(203 days)
Not Found
No
The device description mentions a "patented software algorithm" for ECG analysis, which is typical for traditional signal processing in AEDs and does not explicitly indicate the use of AI or ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended for the treatment of cardiac arrest by delivering energy via defibrillation electrodes, which actively treats a medical condition.
Yes
The device is described as using a "patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present," which indicates it performs a diagnostic function.
No
The device description explicitly states it is a "small, portable, battery operated device" and delivers energy via "disposable defibrillation electrodes," indicating it is a hardware device with embedded software.
Based on the provided information, the LIFEPAK 500 AED is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- LIFEPAK 500 AED Function: The LIFEPAK 500 AED analyzes the patient's electrocardiogram (ECG) rhythm directly from the patient's body via electrodes applied to the chest. It then delivers an electrical shock to the patient's heart if a shockable rhythm is detected. This is a direct intervention on the patient, not a test performed on a specimen outside the body.
The device description and intended use clearly indicate that it is a therapeutic device used to treat cardiac arrest by analyzing the patient's electrical activity and delivering a shock. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIFEPAK 500 AED intended for use on patients in cardiac arrest. It is intended for use in the hospital and in out-of-hospital environments.
The LIFEPAK 500 AED is intended for use by personnel who are authorized by a medical director or physician. At a minimum, the following skills and training:
- CPR training
- AED training equivalent to that recommended by the American Heart Association
- Training in the use of the LIFEPAK 500 AED
The LIFEPAK 500 AED is to be used only 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. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).
Product codes
MKJ
Device Description
The LIFEPAK 500 automated external defibrillator is a small, portable, battery operated device intended for treatment of cardiac arrest. The device uses a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 AED will inform the operator if it detects a shockable rhythm and the operator can press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest.
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
The LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).
Intended User / Care Setting
Personnel who are authorized by a medical director or physician. It is intended for use in the hospital and in out-of-hospital environments.
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)
K955854, K983393, K012428, K013425
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
Kosz057
FEB 1 7 2006
510(k) SUMMARY
Submitter's Name and Address:
Medtronic Emergency Response Systems 11811 Willows Road Northeast Redmond, WA 98052
Contact Person:
Sherri Pocock Regulatory Affairs Manager
Date Summary Prepared:
December 12, 2005
Device:
Medtronic biphasic LIFEPAK® 500 Automated External Defibrillator (AED)
Classification:
Low Energy DC-Defibrillator: Class II Automatic External Defibrillator: Class III
Substantial Equivalence:
The features and functions of the modified biphasic LIFEPAK 500 AED are I the readies and railer. to the previously cleared Medtronic LIFEPAK 500 AED, Substantially Squarants K955854 (11/4/96), K983393 (05/05/99), K012428 (09/28/01), 310(k) hambers 119690); and the Philips Medical Systems Heartstream Heartstart FR2+ AED, 510(k) number K013425 (01/14/2002).
Description:
The LIFEPAK 500 automated external defibrillator is a small, portable, battery operated device intended for treatment of cardiac arrest. The device uses a opented software algorithm to analyze the patient's electrocardiogram (ECG) to patented solve if a shockable rhythm is present. The LIFEPAK 500 AED will inform determine if it detects a shockable rhythm and the operator can press the shock the operator were energy. The energy is delivered via disposable defibrillation electrodes applied to the chest.
1
Intended Use:
The LIFEPAK 500 AED intended for use on patients in cardiac arrest. It is The En EFTIN 500 ALD spital and in out-of-hospital environments.
The LIFEPAK 500 AED is intended for use by personnel who are authorized by a The LIFET AN 500 AED to minimum, the following skills and training:
- . CPR training
- CI K training equivalent to that recommended by the American Heart . Association
- Training in the use of the LIFEPAK 500 AED �
Indications For Use:
The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The LIFEF AN 500 ALD is to be about exampling normally, and showing no signs of The patient must be unconsolous, no coughing, no movement) before the circulation (for example, no pulse, and of 5 rhythm. With Infant/Child Reduced device is used to analyze the pacially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).
Technological characteristics of new and predicate device:
Defibrillation technology and functionality are unchanged from the previously Declorination technology and Imerely and 500 software has been modified to allow the medical director or physician greater control over CPR settings.
The setup options, collectively known as cprMax technology, are intended to The setup options, occroor physicians to more easily implement resuscitation anow modious in their Emergency Medical Services systems or AED programs.
Summary of Design Controls:
This 510(k) includes a summary of design control activities and a declaration of conformity to design controls.
The information in this 510(k) notification demonstrates that the modified LIFEPAK 500 AED is substantially equivalent to the predicate devices.
K05 2057
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Medtronic Emergency Response Systems c/o Ms. Sherri Pocock Regulatory Affairs Manager 11811 Willows Road Northeast Redmond. WA 98052
Re: K052057
: 1892037
Trade Name: LIFEPAK 500 Automatic External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: January 9, 2006 Received: January 10, 2006
Dear Ms. Pocock:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the enerobars) to stg. 25, 1976, the Medical Device Amendments, or to commerce price to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices that have been resulted trequire approval of a premarket approval application (PMA). alla Cosmetic Hot (1101) that to nov sequent to the general controls provisions of the Act. The I ou may, merefore, maniel and include requirements for annual registration, listing of general controls provisions of as tice, 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 If your device is elabilitional controls. Existing major regulations affecting your device can may or subject to back as a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Sherri Pocock
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a babbains with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that I DA has made a decemination administered by other Federal agencies. You must as a light or any Federal statutes and regulations administered of other its registration and listing (21 let comply with an the Act s requirements, mercains, wantacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and If applicable, the electronic forth in the quanty systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections of Levice as described in your Section 510(k) This letter will anow you to begin manteing your antial equivalence of your device to a legally premarket notheadon: The PDF miding of basis.if the 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 ac not as a cases note the regulation entitled, contact the Office of Compulance at (210) 216 or art 807.97). You may obtain "Misoranung by televelee to promantee to promantee the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ochsanter v/swww.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blumimmofor
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the Medtronic logo. The logo consists of a stylized human figure inside of a circle on the left and the word "Medtronic" in bold, black letters on the right. The human figure appears to be in motion, with arms and legs outstretched.
SECTION D - STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: LIFEPAK 500 Automated External Defibrillator
Indications For Use:
The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing ano 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. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumma
Sign-Off
ion of Cardlovascular Devloes ා Number
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