(80 days)
Not Found
No
The device description and lack of mention of AI/ML terms or data sets indicate a mechanical device without AI/ML components.
Yes
The device is intended to treat obstructive sleep apnea (OSA), a medical condition. It also mentions reduced AHI (Apnea-Hypopnea Index) in patients, which is a key metric for OSA severity and treatment effectiveness.
No
The device is intended to treat snoring and sleep apnea, not to diagnose them. While it mentions reducing AHI, this is a performance metric, not an indication of diagnostic capability.
No
The device description explicitly lists physical components (lower tray, upper tray, impression material, hook mechanism) which are hardware.
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 mild to moderate obstructive sleep apnea, OSA." This is a therapeutic or treatment-oriented intended use, not a diagnostic one.
- Device Description: The device is a physical appliance worn in the mouth. It does not involve the examination of biological samples (like blood, urine, or tissue) outside of the body, which is the core characteristic of an IVD.
- Lack of Diagnostic Elements: There is no mention of the device being used to diagnose a condition, measure biomarkers, or provide information about a patient's health status based on in vitro analysis.
In summary, the TAP device is a therapeutic device designed to physically address snoring and sleep apnea, not a diagnostic device used for in vitro testing.
N/A
Intended Use / Indications for Use
The TAP is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA.
Product codes (comma separated list FDA assigned to the subject device)
LRK
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
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
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.
SnoreFree - OSAP - K960673, Distar, Inc. - TheraSnore - K926382, Dental Services group - Adjustable PM Positioner - K# unknown
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.”
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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
1
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 snoring |
| and mild to moderate obstructive sleep apnea, OSA. | |
| Target population -- | Adult patients |
| Environment of Use -- | Home and sleep laboratories |
3
Non-Confidential Summary of Safety and Effectiveness (continued)
page 2 of 3
November 4, 1996
Comparison to Predicate Devices:
| Attribute | TAP
K962516 | OSAP
K960673 | PM Positioner
Unknown | 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 | 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 each
evening | Yes | Yes | Yes | Yes |
| Cleaned daily | Yes | Yes | Yes | Yes |
| Permits lateral and / or vertical
jaw movement | Yes | No | No | No
page 4 of 58 |
| Attribute | TAP
K962516 | OSAP
K960673 | PM Positioner
Unknown | TheraSnore
K926382 |
| Design (continued) | | | | |
| Upper and lower tray unhook
for easy removal from mouth | Yes | No | No | No |
| Permits patient to talk and drink
with appliance in place | Yes | No | No | No |
| Permits patient to breath
through mouth | Yes | No | 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% | Yes | Yes | Yes |
| AHI performance comparable to
СРАР | Yes | Yes | Unknown | Unknown |
E
. .
临
4
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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