(201 days)
Defibrillation is indicated for the termination of 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.
The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.
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 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old.
Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
The LIFEPAK 20 device is a defibrillator/monitor primarily intended for the hospital and clinic setting. It is easy to use, portable, easy to maintain, and fits comfortably on a gurney during transport. It has a built in AC power supply and backup NiMH battery. It uses a biphasic waveform with an energy range from 2 - 360 Joules.
Features and options include: external noninvasive pacemaker; pulse oximeter; 3-, 6-, and 7-lead ECG; defibrillation paddles; ability to use all disposable electrodes or paddles currently used with the LIFEPAK 12 defibrillator/monitor/pacemaker; internal paddles capability; 50 mm printer; automated external defibrillator mode; built in AC power with NiMH battery backup; digital remote synchronization to bedside monitor; and an infrared and serial ports for data download.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Physio-Control LIFEPAK 20 Defibrillator/Monitor:
Overall Assessment:
The provided document (510(k) Premarket Notification) for the LIFEPAK 20 primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (LIFEPAK 9P and LIFEPAK 12). This means that instead of conducting new, extensive clinical studies to prove effectiveness and safety from scratch, the manufacturer argues that the new device is as safe and effective as existing, legally marketed devices.
Therefore, the document does not describe specific acceptance criteria and detailed study results in the manner one might expect for a de novo device submission where new performance metrics are established and then proven through dedicated trials. Instead, it relies on compliance with recognized standards and the inherent equivalence to predicate devices that have already met regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance:
Given the nature of this 510(k) submission, a direct table of "acceptance criteria" against "reported device performance" (in the sense of specific clinical endpoints with numerical targets) is not explicitly provided. The acceptance criteria are implicitly tied to:
- Compliance with recognized standards: AAMI, IEC, and ISO standards for defibrillators, monitors, and pulse oximeters.
- Substantial equivalence to the predicate devices in terms of safety, effectiveness, and performance.
The document states that these criteria are met, but does not provide specific performance data points in a table format.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit/Stated) |
|---|---|
| Compliance with AAMI, IEC, and ISO defibrillator standards | "The 510(k) includes documentation related to the compliance of the LIFEPAK 20 device with AAMI, IEC, and ISO defibrillator, monitor, and pulse oximeter standards." (SECTION E - Summary of Performance Information) |
| Compliance with AAMI, IEC, and ISO monitor standards | "The 510(k) includes documentation related to the compliance of the LIFEPAK 20 device with AAMI, IEC, and ISO defibrillator, monitor, and pulse oximeter standards." |
| Compliance with AAMI, IEC, and ISO pulse oximeter standards | "The 510(k) includes documentation related to the compliance of the LIFEPAK 20 device with AAMI, IEC, and ISO defibrillator, monitor, and pulse oximeter standards." |
| Substantial equivalence to predicate devices (LIFEPAK 9P, 12) | "The features and functions of the LIFEPAK 20 defibrillator/monitor are substantially equivalent to those of the Medtronic Physio-Control LIFEPAK 9P defibrillator/monitor... and the LIFEPAK 12 defibrillator/monitor...""The information in this 510(k) demonstrates that the LIFEPAK 20 defibrillator/monitor is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance." (SECTION E - Substantial Equivalence and Summary of Performance Information) |
| Biphasic waveform effectiveness (adults) | "The biphasic waveform has only been clinically studied on adults" (Implying effectiveness for adults based on previous studies, not necessarily a new study for this specific device). |
| AED mode for patients in cardiopulmonary arrest (>= 8 years old) | "The Automated External Defibrillation mode is for use on patients in cardiopulmonary arrest. It is not intended for use on patients less than 8 years old." (Indication for Use) |
| Noninvasive pacing for symptomatic bradycardia/asystole | "Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole." (Indication for Use) |
| Pulse Oximetry for hypoxemia risk | "Pulse Oximetry is used to check the saturation of oxygen in arterial blood (SpQs). It is indicated for use in any patient who is at risk of developing hypoxemia." (Indication for Use) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific "test set" or a new clinical study with a defined sample size for the LIFEPAK 20 itself. Instead, it relies on the established performance of its predicate devices and compliance with international standards.
- Sample Size for Test Set: Not applicable or not specified for a new, dedicated study. The evidence is based on the general acceptance of the predicate devices and standard compliance.
- Data Provenance: Not applicable in the sense of a new clinical trial. The "data" stems from the validation/clearance of the predicate devices and the technical verification processes (likely in-house testing) to ensure compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. Since no new clinical "test set" (in the sense of patient data requiring expert ground truth) is described for the LIFEPAK 20's performance validation, there's no mention of experts or their qualifications for establishing ground truth for a novel dataset.
4. Adjudication Method for the Test Set:
Not applicable, as no new clinical "test set" requiring expert adjudication is described in this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study is not mentioned or described in the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The LIFEPAK 20 is a medical device that includes various functions (defibrillation, monitoring, pacing, oximetry). While it has an "automated external defibrillator mode," the document does not describe a separate "standalone algorithm" performance study in the context of AI or advanced diagnostic algorithms. Its "automated" function would have been validated as part of its overall design and compliance with AED standards.
7. The Type of Ground Truth Used:
For the LIFEPAK 20 itself, the "ground truth" for its performance is implicitly derived from:
- Compliance with established performance standards (AAMI, IEC, ISO): These standards define performance requirements that are met through engineering validation and testing.
- Performance of predicate devices: The predicate devices (LIFEPAK 9P, LIFEPAK 12) have already undergone their own regulatory clearance, which would have involved demonstrating effectiveness and safety, potentially using clinical data, expert consensus, or other forms of ground truth suitable for those devices at their time of submission.
There's no mention of pathology, explicit expert consensus on a novel dataset for the LIFEPAK 20, or outcomes data specific to the LIFEPAK 20's primary 510(k) submission.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its design and functionality are based on engineering principles and established medical science, not on a machine learning model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device.
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FEB 0 5 2002
KO122 74
Medtronic Physio-Control Corp. LIFEPAK 20 Defibrillator/Monitor 510(k) Premarket Notification
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:
Sherri L. Pocock (425) 867-4332
Date Summary Prepared:
June 12, 2001
Device:
Medtronic Physio-Control LIFEPAK® 20 Defibrillator/Monitor/ Pacemaker
Classification:
Low-Energy DC - Defibrillators: Class II (21 CFR 870.5300)
Automatic External Defibrillators have been considered Class III devices by FDA.
Cardiac Monitors (including Cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300)
External Transcutaneous Cardiac Pacemakers (Noninvasive): Class II (870.5550)
Oximeters: Class II (21 CFR 870.2700)
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Medtronic Physio-Control Corp. LIFEPAK 20 Defibrillator/Monitor 510(k) Premarket Notification
Description:
The LIFEPAK 20 device is a defibrillator/monitor primarily intended for the hospital and clinic setting. It is easy to use, portable, easy to maintain, and fits comfortably on a gurney during transport. It has a built in AC power supply and backup NiMH battery. It uses a biphasic waveform with an energy range from 2 - 360 Joules.
Features and options include: external noninvasive pacemaker; pulse oximeter; 3-, 6-, and 7-lead ECG; defibrillation paddles; ability to use all disposable electrodes or paddles currently used with the LIFEPAK 12 defibrillator/monitor/pacemaker; internal paddles capability; 50 mm printer; automated external defibrillator mode; built in AC power with NiMH battery backup; digital remote synchronization to bedside monitor; and an infrared and serial ports for data download.
Substantial Equivalence:
The features and functions of the LIFEPAK 20 defibrillator/monitor are substantially equivalent to those of the Medtronic Physio-Control LIFEPAK 9P defibrillator/monitor: 510(k) no. K902288, cleared 5/21/90, and the LIFEPAK 12 defibrillator/monitor: 510(k) nos. K973486, cleared 1/9/98; and K991910, cleared 9/3/99.
Indications for Use:
Defibrillation is a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. A direct current defibrillator applies a brief, intense pulse of electricity to the heart muscle. 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.
The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.
The Automated External Defibrillation mode is for use on patients in cardiopulmonary arrest. It is not intended for use on patients less than 8 vears old.
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Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole.
3-lead (3 wire), 6-lead (4 wire), and 7-lead (5 wire) ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.
Pulse Oximetry is used to check the saturation of oxygen in arterial blood (SpQs). It is indicated for use in any patient who is at risk of developing hypoxemia.
Summary of Performance Information:
The 510(k) includes documentation related to the compliance of the LIFEPAK 20 device with AAMI, IEC, and ISO defibrillator, monitor, and pulse oximeter standards.
The information in this 510(k) demonstrates that the LIFEPAK 20 defibrillator/monitor is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle are three stylized lines that resemble an abstract symbol, possibly representing an eagle or a similar bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2002
Ms. Sherri L. Pocock Regulatory Advisor Medtronic Physio-Control Corporation 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706
Re: K012274
Trade Name: LifePak® 20 Defibrillator/Monitor Regulation Number: 21 CFR 870.1025, 870.5300, 870.5550 Regulation Name: Arrhythmia Detector, Defibrillator, External Transcutaneous Cardiac Pacemaker Regulatory Class: Class III (three) Product Code: MKJ, LDD, DRO Dated: November 6, 2001 Received: November 7, 2001
Dear Ms. Pocock:
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.
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Page 2 - Ms. Sherri L. Pocock
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 or any I vith 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 OFF fat 607); adoming (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 promated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ouvision 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,
Dork Tith
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ver/ 3 - 4/24/96
Applicant: Medtronic Physio-Control Corp.
510(k) Number (if known): 510(k) Number Not yet assigned
Device Name: LIFEPAK 20 Defibrillator
Indications For Use:
Defibrillation is indicated for the termination of 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.
The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.
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 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old.
Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012274
Prescription Use
(Per 21 CFR 801.109)
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.