The intended use of the NPB-190 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulserate. For violiti neonatal, pediatric and adult patients, in hospital-type, intra-hospital transport and home environments. For prescription use only.

Device Description

The NPB-190 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett oxygen transducers (sensors). The NPB-190 displays digital values of SpO- and pulse rate and pulse amplitude by means of a "blip bar" presentation. The NPB-190 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 an integral sealed 6V rechargeable lead-acid battery. The NPB-190 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 The NPB-190 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-190 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-190 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 was 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

Here's a breakdown of the acceptance criteria and study information for the Nellcor Puritan Bennett NPB-190 Pulse Oximeter, based on the provided K971946 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific numerical acceptance criteria for the NPB-190 Pulse Oximeter's accuracy (e.g., a specific SpO2 accuracy range). Instead, it relies on demonstrating substantial equivalence to predicate devices and performance against "currently published accuracy specifications" of its sensors.

However, the document mentions:

Substantial equivalence to legally marketed predicate devices:
- NPB-40 Handheld Pulse Oximeter (K963707)
- Nellcord N-200 Pulse Oximeter (K863784)
- BCI 3304 Oximeter (K962156)
Testing to accepted industry standards.
Noninvasive controlled hypoxia studies were conducted to establish the NPB-190's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-190.

Without the "currently published accuracy specifications" or the results of the hypoxia studies, a numerical table cannot be precisely filled. However, we can infer the acceptance criteria are implicitly met if the device performs comparably to the predicate devices and meets its sensor specifications in the hypoxia studies.

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

Sample Size for Test Set: The document does not explicitly state the specific number of subjects or data points used in the noninvasive controlled hypoxia studies.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The "noninvasive controlled hypoxia studies" were conducted to "establish the NPB-190's accuracy," which implies a prospective study design specifically for this device's validation.

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

The document does not specify the number or qualifications of experts used to establish ground truth in the hypoxia studies. In controlled hypoxia studies for pulse oximetry, the "ground truth" (arterial oxygen saturation, SaO2) is typically obtained via arterial blood gas (ABG) analysis, which is a direct measurement performed by laboratory technicians or medical professionals, not usually "experts" in the context of interpretation, but rather skilled operators.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method for establishing ground truth. For controlled hypoxia studies relying on ABG measurements, adjudication as typically seen in image interpretation studies is not usually applicable. The ABG results are considered the direct and objective measurement of SaO2.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human operators in interpreting medical images or data. The NPB-190 Pulse Oximeter is a standalone monitoring device that provides direct readings of SpO2 and pulse rate. There is no human interpretation "with AI vs. without AI assistance" involved in the device's primary function.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was done. The "noninvasive controlled hypoxia studies" described are precisely a standalone performance evaluation. The device (NPB-190 Pulse Oximeter) directly measures and displays SpO2 and pulse rate, and its accuracy was evaluated by comparing its readings to a gold standard (presumably ABG measurements) during induced hypoxia. This assesses the algorithm's (referred to as the "SpO2 software algorithm" and "engine") performance without human intervention in the measurement or calculation process.

7. Type of Ground Truth Used:

For the noninvasive controlled hypoxia studies, the ground truth would be arterial blood gas (ABG) measurements of functional oxygen saturation (SaO2), taken concurrently with the pulse oximeter readings. While not explicitly stated as "ABG," this is the standard gold standard for validating pulse oximeter accuracy.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. The NPB-190 uses an "SpO2 software algorithm" that is stated to be the same as the predicate device NPB-40. This suggests the algorithm was likely developed and "trained" (if machine learning was involved, which is unlikely for a 1997 device) or validated during the development of the NPB-40, rather than the NPB-190 itself. The K971946 submission focuses on demonstrating that the device incorporating this algorithm performs as expected.

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

As the document does not provide information on a training set or its development, it also does not specify how its ground truth would have been established. Given the time period (1997) and the nature of the device (pulse oximeter), it's highly probable that the algorithm was derived from physiological models and empirical data collected from human studies (likely controlled hypoxia studies similar to the validation study) in previous development cycles for the NPB-40 or earlier predicate devices. The ground truth for such development would also have been established via ABG measurements.

Summary

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K971946

Section 16. 510(k) Summary

Section 16.a Date Summary Prepared

23 May 1997

AUG 25 1997

Section 16.b Company Information

Establishment:

Official Correspondent:

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

Roger D. Brown Requlatory 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:	NPB-190 Pulse Oximeter
Common/Usual:	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 comparison of product features as described in the labeling and promotional literature for predicate devices and the NPB-190, as well as testing to accepted industry standards. In addition, noninvasive controlled hypoxia studies were conducted to establish the NPB-190's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-190. The predicate devices are as follows:

1. NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett Inc., K963707
1. Nellcord N-200 Pulse Oximeter, Nellcor Puritan Bennett Inc., K863784
1. BCI 3304 Oximeter, BCI International Inc., K962156

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Section 16.e Device Description

Audible and visual alarms for high/low saturation, pulse rate and pulse search are The NPB-190 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-190 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-190 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 was 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.

Section 16.f Intended Use

The intended use of the NPB-190 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 intra-hospital transport, the hospital, hospital-type facilities and the home. The intended use, patient, population and environment of use are the same or similar to the predicate devices, the NPB-40, N-200 and BCI 3304.

Section 16.g Technological Characteristics

The NPB-190 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-190 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-190 "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-190 engine is the engine used by the predicate device, NPB-40, cleared under K963707. The NPB-190 also uses the same SpO2 software algorithm to process the information from the sensor as the predicate device, NPB-40, cleared under K963707.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 25 1997

Re: K971946 NPB-190 Pulse Oximeter Regulatory Class: II (Two) Product Code: 74 DQA Dated: May 23, 1997 Received: May 27, 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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 A substantially equivalent determination assumes compliance to 895. 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 GMF 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.

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Page 2 - 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.gov/cdrh/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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K971946 510(k) Number (if known):

Device Name: NPB-190 Pulse Oximeter

Indications For Usc:

(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 Devices
510(k) Number. K971946

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).