NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847

K982969 · Nonin Medical, Inc. · CCK · Aug 12, 1999 · Anesthesiology

Device Facts

• Record ID: K982969
• Device Name: NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847
• Applicant: Nonin Medical, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended 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 airway of intubated patients. These functions may be used separately or simultaneously.

Device Story

Hand-held, battery-operated, noninvasive monitor; tracks patient status via visual/audible indicators. Inputs: SpO2 and CO2 signals from patient airway. Operation: processes physiological signals to display SpO2, pulse rate, and CO2 levels; provides audible/visual alarms for apnea, low battery, or sensor conditions. Used by healthcare professionals in clinical settings. Output: real-time patient data and alarm notifications. Clinical utility: assists providers in assessing patient respiratory status and oxygenation; enables timely intervention for apnea or abnormal vital signs.

Clinical Evidence

Bench testing performed per FDA guidance and international standards. Includes hazard analysis, risk assessment, and software/hardware verification and validation. Field evaluations conducted in controlled clinical environments to confirm accuracy of the CO2 detector.

Technological Characteristics

Hand-held, battery-operated, noninvasive monitoring device. Features visual and audible indicators. Includes alarm logic for apnea, low battery, and sensor conditions. Software-controlled monitoring of SpO2, pulse rate, and CO2.

Indications for Use

Indicated for intubated patients requiring monitoring of functional oxygen saturation (SpO2), pulse rate, and airway CO2 changes.

Regulatory Classification

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.

Predicate Devices

• NONIN Models 8500/8500A Pulse Oximeters (893221/945290)
• Nellcor Stat Cap Model N-60B (915494)
• Spegas MicroCap/NPB-75 (K964239)

Submission Summary (Full Text)

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K982969

# 510(k) Summary

| SUBMITTER: | Nonin Medical, Inc. | |
|-----------------|---------------------|-----------------------------------------------------------------------------|
| | Address: | Nonin Medical, Inc.<br>2605 Fernbrook Lane North<br>Plymouth, 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:

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

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:

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.

#### 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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 __

OR

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 ***_***