(88 days)
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No
The description focuses on conventional oximetry technology, embedded software for basic functions, and standard hardware components. There is no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.
No
The device is described as a pulse oximeter intended for non-invasive spot-check measurement of functional arterial oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
The device is intended for "non-invasive spot-check measurement of functional arterial oxygen saturation (SpO2) and pulse rate," which are measurements used to assess a patient's physiological state, thereby contributing to diagnosis.
No
The device description explicitly states it is a "light-weight, portable, hand-held noninvasive pulse oximeter" consisting of a "copper-acrylic-shielded plastic box which houses two PCB boards and a power supply." It also mentions an "LCD display panel" and "audible indicators," all of which are hardware components. While it contains embedded software, it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The NPB-40 Handheld Pulse Oximeter is a non-invasive device that measures physiological parameters (SpO2 and pulse rate) directly from the patient's body using a sensor placed on the skin. It does not analyze samples taken from the body.
Therefore, based on the provided information, the NPB-40 Handheld Pulse Oximeter falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
74DQA
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults, pediatric, and neonatal patients
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.
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