e-mail] |
|-------------------|------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Alternate Contact | Name<br>Title<br>Telephone:<br>Fax:<br>Email Address | Larry Mennemeyer<br>Engineering Manager<br>(314)-638-3800<br>(314)-638-3200<br>[e-mail] |

# Proposed Device- ·

Device Proprietary Name: Classification Name Class Product Code

DA-2006P Defibrillator Tester Class II/21CFR 870.5325 DRL

# Predicate Devices

- Metron QA-40/45M Defibrillator Tester (K963190) .

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### Section 514 Compliance

Not applicable. Special Controls have not been established as of this date.

#### Indications for Use

The DA-2006/DA-2006P are used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output. The DA-2006 tests defibrillators while the DA-2006P additionally tests transcutaneous pacemakers.

### Description of Device

The BC Group International DA-2006 Defibrillator Tester is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with specified requirements.

The DA-2006 is a microprocessor-based instrument that is used in the testing of defibrillators. It measures the energy output and provides information about the pulse. It is used on manual, semi-automatic and automatic defibrillators with monophasic or biphasic outputs.

The DA-2006P model additionally provides a Transcutaneous Pacemaker analysis function. It measures and displays pacer pulse information as well as performing Refractory Period, Sensitivity and Immunity testing,

All models have a built in 50 ohm human body simulation load as well as 12 lead ECG with arrhythmias and performance waveforms. Additionally, they have a centronics printer port, a serial port, oscilloscope output, high level ECG output, as well as provision for a batterv eliminator.

The DA-2006P makes viewing and selecting the desired waveforms and test data quick and intuitive, with all operational information being available on the 240 by 64 pixel graphic display, allowing for easy maneuvering through parameters and scrolling through available options.

NOTE: The instrument is intended for use by trained service technicians.

#### Comparison to Predicate Device

The DA-2006P Defibrillator Tester uses the same exact approach and DUT evaluation procedures as the predicate device.

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## Summary of Technical Characteristics

The DA-2006P Defibrillator Tester shares the same technological characteristics; design, materials, and composition as the predicate device.

# Summary of Non-Clinical Testing/Statement of Equivalence

The DA-2006P Defibrillator Tester was tested to meet international standards for electromagnetic compatibility and electrical safety. Verification and Validation tests were performed to ensure that all of the product specifications were met.

The testing performed indicates that the DA-2006P is as safe and as effective as the predicate device. Table 2 below shows the extent of the testing that was performed.

| Test | Description | Result |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| EN61326 | Electrical equpment for<br>measurement, control,<br>and laboratory use - EMC<br>Requirements | Pass |
| EN61000-3-2 | Electromagnetic<br>Compatibility (EMC) Part<br>3-2 Limits - Limits for<br>Harmonic Current<br>Emmistions | Pass |
| EN61000-3-3 | Electromagnetic<br>Compatibility (EMC) –<br>Part 3: Limits - Section 3:<br>Limitation of Voltage<br>Changes, Voltage<br>Fluctuations and Flicker<br>in Public Low-Voltage<br>Supply Systems | Pass |
| IEC61010-1 | Safety requirements for<br>electrical equipment for<br>measurement, control,<br>and laboratory use Part 1:<br>General Requirements | Pass |

### Table 2: Device Test Summary

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| Test | Description | Result |
|---------------------|------------------------------------------------------------------------------------|--------|
| Debugger Validation | Evaluate device operation<br>under conditions not<br>available under normal<br>use | Pass |
| Device Validation | Validate device function<br>of each hardware and<br>software specification | Pass |
| Device Verification | Ensure device function<br>during assembly. | Pass |

# Conclusion

In conclusion, the results from the nonclinical testing demonstrate that the DA-2006P Defibrillator Tester is as safe, as effective, and performs as well as the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenne Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FFB 8 2011

Intertek Testing Services NA, Inc. C/O Paula Wilkerson Sr. Staff Engineer 2307 E Aurora Rd. Unit B7 Twinsburg, OH 44087

Re: K110192

Trade/Device Name: Defibrillator Analyzer- DA-2006 and Transcutaneous Pacemaker Tester DA-2006P Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator Tester Regulatory Class: Class II Product Code: DRL Dated: January 20, 2011 Received: January 24, 2011

Dear Ms. Paula Wilkerson:

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. Register.

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Page 2-Ms. Paula Wilkerson

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 on quoc mor of the Act or any Federal statutes and regulations administered by other Federal oyencies. 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 531-52 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/uc.m115809.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 protifice: 'on" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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# 4 Statement of Indications for Use

# 510(k) Number (if known): Unknown

Name of Devices: DA-2006 and DA-2006P Defibrillator Tester

Indications for Use:

The DA-2006/DA-2006P are used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output. The DA-2006 tests defibrillators while the DA-2006P additionally tests transcutaneous pacemakers.

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)

W.W.S.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

CONFIDENTIAL