(81 days)
The Hans Rudolph 7600 Vmask series are reusable, multi-use, adult Oro-Nasal CPAP/NPV masks which incorporate a passive, continuous flow exhaust port at the patient connection. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cm H2O pressure measured at the mask.
The Masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures ≥ 3.0 cm H2O at the mask) in homes, hospitals, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.
7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks consists of the following components:
- Mounting Head Gear
- Face Piece with Vent Holes
- Swivel Port Assembly
The Face Piece and the Swivel Port Assembly are both sterilizable and reusable by multiple patients. The Mounting Head Gear is disposable after multiple uses by a single patient only.
The Mounting Head Gear is adjustable in both its size and tension and holds the Face Piece against the patient's face to prevent any gas leakage. The size range of adjustment have been determined by a Mask Human Factors Study. The Mounting Head Gear also holds both the Face Piece and the Swivel Port Assembly onto the patient's head and is capable of adjusting to varying head sizes as determined by the Mask Human Factors Study.
The physical properties and dimensional ranges of the Face Piece (Mask) sizes listed under section #3 above have been determined by a Mask Human Factors Study.
All Face Piece sizes incorporate a series of vent holes in the area of the nose to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient. The incorporation of these holes do not interfere with the other performance requirements of the 7600 Series Mask. The vent holes also function to allow the patient to exhale normally.
The Swivel Port Assembly consists of the following pieces:
- Mask Adapter
- Elbow with Anti-Asphyxia Valve
- 22 mm Swivel Port
The 22 mm Swivel Port is sized to connect to all standard CPAP or ventilation device tubing types. The Elbow provides 360° of swivel rotation both at the Mask Adapter and at the 22 mm Swivel Port. The Anti-Asphyxia Valve is detachable from the Elbow for cleaning, sterilization and replacement.
The Anti-Asphyxia Valve functions as a safety mechanism which allows the patient to breathe fresh air if the CPAP or ventilation device output ceases.
The provided text describes a 510(k) premarket notification for the Hans Rudolph 7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (Hans Rudolph 7600 Series Reusable (Single-Patient Multi-Use) Oro-Nasal CPAP/NPPV Masks, K020759).
The key difference for the new device is that its labeling has been modified to include use on multiple patients after proper cleaning and sterilization/disinfection. Therefore, the "study" proving the device meets acceptance criteria primarily revolves around verification data for the recommended sterilization and disinfection processes.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Evidence Source |
|---|---|---|---|
| Substantial Equivalence | Identical in design, material, and construction to predicate device (K020759). | "These masks are identical in design, material and construction." | 510(k) Summary, Section 6 |
| Labeling modified to include multi-patient, multi-use after cleaning/sterilization. | "The only difference between the two devices is that the labeling of the Multi-Patient Multi-Use Mask has been modified to include mask use on multiple patients after proper cleaning and sterilization or disinfection has been performed." | 510(k) Summary, Section 6 | |
| Cleaning/Sterilization/Disinfection Effectiveness | Device can be safely cleaned, disinfected, and sterilized for multi-patient use. | "The 510(k) includes verification data for both the recommended sterilization and disinfection processes." | 510(k) Summary, Section 6 |
| Biocompatibility | Materials contacting patient skin are biocompatible. | "The mask Face Piece, which contacts the patient's skin, is constructed of silicone rubber (latex-free). This material has successfully undergone biocompatibility testing at a nationally recognized biological testing laboratory." | 510(k) Summary, Section 9; Complications section |
| Safety (General) | Device is safe in construction and use. | "The masks are safe in both construction and use. This has been confirmed by the performance of Verification and Validation Testing, Biocompatibility Testing, Risk Assessment Analysis, and Comparative Testing." | 510(k) Summary, Complications section |
| Human Factors (Mask Fit/Adjustment) | Mask dimensions and headgear adjustment accommodate varying head sizes. | "The size range of adjustment have been determined by a Mask Human Factors Study." "The physical properties and dimensional ranges of the Face Piece (Mask) sizes listed under section #3 above have been determined by a Mask Human Factors Study." | 510(k) Summary, Section 8 |
| Performance (Vent Holes) | Vent holes provide continuous air leak to flush CO2 without interfering with other performance requirements. | "All Face Piece sizes incorporate a series of vent holes... The incorporation of these holes do not interfere with the other performance requirements of the 7600 Series Mask. The vent holes also function to allow the patient to exhale normally." | 510(k) Summary, Section 8 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for the "test set" in terms of clinical performance or a specific number of masks tested for sterilization/disinfection. It refers generally to "verification data" for these processes.
- Sterilization/Disinfection Verification Data: This would typically involve laboratory testing of multiple units of the device subjected to the proposed cleaning, disinfection, and sterilization cycles. The number of cycles and devices tested would be determined by relevant standards (e.g., ISO, AAMI). The document doesn't specify the exact number of samples.
- Biocompatibility Testing: Conducted at a "nationally recognized biological testing laboratory." The sample size for such testing is usually dictated by the specific biocompatibility tests performed (e.g., cytotoxicity, irritation, sensitization).
- Human Factors Study: This would involve human subjects, but the number is not specified.
- Data Provenance: The studies mentioned ("Biocompatibility Testing," "Mask Human Factors Study," "Verification and Validation Testing," "Risk Assessment Analysis," and "Comparative Testing") are internal to the manufacturer (Hans Rudolph, Inc.) or conducted by contract labs on their behalf. The data is likely prospective for the specific tests mentioned, as they are newly performed to support the 510(k) for the multi-patient use claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for testing.
- For biocompatibility testing, the "nationally recognized biological testing laboratory" would have its own qualified scientists and technicians.
- For sterilization/disinfection verification, experts in microbiology and sterilization validation would be involved, likely employed by the testing lab or as consultants.
- For the Mask Human Factors Study, human factors specialists would design and conduct the study, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., for subjective assessments) as it focuses on objective performance criteria (sterilization effectiveness, material properties, fit).
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
There is no MRMC comparative effectiveness study mentioned. This filing is for a medical device (CPAP/NPPV masks), not an AI-powered diagnostic or assistive tool. Therefore, the concept of AI assistance and human reader improvement is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
There is no standalone algorithm performance study mentioned. This device is a physical medical accessory, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Objective Performance Metrics: For sterilization/disinfection, this would be quantitative measures of microbial reduction or inactivation, likely against recognized standards.
- Material Science Standards: For biocompatibility, adherence to ISO standards (e.g., ISO 10993 series) and specific test results (e.g., cytotoxicity, irritation scores).
- Dimensional Measurements and Fit: For the human factors study, this would involve anthropometric data and user feedback on fit and comfort, likely measured against pre-defined ranges or standards.
- Engineering Validation: For the vent hole performance and anti-asphyxia valve function, this would be based on fluid dynamics, pressure measurements, and functional testing.
8. The Sample Size for the Training Set
There is no "training set" as this is not a machine learning or AI device. The concept of training data is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).