(81 days)
Not Found
No
The description focuses on the mechanical components and function of a CPAP/NPPV mask, with no mention of AI or ML technology.
Yes
The device is intended for the "treatment of obstructive sleep apnea" and "non-invasive ventilatory support," which are therapeutic purposes.
No.
The device is a mask for delivering positive airway pressure, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a mounting head gear, face piece, and swivel port assembly, indicating it is a hardware device, not software-only.
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/NPPV therapy to patients for conditions like obstructive sleep apnea. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a mask designed to deliver air pressure to a patient's airway. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- No mention of diagnostic testing: The text does not describe any function related to analyzing biological samples or providing diagnostic information.
IVD devices are used to perform tests on samples (like blood, urine, tissue) to diagnose diseases or conditions. This device is a medical device used for treatment.
N/A
Intended Use / Indications for Use
Intended Use: The Hans Rudolph 7600 Vmask series are reusable, multi-patient 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.
Indications for Use & Environment: 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 HzO 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks consists of the following components:
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- Mounting Head Gear
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- Face Piece with Vent Holes
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- 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:
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- Mask Adapter
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- Elbow with Anti-Asphyxia Valve
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- 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.
Device Materials: 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. The mask Head Gear materials consist of nylon and polyester straps and polycarbonate clips. All other components which are not in contact with the patient's skin are constructed of polysulfone material. All mask components other than the Head Gear are capable of both glutaraldehyde and steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oro-Nasal
Indicated Patient Age Range
Adult (> 30 kilograms weight)
Intended User / Care Setting
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.
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)
The 510(k) includes verification data for both the recommended sterilization and disinfection processes.
Verification and Validation Testing, Biocompatibility Testing, Risk Assessment Analysis, and Comparative Testing were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN - 3 2003
Image /page/0/Picture/1 description: The image shows the text "K030822" in a handwritten style. The text is oriented diagonally, running from the bottom left to the upper right corner of the image. The characters are bold and slightly distorted, giving them a unique, hand-drawn appearance.
SECTION 10: 510(K) SUMMARY
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- Summary Preparation Date: February 5, 2003
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: Kevin Rudolph, Vice President Phone Number: 816-363-5522 Fax Number: 816-822-1414
- Proprietary Name: 7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV 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
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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.]
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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.
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Substantial Equivalence: The Hans Rudolph 7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks are substantially equivalent to the Hans Rudolph 7600 Series Reusable (Single-Patient Multi-Use) Oro-Nasal CPAP/NPPV Masks (K020759).
These masks are identical in design, material and construction. The only difference between the two devices is that the labeling of the Multi-Patient Multi-Use Mask has been modified to
1
include mask use on multiple patients after proper cleaning and sterilization or disinfection has been performed.
The 510(k) includes verification data for both the recommended sterilization and disinfection processes.
7. Intended Use, Indications for Use, & Environment:
Intended Use: The Hans Rudolph 7600 Vmask series are reusable, multi-patient 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.
Indications for Use & Environment: 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 HzO 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.
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 Masks may not be suitable for use on patients with the following conditions:
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- 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, 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER: PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Loftin Winder
510(k) Number: K030822
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)