The Monarch II Mini Mask is a single-patient-use interface for adult patients (> 30 kg) receiving Respironics CPAP or bi-level therapy. The mask consists of a removable silicone skin-contacting cushion, a polycarbonate faceplate, and a polycarbonate elbow (to which 15 mm flexible tubing is attached). The elbow fits on the faceplate at a 90° angle and swivels 360° about faceplate.

The Monarch II Mask incorporates a thin mask cushion that folds inward, creating a flap to improve seal. The mask fits over the tip of the nose (rather than under the nares). This improves the stability of the mask and also accommodates patients with various nose sizes and facial shapes. The shape of the modified cushion is that of a typical nasal mask (triangular). The mask is available in two sizes, small and medium, and is available with or without headgear. The mask does not come in contact with the nasal bridge area.

The faceplate is round and has three slots for the corresponding headgear attachment tabs. One exhalation port is on the elbow. The headgear material is Neoprene encased in nylon/polyester, a common material used for apparel products. It is safe for "next-to-skin" applications. The headgear has three attachment tabs.

Mask tubing is reusable low-density polyethylene with EVA. Mask tubing is 6 inches long, 15 mm diameter at the mask, and gradually widens to 22 mm diameter at the opposing end. The 22mm end of the mask tubing has an "accessory swivel" used to attach a 6-foot patient circuit.

AI/ML Overview

The provided text is a 510(k) summary for the Monarch II Mini Mask. It does not include details about acceptance criteria, specific device performance against those criteria, or details regarding a study to prove such performance.

The document primarily focuses on establishing substantial equivalence to a predicate device (Monarch Mini Mask K945938) based on similarities in:

Indicated use
Operating principle
Skin-contacting mask cushion materials
Technology
Manufacturing process

It also describes the device and its intended use. There is no information about clinical studies, test sets, ground truth establishment, expert adjudication, or MRMC studies.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

This type of information is typically found in performance studies or clinical trial reports, which are not present in this 510(k) summary. The summary explicitly states that "Verification testing has shown the modified mask has the following similarities to the previously cleared predicate device," implying that the assessment was based on demonstrating equivalence rather than a full, standalone performance study with predefined acceptance criteria for a new device.

Summary

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にいない。

ATTACH

510(K) SUMMARY OF SAFETY & EFFECT

Official Contact	David J. VanellaManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
Classification Reference	21 CFR 868.5905
Product Code	BZD - noncontinuous ventilator
Common/Usual Name	nasal mask
Proprietary Name	Monarch II Mini Mask
Predicate Device	Monarch Mini Mask (K945938)
Reason for submission	Change in design; change in materials

Substantial Equivalence

Verification testing has shown the modified mask has the following similarities to the previously cleared predicate device:

O Same indicated use.
0 Same operating principle.
Same skin-contacting mask cushion materials. 0
0 Same technology.
Same manufacturing process.

In summary, the mask described in this submission is substantially equivalent to the predicate device.

The modified mask complies with the applicable standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993.

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Device Description/Intended Use

Image /page/1/Figure/4 description: The image shows a diagram of a mask cushion with tubing. The mask cushion is connected to an exhalation port. The tubing is 6 inches (15.25 cm) long and has a stability clip. The tubing swivel is labeled as an accessory swivel.

Monarch II Mini Mask

The faceplate is round and has three slots for the corresponding headgear attachment tabs. One exhalation port is on the elbow. The headgear material is Neoprene™ encased in nylon/polyester, a common material used for apparel products. It is safe for "next-to-skin" applications. The headgear has three attachment tabs.

(End of Section.)

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, with a wavy line below representing water or air currents.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 1999

Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668-0299

Re: K992336 Monarch™ Mini Mask Requlatory Class: II (two) Product Code: 73 BZD Auqust 6, 1999 Dated: Received: August 9, 1999

Dear Mr. Ward:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David J. Vanella

This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Allehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): L992336

Device Name: Monarch II Mini Mask

Intended Use/Indications for Use

The Respironics Monarch II Mini Mask is intended to provide an interface for application of Respironics CPAP or bi-level therapy to patients.

Environment of Use/Patient Population

For single patient use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30 kg) for whom CPAP or bi-level therapy has been prescribed using a Respironics CPAP or bi-level system.

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510) Nu

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

Congurrence of CDRH, Office of Device Evaluation (ODE) ﺎ OR Over-The-Counter Use Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)

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).