(45 days)
Not Found
No
The document describes a standard semi-automatic defibrillator with optional manual and ECG modes. There is no mention of AI or ML in the intended use, device description, or any of the other sections. The changes described relate to a new battery option.
Yes
The device is a defibrillator, which is used to terminate potentially fatal arrhythmias and is applied to patients in cardiopulmonary arrest. This directly applies a therapy (electrical shock) to correct a medical condition.
Yes
The device can perform ECG rhythm recognition and heart rate monitoring, which are diagnostic functions.
No
The device description clearly states it is a "semi-automatic defibrillator" with different modes of operation, including AED and manual modes, and mentions a battery. This indicates a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a defibrillator used for terminating arrhythmias and monitoring ECG. These are direct interventions and measurements on the patient's body, not tests performed on samples outside the body.
- Intended Use: The intended use describes applying defibrillation to patients in cardiopulmonary arrest and monitoring ECG. This involves direct interaction with the patient.
The device is a therapeutic and monitoring medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. The manual and ECG modes of the LIFEPAK 1000 defibrillator are intended for use by health care providers trained in ECG rhythm recognition.
Indications for Use:
Defibrillation
Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.
ECG Monitoring
ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring
Product codes (comma separated list FDA assigned to the subject device)
LDD, MKJ
Device Description
The LIFPAK 1000 defibrillator is a semi-automatic defibrillator with optional manual mode and ECG display. It is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. There are 3 modes of operation for the LIFEPAK 1000 defibrillator: AED mode (automated external defibrillation), manual mode (operator ECG interpretation, operator control of charge and shock functions), and ECG mode (ECG display allows for rhythm and heart rate monitoring). The currently marketed LIFEPAK 1000 defibrillator is powered by a non-rechargeable lithium-manganese battery.
The proposed LIFEPAK 1000 defibrillator has the same features and functions as the predicate LIFEPAK 1000 defibrillator with an additional battery option - a rechargeable lithium-ion battery.
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
Defibrillation: The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25kg (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.
ECG Monitoring: conscious and unconscious patients of all ages
Intended User / Care Setting
personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. The manual and ECG modes of the LIFEPAK 1000 defibrillator are intended for use by health care providers trained in ECG rhythm recognition.
Description of the training set, sample size, data source, and annotation protocol
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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.)
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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.
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.
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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).
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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.
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122600 Physio-Control Inc. LIFEPAK 1000 defibrillator 510(k) Premarket Notification
SECTION E -- 510(K) SUMMARY
OCT 11 2012
Submitter:
Physio-Control, Inc. 11811 Willows Road Northeast P.O. Box 97006 Redmond, Washington 98073-9706
Contact Person:
Michelle Ackermann Principal Regulatory Affairs Specialist Phone: 425-867-4744, Fax: (425) 867-4154
Date Summary Prepared:
August 24th, 2012
Device Trade Naíne:
LIFEPAK®1000 defibrillator
Device Common Name:
External defibrillator
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 |
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SECTION E - 510(K) SUMMARY
Predicate Devices:
The features and functions of the proposed LIFEPAK 1000 defibrillator are substantially equivalent to the previously cleared LIFEPAK 1000 defibrillator. The 510(k) number for the predicate LIFEPAK 1000 defibrillator is K042404 (cleared on 12/22/05).
Description:
The LIFPAK 1000 defibrillator is a semi-automatic defibrillator with optional manual mode and ECG display. It is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. There are 3 modes of operation for the LIFEPAK 1000 defibrillator: AED mode (automated external defibrillation), manual mode (operator ECG interpretation, operator control of charge and shock functions), and ECG mode (ECG display allows for rhythm and heart rate monitoring). The currently marketed LIFEPAK 1000 defibrillator is powered by a non-rechargeable lithium-manganese battery.
The proposed LIFEPAK 1000 defibrillator has the same features and functions as the predicate LIFEPAK 1000 defibrillator with an additional battery option - a rechargeable lithium-ion battery.
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SECTION E - 510(K) SUMMARY
Intended Use:
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. The manual and ECG modes of the LIFEPAK 1000 defibrillator are intended for use by health care providers trained in ECG rhythm recognition.
Indications for Use:
Defibrillation
Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.
The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25kg (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.
ECG Monitoring
ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring
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SECTION E - 510(K) SUMMARY
Technological characteristics of the proposed and predicate device:
The only difference between the predicate LIFEPAK 1000 defibrillator and the proposed LIFEPAK 1000 defibrillator is a new battery option. The defibrillation waveform, ECG analysis system, and monitoring and defibrillation features of the proposed LIFEPAK 1000 defibrillator are unchanged from the previously cleared LIFEPAK 1000 defibrillator.
Conclusion of Testing
The information in this 510(k) notification demonstrates that the LIFEPAK 1000 defibrillator is substantially equivalent to the predicate LIFEPAK 1000 device with respect to safety, effectiveness, and performance.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 0 2013
Ms. Michelle Ackermann Principal Regulatory Affairs Specialist Physio-Control, Inc. 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073-9706
Re: K122600
Trade/Device Name: LIFEPAK 1000 defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator (Non-Wearable) Regulatory Class: Class III Product Code: MKJ Dated: August 24, 2012 Received: August 27, 2012
Dear Ms. Ackermann:
This letter corrects our substantially equivalent letter of October 11, 2012.
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 (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 additional controls. Existing major regulations affecting your device can be
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Page 2 - Ms. Michelle Ackermann
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.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
M.g. Hilleben
Ja 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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SECTION D - STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): not yet assigned K ) ≥2600
Device Name: LIFEPAK® 1000 defibrillator
Indications For Use:
Defibrillation
Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. .
The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.
The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25kg (55lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.
ECG Monitoring
ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring
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 1 | (Division Sign-Off) | |
| Division of Cardiovascular Devices | ||
| 510(k) Number | K122600 | D-1 |