The LIFEPAK®12 NIBP monitor non-invasively measures blood pressure of the adult and pediatric patients by professionally trained health care providers. It is not designed for continuous, unsupervised monitoring.

EtCO2

The use of the LIFEPAK®12 EtCo2 monitor is indicated whenever professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.

Device Description

The LIFEPAK®12 defibrillator / monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system.
The users will be Advanced Life Support and Basic Life Support providers in a variety of hospital and pre-hospital settings. Emergency Medical Services users will include Paramedics and Emergency Medical Technicians trained and authorized to respond to medical emergencies. This device will be used in the pre-hospital setting and in the hospital, in critical areas (emergency departments, critical care, operating rooms, etc.) and on general duty floors (e.g. medical/surgical). It will also be used for patient transport (air and ground ambulance, in hospital transport, etc.)

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study data for the NIBP and CO2 Options for the Physio-Control LIFEPAK®12 Defibrillator / Monitor System:

Based on the provided 510(k) summary, specific, quantitative acceptance criteria and the detailed study that proves the device meets those criteria are not explicitly described in the provided text. The document focuses primarily on establishing substantial equivalence to predicate devices and adherence to industry standards, rather than presenting a standalone performance study with detailed acceptance criteria and results.

However, we can infer some information from the text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria are not provided. The document states that the device is subject to "extensive safety and performance testing" and that "Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."

The closest we get to "acceptance criteria" are the standards to which the device complies, implying that meeting the requirements of these standards constitutes acceptable performance.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Compliance with ANSI/AAMI SP-10-1992	The NIBP option is developed to comply with this standard.
Compliance with IEC 601-2-30; 1995	The NIBP option is developed to comply with this standard.
Compliance with EN 864; 1997	The CO2 option is developed to comply with this standard.
Compliance with IEC 601-1	The overall device is developed to comply with this general safety standard.
Meets its functional requirements and performance specifications	"Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." (No specific results provided)
Substantial Equivalence to Predicate Devices	Stated to be substantially equivalent to listed predicate NIBP and CO2 monitors.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "performance tests" and "safety testing" but does not provide any details about the number of subjects or cases used in these tests.
Data Provenance: Not specified. There is no information provided about the country of origin of any testing data, nor if the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. There is no mention of any expert consensus or adjudication process for establishing ground truth during testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study: No. The provided text does not mention any multi-reader multi-case comparative effectiveness study or any evaluation of human reader improvement with or without AI assistance. This document describes a modification to a medical device (defibrillator/monitor) with NIBP and CO2 options, which are sensors/measurement tools, not AI-driven diagnostic interpretation tools.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance Study: The document focuses on the device's performance in meeting standards and functional specifications. While "performance tests" are mentioned for the system, it's not described as an "algorithm only" study in the context of typical AI/software device standalone performance. The NIBP and CO2 functions are direct measurements, not an algorithm providing a diagnosis or interpretation that would typically have a "standalone" or "human-in-the-loop" comparison.

7. The Type of Ground Truth Used

Type of Ground Truth: This is not explicitly stated as pathology, outcomes data, or expert consensus in the traditional sense. For NIBP and CO2 measurement, the "ground truth" would typically refer to accepted, gold-standard reference measurement methods. The document states compliance with standards like ANSI/AAMI SP-10-1992 and EN 864, which themselves define reference methods and accuracy requirements for such measurements. Therefore, the ground truth would be implicitly derived from these established reference measurement techniques as per the specified standards.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This document describes a hardware device with integrated measurement capabilities (NIBP and CO2). There is no mention of an AI algorithm that would require a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable/Not specified. As there's no mention of a machine learning component requiring a training set, this information is not relevant to the provided text.

In summary: The 510(k) summary provided focuses on establishing substantial equivalence to predicate devices and adherence to recognized performance and safety standards. It does not contain the detailed, quantitative efficacy study results, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in submissions for novel diagnostic algorithms or AI-driven systems. The "studies" referred to are generally compliance tests against established engineering and medical device standards.

Summary

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SEP 1 1999

510(k) SUMMARY

Modification 510(k) Premarket Notification Submission NIBP and CO2 Options for the Physio-Control LIFEPAK®12 Defibrillator / Monitor System

1.	Submitter's Name	Michael D. WillinghamVice President, Quality and Regulatory Affairs
	Company	Physio-Control Corporation11811 Willows Road NEPO Box 97006Redmond, WA 98073-9708
	Telephone:	(425) 867-4329
	Facsimile:	(425) 867-4154

NIBP and CO2 Options for the Physio-Control LIFEPAK®12 Name of Device 2. Defibrillator / Monitor System

Noninvasive Blood Pressure Measurement System Classification: 74DXN: 21 CFR 870.1130 Class II
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 74CCK; 21 CFR 868.1400 Class II

dioxide monitoring blood pressure and carbon 3. Noninvasive Predicate the existing Physio-Control has been added to Device(s) capabilities LIFEPAK®12 described in K973486. The intended use and function of the modified Physio-Control LIFEPAK®12 is substantially equivalent to the following devices:

The Non-invasive blood pressure (NIBP) monitor portion of this 510(k) submission is substantially equivalent to Oscillomate EMS NIBP Monitor Model 9001 (510[k] reference K982135) and the PROPAQ Models 102, 104, 106, (510[k] reference K914838). All devices non-invasively measure the blood pressure of adult and pediatric patients primarily in the emergency care environment.

The Carbon-Dioxide Gas Analyzer portion of this 510(k) submission is substantially equivalent to MICROCAP (510[k] reference K981114) and NPB-75 (510[k] reference K964239). All devices non-invasively measure the carbon dioxide concentration of the expired and inspired breath and respiration rate.

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1. Device The LIFEPAK®12 defibrillator / monitor series is a complete acute cardiac response system - battery or auxiliary powered Description defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system.
  The users will be Advanced Life Support and Basic Life Support providers in a variety of hospital and pre-hospital settings. Emergency Medical Services users will include Paramedics and Emergency Medical Technicians trained and authorized to respond to medical emergencies. This device will be used in the pre-hospital setting and in the hospital, in critical areas (emergency departments, critical care, operating rooms, etc.) and on general duty floors (e.g. medical/surgical). It will also be used for patient transport (air and ground ambulance, in hospital transport, etc.)
Intended Use The only modification to the LIFEPAK®12 described in న. K973486 is the additional capability to non-invasively monitor blood pressure and expired / inspired carbon dioxide.
The use of the LIFEPAK®12 capnograph monitor is indicated for a patient that requires the continuous, noninvasive measurement and monitoring of carbon dioxide concentration of expired and inspired breath and respiration rate.

The use of the LIFEPAK®12 blood pressure monitor is indicated for a patient that requires the noninvasive measurement of arterial blood pressure using the oscillometric measurement technique, which provides values for the patient's systolic, diastolic, mean arterial pressure and pulse rate.

1. Comparison of The design, components, storage technology and energy source are similar to its predicate devices. All systems provide a Technological Characteristics means for interfacing with a patient, collecting parameter specific physiologic data, and processing the data for alarm generation and display of numeric values and waveforms on the LIFEPAK®12 display screen.

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The NIBP and CO2 Options for the Physio-Control LIFEPAK®12 is subject to extensive safety and performance testing prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety testing will be performed by third party agencies to ensure the device complies to applicable industry and safety standards. The LIFEPAK®12 is also subject to testing to assure compliance to the requirements of various standards:

ANSI/AAMI SP-10-1992, Electronic or Automated Sphygmomanometers

IEC 601-2-30; 1995 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment.

IEC 601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety.

EN 864; 1997 Medical Electrical Equipment - Capnometers for use with humans - Particular requirements.

In conclusion, the NIBP and CO2 Options for the Physio-Control LIFEPAK®12 are as safe and effective as the predicate devices and raises no new issues.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP ।

Mr. Michael D. Willingham Vice President, Quality and Regulatory Affairs Medtronic Physio-Control 11811 Willows Road NE Post Office Box 97006 Redmond, WA 98073-9706

Re: K990338 NIBP & CO2 Options for the LIFEPAK® 12 Defibrillator/Monitor System Requlatory Class: II (Two) Product Code: 74 DXN Dated: July 19, 1999 Received: July 20, 1999

Dear Mr. Willingham:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have

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Page 2 - Mr. Michael D. Willingham

under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): _ _ _ K 990 338

Options for the LIFEPARC 12 Device Name: NIBP CO2 ibnellator/ Noniter System

Indications For Use:

NIBP

EtCO2

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K990338
---------

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number

Signature

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).