(159 days)
The Hans Rudolph 7600 Vmask series is a reusable, single patient multi-use, adult Full-Face CPAP/NIPPV mask which incorporates a passive, continuous flow exhaust port at the patient connection. It is 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 cmH20 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, and 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.
The 7600 Series Reusable Full-Face CPAP/NIPPV 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. The Mounting Head Gear is disposable after multiple uses.
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 regardless as to whether he or she is connected to single or dual level CPAP system or an MNT. MNS or CBK ventilator and regardless of the make or model of the CPAP or MNT. MNS or CBK ventilator blower device being used.
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 MNT, MNS or CBK ventilator blower tubing types. The Elbow provides 360° of swivel rotation both at the Mask Adapter and at the 22 mm Swivel Port. The Anti-Asphxyia Valve is detachable from the Elbow for cleaning, sterilization and replacement.
The Anti-Asphxyia Valve functions as a safety mechanism which allows the patient to breathe fresh air if the CPAP or MNT, MNS, or CBK ventilator blower output ceases.
The provided text describes a 510(k) premarket notification for a medical device, the Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks. This type of submission is a claim of substantial equivalence to a legally marketed predicate device, rather than a claim of meeting specific performance acceptance criteria based on a study with predefined metrics.
Therefore, the document does not contain an acceptance criteria table or a study that "proves the device meets the acceptance criteria" in the way one might expect for a de novo or PMA submission. Instead, the document establishes equivalence through a comparison of characteristics and performance with predicate devices.
Here's an analysis of the provided information based on your request, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document as specific acceptance criteria with defined numerical targets for performance and a direct reporting of how the device met those criteria.
However, the document does contain a "Comparison Table" (Section 10) which implicitly serves a similar purpose by comparing key characteristics and stating if the new device's performance or features are "Similar/Different" from the predicate devices. The goal is to demonstrate that any differences do not raise new questions of safety or effectiveness.
Below is an adapted table from the provided text, re-framing the "Characteristic" columns to reflect a comparison rather than explicit acceptance criteria. The "Reported Device Performance" for the Hans Rudolph 7600 Series is derived directly from the "7600 Series Reusable Full-Face CPAP/NIPPV Masks" column and the "Similar/Different" column in the original document.
| # | Characteristic (Implicit Criteria from Predicate) | Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks (Reported Device Performance) | Notes from "Similar/Different" Column |
|---|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | Connect adult patients to single and dual level CPAP devices and to non-invasively connect adult patients to blower-operated respiratory support ventilators | Similar |
| 2 | Indications | Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support | Similar |
| 3 | Environment | Homes, hospitals, and other clinical settings | Similar |
| 4 | Personnel Education and Training | 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 | Similar |
| 5 | Reuse | Single patient multi-use | Similar (to ResMed and Respironics Reusable); Different (from Respironics Disposable) |
| 6 | Safety Mechanisms | Safety breathe-out valve to guard against loss of flow source; mask pull-string release feature to guard against aspiration or suffocation; mask vent holes to prevent CO2 buildup | Similar |
| 7 | Anti-suffocation Valve Threshold | 3.0 cm H2O minimum | Similar |
| 8 | Fastening Means | Mounting head gear straps | Similar |
| 9 | Mask Sizes | Five sizes (petite, extra small, small, medium, & large) fit a range of adult patients | Model 7600 series has one more size than Respironics and two more sizes than ResMed to ensure a good fit. Different |
| 10 | Mask Material in Contact with Face | Soft biocompatible silicone rubber (latex-free) | Similar (to ResMed and Respironics Reusable); Different (from Respironics Disposable which uses vinyl) |
| 11 | Cleaning Instructions | Yes | Similar (to ResMed and Respironics Reusable); Different (Respironics Disposable has none) |
| 12 | Validated Disinfection Instructions | Model 7600 series has validated disinfection instructions for all reusable mask components | Different (Predicate devices either have unknown validation or only for specific components) |
| 13 | Validated Sterilization Instructions | Model 7600 series has validated sterilization instructions for all reusable mask components | Different (Predicate devices either have none known or only for specific components) |
| 14 | Sterility at Shipment | Provided clean, non-sterile | Similar |
| 15 | Contraindications Listed in Labeling | More contraindications are recognized and these should also apply to predicates | Different (States more comprehensive list of contraindications than predicates, implying a more robust understanding of safety considerations) |
| 16 | Complications Listed in Labeling | More details are given on complications and these should also apply to predicates | Different (States more detailed list of complications than predicates, implying a more robust understanding of safety considerations) |
| 17 | Assemblies | Mounting head gear; face piece with vent holes; and swivel port assembly (includes mask adapter, elbow with anti-asphxyia valve, and 22 mm swivel port) | Similar |
| 18 | Material of Mask Shell & other pieces not in contact with face (excludes anti-suffocation valve) | Transparent polysulfone | Different (Predicate devices use polycarbonate or acrylic) |
| 19 | Service Life | 2 years | Different (Predicate devices' service life is unknown) |
| 20 | Maximum Operating Pressure | Model 7600 is capable of meeting all its specifications while operating at a maximum pressure of 40 cm H2O | Different (Equal to highest predicate; higher than one predicate's listed rating) |
| 21 | Carbon Dioxide Rebreathing | Built-in air leak provided by series of holes in mask near nose flushes CO2 out of mask | Similar |
Study that proves the device meets (implicit) acceptance criteria:
The document mentions that the manufacturer, Hans Rudolph, Inc., "has complied with these Design Control Procedures for all of the verification and validation (V & V) data generated to support the equivalency of this device."
The types of V & V data generated include:
- (a.) risk assessment and reduction analysis
- (b.) laboratory studies comparing the performance of the 7600 Series Masks with predicates
- (c.) human factors studies
- (d.) laboratory performance verification and validation
While these general categories are listed, specific details about the methodologies, sample sizes, or results of these studies are not provided in the publicly available 510(k) summary. The summary only states that these studies were conducted to support the claim of substantial equivalence.
2. Sample sized 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 510(k) summary. The summary broadly states that "laboratory studies" and "human factors studies" were conducted. It does not mention sample sizes for any test sets or the provenance (country, retrospective/prospective) of the data.
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 information is not provided in the 510(k) summary. Given the device type (a full-face mask for CPAP/NIPPV) and the nature of a 510(k) submission, "ground truth" as typically used in AI/image analysis studies with expert annotation is not directly applicable here. The "ground truth" for this device would relate to its physical and functional performance, potentially measured objectively in laboratory settings or subjectively through human factors evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary. Adjudication methods are typically relevant for studies involving subjective human interpretation (e.g., medical image reading) where disagreement among experts needs resolution. This is not the primary type of evaluation documented here.
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
An MRMC comparative effectiveness study is not mentioned and would not be relevant for this type of device (CPAP/NIPPV mask). MRMC studies are typically used to evaluate diagnostic imaging devices or AI tools that assist in interpretation. This device is a physical accessory for respiratory support, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical accessory, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a physical device like a CPAP/NIPPV mask, "ground truth" would generally refer to objective measurements of physical properties (e.g., pressure, leak rate, CO2 washout as described in the comparison table) and performance against established safety and essential performance standards (e.g., biocompatibility, materials testing, functionality of safety valves). The document mentions:
- "laboratory studies comparing the performance of the 7600 Series Masks with predicates"
- "human factors studies" (likely subjective user feedback and fit assessments)
- "laboratory performance verification and validation"
- "Biocompatibility Testing"
- "Risk Assessment Analysis"
- "Comparative Testing"
These activities collectively contribute to understanding the device's "truth" or performance. However, explicitly defining "ground truth" as you might for a diagnostic AI is not directly addressed.
8. The sample size for the training set
This is not applicable as the device is a physical medical accessory and does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
§ 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).