7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS by HANS RUDOLPH, INC.

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.

Device Description

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.

AI/ML Overview

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.

Summary

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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

1. 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

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 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

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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:

1. a minimum pressure < 3 cm H2O at mask
1. open wounds that are prone to infection
hemodynamic or cardiorespiratory instability 3.
unconsciousness 4.
న్న claustrophobia, anxiety, or other discomfort with full-face mask
1. facial or nasopharyngeal deformity, beard, or other inability to fit mask & seal properly
1. excessive reflux, GI blood, or other secretions
impaired cough reflex, hiatal hernia, or inability to swallow or clear secretions 8.
の upper airway obstruction or facial trauma
1. barotrauma
1. need for ventilation or ventilatory support more than 12 hours per day
1. recent facial, esophageal, or gastric surgery
1. patients unable to remove mask
1. patients under medication with a drug that may cause vomiting
1. patients requiring immediate intubation

Complications: The Masks are non-invasive devices. The silich is applied directly to the patient's skin is soft, pliable and a biocompatible material. The masks are safe in

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both construction and use. This has been confirmed by the performance of Verification and Validation Testing, Biocompatibility Testing, Risk Assessment Analysis, and Comparative Testing.

Following are some possible minor to moderate complications:

1. infection due to improper use over open wounds
1. skin irritation after prolonged use caused by rubbing of the mask
1. nasal or dental pain or deformity
1. drying of pharyngeal and nasal mucosa
1. eve irritation or conjunctivitis
1. gastric distention and abdominal pain or flatulence from ingested air
1. some slight discomfort after prolonged use
1. decreased secretion clearance especially during upper respiratory tract infections
1. aspiration of secretions

General Device Description: 7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks consists of the following components:

1. Mounting Head Gear
1. Face Piece with Vent Holes
1. 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 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.

The Swivel Port Assembly consists of the following pieces:

1. Mask Adapter
1. Elbow with Anti-Asphyxia Valve
1. 22 mm Swivel Port

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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.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUN - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin Rudolph Vice President Hans Rudolph, Incorporated 7200 Wyandotte Kansas City, Missouri 64114

Re: K030822

Trade/Device Name: 7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks Regulation Number: 21 CFR 868.5905 Regulation Name: Non-Continuous Ventilator Regulatory Class: II Product Code: 73 BZD Dated: March 12, 2003 Received: March 14, 2003

Dear Mr. Rudolph:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Quare

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4: INDICATIONS FOR USE STATEMENT

KiD30822 510(k) Number (if known) ___

Device Name: Hans Rudolph 7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPV Masks

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER: PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Loftin Winder

510(k) Number: K030822

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).