(88 days)
Not Found
No
The description focuses on the physical components and intended uses of the electrodes, with no mention of AI or ML capabilities. The "electrode ID chip" is described as storing "electrode specific information," not performing complex analysis or learning.
Yes
The device is described as being used for defibrillation, synchronized cardioversion, and external pacing, all of which are therapeutic interventions.
Yes
The device performs "ECG monitoring," which is a diagnostic function because it involves measuring electrical activity of the heart to assess its condition.
No
The device description clearly states it consists of physical electrode pads with hydrogel, an ID chip, and is intended for use with hardware devices (Cardiac Rhythm Module and AECD). This indicates a hardware component is central to the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the Multifunctional Electrodes are used for external procedures performed directly on the patient's body: defibrillation, synchronized cardioversion, ECG monitoring, and external pacing. These are all in vivo (within the living body) procedures, not in vitro (in glass/outside the body) tests.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples.
Therefore, the Multifunctional Electrodes are a medical device used for external physiological interventions and monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Multifunctional Electrodes, Models 9640 and 9650 are single use and intended to be used for defibrillation, synchronized cardioversion, ECG monitoring, and external pacing.
Product codes (comma separated list FDA assigned to the subject device)
MLN, MKJ
Device Description
The Multifunctional Electrodes consist of a pair of single-use, hydrogel polymeric selfadhesive electrode pads of equal dimension intended to be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing. The Multifunctional Electrodes are for use with the Powerheart Cardiac Rhythm Module and the Powerheart Automatic External Cardiac Defibrillator (AECD). The electrodes are packaged in a pouch to prevent the gel from drying out.
The Model 9640 contains an additional small right leg drive (RLD) electrode on the sternum pad. The RLD electrode is used to eliminate the voltage potential between the patient and defibrillator's ground reference.
Inside each electrode connector is an electrode ID chip. The ID chip allows the defibrillator to read the electrode specific information contained in the ID chip.
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)
Performance testing was conducted to verify that the Multifunctional Electrodes meet the applicable requirements for single use hydrogel electrodes in accordance with industry standards ANSI/AAMI DF-2, ANSI AAMI DF-39, and. ANSV/AAMI EC-12. In addition, biocompatibility assessments were conducted on the components that come into contact with the patient's skin. The Multifunctional Electrodes, Models 9640 and 9650 were found to perform as intended.
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
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
K02210
OCT 0 4 2002
510K SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
16.1: ADMINSTRATIVE INFORMATION
| Name and Address
Submitted by: | Cardiac Science Incorporated
16931 Millikan Ave
Irvine, CA 92606 |
|-----------------------------------|------------------------------------------------------------------------|
| Contact Person: | John Carline |
| Telephone No.: | 952-939-4181, x2978 |
| Facsimile No.: | 952-939-4191 |
| Email: | jcarline@cardiacscience.com |
Date Prepared: July 1, 2002
DEVICE INFORMATION 16.2:
| Common or Usual Name: | Disposable Polymer (Hydrogel) External
Monitoring, Pacing, Cardioversion and
Defibrillation Electrode |
|-----------------------|-------------------------------------------------------------------------------------------------------------|
| Trade Name: | Powerheart® Multifunctional Electrodes
Models 9640 and 9650 |
16.3: DEVICE CLASSIFICATION
| Classification Name: | Multifunctional Electrocardiograph Electrode |
|---|---|
| 21 CFR 870.2360 | |
| MLN | |
| Device Class: | III |
16.4: DEVICE DESCRIPTION
.
The Multifunctional Electrodes consist of a pair of single-use, hydrogel polymeric selfadhesive electrode pads of equal dimension intended to be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing. The Multifunctional Electrodes are for use with the Powerheart® Cardiac Rhythm Module and the Powerheart® Automatic External Cardiac Defibrillator (AECD). The electrodes are packaged in a pouch to prevent the gel from drying out.
1
The Model 9640 contains an additional small right leg drive (RLD) electrode on the sternum pad. The RLD electrode is used to eliminate the voltage potential between the patient and defibrillator's ground reference.
Inside each electrode connector is an electrode ID chip. The ID chip allows the defibrillator to read the electrode specific information contained in the ID chip.
16.5: INDICATION FOR USE
The Multifunctional Electrodes, Models 9640 and 9650 are single use and intended to be used for defibrillation, synchronized cardioversion, ECG monitoring, and external pacing.
16.6: IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Contour Medical | |||
| Technology | |||
| (Ludlow Co.) | Disposable Hydrogel | ||
| Defibrillation Electrode | |||
| Model MFE-116 | K960329 | July 1, 2002 |
16.7: SUBSTANTIAL EQUIVALENCE
The Multifunctional Electrodes, Models 9640 and 9650 covered by this submission are substantially equivalent to other legally marketed electrodes for semi-automatic low power DC defibrillators. Specifically, the Multifunctional Electrodes are substantially equivalent to Contour Medical Technology (Ludlow Company) Disposable Hydrogel Defibrillation Electrode, Model MFE 116 cleared under premarket 510(k) notification, K960329 on July 2, 1996.
16.8: PERFORMANCE DATA
Performance testing was conducted to verify that the Multifunctional Electrodes meet the applicable requirements for single use hydrogel electrodes in accordance with industry standards ANSI/AAMI DF-2, ANSI AAMI DF-39, and. ANSV/AAMI EC-12. In addition, biocompatibility assessments were conducted on the components that come into contact with the patient's skin. The Multifunctional Electrodes, Models 9640 and 9650 were found to perform as intended.
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16.9: CONCLUSIONS
Cardiac Science has demonstrated through its evaluation and testing of the Multifunctional electrodes, Models 9640 and 9650 that the device is equivalent to the predicate device with respect to intended use, technological characteristics, materials, function and safety and effectiveness.
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a symbol that appears to be three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 4 2002
Cardiac Science, Inc. c/o Mr. John Carline Manager, Regulatory Affairs 16931 Millikan Avenue Irvine, CA 92606
Re: K022210
Trade Name: Multifunctional Electrodes, Models 9640 and 9650 Regulation Number: 21 CFR 870.1025 Regulation Name: Automated External Defibrillator Electrode Regulatory Class: Class III (three) Product Code: MKJ Dated: July 1, 2002 Received: July 8, 2002
Dear Mr. Carline:
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.
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Page 2 - Mr. John Carline
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); 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
V
Bram D. Zuckerman, M.D.
uckerman. 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:
| Device Name: | Multifunctional Electrodes |
|---|---|
| Models 9640 and 9650 |
- The Multifunctional Electrodes are single use and intended to Indications for Use: be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
XQ6712
Division of Cardiovascular & Respiratory Devices
510(k) Number K022210
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use