(301 days)
Not Found
No
The description focuses on mechanical components and pressure generation, with no mention of AI/ML terms or data processing for decision-making.
Yes
The device is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults, which is a therapeutic purpose.
No
The device is indicated for home use in the "treatment of obstructive sleep apnea (OSA)", not diagnosis. While it monitors pressure and records patient use time, its primary function is therapeutic, not diagnostic.
No
The device description clearly outlines multiple hardware components: a bedside console, a mouthpiece, and tubing. It is not solely software.
Based on the provided information, the Attune Sleep Apnea System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Attune Sleep Apnea System is a physical device that is worn by the patient and applies negative pressure to the oral cavity. It does not analyze any biological samples.
- The intended use is for treatment of obstructive sleep apnea. IVD devices are used for diagnosis, monitoring, or screening, not for direct treatment.
- The device description focuses on mechanical components and their function. There is no mention of reagents, assays, or analysis of biological samples, which are characteristic of IVD devices.
Therefore, the Attune Sleep Apnea System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Attune Sleep Apnea System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Product codes (comma separated list FDA assigned to the subject device)
OZR
Device Description
The Attune Sleep Apnea System consists of three (3) main components: a small electronic bedside console, a soft polymer mouthpiece, and a flexible polymer tube that connects the mouthpiece to the console. A mouthpiece holder is provided for mouthpiece storage and use during weekly system cleaning.
The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
Console
The console generates a gentle negative pressure, collects excess saliva, records patient use time, and monitors pressure. The console is provided with a power cord, which connects to a standard electrical outlet. An optional laboratory console is available for use in a sleep laboratory. The laboratory console includes wires that extend from the console. The wires connect to the sleep laboratory's polysomnography (PSG) system, allowing the sleep technicians to view the console's pressure on the same monitor as the other PSG channels.
Mouthpiece
The mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite wax to obtain an impression of each patient's teeth and a sizing template to determine the best mouthpiece size.
Tubing
The tubing connects to the console by screwing into the console base and to the mouthpiece with luer connectors.
Use
The patient connects the system and places the mouthpiece in his or her mouth. The mouthpiece is worn during sleep. The console generates a gentle, negative pressure, which is delivered through the mouthpiece into the oral cavity and holds the tongue and soft palate out of the airway.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
adults
Intended User / Care Setting
Home use, sleep laboratory
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)
Non-clinical performance testing included functional testing, biocompatibility testing, software validation and cleaning validation. Results of non-clinical testing demonstrate that the Attune Sleep Apnea System is safe and effective for its intended use and substantially equivalent to the predicates.
Clinical performance testing included data from two feasibility studies and one pivotal trial. The pivotal trial was a four-week, multi-center, prospective, open label, randomized first-night order of control vs. treatment, single-arm trial of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study was to demonstrate safety and effectiveness of the Attune Sleep Apnea System. Clinical Success was determined per patient and was prospectively defined as AHI reduction of > 50% and treated AHI 50% and treated AHI
§ 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
2. 510(K) SUMMARY
MAR 3 0 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(a).
Date Summary Prepared: March 29, 2012
510(k) Number: K111549
510(k) Owner Information:
ApniCure, Inc. 900 Chesapeake Drive Redwood City, CA 94063 Phone Number: (650) 361-9300 (650) 361-9399 Fax Number:
Contact Person:
Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC (650) 343-4813
Device Information:
Trade Name: Attune Sleep Apnea System · Intraoral device for obstructive sleep apnea Common Name: Classification: Class II Intraoral devices for snoring and intraoral devices for snoring Classification Name: and obstructive sleep apnea (21 CFR 872.5570, Product Code OZR, Intraoral Pressure Gradient Device)
Physical Description:
The Attune Sleep Apnea System consists of three (3) main components: a small electronic bedside console, a soft polymer mouthpiece, and a flexible polymer tube that connects the mouthpiece to the console. A mouthpiece holder is provided for mouthpiece storage and use during weekly system cleaning.
The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
Console
The console generates a gentle negative pressure, collects excess saliva, records patient use time, and monitors pressure. The console is provided with a power cord, which connects to a standard electrical outlet. An optional laboratory console is available for use in a sleep laboratory. The laboratory console includes wires that extend from the console. The wires connect to the sleep laboratory's polysomnography (PSG) system, allowing the sleep technicians to view the console's pressure on the same monitor as the other PSG channels.
1
Mouthpiece
The mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite wax to obtain an impression of each patient's teeth and a sizing template to determine the best mouthpiece size.
Tubing
The tubing connects to the console by screwing into the console base and to the mouthpiece with luer connectors.
Use
The patient connects the system and places the mouthpiece in his or her mouth. The mouthpiece is worn during sleep. The console generates a gentle, negative pressure, which is delivered through the mouthpiece into the oral cavity and holds the tongue and soft palate out of the airway.
Indications for Use:
The Attune Sleep Apnea System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Predicate Devices:
The Attune Sleep Apnea System is substantially equivalent in intended use, indications for use, and technological characteristics to the following devices:
| Name | Manufacturer | 510(k) # |
|---|---|---|
| SnoreSilencer Pro | Respironics | K033822 |
| Oasys Oral Airway System | Mark Abramson | K030440 |
| Provent Professional Sleep | ||
| Apnea Therapy | Ventus Medical | K071560 |
| Repose Bone Screw | ||
| System | Influence, Inc. | K981677 |
| Prelude III™ Tongue | ||
| Suspension System | Siesta Medical, Inc. | K110127 |
| Sleepstyle 200 Series | ||
| HC234 CPAP, Opus Mask | Fisher & Paykel | K040941, |
| K063036 | ||
| S8 Aspen CPAP | Resmed Ltd. | K091947 |
Non-clinical Performance Data:
Non-clinical performance testing included functional testing, biocompatibility testing, software validation and cleaning validation. Results of non-clinical testing demonstrate that
2
the Attune Sleep Apnea System is safe and effective for its intended use and substantially equivalent to the predicates.
Clinical Performance Data:
Clinical performance testing included data from two feasibility studies and one pivotal trial. The pivotal trial was a four-week, multi-center, prospective, open label, randomized firstnight order of control vs. treatment, single-arm trial of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study was to demonstrate safety and effectiveness of the Attune Sleep Apnea System. Clinical Success was determined per patient and was prospectively defined as AHI reduction of > 50% and treated AHI (Division Sign-Off) Division of Anesthesiology, General Hospital :nfection Control, Dental Devices
1111549 510(k) Number: _
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ApniCure, Inc.
CONFIDENTIAL