(180 days)
Not Found
No
The summary describes a standard defibrillator/monitor with various physiological monitoring capabilities and data transmission, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for therapeutic uses such as manual and automated external defibrillation, noninvasive pacing, and synchronized cardioversion, all of which directly treat medical conditions.
Yes
Explanation: The device performs various diagnostic functions, including ECG monitoring, pulse oximetry, and End-Tidal CO2 monitoring, all of which are used to assess a patient's physiological state and aid in diagnosis.
No
The device description clearly outlines hardware components such as defibrillator/monitor, battery, and accessories, indicating it is not solely software.
Based on the provided text, the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The LIFEPAK 20 and 20e are used for direct patient monitoring and treatment (defibrillation, pacing, ECG, pulse oximetry, EtCO2). They do not analyze samples taken from the body.
- Intended Use: The intended use describes direct patient care and emergency response, not laboratory analysis of specimens.
Therefore, the LIFEPAK 20 and LIFEPAK 20e are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director. Thev are intended for use on a "crash cart" as well as for portable emergency response throughout a hospital.
Indications for Use (for both the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors):
Manual Defibrillation
Indications: Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 20 (and LIFEPAK 20e) defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is used to detect the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Product codes (comma separated list FDA assigned to the subject device)
LDD, MKJ, DRT, DRO, DQA, CCK
Device Description
The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors were designed especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. Features of the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion. The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are powered by AC power and a backup internal battery. The LIFEPAK 20 defibrillator/monitor utilizes a nickel-metal hydride internal battery while the LIFEPAK 20e defibrillator/monitor utilizes a lithium-ion internal battery. The LIFEPAK 20e defibrillator/monitor also has a battery status indicator on the device screen.
In addition to the features described above, the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors have a new CO2 monitoring feature, CPR metronome feature, wireless data transmission capability and a new optional accessory named the CodeManagement Module™.
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 AED mode...is not intended for use on pediatric patients less than 8 years old.
Intended User / Care Setting
The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director.
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)
No clinical studies or non-clinical (i.e. animal) studies were submitted as part of this 510(k) notification. Performance testing of the proposed devices consisted of bench testing.
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.
K012274, K033275, K063119, K073089, K082937, K103567
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
Image /page/0/Picture/1 description: The image shows the logo for Physio-Control. The logo is in white text on a black background. The text is stacked, with "PHYSIO" on top and "CONTROL" on the bottom.
Submitter:
Physio-Control, Inc. 11811 Willows Road Northeast P.O. Box 97006 Redmond, Washington 98073-9706
AUG 21 2013
Contact Person:
Michelle Ackermann Principal Regulatory Affairs Specialist Phone: 425-867-4744, Fax: (425) 867-4154
Date Summary Prepared:
February 21, 2013
Device Trade Name:
LIFEPAK®20 defibrillator/monitor LIFEPAK®20e defibrillator/monitor
Device Common Name:
External defibrillator/monitor
Device Classification:
| Classification Name | Class |
|---|---|
| Low Energy DC-Defibrillator (Including Paddles), (21CFR | |
| 870.5300, Product Code LDD) | II |
| Automatic External Defibrillators (Non-Wearable) (21CFR | |
| 870.5310, Product Code MKJ) | III |
| Cardiac Monitor (Including Cardiotachometer & Rate Alarm) | |
| (21CFR870.2300, Product Code DRT) | II |
| External Cardiac Transcutaneous (Non-Invasive) | |
| Pacemaker (21CFR870.5550, Product Code DRO) | II |
| Electrocardiograph | II |
| Hydraulic, Pneumatic, or Photoelectric Plethysmographs | II |
| Oximeter (21CFR870.2700, Product Code DQA) | II |
| Carbon-Dioxide Gas Analyzer Gaseous-Phase | |
| (21CFR868.1400 Product Code CCK) | II |
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Image /page/1/Picture/1 description: The image shows the logo for Physio-Control. The logo is in a black box with white text. The text is stacked on top of each other with "PHYSIO" on top and "CONTROL" on the bottom.
Predicate Devices:
The features and functions of the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are substantially equivalent to the previously cleared LIFEPAK 20 defibrillator/monitor, LIFEPAK 20e defibrillator/monitor and the LIFEPAK 15 monitor/defibrillator. 510(k) clearance numbers for the predicate devices are below:
| Predicate Device | 510(k) Number(s) |
|---|---|
| LIFEPAK® 20 defibrillator/monitor | K012274, K033275, |
| K063119 | |
| LIFEPAK® 20e defibrillator/monitor | K073089 |
| LIFEPAK® 15 monitor/defibrillator | K082937, K103567 |
Description:
The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors were designed especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. Features of the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion. The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are powered by AC power and a backup internal battery. The LIFEPAK 20 defibrillator/monitor utilizes a nickel-metal hydride internal battery while the LIFEPAK 20e defibrillator/monitor utilizes a lithium-ion internal battery. The LIFEPAK 20e defibrillator/monitor also has a battery status indicator on the device screen.
In addition to the features described above, the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors have a new CO2 monitoring feature, CPR metronome feature, wireless data transmission capability and a new optional accessory named the CodeManagement Module™.
2
Image /page/2/Picture/1 description: The image shows the logo for Physio-Control. The logo consists of the word "PHYSIO" stacked on top of the word "CONTROL". The text is white and set against a black background. The logo is simple and easy to read.
Intended Use:
The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director. Thev are intended for use on a "crash cart" as well as for portable emergency response throughout a hospital.
Indications for Use (for both the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors):
Manual Defibrillation
Indications: Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 20 (and LIFEPAK 20e) defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
3
Image /page/3/Picture/1 description: The image shows the logo for Physio-Control. The logo is in white text on a black background. The word "PHYSIO" is on the top line, and the word "CONTROL" is on the bottom line.
Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is used to detect the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
4
Image /page/4/Picture/1 description: The image shows the logo for Physio-Control. The logo is in a rectangular box with a black background. The words "PHYSIO" and "CONTROL" are stacked on top of each other in white, sans-serif font.
Technological characteristics of the proposed and predicate devices:
The main difference between the predicate LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors and the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors is the new CO2 monitoring indication and CPR metronome feature. Device characteristics such as defibrillation waveform and the ECG analysis system are unchanged from the predicate LIFEPAK 20 and LIFEPAK 20e devices.
The CO2 monitoring and CPR metronome features in the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor are similar to the CO2 monitoring and CPR metronome features in the predicate LIFEPAK 15 monitor/defibrillator.
Conclusion of Testing
The information in this 510(k) notification demonstrates that the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are substantially equivalent to the predicate LIFEPAK 20 defibrillator/monitor, LIFEPAK 20e defibrillator/monitor and the LIFEPAK 15 monitor/defibrillator with respect to safety, effectiveness, and performance.
No clinical studies or non-clinical (i.e. animal) studies were submitted as part of this 510(k) notification. Performance testing of the proposed devices consisted of bench testing.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2013
Physio-Control, Inc. c/o Ms. Michelle Ackermann Principal Regulatory Affairs Specialist 11811 Willows Road Northeast P.O. Box 97006 Redmond. WA 98073
Re: KI30454
Trade/Device Name: LIFEPAK 20/20e defibrillator/monitor Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: July 23, 2013 Received: July 24, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Owen P. Faris -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Physio-Control Inc. LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 510(k) Premarket Notification
SECTION D - STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): _ ... . . . . . . . . . . . .
Device Name: LIFEPAK® 20 defibrillator/monitor and LIFEPAK® 20e defibrillator/monitor
Indications For Use:
Manual Defibrillation
Indications: Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 20 (and LIFEPAK 20e) defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
र Prescription Use (Part 21 CFR 801 Subpart D) AND/OR AND/OR 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)
Page 1 of 2
Digitally signed by Owen P. Faris -S Date: 2013.08.21 14:58:43 -04'00'
D-1
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Image /page/8/Picture/1 description: The image shows the word "PHYSIO" stacked on top of the word "CONTROL". The words are in white font and are on a black background. The words are bolded and sans-serif.
Physio-Control Inc. LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 510(k) Premarket Notification
SECTION D - STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: LIFEPAK 20 defibrillator/monitor and LIFEPAK 8 20e defibrillator/monitor
Indications For Use:
Noninvasive Pacing
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.
End-Tidal CO2 monitoring:
Indications: EtCO2 monitoring is used to detect the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
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)
Page 2 of 2
Digitally signed by
Owen P. Faris -S
Date: 2013.08.21
14:59:01-04'00'
Image /page/8/Picture/21 description: The image contains the text "D-2" in a large, bold, sans-serif font. The "D" is followed by a hyphen and the number "2". The text is black against a white background, and the overall impression is simple and clear.