(46 days)
Not Found
No
The device description indicates it is a non-powered, selectable resistive load bank for testing defibrillators, with no mention of AI or ML capabilities.
No
This device is a testing instrument for defibrillators, not a device used for therapy on a patient.
No
The device is described as a precision instrument for testing and ensuring defibrillators comply with performance specifications and international standards, rather than directly diagnosing a patient's medical condition. It is used by trained service technicians for equipment calibration and verification.
No
The device description explicitly states it is a "non-powered, selectable resistive load bank" and a "precision instrument," indicating it is a hardware device used for testing defibrillators.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to test the performance of defibrillators, which are medical devices used on patients. It does not analyze biological samples (like blood, urine, or tissue) to provide information about a person's health or condition.
- Device Description: It's described as a "precision instrument for testing defibrillators" and a "selectable resistive load bank." This aligns with testing equipment, not diagnostic equipment that interacts with biological samples.
- No mention of biological samples or analysis: The description focuses on electrical loads and testing defibrillator output. There is no mention of analyzing any type of biological material.
Therefore, the DA-2006-VL is a medical device testing equipment, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained service technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Test: IEC61010-1
Description: Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements
Result: Pass
Test: Device Validation
Description: Validate device function of each hardware specification
Result: Pass
Test: Device Verification
Description: Ensure device function during assembly.
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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)
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)
| 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, Inc
3081 Elm Point Industrial Drive
St. Charles, MO 63301 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/Operator | BC Group International, Inc
3081 Elm Point Industrial Drive
St. Charles, MO 63301 USA |
| Manufacturing Sites | BC Group International, Inc
3081 Elm Point Industrial Drive
St. Charles, MO 63301 USA
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: | 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
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 | |||
| Characteristic | Fluke Impulse 7010 | BC Biomedical | |
| DA-2006-VL | |||
| Specifications | |||
| General Specifications | 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 | 100 | ||
| Joules | |||
| ± 2 Joules for ≤100 Joules | |||
| Low Range | |||
| ± 2 % of reading for >20 | |||
| Joules | |||
| ± 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 | |||
| Characteristic | Fluke Impulse 7010 | BC Biomedical | |
| DA-2006-VL | |||
| Specifications | |||
| Accuracy (25 Ω, 75- | |||
| 200 Ω) | ± 2% of reading + 0.1 J | High Range | |
| ± 3 % of reading for >100 | |||
| Joules | |||
| ± 3 Joules for ≤100 Joules | |||
| Low Range | |||
| ± 3 % of reading for >20 | |||
| Joules | |||
| ± 0.6Joules for ≤20 Joules | |||
| Pysical | 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 |
- 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 | |
| electrical equipment for | ||
| measurement, control, and | ||
| laboratory use Part 1: | ||
| General Requirements | Pass | |
| Device Validation | Validate device function of | |
| each hardware specification | Pass | |
| Device Verification | Ensure device function | |
| 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.