The intended use of the NPB-290 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-type, intra-hospital transport and home environments. For prescription use only.

Device Description

The NPB-290 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-290 displays digital values of SpO2 and pulse rate, and pulse amplitude by means of a "blip bar" presentation. The NPB-290 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-290 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-290 also includes adjustable alarm silence duration and other configurable power on settings. The NPB-290 provides an audible low battery warning fo alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-290 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 (ElA-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

Here's an analysis of the provided text regarding the acceptance criteria and study for the NPB-290 Pulse Oximeter:

The provided 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (N-3000 Pulse Oximeter) and describes the device's features, intended use, and technological characteristics. It does not explicitly detail specific acceptance criteria values or a comprehensive study report with quantified performance metrics to prove the device meets those criteria.

However, it does mention that "in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-290's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-290." This indicates that such studies were performed, but the results and the specific acceptance criteria are not presented in this document.

Given the limitations of the provided text, I will infer what would typically be acceptance criteria for a pulse oximeter in 1997 and present the information as per your request, noting where details are not present in the provided document.

Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria and precise performance data are NOT explicitly stated in the provided 510(k) summary. The table below represents typical acceptance criteria and inferred performance claims based on the text's assertion of equivalence and testing.

Acceptance Criteria (Inferred/Typical for Pulse Oximeters)	Reported Device Performance (Inferred/Claimed)
SpO2 Accuracy (controlled hypoxia studies):	SpO2 Accuracy: "in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-290's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-290." This implies the device achieved accuracy comparable to industry standards and the predicate device's specifications, but no explicit numerical accuracy (e.g., RMS error or bias) is provided.
Pulse Rate Accuracy:	Pulse Rate Accuracy: The device utilizes "the same SpO2 and Pulse Rate software algorithm... as the predicate device, N-3000." This suggests similar pulse rate accuracy as the predicate, but specific performance data is not provided.
Performance Across Patient Populations (Adult, Pediatric, Neonatal):	Performance Across Patient Populations: The device is intended for "adult, pediatric and neonatal patients." The hypoxia studies would typically involve subjects from these populations to demonstrate accuracy across the specified range, though details are absent.
Environmental Performance (Hospital, Home, Transport):	Environmental Performance: The device is intended for "hospital, hospital-type, intra-hospital transport and home environments." While not explicitly performance criteria, the design considerations (e.g., battery power, portability) suggest adherence to suitability for these environments.
Electromagnetic Compatibility (EMC):	Not explicitly mentioned in the provided text, but would be a standard acceptance criterion for medical devices.
Safety (Electrical, Mechanical):	Not explicitly mentioned in the provided text, but would be a standard acceptance criterion for medical devices.
Usability/Alarm Functionality:	Usability/Alarm Functionality: "Audible and visual alarms for high/low saturation, pulse rate and pulse search are provided. The NPB-290 also includes adjustable alarm silence duration and other configurable power on settings." The presence of these features implies successful implementation and functionality.

Study Details (Based on available information)

Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The text only mentions "in-vitro and non-invasive controlled hypoxia studies."
- Data Provenance: Not specified. It's likely these were conducted in a controlled lab or clinical setting for the purpose of the submission, but country of origin or specific study sites are not mentioned. The studies were prospective as they were specifically "conducted to establish the NPB-290's accuracy."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For controlled hypoxia studies, ground truth for SpO2 is typically established by co-oximetry of arterial blood samples, performed by trained laboratory personnel or clinical staff.
Adjudication method for the test set:
- Adjudication Method: Not applicable/not specified. For controlled hypoxia studies, the comparison is typically made directly between the device's SpO2 readings and the arterial blood gas co-oximeter results; there isn't usually an "adjudication" process in the sense of multiple independent readers evaluating interpretations.
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:
- MRMC Study: No, this is not an MRMC study. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers or interpretations of images/data by varying experts.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, the core accuracy evaluation (controlled hypoxia studies) for the SpO2 and pulse rate measurement is a standalone performance assessment of the device's algorithm and sensor system against a gold standard (arterial blood co-oximetry). The purpose of these studies was specifically to demonstrate the device's intrinsic accuracy.
The type of ground truth used:
- Ground Truth: For SpO2 accuracy, the ground truth would be arterial blood co-oximetry (i.e., laboratory analysis of arterial blood samples). This is the gold standard for directly measuring functional oxygen saturation.
The sample size for the training set:
- Sample Size for Training Set: Not specified. The document states that the NPB-290 uses "the same SpO2 and Pulse Rate software algorithm... as the predicate device, N-3000, cleared under K942347." This implies that the algorithm was developed and likely "trained" (or validated, if not a machine learning algorithm in the modern sense) with data associated with the N-3000, rather than a new training set for the NPB-290 itself. Details about the N-3000's algorithm training data are not in this document.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Given the algorithm is stated to be the same as the predicate N-3000, the ground truth for its original development/validation would also have been established through arterial blood co-oximetry in controlled hypoxia studies. However, the details of that process are not in this document for the NPB-290.

Summary

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KG72837

OCT 21 1997

Section 16. 510(k) Summary

Section 16.a Date Summary Prepared

30 July 1997

Section 16.b Company Information

Establishment:

Official Correspondent:

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

Roger D. Brown Requiatory 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:

Classification:

NPB-290 Pulse Oximeter

Pulse Oximeter

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-290, as well as testing to accepted industry standards. In addition, in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-290's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-290. The predicate devices are as follows:

N-3000 Pulse Oximeter, Nellcor Puritan Bennett Inc., K942347

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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-290 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-290 provides an audible low battery warning fo alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-290 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 (ElA-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 NPB-290 Pulse Oximeter is for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO3) 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 device, the N-3000 Pulse Oximeter.

Section 16.g Technological Characteristics

The NPB-290 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-290 receives this electrical information from the sensor and processes the information by use of an oximetry algorithm to provide a real time value of SpOx, Pulse Rate and Pulse Amplitude.

The oximetry algorithm is contained in the NPB-290 "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 NPB-290 uses the same SpO2 and Pulse Rate software algorithm to process the information from the sensor as the predicate device, N-3000, cleared under K942347.

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Image /page/2/Picture/2 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 three curved lines representing its wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1997

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

K972837 Re: NPB-290 Pulse Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: July 30, 1997 Received: July 31, 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 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.

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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.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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510(k) Number (if known):	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 - 1

Device Name: NPB-290 Pulse Oximeter

Indications For Use:

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(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)

Over-The-Counter Use

(Optional Format 1-2-96)

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Ath. A. Ciarkowski

(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devices 510(k) Number

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).