TAP

K964516 · Nellcor Puritan Bennett, Inc. · LRK · Jan 24, 1997 · Dental

Device Facts

• Record ID: K964516
• Device Name: TAP
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: LRK · Dental
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TAP is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA.

Device Story

TAP is an intraoral anti-snoring device consisting of upper and lower rigid trays fitted to the patient's teeth using heat-sensitive impression material. A hook mechanism connects the two trays, holding the lower jaw in a forward position to maintain airway patency during sleep. The device is intended for home or sleep laboratory use by adult patients. The two-piece construction allows for easy removal, permits lateral and vertical jaw movement, and enables the patient to talk, drink, and breathe through the mouth while the appliance is in place. The device is custom-fitted for each patient and cleaned daily.

Clinical Evidence

The device documentation reports a 72% reduction in Apnea-Hypopnea Index (AHI) in patients. Performance is stated to be comparable to CPAP. No further clinical study details or specific sample sizes are provided.

Technological Characteristics

Intraoral appliance; rigid tray pieces; heat-sensitive impression material for custom fitting; hook mechanism for jaw advancement; two-piece construction; permits lateral and vertical jaw movement.

Indications for Use

Indicated for adult patients to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• SnoreFree - OSAP (K960673)
• Distar, Inc. - TheraSnore (K926382)
• Dental Services group - Adjustable PM Positioner (K# unknown)

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 2 - 2005

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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 [phone]. 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 Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,


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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NELLCOR PURITAN BENNETT
JAN 24 1997
K964576

# Non-Confidential Summary of Safety and Effectiveness

page 1 of 3
November 4, 1996

Nellcor Puritan-Bennett, Inc.
10200 Valley View Rd.
Eden Prairie, MN 55344
Tel - [phone]
Fax - [phone]

**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

page 3 of 58

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# 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

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Non-Confidential Summary of Safety and Effectiveness (continued)
page 3 of 3
November 4, 1996

## Comparison to Predicate Devices: (continued)

| 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 CPAP | Yes | Yes | Unknown | Unknown |

## 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.

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