The Natus Breath Analyzer is intended for non-invasive, quantitative measurement of respiratory rate, end tidal carbon dioxide concentration, and end tidal carbon monoxide (corrected for background carbon monoxide) concentration in the breath. The analyzer is intended for use with neonates, children, and adults breathing spontaneously.

The analyzer measures the carbon monoxide concentration in end tidal breath, as an indicator of the blood level of COHb. The level of COHb (and consequently the concentration of carbon monoxide in the end tidal breath) can be affected by endogenous sources (for example the rate of hemolysis), exogenous sources (for example, combustion engine exhaust), or in some cases both. The COHb level, elevated or normal, can be used in the diagnosis of medical conditions in which the rate of hemolysis may be relevant, and in the monitoring of patient populations affected by the rate of hemolyzer is also indicated for use in respiratory status evaluation, whenever measurements of respiratory rate and end tidal carbon dioxide concentration are desired.

The analyzer is intended for use under the direction of a physician in hospitals and a variety of health care settings.

Device Description

The Natus Breath Analyzer system is a point-of-care test that consists of the instrument and a single-use patient sampler. The patient sampler incorporates a flexible nasal catheter with a filter cartridge that attaches to the device. An integral adhesive strip on the catheter aids in proper placement in the nostril.

The computer-controlled instrument contains two gas analysis sensors: an infra-red carbon dioxide sensor and an electrochemical carbon monoxide sensor. The signal produced by the carbon dioxide sensor is analyzed to determine the end tidal carbon dioxide concentration and the respiratory rate. The signal produced by the carbon monoxide sensor is analyzed to determine the average carbon monoxide concentration. The end tidal carbon monoxide concentration is calculated by an algorithm using carbon monoxide and carbon dioxide concentrations.

During the automated test procedure the device displays appropriate prompts. The user operates the instrument by selecting menu options from the display screen. During sampling, a small volume of the patient's breath is continuously drawn into the instrument for a short time. Results are displayed and printed at the end of the test.

The Natus Breath Analyzer utilizes the same respiratory gas concentration measurement technology as the predicate devices.

AI/ML Overview

Here's an analysis of the provided text regarding the Natus Breath Analyzer's acceptance criteria and study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the Natus Breath Analyzer. Instead, the primary acceptance criterion appears to be substantial equivalence to predicate devices. The performance is reported in terms of this equivalence across various patient populations and measured parameters.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial equivalence to predicate devices for: - End tidal carbon monoxide measurement - End tidal carbon dioxide measurement - Respiratory rate measurement	Demonstrated substantial equivalence in adult and pediatric populations for all three measurements.
	Demonstrated substantial equivalence in neonatal population for carbon dioxide and respiratory rate measurements.
Accurate measurement for a wide range of breath parameters (simulated)	Device accurately measured end tidal CO, end tidal CO2, and respiratory rate for various simulated breath parameters (rate, tidal volume, gas concentrations, I:E ratio), including neonatal values.

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

Sample Size for Clinical Test Set: Not explicitly stated. The document mentions "adult, pediatric, and neonatal subjects" and "three clinical sites" but does not provide specific numbers for the total subjects or per population.
Data Provenance: The data is prospective, generated from a "clinical study" performed on actual patients. The country of origin is not explicitly stated, but given the 510(k) application to the FDA, it is highly likely to be the United States.

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

The document does not describe the establishment of a "ground truth" by experts in the traditional sense (e.g., expert consensus on images). Instead, the clinical study compared the Natus Breath Analyzer's measurements to those of predicate devices (Vitalograph and Pryon). Therefore, the "ground truth" for the clinical study was derived from the measurements provided by these already-marketed, presumably validated, devices.

4. Adjudication Method for the Test Set

Not applicable. The study design described is a comparative one against predicate devices, not one involving independent expert adjudication to establish a "ground truth" separate from the comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices where multiple human readers interpret cases with and without AI assistance. The Natus Breath Analyzer is a measurement device for respiratory gases, and the study focused on device-to-device comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was effectively done. The clinical study directly compared the Natus Breath Analyzer's measurements (algorithm output) to those of predicate devices. The non-clinical tests also assessed the device's accuracy in a standalone capacity using a breathing simulator.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on measurements from predicate devices (Vitalograph and Pryon). For the non-clinical tests, the ground truth was derived from known, controlled parameters set on a breathing simulator.

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device, not a machine learning algorithm that undergoes a training phase with a dedicated dataset. The device's algorithms for calculating end-tidal CO, CO2, and respiratory rate are based on established scientific principles and sensor data, not a "training set" in the context of recent AI/ML development.

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

As noted above, there is no "training set" in the context of this device. The underlying physics and chemical principles of the sensors and calculations form the basis of the device's operation.

Summary

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K974805

MAR | | 1998

Numbers

510(k) Summary

This summary of safety and effectiveness is provided in accordance with the requirements of the Safe Medical Devices Act 1990 and 21 CFR § 807.92(c).

1. Manufacturer's Information	Contact Person	Phone & Fax Numbers
Natus Medical, Inc.	Esther Kadash	(650) 802-0400
1501 Industrial Road	Director, Regulatory Affairs	(650) 802-0531 (fax)
San Carlos, CA 94070-4111		(650) 802-0401 (alt. fax)

Summary prepared on December 22, 1997

Device Name and Classification Information 2.

Device Trade or Proprietary Name	CO-STAT™ End Tidal Breath Analyzer
Common, Usual, or Classification Name	Common: Breath analyzerClassification: Carbon monoxide gas analyzer
Classification	Carbon monoxide gas analyzer - 21 CFR § 868.1430Class II
Product Code	CCJ

Marketed Devices to which the Natus Breath Analyzer is substantially equivalent. 3.

Manufacturer	Common name	DeviceClass	ClassificationPanel	Product Code	K#
Vitalograph	Carbon monoxidegas analyzer	II	Anesthesiology	73 CCJ	K902113A
Pryon	Carbon dioxide gasanalyzer	II	Anesthesiology	73 CCK	K935272
Iadec	Carboxyhemoglobinassay	II	Hematology	GHS	K770209

Table 2: Predicate Devices

Device Intended Use 4.

The Natus Breath Analyzer is intended for non-invasive measurement of respiratory rate, end tidal carbon dioxide concentration, and end tidal carbon monoxide (corrected for background carbon monoxide) concentration in the breath. Respiratory rate and end tidal carbon dioxide provide an indication of respiratory status; end tidal carbon monoxide is used for the detection and identification of levels of carboxyhemoglobin (COHb). Elevated levels of COHb may be due to environmental exposure or an increased rate of hemolysis; normal levels of COHb may indicate a normal rate (i.e., the absence of an elevated rate) of hemolysis.

Device Description ನ.

The Natus Breath Analyzer is indicated for use with neonates, children, and adults breathing spontaneously. The analyzer measures the carbon monoxide concentration in end tidal breath, as an indicator of the blood level of COHb. The level of COHb (and consequently the concentration of carbon monoxide in the end tidal breath) can be affected by endogenous sources (for example hemolysis), exogenous sources (for example, combustion engine exhaust), or in some cases both. The analyzer is also indicated for use in respiratory status evaluation, whenever measurements of

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respiratory rate and end tidal carbon dioxide concentration are desired. The analyzer is indicated for use under the direction of a physician in hospitals and a variety of health care settings.

The Natus Breath Analyzer utilizes the same respiratory gas concentration measurement

Summary of Technological characteristics compared to marketed devices. 6.

technology as the predicate devices. | Vitalograph Iadec Pryon | Natus

Technology	NatusBreathAnalyzer	VitalographBreathCOmonitor	IadeeEcolyzercarboximeter	FryonSC-210 CO2monitor
Electrochemical fuel cell tomeasure carbon monoxide	Yes	Yes	Yes	N/A
Infrared technology to measurecarbon dioxide	Yes	N/A	N/A	Yes
End-tidal measurements	Yes	Yes	Yes	Yes
Measures ambient carbonmonoxide	Yes	Yes	Yes	N/A
Non-continuous single test	Yes	Yes	Yes	Yes ‡
Sidestream sample method	Yes	No	No	Yes
Method of defining end-tidalcarbon monoxide	Derivedfrom CO2waveformand averageCO output	Voluntarybreathingmaneuver	Voluntarybreathingmaneuver	N/A

Table 3: Technology Comparisons with Predicate Devices

Pryon device can also be used in continuous monitoring mode.

Materials are shown appropriate for use based on testing. There are no known biocompatibility or toxicology issues.

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7. Summary of Non-Clinical Tests

Non-clinical tests performed on a breathing simulator demonstrated that the device can accurately measure end tidal carbon monoxide, end tidal carbon dioxide, and respiratory rate for a wide range of breath parameters (breath rate, tidal volume, gas concentrations, I:E ratio,), including values expected from the neonatal population.

Summary of Clinical Tests 8.

A clinical study was performed to compare the carbon monoxide, carbon dioxide, and respiratory rate measurement performance of the Natus Breath Analyzer with the predicate devices (Vitalograph and Pryon). This study was performed on adult, pediatric, and neonatal subjects at three clinical sites. The study demonstrated that device performance is substantially equivalent to the predicate devices.

9. Conclusions from Testing

Testing results demonstrated no significant difference between the Natus Breath Analyzer and the predicate devices in adult and pediatric populations for all three measurements (respiratory rate, end tidal carbon monoxide, and carbon dioxide), and demonstrated no significant difference for carbon dioxide and respiratory rate measurements in the neonatal population. The neonatal population was not tested for carbon monoxide with the predicate device because this population is unable to perform the voluntary breathing maneuver required for the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Esther Kadash . Director of Regulatory Affairs Natus Medical Inc. 1501 Industrial Road 94070-4111 San Carlos, California

MAR 11 1998

Re : K974805 CO-STAT™ End Tidal Breath Analyzer Regulatory Class: II Product Code: GHS, CCK, CCJ .... December 22, 1997 Dated: Received: January 5, 1998

Dear Ms. Kadash:

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 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 mav 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 895. A substantially equivalent determination assumes compliance with 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 requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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) 594-4588. 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 regulation entitled, "Misbranding by reference to 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/dsmamain.html".

Sincerely yours,
Steven Ditman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K974805

Device Name: Natus Breath Analyzer

Indications for Use:

The analyzer is intended for use under the direction of a physician in hospitals and a variety of health care settings.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	974805

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Regulation Number and Section

§ 864.7425 Carboxyhemoglobin assay.

(a)
Identification. A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.(b)
Classification. Class II (performance standards).