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510(k) Data Aggregation
(573 days)
circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550
reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550
reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550
ClearMate™ is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate" enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.
This device is intended to induce isocapnic hyperventilation in patients to speed up elimination of carbon monoxide (CO). Isocapnic hyperventilation can be defined as large increases in patient minute volume with minimal changes in arterial partial pressure of carbon dioxide (CO2). This device replaces CO2 levels in the airway, thereby maintaining CO2 levels in the blood that ultimately causes hyperventilation. This pneumatic device initially provides 100% supplemental oxygen (O2) at minute volumes selected based on patient weight. If the patient minute volume demand is more than the preset supplement O2 volume, this device supplies a mixture of 94%/6% (O2/CO2), which maintains CO2 levels in the airway to enable isocapnic breathing by partial simulated rebreathing (of CO2). This device consists of:
- The subject of this De Novo, the Control unit ("briefcase"), connects to sources of O2 and CO2 (neither gas is supplied with this device). The unit includes pressure gauges to read the source gas pressures. Internal components control supplemental gas flowrates, gas concentrations, and CO2 diversion away from the gas delivery pathway should O2 pressures be insufficient. This unit weighs about 2 kg and is pneumatically driven (i.e., no electronics).
- Two breathing circuits, which are not the subject of this De Novo, can attach to the gas outlet ports of the control unit. These circuits are constructed of reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550, cleared under K953107), valves (21 CFR 868.5870, cleared under K142402), resuscitation bags (21 CFR 868.5915, cleared under K912203), and/or tubing (21 CFR 868.5925, cleared under K161420).
- Hoses for source gas connections and a device stand for steadying the device, which are a subject of this De Novo.
Here's a breakdown of the acceptance criteria and the study information for the ClearMate device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Special Controls - 21 CFR 868.5480) | Reported Device Performance |
|---|---|
| Non-clinical performance testing demonstrates device performs as intended under anticipated conditions of use, including: | Verified through bench testing. |
| A. Gas concentration accuracy testing for the range of intended concentrations; | Control Unit Performance: Ten control units were tested. "Operation of supplemental O2 concentration, blended gas concentrations... All predefined specifications were met." |
| B. Airway pressure delivery accuracy testing; | Breathing Circuit Performance: "One-way valves (e.g., relief valves, demand valves) were individually tested for minimum pressure responses. Testing validated the worst case range of pressures experienced in the circuits, leakage rate of the circuit... All predefined specifications were met." Control Unit Performance: Not directly mentioned, but implied through the overall performance of the circuits. |
| C. Supplemental O2 flowrate accuracy testing; | Breathing Circuit Performance: "Supplemental O2 flowrate accuracy specifications. Circuits were tested to facilitate the correct gas concentrations output by the control unit... All predefined specifications were met." Control Unit Performance: "Supplemental O2 flowrate accuracy. All predefined specifications were met." |
| D. Alarm testing; | Control Unit Performance: Ten control units were tested. "Low O2 pressures (upper and lower limits) that trigger the CO2-driven alarm. CO2 diversion to drive the alarm... All predefined specifications were met." |
| E. Use life testing. | Use life Performance: Challenged 5 device samples at double the typical maximum breaths per minute and 1.4 times the typical adult tidal volume for 10 hours (simulating 8 patients/year over 5 years). "The results confirm supplemental O2 output and O2/CO2 demand valve operating specifications, which are the components subjected to most repeated use over the use life." |
| The patient-contacting components of the device must be demonstrated to be biocompatible. | Biocompatibility/Materials: A biological risk assessment was performed in accordance with ISO 10993-1. Components (face mask, adapters, resuscitation bag, leaflet valve) were either previously cleared with similar biocompatibility concerns or tested for dry gas pathway concerns (particulate matter and VOCs). "Based on the submitted testing and evaluations, the applicant has demonstrated device biocompatibility for this intended use." |
| Labeling must include: | Labeling is required to inform proper use. |
| A. Instructions for use; | Required. |
| B. A precaution that monitoring of capnography is necessary during treatment with nonspontaneously breathing patients; and | Required. "When providing treatment to a non-spontaneously breathing patient using the ClearMate™ non-spontaneous breathing patient circuit, CO2 monitoring equipment for the measurement of expiratory carbon dioxide concentration must be used." and "A precaution that monitoring of capnography is necessary during treatment with nonspontaneously breathing patients." |
| C. Use life specification. | Required. "The applicant proposed a 5-year use life." |
Study Information
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily discusses preclinical (animal and bench) and clinical literature review, rather than a single prospective "test set" for the device itself in the traditional sense of an AI/algorithm.
-
Bench Testing:
- Breathing Circuit Performance: 10 samples of spontaneously breathing circuits and 10 samples of non-spontaneously breathing circuits (20 samples total).
- Control Unit Performance: 10 control units.
- Use Life Performance: 5 device samples.
- Data Provenance: Retrospective, conducted by the applicant (Thornhill Research, Inc.) presumably in Canada (given the contact address is in Scottsdale, AZ, but the company is Thornhill Research, Inc., which is Canadian). This is inferred as internal testing presented to the FDA.
-
Animal Studies:
- Fisher JA et al. (1999): Dog model (specific N not provided in the summary). Provenance: Published U.S. study.
- Krech T et al. (2001): Mechanically ventilated sheep (specific N not provided in the summary). Provenance: Published U.S. study.
-
Human Clinical Literature Review (considered as evidence of effectiveness):
- Anand et al. (2017): 13 healthy volunteers (chronic smokers). Provenance: Published study (journal name "PLOS One" suggests an international publication, DOI:10.1371/journal.pone.0170621).
- Rucker et al. (2002): 14 healthy volunteers. Provenance: Published U.S. study.
- Takeuchi et al. (2000): Healthy human volunteers (specific N not provided in the summary). Provenance: Published U.S. study.
- Katznelson et al. (2008): Specific N not provided in the summary (anesthetic agents study). Provenance: Published study.
- Katznelson et al. (2011): 44 obese elective surgical patients (anesthetic agents study). Provenance: Published study.
- Wu et al. (2015) - external study, not used for efficacy but for safety: 319 patients in treatment group, 320 in control group. Provenance: Chinese study, published in "Chinese Journal of Clinicians."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This device is not an AI/algorithm requiring expert-established ground truth for a test set in the diagnostic sense. The "ground truth" for its performance is derived from:
- Bench Testing: Engineering specifications and physical measurements. Experts involved would be engineering and quality control personnel. Their specific qualifications are not detailed, but they would be presumed to be qualified engineers/technicians.
- Animal Studies: Scientific observation and measurement by researchers/veterinarians.
- Human Clinical Studies: Clinical endpoints (e.g., COHb levels, elimination half-life, cerebral blood flow) measured by medical professionals and researchers. The peer-review process for these published studies implicitly involves expert clinicians and scientists.
4. Adjudication Method for the Test Set:
Not applicable, as this is not an AI/diagnostic algorithm using expert review for a "test set." For the literature review, the FDA's internal review team served as the adjudicators of the existing scientific evidence.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study, in the context of human reader performance with/without AI assistance, was not performed. The device is a physical therapeutic device, not a diagnostic AI system intended to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the device itself is the "standalone" component. Its performance was evaluated independently through bench testing (as detailed in item #2) and animal studies. The human clinical studies also assess the device's effect on physiological markers when used therapeutically.
7. The Type of Ground Truth Used:
- Bench Testing: Device specifications, physical properties, engineering standards, and direct measurement of gas concentrations, flow rates, and pressures.
- Animal Studies: Physiological measurements (e.g., COHb levels, cardiac output, oxygen delivery) directly measured from the animal subjects.
- Human Clinical Studies (for effectiveness): Physiological measurements (e.g., COHb levels, elimination half-life, cerebral blood flow) obtained from human volunteers or patients using established medical measurement techniques.
- Human Clinical Study (Wu et al. for safety, but with limitations on efficacy): Clinical outcomes adjudicated by medical personnel based on consciousness, continence, disappearance of CO poisoning signs, EEG findings, and BI (Barthel Index) scores.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model requiring a training set in the machine learning sense. The device's design is based on scientific principles of isocapnic hyperventilation, not data training.
9. How the Ground Truth for the Training Set was Established:
Not applicable (as above). The design and performance targets for the ClearMate device are based on established physiological principles and engineering requirements, not on a "ground truth" derived from a training dataset for an AI algorithm.
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(264 days)
|
| | 868.5550
| 868.5550
| 868.5550
The SuperNO2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care.
It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas.
The SuperNO2VA Et™ Device is intended for short-term (30 kg.). It is a single patient use, disposable.
The SuperNO2VA Et™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.
To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
The SuperNO2VA Et™ Device is a nasal mask with a sampling port for the nasal portion and a sampling "hood" for over the mouth.
The subject device is similar to an anesthesia or oxygen mask with gas sampling port. Instead of covering the full face the SuperNO2VA Et™ Device design is to allow the clinician to have access to the oral cavity during a procedure but still be able to provide air, oxygen or anesthesia gases to the patient while also sampling expired gases from the nasal or oral areas.
The design incorporates the standard 15 mm male circuit connector, luer fitting for the gas sampling line and a slip-fit port for pressure monitoring or oxygen if the mask is used with a manual resuscitator or hyperinflation bag.
The mask is not considered a long-term use device as it would only be used from pre- to postoperative care. This would be similar to the standard anesthesia mask.
It is not for use in long-term ventilation conditions or the treatment of sleep apnea.
Here's a breakdown of the acceptance criteria and study information for the SuperNO2VA Et™ Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than explicitly stating pre-defined acceptance criteria for each tested parameter. However, we can infer some criteria from the comparative testing and performance values presented. The "Proposed SuperNO2VA EtTM Device" column shows the reported performance.
| Feature | Acceptance Criteria (Inferred from Predicate/Equivalence) | Reported Device Performance (SuperNO2VA Et™ Device) |
|---|---|---|
| Mechanical Performance | ||
| Internal Volume (Nasal mask only) | Comparable to K163277 (Medium – 53 ml, Large – 87 ml) | Medium – 53 ml, Large - 87 ml |
| Pressure to maintain a seal | Comparable to K163277 (Up to 30 cmH2O) | Up to 30 cmH2O |
| Resistance to flow | Comparable to K163277 (0.46 cmH2O @ 50 lpm, 1.8 cmH2O @ 100 lpm) & Medline (30 lpm – 0.13 cmH2O, 60 lpm – 0.25 cmH2O, 90 lpm – 0.51 cmH2O) | 0.46 cmH2O @ 50 lpm, 1.8 cmH2O @ 100 lpm |
| Leak rate under pressure | Comparable to K163277 (0.8 Lpm @ 20 cmH2O) | 0.8 Lpm @ 20 cmH2O |
| Dead space (Nasal mask only) | Comparable to K163277 (Medium – 53 ml, Large – 87 ml) | Medium – 53 ml, Large – 87 ml |
| Pressure / Leakage (General) | Maintain pressure > 20 cmH2O with 10 lbs. force, Leakage 20 cmH2O with 10 lbs. force, Leakage |
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(326 days)
Springs, Florida 34134
Re: K163277
Trade/Device Name: SuperNO2VATM Device Regulation Number: 21 CFR 868.5550
mask |
| Classification Code/Name: | BSJ – Anesthesia face mask
| 21CFR 868.5550 |
|---|
| Product Classification |
| 21 CFR 868.5550 |
| BSJ – anesthetic face mask |
| 21 CFR 868.5550 |
The SuperNOsY A™ Device is a mask that creates a seal when positioned over a patient's nose and mouth, or nose only, to direct anesthesia gas, air, and / or oxygen to the continum of anesthesia care. To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
The SuperNOsVA™ Device is intended for short-term (30 kg.) It is a single patient use, disposable.
The SuperNOsY A™ Device is contraindicated for use in long-term ventilation and treatment of sleep apnea.
The SuperNO>VA™ is a 2-piece construction with a nasal and an oral portion. When assembled together the oral portion is connected to the nasal portion (chamber) contains 2 one way (duck bill) valves which are normally closed until the oral chamber is connected. Then gas passes through each portion to the patient. If one desires to remove the oral chamber during a procedure which requires oral access, then gas can still be provided via the nasal portion. Depending upon the equipment and the clinician's desire one can provide non-invasive positive pressure ventilation as well.
This document (K163277) is a 510(k) summary for the SuperNO2VA™ Device, an anesthetic gas mask. It focuses on demonstrating substantial equivalence to a predicate device (K953107) rather than proving the device meets specific acceptance criteria based on a clinical study or AI performance metrics.
Therefore, the provided text does not contain the information necessary to answer the questions about acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI/ML device study.
The document describes a medical device (an anesthetic gas mask) and its regulatory review for market clearance. It outlines:
- Device Name: SuperNO2VA™ Device
- Regulation Number: 21 CFR 868.5550 (Anesthetic Gas Mask, Class I)
- Indications for Use: Creating a seal over a patient's nose and mouth (or nose only) to direct anesthesia gas, air, and/or oxygen to the upper airway during anesthesia care. Also for short-term (30 kg), single patient use, disposable. Contraindicated for long-term ventilation and sleep apnea.
- Predicate Device: K953107 - Medical Marketing Concepts – Anesthesia Respiratory Face Mask
- Comparison to Predicate: A detailed table comparing features like product classification, indications for use, patient population, environment of use, duration of use, anatomical seal, components, and other features.
- Non-Clinical Testing Summary: Internal volume/dead space, resistance through connector, age and shelf-life, seal of duck-bill valves, drop testing, and biocompatibility testing. These are physical/performance tests of the mask itself, not a study evaluating diagnostic or prognostic capabilities (which would be relevant for an AI device).
- Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation.
In summary, the provided document does not support answering the questions about acceptance criteria and study design for an AI/ML device. It pertains to the regulatory clearance of a physical medical device (anesthetic mask) based on substantial equivalence to a predicate, predominantly through non-clinical performance and material testing.
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(127 days)
| Mask, gas, anesthetic
BSJ
868.5550
The ISO-GARD® ClearAir™ Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-GARD® ClearAir™ Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-GARD® ClearAir™ mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases ("WAGS") exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit ("PACU"). Vacuum/suction for scavenging of WAGS 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.
The ISO-GARD® ClearAir™ mask is offered in several configurations, the differences being some of the components.
The provided document describes a 510(k) premarket notification for the ISO-GARD® ClearAir™ mask. This device is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAGS) and provides supplemental oxygen. The submission is a comparison to legally marketed predicate devices, not a study presenting novel acceptance criteria.
The document explicitly states: "There is no pass / fail criteria for the ISO-GARD® ClearAir™ mask. The testing performed is for disclosure only." This indicates that the study was not designed to meet specific, pre-defined acceptance criteria with pass/fail thresholds. Instead, the testing aimed to characterize the device's performance and demonstrate substantial equivalence to predicate devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, as such criteria were not defined as "pass/fail" for this submission type. However, I can summarize the performance data disclosed and the nature of the study.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
As mentioned, no explicit "pass/fail" acceptance criteria were set for this device in the context of this 510(k) submission for the performance testing. The reported performance data is primarily for disclosure and comparison.
| Performance Characteristic | Reported Device Performance (ISO-GARD® ClearAir™ Mask) | Comparison/Context |
|---|---|---|
| Delivered Oxygen % (4 lpm O2 flow, 30-50 mm Hg Vacuum) | 21-23% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (6 lpm O2 flow, 30-50 mm Hg Vacuum) | 31-32% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (8 lpm O2 flow, 30-50 mm Hg Vacuum) | 38% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (10 lpm O2 flow, 30-50 mm Hg Vacuum) | 43-44% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| No₂O detection in chamber | No measurable N₂O detected | Supports effective scavenging at the patient. |
| Delivered Oxygen % (with no N₂O, compared to standard mask with no N₂O) | Higher than a standard oxygen mask at all flow rates and vacuum settings. | Performance superior to a standard oxygen mask in these conditions. |
| End-tidal CO₂ tracing and waveform | More consistent than the predicate Bi-Flo nasal sampling cannula. | Indicates improved or equivalent ETCO2 monitoring capabilities. |
| Biocompatibility | Meets the requirements of ISO 10993 (cytotoxicity, sensitization, irritation). | Demonstrates material safety. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many devices were tested or how many test conditions were numerically replicated. It describes performance testing in a "simulation bench set-up."
- Data Provenance: The studies are described as "Non-clinical Performance Testing" and "simulation bench set-up." This indicates a prospective, controlled laboratory setting. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA by Teleflex Medical, Inc., located in Research Triangle Park, NC, USA.
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)
This type of information is not applicable to this submission. The "ground truth" for this device's performance (e.g., oxygen percentage, scavenging effectiveness) would be established through a validated physical measurement system in the benchtop simulation, not through expert consensus or clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. As the testing involved objective physical measurements on a benchtop, there was no need for expert adjudication of results.
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. This is a medical device, not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device. "Standalone (algorithm only)" is a concept for AI or software devices, not relevant here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims in this submission is based on objective physical measurements from a validated simulation bench set-up. For example, oxygen percentage was measured, and the absence of N₂O was detected. Biocompatibility was assessed against ISO 10993 standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this traditional medical device submission. Training sets are typically associated with machine learning or AI algorithm development.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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