(71 days)
Manual Defibrillation:
Indications: Defibrillation is a recognized means of terminating certain 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.
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.
The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. The LIFEPAK 20 defibrillator/monitor is equipped with AC power and a backup internal battery. Features of the LIFEPAK 20 defibrillator/monitor include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion.
The LIFEPAK 20 defibrillator/monitor has been modified with new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC.
The provided document describes a 510(k) premarket notification for a modification to the Medtronic LIFEPAK® 20 Defibrillator/Monitor. While it outlines the device's features and intended use, it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria for its modified features.
The modification described is related to "new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC."
The document states: "The new cprMAX setup options only affect operation in automated external defibrillation mode. Features of the modified LIFEPAK 20 defibrillator/monitor such as the ECG analysis system, defibrillation waveform, pacing, and pulse oximetry are the same as those of the predicate device. Defibrillation technology and functionality of the LIFEPAK 20 defibrillator/monitor has not changed from the previously cleared device."
This implies that for the new setup options, the company is asserting substantial equivalence based on consistency with guidelines rather than presenting a new study with acceptance criteria. For the core functionalities (ECG analysis, defibrillation waveform, pacing, pulse oximetry), they rely on the previous clearances (K033275, K012274) of the predicate device, as those features have not changed.
Therefore, I cannot extract the requested information (1-9) as it pertains to a new study proving performance against acceptance criteria for the modified device, because such information is not present in the provided text. The document focuses on regulatory compliance through substantial equivalence, not on new performance study data for the specific modification.
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Ka631/9
DEC 2 2 2006
SECTION E - 510(k) SUMMARY
Submitter's Name and Address:
Medtronic Emergency Response Systems 11811 Willows Road Northeast Redmond, WA 98052
Contact Person:
Michelle Ackermann Senior Regulatory Affairs Specialist
Date Summary Prepared:
December 20, 2006
Device:
Medtronic LIFEPAK® 20 Defibrillator/Monitor
Classification:
| Classification Name | Class |
|---|---|
| Low Energy DC-Defibrillator | II |
| Automatic External Defibrillator | III |
| Cardiac Monitor (Including Cardiotachometer & Rate alarm) | II |
| Cardiac External Transcutaneous (Non-invasive) | II |
| Pacemaker | |
| Oximeter | II |
{1}------------------------------------------------
Substantial Equivalence:
The features and functions of the modified LIFEPAK 20 defibrillator/monitor are substantially equivalent to the previously cleared LIFEPAK 20 defibrillator/monitor (K033275, K012274).
Description:
The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. The LIFEPAK 20 defibrillator/monitor is equipped with AC power and a backup internal battery. Features of the LIFEPAK 20 defibrillator/monitor include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion.
The LIFEPAK 20 defibrillator/monitor has been modified with new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC.
Intended Use:
In automated external defibrillation mode, the LIFEPAK 20 defibrillator/monitor is intended for use on patients in cardiopulmonary arrest by personnel who are authorized by a physician/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 20 defibrillator/monitor in . automated external defibrillation mode
Indications for Use:
Manual Defibrillation:
Indications: Defibrillation is a recognized means of terminating certain 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.
{2}------------------------------------------------
The biphasic defibrillation waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients.
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 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 Oximetrv
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.
Technological characteristics of new and predicate device:
The new cprMAX setup options only affect operation in automated external defibrillation mode. Features of the modified LIFEPAK 20 defibrillator/monitor such as the ECG analysis system, defibrillation waveform, pacing, and pulse oximetry are the same as those of the predicate device.
Defibrillation technology and functionality of the LIFEPAK 20 defibrillator/monitor has not changed from the previously cleared device.
{3}------------------------------------------------
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 20 defibrillator/monitor is substantially equivalent to the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2006
Medtronic Emergency Response Systems c/o Michelle Ackermann Senior Regulatory Affairs Specialist 11811 Willows Road Northeast Redmond, WA 98052
Re: K063119
Trade/Device Name: Lifepak 20 Defibrillator/Monitor Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LDD, DRT, DRO, DQA Dated: December 1, 2006 Received: December 4, 2006
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.
{5}------------------------------------------------
Page 2 -- Ms. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmer 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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Image /page/6/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, sans-serif font on the right. The graphic appears to be a stylized representation of a person inside of a circle.
SECTION D - STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): not yet assigned
Device Name: LIFEPAK 20 Defibrillator/Monitor
Indications For Use:
Manual Defibrillation:
Indications: Defibrillation is a recognized means of terminating certain 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 defibrillation waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients.
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 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
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 1 of 2
- Division of Cardiovascular Devices
D-1
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Image /page/7/Picture/0 description: The image shows the Medtronic logo. The logo consists of a stylized human figure inside a circle on the left and the word "Medtronic" in bold, sans-serif font on the right. The human figure appears to be in motion, with lines indicating different positions or movements.
SECTION D - STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): not yet assigned
Device Name: LIFEPAK 20 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.
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)
43119 R.L. Summor
Page 2 of 2
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
§ 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.