Search Results
Found 1 results
510(k) Data Aggregation
(86 days)
The ISO-Gard® Mask is intended to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAG) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAG is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
This document describes the Teleflex Medical, Inc. ISO-Gard Mask (K142138), a gas-scavenging apparatus intended to remove waste anesthetic gases and provide supplemental oxygen to patients recovering from general anesthesia.
Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Test Objective | Acceptance Criteria | Reported Device Performance and Conclusion |
|---|---|---|---|
| Oxygen Delivery with Vacuum Tubing | To evaluate the oxygen delivery performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml. | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all vacuum settings and oxygen flow rates. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Oxygen Delivery with Vacuum Tubing Removed | To evaluate the oxygen delivery performance with vacuum tubing removed at variable oxygen flow rates. | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all oxygen flow rates. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Strength of Connection | To validate the Oxygen Flow Concentrator to Mask bond strength. | The Oxygen Flow Concentrator will not detach at 30 lpm flow rate and the initial gauge pressure reading will remain the same as the final pressure reading for each tested mask. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Biocompatibility Testing: Cytotoxicity | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (< 24 hours). | Must meet the requirements as outlined in ISO 10993-1. | The text states: "All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below." This indicates the new material (PVC dye: CV5M664907 Dark Blue) passed due to satisfying ISO 10993-1 requirements. |
| Biocompatibility Testing: Sensitization | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (< 24 hours). | Must meet the requirements as outlined in ISO 10993-1. | The text states: "All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below." This indicates the new material (PVC dye: CV5M664907 Dark Blue) passed due to satisfying ISO 10993-1 requirements. |
| Biocompatibility Testing: Irritation | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (< 24 hours). | Must meet the requirements as outlined in ISO 10993-1. | The text states: "All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below." This indicates the new material (PVC dye: CV5M664907 Dark Blue) passed due to satisfying ISO 10993-1 requirements. |
| Biocompatibility Testing: Acute Systemic Toxicity | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (< 24 hours). | Must meet the requirements as outlined in ISO 10993-11. (Note: The table lists ISO 10993-11, indicating this specific part for acute systemic toxicity). | The text states: "All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below." This indicates the new material (PVC dye: CV5M664907 Dark Blue) passed due to satisfying ISO 10993-1 or ISO 10993-11 requirements, as appropriate for the specific test. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the oxygen delivery and bond strength tests. However, the biocompatibility testing was performed on the "new material" (PVC dye: CV5M664907 Dark Blue). The provenance of the data for these performance tests is internal to Teleflex Medical, Inc. and is likely based on laboratory testing rather than patient data, given the nature of the device (mask for gas scavenging/oxygen delivery). The study is retrospective in the sense that it evaluates the performance of the device's design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the studies described are performance and biocompatibility tests on a physical device, not related to image interpretation or diagnosis requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
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:
This information is not applicable. The device is a medical mask, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
For the oxygen delivery and strength of connection tests, the "ground truth" is based on engineering and performance standards (e.g., maintaining a certain oxygen percentage, not detaching under specific flow rates). For biocompatibility, the "ground truth" is adherence to established international standards (ISO 10993-1 and ISO 10993-11).
8. The Sample Size for the Training Set:
This information is not applicable as there is no mention or implication of a "training set" in the context of this device's performance testing. The device is not based on a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons as point 8.
Ask a specific question about this device
Page 1 of 1