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.

Manual Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial 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 early 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-defibrillation 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.

Device Description

The LIFEPAK 12 defibrillator/monitor is a complete acute cardiac response system, which consists of a battery or auxiliary powered defibrillator (manual or automated), external pacemaker, ECG monitor (3-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor. Patient data can be transmitted from the LIFEPAK 12 defibrillator to a fax machine, computer, or to a receiving station. This modification changes the pulse oximetry module and sensors used in the LIFEPAK 12 defibrillator/monitor from Nellcor to Masimo.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria for the pulse oximetry feature. The document is a 510(k) premarket notification for a modification to the LIFEPAK 12 Defibrillator/Monitor, specifically changing the pulse oximetry module and sensors from Nellcor to Masimo.

The submission claims substantial equivalence to previously cleared devices and mentions design control activities, but it does not include granular data on the performance of the new Masimo pulse oximetry module against predefined acceptance criteria from a study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based only on the provided information, noting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria	Reported Device Performance
Pulse Oximetry Accuracy	Not explicitly stated in the provided text.	Not explicitly stated in the provided text. The document indicates the modification involves changing the pulse oximetry module and sensors from Nellcor to Masimo, and states "The modified LIFEPAK 12 uses the same sensors and an updated version of the Masimo SET pulse oximetry module used in the currently marketed LIFEPAK 20 defibrillator/monitor." This suggests performance parity with the existing Masimo SET technology in the LIFEPAK 20, but specific accuracy metrics are not provided.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified, as no study details (like ground truth establishment) are provided for the pulse oximetry performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified, as no study details are provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A MRMC study is not mentioned. This device is a defibrillator/monitor with a pulse oximetry feature, not an AI diagnostic tool that human readers would use in conjunction with.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

A standalone performance study for the pulse oximetry accuracy is implied by the need for regulatory clearance for a new module, but the details (methodology, results, and whether it's "algorithm only") are not provided in this specific document. The document focuses on substantial equivalence via design control summaries and comparison to predicate devices, rather than a detailed performance study report.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not specified, as no study details for pulse oximetry accuracy are provided. For pulse oximetry, the typical ground truth would involve co-oximetry measurements from arterial blood gas analysis.

8. The sample size for the training set:

Not applicable, as this is hardware/firmware modification of a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable for the same reason as above.

Summary of what the document does provide regarding "proof":

The document primarily states that "This 510(k) includes a summary of design control activities and a declaration of conformity to design controls." and that "The information in this 510(k) notification demonstrates that the modified LIFEPAK 12 defibrillator/monitor is substantially equivalent to the predicate device."

The basis for the pulse oximetry change is that "The modified LIFEPAK 12 uses the same sensors and an updated version of the Masimo SET pulse oximetry module used in the currently marketed LIFEPAK 20 defibrillator/monitor." This implies that the performance of the new Masimo module is already established and cleared through the predicate LIFEPAK 20, and that the "proof" for the LIFEPAK 12 modification relies on this existing equivalence and design control adherence, rather than new, detailed performance study data presented within this 510(k) summary.

Summary

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K041459

'JUL - 1 2004

Medtronic Emergency Response Systems LIFEPAK® 12 Defibrillator/Monitor -Pulse Oximetry 510(k) Premarket Notification

SECTION E: 510(k) SUMMARY

Submitter's Name and Address:

Medtronic Emergency Response Systems (formerly known as Medtronic Physio-Control) 11811 Willows Road Northeast Redmond, WA 98052

Contact Person:

Michelle Ackermann (425) 867-4744

Date Summary Prepared:

June 1st, 2004

Device:

Medtronic LIFEPAK® 12 Defibrillator/Monitor

Classification:

Low Energy DC-Defibrillator: Class II Automatic External Defibrillator: Class III Oximeter, Class II

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 K040775 (04/23/04), 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:

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This modification changes the pulse oximetry module and sensors used in the LIFEPAK 12 defibrillator/monitor from Nellcor to Masimo.

Intended Use:

Intended users of the LIFEPAK 12 defibrillator/monitor are Advanced Life Support and Basic Life Support providers in a variety of hospital and prehospital settings. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (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 defibrillator/monitor are the same as those of the currently marketed LIFEPAK 12 defibrillator/monitor. The modified LIFEPAK 12 uses the same sensors and an updated version of the Masimo SET pulse oximetry module used in the currently marketed LIFEPAK 20 defibrillator/monitor.

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 12 defibrillator/monitor is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 2004

Medtronic Emergency Response Systems c/o Ms. Michelle Ackermann Senior Regulatory Affairs Specialist 11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706

Re: K041459

LIFEPAK 12 Defibrillator/Monitor with pulse oximetry feature Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: June 1, 2004 Received: June 2, 2004

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.

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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); 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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Neil K.P. Ogde
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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Indications for Use

510(k) Number (if known): _ K041459

Device Name: ___LIFEPAK 12 Defibrillator/Monitor

Indications For Use:

Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole.

12-Lead Electrocardiography is useful in the early 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. ﺍﻟ ﮧ

(Division Sign-Off)
Division of Cardiovascular Devices

10(k) Number	K041459
--------------	---------

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)

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Indications for Use

510(k) Number (if known): _ K041459

Device Name: LIFEPAK 12 Defibrillator/Monitor

Indications For Use:

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.

(Division Sign-Off)	Milre Ryden for BDZ
Division of Cardiovascular Devices
510(k) Number	K041459
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)

Regulation Number and Section

§ 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.