TAP ANTI-SNORING DEVICE

K962516 · Nellcor Puritan Bennett, Inc. · LRK · Sep 10, 1996 · Dental

Device Facts

• Record ID: K962516
• Device Name: TAP ANTI-SNORING DEVICE
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: LRK · Dental
• Decision Date: Sep 10, 1996
• 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.

Device Story

TAP is an intraoral anti-snoring device consisting of upper and lower trays fitted over the patient's teeth using impression material. A hook mechanism attaches the lower tray to the upper tray, holding the lower jaw in a forward position during sleep. Used at home or in sleep laboratories, the device is placed in the mouth each evening. The two-piece construction allows the patient to talk, drink, and breathe through the mouth while the appliance is in place. It is custom-fitted for each patient and can be adjusted or refitted.

Clinical Evidence

No clinical data; performance testing not applicable.

Technological Characteristics

Intraoral appliance consisting of rigid tray pieces and heat-sensitive impression material for custom fitting. Features a hook mechanism for tray attachment. Mechanical design permits lateral and vertical jaw movement.

Indications for Use

Indicated for patients who have a problem with snoring.

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

• H&M Anti-snoring device (K882303)
• TheraSnore (K926382)
• PM and Adjustable PM Positioner (K# unknown)

Submission Summary (Full Text)

{0}

SEP 10 1996

Nellcor Puritan-Bennett Inc.
10252 Valley View Road
Eden Prairie, MN 55344-3544
612 941-3006
612 829-5423 Fax

K962516

# Non-Confidential Summary of Safety and Effectiveness

page 1 of 3

June 26, 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:**
H&M Anti-snoring device - K882303
Distar, Inc. - TheraSnore - K926382
Dental Services group - PM and 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.
**Target population --** Patients who have a problem with snoring.
**Environment of Use --** Home and sleep laboratories

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# Non-Confidential Summary of Safety and Effectiveness (continued)

page 2 of 3
June 26, 1996

## Comparison to Predicate Devices:

| Attribute | Intended device | H&M anti-snoring | PM Positioner | TheraSnore |
| --- | --- | --- | --- | --- |
| **Use** | | | | |
| Intended as an intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce snoring | Yes | Yes | Yes | Yes |
| Indicated for use with patients who snore | 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 impressible 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 | 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 | Yes | Yes |

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page 3 of 3
June 26, 1996

# Non-Confidential Summary of Safety and Effectiveness (continued)

## Comparison to Predicate Devices: (continued)

| Attribute | Intended device | H&M anti-snoring | PM Positioner | TheraSnore |
| --- | --- | --- | --- | --- |
| **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 | Yes | Yes | Yes | Yes |

## Differences Between Other Legally Marketed Predicate Devices

The difference between the intended device and predicates is only in the design of the device.

* Two piece construction (upper and lower trays) design permits patient to talk, drink and breath through the mouth with the appliance in place.

These differences do not have a significant effect on the safety or effectiveness of the device.

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