(141 days)
No
The device description details a simple electrical circuit with resistors and a neon light for continuity testing, and there is no mention of AI, ML, or any complex data processing or learning algorithms.
No
The device is intended for testing the functionality of defibrillator systems' wires, not for treating a patient.
No
Explanation: A diagnostic device is used to identify the nature or cause of a disease or condition. The ZAP GUARD II is used to test the functional integrity of a medical device (defibrillator wires), not a patient's health condition. It's a testing tool for equipment, not a diagnostic tool for a patient.
No
The device description explicitly states it consists of an "electrical circuit incorporating resistors and a neon light," which are hardware components.
Based on the provided information, the ZAP GUARD II is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to test the continuity and integrity of the wires of Biphasic Defibrillator Systems. This is a test of the device itself (the defibrillator system), not a test performed on a biological sample (like blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health.
- Device Description: The device works by testing the electrical circuit of the defibrillator system. It does not interact with or analyze any biological material.
- Lack of Biological Sample Testing: There is no mention of the device being used with any biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ZAP GUARD II does not fit this description.
N/A
Intended Use / Indications for Use
The ZAP GUARD II is intended to be used for the testing of the continuity and the integrity of the wires of Biphasic Defibrillator Systems.
Product codes
DRL
Device Description
The ZAP GUARD II device consists of an electrical circuit incorporating resistors and a neon light within the pathway. Upon contact with the paddles of a biphasic defibrillator system which is operational, energy is delivered through the circuit. If the defibrillator system's wires are intact and energy delivery is continuous, then the neon lamp will illuminate.
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
Bench testing demonstrated that the ZAP GUARD II conforms to the original voltage and amperage design specifications. The ZAP GUARD II was also functionally tested using a biphasic defibrillator and performed as expected.
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
JUL 1 1 2003
K0305477
510(k) SUMMARY Guardian Angel Product's ZAP GUARD II
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Guardian Angel Products, Inc. 2771 Philmont Ave Huntingdon Valley, PA 19006
Phone: 215-938-7677 Facsimile: 215-947-2280
Contact Person: Ernest H. Pescatore June 2003 Date Prepared:
Name of Device and Name/Address of Sponsor/Applicant
ZAP GUARD II
Guardian Angel Products, Inc. 2771 Philmont Ave Huntingdon Valley, PA 19006
Common or Usual Name: Defibrillator Testing Probe
Classification Name: Tester, Defibrillator
Predicate Devices: ZAP GUARD (K896985)
Purpose of 510(k):
.
The purpose of this Special 510(k) is to modify the ZAP GUARD device used for testing monophasic defibrillator systems. The differences between the devices is that the resistor configuration of the new device was modified for use in testing biphasic defibrillator systems.
Intended Use:
The ZAP GUARD II is intended to be used for the testing of the continuity and the integrity of the wires of Biphasic Defibrillator Systems.
1
GUARDIAN ANGEL PRODUCT INC.'S ZAP GUARD II 510(K) SUMMARY PAGE 2
Technological Characteristics:
The ZAP GUARD II device consists of an electrical circuit incorporating resistors and a neon light within the pathway. Upon contact with the paddles of a biphasic defibrillator system which is operational, energy is delivered through the circuit. If the defibrillator system's wires are intact and energy delivery is continuous, then the neon lamp will illuminate.
Performance Data
Bench testing demonstrated that the ZAP GUARD II conforms to the original voltage and amperage design specifications. The ZAP GUARD II was also functionally tested using a biphasic defibrillator and performed as expected.
Substantial Equivalence
The Zap Guard II has the same intended use, principles of operation, and technological characteristics as the original ZAP GUARD device. The minor differences in the ZAP GUARD II do not raise any new questions of safety or effectiveness. Performance data demonstrates that the ZAP GUARD II is as safe and effective as the original ZAP GUARD. Thus, the ZAP GUARD II is substantially equivalent to its predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, head, and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
JUL 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Guardian Angel Products, Inc. c/o Mr. Ernest Pescatore 2771 Philmont Avenue Huntingdon Valley, PA 19006
Re: K030547
Trade/Device Name: Zap Guard II Defibrillator Test Probe Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator tester Regulatory Class: Class II (two) Product Code: DRL Dated: June 11, 2003 Received: June 11, 2003
Dear Mr. Pescatore:
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 or any Federal statutes and regulations administered by other Federal agencies. You must
3
Page 2 - Mr. Ernest Pescatore
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K030547
Device Name: ZAP GUARD II
Indications for Use:
The ZAP GUARD II is intended to be used for testing the continuity and integrity of the wires of Biphasic Defibrillator Systems.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K030547 |
| Prescription Use | X | OR | Over-The-Counter |
|---|---|---|---|
| Use | |||
| (Per 21 C.F.R. 801.109) |
(Optional Format 1-2-96)