(125 days)
EnviteC Reusable SoftTip Y SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and infant patients in hospitals, hospital-type facilities, mobile, and home environments.
EnviteC's Reusable SoftTip Y sensors are a modification of EnviteC's Multi-Site Y SpO2 Sensors listed in K043463. The modification integrates the two Y-sensor housing tips into a single molded rubber tube which facilitates placement on a digit. This modification preserves in its entirety the original optical geometry and specifications of the predicate Y-sensors.
Like the Multi-site Y SpO2 sensors, EnviteC's SoftTip Y SpO2 sensors consist of a connector and a duplex cable which divides at the distal end to the LED light source and light sensitive photodetector.
The EnviteC SoftTip Y SpO2 Sensors comprise a family of oximeter sensors designed and validated for compatibility with the same oximeter monitor manufacturers as the Y-Sensors.
A unique SoftTip Y sensor exists for each manufacturer series, and each SoftTip Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.).
Each sensor type includes the following unique features:
- Connector pin-outs specific for the manufacturer type .
- . Component specifications specific for the manufacture type
Each sensor also specifies the manufacturer type with two compatibility statements:
- One printed on or attached to the sensor .
- . One on the instructions for use.
The provided text describes a 510(k) premarket notification for a medical device (EnviteC Reusable SoftTip Y SpO2 Sensors) and its substantial equivalence to a predicate device. The information primarily focuses on the device modification and why existing clinical data for the predicate device is sufficient.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Non-Clinical: | |
| Meet applicable standards for medical device Electrical Safety, temperature, and Electromagnetic Compatibility. | "The modified sensors were tested in accordance with applicable standards for medical device Electrical Safety, temperature, and Electromagnetic Compatibility. The SoftTip Y SpO2 sensors passed all of the tests." |
| Maintain original optical geometry and specifications of the predicate Y-sensors. | "This modification preserves in its entirety the original optical geometry and specifications of the predicate Y-sensors." and "The optical geometry and electro-optical specifications of the unmodified Y-sensors are preserved in the SoftTip Y modifications." |
| Clinical: | |
| Accuracy claims for the specified SaO2 range of 70% to 100%. | "Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2." (This is attributed to the predicate device's testing and deemed valid for the modified device). |
| Compatibility with same oximeter monitor manufacturers as Y-Sensors. | "The EnviteC SoftTip Y SpO2 Sensors comprise a family of oximeter sensors designed and validated for compatibility with the same oximeter monitor manufacturers as the Y-Sensors." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that no new clinical testing was performed for the modified device. Instead, it relies on the clinical hypoxia testing performed for the predicate Y SpO2 Sensors.
- Sample size: Not specified for the predicate device's clinical testing.
- Data provenance: Not specified for the predicate device's clinical testing.
- Retrospective/Prospective: Not specified for the predicate device's clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as new clinical testing with ground truth establishment was not performed for this device. The document defers to prior clinical testing of the predicate device, for which this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as new clinical testing with adjudication was not performed for this device. The document defers to prior clinical testing of the predicate device, for which this information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an oximeter sensor, not an AI-powered diagnostic tool. The concept of human readers improving with or without AI assistance does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an oximeter sensor, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate device, the clinical hypoxia testing would have likely used a co-oximeter or arterial blood gas (ABG) analysis as the reference standard (ground truth) for SaO2 measurements. However, the document does not explicitly state the specific type of ground truth used.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm that requires a training set.
§ 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).