(15 days)
Not Found
No
The description focuses on the device's function as a precision instrument for measuring and analyzing electrical outputs from defibrillators and pacemakers. It mentions a microprocessor and graphic display but no features or capabilities indicative of AI or ML.
No.
This device is designed to test other medical devices (defibrillators and transcutaneous pacemakers) to ensure they are performing within specifications, rather than directly treating a patient. It is a diagnostic/testing tool for medical equipment, not a therapeutic device.
No
This device is used to test the performance of other medical devices (defibrillators and pacemakers) rather than to diagnose conditions in a patient.
No
The device description explicitly states it is a "precision instrument" and a "microprocessor-based instrument" with physical components like a built-in load, ECG leads, ports, and a display. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to test the performance of defibrillators and transcutaneous pacemakers by measuring energy output. This is a quality control/maintenance function for medical devices, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a "precision instrument for testing defibrillators" and a "microprocessor-based instrument that is used in the testing of defibrillators." It measures electrical parameters and simulates a human body load. This aligns with a test and measurement device for medical equipment.
- No mention of biological samples: There is no indication that this device interacts with or analyzes any biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Intended User: The intended user is "trained service technicians," further supporting its role in equipment maintenance rather than patient diagnosis.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
DRL
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.
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
NOTE: The instrument is intended for use by 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
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: EN61326; Description: Electrical equpment for measurement, control, and laboratory use - EMC Requirements; Result: Pass
Test: EN61000-3-2; Description: Electromagnetic Compatibility (EMC) Part 3-2 Limits - Limits for Harmonic Current Emmistions; Result: Pass
Test: EN61000-3-3; Description: Electromagnetic Compatibility (EMC) – Part 3: Limits - Section 3: Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-Voltage Supply Systems; Result: Pass
Test: IEC61010-1; Description: Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1: General Requirements; Result: Pass
Test: Debugger Validation; Description: Evaluate device operation under conditions not available under normal use; Result: Pass
Test: Device Validation; Description: Validate device function of each hardware and software specification; Result: Pass
Test: Device Verification; Description: Ensure device function during assembly.; Result: Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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, 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: Pending |
Submission Contact Information:
| Primary Contact | Name
Title
Telephone:
Fax:
Email Address | Mel Roche
President
(314)-638-3800
(314)-638-3200
mroche@bcgroupintl.com |
|-------------------|------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Alternate Contact | Name
Title
Telephone:
Fax:
Email Address | Larry Mennemeyer
Engineering Manager
(314)-638-3800
(314)-638-3200
Imennemeyer@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) .
1
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.
2
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 | |
| measurement, control, | ||
| and laboratory use - EMC | ||
| Requirements | Pass | |
| EN61000-3-2 | Electromagnetic | |
| Compatibility (EMC) Part | ||
| 3-2 Limits - Limits for | ||
| Harmonic Current | ||
| Emmistions | 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 |
Table 2: Device Test Summary
3
| Test | Description | Result |
|---|---|---|
| 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 |
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.
4
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.
5
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
6
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