The intended use of the NPB-295 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with nconatal, pediatric and adult patients, in hospital-type, intra-hospital transport and home cnvironments. For prescription use only.

Device Description

The NPB-295 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 or a range of compansio from of SpO₂ and pulse rate, and pulse amplitude by means of a "blip bar" presentation. The NPB-295 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-295 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-295 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-295 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-295 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. TThere is also an interface for nurse call systems through the rear connector. The device is also Flash ROM upgradable.

AI/ML Overview

Acceptance Criteria and Device Performance for NPB-295 Pulse Oximeter

The provided document describes the NPB-295 Pulse Oximeter and its substantial equivalence to predicate devices, but it does not explicitly state specific acceptance criteria or a dedicated study that proves the device meets predefined criteria with quantitative performance metrics.

Instead, the document mentions that "in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-295's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-295." This implies that the acceptance criteria are tied to the "currently published accuracy specifications" of the compatible sensors and the general expectation of accuracy for pulse oximeters, as established by the predicate devices.

Given the information, a table of stated acceptance criteria and reported device performance cannot be conclusively filled with specific numerical targets from this document. However, we can infer the intent and the type of evaluation performed.

Here's a breakdown based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for accuracy or precision. The performance is implied to be equivalent to the predicate devices and to meet sensor specifications.

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance (Inferred from study description)
SpO₂ Accuracy	Equivalent to predicate devices (N-3000 Pulse Oximeter)	Established through in-vitro and non-invasive controlled hypoxia studies. Sensors met their currently published accuracy specifications with the NPB-295.
Pulse Rate Accuracy	Equivalent to predicate devices (N-3000 Pulse Oximeter)	Established through in-vitro and non-invasive controlled hypoxia studies. Sensors met their currently published accuracy specifications with the NPB-295.
General Functionality	Consistent with "accepted industry standards" and the features of predicate devices.	Functionality confirmed through testing to accepted industry standards and comparison to predicate devices.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: The studies conducted were "in-vitro and non-invasive controlled hypoxia studies." This suggests the data was likely prospective and collected in a controlled environment as part of the device testing. The country of origin of the data is not specified, but given the company (Nellcor Puritan Bennett Inc.) and the FDA submission, it's likely from the US or a region adhering to similar medical device standards.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

The nature of pulse oximetry accuracy assessment typically involves comparison to a reference standard (e.g., co-oximetry of arterial blood samples). While experts (e.g., clinicians, laboratory technicians) would be involved in executing these studies and interpreting results, the document doesn't detail their specific role in "establishing ground truth" as might be the case for image-based diagnostic devices requiring expert consensus.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified.

For pulse oximeter accuracy studies using controlled hypoxia and co-oximetry, the ground truth (arterial oxygen saturation) is a direct physiological measurement, not typically subject to expert adjudication in the same way as, for example, classifying medical images.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or indicated. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role and the AI's impact on reader performance is being evaluated. The NPB-295 is a monitoring device that provides direct physiological measurements.

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

Standalone Study: Yes, implied. The "in-vitro and non-invasive controlled hypoxia studies" were conducted to "establish the NPB-295's accuracy." This type of study evaluates the device's output (SpO₂ and pulse rate) directly against a reference standard, which is a standalone performance evaluation of the algorithm and hardware without human intervention in the interpretive output.

7. Type of Ground Truth Used

Type of Ground Truth: The context of "non-invasive controlled hypoxia studies" for pulse oximeters strongly suggests that the ground truth would be established using arterial blood gas analysis (e.g., co-oximetry), which is considered the gold standard for measuring arterial oxygen saturation (SaO₂).

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified.

The document states that "The NPB-295 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 and K952316." This implies that the algorithm itself might have been trained or developed based on data used for the predicate device, or it's a well-established, validated algorithm. The current submission focuses on demonstrating the new device's implementation of this existing algorithm.

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

How Ground Truth for Training Set Was Established: Not specified.

As mentioned above, the algorithm is stated to be the same as the predicate device. Therefore, any "training" (if applicable to the type of algorithm used) would have occurred prior to the predicate device's clearance. The document focuses on demonstrating the new device's performance with this established algorithm.

Summary

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NOV I 4 1997

Section 16. 510(k) Summary

Section 16.a Date Summary Prepared

22 August 1997

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:

Pulse Oximeter

NPB-295 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 the NPB-295, as well as testing to accepted industry standards. In addition, in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-295's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-295. The predicate devices are as follows:

N-3000 Pulse Oximeter, Nellcor Puritan Bennett Inc., K942347 and K952316

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Section 16.e Device Description

Section 16.f Intended Use

The intended use of the NPB-295 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-295 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-295 receives this electrical information from the sensor and processes the information by use of an oximetry algorithm to provide a real time value of SpO3, Pulse Rate and Pulse Amplitude.

The oximetry algorithm is contained in the NPB-295 "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-295 uses the same SpO, and Pulse Rate software algorithm to process the information from the sensor as the predicate device, N-3000, cleared under K942347 and K952316.

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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.

Roger D. Bu

Roger D. Brown Regulatory Affairs Specialist for Nellcor Puritan Bennett Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 4 1997

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

Re: K973147 NPB-295 Pulse Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: Auqust 19, 1997 Received: August 22, 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 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. 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):	K973147
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Device Name: NPB-295 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)

ﻧﻪ ﺩﺭ ﺍﺳ

Over-The-Counter Use

(Optional Format 1-2-96)

th. A. Cill.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K973147 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).