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KardiFlexTM NC Coronary Dilatation Catheter is indicated for:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

• · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
• · in-stent restenosis.
• · post-delivery expansion of balloon expandable coronary stents.

The KardiFlex™ NC Coronary Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 5.0mm and lengths from 6mm to 30mm. The balloon material is made of a minimally Nylon material and balloons have a rated burst pressure of 22 atmospheres. The minimally material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.

The KardiFlex™ NC Coronary Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-5.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube).

The KardiFlex™ NC Coronary Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.

This document describes the regulatory submission for the KardiFlex™ NC Coronary Dilatation Catheter (K202578). This is a physical device, not an AI/ML powered device, so many of the requested fields are not applicable.

Here's a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Pass test" for each specified performance test. The reported device performance for all listed tests is "Pass test," indicating that the device met these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "the subject device, KardiFlex™ NC Coronary Dilatation Catheter, was subjected to the following applicable testing." This implies that a sufficient number of device units (the "test set") were used for each test to demonstrate compliance with the relevant standards.

The data provenance is from bench testing and biocompatibility testing conducted by the manufacturer, Medcaptain Life Science Co., Ltd., based in Shenzhen, Guangdong, China. This is prospective testing, as it's performed on the device prototypes to demonstrate compliance before marketing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

This is not applicable as the evaluation involves physical device performance against established engineering and biological standards, not human interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed are objective, quantitative technical assessments (e.g., measuring burst pressure, inflation time, etc.) against pre-defined thresholds from regulatory standards (ISO, FDA guidance). There is no "adjudication method" in the sense of reconciling differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable. The KardiFlex™ NC Coronary Dilatation Catheter is a physical medical device (balloon catheter), not an AI/ML diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study with or without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" used for these tests are the established performance specifications and safety requirements outlined in international standards (e.g., ISO 10993, ISO 10555) and FDA guidance documents. These are objective, quantifiable criteria that the device's physical properties and behavior must meet.

8. The Sample Size for the Training Set

This is not applicable. As a physical device, there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing process are refined through engineering development and quality control, not by training on a dataset.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no "training set" for a physical device.

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1. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea.
2. For the treatment of snoring.
3. For the prevention of bruxism.

The Full Breath Sleep Appliance PB & PBB is a custom device fabricated typically by a Professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night function of control of vertical dimension and mandibular advancement for reduction/elimination of snoring. It also incorporates the posterior trans-palatal bar of the Quiet Night and Quiet Night MA to prevent the tongue from sealing against the palate and thus reduce snoring. It also restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping.

This 510(k) premarket notification for the Full Breath Sleep Appliance (PB and PBB) does not contain a study that establishes acceptance criteria or demonstrates device performance against those criteria. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's a breakdown of what can be inferred from the provided text regarding a study, and what information is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated or defined in the provided document. The 510(k) relies on substantial equivalence to predicate devices, implying that acceptable performance is generally aligned with those devices.
• Reported Device Performance: The document only makes a qualitative claim: "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping." No quantitative data or metrics are provided to support this claim. Therefore, a table comparing acceptance criteria to reported performance cannot be constructed from this document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• This information is not provided in the document. The statement "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping" is a general claim without details of a specific study, sample size, or data provenance.

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 because no specific study with a "test set" and "ground truth" establishment is detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This information is not provided as no specific study or 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

• This is not applicable to the Full Breath Sleep Appliance. This device is a physical intraoral appliance, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable to the Full Breath Sleep Appliance, for the same reasons as point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• This information is not provided as no specific study with established ground truth is detailed.

8. The sample size for the training set

• This information is not provided. This device is not an AI/machine learning model, and thus does not have a "training set" in that context. If a clinical study was undertaken, it would involve participants to evaluate clinical outcomes, but details of such a study are absent.

9. How the ground truth for the training set was established

• This information is not provided as there is no "training set" in the context of an AI/machine learning model.

Summary of Study Information in the K053065 510(k):

The provided 510(k) summary for the Full Breath Sleep Appliance is focused on demonstrating substantial equivalence to predicate devices (Quiet Night & Quiet Night MA, Breathe EZ Anti-Snoring Device, Sleepbite, The Silencer) that have already been cleared for similar indications. It does not include detailed clinical study data or a statistical analysis of performance against specific acceptance criteria.

The only statement related to performance is: "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping." This is a general claim about the device's effect, but no supporting data (e.g., from a clinical trial, sample size, methodology, statistical significance) are presented in the provided text. For a 510(k) submission, particularly for Class II devices, clinical data demonstrating safety and effectiveness may not always be required if substantial equivalence to a predicate device can be established through technological characteristics and indications for use.

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1. AN ORA/ Appliance to be used for the theatment of mild And Moderate Obstructive Sleep ApNCA
2. For the treatment of SNORING
3. For the prevENTION OF DRUKIEM.

The Full Breath Sleep Appliance is a custom fabricated device typically by a professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night and the NTI (K010867) anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancerient for reduction/elimination of snoring. It also has the posterior trans-palatal bar to prevent the tongue from sealing against the palate and reducing snoring, and restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's and reduction of ODI's.

This document is a 510(k) summary for the Full Breath Sleep Appliance. The device is intended for the treatment of mild and moderate Obstructive Sleep Apnea, the treatment of snoring, and the prevention of bruxism.

The key information provided includes:

• Acceptance Criteria and Device Performance: Not explicitly stated as acceptance criteria in the prompt's sense. However, the device is considered substantially equivalent to predicate devices, implying it meets similar performance expectations. The efficacy is based on its design incorporating features from existing devices known to achieve these indications.
• Sample Size and Data Provenance: No specific study data, sample size, or provenance (country of origin, retrospective/prospective) is provided in this 510(k) summary. The submission focuses on substantial equivalence to predicate devices rather than new clinical trials.
• Ground Truth Establishment: Not applicable as no new clinical study validating performance against a ground truth is presented.
• Expert and Adjudication Methods: Not applicable as no new clinical study validating performance against a ground truth is presented.
• MRMC Comparative Effectiveness Study: Not performed or reported in this document. The submission is not related to assessing AI assistance.
• Standalone Performance: Not applicable as this is not a standalone algorithm, but a physical medical device.
• Type of Ground Truth: Not applicable, as detailed above.
• Training Set Sample Size and Ground Truth: Not applicable, as this is not an AI/algorithm-based device requiring a training set.

Summary of Device Performance (Implied by Substantial Equivalence):

The Full Breath Sleep Appliance (AB and ABB) is described as a simple enhancement to existing predicate devices (Quiet Night & Quiet Night MA - K032410, and NTI - K010867). Its design incorporates the anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancement for reduction/elimination of snoring, similar to the NTI. It also includes a posterior trans-palatal bar, which is stated to prevent tongue sealing against the palate, reduce snoring, and restrain the tongue from up and back movement, leading to "reduced AHI/RDI's and reduction of ODI's."

Predicate Device Comparison Table:

Note: The FDA's 510(k) clearance process involves demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that explicitly define acceptance criteria and studies to meet them in the manner described in the prompt for AI/algorithm-based devices. The "study" in this context is the comparison to existing, approved devices and the rationale for how the new device's design achieves similar intended effects.

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