(203 days)
The LIFEPAK 500 AED is intended for use on patients in cardiac arrest. It is intended for use in hospital and in out-of-hospital environments.
The LIFEPAK 500 AED is intended for use by personnel who are authorized by a medical director and have, 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).
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.
The provided 510(k) summary for the Medtronic biphasic LIFEPAK 500 Automated External Defibrillator (AED) focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the traditional sense of a performance study with numerical endpoints.
The submission states: "The features and functions of the modified biphasic LIFEPAK 500 AED are the readies and railer [likely a typo, suggesting 'the same as and similar'] 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)." It also mentions, "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."
Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices, and the "study" is a demonstration of substantial equivalence through design control activities and comparison to those predicates. The document does not provide quantitative performance metrics, sample sizes for a test set, ground truth experts, or details of a standalone or MRMC study.
However, based on the information provided, we can infer some aspects and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (as stated in 510(k)) |
|---|---|
| Safe and effective cardiac arrest treatment | Intended for treatment of cardiac arrest |
| Accurate ECG rhythm analysis for shockable rhythms | Uses software algorithm to analyze ECG and determine if a shockable rhythm is present |
| Delivers appropriate energy for defibrillation | Informs operator of shockable rhythm and allows energy delivery via disposable defibrillation electrodes |
| Equivalent defibrillation technology and functionality as predicate devices | "Defibrillation technology and functionality are unchanged from the previously [cleared] Medtronic LIFEPAK 500" |
| Compliance with design controls | Includes a summary of design control activities and a declaration of conformity to design controls |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The submission relies on substantial equivalence to predicate devices, which would have undergone their own testing. There is no new, independent clinical or performance test set described for this modified device.
- Data Provenance: Not specified for new testing. The reference devices K955854, K983393, K012428, and K013425 would have generated their own clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no independent test set or ground truth establishment process is described for this specific 510(k). The regulatory review of the predicate devices would have involved expert review.
4. Adjudication method for the test set
- Not applicable as no independent test set or adjudication process is described for this specific 510(k).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study is mentioned. This device is an AED that uses an algorithm to determine shockable rhythms, not an AI-assisted diagnostic tool for human readers in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device inherently operates as a "standalone" algorithm in its primary function of ECG analysis. The human operator presses the shock button after the device informs them a shockable rhythm is detected. However, the document does not describe a formal "standalone performance study" with specific metrics (e.g., sensitivity, specificity for rhythm analysis) for this specific modified device. It relies on the performance of the predicate devices. The algorithm's performance for rhythm analysis would have been established for the original LIFEPAK 500.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified for this 510(k). For AEDs, ground truth for rhythm analysis typically involves expert review of ECGs, often verified against clinical outcomes where appropriate.
8. The sample size for the training set
- Not specified. The software algorithm is "patented" and "modified to allow the medical director or physician greater control over CPR settings," suggesting the core rhythm detection algorithm was developed and validated previously with an unspecified training set.
9. How the ground truth for the training set was established
- Not specified. This would have been established during the development of the original LIFEPAK 500 algorithm. Typically, this involves a large dataset of ECGs with rhythm classifications established by expert cardiologists or electrophysiologists.
Summary of the "Study" provided in the 510(k):
The "study" for this 510(k) is a demonstration of substantial equivalence rather than a traditional performance study with new raw data. The core of the argument is that:
- The device's intended use and indications for use are the same as predicate devices.
- The fundamental defibrillation technology and functionality remain unchanged from previously cleared versions of the LIFEPAK 500.
- The software modification is related to CPR settings, not the core rhythm analysis or energy delivery, implying no impact on primary safety or effectiveness.
- The submission includes "a summary of design control activities and a declaration of conformity to design controls," which is the regulatory mechanism used to demonstrate that the modified device's changes do not introduce new safety or effectiveness concerns compared to the predicates.
Therefore, the acceptance criteria are met by virtue of the modified device being substantially equivalent to legally marketed predicate devices which have already met their respective acceptance criteria for safety and effectiveness.
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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.
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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
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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.
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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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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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§ 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.