(41 days)
Not Found
No
The description details a device that uses physical resistors and switching to simulate different electrical loads for testing defibrillators. There is no mention of AI, ML, or any computational analysis of data that would suggest the use of these technologies.
No
This device is an accessory for testing defibrillators; it simulates loads but does not directly treat a patient.
No
The device is an accessory used to test the performance of a defibrillator by simulating different loads, not to diagnose a medical condition in a patient.
No
The device description explicitly states it is an "optional accessory" that uses "four 50 Ohm resistors" which are "switched in combinations" to simulate impedance, indicating it is a hardware device.
Based on the provided information, the Impulse 7010 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to test the performance of a defibrillator by simulating different electrical loads. This is a quality control/testing function for a medical device, not a diagnostic test performed on a biological sample.
- Device Description: The device description clearly states it simulates electrical impedance and works in conjunction with a defibrillator analyzer. It does not interact with biological samples or perform any analysis on them.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the Impulse 7010 is a medical device accessory used for testing and calibration of other medical devices (defibrillators), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Impulse 7010 is used to determine that a defibrillator is performing within its operating specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms, The Impulse 7010 is used in conjunction with the Impulse 7000DP Defibrillator Analyzer.
Product codes
DRL
Device Description
The Impulse 7010 Defibrillator Selectable Loads is an optional accessory to the Impulse 7000DP to simulate 25 to 200 Ohm thoracic impedance. Four 50 Ohm resistors are switched in combinations to make series or parallel circuits of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. Defibrillator output energy is measured by the Impulse 7000DP Defibrillator Tester.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
SYBRON DENTAL SPECIAL
DEC 2 4 2008
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: November 2008
Device Name:
- Trade Name Impulse 7010 Defibrillator Selectable Loads .
- Common Name Accessory to Defibrillator Tester .
- Classification Name Defibrillator Tester, per 21 CFR § 870.5325 .
Devices for Which Substantial Equivalence is Claimed:
- . Datrend Systems Inc., Phase 3Variable Load Module (VI.M)
Device Description:
The Impulse 7010 Defibrillator Selectable Loads is an optional accessory to the Impulse 7000DP to simulate 25 to 200 Ohm thoracic impedance. Four 50 Ohm resistors are switched in combinations to make series or parallel circuits of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. Defibrillator output energy is measured by the Impulse 7000DP Defibrillator Tester.
Indication for Use:
The Impulse 7010 is used to determine that a defibrillator is performing with in its operating specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The Impulse 7010 is used in conjunction with the Impulse 7000DP Defibrillator Analyzer.
Substantial Equivalence:
The Impulse 7010 is substantially cquivalent to other legally marketed devices in the United States. The Impulse 7010 functions in a manner similar to and is intended for the same use as the Phase 3 Variable Load Module (VLM) marketed by Datrend Systems Inc.
800 537 7824 754 316 7400 1717 Wast Lattins Avenue, Drange, LA 97867
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fluke Biomedical c/o Sybron Dental Specialties, Inc. Ms. Colleen Boswell 1717 West Collins Ave. Orange, California 92867
DEC 2 4 2008
Re: K083347
Trade/Device Name: Impulse 7010 Defibrillator Selectable Loads Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator Tester Regulatory Class: Class II Product Code: DRL Dated: November 13, 2008 Received: November 13 2008
Dear Ms. Boswell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
2
Page 2 - Ms. Colleen Boswell
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); 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 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number:
Device Name: Impulse 7010 Defibrillator Selectable Loads
Indications for Use:
The Impulse 7010 is used to determine that a defibrillator is performing within its operating specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms, The Impulse 7010 is used in conjunction with the Impulse 7000DP Defibrillator Analyzer.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
urrence of CDRH, Office of Device Evaluation (ODE)
elmoe
(Division Sian-Off) Division of Cardiovascular Devices K083347 510(k) Number
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