(161 days)
Not Found
No
The summary describes a standard pulse oximeter and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No
The device is a pulse oximeter intended for monitoring physiological parameters (SpO2 and pulse rate), not for treating or curing a medical condition.
Yes
The device continuously monitors SpO2 and pulse rate, which are physiological parameters used to assess a patient's health status. While it doesn't provide a diagnosis itself, the data it collects is crucial for healthcare professionals to make diagnostic decisions and monitor conditions, falling under the umbrella of diagnostic tools.
No
The device description explicitly details hardware components such as a pulse oximeter, sensors, cables, internal power supply, and battery. It is a physical device with software functionality, not a software-only medical device.
Based on the provided information, the Nellcor OxiMax N-600x Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- Device Function: The Nellcor OxiMax N-600x Pulse Oximeter is described as a device for the "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." This monitoring is done on the patient's body (in vivo) using a sensor.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens.
Therefore, the device's function and intended use clearly fall outside the scope of an In Vitro Diagnostic device. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The Nellcor OxiMax N-600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor OxiMax N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only
Product codes (comma separated list FDA assigned to the subject device)
74DQA
Device Description
The OxiMax N-600x Pulse Oximeter is a modification OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors and Cables. The N-600x is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMax pulse oximetry sensors and the DOC-10 cable. The N-600x Pulse Oximeter displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The N-600x can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively by an internal 6V rechargeable sealed lead-acid battery. The OxiMax N-600x Pulse Oximeter is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
Audible and visual alarms for high/low saturation, pulse rate and pulse search are provided. The N-600x Pulse Oximeter also includes adjustable alarm silence duration and other configurable power-on settings. The N-600x provides a back-up piezo alarm that sounds if a high-level audible alarm has not been responded to within 45 seconds. The piezo alarm will also activate in the event of a primary alarm failure. The N-600x provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The N-600x Pulse Oximeter has visual indicators for pulse search, interference, power mode (i.e., battery or AC), alarm silence and alarm features. There is also a serial port (EIA-232 and RS-422 interface) that provides ASCII output of real-time data. Via the serial port, the N-600x interfaces with selected multiparameter monitors.
The Nellcor pulse oximetry cable, Model DOC-10, links individual OxiMax sensors to the N-600x Pulse Oximeter. The N-600x and DOC-10 are intended for use only with the OxiMax family of sensors. These OxiMax sensors each contain 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. These OxiMax sensors include the following models: OxiMax MAX-A, MAX-AL, MAX-P, MAX-I, MAX-N, MAX-R, MAX-FAST, OxiCliq-A, OxiCliq-P, OxiCliq-I, OxiCliq-N, DS-100A, D-YS, D-YSE, D-YSPD, SC-A, SC-NEO, SC-PR, OXI-A/N, OXI-P/I, and NeoMax.
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 patients
Intended User / Care Setting
hospitals, hospital-type facilities, intra-hospital transport, and home environments. 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): 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
Kobos76
AUG 1 4 2006
510(k) Summary
| Submitted by: | Nellcor Puritan Bennett Incorporated
4280 Hacienda Drive
Pleasanton, CA 94588 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Patrick Garvey
Regulatory Affairs Manager
Phone: (925) 463-4479
Fax: (925) 463-4020 |
| Date Summary Prepared: | October 10, 2005 |
| Trade Name: | OxiMax Pulse Oximetry System with N-600x Pulse
Oximeter and OxiMax Sensors and Cables (aka
"Accessories") |
| Common/Usual Name: | Pulse Oximeter, Sensors and Cables |
| Classification Name: | Oximeter (74DQA) (per 21 CFR §870.2700)
Patient Transducer and Electrode Cable (including
connector) (74DSA) (per 21 CFR §870.2900) |
| Substantially Equivalent
Devices: | 1. Nellcor OxiMax Pulse Oximetry System with
N-595 Pulse Oximeter, 510(k) #K012891
2. Nellcor N-200 Pulse Oximeter, 510(k)
#K863784 & K022819 |
I. Device Description
The OxiMax N-600x Pulse Oximeter is a modification OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors and Cables. The N-600x is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMax pulse oximetry sensors and the DOC-10 cable. The N-600x Pulse Oximeter displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The N-600x can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively by an internal 6V rechargeable sealed lead-acid battery. The OxiMax N-600x Pulse Oximeter is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
510(k) Summary - Page 1
1
Audible and visual alarms for high/low saturation, pulse rate and pulse search are provided. The N-600x Pulse Oximeter also includes adjustable alarm silence duration and other configurable power-on settings. The N-600x provides a back-up piezo alarm that sounds if a high-level audible alarm has not been responded to within 45 seconds. The piezo alarm will also activate in the event of a primary alarm failure. The N-600x provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The N-600x Pulse Oximeter has visual indicators for pulse search, interference, power mode (i.e., battery or AC), alarm silence and alarm features. There is also a serial port (EIA-232 and RS-422 interface) that provides ASCII output of real-time data. Via the serial port, the N-600x interfaces with selected multiparameter monitors.
The Nellcor pulse oximetry cable, Model DOC-10, links individual OxiMax sensors to the N-600x Pulse Oximeter. The N-600x and DOC-10 are intended for use only with the OxiMax family of sensors. These OxiMax sensors each contain 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. These OxiMax sensors include the following models: OxiMax MAX-A, MAX-AL, MAX-P, MAX-I, MAX-N, MAX-R, MAX-FAST, OxiCliq-A, OxiCliq-P, OxiCliq-I, OxiCliq-N, DS-100A, D-YS, D-YSE, D-YSPD, SC-A, SC-NEO, SC-PR, OXI-A/N, OXI-P/I, and NeoMax.
II. Intended Use
The Nellcor OxiMax Pulse Oximeter N-600x is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
III. Technological Characteristics
The OxiMax Pulse Oximetry System measures functional oxygen saturation noninvasively via a light signal interacting with tissue, by utilizing the time-varying changes in tissue optical properties that occur with pulsatile blood flow. Red and infrared lightemitting diodes (LEDs) are utilized as light sources. A photodiode acting as a photodetector senses the signal strengths of the two wavelengths of light, which vary with the amount of light transmitted through the tissue. The N-600x Pulse Oximeter receives this electrical information from the sensor and processes the information by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude.
OxiMax technology encompasses:
- OxiMax Advanced Digital Signal Processing for reading through motion artifact and . low perfusion
- . Advanced Signal Evaluation providing the user information on sensor placement
- . SatSeconds Alarm Management
- . OxiMax Sensor Technology, including in-sensor data, allows the N-600x to write data to and read data from OxiMax adhesive sensors
The N-600x uses SpO2 and Pulse Rate software algorithms, interference-filtering software, and SatSeconds alarm management similar to the software in the legally
2
marketed predicate device cleared under K012891, with minor changes that do not raise new questions of safety or efficacy.
The Nellcor brand sensors containing OxiMax technology are compatible with the N-600x, other Nellcor oximeters and instruments containing Nellcor OxiMax oximetry, or with instruments licensed to use Nellcor sensors (Nellcor-compatible instruments). OxiMax Sensor Technology, including in-sensor data, allows the N-600x to write data to and read data from OxiMax adhesive sensors allowing patient history, namely SpO2 and pulse rate alarm events, to travel with the patient, and enabling quick patient assessment upon transfer to a new point of care. The N-600x provides on-screen viewing of insensor patient data including SpO2 and pulse rate trend of events.
IV. 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.
V. Conclusions
The technological characteristics of the OxiMax N-600x Pulse Oximetry System and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three abstract human profiles facing right, with three parallel lines above them. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick Garvey Regulatory Affairs Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588-2719
Re: K060576
Trade/Device Name: The Nellcor® OxiMax® N-600x Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 7, 2006 Received: August 8, 2006
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.
4
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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
Enclosure
5
510(k) Number (if known):
The Nellcor® OxiMax® N-600x Pulse Oximeter Device Name:
Indications For Use:
The Nellcor OxiMax N-600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor OxiMax N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in bospitals, hospital-type facilities, intra-hospital transport, and home environments. 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)
Mitchell Nichols for Ann Graham
്:r)
schesiology, General Hospital,
(Optional Format 3-10-98)