(352 days)
893221/945290, 915494, K964239
Not Found
No
The description focuses on standard physiological monitoring and alarm functions, with no mention of AI or ML algorithms for data analysis, interpretation, or prediction.
No
The device is indicated for measuring and displaying physiological parameters (SpO2, pulse rate, CO2 changes) for monitoring purposes, and does not provide therapy or treatment.
Yes
The device 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," which are measurements used to inform a diagnosis or monitor a patient's condition.
No
The device description explicitly states it is a "hand-held, battery-operated, noninvasive monitoring device" and mentions "software/hardware verification and validation procedures," indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes measuring physiological parameters (oxygen saturation, pulse rate, and carbon dioxide changes) directly from the patient's airway. This is a non-invasive, in-vivo measurement.
- Device Description: The description reinforces that it's a "hand-held, battery-operated, noninvasive monitoring device."
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing these types of samples.
The device is a patient monitoring device that measures physiological signals directly from the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
73 CCK, 74 DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway (of intubated patients), arterial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional / controlled clinical environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Field evaluations have confirmed the accuracy of the Carbon Dioxide Detector in a controlled clinical environment.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
893221/945290, 915494, K964239
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary
| SUBMITTER: | Nonin Medical, Inc. | |
|---|---|---|
| Address: | Nonin Medical, Inc. | |
| 2605 Fernbrook Lane North | ||
| 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
1
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.
2
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.
3
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
4
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 _