(28 days)
Not Found
No
The document describes a multi-functional medical device with standard monitoring and therapeutic capabilities. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The modifications described relate to data transmission methods.
Yes
The device explicitly states its intended use for treating various medical conditions, such as terminating arrhythmias, pacing symptomatic bradycardia, and checking oxygen saturation, all of which fall under therapeutic applications.
Yes
The device performs several diagnostic functions, including 12-Lead Electrocardiography for detecting acute myocardial infarction, Pulse Oximetry for checking oxygen saturation and identifying hypoxemia, Noninvasive Blood Pressure Monitoring for detecting hypertension or hypotension trends, End-Tidal CO2 monitoring for evaluating breathing efficacy, and Invasive Pressure Monitoring for measuring various physiological pressures.
No
The device description explicitly states it is a "complete acute response system" consisting of various hardware components like a defibrillator, pacemaker, ECG monitor, pulse oximeter, blood pressure monitor, CO2 monitor, and invasive pressure monitor. While it includes a new method of data transmission (software-related), the core device is a multi-functional hardware system.
Based on the provided information, the LIFEPAK 12 defibrillator/monitor/pacemaker is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use 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 or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- LIFEPAK 12 Functionality: The description of the LIFEPAK 12 clearly indicates it is a device that directly interacts with the patient's body to perform various physiological measurements and interventions (defibrillation, pacing, ECG, pulse oximetry, blood pressure, CO2 monitoring, invasive pressure monitoring). It does not analyze specimens in vitro.
- Intended Use: The intended uses described are all related to direct patient monitoring and treatment, not the analysis of samples outside the body.
Therefore, the LIFEPAK 12 falls under the category of a therapeutic and monitoring medical device used directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
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 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Munual Defibrillation is indicated for the termination of certain potentially fatal arthythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating attial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole.
12-Lead Electrocardiography is useful in the carly detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetry is used to check the saturation of oxygen in arterial blood. It is indicated for use in any patient who is at risk of developing hypoxemia.
Noninvasive Blood Pressure Monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibriliation recovery analysis.
End-Tidal CO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy 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.
Invasive Pressure Monitoring is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is a complete acute The Ett Life in the response system, which consists of a battery or auxiliary powered cardide response bystor automated), pacemaker, ECG monitor (3-lead, 5-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor.
The modified LIFEPAK® 12 defibrillator/monitor/pacemaker provides the user with a new method of transmitting data from the LIFEPAK 12 defibrillator; the user can transmit data using either a data transfer cable or wirelessly via Bluetooth® wireless technology.
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
In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Intended User / Care Setting
Intended users of the LIFEPAK® 12 defibrillator are Advanced Life Support michded users of the Eif iders in a variety of hospital and pre-hospital settings. The bepport pred in various areas of the hospital such as critical schuigs. The device is assess is, critical care, operating room, etc.) and general areas (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
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.
K033275, K010918, K002445, K990338, K991910, K973486
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:
March 25th, 2004
Device:
Medtronic Physio-Control LIFEPAK® 12 Defibrillator/Monitor/Pacemaker
Classification:
Low Energy DC-Defibrillator: Class II Automatic External Defibrillator: Class III
Substantial Equivalence:
The features and functions of the modified LIFEPAK® 12 defibrillator are substantially equivalent to the previously cleared LIFEPAK 12 defibrillator, 510(k) numbers K033275 (11/06/03), K010918 (03/26/01), K002445 (01/31/01), K990338 (09/01/99), K991910 (06/03/99), K973486 (01/09/98).
Description:
The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is a complete acute The Ett Life in the response system, which consists of a battery or auxiliary powered cardide response bystor automated), pacemaker, ECG monitor (3-lead, 5-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor.
The modified LIFEPAK® 12 defibrillator/monitor/pacemaker provides the user with a new method of transmitting data from the LIFEPAK 12
1
defibrillator; the user can transmit data using either a data transfer cable or wirelessly via Bluetooth® wireless technology.
Intended Use:
Intended users of the LIFEPAK® 12 defibrillator are Advanced Life Support michded users of the Eif iders in a variety of hospital and pre-hospital settings. The bepport pred in various areas of the hospital such as critical schuigs. The device is assess is, critical care, operating room, etc.) and general areas (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
Technological characteristics of new and predicate device:
The features and functions of the LIFEPAK® 12 The reatures and rest/pacemaker are the same as those of the currently marketed LIFEPAK®12 defibrillator/monitor/pacemaker.
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 I he mormation in uns 316(tr) neasis substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The words are arranged on a single line and are left-aligned.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings and tail feathers. The logo is rendered in black and white.
APR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Physio-Control Corp. c/o Ms. Michelle Ackermann Senior Regulatory Affairs Specialist 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073
Re: K040775
K040775
Trade Name: LIFEPAK® 12 Defibrillator/Monitor/Pacemaker Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MKJ Dated: March 25, 2004 Received: March 26, 2004
Dear Ms. Ackermann:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantially interstale referenced above and have determined the devices marketed in interstate for use stated in the encrosule) to regally mances a procession in the Medical Device Ameralments, or to commerce prof to May 28, 1976, the chaomic and be arrange with Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require the general controls provisions of the Act. The Y our may, therefore, market the devices, see as a comments for annual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the Fiel Inc. Includes seat.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controls. Existing in the 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 8 be found in the Code of Feactal Regaraing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that 1 17A 5 tosames or our device complies with other requirements of the Act
3
Page 2 - Ms. Michelle Ackermann
or any Federal statutes and regulations administered by other Federal agencies and list or any Federal statutes and regulations daminities or registration and listing (21 l
comply with all the Act's requirements, including, but not limited to reguirements as set comply with all the Act s requirements, me, good manufacturing practice requirements as setter CFR Parl 807); labeling (21 CFR Part 801); good and fapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electro forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (Declons of Controlled in your Section 510(k)
This letter will allow you to begin marketing your device as described in your since to 10c I his letter will anow you to ocgin maneting your artial equivalence of your device to a legally premarket notheation. The PDA miding of backanding of 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 If you desire specific advice for your ac not 100 %. Also, please note the regulation entitled, contact the Office of Compliance to (Set Part 807.97) you may obtain. "Misbranding by reference to premailser nowlities under the Act may be obtained from the Other general mionmation on your responsional 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,
uma R. Loclines
(J) Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040775
Device Name: LIFEPAK 12 Defibrillator/Monitor/Pacemaker
Indications For Use:
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 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Munual Defibrillation is indicated for the termination of certain potentially fatal arthythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating attial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole.
12-Lead Electrocardiography is useful in the carly detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetry is used to check the saturation of oxygen in arterial blood. It 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)
Duana R. Lochner
novascular Devices
510(k) Number_
Page 1 of 2
5
Indications for Use
510(k) Number (if known): K040775
Device Name: LIFEPAK 12 Defibrillator/Monitor/Pacemaker
Indications For Use:
Noninvasive Blood Pressure Monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibriliation recovery analysis.
End-Tidal CO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy 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.
Invasive Pressure Monitoring is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.
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)
Duna R. Lochner
sion DigirOn)
ision of Cardiovascular Devices
Page 2 of 2
*(k) Number K040775