COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER

K981744 · W. Keith Thornton, D.D.S. · BZD · Oct 14, 1998 · Anesthesiology

Device Facts

• Record ID: K981744
• Device Name: COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
• Applicant: W. Keith Thornton, D.D.S.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Device consists of an extension bracket with a mask flange; attaches to an upper oral appliance tray. Functions as an alternative to standard headgear for securing nasal masks. Used in hospitals, homes, and sleep laboratories by adult patients. The oral appliance is secured to the patient's upper teeth; the bracket holds the nasal mask in place. Enables simultaneous use of an oral appliance and positive airway pressure delivery for OSA/snoring therapy. Benefits include improved mask stability and elimination of traditional headgear straps.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Device comprises a rigid tray piece and heat-sensitive impressionable material for custom fitting to patient teeth. Features an extension bracket for mask attachment. Non-electronic, mechanical accessory. Reusable, single-patient device.

Indications for Use

Indicated for adult patients with snoring or obstructive sleep apnea (OSA) requiring a nasal mask for positive airway pressure delivery. Used as an accessory to secure the nasal mask to the patient's face via an intraoral appliance.

Regulatory Classification

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.

Predicate Devices

• Thornton - TOA - K972061
• Respironics, Inc. - Standard Head Gear for Nasal Mask

Submission Summary (Full Text)

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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 - [phone] |
|------------------------------------------------|---------------------------------------------------------------|
| 6131 Luther Lane Suite 208<br>Dallas, TX 75225 | Fax - [phone] |
| 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.
- 2. 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

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#### 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,<br>sleep laboratories | Yes | Yes | Yes |
| Targeted patients - Adult | Yes | Yes | Yes |

| Rigid tray piece | Yes | Yes | No |
|----------------------------------------------------------------|-----|-----|-----|
| Heat sensitive impressionable<br>material 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 and<br>drink with appliance in place | Yes | Yes | N/A |
| Permits patient to breath through mouth | Yes | Yes | Yes |

4

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#### Non-Confidential Summary of Safety and Effectiveness

#### (continued)

page 3 of 4

#### May 8, 1998

| Attribute | Combination<br>OA<br>(New device) | Thornton<br>TOA<br>K972061 | Respironics<br>Head 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.
- 2. 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.
- 3. 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

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 -

: 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.
- 2. 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.
- 3. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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 Appliance<br>Holder is that is may be used with or without the complete<br>Oral Appliance approved for Snoring and OSA to serve as<br>an accessory to hold a Nasal Mask on a patient's face. The<br>designed attachment can be fitted to hold the nasal mask in<br>place via an oral appliance secured by the upper teeth of the<br>patient. The accessory will have the same indications for<br>use 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)

or

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

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

510(k) Number _

8