(149 days)
Not Found
No
The device description and intended use focus on a mechanical accessory for holding a nasal mask. There is no mention of AI, ML, or any computational analysis of data.
No
The device is described as an accessory to hold a nasal mask in place, serving as an alternative to standard headgear. While it facilitates therapy for OSA and snoring when used with an approved oral appliance and positive airway pressure delivery device, it is not itself performing the therapeutic action. Its function is mechanical support.
No
This device is described as an "accessory to hold a Nasal Mask on a patient's face" and an "alternative to the use of standard headgear." Its purpose is to facilitate therapy for OSA and snoring via an oral device and a positive airway pressure delivery device, not to diagnose a condition.
No
The device description clearly outlines physical components (Extension Bracket with Mask Flange, upper tray of the Oral Appliance) and their mechanical function (attaching, holding in place). There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold a nasal mask on a patient's face, serving as an accessory to an oral appliance used for snoring and OSA. This is a mechanical function related to patient support and therapy delivery.
- Device Description: The description details a physical bracket and its attachment to an oral appliance. It describes a physical accessory for holding a medical device (nasal mask) in place.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside the living body).
The device is clearly designed to be used in vivo (on the living body) to facilitate the use of other medical devices (oral appliance and nasal mask) for therapeutic purposes. It is a medical device accessory, but not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Hospital, home and sleep laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Thornton - TOA - K972061, Respironics, Inc. - Standard Head Gear for Nasal Mask - no K#
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 208 | |
| Dallas, 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
-
- 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.
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 impressionable | |||
| 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 | |||
| drink with appliance in place | Yes | Yes | N/A |
| Permits patient to breath through mouth | Yes | Yes | Yes |
4
2
Non-Confidential Summary of Safety and Effectiveness
(continued)
page 3 of 4
May 8, 1998
| Attribute | Combination
OA
(New device) | Thornton
TOA
K972061 | Respironics
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 -
-
- 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.
-
- 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.
-
- 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.
3
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:
-
- 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.
-
- 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.
-
- 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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4
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.
5
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
6
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 |
| 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. | |
| 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