The NPB-500 Spirometry System's intended use is simple diagnostic forced vital capacity (FVC) testing for adults of all ages plus pediatric patients, in the patient examination rooms of a physician's practice and in hospital-type facilities such as respiratory care centers. The NPB 500 Spirometry System is for prescription use only.

Device Description

The NPB-500 Spirometry System comprises the following five components, including accessories: NPB-500 Spirometer (hand held), Flow Sensor II, Pressure Tubing, NPB-510 Spirometer Base (optional) and Printer/PC Cable (optional). Two versions of the cable are available, namely, a parallel cable for a Printer and a serial cable for a PC. The NPB-500 is a hand held diagnostic Spirometer intended for patient use in the performance of Forced Vital Capacity, FVC, testing. The patient performing a test is requested to take a deep breath and then exhale vigorously and continuously into the sensor's mouthpiece until complete exhalation is achieved. Initially, the testing process requires patient cooperation and supervisory coaching to achieve optimum results. FVC parameter test results may be displayed on the Spirometer's front face LCD display. Alternatively, the Spirometer can be inserted into the optional Spirometer Base, enabling data to be interfaced, via an output data port, to a parallel printer for graphical printout of the patient's test record, or to a PC. In addition to the above mentioned device features, the instrument has been designed to satisfy the needs of both the user and the patient. An audible, mid frequency, beep tone is provided to prompt the User for input, inform the User of the successful completion of a process step or warn of low battery condition. The NPB-500 System is powered by two AA size standard alkaline batteries which can provide an estimated operating time of six months under normal use.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria for the NPB-500 Spirometry System, nor does it describe a detailed study proving the device meets those criteria with specific performance metrics.

However, based on the general information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not directly available in the provided text. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with explicit acceptance criteria and corresponding results for the NPB-500.

However, it states: "Safety and environmental testing to accepted industry standards has been conducted as well as in-vitro testing to confirm the accuracy of the NPB-500 Spirometry System." This implies that some form of accuracy testing was performed.

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

This information is not provided in the text. The document mentions "in-vitro testing," which generally refers to testing in a controlled environment, often on simulated biological materials or using calibrated equipment. It does not mention patient data.

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

This information is not provided. Since the document mentions "in-vitro testing," it's unlikely that human experts were used to establish ground truth in the traditional sense of clinical studies.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical test set with human assessments is described, an adjudication method would not be applicable within the scope of the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the provided text does not mention an MRMC comparative effectiveness study. The document primarily focuses on demonstrating substantial equivalence by comparing product features and in-vitro testing.

6. If a Standalone Performance Study was done

Yes, a standalone performance study in the form of "in-vitro testing" was performed. The text states: "...as well as in-vitro testing to confirm the accuracy of the NPB-500 Spirometry System." However, the details of this testing (e.g., methodology, specific measurements, acceptance thresholds, and actual results) are not provided.

7. The Type of Ground Truth Used

Based on "in-vitro testing," the ground truth would likely be established by:

Calibrated reference standards: Using precisely known flow and volume measurements from calibrated spirometry testing equipment.
Simulated breath profiles: Generating known breath patterns to test the device's accuracy in measuring FVC parameters.

8. The Sample Size for the Training Set

This information is not explicitly provided. The document mentions: "The embedded software contains substantially the same software algorithm for determining test values of FVC parameters as used on the predicate device, the NPB-Renaissance, cleared under K944762, except for the inclusion of non-linear correction terms in the pressure/flow equation of the sensor." This suggests that the algorithm was likely developed and refined using data, but the size and nature of this "training set" (if applicable in the modern sense of machine learning) are not specified.

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

This information is not explicitly provided. Given the nature of spirometry algorithms, the ground truth for training (or development/calibration) would typically involve:

Highly accurate reference spirometry systems: Gold-standard devices providing precise flow and volume measurements.
Known physical models: Data generated from mechanical lung simulators with controlled parameters.
Clinical data with expert review: Though less likely for pure algorithm training in this context, it could involve data where respiratory physiologists or similar experts confirm the accuracy of reference measurements.

In summary, the provided document does not offer the detailed breakdown of acceptance criteria and performance study results as requested, but rather focuses on substantial equivalence based on device features and general "in-vitro accuracy testing."

Summary

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APR 3 0 1998

K980411

Section 16. 510(k) Summary

Section 16.a Date Summary Prepared

30 January 1998

Section 16.b Company Information

Establishment:

Official Correspondent:

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

David A.C. Green Manager, Regulatory Affairs Nellcor Puritan Bennett Inc. 11150 Thompson Avenue Lenexa, KS 66219 (913) 495-7140 (direct phone) (913) 495-7285 (fax)

Section 16.c Name of Device

Proprietary:

Common/Usual:

Classification:

NPB-500 Spirometry System Spirometer Spirometer (§868.1840/73BZG)

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 the predicate devices and the NPB-500 Spirometry System. Safety and environmental testing to accepted industry standards has been conducted as well as in-vitro testing to confirm the accuracy of the NPB-500 Spirometry System. The predicate devices are as follows:

1. Nellcor Puritan Bennett Inc., NPB-Renaissance Spirometer, K944762
1. Vitalograph Ltd., Model 2120 Spirometer, K946075

Section 16.e Device Description

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The NPB-500 is a hand held diagnostic Spirometer intended for patient use in the performance of Forced Vital Capacity, FVC, testing. The patient performing a test is requested to take a deep breath and then exhale vigorously and continuously into the sensor's mouthpiece until complete exhalation is achieved. Initially, the testing process requires patient cooperation and supervisory coaching to achieve optimum results.

FVC parameter test results may be displayed on the Spirometer's front face LCD display. Alternatively, the Spirometer can be inserted into the optional Spirometer Base, enabling data to be interfaced, via an output data port, to a parallel printer for graphical printout of the patient's test record, or to a PC.

In addition to the above mentioned device features, the instrument has been designed to satisfy the needs of both the user and the patient. An audible, mid frequency, beep tone is provided to prompt the User for input, inform the User of the successful completion of a process step or warn of low battery condition. The NPB-500 System is powered by two AA size standard alkaline batteries which can provide an estimated operating time of six months under normal use.

Section 16.f Intended Use

The NPB-500 Spirometry System is intended for prescription use only to conduct simple diagnostic forced vital capacity (FVC) testing of adults plus pediatric patients, in the patient examination rooms of a physician's practice and in hospital or hospital-type facilities such as respiratory care centers. The intended use, patient population and environment of use are the same or similar to the predicate devices, the NPB-Renaissance Spirometer and the Vitalograph model 2120 Spirometer.

Section 16.g Technological Characteristics

A pneumotachometer sensor is used to convert the expired breath flow signal into a pressure signal. The NPB-500 Spirometry System measures the values of FVC parameters by continuously sensing this pressure throughout an expired breath. This signal is pneumatically coupled to a pressure transducer in the NPB-500 Spirometer to develop corresponding electrical data. Conventional electronics and embedded software are used to process this data and generate numerical values of FVC parameters for presentation on the NPB-500's LCD display. Alternatively, graphical test results may be recorded on a printer.

The embedded software contains substantially the same software algorithm for determining test values of FVC parameters as used on the predicate device, the NPB-Renaissance, cleared under K944762, except for the inclusion of non-linear correction terms in the pressure/flow equation of the sensor.

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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 Manager, Regulatory Affairs for Nellcor Puritan Bennett Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Mr. David A.C. Green Nellcor Puritan Bennett Inc. 11150 Thompson Avenue Lenexa, KS 66219-2301

K980441 Re: NPB-500 Spirometry System Regulatory Class: II (two) Product Code: 73 BZG Dated: February 3, 1998 Received: February 4, 1998

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 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 requlations 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 Failure to comply with the GMP regulation may result in assumptions. 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. 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 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): 6980441

NPB-500 Spirometry System Device Name:

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)

Over-The-Counter Use

(Optional Format 1-2-96)

M. Ruan

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

510(k) Number

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).