Defibrillator Analyzer Variable Load

K153210 · Bc Group International, Inc. · DRL · Dec 21, 2015 · Cardiovascular

Device Facts

• Record ID: K153210
• Device Name: Defibrillator Analyzer Variable Load
• Applicant: Bc Group International, Inc.
• Product Code: DRL · Cardiovascular
• Decision Date: Dec 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5325
• Device Class: Class 2

Indications for Use

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 Story

DA-2006-VL is a non-powered, selectable resistive load bank used for testing defibrillator performance; operates in conjunction with DA-2006/DA-2006P analyzer. Device provides specific resistive loads (25, 50, 75, 100, 125, 150, 175, 200 Ohms) via series/parallel resistor combinations to verify defibrillator output compliance with IEC 60601-2-4 and AAMI DF80 standards. Used by trained service technicians in clinical or service environments. Output allows technicians to confirm defibrillator energy delivery accuracy; ensures device safety and effectiveness during maintenance.

Clinical Evidence

Bench testing only. Verification and validation testing performed to ensure hardware specifications met. Compliance with IEC 61010-1 (safety requirements for electrical equipment) confirmed. No clinical data.

Technological Characteristics

Non-powered, manually selectable resistive load bank. Materials/construction identical to predicate. Dimensions: 248.9 x 205.7 x 120.7 mm. Weight: 2.27 kg. Operating temperature: 15-40 C. Complies with IEC 60601-2-4 and AAMI DF80. Exempt from EMC testing.

Indications for Use

Indicated for use by trained service technicians to test defibrillator performance against specifications by providing selectable resistive loads (25-200 Ohms).

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

• Fluke Impulse 7010 Defibrillator Selectable Loads (K083347)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <span></span> Research Use (Part 21 CFR 361. Subpart B) | <span></span> 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/<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: 2939012 |

#### Submission Contact Information:

| Primary Contact | Name | Mel Roche |
|-------------------|----------------|-------------------------|
| | Title | President |
| | Telephone: | (314)-638-3800 |
| | Fax: | (314)-638-3200 |
| | Email Address: | [e-mail] |
| Alternate Contact | Name | Lucio Simoni |
| | Title | Engineering Manager |
| | Telephone: | (314)-638-3800 |
| | Fax: | (314)-638-3200 |
| | Email Address: | [e-mail] |

#### 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

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.

## Description of Device

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.

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 or<br>Characteristic | Fluke Impulse 7010 | BC Biomedical<br>DA-2006-VL<br>Specifications |
| General Specifications | Maximum voltage | 5000 V | 5000 V |
| | Maximum Continuous<br>Power | 12 W, 10 defib pulses of<br>360 J every 5 minutes | 12 W, 10 defib pulses of 360<br>J every 5 minutes |
| | Inductance | < 2 μH, @25 Ω<br>< 3 μH, @50 Ω<br>< 4 μH, @75 Ω and 100 Ω<br>< 5 μH, @125 Ω<br>< 6 μH, @150 Ω<br>< 7 μH, @175 Ω<br>< 8 μH, @200 Ω | < 10 μH |
| | Electrical Specifications | Load Settings | 25, 50, 75, 100, 125, 150,<br>175, 200 Ohms, ±1% |
| Accuracy (50 Ω) | | ± 1% of reading + 0.1 J | High Range<br>± 2 % of reading for >100<br>Joules<br>± 2 Joules for ≤100 Joules<br>Low Range<br>± 2 % of reading for >20<br>Joules<br>± 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 or<br>Characteristic | Fluke Impulse 7010 | BC Biomedical<br>DA-2006-VL<br>Specifications |
| | Accuracy (25 Ω, 75-<br>200 Ω) | ± 2% of reading + 0.1 J | High Range<br>± 3 % of reading for >100<br>Joules<br>± 3 Joules for ≤100 Joules<br>Low Range<br>± 3 % of reading for >20<br>Joules<br>± 0.6Joules for ≤20 Joules |
| Pysical | Dimensions | 138.7 mm x 154 mm x 272 mm | 248.9 mm x 205.7 mm x<br>120.7 mm |
| | Weight | 1.54 kg | 2.27 kg |
| | Operating<br>Temperature | 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 for<br>electrical equipment for<br>measurement, control, and<br>laboratory use Part 1:<br>General Requirements | Pass |
| Device Validation | Validate device function of<br>each hardware specification | Pass |
| Device Verification | Ensure device function<br>during 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.