(202 days)
Not Found
No
The device description explicitly states it is a "passive accessory device" consisting of a "resistive voltage divider circuit" that only attenuates the energy amplitude. It also states that "arrhythmia detection algorithms are not affected by device use," indicating the core decision-making logic of the AED remains separate and is not modified or enhanced by this accessory. There is no mention of any computational or learning components.
Yes
The device is intended to treat patients in cardiopulmonary arrest by attenuating energy from a defibrillator, which is a therapeutic intervention.
No
The device is described as an "Energy Reducer" that attenuates the energy from a defibrillator. Its purpose is to deliver appropriate therapy, not to diagnose a condition.
No
The device description explicitly states it is a "passive accessory device" consisting of a "resistive voltage divider circuit encapsulated in a protective plastic housing." This describes a hardware component, not software.
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 Pediatric Energy Reducer is a passive accessory device that modifies the electrical energy delivered by a defibrillator. It does not analyze or interact with biological samples from the patient.
- Intended Use: The intended use is to treat patients in cardiopulmonary arrest by adjusting the energy delivered during defibrillation, a direct medical intervention on the patient's body.
The device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Pediatric Energy Reducer product is intended to be used to treat patients in cardiopulmonary arrest. It should only be used on patients who are unconscious, without a pulse and not breathing spontaneously. It is intended for use in either inhospital or out-of-hospital arrests. The Pediatric Energy Reducer is to be used only in conjunction with Automatic External Defibrillator (AED) and disposable electrode products marketed by Welch Allyn, or as formerly marketed by Medical Research Laboratories (MRL). The AED 10™ was formerly marketed as the MRL JumpStart and AED 20™ was formerly marketed as the MRL LifeQuest AEDefibrillator.
The Pediatric Energy Reducer product is intended to be used to treat infants and children up to approximately 8 years of age or 25 kg (55 lbs) weight; therapy should not be delayed to determine the child's exact age or weight.
It is intended to be used with normal (non-attenuating) adult electrodes on patients who are sufficiently large for the electrodes to be applied (in the anterior / posterior position), or with normal (non-attenuating) pediatric electrodes on smaller patients.
Product codes (comma separated list FDA assigned to the subject device)
74MKJ, MKJ
Device Description
The reusable Pediatric Energy Reducer products are small, lightweight, passive accessory devices for use with Welch Allyn automatic external defibrillators (AED). The Pediatric Energy Reducer product is inserted between the AED and suitable size non-attenuating defibrillation electrodes. The Pediatric Energy Reducer product attenuates the energy from the defibrillator by a factor of four, making the energy delivered to the electrodes suitable for use on pediatric patients. The Pediatric Energy Reducer product only affects the amplitude of the delivered waveform; the wave shape and arrhythmia detection algorithms are not affected by device use. The device consists of a resistive voltage divider circuit encapsulated in a protective plastic housing. Suitable connectors are provided to engage the Pediatric Energy Reducer to the AED and the electrodes to the Pediatric Energy Reducer.
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
infants and children up to approximately 8 years of age
Intended User / Care Setting
in-hospital or out-of-hospital arrests
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)
Comparison: The Pediatric Energy Reducer product used in conjunction with non-attenuating defibrillation electrodes provides functionality equal to that of the predicate product. The two products use the same technology to provide the attenuation function. The only difference between the subject device and the predicate is that, where the predicate device incorporates the resistive attenuation circuit as part of the disposable electrode assembly, Welch Allyn provides the attenuator as a separate accessory. This facilitates the use of less costly nonattenuating electrodes for all patients, eliminating the potential to confuse attenuating electrodes with non-attenuating electrodes as well as the need to assure sufficient stock of the two styles of electrodes.
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
SEP 1 4 2004
0404/79
Attachment XVI Premarket Notification [510(k)] Summary As Required By 21 CFR 807.92
| Submitted By: | Welch Allyn, Inc.
4341 State Street Road
P.O. Box 220
Skaneateles Falls, New York 13153-0220
Phone: (315) 685-3694
Fax: (315) 685-2532
Contact: Christopher A. Klaczyk, Sr. Regulatory Engineer |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Pediatric Energy Reducer for AED 10TM
Pediatric Energy Reducer for AED 20TM |
| Proprietary Name: | Same as Trade Name |
| Common Name: | Defibrillator, Automatic, External |
| Product Code: | 74MKJ |
| Classification: | All products are Class III per 21 CFR 870.5310,
Defibrillator, Automatic, External |
| Predicate Device: | Medtronic Physio-Control Infant/Child Reduced Energy
Electrodes (K022732)
Class III
Common Names: Defibrillator, Automatic, External (MKJ) and
Electrode, Electrocardiograph, Multi-Function (MLN) |
| Description: | The reusable Pediatric Energy Reducer products are small,
lightweight, passive accessory devices for use with Welch Allyn
automatic external defibrillators (AED). The Pediatric Energy
Reducer product is inserted between the AED and suitable size
non-attenuating defibrillation electrodes. The Pediatric Energy
Reducer product attenuates the energy from the defibrillator by
a factor of four, making the energy delivered to the electrodes
suitable for use on pediatric patients. The Pediatric Energy
Reducer product only affects the amplitude of the delivered
waveform; the wave shape and arrhythmia detection algorithms
are not affected by device use. The device consists of a
resistive voltage divider circuit encapsulated in a protective
plastic housing. Suitable connectors are provided to engage
the Pediatric Energy Reducer to the AED and the electrodes to
the Pediatric Energy Reducer. |
1
The Pediatric Energy Reducer product is intended to be used Intended Use: to treat patients in cardiopulmonary arrest. It should only be used on patients who are unconscious, without a pulse and not breathing spontaneously. It is intended for use in either inhospital or out-of-hospital arrests. The Pediatric Energy Reducer is to be used only in conjunction with Automatic External Defibrillator (AED) and disposable electrode products marketed by Welch Allyn, or as formerly marketed by Medical Research Laboratories (MRL). The AED 10™ was formerly marketed as the MRL JumpStart and AED 20™ was formerly marketed as the MRL LifeQuest AEDefibrillator.
The Pediatric Energy Reducer product is intended to be used to treat infants and children up to approximately 8 years of age or 25 kg (55 lbs) weight; therapy should not be delayed to determine the child's exact age or weight.
It is intended to be used with normal (non-attenuating) adult electrodes on patients who are sufficiently large for the electrodes to be applied (in the anterior / posterior position), or with normal (non-attenuating) pediatric electrodes on smaller patients.
Comparison: The Pediatric Energy Reducer product used in conjunction with non-attenuating defibrillation electrodes provides functionality equal to that of the predicate product. The two products use the same technology to provide the attenuation function. The only difference between the subject device and the predicate is that, where the predicate device incorporates the resistive attenuation circuit as part of the disposable electrode assembly, Welch Allyn provides the attenuator as a separate accessory. This facilitates the use of less costly nonattenuating electrodes for all patients, eliminating the potential to confuse attenuating electrodes with non-attenuating electrodes as well as the need to assure sufficient stock of the two styles of electrodes.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes above its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 2004
Welch Allyn, Inc. c/o Mr. Christopher Klaczyk. Senior Regulatory Engineer 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220
K040479 Re:
Ro40477
Trade name: Pediatric Energy Reducer, Models AED-10 and AED-20 Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: July 22, 2004 Received: July 23, 2004
Dear Mr. Klaczyk:
We have reviewed your Section 510(k) premarket notification of intent to market the devices we have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars annual date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the exactions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a premarket approval one of the Ast and Cosment Act (Act) that do not require approvis controls provisions of the Act. The You may, therefore, market the devices, saloject to the ments for annual registration, listing of the general controls provisions of the fielding, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controlls) or class III (PMA), it If your device is classifica (sec above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major 1990 - 1 a 1 litt may be subject to such additional controllor Life 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addi be found in the Ood of Peachar Engerning your device in the Federal Register.
3
Page 2 - Mr. Christopher Klaczyk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buobeine complies with other requirements of the Act
that FDA has made a determination that your device complies with other matt that FDA has made a decidination that your correst by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21)
comply with all the Act's requirements, including, but not limited to: registration and comply with an the Act s requirements, mercess anufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and If applicable, the electronic as a construction forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decisions vour device as described in your Section 510(k) This letter will anow you to begin maneting your as revealence of your device to a legally premarket nothlication. The FDA midning of battained of the revice 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 If you desire specific advice for your as 110 % 4648. Also, please note the regulation entitled, contact the Office of Compuners at (301) 25 - 100 - 100 - 100 may obtain " MISofallung by reference to promantee nowler the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990s C28 AA other general Information on your response in its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Bhimmer
R. D. Zuchlewski, M.D.
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
Page 1 of 1
510(k) Number (if known): K040479
Pediatric Energy Reducer Device Name:
Indications For Use:
The Pediatric Energy Reducer product is intended to be used to treat patients in The Pediative Energy Reducer production in the interior who are unconscious,
cardiopulmonary arrest. It should only be used on patients who in either in cardlopulifionaly arrest. "It should only be audy. It is intended for use in either inwithout a pulse and not breathing opential in Energy Reducer is to be used only nospital or out-of-nospital arrests: "The Poulune =1009)
in conjunction with Automatic External Defibrillator (AED) and disposable electrode in conjunction with Automatio External Donamal (artherly marketed by Medical Research products marketed by Welch Allyn, or as formerly marketed as the MRL JumpStart
Laboratories (MRL). The AED 10™ was formerly hif Orea AED of AFDefiniliater Laboratores (MRL): The AED To - the MDL LifeQuest AEDefibrillator.
The Pediatric Energy Reducer product is intended to be used to treat infrants and The Pediative Energy Neducer product is interrass of age or 25 lbs) weight; therapy should children up to approxermine the child's exact age or weight.
It is intended to be used with normal (non-attenuating) adult electrodes on patients It is intended to be used will normal (normal (normal shorther (in the anterior / posterior who are sumclently large for the clocal out to be appear on smaller patients.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhummer
on Sign-Oli)
on of Cardiovascular Devices
510(k) Number K040179
Prescription Use _ × (Part 21 CFR 801 Subpart D) or
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(Optional Format 3-10-98)