(119 days)
Not Found
No
The device description focuses on passive components (resistors, surge protector) for energy attenuation and does not mention any computational or algorithmic processes indicative of AI/ML. The clinical testing mentioned is for algorithm accuracy on pediatric rhythms, but this refers to the defibrillator's existing rhythm analysis algorithm, not a new AI/ML component in the electrodes themselves.
Yes.
The device functions to deliver reduced energy for defibrillation in infants and children, which is a therapeutic intervention for cardiopulmonary arrest.
Yes
The device analyzes the patient's ECG rhythm to determine if defibrillation is needed, which is a diagnostic function.
No
The device description explicitly states it consists of physical components including electrode pads, wires, a connector, and an attenuator comprised of resistors and a surge protector mounted on a PCB in a plastic case. This is a hardware device, not software only.
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 described device is a set of defibrillation electrodes with an attenuator. Its function is to deliver an electrical shock to the heart to treat cardiopulmonary arrest. This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it's for use with defibrillators on patients in cardiopulmonary arrest. This is a treatment scenario, not a diagnostic one.
Therefore, the device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (55lbs). Do not delay therapy to determine child's exact age or weight.
These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK® 500 AEDs configured with a pink cable connector.
The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm.
The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
Product codes
74 MKJ, MLN
Device Description
The attenuating electrode is designed to allow minimally trained responders to safely and effectively defibrillate infants and children under 8 using the LIFEPAK® CR Plus or biphasic LIFEPAK 500 AEDs manufactured after a certain date. (Compatible biphasic LIFEPAK 500 AEDs can be identified by the pink connector on the AED.)
The Infant / Child Reduced Energy Electrode assembly consists of currently marketed Pediatric QUIK-COMBO electrode pads, wires, a connector, and an attenuator. The attenuator is comprised of multiple resistors and a surge protector mounted on a PCB and installed in a flat plastic case.
The attenuator reduces the standard "adult" AED energy at a ratio of about 4 to 1. When used with the Infant / Child Reduced Energy electrodes, an AED set to deliver 200J first shock, 300J second shock, and 360J third shock for adult patients, will instead deliver about 50, 75, and 86J.
Packaging and labeling have been designed to make it (1) readily apparent if Infant/Child electrodes are available, (2) intuitive that these electrodes are for infants and children only, (3) easy for the user to determine when to select the pediatric electrode, and (4) easy for the user to quickly deliver defibrillation therapy regardless of patient's age.
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
infant or child up to 8 years old
Intended User / Care Setting
personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
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 510(k) includes:
Clinical testing of algorithm accuracy on pediatric rhythms:
Non-Clinical testing of energy dosing;
Bench testing to verify electrodes meet their specifications; and
Labeling Usability Validation.
The information in this 510(k) demonstrates that the Infant / Child Reduced Energy Electrodes are substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.
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
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
| Trade Name: Infant/Child Reduced Energy Electrodes Regulation Number: 21 CFR 870.1025 Regulation Name: Automated External Defibrillator Electrode Regulatory Class: Class III (three) Product Code: 74 MKJ, MLN Dated: November 25, 2002 Received: November 26, 2002
Dear Ms. Pocock:
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 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
4
Page 2 – Ms. Sherri Pocock
forth in the quality systems (OS) 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,
K. Karla Telen
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Medtronic Physio Control
SECTION D - STATEMENT OF INDICATIONS FOR USE
Ver/ 3 - 4/24/96
Applicant: Medtronic Physio-Control Corp.
510(k) Number (if known): 510(k) Number Not yet assigned
Device Name: Infant / Child Reduced Energy Electrodes
Indications For Use:
Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (55lbs). Do not delay therapy to determine child's exact age or weight.
These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK® 500 AEDs configured with a pink cable connector.
The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm.
The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
D-1
Division Sign-Off
Division of Cardiovascular
and Respiratory Devices
510(k) Number K022732