(79 days)
The TOA is intended to reduce or alleviate night time snoring and obstructive sleep apnea, OSA.
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
Here's an analysis of the provided text regarding the TOA Anti-snoring device, focusing on acceptance criteria and supporting studies, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds that the new device must meet to demonstrate safety and effectiveness. Instead, it relies on substantial equivalence to predicate devices. The "Performance Testing" section in the comparison table is the closest equivalent to reporting on device performance relative to a defined metric.
| Metric/Attribute | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (TOA) |
|---|---|---|
| Reduction in Apnea-Hypopnea Index (AHI) in patients | 72% (based on NPB TAP predicate) | 72% |
| AHI performance comparable to CPAP | Yes (based on NPB TAP predicate) | Yes |
| Intended as intraoral device | Yes | Yes |
| Intended to reduce/alleviate snoring | Yes | Yes |
| Indicated for mild to moderate OSA | Yes | Yes |
| Indicated for single patient multi-use | Yes | Yes |
| Indicated for home/sleep labs | Yes | Yes |
| Rigid tray pieces | Yes | Yes |
| Heat sensitive impermissible material | Yes | Yes |
| Separate tray pieces | Yes | Yes |
| Custom fit | Yes | Yes |
| Works by holding lower jaw forward | Yes | Yes |
| Can be adjusted or refit | Yes | Yes |
| Placed in mouth each evening | Yes | Yes |
| Cleaned daily | Yes | Yes |
| Permits lateral/vertical jaw movement | Yes (TOA, NPB TAP) | Yes |
| Upper/lower tray unhook for easy removal | Yes (TOA, NPB TAP) | Yes |
| Permits talking and drinking | Yes (TOA, NPB TAP) | Yes |
| Permits breathing through mouth | Yes (TOA, NPB TAP) | Yes |
| Rigid tray material | Yes | Yes |
| Heat-sensitive impression material | Yes | Yes |
| None applicable under Section 514 (Performance Testing) | Yes | Yes |
2. Sample Size for Test Set and Data Provenance
The provided summary does not contain information about a specific test set or clinical study conducted for the TOA device itself to establish the 72% AHI reduction. The 72% figure appears to be directly copied from the performance claimed by the predicate device, NPB TAP (K962516), implying that if the TOA device is "substantially equivalent" in design and intended use, its performance would also be substantially equivalent.
Therefore, there is no direct information on:
- Sample size used for a test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no specific study for the TOA device is described, there's no information on experts used to establish ground truth or their qualifications. The performance metric of "reduced AHI" is a quantifiable physiological measurement typically derived from polysomnography studies, not expert consensus in the way a diagnostic image might be.
4. Adjudication Method for the Test Set
Not applicable, as no specific test set or study for the TOA device is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done or described in this submission. The device is not a diagnostic tool where "human readers" would be involved in interpreting outputs. It's a therapeutic device for a physiological condition.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to an anti-snoring oral appliance. The device itself is the intervention, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the reported performance (72% AHI reduction) would be physiological measurements from polysomnography (PSG) studies that quantify snoring events and apneas/hypopneas. However, this "ground truth" data is attributed to the predicate device (NPB TAP), not presented as directly generated by a study on the TOA device.
8. Sample Size for the Training Set
Not applicable. The TOA is a physical medical device, not an AI/algorithm-based system that 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 type of device.
{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 snoringand 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 TAPK962516 | OSAPK960673 | TheraSnoreK92638 |
|---|---|---|---|---|
| Use | ||||
| Intended as an intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce snoring orhelp alleviate snoring | Yes | Yes | Yes | Yes |
| Indicated for use with patientswith mild to moderate OSA | Yes | Yes | Yes | Yes |
| Indicated for single patientmulti - use | Yes | Yes | Yes | Yes |
| Indicated for use at home orsleep laboratories | Yes | Yes | Yes | Yes |
| Design | ||||
| Rigid tray pieces | Yes | Yes | Yes | Yes |
| Heat sensitive impermissiblematerial 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 eachevening | Yes | Yes | Yes | Yes |
| Cleaned daily | Yes | Yes | Yes | Yes |
| Permits lateral and / or verticaljaw movement | Yes | Yes | No | No |
| Attribute | TOA | NPB TAPK962516 | OSAPK960673 | TheraSnoreK92638 |
| Design (continued) | ||||
| Upper and lower tray unhookfor easy removal from mouth | Yes | Yes | No | No |
| Permits patient to talk and drinkwith appliance in place | Yes | Yes | No | No |
| Permits patient to breaththrough mouth | Yes | Yes | No | No |
| Materials | ||||
| Rigid tray material | Yes | Yes | Yes | Yes |
| Heat sensitive impressionmaterial | 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 toCPAP | 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
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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 obstructivesleep 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
l
§ 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.”