(314 days)
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Not Found
No
The document describes a standard pulse oximeter based on light absorption, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a pulse oximeter, and its stated intended use is for measuring, displaying, and recording physiological parameters (SpO2 and pulse rate), not for delivering therapy or treatment.
No
This device is used for monitoring physiological parameters (SpO2 and pulse rate), not for diagnosing a disease or condition. While the data collected might be used by a clinician for diagnostic purposes, the device itself performs measurements rather than providing a diagnosis.
No
The device description explicitly states it is a "portable, tabletop device" and describes measuring light absorption through tissue, indicating it is a hardware device with integrated software.
Based on the provided information, the NONIN® AVANT™ 9600 Digital Pulse Oximeter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Avant 9600 Pulse Oximeter measures oxygen saturation and pulse rate by passing light through tissue (specifically, a finger or other body part). This is a non-invasive measurement taken in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
- Intended Use: The intended use describes monitoring and spot-checking patients directly, not analyzing samples taken from patients.
Therefore, the device's mechanism of action and intended use clearly place it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals. medical facilities. home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients.
Product codes
DQA
Device Description
The Model 9600 Pulse Oximeter determines arterial hemoglobin saturation (%SpO2) by measuring absorption of red and infrared (IR) light passed through the tissue. The Model 9600 also measures pulse rate and displays the rate in beats per minute.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult, pediatric, infant, and neonatal patients
Intended User / Care Setting
hospitals, medical facilities, home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Model Avant 9600 Digital Pulse Oximeter has followed (where applicable) the Reviewer Guidance for Premarket Notification Submission of November of 1993, from the Anesthesiology and Respiratory Branch, Division of Cardiovascular, Respiratory and Neurological Devices. In addition, Nonin has conducted a Hazard Analysis and Risk Assessment, and developed extensive software/hardware procedures to confirm the performance of the design requirements. Bench and safety testing have been done to verify the performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
The Nonin, Model Avant 2120 Pulse Oximeter/Non Invasive Blood Pressure (NIBP) Monitor
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Ko23044
| SUBMITTER: | Nonin Medical, Inc. |
|---|---|
| Address: | Nonin Medical, Inc. |
| 2605 Fernbrook Lane North | |
| Plymouth, MN 55447-4755 | |
| Telephone: | 763-553-9968 |
| CONTACT PERSON: | Richard P. Bennett, Director of Regulatory Affairs |
| DATE PREPARED: | August 26, 2002 |
| TRADE NAME: | Nonin® Avant™, Model 9600, Pulse Oximeter |
| COMMON NAME: | Pulse Oximeter |
SUBSTANTIALLY EQUIVALENT TO:
The Nonin, Model Avant 2120 Pulse Oximeter/Non Invasive Blood Pressure (NIBP) Monitor
DESCRIPTION OF THE DEVICE:
The Model 9600 Pulse Oximeter determines arterial hemoglobin saturation (%SpO2) by measuring absorption of red and infrared (IR) light passed through the tissue. The Model 9600 also measures pulse rate and displays the rate in beats per minute.
INDICATIONS FOR USE:
The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals. medical facilities. home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients.
INTENDED USE:
The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients for Oxygen saturation SpO2 and pulse rate.
SUMMARY OF TESTING:
The Model Avant 9600 Digital Pulse Oximeter has followed (where applicable) the Reviewer Guidance for Premarket Notification Submission of November of 1993, from the Anesthesiology and Respiratory Branch, Division of Cardiovascular, Respiratory and Neurological Devices. In addition, Nonin has conducted a Hazard Analysis and Risk Assessment, and developed extensive software/hardware procedures to confirm the performance of the design requirements. Bench and safety testing have been done to verify the performance of the device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or flowing lines.
Public Health Service
JUL 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard P. Bennett Director of Regulatory Affairs Nonin Medical, Inc. 2605 Fernbrook Lane North Plymouth, MN 55447
Re: K023044
Trade/Device Name: Model 9600 Avant Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 1, 2003 Received: May 2, 2003
Dear Mr. Bennett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Richard P. Bennett
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours.
Patricia Cucerite/for
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Indications for Use Statement
510(k) Number:
KO236.44
Device Name:
Nonin Medical Inc AVANT™, Model 9600
Indications for Use:
The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording function of arterial hemoglobin (SpO-3) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 is intended for continuous monitoring and/or spot-checking of patients.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | R023044 |
|---|---|
| ---------------- | --------- |
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________