(148 days)
The LNCS oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The SPO2.COM oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The LNCS Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The SPO2.COM Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The LNCS Oximery Sensors are fully compatible disposable sensors for use with Masimo SET compatible pulse oximeter monitors and also with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.
The SPO2.COM Oximetry Sensors are fully compatible disposable sensors for use with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.
The provided 510(k) summary (K060143) describes LNCS and SPO2.COM Oximetry Sensors. The submission is for a modification to existing, legally marketed sensors to add clearance for Ethylene Oxide (EtO) sterilization. This is explicitly stated in the "Device Description" sections for both types of sensors: "There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide."
Therefore, the performance testing described is focused on demonstrating that EtO sterilization does not negatively impact the performance of the sensors, and that the sensors remain "substantially equivalent" to their non-EtO sterilized counterparts. This is a crucial distinction, as the study is not intended to establish the foundational accuracy or performance of the oximetry technology itself, but rather to confirm the safety and effectiveness after a new sterilization method is applied.
Given this context, the request for "acceptance criteria," "reported device performance," and details about the "study that proves the device meets the acceptance criteria" must be interpreted in relation to the impact of EtO sterilization. The original oximeter performance, including accuracy, would have been established and reviewed in the predicate device submissions (K033298, K041815, K051212).
Here's an analysis based on the provided text, acknowledging the specific nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for EtO Sterilization) | Reported Device Performance (Post-EtO) |
|---|---|
| Maintain equivalency to predicate devices in: | "The LNCS and SPO2.COM sensors are substantially equivalent to the LNCS and SPO2.COM sensors before and after Ethylene Oxide Sterilization." |
| - Intended Use | Confirmed to be identical to predicate devices. |
| - Design | Confirmed to be identical to predicate devices (no design change). |
| - Principles of Operation | Confirmed to be identical to predicate devices. |
| - Materials | Confirmed to be identical to predicate devices. |
| - Performance (e.g., accuracy) | "The accuracy of the LNCS and SPO2.COM oximetry sensors is equivalent to those of the predicate devices." |
| - Safety and Effectiveness | "The results of the performance data demonstrate that the LNCS and SPO2.COM oximetry sensors are as safe and effective than the legally marketed predicate devices." |
Study Description:
The study conducted was a Performance Testing that included:
- Ethylene Oxide Sterilization Testing: This would typically involve validating the sterilization cycle to ensure sterility assurance levels (SAL) are met, and then testing the functional performance of sensors that have undergone this sterilization process.
- In-house laboratory testing: This would involve a battery of tests to confirm that the sensors still meet all functional, material, and electrical specifications after EtO sterilization. This could include tests for mechanical integrity, response time, electrical performance, and critically, oximetry accuracy when subjected to known SpO2 levels (often through testing with blood gas analyzers or calibrated simulators) to ensure the sterilization process has not degraded the sensor's ability to accurately measure SpO2.
The key outcome reported is that the performance data demonstrate that the LNCS and SPO2.COM sensors are substantially equivalent to the LNCS and SPO2.COM sensors before and after Ethylene Oxide Sterilization. This confirms that the sterilization process did not negatively impact the device's ability to meet its established performance.
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary does not explicitly state the sample size used for the Ethylene Oxide Sterilization Testing or the in-house laboratory testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective data) for these specific tests.
It is common for 510(k) summaries, especially for modifications to predicate devices, to summarize performance testing results rather than providing granular detail on sample sizes, as these details are typically found in the full 510(k) submission document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. Given that the testing primarily involved "Ethylene Oxide Sterilization Testing and in-house laboratory testing," the ground truth would likely be established through objective laboratory measurements and validated sterilization processes, rather than expert human interpretation in a clinical context.
4. Adjudication Method for the Test Set
This information is not provided. As mentioned above, the nature of the testing (sterilization and lab performance) suggests that adjudication by human experts in the traditional sense (e.g., 2+1 reading consensus for images) would not be applicable.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, nor would it be relevant for this type of device modification. This submission relates to pulse oximetry sensors and their sterilization, not an AI-powered diagnostic or interpretive device that would assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. The device is a medical sensor, not an algorithm, and operates as a standalone measurement device providing data to a pulse oximeter monitor.
7. The Type of Ground Truth Used
For the Ethylene Oxide Sterilization Testing and in-house laboratory testing, the ground truth would be based on:
- Sterility Assurance Level (SAL) validation: Demonstrating that the sterilization process achieves a predefined probability of a non-sterile unit.
- Physical and electronic measurements: Using calibrated equipment to assess the mechanical integrity, electrical characteristics, and functional performance (e.g., accuracy against a reference oximeter or blood gas analyzer, simulated SpO2 values) of the sensors after sterilization.
- Material compatibility testing: Ensuring that the materials of the sensor are not degraded or altered by the EtO process, which could affect performance or biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device does not use machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided, as there is no 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).