The DA-2006-VL is used to determine that defibrillators are performing within their performance specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P.

Device Description

The BC Group International DA-2006-VL Variable Load is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with international standards IEC 60601-2-4 and AAMI DF80.

The DA-2006-VL is a non-powered, selectable resistive load bank. Through various series and parallel resistor combinations. the DA-2006-VL allows a user to select 25, 50, 75, 100, 125, 150, 175, and 200 Ohm loads.

The DA-2006-VL is used in conjunction with the DA-2006/DA-2006P Defibrillator Analyzer.

AI/ML Overview

The provided text describes a medical device, the DA-2006-VL Defibrillator Analyzer Variable Load, and its equivalency to a predicate device, the Fluke Impulse 7010 Defibrillator Selectable Loads. However, the document does not contain information about an AI-powered device or a study involving human readers or AI assistance. Therefore, most of the requested information cannot be extracted from this document.

Here's the information that can be extracted and a note on what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from Predicate/DA-2006-VL Specifications)	Reported Device Performance (DA-2006-VL)
Maximum voltage: 5000 V	5000 V
Maximum Continuous Power: 12 W, 10 defib pulses of 360 J every 5 minutes	12 W, 10 defib pulses of 360 J every 5 minutes
Inductance: < 2 μH (@25 Ω), < 3 μH (@50 Ω), < 4 μH (@75 Ω and 100 Ω), < 5 μH (@125 Ω), < 6 μH (@150 Ω), < 7 μH (@175 Ω), < 8 μH (@200 Ω)	< 10 μH
Load Settings: 25, 50, 75, 100, 125, 150, 175, 200 Ohms, ±1%	25, 50, 75, 100, 125, 150, 175, 200 Ohms, ±1%
Accuracy (50 Ω) High Range: ± 1% of reading + 0.1 J for >100 Joules, ± 1 J for ≤100 Joules	High Range: ± 2 % of reading for >100 Joules, ± 2 Joules for ≤100 Joules
Accuracy (50 Ω) Low Range: Not explicitly stated for predicate in table, but implied by DA-2006-VL description	Low Range: ± 2 % of reading for >20 Joules, ± 0.4 Joules for ≤20 Joules
Accuracy (25 Ω, 75-200 Ω) High Range: ± 2% of reading + 0.1 J for >100 Joules, ± 2 J for ≤100 Joules	High Range: ± 3 % of reading for >100 Joules, ± 3 Joules for ≤100 Joules
Accuracy (25 Ω, 75-200 Ω) Low Range: Not explicitly stated for predicate in table, but implied by DA-2006-VL description	Low Range: ± 3 % of reading for >20 Joules, ± 0.6 Joules for ≤20 Joules
Dimensions: 138.7 mm x 154 mm x 272 mm	248.9 mm x 205.7 mm x 120.7 mm
Weight: 1.54 kg	2.27 kg
Operating Temperature: 10 to 40 C	15 to 40 C
Storage Temperature: -20 to +60 C	-20 to +65 C

The device was also tested to a standard:

IEC61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements. Result: Pass

2. Sample size used for the test set and the data provenance: Not applicable. This document describes a physical medical device (defibrillator analyzer), not a software or AI algorithm that would typically have a "test set" in the context of data. The testing performed was related to device function and electrical safety. The data provenance is also not applicable for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI algorithms (e.g., expert labels on images) is not relevant for this device. The "ground truth" for this device's functionality would be established by engineering specifications and measurements using calibrated reference equipment.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No. This document is not about an AI-powered device or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.

7. The type of ground truth used: For the functional performance, the "ground truth" would be established by calibrated measurement standards and the device's design specifications. For the IEC standard, the ground truth is adherence to the standard's requirements.

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.

Public Health Service

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

December 21, 2015

BC Group International, Inc. % Mel Roche President 3081 Elm Point Industrial Drive Saint Charles, Missouri 63301

Re: K153210

Trade/Device Name: Defibrillator Analyzer Variable Load, Model DA-2006-VL Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator Tester Regulatory Class: Class II Product Code: DRL Dated: July 17, 2015 Received: November 5, 2015

Dear Mel Roche:

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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mitchell Stein

forBram 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) K153210

Device Name

DA-2006-VL Defibrillator Analyzer Variable Load

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Research Use (Part 21 CFR 361. Subpart B)	Over-The-Counter Use (21 CFR 331. Subpart C)
---------------------------------------------------------	------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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The CDRH Premarket Review Submission Cover Sheet for the DA-2006-VL 5 Variable Load is contained in this section 510(k) Summary (As required by 21 CFR 807.92)

Date Prepared: February 1, 2015 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: 2939012

Submission Contact Information:

Primary Contact	Name	Mel Roche
	Title	President
	Telephone:	(314)-638-3800
	Fax:	(314)-638-3200
	Email Address:	mroche@bcgroupintl.com
Alternate Contact	Name	Lucio Simoni
	Title	Engineering Manager
	Telephone:	(314)-638-3800
	Fax:	(314)-638-3200
	Email Address:	lsimoni@bcgroupintl.com

Proposed Device

Device Proprietary Name: Classification Name Class Product Code

DA-2006-VL Defibrillator Analyzer Variable Load Defibrillator Tester Variable Load Class II/21CFR 870.5325 DRL

Predicate Devices

Fluke Impulse 7010 Defibrillator Selectable Loads (K083347)

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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 DA-2006-VL is used in conjunction with the DA-2006/DA-2006P Defibrillator Analyzer.

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

Comparison to Predicate Device

The DA-2006-VL Variable Load uses the same exact approach and DUT evaluation procedures as the predicate device.

Summary of Technical Characteristics

The DA-2006-VL Variable Load shares the same technical characteristics; design, materials, and composition as the predicate device.

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Table 2: Predicate Feature Comparison
	Device Feature orCharacteristic	Fluke Impulse 7010	BC BiomedicalDA-2006-VLSpecifications
General Specifications	Maximum voltage	5000 V	5000 V
	Maximum ContinuousPower	12 W, 10 defib pulses of360 J every 5 minutes	12 W, 10 defib pulses of 360J every 5 minutes
	Inductance	< 2 μH, @25 Ω< 3 μH, @50 Ω< 4 μH, @75 Ω and 100 Ω< 5 μH, @125 Ω< 6 μH, @150 Ω< 7 μH, @175 Ω< 8 μH, @200 Ω	< 10 μH
	Electrical Specifications	Load Settings	25, 50, 75, 100, 125, 150,175, 200 Ohms, ±1%
Accuracy (50 Ω)		± 1% of reading + 0.1 J	High Range± 2 % of reading for >100Joules± 2 Joules for ≤100 JoulesLow Range± 2 % of reading for >20Joules± 0.4 Joules for ≤20 Joules

Summary of Technological Characteristics in Comparison with the Predicate Device

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Table 2: Predicate Feature Comparison
	Device Feature orCharacteristic	Fluke Impulse 7010	BC BiomedicalDA-2006-VLSpecifications
	Accuracy (25 Ω, 75-200 Ω)	± 2% of reading + 0.1 J	High Range± 3 % of reading for >100Joules± 3 Joules for ≤100 JoulesLow Range± 3 % of reading for >20Joules± 0.6Joules for ≤20 Joules
Pysical	Dimensions	138.7 mm x 154 mm x 272 mm	248.9 mm x 205.7 mm x120.7 mm
	Weight	1.54 kg	2.27 kg
	OperatingTemperature	10 to 40 C	15 to 40 C
	Storage Temperature	-20 to +60 C	-20 to +65 C

there are 7 differences, .
there are 0 features where a comparison cannot be made due to lack of predicate ● specifications,
there are 3 features where the DA-2006-VL is identical to the predicate. .

Overall, the devices are very similar, with the 6 differences not having any effect on the indications for use or the device's safety. There are a few minor effects on the performance characteristics of the device; some of these are discrepancies in size, weight, and accuracy. The DA-2006-VL is heavier than the predicate device and is slightly less accurate.

None of the differences raise new questions of safety or effectiveness.

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Summary of Non-Clinical Testing/Statement of Equivalence

The DA-2006-VL Defibrillator Tester was tested to meet international standards for electrical safety. Since the DA-2006-VL is a non-powered, manually selectable resistive load, it is exempt from electromagnetic compatibility testing. Verification and Validation tests were performed to ensure that all of the product specifications were met.

The testing performed indicates that the DA-2006-VL 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
IEC61010-1	Safety requirements forelectrical equipment formeasurement, control, andlaboratory use Part 1:General Requirements	Pass
Device Validation	Validate device function ofeach hardware specification	Pass
Device Verification	Ensure device functionduring assembly.	Pass

Table 3: Device Test Summary

Conclusion

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

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).