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510(k) Data Aggregation
(125 days)
Lap.Ox Laparoscopic Tissue Oximeter
The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy.
The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy.
The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.
The proposed Lap.Ox™ Laparoscopic Tissue Oximeter ("Lap.Ox" or "Device") is a cordless, battery-powered device that estimates the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue. The device includes two components:
- a Reusable Main Unit that shows a digital readout of percent oxygen saturation (StO2) when the system is in contact with tissue (also denoted as "main unit" or "durable"); and
- a Disposable Kit that contains two AA batteries and a sterile single-use disposable consisting of sources, detectors, a laparoscopic tube, and a sheath that is placed around the Reusable Main Unit (denoted as "Disposable").
The Device uses spatially-resolved optical measurements at three wavelengths. The Device displays the StO2 estimate on the built-in screen. The Device is constructed from biocompatible materials that can tolerate bodily fluids. The basic principle of operation of the Lap.Ox Laparoscopic Tissue Oximeter is spectrophotometric oximetry which entails utilizing red and near-infrared light to measure the color of blood and determine an oxygen saturation value.
The provided FDA 510(k) clearance letter for the Lap.Ox™ Laparoscopic Tissue Oximeter details aspects of its regulatory review, including its intended use, technological characteristics, and a summary of performance testing. However, the document does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria, particularly in the context of clinical performance or accuracy of StO2 measurements with numerical values.
The letter broadly states that "The verification and validation studies demonstrated that Lap.Ox performs as intended" and "ViOptix conducted a clinical study... The results demonstrated that the performance of the Lap.Ox Laparoscopic Tissue Oximeter, on human subjects, is comparable to the predicate device."
Without the actual study report or more detailed submission information, it's impossible to explicitly fill out the table and answer all questions with specific numerical values for device performance and study details.
Based on the provided text, here is what can be inferred and what information is missing:
Acceptance Criteria and Device Performance (Inferred/Missing)
Given the device is an oximeter, typical acceptance criteria would involve accuracy and precision compared to a reference method (e.g., arterial blood gas analysis, or the predicate device's measured values). However, these specific criteria and the measured performance are not detailed in the provided text.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred/Expected, but NOT explicitly stated in text) | Reported Device Performance (NOT explicitly stated in text) |
|---|---|---|
| StO2 Measurement Accuracy | e.g., Mean Absolute Error (MAE) |
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