The intended use of the N-395 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. For use with neonatal, pediatric and adult patients, in hospitals, hospital-type facilities and intra-hospital transport environments. For prescription use only.

Device Description

The N-395 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 oxygen transducers (sensors). The N-395 displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation. The N-395 can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable From 100V to 240V) or alternatively by an integral sealed 6V rechargeable lead-acid battery. The N-395 is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities and intra-hospital transport environments. Audible and visual alarms for high/low saturation, pulse rate and pulse search are provided. The N-395 also includes adjustable alarm silence duration and other configurable power-on settings. The N-395 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The N-395 Pulse Oximeter has visual indicators for pulse search, motion, power mode (i.e. battery or AC) and alarm silence in addition to alarm features. In addition to the above mentioned device features, the instrument has been designed to satisfy the needs of both the user and the patient. A convenient carrying handle is incorporated into the case. There is also a serial port (EIA-232 and RS-422 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers. There is also an interface for nurse call systems through the rear connector. The device is also Flash ROM upgradable.

AI/ML Overview

The N-395 Pulse Oximeter is designed to monitor functional oxygen saturation (SpO2) and pulse rate. The submission does not explicitly state acceptance criteria in a quantitative table format. However, it indicates reliance on "in-vitro and non-invasive controlled hypoxia studies ... to establish the N-395's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the N-395."

Given the information provided, here's a breakdown of the study and its characteristics:

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
SpO2 Accuracy	Meet currently published accuracy specifications of sensors.	Established by controlled hypoxia studies.
Pulse Rate Accuracy	Meet currently published accuracy specifications of sensors.	Established by controlled hypoxia studies.
Safety	Compliance with accepted industry standards; equivalent to predicates.	Demonstrated through comparison to predicate devices and testing.
Performance	Similar SpO2 and Pulse Rate software algorithm to predicate N-3000.	Processes information from the sensor using a similar algorithm to N-3000.

Note: The submission refers to "currently published accuracy specifications" for the sensors but does not explicitly state what those specifications are (e.g., RMS error, bias).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The study involved "controlled hypoxia studies" which simulate different oxygen levels in human subjects.
Data Provenance: The studies were "non-invasive controlled hypoxia studies," implying the use of human subjects under controlled conditions to induce varying oxygen saturation levels. The country of origin is not specified but is presumably where Nellcor Puritan Bennett Inc. operates or conducts its research (e.g., USA). The studies are inherently prospective as they are specifically conducted to test the device's accuracy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Ground Truth: The "ground truth" for SpO2 in controlled hypoxia studies typically refers to arterial blood gas measurements (SaO2) taken concurrently with the pulse oximeter readings. These measurements are performed by trained medical professionals (e.g., phlebotomists, laboratory technicians).
Number of Experts/Qualifications: The submission does not specify the number of experts or their qualifications for establishing the ground truth (SaO2). However, it is standard practice in such studies to have trained medical personnel for blood sampling and laboratory analysis, ensuring accurate SaO2 measurements.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable in the context of controlled hypoxia studies for pulse oximeters in the way it would be for image-based diagnostic AI. The "ground truth" (SaO2) is an objective physiological measurement, not subject to individual interpretation or consensus among experts. The pulse oximeter's reading is compared directly to this objective measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret images, and the AI's effect on their performance is being evaluated. This submission is for a pulse oximeter, which provides a direct physiological measurement, not an interpretation of images by human readers in the classical sense of an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance assessment was done. The controlled hypoxia studies are a direct evaluation of the device's (algorithm + sensor) ability to accurately measure SpO2 and pulse rate without human intervention in the measurement process itself. The device is used to generate readings, which are then compared to the ground truth.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth used in controlled hypoxia studies for pulse oximeters is arterial blood gas measurements (SaO2). This is a direct, objective physiological measurement of oxygen saturation in arterial blood.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided. Pulse oximeters of this era (1999) typically relied on empirically derived algorithms and calibration curves established through extensive physiological studies, rather than "training sets" in the modern sense of supervised machine learning. While the algorithm was developed based on physiological data, the concept of a distinct, labeled "training set" as used in current AI/ML applications is not directly analogous here. The submission states the N-395 uses a "similar SpO2 and Pulse Rate software algorithm" to the predicate, N-3000, implying the core algorithm was already established.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable / Not Provided. As mentioned above, the device likely relies on a pre-existing algorithm developed from physiological principles and empirical data. The submission doesn't detail the development and "training" of this algorithm, but it would have involved similar controlled human studies where pulse oximeter readings were correlated with simultaneously obtained arterial blood gas measurements across a range of oxygen saturation levels.

Summary

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AUG 25 1999

991823

Section 16. 510(k) Summary

Section 16.a Date Summary Prepared

May 26. 1999

Section 16.b Company Information

Establishment:

Official Correspondent:

Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588

David A. C. Green Site Manager, Requlatory Affairs Nellcor Puritan Bennett Inc. 2200 Faraday Avenue Carlsbad, CA 92008-7208 (760) 603-5978 (direct phone) (760) 603-5907 (fax)

Section 16.c Name of Device

Proprietary:

Common/Usual:

N-395 Pulse Oximeter

Pulse Oximeter

Classification:

Oximeter (§870.2700/74DQA)

Section 16.d Equivalent Devices

Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for predicate devices and for the N-395, as well as testing to accepted industry standards. In addition, in-vitro and non-invasive controlled hypoxia studies were conducted to establish the N-395's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the N-395. The predicate devices are as follows:

1. N-3000 Pulse Oximeter, Nellcor Puritan Bennett Inc., K955642
1. Model 2000 Pulse Oximeter, Ivy Biomedical Systems, Inc., K982255

Section 16.e Device Description

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From 100V to 240V) or alternatively by an integral sealed 6V rechargeable lead-acid battery. The N-395 is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities and intra-hospital transport environments.

Audible and visual alarms for high/low saturation, pulse rate and pulse search are The N-395 also includes adjustable alarm silence duration and other provided. configurable power-on settings. The N-395 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The N-395 Pulse Oximeter has visual indicators for pulse search, motion, power mode (i.e. battery or AC) and alarm silence in addition to alarm features.

In addition to the above mentioned device features, the instrument has been designed to satisfy the needs of both the user and the patient. A convenient carrying handle is incorporated into the case. There is also a serial port (EIA-232 and RS-422 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers. There is also an interface for nurse call systems through the rear connector. The device is also Flash ROM upgradable.

Section 16.f Intended Use

The intended use of the N-395 Pulse Oximeter is for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and neonate patients. The environments of use are hospitals, hospital-type facilities and intra-hospital transport. The intended use, patient population and environment of use are the same or similar to the predicate devices, the Nellcor Puritan Bennett Model N-3000 Pulse Oximeter and the Ivy Biomedical Systems Model 2000 Pulse Oximeter.

Section 16.g Technological Characteristics

The N-395 Pulse Oximeter measures functional oxygen saturation by calculating the light absorption of tissue, bone and blood in the sampling light beam path during thepulsatile cycle. Red and infrared LED's are utilized as light sources. A photodiode acting as a photodetector senses the signal strengths of the two wavelengths of light. which vary inversely with the amount of light transmitted through the tissue. The N-395 receives this electrical information from the sensor and processes the information by use of an oximetry algorithm to provide real time values of SpO2, Pulse Rate and Pulse Amplitude.

The N-395 uses a similar SpO2 and Pulse Rate software algorithm to process the information from the sensor as the predicate device, N-3000, cleared under K955642.

In addition. The N-395 possesses motion-filtering software that reduces the effects of patient/sensor motion, enabling the N-395 to read through motion artifact to provide valid SpO2 and Pulse Rate readings for many types of motion.

Also included is an alarm management software technique, known as SatSeconds which allows the careqiver to set the N-395 to accept desaturations below a specified threshold without alarming if those desaturations are of short duration or small magnitude.

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Section 16.h Certification Statement

In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:

Nellcor Puritan Bennett Inc. believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.

David A. C. Cullen.

David A. C. Green Site Manager, Regulatory Affairs for Nellcor Puritan Bennett Inc.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight, with three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1999

Mr. David A. C. Green Nellcor Puritan Bennett, Inc. 2200 Faraday Avenue Carlsbad, CA 92008-7208

Re: K991823 N-395 Pulse Oximeter Requlatory Class: II (two) Product Code: 74 DQA Dated: May 26, 1999 Received: May 27, 1999

Dear Mr. Green:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David A. C. Green

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: N-395 Pulse Oximeter

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)Division of Cardiovascular, Respiratory, and Neurological Devices	(Division Sign-Off)	Division of Cardiovascular, Respiratory, and Neurological Devices
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K991823
Prescription Use(Per 21 CFR 801.109)	OROver-The-Counter Use
	(Optional Format 1-2-96)

Regulation Number and Section

§ 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).