(116 days)
The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits patient monitoring with adjustable alarms limits as well as visible and audible alarm signals.
The subject device is the same as the legally marketed predicate device BCl 3304 Autocorr M Digital Pulse Oximeter (K962156) with one minor change to the labeling that does not raise new questions of safety and efficacy. This pulse oximeter was originally cleared with the current algorithms. However, it was not clinically validated under motion conditions and no motion claims were made. The aim of this premarket submission is to obtain clearance for an additional motion claim.
The 3304 Autocorrille pulse oximeter is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifiact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence. Alarm Volume, Pulse Volume). The oximeter has a printer/pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.
This Special 510(k) covers the labeling modification of BCI® Autocorr™ 3304 Digital Pulse Oximeter that was cleared under 510(k) K962156. The modification involves revising the 3304 labeling to add pulse oximetry performance specifications with motion. Results from clinical evaluation are provided to support the labeling change. No significant device modifications have been made to the 3304. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BCI® Autocorr™ 3304 Digital Pulse Oximeter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Target Specification) | Reported Device Performance (Motion Condition) | Unit |
|---|---|---|
| Less than 3 | 2.95 (ARMS) | %SpO2 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 10 paid, adult, volunteer subjects.
- Data Provenance: The study was a descriptive, cross-sectional investigation conducted within a controlled clinical setting, comparing measured SpO2 values to a reference CO-oximeter. This is considered prospective data, specifically designed for this study. The country of origin is not explicitly stated, but based on the manufacturer's address (Waukesha, WI, USA) and the FDA submission, it can be inferred that the study was conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no experts used to establish the ground truth in the traditional sense of medical image interpretation or clinical diagnosis. The ground truth for oxygen saturation (SaO2) was established by a CO-oximeter, which is a highly accurate laboratory device used to measure actual arterial oxygen saturation. This is a direct physical measurement, not an expert interpretation.
4. Adjudication Method for the Test Set
There was no adjudication method described for the test set regarding expert consensus. The study compared the device's SpO2 readings directly against the objective measurements from a CO-oximeter (reference condition).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focused on the device's standalone performance under motion, not on its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire study evaluated the accuracy of the BCI® Autocorr™ 3304 Digital Pulse Oximeter's algorithm (which provides the SpO2 measurement) in a motion condition, directly comparing its output to a reference standard (CO-oximeter). There was no human interpretation or intervention in the measurement process itself, only the application and reading of the device.
7. The Type of Ground Truth Used
The type of ground truth used was objective measurement by a CO-oximeter (co-oximeter determined functional oxygen saturation, SaO2). This is a highly accurate and direct physiological measurement often considered the gold standard for arterial oxygen saturation.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set. The device (BCI® Autocorr™ 3304 Digital Pulse Oximeter) was already cleared with its current algorithms (K962156). The current submission is for an additional motion claim and involves clinical validation of the existing algorithms under motion conditions, not the development or retraining of new algorithms. Therefore, a "training set" in the context of machine learning model development is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the context of algorithm development for this submission) is mentioned, the method for establishing its ground truth is not applicable/not provided. The existing algorithms were presumably developed and validated prior to the original K962156 clearance, but details of that process are not included in this document.
§ 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).