The NONIN® Pulse Oximeter and Carbon Dioxide Detector (Model 9840-Series) is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and approximate carbon dioxide (CO2) changes in the airway of intubated patients. These functions may be used separately or simultaneously.

Device Description

The NONIN® Pulse Oximeter and Carbon Dioxide Detector (Model 9840-Series), is a hand-held, battery-operated, noninvasive monitoring device that has visual and audible indicators for tracking patient status. Each Pulse Oximeter and Carbon Dioxide Detector model performs similar basic functions, but each model has been customized to meet the needs of different demands placed upon the health care professional. Each model of the NONIN® Models 9840-Series has informational tones, (along with visible indicators) to alert healthcare providers to patient conditions. However only Model 9845 and Model 9847 have an high priority "absence-of-breath" (apnea) audible alarm. The Model 9843 indicates that there is an "absence-of breath" by the cessation of the information tone, the breath-beep indicator. Model 9845 and Model 9847 have medium priority (equipment) alarm that either indicates that the batteries have reached a critically low power state or that a CO2 sensor alarm condition is occurring. The Model 9843 indicates a low battery condition by an illuminated low battery indicator. Model 9847 has a high priority (patient) alarm to alert the healthcare provider to "absence of breath" (apnea), a high or low oxygen saturation, a high or low pulse rate or inadequate pulse quality conditions. Audible alarms can be "permanently" or "temporarily" disabled using the audible alarm disable switch on Model 9845 and Model 9847.

AI/ML Overview

The provided 510(k) summary for the NONIN Pulse Oximeter and Carbon Dioxide Detector (Model 9840-Series) offers limited detail on specific acceptance criteria and the comprehensive study methodologies for performance validation. While it states that "Field evaluations have confirmed the accuracy of the Carbon Dioxide Detector in a controlled clinical environment," it does not provide the detailed information requested in the prompt.

Here's a breakdown of the available information and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device's performance was confirmed through "Field evaluations" and "extensive software/hardware verification and validation procedures." However, it does not provide a table with specific acceptance criteria (e.g., accuracy ranges for SpO2, pulse rate, or CO2 measurements) and the corresponding reported device performance against those criteria.

Acceptance Criteria	Reported Device Performance
Not provided.	Not provided.
(e.g., SpO2 accuracy: ±2% between 70-100%)	(e.g., "The field evaluations confirmed SpO2 accuracy within ±1.5% for 95% of measurements.")
(e.g., CO2 accuracy: ±3 mmHg)	(e.g., "CO2 measurements were within ±2.8 mmHg of reference standard in clinical settings.")

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

The document mentions "Field evaluations" in a "controlled clinical environment."

Sample Size for Test Set: Not specified.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. We only know it was a "clinical environment" but not if it was prospective, retrospective, or where it took place.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

This information is not provided in the summary. While a "controlled clinical environment" implies medical oversight, it doesn't detail the role or number of experts involved in establishing ground truth.

4. Adjudication Method for the Test Set:

This information is not provided.

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

No, an MRMC comparative effectiveness study is not mentioned. Pulse oximeters and CO2 detectors are typically standalone measurement devices, and the concept of human readers "improving with AI vs. without AI assistance" does not directly apply to the primary function of these devices as described. The device provides direct physiological measurements, not interpretations that would typically be augmented by AI for human readers.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

The "Field evaluations" implicitly relate to the standalone performance of the device in a clinical setting. The "extensive software/hardware verification and validation procedures" also confirm a standalone evaluation of the algorithm and hardware. However, specific details of a standalone study, such as the methodology or specific results, are not explicitly described beyond the general statement of validation.

7. The Type of Ground Truth Used:

The document states, "Field evaluations have confirmed the accuracy of the Carbon Dioxide Detector in a controlled clinical environment." This implies that the ground truth for the CO2 detector was established using a reference standard or another validated method in a clinical setting (e.g., a laboratory-grade capnograph, blood gas analysis for oxygen saturation). However, the specific type of ground truth (e.g., expert consensus vs. pathology vs. outcomes data) is not explicitly detailed. For SpO2, historically, pulse oximeter validation involves human desaturation studies with co-oximetry as the ground truth. This is not mentioned here.

8. The Sample Size for the Training Set:

This information is not applicable/provided as the device is a medical measurement instrument. It's not an AI/ML-based diagnostic system that typically requires a distinct "training set" in the conventional sense. The "training" for such devices refers to internal calibration and design optimization rather than learning from labeled data sets.

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

This information is not applicable/provided for the reasons stated above.

Summary

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K982969

510(k) Summary

SUBMITTER:	Nonin Medical, Inc.
	Address:	Nonin Medical, Inc.2605 Fernbrook Lane NorthPlymouth, MN 55447-4755
	Telephone:	612-553-9968
CONTACT PERSON:		Richard P. Bennett, Director of Regulatory Affairs
DATE PREPARED:		August 21, 1998
TRADE NAME:		NONIN® Pulse Oximeter and Carbon Dioxide Detector
	COMMON NAME:	Pulse oximeter and carbon dioxide detector

SUBSTANTIALLY EQUIVALENT TO:

The NONIN Pulse Oximeter and Carbon Dioxide Detector are substantially equivalent to: (1) The pulse oximeter segment is substantially equivalent to the NONIN Models 8500/8500A Pulse Oximeters [510(k)s 893221/945290]. (2) The Carbon Dioxide [CO2] Detector segment is substantially equivalent to the Nellcor Stat Cap Model N-60B [510(k) 915494]. (3) The NONIN Model 9843, 9845, and 9847 Pulse Oximeter and CO2 Detector is substantially equivalent to the two-parameter Spegas MicroCap/NPB-75 [K964239] which likewise functions as a dual function instrument displaying CO2 and SpO2.

DESCRIPTION of the DEVICE:

Each model of the NONIN® Models 9840-Series has informational tones, (along with visible indicators) to alert healthcare providers to patient conditions. However only

510(k) Submission Pulse Oximeter & Carbon Dioxide Detector Model 9840-Series - 81098

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510(k) Summary-Continued

Model 9845 and Model 9847 have an high priority "absence-of-breath" (apnea) audible alarm. The Model 9843 indicates that there is an "absence-of breath" by the cessation of the information tone, the breath-beep indicator.

Model 9845 and Model 9847 have medium priority (equipment) alarm that either indicates that the batteries have reached a critically low power state or that a CO2 sensor alarm condition is occurring. The Model 9843 indicates a low battery condition by an illuminated low battery indicator.

Model 9847 has a high priority (patient) alarm to alert the healthcare provider to "absence of breath" (apnea), a high or low oxygen saturation, a high or low pulse rate or inadequate pulse quality conditions.

Audible alarms can be "permanently" or "temporarily" disabled using the audible alarm disable switch on Model 9845 and Model 9847.

INDICATIONS FOR USE:

SUMMARY of TESTING:

The Model 9840-Series testing has followed (where applicable), the Reviewer Guidance for Premarket Notification Submission of November 1993, from the Anesthesiology and Respiratory Branch, Division of Cardiovascular, Respiratory and neurological Devices. In addition, NONIN Medical, Inc. has evaluated these models for conformance with referenced voluntary international standards. NONIN Medical, Inc. has conducted an extensive Hazard Analysis and Risk Assessment, and developed extensive software/hardware verification and validation procedures to confirm the performance of the product to design requirements. Field evaluations have confirmed the accuracy of the Carbon Dioxide Detector in a controlled clinical environment.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Mr. Richard P. Bennett Nonin Medical, Inc. 2605 Fernbrook Lane North Plymouth, MN 55447-4755

Re: K982969 NONIN Pulse Oximeter and Carbon Dioxide Detectors: Model 9840-Series Regulatory Class: II (two) Product Code: 73 CCK and 74 DQA Dated: July 3, 1999 Received: July 8, 1999

Dear Mr. Bennett:

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 leqally 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, Druq, 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 Regulations, 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation 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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Page 2 - Mr. Richard P. Bennett

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 labelinq 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 regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name: NONIN® Pulse Oximeter and Carbon Dioxide Detector

Indications for Use:

The NONIN® Pulse Oximeter and Carbon Dioxide Detector (Model 9840-Series) is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and approximate carbon dioxide (CO2) changes in the nemogrom (bpoz), paise rates, assess functions may be used separately or simultaneously.

(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)

Joann A. Weathershen
Shipp, Sh. M.

Sion-Off Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).