(159 days)
No
The document describes a physical medical device (a CPAP/NIPPV mask) and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies mentioned are related to physical characteristics and human factors, not data analysis or pattern recognition.
Yes
The device is a CPAP/NIPPV mask intended for the treatment of obstructive sleep apnea and other conditions requiring ventilatory support, which directly addresses a medical condition.
No
The device is a CPAP/NIPPV mask used for treatment of sleep apnea and other conditions requiring ventilatory support. It is not used to diagnose a medical condition.
No
The device description clearly outlines physical components (Mounting Head Gear, Face Piece, Swivel Port Assembly) and their functions, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing CPAP/NIPPV therapy for conditions like obstructive sleep apnea. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a mask designed to deliver air pressure to a patient's airway. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, preparing, or analyzing biological specimens (like blood, urine, tissue, etc.) to diagnose a disease or condition.
Therefore, the Hans Rudolph 7600 Vmask series is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are 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.
Product codes
BZD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face / Nasopharyngeal
Indicated Patient Age Range
Adult (> 30 kilograms weight)
Intended User / Care Setting
Environment of Use: The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are for use in homes, hospitals, and other clinical settings by individuals that have received at least minimal instruction or training on the use of the device and system to which the masks are intended to connect.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Hans Rudolph has created a Design Control Procedure system which is in accordance with ISO 9001, EN 46001, and the FDA Quality System Requirements detailed in 21 CFR 820. It 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.
Among the V & V data generated to support the equivalency of the Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks to the predicates is: (a.) risk assessment and reduction analysis. (b.) laboratory studies comparing the performance of the 7600 Series Masks with predicates, (c.) human factors studies, and (d.) laboratory performance verification and validation.
The silicone surface which is applied directly to the patient's soft, pliable and a biocompatible material. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SECTION 14: 510(K) SUMMARY
1. Summary Preparation Date: August 7, 2001
2. Manufacturer/Applicant Information:
Name: Hans Rudolph, Inc. Company Headquarters and Manufacturing Location: 7205 Central Kansas City, MO 64114 FDA Establishment Registration Number: 1922553 Contact Name and Title Official Correspondent: Kevin Rudolph, Vice President Phone Number: 816-363-5522 Fax Number: 816-822-1414
- Proprietary Name: 7600 Series Reusable Full-Face CPAP/NIPPV Masks
Model Numbers & Sizes:
a. 7620 Large b. 7630 Medium c. 7640 Small d. 7650 Extra Small e. 7660 Petite Common/Usual Name: Face Mask Classification Name: Noncontinuous Ventilator (IPPB) Accessory Classification Panel: Anesthesiology Classification Code Based on Full-Face Mask Predicates: BZD
-
BZD Device Identification: (21 CFR Part 868.5905): 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. [The device which is the subject of this 510(k) submittal is an accessory to such a device (FDA product code BZD) and also to other bloweroperated ventilation devices with product codes MNT, MNS, and CBK. ]
-
Regulatory Status: Noncontinuous ventilators and their accessories (FDA product code BZD) have been classified by the FDA as class II. Ventilation devices MNT. MNS and CBK have also been classified by the FDA as class II. There are currently no performance standards or special control requirements for any of these devices.
-
Substantial Equivalence: The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are substantially equivalent to the ResMed Sullivan7 Mirage Masks (K936047), and the Respironics Spectrum " Reusable Full Face Masks (K961915).
1
The characteristics of the Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are similar to those of the predicates mentioned above. The few minor differences in technological characteristics do not raise any new questions regarding safety or effectiveness.
Hans Rudolph has created a Design Control Procedure system which is in accordance with ISO 9001, EN 46001, and the FDA Quality System Requirements detailed in 21 CFR 820. It 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.
Among the V & V data generated to support the equivalency of the Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks to the predicates is: (a.) risk assessment and reduction analysis. (b.) laboratory studies comparing the performance of the 7600 Series Masks with predicates, (c.) human factors studies, and (d.) laboratory performance verification and validation.
- General Device Description: 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
2
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.
8. Intended Use, Indications for Use, & Environment:
Intended Use: The Hans Rudolph 7600 Vmask Series is a reuseable, single patient multi –use, adult Full-Face CPAP/NPPV 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 annea, and for use with other similators that use this exhaust port configuration providing a minimum of 3 cm H2O pressure measured at the mask.
Environment of Use: The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are for use in homes, hospitals, and other clinical settings by individuals that have received at least minimal instruction or training on the use of the device and system to which the masks are intended to connect.
Indications for Use: The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are 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.
Contraindications: The masks will not remain sterile between repeated single-patient uses and should not be placed over open wounds that are prone to infection. Cleaning, disinfection, and sterilization procedures are included as part of the Instructions for Use.
The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks may not be suitable for use on patients with the following conditions:
-
- a minimum pressure 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| -- | -------------------------------------------------------------------------- |
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K020759 |
|---|---|
| ---------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
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