(27 days)
Not Found
No
The document describes a "patented software algorithm" for ECG analysis, which is a common feature in AEDs and does not inherently indicate the use of AI or ML. There are no mentions of AI, ML, or related concepts like training or test sets.
Yes
The device is intended for the treatment of cardiac arrest by delivering energy to the heart, which is a therapeutic intervention.
Yes.
The device's intended use is to analyze the patient's ECG rhythm to determine if a shockable rhythm is present, which is a diagnostic function.
No
The device description clearly states that these are physical, portable, battery-operated devices that deliver energy via disposable electrodes. While they utilize software algorithms, they are fundamentally hardware devices with integrated software.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The LIFEPAK devices described are designed to analyze the patient's ECG rhythm (electrical activity of the heart) and deliver an electrical shock to treat cardiac arrest. This is a direct intervention on the patient's body, not an examination of a specimen outside the body.
- Intended Use: The intended use is to treat patients in cardiac arrest by analyzing their ECG and delivering defibrillation, not to provide information about a physiological state through the examination of a specimen.
Therefore, these devices fall under the category of therapeutic medical devices, specifically defibrillators, rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The LIFEPAK 500, LIFEPAK CR Plus, and the LIFEPAK 12 and LIFEPAK 20 in automated external defibrillation mode are intended for use on patients in cardiac arrest.
Indications for AED Use [for LIFEPAK 12 and LIFEPAK 20 Defibrillator/Monitor/Pacemakers]: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 and LIFEPAK 20 defibrillator/monitors are not intended for use on pediatric patients less than 8 years old.
Indications for Use [for LIFEPAK 500 Automated External Defibrillator]: 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).
Indications for Use [for LIFEPAK CR Plus Automated External Defibrillator]: The LIFEPAK CR Plus defibrillator is indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus defibrillator may be used on children up to 8 years old of 25kg (55 lb).
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators are small, portable, battery operated devices intended for treatment of cardiac arrest. Both devices use a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 and the semi-automatic version of the LIFEPAK CR Plus will then inform the operator if it detects a shockable rhythm and the operator can then press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest. The LIFEPAK CR Plus is also available in a fully automatic version which does not require operator interaction to charge and discharge.
The LIFEPAK 12 and LIFEPAK 20 devices use the same shock advising software algorithm as the devices described above. Features available in addition to automated external defibrillation include manual external defibrillation, noninvasive pacing, ECG monitoring, pulse oximetry, and synchronized cardioversion. The LIFEPAK 12 also offers noninvasive blood pressure monitor, invasive blood pressure monitor, and end-tidal CO2 monitor features.
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
LIFEPAK 12 and LIFEPAK 20: not intended for use on pediatric patients less than 8 years old.
LIFEPAK 500 and LIFEPAK CR Plus: may be used on children up to 8 years old or 25kg (55 lb) with Infant/Child Reduced Energy Defibrillation Electrodes.
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)
Not Found
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.
K991910, K010918, K012274, K983393, K012428, K011144
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
SECTION E: 510(k) SUMMARY
Submitter's Name and Address:
Medtronic Physio-Control Corp. 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073
Contact Person:
Michelle Ackermann (425) 867-4744
Date Summary Prepared:
September 22nd, 2003
Devices:
Medtronic Physio-Control LIFEPAK® 12, 20, 500, and CR Plus Defibrillators
Classification:
Low Energy DC-Defibrillator: Class II Automatic External Defibrillator: Class III
Substantial Equivalence:
The features and functions of the LIFEPAK 12, LIFEPAK 20, LIFEPAK 500, and LIFEPAK CR Plus are substantially equivalent to the previously cleared version of each device listed in the table below.
Device | 510(k) Information |
---|---|
Medtronic Physio-Control LIFEPAK 12 | |
Defibrillator | K991910 (09/03/99) |
K010918 (08/23/01) | |
Medtronic Physio-Control LIFEPAK 20 | |
Defibrillator | K012274 (02/05/02) |
Medtronic Physio-Control LIFEPAK 500 | |
AED | K983393 (05/05/99) |
K012428 (09/28/01) | |
Medtronic Physio-Control LIFEPAK CR | |
Plus AED | K011144 (12/03/01) |
1
Description:
The LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators are small, portable, battery operated devices intended for treatment of cardiac arrest. Both devices use a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 and the semi-automatic version of the LIFEPAK CR Plus will then inform the operator if it detects a shockable rhythm and the operator can then press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest. The LIFEPAK CR Plus is also available in a fully automatic version which does not require operator interaction to charge and discharge.
The LIFEPAK 12 and LIFEPAK 20 devices use the same shock advising software algorithm as the devices described above. Features available in addition to automated external defibrillation include manual external defibrillation, noninvasive pacing, ECG monitoring, pulse oximetry, and synchronized cardioversion. The LIFEPAK 12 also offers noninvasive blood pressure monitor, invasive blood pressure monitor, and end-tidal CO2 monitor features.
Intended Use:
The LIFEPAK 500, LIFEPAK CR Plus, and the LIFEPAK 12 and LIFEPAK 20 in automated external defibrillation mode are intended for use on patients in cardiac arrest.
Technological characteristics of new and predicate devices:
The features and functions of the LIFEPAK 12, LIFEPAK 20, LIFEPAK 500, and LIFEPAK CR Plus are the same as those of the currently marketed versions of each device.
Summary of Design Controls:
This 510(k) includes a summary of design control activities and a declaration of conformity to design controls.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
NOV - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Physio-Control Corp. c/o Ms. Michelle Ackermann Regulatory Affairs Specialist 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706
Re: K033275
Trade Name: LIFEPAK® 12, 20, 500 and CR Plus Defibrillators Regulation Number: 21 CFR 870.1025 Regulation Name: Automatic External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: October 9, 2003 Received: October 10, 2003
Dear Ms. Ackermann:
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.
3
Page 2 - Ms. Michelle Ackermann
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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Dng Leiseher for
Brent D. Zuckerman, M.D.
ram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION D: STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): Not yet assigned
Device Name: LIFEPAK 12 and LIFEPAK 20 Defibrillator/Monitor/Pacemakers
Indications for AED Use:
The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 and LIFEPAK 20 defibrillator/monitors are not intended for use on pediatric patients less than 8 years old.
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 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).
Device Name: LIFEPAK CR Plus Automated External Defibrillator
Indications for Use:
The LIFEPAK CR Plus defibrillator is indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus defibrillator may be used on children up to 8 years old of 25kg (55 lb).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
fice of Device Evaluation (ODE)
(Optional Format 3-10-98)
Ana Luna
Division Sign-Off
5 iu(K) number K03275