(34 days)
Not Found
No
The summary describes a standard pulse oximeter and does not mention any AI or ML capabilities.
No.
The device is for monitoring physiological parameters (SpO2 and pulse rate) and does not provide therapy or treatment.
Yes
Explanation: The device is described as a pulse oximeter, which is used for monitoring physiological parameters (oxygen saturation and pulse rate). Monitoring these parameters helps in assessing a patient's health status and diagnosing conditions, thus fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "Pulse Oximeter" and is designed for use with "compatible Nellcor Puritan Bennett OxiMAX oxygen transducers (sensors)". This indicates the device includes hardware components (the oximeter unit and sensors) in addition to any potential software.
Based on the provided information, the N-550 Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." This involves measuring physiological parameters directly from the patient's body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces this by stating it monitors SpO2 and pulse rate "by use of one of a range of compatible Nellcor Puritan Bennett OxiMAX oxygen transducers (sensors)." These sensors are applied externally to the patient.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The N-550 Pulse Oximeter directly measures physiological signals from the patient.
N/A
Intended Use / Indications for Use
The N-550 Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-550 Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. This device is for prescription use only.
Product codes
74 DQA
Device Description
The N-550 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett OxiMAX oxygen transducers (sensors). The N-550 Pulse Oximeter displays digital values of SpO2 and Pulse Rate, and individual LED's are used for status indicators. Pulse Amplitude is displayed by means of a "blip bar" presentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric, and adult
Intended User / Care Setting
hospitals, hospital-type facilities, intra-hospital transport, and home environments. This device is for prescription use only.
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)
Clinical and non-clinical tests were performed to support the determination of substantial equivalence. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KO210AD
AY 0 8 2002
tyco
Healthcare
Nellcor
4280 Hacienda Drive Pleasanton, CA 94588
Tele: 925 463-4000 Fax: 925 463-4020
510(k) Summary
Nellcor Puritan Bennett, Incorporated Submitted by: (a business unit of Mallinckrodt Inc., a division of Tyco Healthcare Group, LP) 4280 Hacienda Drive Pleasanton, CA 94588 Gina To Company Contact: Senior Regulatory Affairs Project Manager (925) 463-4427 (925) 463-4020 - FAX April 3, 2002 Date Summary Prepared: OxiMAX N-550 Pulse Oximeter Trade Name: Pulse Oximeter Common/Usual Name: Classification Name: Oximeter (74DQA) per 21 CFR §870.2700 Legally Marketed (Unmodified) Nellcor Puritan Bennett, Inc., OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and Device: OxiMAX Sensors (510(k) #K012891)
Device Description
The N-550 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett OxiMAX oxygen transducers (sensors). The N-550 Pulse Oximeter displays digital values of SpO2 and Pulse Rate, and individual LED's are used for status indicators. Pulse Amplitude is displayed by means of a "blip bar" presentation.
Intended Use
The N-550 Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-550 Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. This device is for prescription use only.
1
Summary of Technological Characteristics of the Device Compared to the Legally Marketed (Unmodified) Device
The N-550 Pulse Oximeter has the same technological characteristics as the above referenced predicate device, the N-595 Pulse Oximeter. The only modifications relate to an ergonomic change from LCD to LED display and a change in oximeter module.
Tests Performed to Support Determination of Substantial Equivalence
Clinical and non-clinical tests were performed to support the determination of substantial equivalence. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
Conclusions
The technological characteristics of the N-550 Pulse Oximeter and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed (unmodified) device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle image.
JUN 2 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nellcor Puritan Bennett, Incorporated c/o Ms. Gina To 4280 Hacienda Drive Pleasanton, CA 94588
Re: K021090
OxiMAX N-550 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: April 24, 2002 Received: April 25, 2002
Dear Ms. To:
This letter corrects our substantially equivalent letter of May 8, 2002 regarding the indications for use of your device. Our letter incorrectly limited your device to use in military environments.
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 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). 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
3
Page 2 - Ms. Gina To
addition. FDA may publish further announcements concerning your device in the Federal Register.
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 (OS) 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 continue 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 Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known): KO21090
OxiMAX N-550 Pulse Oximeter Device Name:
Indications For Use:
The N-550 Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-550 Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. This device is for prescription use only.
(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)
Optional Format 3-10-98) ratory Devic
00009