(76 days)
No
The document describes a pulse oximetry sensor with a memory chip for calibration information. There is no mention of AI, ML, or any algorithms that would suggest their use.
No
The device is a sensor used for monitoring arterial oxygen saturation and pulse rate, which are diagnostic measurements, not a therapeutic intervention.
No
The device is a sensor used for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate. While it provides physiological data, its primary function is monitoring, not diagnosing a specific condition. Diagnosis typically involves interpretation of various data points, often by a clinician, to identify a disease or condition.
No
The device description explicitly states it is a "disposable adhesive sensor for the forehead" and contains a "memory chip," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nellcor OxiMAX MAX-FAST sensor is a noninvasive device that measures arterial oxygen saturation and pulse rate by being placed on the forehead. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "continuous noninvasive arterial oxygen saturation and pulse rate monitoring." This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the device described is a noninvasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (≥ 10 kg) patients.
Product codes
74DQA
Device Description
The OxiMAX MAX-FAST Adhesive Forehead Sensor is a disposable adhesive sensor for the forehead. MAX-FAST may be used on mechanically ventilated patients and on patients in supine position. MAX-FAST may be used continuously up to two days with appropriate site inspections, and will allow a maximum of four site changes and/or inspections with the removal of adhesive layers.
The OxiMAX MAX-FAST sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation.
The OxiMAX MAX-FAST adhesive forehead sensor was cleared as part of the OxiMAX Pulse Oximetry System (510(k) #K012891). This forehead sensor was labeled for adults. The labeling has been updated to add pediatric use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
adult or pediatric (≥ 10 kg) patients.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Nellcor Puritan Bennett, Incorporated OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors 510(k) #K012891
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
4280 Hacienda Drive Pleasanton, CA 94588
Tele: 925 463-4000 Fax: 925 463-4020
JUN 1. 9 2002
tyco
Healthcare
Nellcor
510(k) Summary
| Submitted by: | Nellcor Puritan Bennett Incorporated
(A business unit of Mallinckrodt Inc.,
a division of Tyco Healthcare Group LP)
4280 Hacienda Drive
Pleasanton, CA 94588 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Gina To
Senior Regulatory Affairs Project Manager
(925) 463-4427
(925) 463-4020 - FAX |
| Date Summary Prepared: | April 3, 2002 |
| Trade Name: | OxiMAX MAX-FAST Adhesive Forehead Sensor |
| Common/Usual Name: | Oxygen Sensor |
| Classification Name: | Patient Transducer and Electrode Cable (including
connector) (74DSA) (per 21 CFR §870.2900) |
| Substantially Equivalent
Devices: | Nellcor Puritan Bennett, Incorporated
OxiMAX Pulse Oximetry System with N-595 Pulse
Oximeter and OxiMAX Sensors
510(k) #K012891 |
DEVICE DESCRIPTION
The OxiMAX MAX-FAST Adhesive Forehead Sensor is a disposable adhesive sensor for the forehead. MAX-FAST may be used on mechanically ventilated patients and on patients in supine position. MAX-FAST may be used continuously up to two days with appropriate site inspections, and will allow a maximum of four site changes and/or inspections with the removal of adhesive layers.
The OxiMAX MAX-FAST sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation.
The OxiMAX MAX-FAST adhesive forehead sensor was cleared as part of the OxiMAX Pulse Oximetry System (510(k) #K012891). This forehead sensor was labeled for adults. The labeling has been updated to add pediatric use.
1
INTENDED USE
The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (≥ 10 kg) patients.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE LEGALLY MARKETED (UNMODIFIED) DEVICE
No design modifications have been made to the OxiMAX MAX-FAST adhesive forehead sensor. Only labeling has been revised.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·
JUN 1 9 2002
Nellcor Puritan Bennett, Inc. c/o Ms. Gina To 4280 Hacienda Drive Pleasanton, CA 94588
Re: K021089
OxiMAX MAX-FAST Adhesive Forehead Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: April 3, 2002 Received: April 4, 2002
Dear Ms. To:
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 your 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.
3
Page 2 - Ms. Gina To
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours.
Donna Rea Tillman, Ph.D.
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): KO21089
OxiMAX MAX-FAST Adhesive Forehead Sensor Device Name:
Indications For Use:
The Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (≥ 10 kg) patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021089
(Optional Format 3-10-98)