(200 days)
The Nellcor Flexible SpO2 Sensors, models FLEXMAX and FLEXMAX-P, are indicated for use with monitoring systems that use Nellcor OxiMax and Nellcor compatible pulse oximeters.
The Nellcor Flexible SpO2 Sensors are intended for use in non-invasive continuous or spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The sensor size range includes a large and small sensor. The sensors are intended for use on adult and pediatric (excluding infant and neonatal) patients weighing greater than 20kg.
The use environment may include: hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport, and home use. Transport environments may include intra-hospital transport and both ground and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The use is dependent upon the use environments specified for the monitoring system utilized in conjunction with the sensor.
The Nellcor Flexible SpO2 Sensors are for prescription use only.
Bluepoint Medical's Nellcor-branded reusable Flexible SpO2 Sensors models FLEXMAX and FLEXMAX-P are pulse oximeter sensors designed and validated for compatibility with Nellcor pulse oximetry and monitoring systems.
Bluepoint Medical reusable Nellcor Flexible SpO2 Sensors models FLEXMAX and FLEXMAX-P are designed for the same functionality as the predicate device sensors, measuring functional oxygen saturation using the patient's finger as the measurement site. They are constructed with the following features:
- Unitary flexible silicone rubber housing containing the optical transmitter l and detector
- . Sensor and cable are immersible for cleaning and disinfection
- . Jacketed and shielded medical grade cable with ferrite for EMC suppression
- . Manufacturer specific connector with sensor labeling for compatibility with Nellcor pulse oximetry and monitoring systems
The reusable Nellcor Flexible SpO2 Sensors are offered in two models corresponding to two sizes:
- . FLEXMAX: Reqular Size, with 40 mm housing width
- FLEXMAX-P: Small Size, with 38 mm housing width
Additionally, two models are packaged specifically for homecare:
- . FLEXMAX-HC: Flexible SpO2 finger Sensor, Regular, Homecare
- FLEXMAX-P-HC: Flexible SpO2 finger Sensor. Small. Homecare .
The homecare sensor models with -HC designation are identical in all respects to their professional use counterparts, however the sensors are packaged to additionally include the Home Use Guide for lay users.
The document provided describes the Nellcor Flexible SpO2 Sensors models FLEXMAX and FLEXMAX-P. Here is an analysis of its acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (SpO2 Accuracy) | Reported Device Performance (SpO2 Accuracy) |
|---|---|
| ARMS ≤ 2.5% (This is inferred from the comparison table for the predicate device, as the submission states the new device matches the predicate's technological characteristics. The document explicitly states the new device met the acceptance criteria for clinical accuracy according to ISO 80601-2-61 and FDA guidance.) | Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2. (The specific ARMS value for the new device itself is not directly stated in the summary, but it implies it met the standard's requirements, which typically involves an ARMS ≤ 3.5% for adult subjects.) |
| Acceptance Criterion (Pulse Rate Accuracy) | Reported Device Performance (Pulse Rate Accuracy) |
|---|---|
| ± 3 BPM | The sensors met the acceptance criteria for pulse rate accuracy. |
| Acceptance Criterion (Electrical Safety) | Reported Device Performance (Electrical Safety) |
|---|---|
| Compliance with IEC 60601-1 | The sensors met the acceptance criteria for compliance to the standards. |
| Acceptance Criterion (EMC) | Reported Device Performance (EMC) |
|---|---|
| Compliance with IEC 60601-1-2 | The sensors met the acceptance criteria for compliance to the standards. |
| Acceptance Criterion (Home Healthcare Environment) | Reported Device Performance (Home Healthcare Environment) |
|---|---|
| Compliance with IEC 60601-1-11 | The sensors met the acceptance criteria for compliance to the standards. |
| Acceptance Criterion (Emergency Medical Services Environment) | Reported Device Performance (Emergency Medical Services Environment) |
|---|---|
| Compliance with IEC 60601-1-12 | The sensors met the acceptance criteria for compliance to the standards. |
| Acceptance Criterion (Pulse Oximeters Specific Requirements) | Reported Device Performance (Pulse Oximeters Specific Requirements) |
|---|---|
| Compliance with ISO 80601-2-61 | The sensors met the acceptance criteria for compliance to the standards. |
| Acceptance Criterion (Environmental Testing) | Reported Device Performance (Environmental Testing) |
|---|---|
| Compliance with IEC 60601-1-11 and IEC 60601-1-12 test levels | The sensors met the acceptance criteria for compliance to the standards. |
| Acceptance Criterion (Mechanical Testing) | Reported Device Performance (Mechanical Testing) |
|---|---|
| Compliance with ISO 80601-2-61 and IEC 60601-1-12 test levels | The sensors met the acceptance criteria for compliance to the standards. |
| Acceptance Criterion (Risk Management) | Reported Device Performance (Risk Management) |
|---|---|
| Compliance with ISO 14971 (residual risks acceptable) | The sensors met the acceptance criteria for residual risks. |
| Acceptance Criterion (Usability) | Reported Device Performance (Usability) |
|---|---|
| Compliance with IEC 60601-1-6, IEC 62366, and FDA Human Factors and Usability Guidance | The sensors met the acceptance criteria for usability. |
| Acceptance Criterion (Biocompatibility) | Reported Device Performance (Biocompatibility) |
|---|---|
| Compliance with ISO-10993-1, ISO-10993-5 and ISO-10993-10 | The sensor materials met the acceptance criteria for biocompatibility. |
| Acceptance Criterion (Cleaning and Disinfection) | Reported Device Performance (Cleaning and Disinfection) |
|---|---|
| Compliance with ISO 15583-5, AAMI TIR12, AAMI TIR30, FDA Guidance for Reprocessing Medical Devices | The sensor materials met the acceptance criteria for cleaning and disinfection. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "healthy adult subjects" for the clinical study but does not specify the exact number of subjects.
- Data Provenance: The clinical study was a "controlled hypoxia study" conducted under an "institutionally approved protocol." The document does not explicitly state the country of origin, but the submission is to the US FDA, implying the study was conducted to meet US regulatory requirements. It is a prospective study given the nature of a controlled hypoxia experiment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth for SpO2 accuracy was determined by "arterial oxygen saturation determined by co-oximetry." Co-oximetry is a laboratory measurement, not typically established by human experts. The document does not refer to experts for ground truth establishment.
4. Adjudication Method for the Test Set
- Not applicable, as ground truth was established by co-oximetry, not expert consensus requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a pulse oximeter sensor, not an AI-assisted diagnostic tool that would typically involve human reader performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Yes, the clinical accuracy study was a standalone performance evaluation of the device. The sensor's output was compared directly against co-oximetry measurements during controlled hypoxia, independent of human interpretation or intervention beyond standard monitoring procedures.
7. The Type of Ground Truth Used
- The ground truth for SpO2 accuracy in the clinical study was co-oximetry performed on arterial blood samples.
8. The Sample Size for the Training Set
- The document does not mention a training set sample size. This is expected as the device is a medical sensor, not a machine learning or AI algorithm that typically requires a separate training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a training set for this device.
§ 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).