The intended use of the NPB-195 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 hospital, hospital-type, intra-hospital transport and home environments. For prescription use only.

Device Description

The NPB-195 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 NPB-195 displays digital values of SpO2 and pulse rate, and pulse amplitude by means of a "blip bar" presentation. The NPB-195 is also capable of displaying a Pleth Waveform and trends on its LCD display. The NPB-195 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 integral sealed 6V rechargeable lead-acid battery. The NPB-195 is intended for prescription use with adult, pediatric and neonatal patients in hospital, hospital-type, intra-hospital transport and home environments.

Audible and visual alarms for high/low saturation, pulse rate and pulse search are provided. The NPB-195 also includes adjustable alarm silence duration and other configurable power on settings. The NPB-195 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-195 Pulse Oximeter has visual indicators for pulse search, 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 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers and can interface with nurse call systems through the rear connector. The device is also Flash ROM upgradable.

AI/ML Overview

The provided text mentions that "noninvasive controlled hypoxia studies were conducted to establish the NPB-195's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-195." However, it does not explicitly state the acceptance criteria or provide the specific results of these studies in a format that allows for a table of acceptance criteria versus reported performance.

Therefore, I cannot directly fulfill item 1, 2, 3, 4, 5, 6, 7, 8, and 9 with the information given. The document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices and describes the device's main features and intended use. It does not contain the detailed study results or methodology typically found in a clinical study report.

Based on the provided text, here's what can be extracted and what cannot be:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided directly. The document states that studies were done "to establish the NPB-195's accuracy and to ensure that the sensors meet their currently published accuracy specifications," but it does not list what those specifications are, nor does it provide the accuracy results from these studies.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be provided directly. The text mentions "noninvasive controlled hypoxia studies" but does not specify the number of subjects, their demographics, or where the studies were conducted. It implies prospective studies ("were conducted").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Cannot be provided. For pulse oximeters, the "ground truth" for oxygen saturation is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual assessment. The document does not mention the methodology for establishing ground truth during the hypoxia studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Cannot be provided. As the ground truth would likely be established by objective measurements (e.g., co-oximetry), an adjudication method by experts is not relevant in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a pulse oximeter, which is an automated measurement device, not an AI-powered diagnostic imaging tool that requires human reader interpretation. Therefore, an MRMC study with human readers improving with AI assistance is not relevant to this technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The "noninvasive controlled hypoxia studies" described would assess the accuracy of the device (algorithm and sensor combined) in measuring SpO2 and pulse rate, which is a standalone performance evaluation for a pulse oximeter. However, the specific results of this standalone performance are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Implied arterial blood gas analysis (co-oximetry). While not explicitly stated, the standard for establishing ground truth for oxygen saturation in controlled hypoxia studies for pulse oximeters is simultaneously drawn arterial blood samples analyzed by a co-oximeter. This is the gold standard for SpO2 accuracy.

8. The sample size for the training set:

Not applicable/Cannot be provided. The text states that the NPB-195 uses the "same SpO2 software algorithm" as the predicate device, NPB-40 (cleared under K963707). This suggests that the algorithm was developed and "trained" (in a historical sense) prior to the NPB-195, likely during the development of the NPB-40. The document does not provide details of the training set used for that algorithm.

9. How the ground truth for the training set was established:

Not applicable/Cannot be provided. Similar to point 8, this information pertains to the original algorithm development, which is not detailed for either the NPB-195 or its predicate in this summary. It would likely have been established using arterial blood gas analysis during earlier development studies.

Summary

{0}------------------------------------------------

11-1 171 11

Section 16. 510(k) Summary

Section 16.a Date Summary Prepared

30 June 1997

SEP 2 5 199

Section 16.b Company Information Establishment:

Official Correspondent:

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

Roger D. Brown Regulatory Affairs Specialist Nellcor Puritan Bennett Inc. 11150 Thompson Avenue Lenexa, KS 66219 (913) 495-7146 (direct phone) (913) 495-7285 (fax)

Section 16.c Name of Device

Proprietary:

Common/Usual:

NPB-195 Pulse Oximeter

Pulse Oximeter

Classification:

Altrades plant

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 the NPB-195, as well as testing to accepted industry standards. In addition, noninvasive controlled hypoxia studies were conducted to establish the NPB-195's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-195. The predicate devices are as follows:

NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett Inc., K963707
Ohmeda 3800 Pulse Oximeter, Ohmeda Inc., K962127

847

{1}------------------------------------------------

Section 16.e Device Description

Section 16.f Intended Use

The intended use of the NPB-195 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 hospital, hospitaltype facilities, intra-hospital transport and the home. The intended use, patient population and environment of use are the same or similar to the predicate devices, the NPB-40 and Ohmeda 3800,

Section 16.g Technological Characteristics

The NPB-195 Pulse Oximeter measures functional oxygen saturation by calculating the light absorption of tissue, bone, and blood in the sampling light beam path during the pulsatile cycle. Red and infrared LED's are utilized as light sources. A photodiode acting as a photodetector senses the signal strength of the two wavelengths of light, which vary inversely with the amount of light transmitted through the tissue. The NPB-195 receives this electrical information from the sensor and processes the information by use of an SpO2 software algorithm to provide a real time value of SpO2.

The software algorithm is contained in the NPB-195 "engine". The "engine" (part of the instrument that processes the analog signals from the sensors) consists of electrical circuitry and processors that calculate the SpO2, pulse rate, and pulse amplitude. The electrical circuitry of the NPB-195 engine is the same as the engine used by the predicate device, NPB-40, cleared under K963707. The NPB-195 also uses the same SpO2 software algorithm to process the information from the sensor as the predicate device, NPB-40, cleared under K963707.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 1997

Mr. Roger D. Brown Nellcor Puritan Bennett Inc. 11150 Thompson Avenue Lenexa, Kansas 66219-2301

K972468 Re: NPB-195 Pulse Oximeter Regulatory Class: II (two) 74 DQA Product Code: Dated: June 30, 1997 Received: July 1, 1997

Dear Mr. Brown:

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 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 Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, 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 requlation (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 regulatory 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.

{3}------------------------------------------------

Page 2 - Mr. Roger D. Brown

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 regulation (21 CFR Part 801 and additionally 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" (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.qov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

{4}------------------------------------------------

Page	1 of 1
------	--------

510(k) Number (if known):	K972468
Device Name:	NPB-195 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)

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
------------------------------------------	----	--------------------------------------------------

(Division Sign-Off)Division of Cardiovascular, Respiratory,and Neurological Devices510(k) Number	K972468
--------------------------------------------------------------------------------------------------------------	---------

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).