(80 days)
The TAP is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA.
The TAP 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
The provided text describes a medical device called "TAP" (an oral appliance) for reducing snoring and mild to moderate obstructive sleep apnea (OSA). However, the document is a 510(k) premarket notification summary from 1996, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a rigorous study proving device performance against those criteria in the modern sense of AI/medical imaging devices.
Here's a breakdown of what can be extracted and what information is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of explicit "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, or a specific range of improvement (e.g., AHI reduction by X%) is not clearly defined in this 510(k) summary as it would be for a modern AI device. Instead, the performance is compared qualitatively or with a single percentage to predicate devices.
| Metric | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance (TAP) |
|---|---|---|
| Reduce/Alleviate Snoring | Yes (similar to predicates) | Yes |
| Indicated for mild to moderate OSA | Yes (similar to predicates) | Yes |
| AHI Reduction | Comparable to CPAP (predicate claim) | 72% reduced AHI in patients |
| Allows Jaw Movement (lateral/vertical) | Yes (a distinguishing feature) | Yes |
| Allows Unhooking for easy removal | Yes (a distinguishing feature) | Yes |
| Permits talking/drinking with appliance in place | Yes (a distinguishing feature) | Yes |
| Permits breathing through mouth | Yes (a distinguishing feature) | Yes |
Note: The "acceptance criteria" are inferred from the attributes compared against predicate devices. The document does not state quantitative thresholds that the TAP device needed to meet directly.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "72% reduced AHI in patients" but does not specify the number of patients, how they were selected, or where the data came from.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The assessment of AHI reduction or other clinical outcomes would typically involve medical professionals, but their number and qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and its effect size
This information is not provided. MRMC studies are typically associated with imaging diagnostics or AI-assisted diagnostic tools, which is not the nature of this physical oral appliance. The document focuses on the device's physical and functional attributes compared to predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the TAP device is a physical oral appliance, not an algorithm or AI system. Human intervention (e.g., fitting by a dentist) is inherent to its use.
7. The type of ground truth used
Based on the mention of "reduced AHI in patients," the ground truth would likely be polysomnography (PSG) results or other objective measures of sleep apnea severity, which are considered clinical outcomes/pathology in this context. The reduction in AHI is a direct clinical measure related to the device's effectiveness.
8. The sample size for the training set
This information is not provided. The concept of a "training set" in the context of device development (especially for mechanical devices like this pre-AI era) is not directly applicable in the same way it is for AI algorithms. Development would involve engineering, material testing, and potentially small-scale clinical trials rather than data-driven machine learning training.
9. How the ground truth for the training set was established
This information is not provided and is largely not applicable for this type of device and submission. If any early clinical data informed design, it would likely have involved similar clinical outcome measures (e.g., AHI reduction from PSG), but the process is not detailed as "ground truth establishment for training."
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 - 2005
Mr. James Bonds Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588-2719
Re: K964516 Trade/Device Name: Tap Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: November 04, 1996 Received: November 05, 1996
Dear Mr. Bonds:
This letter corrects our substantially equivalent letter of January 24, 1997, regarding the classification of your device which was incorrectly identified as "unclassified."
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with
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Page 2 - Mr. James Bonds
all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Division of Small Manufacturers, International and Consumer Assistance at its toll-fiee number (800) 638-2041 or (301) 443-6597 or at its internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Chu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows the logo for Nellcor Puritan Bennett. The logo consists of a black square with two curved white lines extending from the left side of the square. To the right of the square, the text "NELLCOR PURITAN BENNETT" is arranged in three lines.
Non-Confidential Summary of Safety and Effectiveness
page 1 of 3 November 4, 1996
| Nellcor Puritan-Bennett, Inc. | Tel - (612) 941-3006 |
|---|---|
| 10200 Valley View Rd. | |
| Eden Prairie, MN 55344 | Fax - (612) 829-5423 |
| Official Contact: | Chris Hadland, Director, RA and QA |
|---|---|
| Proprietary or Trade Name: | TAP |
| Common/Usual Name: | Oral Appliance - anti-snoring device |
| Classification Name: | Anti-snoring device |
| Device: | TAP |
| Predicate Devices: | SnoreFree - OSAP - K960673 |
| Distar, Inc. - TheraSnore - K926382 | |
| Dental Services group - Adjustable PM Positioner - K# unknown |
Device Description:
The TAP 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 TAP is intended to reduce or alleviate night time snoringand mild to moderate obstructive sleep apnea, OSA. |
| Target population -- | Adult patients |
| Environment of Use -- | Home and sleep laboratories |
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Non-Confidential Summary of Safety and Effectiveness (continued)
page 2 of 3
November 4, 1996
Comparison to Predicate Devices:
| Attribute | TAPK962516 | OSAPK960673 | PM PositionerUnknown | 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 | No | 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 | No | Yes | Yes |
| Placed in patient mouth eachevening | Yes | Yes | Yes | Yes |
| Cleaned daily | Yes | Yes | Yes | Yes |
| Permits lateral and / or verticaljaw movement | Yes | No | No | Nopage 4 of 58 |
| Attribute | TAPK962516 | OSAPK960673 | PM PositionerUnknown | TheraSnoreK926382 |
| Design (continued) | ||||
| Upper and lower tray unhookfor easy removal from mouth | Yes | No | No | No |
| Permits patient to talk and drinkwith appliance in place | Yes | No | No | No |
| Permits patient to breaththrough mouth | Yes | No | 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% | Yes | Yes | Yes |
| AHI performance comparable toСРАР | Yes | Yes | Unknown | Unknown |
E
. .
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Non-Confidential Summary of Safety and Effectiveness (continued)
page 3 of 3
November 4, 1996
Comparison to Predicate Devices: (continued)
Differences Between Other Legally Marketed Predicate Devices
The difference between the intended device and predicates 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 58
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§ 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.”