Search Results

The F&P Bubble CPAP System is intended to provide CPAP to spontaneously breathing neonates and infants who require breathing support due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired and is prescribed by a physician.

The Bubble CPAP System is for use in the hospital clinical environment such as the NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit).

The Fisher & Paykel Healthcare (F&P) Bubble CPAP (continuous positive airway pressure) System provides respiratory support to spontaneously breathing infants. The F&P Bubble CPAP System delivers heated and humidified respiratory gas through an inspiratory breathing circuit to the infant via a nasal interface. An expiratory circuit connects to a water column threshold resistor which pressurizes the circuit. The F&P Bubble CPAP System consists of an in-line pressure relief valve, a humidification chamber, a heated breathing circuit, patient nasal interface and CPAP generator (water column threshold resistor). The System is intended to be operated at input gas flows of 4 - 15 L/min with available CPAP levels of 3 - 10 cmH2O.

The Fisher & Paykel Healthcare (F&P) Bubble CPAP System provides respiratory support to spontaneously breathing infants.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of numerical "acceptance criteria" for the device's main function (CPAP delivery) or a direct comparison to specific threshold values. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Study Details Proving Acceptance Criteria:

The submission outlines a combination of bench testing and a summary of existing clinical literature to establish substantial equivalence.

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

• Bench Tests: The specific sample sizes for the various bench tests are not explicitly stated in the provided summary.
• Clinical Performance: "Eight peer reviewed and published reports using the F&P Bubble CPAP System, including three randomized controlled trials."
  • Data Provenance: "Used around the world" and "compared with other forms of respiratory support in a variety of settings." These are retrospective studies (already published). The countries of origin are not specified beyond "around the world."

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

• Bench Tests: The summary does not specify the number or qualifications of experts involved in establishing ground truth for the bench tests. Ground truth would likely be based on established engineering principles and measurement standards.
• Clinical Performance: For the eight peer-reviewed and published reports, the "ground truth" (i.e., clinical outcomes, efficacy, safety) would have been established by the clinicians and researchers involved in those studies. The number and specific qualifications of these experts are not detailed in this 510(k) summary. These would be implicit in the peer-reviewed publications.

4. Adjudication Method for the Test Set

• Bench Tests: No adjudication method is described. Bench tests typically rely on direct measurements against predefined standards.
• Clinical Performance: For the summarized clinical reports, the adjudication method would have been specific to each individual study and subject to the peer-review process of the journal in which they were published. This summary does not detail these methods (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not performed or referenced. The device is a medical device (CPAP system), not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases. The comparison is between the F&P Bubble CPAP System and a predicate CPAP device, primarily through bench testing of physical performance and a review of existing clinical literature on the F&P system.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• The F&P Bubble CPAP System is a medical device that delivers a therapy, not an algorithm in the sense of a software-only tool. Its "standalone performance" is understood through its function of generating and delivering CPAP. The bench tests described (CPAP level delivered, work of breathing, compliance with ISO standards) directly assess its standalone physical performance.
• There isn't an "algorithm only" component in the context of typical AI/software medical devices. The device's operation is its standalone performance.

7. Type of Ground Truth Used

• Bench Tests: Engineering measurements, adherence to ISO standards, and comparison to the predicate device's measured performance.
• Clinical Performance: Clinical outcomes, safety data, and efficacy measures reported in peer-reviewed medical literature.

8. Sample Size for the Training Set

• The F&P Bubble CPAP System is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of artificial intelligence or machine learning. The device's design is based on engineering principles and knowledge, validated through testing.

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

• As there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the device's development would be established engineering specifications, medical requirements for CPAP delivery, and safety standards, which are met through design and validation testing.

Ask a specific question about this device

The Zest™ Nasal Mask is intended for single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level ventilator treatment in the home, hospital or other clinical setting.

The Zest™ Nasal Mask is a respiratory mask which is non invasive, the Silicone Seal is positioned over the nose, and it seals on the area around the nose, and the upper lip. The mask is held on the face with headgear straps. It connects to a single breathing tube via a swivel adaptor, to receive pressurized gases. On the mask base are exhalation vents (bias holes) that allow exhaled gases to be continually flushed and removed to room air. The silicone seal is contoured for comfort and to reduce leakage.

The provided text describes a 510(k) premarket notification for the Zest™ Nasal Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria and a detailed study design. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this type of regulatory submission and is not present in the provided document.

The document primarily relies on non-clinical comparative testing to establish substantial equivalence.

Here's a breakdown of the information that can be extracted or inferred from the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., leakage rate, pressure drop limits). Instead, the acceptance criterion for regulatory approval is "substantial equivalence" to the predicate device. This is demonstrated through comparative testing rather than meeting pre-defined numerical thresholds for new performance.
• Reported Device Performance: The document states that "Testing of the Zest™ Nasal Mask was compared to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance... These tests demonstrate substantial equivalence of the Zest™ Nasal Mask to the predicate mask." The specifics of the performance results are summarized as demonstrating equivalence, but no raw data or numerical outcomes are provided in this summary.

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

• Sample Size for Test Set: Not applicable/Not provided. The "test set" in this context refers to non-clinical comparative testing (e.g., bench tests, materials testing), not a clinical study involving human subjects or a large dataset in the way AI/ML models are evaluated. The document references "test reports included in Appendix B," but the details of these tests (e.g., number of masks tested, number of cycles) are not in the provided summary.
• Data Provenance: Not applicable/Not provided. As it's non-clinical testing, there's no data provenance in terms of country of origin for patient data. The testing would have been conducted by the manufacturer or a contracted lab. It's retrospective in the sense that the test results are reviewed after completion.

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

• Number of Experts: Not applicable. For non-clinical validation of medical devices like a nasal mask, "ground truth" is typically established by engineering specifications, international standards, or physical measurements, not expert clinician consensus on a dataset.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation or adjudication of test results in the way it's done for diagnostic AI algorithms. Test results are compared against engineering/performance specifications or directly against the predicate device's performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This type of study is not relevant for the regulatory clearance of a physical medical device like a nasal mask. MRMC studies are typically used for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers interpret cases.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No. The device is a physical nasal mask, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used

• Type of Ground Truth: For the performance testing, the "ground truth" would be established by:
  • Engineering Specifications: Adherence to design specifications and relevant industry standards (e.g., for airflow, pressure integrity, dead space).
  • Predicate Device Performance: Direct comparison of the Zest™ Nasal Mask's measured performance characteristics against those of the K063036 Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask.
  • Biocompatibility Standards: Compliance with recognized standards for material safety, likely demonstrated by reference to the K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask, which was also found to be substantially equivalent for biocompatibility.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The design of the mask is based on engineering principles and potentially anthropometric data, not machine learning from a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary of the Study:

The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) was a series of non-clinical comparative tests.

• Purpose: To demonstrate that the Zest™ Nasal Mask is substantially equivalent in terms of safety and effectiveness to its predicate devices.
• Comparison for Performance: The Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask (K063036).
• Comparison for Biocompatibility: The Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask (K061236).
• Methodology: The document states "Testing... was compared to the predicate... for performance and... for biocompatibility." This implies bench testing and material analyses were conducted, and the results were evaluated against the predicate's known characteristics. The specifics are in "Appendix B" which is not provided.
• Conclusion: The manufacturer concluded, and the FDA agreed, that "The comparison of features, performance, and intended use demonstrate that the Zest™ Nasal Mask is substantially equivalent to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and the HC432 Full Face Mask for biocompatibility."

Ask a specific question about this device

The Fisher & Paykel Healthcare Oracle Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) as per 73 BZD, 21 CFR §868.5905.

The Oral Mask is indicated for use by adults requiring CPAP or Bilevel ventilator treatment in home, hospital and laboratory environments for the treatment of Obstructive Sleep Apnea (OSA). It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is a reusable device for use on the prescription of a suitably qualified physician. The Oral Mask may be reprocessed for multi-patient use.

The Oracle Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) according to 21 CFR §868.5905. It constitutes the patient to ventilator interface in a noncontinuous ventilator system.

The Oracle Oral Mask consists of a mouthpiece and flexible breathing tube. The flexible breathing tube is connected to the output breathing tube of the ventilator. The ventilator supplies air at CPAP or Bilevel pressures (typically in the range 3 - 19 cm H2O) which is available at the Oral Mask mouthpiece.

The mouthpiece is positioned in the patient's mouth during CPAP or Bilevel treatment. Features of the mouthpiece ensure the desired positive airway pressure is delivered to the patient with minimal leakage and that the mouthpiece is retained in the mouth while asleep.

The flexible breathing tube provides a transition between the more rigid output tube of the ventilator and the mouthpiece, facilitating freedom of movement while maintaining circuit integrity. An exhaust port adjacent to the mouthpiece provides a means to purge exhaled gases from the breathing circuit.

This document describes a 510(k) submission for the Fisher & Paykel Healthcare Oracle Oral Mask, an accessory to a noncontinuous ventilator. The submission aims to demonstrate substantial equivalence to a predicate device (Fisher & Paykel Healthcare, LTD., Oracle Oral Mask, Model 900HC451. K003894). As such, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence through non-clinical testing.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" sample size in terms of patient numbers or the number of masks tested for each non-clinical test. The testing mentioned refers to "tests, relevant to the modifications, were performed on the new Oral Mask."

• Sample Size: Not specified. It generally refers to samples of the device itself rather than patient data in this context.
• Data Provenance: The document does not specify the country of origin of the data. It's a submission from Fisher & Paykel Healthcare Ltd, based in New Zealand. The tests are non-clinical, likely performed in-house or by a third-party lab. The data is retrospective in the sense that the tests were performed to support the 510(k) submission, not as a prospective clinical trial.

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

Not applicable. This is a 510(k) submission for a Class II medical device (accessory to a non-continuous ventilator) demonstrating substantial equivalence based on non-clinical tests (strength, durability, biocompatibility, sterilization effectiveness). It does not involve human users or a "ground truth" derived from expert interpretation of medical images or patient outcomes in the way an AI/ML device would.

4. Adjudication Method for the Test Set

Not applicable. As this involves non-clinical testing of physical and material properties, there would be no adjudication method in the context of expert consensus found in clinical or AI/ML studies. Test results would be objectively measured against predefined specifications.

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 not an AI/ML device. It's a physical medical device.

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

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this submission are objective performance specifications and regulatory standards relevant to the device's physical properties, material composition, and intended function. These include:

• Objective Test Results: Measurements of strength, durability, and effectiveness of sterilization.
• Biocompatibility Standards: Compliance with ISO 10993-1.
• Industry Standards: Compliance with ISO 5356-1, ASTM F1054 for connecting tubes.
• Predicate Device Performance: The primary "ground truth" for substantial equivalence is the previously cleared predicate device, meaning the new device must perform comparably in relevant aspects.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.

The ThromboScreen® 1000 (TS1000) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting procedures in the clinical laboratory. The instrument utilizes photo-optical principles to measure and record the time required for subject plasma specimens to clot. The TS1000 light source is provided by a 660 nm LED. The incubator block is temperature regulated to 36.5 - 37.5°C and contains six measuring positions and six reagent positions.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is identical to the Pacific Hemostasis® Thrombin for Fibrinogen Kit, except that the thrombin is reconstituted with water containing kaolin rather than water. Kaolin is added to increase the visibility of the clot in the stirred reaction cell.

Here's a breakdown of the acceptance criteria and the study details for the Fisher Diagnostics ThromboScreen® 1000 and Pacific Hemostasis® Fibrinogen Reagent plus Kaolin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "The correlation coefficient must be >0.95"). Instead, it presents comparative performance data against predicate devices to demonstrate substantial equivalence. The implication is that the performance must be comparable to the legally marketed predicate devices.

Important Note: The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate devices. The correlation coefficients are all very high (close to 1.0), and the precision data (CV%) also appears comparable between the ThromboScreen 1000 and the predicate MLA instruments.

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

• Test Set Sample Sizes:

  • Method Comparison (Correlation Studies):
    • Prothrombin Time (General Clinical Samples): 60 samples per site (across 3 sites = 180 total)
    • Prothrombin Time (Coumadin Samples): 100 samples per site (Site 1 & 2), 92 samples (Site 3) = 292 total
    • Activated Partial Thromboplastin Time (General Clinical Samples): 58 (Site 1), 60 (Site 2), 60 (Site 3) = 178 total
    • Activated Partial Thromboplastin Time (Heparin Samples): 60 samples per site (across 3 sites = 180 total)
    • Fibrinogen Concentration (General Clinical Samples): 28 (Site 1), 30 (Site 2), 30 (Site 3) = 88 total
  • Precision Studies: The specific number of samples for precision studies is not explicitly stated, but it involves "Coag 1, Coag 2, Coag 3" which likely represent different control levels or concentrations, and were performed "within-run," "run-to-run," and "day-to-day" at three sites.

• Data Provenance: The studies were conducted "in-house and at two external testing laboratories." While specific countries are not mentioned, the context of the FDA submission (U.S. Department of Health & Human Services) strongly suggests the data was generated within the United States or from sites compliant with U.S. regulatory standards. The data is prospective as it involves comparison testing and precision measurements on collected specimens. The document indicates specimens were collected from "apparently healthy individuals and from subjects with different pathological conditions which are expected to affect the results for a particular assay."

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

The description does not mention the use of "experts" in the sense of human readers adjudicating results or establishing ground truth for the test results. This is an in-vitro diagnostic device (IVD) where the "ground truth" is typically established by comparing the device's quantitative measurements against a legally marketed predicate device (MLA 900C/1600C) using the same patient samples and/or established reference methods for precision. The performance is assessed by correlation coefficients and precision metrics against these established methods, not by expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable. As described above, this is an IVD device measuring quantitative coagulation parameters. The "ground truth" is based on the results from predicate devices and internal validation, not human adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for imaging or diagnostic interpretation devices where multiple human readers interpret cases. The ThromboScreen® 1000 is an automated instrument for quantitative laboratory tests (Prothrombin Time, APTT, Fibrinogen), not an interpretation aid for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance evaluation was done. The entire study focuses on the performance of the ThromboScreen® 1000 instrument and the Pacific Hemostasis® Fibrinogen Reagent plus Kaolin. Its measurements are compared directly to those of established predicate instruments (MLA 900C/1600C). There is no "human-in-the-loop" aspect to its measurement process; it's an automated photo-optical instrument.

7. The Type of Ground Truth Used:

The ground truth for the device's performance was established by:

• Predicate Device Comparison: The results obtained from the ThromboScreen® 1000 were compared against results from legally marketed predicate devices, the MLA 900C and MLA 1600C, using the same "citrated plasma specimens."
• Internal Validation/Reference Methods: For precision studies, it implies that control materials or repeated measurements on samples were used to establish the variability (CV%) of the device itself and in comparison to the predicate devices.

Therefore, the ground truth is based on comparative measurements to predicate devices and established laboratory standards for precision and accuracy, rather than pathology, expert consensus, or outcomes data in the typical sense for imaging or pathology devices.

8. The Sample Size for the Training Set:

The document does not contain information about a "training set" or "training data." This type of terminology is usually associated with machine learning or artificial intelligence models. The ThromboScreen® 1000 is a photo-optical instrument. Its design and operational parameters would be developed through engineering and calibration processes, not a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a "training set" in the context of this device's development or evaluation.

Ask a specific question about this device