(75 days)
Not Found
No
The device description and lack of mention of AI/ML terms or data sets indicate a purely mechanical device.
Yes
The device is intended to "reduce or alleviate night time snoring," which is a health-related condition, making it a therapeutic device.
No
The device's intended use is to "reduce or alleviate night time snoring," which is a treatment or alleviative function, not a diagnostic one. There is no mention of it being used to detect, identify, or assess a medical condition.
No
The device description explicitly lists physical components like trays, impression material, and a hook mechanism, indicating it is a hardware device.
Based on the provided information, the TAP device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce or alleviate night time snoring." This is a therapeutic or symptomatic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical appliance worn in the mouth. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in those samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The TAP device is a medical device intended for the treatment of snoring, likely by repositioning the jaw or tongue. It falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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
Product codes
Not Found
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
Not Found
Intended User / Care Setting
Not Found
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)
None applicable
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.
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.”
0
SEP | 0 |996
Nellcor Puritan Bennett Inc 10252 Valley View Road Eden Prairie MN 55344-3544
12 941.3006 212 8295423 Fa
Non-Confidential Summary of Safety and Effectivene
page 1 of 3 June 26, 1996
Nellcor Puritan-Bennett, Inc. 10200 Valley View Rd. Eden Prairie, MN 55344
Tel - (612) 941-3006 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: | 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 |
Image /page/0/Picture/17 description: The image shows the logo for Nellcor Puritan Bennett. The logo consists of a black square with a white swirl design inside. To the right of the square are the words "NELLCOR", "PURITAN", and "BENNETT" stacked vertically.
1
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 |
| 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 |
2
Non-Confidential Summary of Safety and Effectiveness (continued)
page 3 of 3
June 26, 1996
to Predicate Devices: (continued)
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.
- Two piece construction (upper and lower trays) design permits patient to talk, drink and breath through the mouth with the appliance in place.
page 5 of 64