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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the DA-2006P Defibrillator Tester:

Device: DA-2006P Defibrillator Tester

Indications for Use: To determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications through the measurement of energy output.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily defined by compliance with specific international standards for electromagnetic compatibility and electrical safety, and the successful execution of internal validation and verification tests. The reported device performance is simply that the device "Pass"ed all these tests.

Test / Acceptance Criterion (Implicit)	Reported Device Performance
International Standards Compliance:
EN61326: Electrical equipment for measurement, control, and laboratory use - EMC Requirements	Pass
EN61000-3-2: Electromagnetic Compatibility (EMC) Part 3-2 Limits - Limits for Harmonic Current Emissions	Pass
EN61000-3-3: Electromagnetic Compatibility (EMC) – Part 3: Limits - Section 3: Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-Voltage Supply Systems	Pass
IEC61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements	Pass
Internal Testing & Functionality:
Debugger Validation: Evaluate device operation under conditions not available under normal use	Pass
Device Validation: Validate device function of each hardware and software specification	Pass
Device Verification: Ensure device function during assembly	Pass

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

The document does not specify a sample size for any "test set" in the context of clinical or performance data from actual defibrillator/pacemaker measurements. The testing described is for the device itself (DA-2006P), not for the performance of defibrillators/pacemakers measured by the DA-2006P.

Sample Size: Not applicable/Not specified for a "test set" related to clinical performance. The tests are on the device itself.
Data Provenance: Not applicable in the sense of clinical data origin. The testing involves engineering and safety standards verification, likely performed in a controlled laboratory environment. There is no mention of country of origin for data or whether it was retrospective or prospective.

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

This information is not provided in the document. The "tests" described are against international engineering and safety standards (EN, IEC), and internal device validation/verification. These are typically assessed by qualified engineers and technicians, not clinical "experts" establishing a "ground truth" for medical imaging or diagnosis.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable in the context of the described engineering and safety tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where human interpretation of medical data is involved and discrepancies need to be resolved. The "Pass" results indicate direct compliance with predefined technical specifications or standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human readers' performance with and without AI assistance is compared. The DA-2006P is a test instrument, not a diagnostic AI device intended for human interpretation of medical cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The concept of "standalone" performance without human-in-the-loop is typically applied to software algorithms that make independent assessments. The DA-2006P is a physical hardware device with embedded software. The described "Device Validation" and "Device Verification" could be considered "standalone" in the sense that they are testing the device's inherent functionality against its specifications, independent of a specific human operator's diagnostic interpretation. However, it's not "standalone" in the context of an AI algorithm making a clinical decision. The device is designed to be operated by a "trained service technician" to measure and display data.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the DA-2006P is based on:

International Engineering and Safety Standards: The requirements and limits defined in EN61326, EN61000-3-2, EN61000-3-3, and IEC61010-1.
Manufacturer's Internal Specifications: The defined hardware and software specifications and operational parameters of the DA-2006P itself, used for "Device Validation" and "Device Verification."

There is no mention of expert consensus, pathology, or outcomes data, as these are not relevant for the type of device and testing described.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The DA-2006P is not an AI/ML device that requires a "training set" in the conventional sense. It's a measurement instrument.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary

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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/Address	BC Group International, Inc3081 Elm Point Industrial DriveSt. Charles, MO 63301
Owner/Operator	BC Group International, Inc3081 Elm Point Industrial DriveSt. Charles, MO 63301 USA
Manufacturing Sites	BC Group International, Inc3081 Elm Point Industrial DriveSt. Charles, MO 63301 USAFDA Establishment Registration Number: Pending

Submission Contact Information:

Primary Contact	NameTitleTelephone:Fax:Email Address	Mel RochePresident(314)-638-3800(314)-638-3200mroche@bcgroupintl.com
Alternate Contact	NameTitleTelephone:Fax:Email Address	Larry MennemeyerEngineering Manager(314)-638-3800(314)-638-3200Imennemeyer@bcgroupintl.com

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

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.

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 formeasurement, control,and laboratory use - EMCRequirements	Pass
EN61000-3-2	ElectromagneticCompatibility (EMC) Part3-2 Limits - Limits forHarmonic CurrentEmmistions	Pass
EN61000-3-3	ElectromagneticCompatibility (EMC) –Part 3: Limits - Section 3:Limitation of VoltageChanges, VoltageFluctuations and Flickerin Public Low-VoltageSupply Systems	Pass
IEC61010-1	Safety requirements forelectrical equipment formeasurement, control,and laboratory use Part 1:General Requirements	Pass

Table 2: Device Test Summary

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Test	Description	Result
Debugger Validation	Evaluate device operationunder conditions notavailable under normaluse	Pass
Device Validation	Validate device functionof each hardware andsoftware specification	Pass
Device Verification	Ensure device functionduring 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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 870.5325 Defibrillator tester.

(a)
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.(b)
Classification. Class II (performance standards).