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510(k) Data Aggregation
(114 days)
HOFFMAN LABORATORIES, LLC
The BreatheX Nasal Interface System is intended for use as accessory device to CPAP machines in the treatment of obstructive sleep apnea (OSA).
The BreatheX Nasal Interface System is for use on adult spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic.
The BreatheX Nasal Interface System is an accessory intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.
The BreatheX Nasal Interface System has been designed for use as an accessory with commonly marketed CPAP units. The device consists of a plastic manifold with integral exhaust port, nasal mask cushion, a set of nasal pillows, adjustable headgear straps, and an interface tube with a 22mm fitting.
The Nasal Interface System allows a patient to use either the nasal pillows or nasal mask cushion interchangeably. The lightweight construction of the device is designed to maximize patient comfort.
The device is labeled for single patient use.
The Hoffman Laboratories BreatheX™ Nasal Interface System is a CPAP device accessory. The provided document does not detail specific quantitative acceptance criteria or a formal study proving the device met such criteria in the way one might expect for a diagnostic or therapeutic medical device involving clinical outcomes.
Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices through non-clinical testing and comparison of technological characteristics.
Here's an breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate devices and standards) | Reported Device Performance |
|---|---|---|
| Environmental Performance | Compliance with standards for temperature, humidity, shock, vibration, moisture ingress. | "The BreatheX Nasal Interface System passed all of the tests." |
| Static Performance | Comparable dead space to predicate devices. | "The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Dynamic Performance | Comparable pressure-flow characteristics to predicate devices. | "The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Sound Output Level | Comparable sound output level to predicate devices. | "The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Biocompatibility | Materials comply with biocompatibility requirements for intended use. | "The materials utilized in the device comply with biocompatibility requirements appropriate for the intended use." |
| Risk & Hazard Analysis | Residual risks acceptable for intended use. | "Risk and Hazard analyses were performed, and the results of the analyses demonstrated that the residual risks were acceptable for the intended use." |
| Technological Equivalence | Similar technological characteristics as predicate devices (e.g., rigid plastic manifold, soft silicone rubber seal, head straps, integral exhaust port). | "The BreatheX Nasal Interface device utilizes similar technological characteristics as the predicate devices... Like the predicate devices, the manifold... has an integral exhaust port..." |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified quantitatively. The "tests" mentioned are likely engineering and bench tests, not involving human subjects. For example, "dead space" or "pressure-flow characteristics" would be measured on a single or a small number of device units.
- Data Provenance: The tests were conducted internally by Hoffman Laboratories, LLC. "Laboratory and standards compliance tests" are mentioned, suggesting controlled lab environments. No country of origin for data is stated beyond the company's location in Chatsworth, CA, USA. The data is retrospective in the sense that it was collected prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The "ground truth" for this type of device (a CPAP accessory) in a 510(k) submission is typically based on engineering specifications, industry standards, and comparison to predicate devices, rather than expert interpretation of clinical data.
4. Adjudication method for the test set
- Not applicable and not provided. As mentioned above, this is not a study requiring adjudication of expert opinions.
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 MRMC study was conducted. This device is not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests was based on engineering specifications, industry standards (e.g., for environmental testing), and predefined performance characteristics that were considered acceptable or comparable to the predicate devices. For example, the "specified requirements" for dead space and pressure-flow characteristics served as the ground truth against which the device's performance was measured. Biocompatibility requirements per relevant standards also acted as ground truth.
8. The sample size for the training set
- Not applicable. This device is not an AI or machine learning system, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
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(86 days)
HOFFMAN LABORATORIES, LLC
The BreatheX Omega continuous positive airway pressure (CPAP) device is intended for use in the treatment of obstructive sleep apnea (OSA).
The BreatheX Omega CPAP is used while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) at a specified pressure level in order to prevent airway obstruction.
The BreatheX Omega CPAP is for use on adult patients weighing at least 30 kg, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic.
The BreatheX Omega is not intended for life support.
The BreatheX Omega CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg.
The BreatheX Omega CPAP device provides continuous positive airway pressure.
Caution: Federal law restricts this device to sale by or on the order of a physician.
The BreatheX provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The device is battery operated.
The BreatheX Omega is comprised of a motorized blower assembly that provides positive air pressure. The blower speed is directly related to air pressure, and is controlled by software.
The BreatheX Omega CPAP device consists of the following main components:
- CPAP blower .
- Battery/Battery charger .
- Therapy Tubing .
The patient interface (CPAP mask) is a commercially available accessory provided separately. The patient interface is not covered in this submission.
The provided document is a 510(k) summary for the BreatheX™ Omega™ CPAP Device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical performance study using human subjects or AI algorithms. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical tests rather than specific clinical acceptance criteria or performance metrics directly comparable to a predicate device in a tabulated format. The acceptance criteria were implicit in "meeting specified requirements" and being "comparable to the applicable specifications of the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with medical electrical safety standards | Device passed all applicable standards for medical electrical safety. |
| Compliance with electromagnetic compatibility standards | Device passed all applicable standards for electromagnetic compatibility. |
| Compliance with shock and vibration standards | Device passed all applicable standards for shock and vibration. |
| Compliance with environmental temperature and humidity standards | Device passed all applicable standards for environmental temperature and humidity. |
| Static and dynamic pressure performance | Device met specified requirements and was comparable to the applicable specifications of the predicate device (Fisher & Paykel HC200). |
| Software verification to requirements | Embedded software was verified to requirements. |
| Software validation to meet intended use | Embedded software was validated to meet intended use by software and system level performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable to this 510(k) submission. The non-clinical tests described were laboratory-based, focusing on engineering and software validation. There is no mention of a "test set" of patient data in the context of an AI/medical device study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for the non-clinical tests would be the accepted engineering standards and the specifications of the predicate device. Expert human review of data for diagnostic accuracy, as would be relevant for AI, is not mentioned.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states "Clinical Tests Submitted: None."
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The device described is a physical CPAP device, not an AI algorithm. The software mentioned is embedded control software for the device's function, not a diagnostic or interpretive algorithm.
7. Type of Ground Truth Used
The ground truth used for the non-clinical tests was based on:
- Applicable engineering and medical device standards (e.g., for safety, EMC).
- The specifications and performance of the predicate device (Fisher & Paykel HC200) for static and dynamic pressure testing.
- Software requirements and intended use for software validation.
8. Sample Size for the Training Set
Not applicable. The document describes a physical CPAP device and its embedded control software, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no AI model or training set, there was no establishment of ground truth for a training set.
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