(85 days)
The SenTec Digital Monitoring System – consisting of the SenTec Digital Monitor (SDM), the V-Sign™ Sensor and Accessories - is indicated for continuous, non-invasive patient monitoring. The SenTec Digital Monitoring System is indicated for use in hospital-type facilities, intra-hospital transport environments, and - if under clinical supervision - home environments. The SenTec Digital Monitoring System is for prescription use only.
The V-Sign™ Sensor, model VS-A/P, is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. In neonatal patients the use of the V-Sign™ Sensor is indicated for carbon dioxide tension monitoring only.
SenTec's Ear Clip, model EC-A/P, is intended for use with the V-Sign™ Sensor when continuous, noninvasive carbon dioxide tension, oxygen saturation and pulse rate monitoring are required. The Ear Clip is for single-patient use and is indicated to attach the V-Sign™ Sensor to the ear lobe of the patient. The use of the Ear Clip is contraindicated for patients whose ear-lobes are too small to ensure adequate sensor application.
SenTec's Multi-Site Attachment Ring, model MAR-A/P/N, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult pediatric, and neonatal patients. The Multi-Site Attachment Ring, model MAR-A/P/N, is for single use and is indicated to attach the V-Sign™ Sensorto conventional measurement sites for carbon dioxide tension monitoring,
SenTec's Multi-Site Attachment Ring, model MAR-A/P, is intended for use with the V-Sign™ Sensor when continuous, non-invasive carbon dioxide tension monitoring is required for adult and pediatric patients. The Multi-Site Attachment Ring, model MAR-A/P, is for single use and is indicated to attach the V-Sign™ Sensor to conventional measurement sites for carbon dioxide tension monitoring.
The SenTec Digital Monitoring System (SDMS) is a device consisting of a stand-alone monitor, a digital sensor, a connecting cable, and accessories for sensor application and maintenance. The SDMS is designed for the continuous and non-invasive monitoring of carbon dloxide partial pressure (PCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using a single, digital sensor (V-Sign™ Sensor) applied to the ear lobe with the SenTec Ear Clip.
This new 510(k) adds two new Multi-Site Attachment Rings for PCQ2 monitoring only, applied to a conventional PCO2 measurement site:
- MAR-A/P/N for adult, pediatric and neonatal patients .
- MAR-A/P for adult and pediatric patients
The monitoring features of the SDMS are unchanged
The Multi-Site Attachment Rings consists of a round adhesive pad integrated with a snap ring. The adhesive pad attaches to the patient's skin at the measurement site and the snap ring captures the V-Sign™ Sensor while permitting rotation and removal/reinsertion of the ring is prepared for application by removing an adhesive liner film.
The provided document describes the SenTec Digital Monitoring System (SDMS) and its 510(k) submission for new multi-site attachment rings. However, the document does not contain specific acceptance criteria or details of a clinical study that proves the device meets such criteria.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. It states:
- "In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed."
- "The results of all laboratory and performance tests demonstrate that the SenTec Digital Monitoring System meets specified requirements." (However, these "specified requirements" are not detailed or quantified in the provided text).
- "As described above, the SenTec Digital Monitoring System with Multi-Site Attachment Rings performs in a manner equivalent to the predicate devices. Device safety is substantiated by risk analyses and biocompatibility of patient contact materials."
Therefore, based on the provided text, I cannot complete many of the requested sections as the information is not present. The device's "performance" is primarily described as being "equivalent" to predicate devices, and the document explicitly states that no additional clinical studies were performed.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Cannot be created. The document does not provide a table of acceptance criteria or quantified performance metrics for the SenTec Digital Monitoring System with the new multi-site attachment rings. It only states that "laboratory and performance tests demonstrate that the SenTec Digital Monitoring System meets specified requirements" and performs "in a manner equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance
- Not applicable for clinical studies. The document explicitly states: "In consideration of the Guidance Document for Cutaneous Carbon Dioxide Monitors no additional Clinical studies were required and none were performed."
- For non-clinical tests: "Application tests performed with the V-Sign Sensor and Multi-Site Attachment Rings confirmed that the sensor was properly positioned for measurement of PCO2." The sample size, data provenance, and specific results of these application tests are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set or ground truth established by experts is described, as no clinical studies were performed for this specific submission.
4. Adjudication method for the test set
- Not applicable. No clinical test set is described.
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
- No. This is a medical device for monitoring physiological parameters (PCO2, SpO2, PR), not an AI-powered diagnostic tool involving human readers. Therefore, an MRMC study or AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable in the context of an AI algorithm. This device is a monitoring system and its performance is assessed based on its ability to accurately measure physiological parameters, not an algorithm's classification performance. The "clinical performance data" section states no additional clinical studies were required or performed.
7. The type of ground truth used
- Not explicitly stated for the "specified requirements" or equivalence claim. For the initial predicate device (K041548), one would infer that the ground truth for PCO2 and SpO2 measurements would have been established using reference methods (e.g., arterial blood gas analysis for PCO2/SpO2, and ECG for pulse rate). However, for this specific submission, no new ground truth is described as no new clinical studies were performed. The "equivalence" relies on the ground truth established for the predicate devices.
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.
Summary of available information regarding performance:
- Non-Clinical Performance:
- Biocompatibility testing: "All materials met Biocompatibility requirements" per ISO 10993-1:2003.
- Risk/Hazard Analysis: "All hazards were mitigated to ALARP levels... and residual risks were determined to be acceptable."
- Application tests: "confirmed that the sensor was properly positioned for measurement of PCO2." (No further details on sample size or specific results provided).
- Clinical Performance:
- "no additional Clinical studies were required and none were performed."
- The device is deemed to perform "in a manner equivalent to the predicate devices."
In essence, the 510(k) submission for the new multi-site attachment rings for the SenTec Digital Monitoring System relies on showing substantial equivalence to existing legally marketed predicate devices, rather than presenting new clinical study data with specific acceptance criteria.
§ 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).