(27 days)
The N-395 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with neonatal, pediatric and adult patients during both no motion conditions and for patients who are well or poorly perfused, in hospital-type facilities and intra-hospital transport environments. For prescription use only.
The N-395 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 N-395 displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation. The N-395 can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 100V to 240V) or alternatively by an integral sealed 6V rechargeable lead-acid battery. The N-395 is intended for prescription use with adult, pediatric and neonatal patients in hospital-type facilities and intrahospital transport environments. Audible and visual alarms for high/low saturation, pulse search are provided. The N-395 also includes adjustable alarm silence duration and other configurable power-on settings. The N-395 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The N-395 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. There is also an interface for nurse call systems through the rear connector. The device is also Flash ROM upgradable. The N-395 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 strengths of the two wavelengths of light, which vary inversely with the amount of light transmitted through the tissue. The N-395 receives this electrical information from the sensor and processes the information by use of an oximetry algorithm to provide real time values of SpO2, Pulse Rate and Pulse Amplitude. The N-395 uses a similar SpO2 and Pulse Rate software algorithm to process the information from the sensor as the predicate device, N-3000, cleared under K955642, In addition, the N-395 possesses motion-filtering software that reduces the effects of patient/sensor motion, enabling the N-395 to read through motion artifact to provide valid SpO2 and Pulse Rate readings for many types of motion. Also included is an alam management software technique, known as SatSeconds which allows the caregiver to set the N-395 to accept desaturations below a specified threshold without alarming if those desaturations are of short duration or small magnitude. This submission requests clearance for a labeling modification to the original N-395, cleared under K991823, to extend Motion Performance Claims to three additional oximetry sensors, as follows: N-395 Motion Performance Device Claims: The N-395 features OXISMART®XL advanced digital signal processing which 1. enables the N-395 to read through motion artifact to deliver accurate saturation and pulse rate values. The N-395 reads through challenging motion conditions giving valid SpO2 and 2. Pulse Rate readings for many types of motion.
The provided document is a 510(k) summary for a pulse oximeter, primarily focusing on extending motion performance claims to additional sensors. While it describes the device and its intended use, it does not contain a detailed study with acceptance criteria and device performance results in the format requested.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, number of experts, adjudication methods, or type of ground truth used for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with/without AI assistance.
- Ground truth details (expert consensus, pathology, outcome data) for the training set or its establishment.
- Sample size for the training set.
However, based on the information provided, we can infer some aspects related to the device's claims and the general nature of its verification.
Inferred Information from the Document:
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Acceptance Criteria and Reported Device Performance (Inferred from Motion Performance Claims):
Acceptance Criterion (Inferred from Note 2) Reported Device Performance (Inferred from Note 2) 20% improvement in motion performance compared to the N-3000. The N-395 produces a 20% improvement in motion performance compared to the N-3000 under "challenging motion" conditions. Ability to read through motion artifact to deliver accurate saturation and pulse rate values. The N-395 enables reading through motion artifact to deliver accurate saturation and pulse rate values. Ability to read through challenging motion conditions, giving valid SpO2 and Pulse Rate readings. The N-395 reads through challenging motion conditions, giving valid SpO2 and Pulse Rate readings for many types of motion. "Challenging motion" defined as causing the N-3000 to be in Pulse Search at least 40% of the time. Tested under conditions where the predicate device (N-3000) would be in Pulse Search at least 40% of the time. -
Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Adult and Neonatal patients" for verification of motion performance claims for specific sensors, but no sample size or specific data provenance (country, retrospective/prospective) is provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a pulse oximeter, the ground truth for oxygen saturation would typically come from an invasive arterial blood gas analyzer, not expert consensus on images. The document does not describe such a ground truth establishment process.
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Adjudication method for the test set: Not applicable based on the information provided, as the ground truth is not established by multiple human experts.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for a pulse oximeter's primary performance claims. The comparison is between devices (N-395 vs. N-3000), not human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. A pulse oximeter's performance, especially its algorithm for reading through motion, is assessed as a standalone device function. The claims refer to the N-395's ability to "read through motion artifact" and "deliver accurate saturation and pulse rate values" which is a device-only performance evaluation.
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The type of ground truth used: Not explicitly stated, but for pulse oximeters, the gold standard for oxygen saturation (SaO2) in clinical studies is typically obtained via arterial blood gas analysis, against which the SpO2 readings are compared. The document does not specify how "accurate saturation and pulse rate values" were determined for the performance claims.
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The sample size for the training set: Not applicable and not mentioned. Pulse oximeters typically use a fixed algorithm derived from physiological principles and extensive sensor calibration, rather than a machine learning model that requires a "training set" in the conventional sense. The N-395 uses a "similar SpO2 and Pulse Rate software algorithm" to its predicate device, N-3000, and includes "motion-filtering software".
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How the ground truth for the training set was established: Not applicable, as there's no mention of a training set or its ground truth in the context of machine learning.
§ 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).