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

Device Description

The Reusable Contour II Nasal Mask is intended to provide a single-patient use interface for adult patients (>30 kg) receiving Respironics CPAP or bi-level therapy. It consists of a silicone skincontacting cushion, a polycarbonate faceplate and a polycarbonate elbow (to which 22 mm flexible tubing is attached). The mask elbow swivels 360 degrees relative to the faceplate. The Reusable Contour II Nasal mask has two permanently fixed exhalation ports (vent holes), one on each side of the mask elbow, which eliminate the need for a separate exhalation device. An accessory swivel allows rotation of the flexible tubing about its center axis. Thus the elbow swivels at both the faceplate and the tubing connection. The mask cushion material varies in thickness for better seal and fit. The cushion material is thinnest where the cushion contacts the nose. The faceplate has a streamlined, compact shape to reduce mask volume. The gel forehead spacer is mounted on the mask's forehead extension. Because it distributes force more evenly than the current foam spacer, it allows the patient or caregiver to increase strap tension without jeopardizing patient comfort. The Reusable Contour II Nasal Mask (with an optional headstrap) is available in three sizes to fit a broad range of facial structures.

AI/ML Overview

This document describes the Reusable Contour II Nasal Mask and its comparison to a predicate device for 510(k) clearance. The focus of the provided text is on demonstrating substantial equivalence through design and material changes, rather than a detailed performance study with quantitative acceptance criteria typically associated with new algorithm development or significant device modifications requiring extensive clinical trials.

Therefore, the information regarding acceptance criteria and performance data is limited to what is typically found in a 510(k) submission for minor device modifications, which emphasizes equivalence to an already cleared device.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" reported is primarily in terms of maintaining functional and safety characteristics similar to the predicate.

Acceptance Criteria Category (Implied)	Reported Device Performance
Intended Use	Same indicated use as predicate device
Operating Principle	Same operating principle as predicate device
Skin-Contacting Materials	Same skin-contacting mask cushion materials as predicate device
Technology	Same technology as predicate device
Manufacturing Process	Same manufacturing process as predicate device
Compliance to Standards	Complies with applicable standards referenced in "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993.
Functionality (Design Changes)	Modified mask incorporates: - Permanently fixed exhalation ports. - Accessory swivel for tubing rotation. - Varied cushion thickness for better seal and fit. - Streamlined, compact faceplate. - Gel forehead spacer (replaces foam) for more even force distribution and improved comfort.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a numerical sample size for any testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective). The statement is "Verification testing has shown the modified mask has the following similarities..." which indicates internal testing was performed, but no specifics are given.

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 type of information is not relevant or provided for this 510(k) submission. "Ground truth" and expert adjudication are concepts typically associated with diagnostic algorithms or imaging evaluations, which are not the subject of this device (a nasal mask). The assessment here is based on engineering verification and comparison to an established predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device submission. Adjudication methods are used in studies where subjective interpretation or classification by multiple experts is required to establish ground truth for a diagnostic or AI system.

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

Not applicable. An MRMC study is used to evaluate the performance of diagnostic imaging devices or AI algorithms often with human readers. This submission is for a medical device (a nasal mask) where such a study design is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical mask, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic studies is not directly applicable here. For this nasal mask, the "truth" or benchmark for demonstrating substantial equivalence is the performance and safety profile of the predicate device. Testing would have focused on engineering specifications, biocompatibility, fit, seal, and exhalation port performance to ensure they meet requirements similar to the predicate and applicable standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this device is not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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Reusable Contour II Nasel Mask

K 91648

P.04

Premarket Notification - Special 610(K)

& EFFECT 30MMAH

Image /page/0/Picture/4 description: The image shows the logo for Respironics Inc. The logo features a stylized graphic above the company name, with the address "1001 Murry Ridge Lane, Murrysville, PA 15668" printed below. The logo is in black and white and appears to be from a printed document.

Official Contact

David J, Vanella Manager, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668

Classification Reference

21 CFR 868.5895

Product Code

BZD - noncontinuous ventilator

Common/Usual Name nasal mask

Proprietary Namp

Reusable II Contour Nasal Mask

Predicate Device

Reusable Contour Nasal Mask Hausable Conton Nasal Mask

Change in design; change in materials Reason for submission,

Substantial Equivalence

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

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

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P.05

fire summary, the mask described in this submission is, in our opinion, 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.

evice Description/Intended Use

Image /page/1/Figure/7 description: This image shows a diagram of a medical mask and its components. The mask includes a faceplate, gel forehead spacer, mask cushion, pressure pickoff port, modified elbow, exhalation ports, accessory swivel, and 22 mm flexible tubing. The exhalation ports are located on each side of the elbow.

eusable Contour II Nasal Mask.

The Reusable Contour II Nasal mask has two permanently fixed exhalation ports (vent holes), one on each side of the mask elbow, which eliminate the need for a separate exhalation device. An accessory swivel allows rotation of the flexible tubing about its center axis. Thus the elbow swivels at both the faceplate and the tubing connection. The mask cushion material varies in thickness for hetter seal and fit. The cushion material is thinnest where the cushion contacts the nose.

The faceplate has a streamlined, compact shape to reduce mask volume. The gel forehead spacer is mounted on the mask's forehead extension. Because it distributes force more evenly than the current foam spacer, it allows the patient or caregiver to increase strap tension without jeopardizing patient comfort. The Reusable Contour II Nasal Mask (with an optional headstrap) is available in three sizes (End of Section.) fit a broad range of facial structures.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 1999

Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550

Re: K991648 Reusable Contour Nasal Mask Regulatory Class: II (two) 73 BZD Product Code: May 12, 1999 Dated: Received: May 13, 1999

Dear Mr. Vanella:

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 reqistration, 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 Reqister. 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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Paqe 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 labeling 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. Callahon

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): K991 to 4

Device Name: Reusable Contour II Nasal Mask

Intended Use/Indications for Use

The Respironics Reusable Contour II Nasal Mask is intended to provide an interface for application of Respironics bi-level or CPAP 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 (>30kg) for whom bi-level or CPAP therapy has been prescribed using a Respironics bi-level or CPAP system.

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

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K991648

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).