(88 days)
The NPB-40 Handheld Pulse Oximeter is intended for non-invasive spot-check measurement of functional arterial oxygen saturation (SpO2) and pulse rate of adults, pediatric, and neonatal patients in hospital, emergency, transport, and mobile environments, as well as in the home. The NPB-40 is for attended monitoring only and is intended to be used under the direct observation of a qualified health care provider.
The NPB-40 Handheld Pulse Oximeter is a light-weight, portable, hand-held noninvasive pulse oximeter that operates on four size "AA" alkaline batteries and utilizes conventional oximetry technology to measure arterial oxygen saturation and pulse rate. The device consists of a copper-acrylic-shielded plastic box which houses two PCB boards and a power supply. On the boards are the digital and analog hardware with embedded software and power supply regulation. On the front of the device is an LCD display panel for the various readouts provided. The readouts consist of a numeric display showing oxygen saturation (SpO2) and pulse rate along with a lighted bar showing pulse amplitude. The display panel has visual icons to indicate low battery, pulse search, sensor disconnect, store data and print data. The device has audible indicators of varying tones and duration for the following conditions: pass self-test, sensor disconnect, no pulse detected initially, pulse detected then lost, low battery, impending dead battery. The device produces a constant pitch "beep" sound for each pulse. The NPB-40 is not equipped with alarms and is labeled for "attended" monitoring only. The NPB-40 has the ability to print stored event data when used with a Hewlett Packard printer, model HP82240B. Available accessories include a protective rain boot, a rain jacket, EC-4 sensor extension cable, and a carrying case. The NPB-40 is compatible with all Nellcor Puritan Bennett reusable and patient-dedicated oxygen transducers (sensors).
Below is the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating equivalence to a predicate device (N-20 Handheld Pulse Oximeter) rather than explicitly stating quantitative acceptance criteria for the NPB-40's standalone performance. However, it does highlight areas of evaluation:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pulse Rate Accuracy relative to specifications | Performed in accordance with its specification relative to pulse rate accuracy (in vitro tests). |
| Oxygen Saturation Accuracy equivalent to predicate (N-20) | Demonstrated equivalent oxygen saturation accuracy to the N-20 Handheld Pulse Oximeter (Non-Invasive Controlled Hypoxia Study). |
| Software design and validation | Conducted in accordance with Reviewer's Guidance for Computer Controlled Medical Devices, with all applicable requirements met. |
| Environmental and EMC testing | Conducted as recommended by applicable sections of the Anesthesiology and Respiratory Devices Branch Draft Reviewer's Guidance for Premarket Notification Submissions, November 1993. |
2. Sample Size Used for the Test Set and Data Provenance:
- Pulse Rate Accuracy (in vitro): The document does not specify the sample size for the in vitro tests for pulse rate accuracy.
- Oxygen Saturation Accuracy (Non-Invasive Controlled Hypoxia Study): The document does not specify the sample size (number of patients) involved in this study.
- Data Provenance: The Non-Invasive Controlled Hypoxia Study was described as being conducted, implying a prospective design, but the country of origin is not mentioned. It states "informed consent was obtained from each patient," confirming a prospective human study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for either the in vitro pulse rate accuracy tests or the Non-Invasive Controlled Hypoxia Study. The ground truth for oxygen saturation would likely be established by a co-oximeter or blood gas analyzer, which are considered the gold standard for measuring arterial oxygen saturation, rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set:
Not applicable. This device is a pulse oximeter, and the ground truth for its measurements (pulse rate, oxygen saturation) is typically established by objective instrumentation or blood analysis, not by human adjudication of observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device measures physiological parameters directly.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Yes, the studies described are essentially standalone performance evaluations of the device.
- The "in vitro laboratory studies" for pulse rate accuracy would be a standalone evaluation of the device's algorithm and hardware.
- The "Non-Invasive Controlled Hypoxia Study" also evaluates the standalone performance of the NPB-40's oxygen saturation measurement against a reference standard in a clinical setting.
The "oximetry algorithm" is embedded in the device, and the testing demonstrates its performance. Human "in-the-loop" performance is not evaluated beyond the statement that the device is for "attended monitoring only" and "under the direct observation of a qualified health care provider," which defines its intended use environment, not its measurement performance.
7. The Type of Ground Truth Used:
- Pulse Rate Accuracy: The ground truth for in vitro pulse rate accuracy would typically be established by a reference signal generator or very precise mechanical measurement. The document does not specify the exact method but implies a highly accurate reference.
- Oxygen Saturation Accuracy: For the Non-Invasive Controlled Hypoxia Study, the ground truth for oxygen saturation would be established by a "gold standard" method, most commonly a co-oximeter or arterial blood gas analysis, which provides precise measurements of functional arterial oxygen saturation.
8. The Sample Size for the Training Set:
The document does not provide information about a "training set" or its sample size. This is typical for medical devices that implement established physiological measurement principles. While there might have been internal development data used to optimize algorithms, the 510(k) summary focuses on the validation of the device's final performance, not its development or training phases. The N-20 (predicate device) used the "same oximetry algorithm," suggesting that the core algorithm was developed previously.
9. How the Ground Truth for the Training Set Was Established:
As no training set information is provided, there is no detail on how its ground truth was established.
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16. 510(k) SUMMARY
September X, 1996
DEC 13 1996
- COMPANY INFORMATION
| Establishment: | Nellcor Puritan Bennett Incorporated 4280 Hacienda Drive Pleasanton, CA 94588 (510) 463-4348 |
|---|---|
| Official Correspondent: | Donna Page Manager, Regulatory Affairs |
- DEVICE NAME
| Proprietary: | NPB-40 Handheld Pulse Oximeter |
|---|---|
| Common/Usual: | Pulse Oximeter |
| Classification: | Oximeter, 74DQA |
3. EQUIVALENT DEVICE
The NPB-40 Handheld Pulse Oximeter is technically equivalent to the N-20 Handheld Pulse Oximeter. The NPB-40's indications for use are also equivalent to the intended use of the N-20 Handheld Pulse Oximeter. The N-20 Handheld Pulse Oximeter was originally cleared under 510(k) #K915699 on May 27, 1993.
4. DEVICE DESCRIPTION
The NPB-40 Handheld Pulse Oximeter is a light-weight, portable, hand-held noninvasive pulse oximeter that operates on four size "AA" alkaline batteries and utilizes conventional oximetry technology to measure arterial oxygen saturation and pulse rate. The device consists of a copper-acrylic-shielded plastic box which houses two PCB boards and a power supply. On the boards are the digital and analog hardware with embedded software and power supply regulation. On the front of the device is an LCD display panel for the various readouts provided. The readouts consist of a numeric display showing oxygen saturation (SpO2) and pulse rate along with a lighted bar showing pulse amplitude. The display panel has visual icons to indicate low battery, pulse search, sensor disconnect, store data and print data. The device has audible indicators of varying tones and duration for the following conditions: pass self-test, sensor disconnect, no pulse detected initially, pulse detected then lost, low battery, impending dead battery. The device produces a constant pitch "beep" sound for each pulse. The NPB-40 is not equipped with alarms and is labeled for "attended" monitoring only. The NPB-40 has the ability to
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print stored event data when used with a Hewlett Packard printer, model HP82240B. Available accessories include a protective rain boot, a rain jacket, EC-4 sensor extension cable, and a carrying case. The NPB-40 is compatible with all Nellcor Puritan Bennett reusable and patient-dedicated oxygen transducers (sensors).
The NPB-40's pulse oximetry technology is based on the principles of spectrophotometry and plethysmography.
5. INTENDED USE
The NPB-40 Handheld Pulse Oximeter is intended for non-invasive spot-check measurement of functional arterial oxygen saturation (SpO2) and pulse rate of adults, pediatric, and neonatal patients in hospital, emergency, transport, and mobile environments, as well as in the home. The NPB-40 is for attended monitoring only and is intended to be used under the direct observation of a qualified health care provider. The indications for use of the NPB-40 are equivalent to those for the legally marketed predicate device, the N-20 Handheld Pulse Oximeter, therefore, there is no impact on safety and effectiveness.
6. TECHNOLOGICAL CHARACTERISTICS
The NPB-40 Handheld Pulse Oximeter has technological characteristics equivalent to those of the N-20 Handheld Pulse Oximeter. A comparison of the devices' design, features, principles and methods of operation and labeling support technical equivalency. In addition, testing has been done on the NPB-40 to confirm that oximetry performance is equivalent to that of the predicate N-20. The same oximetry algorithm is used in both products.
Comparative Performance Evaluations - The safety and effectiveness of the NPB-40 Handheld Pulse Oximeter has been demonstrated by design and testing. Environmental and EMC testing has been conducted as recommended by applicable sections of the Anesthesiology and Respiratory Devices Branch Draff Reviewer's Guidance for Premarket Notification Submissions, November 1993. Software design and validation has been conducted in accordance with the Reviewer's Guidance for Computer Controlled Medical Devices. Testing results demonstrated that all applicable requirements have been met.
Nellcor Puritan Bennett evaluated the NPB-40 Handheld Pulse Oximeter in comparison to the currently marketed N-20 Handheld Pulse Oximeter in in vitro laboratory studies in order to demonstrate equivalent pulse rate accuracy between the two devices. Results of the in vitro tests demonstrated that the NPB-40 performed in accordance with its specification relative to pulse rate accuracy. NPB also conducted a Non-Invasive Controlled Hypoxia Study to validate oxygen saturation accuracy of the NPB-40 across the NPB sensor line. The goal of this study was to validate that the NPB-40 has oxygen saturation accuracy performance equivalent to the predicate N-20 pulse oximeter. Results of this study demonstrated that the NPB-40 and N-20 Handheld Pulse Oximeters have equivalent oxygen saturation accuracy. The Non-Invasive Controlled Hypoxia Study was conducted
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under a non-significant risk IDE and informed consent was obtained from each patient.
Conclusions: It can be concluded from the above referenced nonclinical and clinical tests that the NPB-40 Handheld Pulse Oximeter is equivalent to the N-20 Handheid Pulse Oximeter.
:
§ 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).