The intended use for the Nasal Mask Oral Appliance Holder is that is may be used with or without the complete Oral Appliance approved for Snoring and OSA to serve as an accessory to hold a Nasal Mask on a patient's face. The designed attachment can be fitted to hold the nasal mask in place via an oral appliance secured by the upper teeth of the patient. The accessory will have the same indications for use as those of the equipment to which it is an accessory.

Device Description

The Universal Nasal Mask Oral Appliance Holder includes the Extension Bracket with Mask Flange which attaches to the upper tray of the Oral Appliance, approved under K972061. This device would be considered an accessory to the Nasal Mask and is designed to hold the Nasal Mask in place. It is an alternative to the use of standard headgear. It is adaptable to several different nasal masks styles.
In combination with the already approved, K972061, Oral Appliance which has both an upper and lower tray. The upper tray has a fitting which permits the attachment of the Extension Bracket with Mask Flange. This combined device permits therapy for OSA and snoring by an oral device and a positive airway pressure delivery device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study with statistical endpoints. Therefore, many of the requested elements (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not typically included in this type of submission and are not present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not outline specific numerical acceptance criteria or present quantitative performance data. Instead, it relies on a comparison of attributes and the assertion that "There is no significant difference" in performance relevant to safety and effectiveness compared to predicate devices. The "Performance Testing" section explicitly states "None applicable under Section 514" and "Equivalent leak rates," indicating that specific performance tests for this type of accessory device were not considered necessary beyond demonstrating functional equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance
Equivalence to predicate devices in function and intended use	"No significant difference between the intended device, Combination OA and Nasal Mask Holder and the Thornton TOA device approved under K972061 and the Respironics Head Gear."
"Equivalent leak rates" (Functional assertion, not quantified)	Stated as "Equivalent leak rates" without specific data.

2. Sample Size and Data Provenance for Test Set

Not applicable. The document does not describe a clinical test set with a specific sample size. The demonstration of equivalence is based on a comparison of design attributes and intended uses with predicate devices.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. No ground truth establishment by experts is described, as this is a regulatory submission for device equivalence, not a performance study requiring ground truth.

4. Adjudication Method

Not applicable. There is no mention of adjudication, as this is not a study involving expert review or conflict resolution.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was conducted or referenced. This type of study is more common for diagnostic or AI-driven devices where human interpreter performance is being evaluated.

6. Standalone Performance Study

Not applicable. No standalone performance study (algorithm only, without human-in-the-loop performance) was conducted or described. The device is a physical accessory, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The submission relies on establishing substantial equivalence to existing, legally marketed predicate devices rather than validating performance against an independent "ground truth." The implicit "ground truth" is the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a submission for a physical medical device accessory, not an AI or algorithm-driven device that typically requires a training set.

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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K 981744

W. Keith Thornton, D.D.S. 6131 Luther Lane, Suite 208 Dallas, TX 75225

Non-Confidential Summary of Safety and Effectiveness

page 1 of 4 May 8, 1998

W. Keith Thornton, D.D.S.	Tel - (214) 691-5621
6131 Luther Lane Suite 208Dallas, TX 75225	Fax - (214) 691-4934
Official Contact:	Keith Thornton, D.D.S.
Proprietary or Trade Name:	Nasal Mask Holder
Common/Usual Name:	Nasal Mask Holder
Classification Name:	Accessory to Non-continuous Ventilator
Device:	Universal Nasal Mask Holder and Combination Oral Appliance
Predicate Devices:	Thornton - TOA - K972061
	Respironics, Inc. - Standard Head Gear for Nasal Mask - no K#

Device Description: Contractor varies works works were works of the state

1. The Universal Nasal Mask Oral Appliance Holder includes the Extension Bracket with Mask Flange which attaches to the upper tray of the Oral Appliance, approved under K972061. This device would be considered an accessory to the Nasal Mask and is designed to hold the Nasal Mask in place. It is an alternative to the use of standard headgear. It is adaptable to several different nasal masks styles.
1. In combination with the already approved, K972061, Oral Appliance which has both an upper and lower tray. The upper tray has a fitting which permits the attachment of the Extension Bracket with Mask Flange. This combined device permits therapy for OSA and snoring by an oral device and a positive airway pressure delivery device.

Intended Use:

The intended use for the Nasal Mask Oral Appliance Holder is that Indicated Use -is may be used with or without the complete Oral Appliance approved for Snoring and OSA to serve as an accessory to hold a 3 Nasal Mask on a patient's face. The designed attachment can be

{1}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness

(continued)

page 2 of 4 May 8, 1998

fitted to hold the nasal mask in place via an oral appliance secured by the upper teeth of the patient. The accessory will have the same indications for use as those of the equipment to which it is an accessory.

Adult patients Target population - -

Hospital, home and sleep laboratories Environment of Use - -

Comparison to Predicate Devices: Devices:

Attribute Combination Thornton Respironics
OA TOA Head gear
(New device) K972061

Use
Intended as an intraoral device	Yes	Yes	No
Indicated for use with nasal mask	Yes	No	Yes
Indicated for single patient / multi - use	Yes	Yes	Yes
Indicated for use at home, hospital,sleep laboratories	Yes	Yes	Yes
Targeted patients - Adult	Yes	Yes	Yes

Rigid tray piece	Yes	Yes	No
Heat sensitive impressionablematerial for fitting to teeth	Yes	Yes	No
Custom fit for each patient	Yes	Yes	No
Method of adjusting for mask fit	Yes	No	Yes
Can be adjusted or refit	Yes	Yes	Yes
Placed in patient mouth each evening	Yes	Yes	N/A
Cleaned daily	Yes	Yes	Yes
Permits patient to talk anddrink with appliance in place	Yes	Yes	N/A
Permits patient to breath through mouth	Yes	Yes	Yes

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Non-Confidential Summary of Safety and Effectiveness

(continued)

page 3 of 4

May 8, 1998

Attribute	CombinationOA(New device)	ThorntonTOAK972061	RespironicsHead gear
Materials
Rigid tray material	Yes	Yes	N/A
Heat sensitive impression material	Yes	Yes	N/A
Elastic and Velcro strapping	No	No	Yes
Performance Testing
None applicable under Section 514	Yes	Yes	Yes
Equivalent leak rates

There is no significant difference between the intended device, Combination OA and Nask Holder and the Thornton TOA device approved under K972061 and the Respironics Head Gear, no separate 510(k) K#. (Included as a accessory in the mask submissions.)

The differences between the intended device, OA, and the predicates are -

1. The Combination Oral Appliance and Holder as compared to the Thornton TOA, K972061, is that the intended device permits the addition of a nasal mask to be attached to the oral appliance.
1. The Universal Nasal Mask Holder as compared to the Thornton TOA, K972061, utilizes only one tray and has an extension bracket to hold the nasal mask in place.
1. The Universal Nasal Mask Holder as compared to Respironics Head Gear utilizes a different method to hold a nasal mask in place. The oral tray with attached bracket vs. straps around the head.

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Non-Confidential Summary of Safety and Effectiveness (continued) page 4 of 4 May 8, 1998

The differences between the intended device, OA, and the predicates are -

: 上一篇:

1. The Combination Oral Appliance and Holder as compared to the Thornton TOA, K972061, is that the intended device permits the addition of a nasal mask to be attached to the oral appliance.
1. The Universal Nasal Mask Holder as compared to the Thornton TOA, K972061, utilizes only one tray and has an extension bracket to hold the nasal mask in place.
1. The Universal Nasal Mask Holder as compared to Respironics Head Gear utilizes a different method to hold a nasal mask in place. The oral tray with attached bracket vs. straps around the head.

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and healing. The caduceus is depicted as a staff with two snakes coiled around it, and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1998

W. Keith Thornton, D.D.S. 6131 Luther Lane, Suite 208 Dallas, TX 75225

Re: K981744 Combination Nasal Mask/Oral Appliance and Nasal Mask Holder Regulatory Class: II (two) Product Code: 73 BZD Dated: October 8, 1998 Received: October 9, 1998

Dear Dr. Thornton:

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, Druq, 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 Failure to comply with the GMP regulation may result in assumptions. 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 - W. Keith Thornton, D.D.S.

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 requlation (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. Callahan

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

Enclosure

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INDICATIONS FOR USE

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number:	K981744 (To be assigned)
Device Name:	Nasal Mask Oral Appliance Holder
Intended Use :	The intended use for the Nasal Mask Oral ApplianceHolder is that is may be used with or without the completeOral Appliance approved for Snoring and OSA to serve asan accessory to hold a Nasal Mask on a patient's face. Thedesigned attachment can be fitted to hold the nasal mask inplace via an oral appliance secured by the upper teeth of thepatient. The accessory will have the same indications foruse as those of the equipment to which it is an accessory.
Environment of use:	Hospital, Home, and Sleep laboratories
Disposable / Reusable:	Single patient - multi- use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dren
10/14/98

Prescription Use (Per CFR 801.109)

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

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

510(k) Number _

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).