(238 days)
Not Found
No
The summary describes a sensor with a memory chip for storing sensor information and compatibility data. There is no mention of AI, ML, or any algorithms that would process data in a way indicative of AI/ML. The performance studies focus on accuracy and precision through human and bench tests, not on the performance of an AI/ML model.
No
The device is a sensor used for continuous noninvasive arterial oxygen saturation and pulse rate monitoring, which are diagnostic indicators rather than therapeutic interventions.
Yes
This device is a sensor used for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate. The information it collects (oxygen saturation and pulse rate) is used to assess a patient's physiological state, which falls under the definition of diagnosis, even though it may not provide a definitive medical diagnosis on its own.
No
The device description explicitly states it is a "sterile, latex-free, single patient use forehead sensor" and contains a "memory chip," indicating it is a physical hardware device, 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® NeoMAX adhesive forehead reflectance sensor is used for continuous noninvasive arterial oxygen saturation and pulse rate monitoring. This is a physiological measurement taken directly from the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "continuous noninvasive arterial oxygen saturation and pulse rate monitoring," which is a direct physiological measurement.
Therefore, this device falls under the category of a medical device used for patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nellcor® OxiMax® NeoMAX adhesive forchead reflectance sensor is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The OxiMax NeoMAX is a sterile, latex-free, single patient use forehead sensor, sized appropriately to fit the forehead of a neonatal or pediatric patient.
The OxiMax NeoMAX sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data. Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax NeoMAX sensor is compatible with OxiMAX monitors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
neonatal and pediatric patients (≤ 40 kg)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Human and bench tests were performed to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications. The technological characteristics of the OxiMax NeoMAX sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.
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.
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
§ 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
K05/27/
4280 Haclenda Drive
Tele: 925 463-4000 Fax: 925 463-4020
Pleasanton, CA 94588
tyco
Healthcare
Nellcor
510(k) Summary
JAN 1 0 2006
| Submitted by: | Nellcor Puritan Bennett, Inc.
4280 Hacienda Drive
Pleasanton. CA 94588 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | James Patrick Garvey II, RRT
Regulatory Affairs Manager
(925) 463-4479
(925) 463-4020 - FAX |
| Date Summary Prepared: | May 4, 2005 |
| Trade Name: | OxiMax NeoMAX Adhesive Forehead Reflectance
Oximetry Sensor |
| Common/Usual Name: | Oxygen Sensor |
| Classification Name: | Oximeter (DQA) per 21 CFR §870.2700 |
| Substantially Equivalent
Devices: | • Nellcor Puritan Bennett, Inc.. OxiMax Pulse Oximet
System with N-595 Pulse Oximeter and OxiMax
Sensors, K012891
• Nellcor Puritan Bennett, Inc., OxiMax MAX-FAST
Adhesive Forehead Sensor, K021089 |
DEVICE DESCRIPTION
The OxiMax NeoMAX is a sterile, latex-free, single patient use forehead sensor, sized appropriately to fit the forehead of a neonatal or pediatric patient.
The OxiMax NeoMAX sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data. Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax NeoMAX sensor is compatible with OxiMAX monitors.
INTENDED USE
The Nellcor® OxiMax® adhesive forehead reflectance sensor, model NeoMAX, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).
1
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The OxiMax NeoMAX sensor has the same technological characteristics as the OxiMax MAX-FAST. The differences relate to dimensions. lighter adhesive on the patient contact surface, and labeling.
TESTS PERFORMED TO SUPPORT DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Human and bench tests were performed to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications.
CONCLUSIONS
The technological characteristics of the OxiMax NeoMAX sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN I 0 2006
Mr. James P. Garvey Regulatory Affairs Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588
Re: K051271
Trade/Device Name: OxiMax NeoMax Adhesive Forehead Reflectance Regulation Number: 21 CFR 870.2700 Regulation Name: Oximcter Regulatory Class: II Product Code: DQA Dated: December 22, 2005 Received: December 23, 2005
Dear Mr. Garvey:
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 - Mr. Garvey
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 (240) 276-0120. 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutte if. Michin Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
The Nellcor® OxiMax® NeoMAX adhesive forchead reflectance sensor is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).
ﻟﺴ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suette y. Michael Ond
Henry General Hospital,
Rehabilitation Services