(79 days)
Not Found
No
The device description and summary of performance studies focus on a mechanical oral appliance and its clinical effectiveness, with no mention of AI or ML components.
Yes.
The device is intended to "reduce or alleviate night time snoring and obstructive sleep apnea (OSA)", which are medical conditions, and clinical studies show it "reduced AHI in patients 72%", demonstrating a therapeutic effect.
No
The device is intended to reduce or alleviate night time snoring and OSA, which is a therapeutic function, not a diagnostic one. While it impacts AHI, that is a performance measure of its therapeutic effect, not an indication that it diagnoses the condition.
No
The device description clearly lists physical components (lower tray, upper tray, impression material, hook mechanism) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce or alleviate night time snoring and obstructive sleep apnea (OSA)". This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical appliance worn in the mouth. It does not involve the analysis of biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD-related information: The description does not mention any components or processes related to in vitro testing, such as reagents, assays, or sample analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The TOA is intended to reduce or alleviate night time snoring and obstructive sleep apnea, OSA.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The TOA Anti-snoring device is comprised of -
-
- Lower tray fitted over the lower teeth.
-
- Upper tray fitted over the upper teeth.
-
- Impression material
-
- Hook mechanism to attach lower tray to upper tray
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
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)
Performance Testing:
- None applicable under Section 514
- reduced AHI in patients: 72%
- AHI performance comparable to CPAP: Yes
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.
Nellcor Puritan Bennett - TAP - K962516, SnoreFree - OSAP - K960673, Distar, Inc. - TheraSnore - K926382
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
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
0
W. Keith Thornton, D.D.S. 6131 Luther Lane, Suite 208 Dallas, TX 75225
K972061..
AUG 21 1997
Non-Confidential Summary of Safety and Effectiveness
page 1 of 3 June 2, 1997
Tel - (214) 691-5621 W. Keith Thornton, D.D.S. 6131 Luther Lane Suite 208 Fax - (214) 691-4934 Dallas, TX 75225
| Official Contact: | Keith Thornton, D.D.S. |
|---|---|
| Proprietary or Trade Name: | TOA |
| Common/Usual Name: | Oral Appliance - anti-snoring device |
| Classification Name: | Anti-snoring device |
| Device: | TOA |
| Predicate Devices: | Nellcor Puritan Bennett - TAP - K962516 |
| SnoreFree - OSAP - K960673 | |
| Distar, Inc. - TheraSnore - K926382 |
Device Description:
The TOA Anti-snoring device is comprised of -
-
- Lower tray fitted over the lower teeth.
-
- Upper tray fitted over the upper teeth.
-
- Impression material
-
- Hook mechanism to attach lower tray to upper tray
| Intended Use: | |
|---|---|
| Indicated Use -- | The TOA is intended to reduce or alleviate night time snoring |
| and obstructive sleep apnea, OSA. | |
| Target population -- | Adult patients |
| Environment of Use -- | Home and sleep laboratories |
1
Non-Confidential Summary of Safety and Effectiveness (continued)
page 2 of 3
June 2, 1997
Comparison to Predicate Devices: Devices: Devices Comments Comparison
.
: 上一篇:
11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
| Attribute | TOA | NPB TAP
K962516 | OSAP
K960673 | TheraSnore
K92638 |
|---------------------------------------------------------------|-----|--------------------|-----------------|----------------------|
| Use | | | | |
| Intended as an intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce snoring or
help alleviate snoring | Yes | Yes | Yes | Yes |
| Indicated for use with patients
with mild to moderate OSA | Yes | Yes | Yes | Yes |
| Indicated for single patient
multi - use | Yes | Yes | Yes | Yes |
| Indicated for use at home or
sleep laboratories | Yes | Yes | Yes | Yes |
| Design | | | | |
| Rigid tray pieces | Yes | Yes | Yes | Yes |
| Heat sensitive impermissible
material for fitting to teeth | Yes | Yes | Yes | Yes |
| Separate tray pieces | Yes | Yes | No | No |
| Custom fit for each patient | Yes | Yes | Yes | Yes |
| Works by holding lower jaw forward | Yes | Yes | Yes | Yes |
| Can be adjusted or refit | Yes | Yes | Yes | Yes |
| Placed in patient mouth each
evening | Yes | Yes | Yes | Yes |
| Cleaned daily | Yes | Yes | Yes | Yes |
| Permits lateral and / or vertical
jaw movement | Yes | Yes | No | No |
| Attribute | TOA | NPB TAP
K962516 | OSAP
K960673 | TheraSnore
K92638 |
| Design (continued) | | | | |
| Upper and lower tray unhook
for easy removal from mouth | Yes | Yes | No | No |
| Permits patient to talk and drink
with appliance in place | Yes | Yes | No | No |
| Permits patient to breath
through mouth | Yes | Yes | No | No |
| Materials | | | | |
| Rigid tray material | Yes | Yes | Yes | Yes |
| Heat sensitive impression
material | Yes | Yes | Yes | Yes |
| Performance Testing | | | | |
| None applicable under Section 514 | Yes | Yes | Yes | Yes |
| reduced AHI in patients | 72% | 72% | Yes | Yes |
| AHI performance comparable to
CPAP | Yes | Yes | Yes | Unknown |
page 4 of 30
2
Non-Confidential Summary of Safety and Effectiveness (continued)
page 3 of 3
June 2, 1997
Comparison to Predicate Devices: (continued)
Differences Between Other Legally Marketed Predicate Devices
The difference between the intended device and predicates, except the Nellcor Puritan Bennett - TAP device, is that the intended device is a 2 piece construction. This difference does not have a significant effect on the safety or effectiveness of the device.
page 5 of 30
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W. Keith Thornton, D.D.S. ·6131 Luther Lane, Suite 208 Dallas, Texas 75225 -
AUG 2 1 1997
Re: K972061 Trade Name: TOA Unclassified Requlatory Class: Product Code: LRK Dated: June 2, 1997 Received: June 3, 1997
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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 In addition, FDA may publish further announcements action. 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
4
Page 2 - Dr. Thornton "
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4692. 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ülatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS POR USE
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding tisting of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | (To be assigned) |
|---|---|
| Device Name: | TOA Anti-snoring Device |
| Intended Use : | To reduce or alleviate night time snoring and obstructive |
| sleep apnea (OSA) | |
| Environment of use: | Home and sleep laboratories |
| Disposable / Reusable: | Single patient - multi- use |
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K972961
Prescription Use
(Per CFR 801.109)
Over-the-counter use _
page 15 of 30
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