(165 days)
Not Found
No
The device description details a mechanical "boil & bite" dental appliance with no mention of computational or data-driven components. The "Advantage TM" appears to be a product name, not indicative of AI/ML technology.
Yes
The device is intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA), which are medical conditions affecting a patient's health.
No
The device description and intended use indicate it is used to alleviate snoring and OSA, similar to a chin strap or mouth tape, and there are no mentions of diagnosing these conditions or performing any diagnostic functions.
No
The device description clearly outlines physical components ("boil & bite" devices, spacers, post) that are part of the medical device, indicating it is a hardware device, not software-only.
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 nighttime snoring and obstructive sleep apnea (OSA) by being used with CPAPs and limiting mouth opening. This is a therapeutic and mechanical function, not a diagnostic one.
- Device Description: The device is a physical appliance that fits in the mouth to modify the patient's anatomy and breathing during sleep. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device performing any tests or measurements on biological samples to diagnose a condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Advantage TM is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The CPAP/Pro Interface with Advantage ™ is available for upper and lower teeth. As such, it utilizes two typical "boil & bite" devices to be placed in patient's upper and lower dental arches. They are then affixed to one another anteriorly to limit the mouth opening, while still permitting a degree of mouth opening through spacers and resiliency.
The upper member is slotted and slides forward and backward on a fixed post for patient comfort. Additionally, it allows lateral movement with the post as a pivot point. The CPAP/Pro Interface with Advantage TM, similar to chin straps or mouth tapes, minimizes the mouth breathing but provides comfort and ease of use for patients. The device is used for adult patients at home or clinical facilities, such as hospitals or sleep labs.
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
adults weighing more than 66 lb (30 Kg)
Intended User / Care Setting
used at home, hospital or other clinical settings per order of a physician.
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)
All applicable tests were completed and passed. Bench testing was performed and confirms that the device meets design requirements and specifications. Validation was also satisfactory completed. Post-market studies of CPAP/Pro has supported the safety and effectiveness of the product. The Advantage ™ has also been validated to demonstrate product equivalency with the predicate.
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Stevenson Industries, Incorporated Ms. Serrah Namini Regulatory 780 Chambers Lane, #200 Simi Valley, CA 93065
Re: K141152
Trade/Device Name: CPAP/Pro® Interface with Advantage Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: September 15, 2014 Received: September 16, 2014
Dear Ms. Namini:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Ms. Namini
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 all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Stevenson Industries, Inc.CPAP/PRO with Advantage™
INDICATION FOR USE STATEMENT
Page __ 1_ of __ 1__
K141152 510(k) Number (if known):
Device Name:
CPAP/Pro Interface with Advantage TM
Indication for Use: The Advantage TM is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.
Prescription Use: __ (Per 21 CFR 801.109)
Or
Over-The-Counter______________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Stevenson Industries, Inc.CPAP/PRO with Advantage™
4
510(k) Summary
■ Summary Date: May 1, 2014
Submitter Information: I Mr. Joseph Goldstein, President Stevenson Industries, Inc. 780 Chambers Ln #200 Simi Valley, CA 93065 Tel: 800-538-8803 Fax: 805-426-3551
. Primary Contact: Serrah Namini, Regulatory naminib@yahoo.com (949) 734-3570
■ Trade/ Device Name: CPAP/Pro Interface with Advantage TM
Common Name: . CPAP interface
트 Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation: ■ 21 CFR 868.5905
- Regulatory Class: Class II
- . Primary Product Code(s): BZD
트 Predicate Information
CPAP/PRO by Stevenson Industries, Inc. ; K992384
트 Device Description
The CPAP/Pro Interface with Advantage ™ is available for upper and lower teeth. As such, it utilizes two typical "boil & bite" devices to be placed in patient's upper and lower dental arches. They are then affixed to one another anteriorly to limit the mouth
5
opening, while still permitting a degree of mouth opening through spacers and resiliency.
The upper member is slotted and slides forward and backward on a fixed post for patient comfort. Additionally, it allows lateral movement with the post as a pivot point. The CPAP/Pro Interface with Advantage TM, similar to chin straps or mouth tapes, minimizes the mouth breathing but provides comfort and ease of use for patients. The device is used for adult patients at home or clinical facilities, such as hospitals or sleep labs.
I Indications for Use
The Advantage ™ is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.
■ Technological Characteristics
Technological characteristics of the device is the same as predicate. The additional accessory, Advantage TM , uses the same design and materials as the upper mouthpiece provided with the predicate. It is available with upper and lower mouthpiece with a post and without a bracket. The post allows a comfortable forward/backward movement as well as some lateral side -to- side capability. No new questions of safety and effectiveness were introduced.
. Performance Data
All applicable tests were completed and passed. Bench testing was performed and confirms that the device meets design requirements and specifications. Validation was also satisfactory completed. Post-market studies of CPAP/Pro has supported the safety and effectiveness of the product. The Advantage ™ has also been validated to demonstrate product equivalency with the predicate.
. Substantial Equivalence
Based on the information drawn from the Testing and Validation as well as the risk assessment, it is demonstrated that the device is substantially equivalent and performs as well as the predicate device.
| Feature | CPAP/PRO (K992384) | New device
CPAP/PRO with
Advantage™ |
|--------------|------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Intended Use | To reduce or alleviate night time
snoring and obstructive sleep
apnea (OSA) for adult patients | Similar |
6
| | for use at home or clinical
setting; for adult patients
(>66lb/30kg) | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Materials | Teflon, polyethylene, silicone,
elastomer, styrene, nylon, EVA
thermoplastic | Similar |
| Design CPAP nasal | Nasal cannula CPAP | Similar |
| Design Oral
Appliance | Dental appliance holds nasal
CPAP cannula. Appliance
positions jaw and holds nasal
CPAP cannula (including upper
mouthpiece) | Same with additional
mouth-piece
(AdvantageTM) for
minimizing mouth-
breathing |
| Performance
standard | ASTM (ex: D1238) | Similar |
| Reusable | Yes (single patient) | Similar |
| Method of
cleaning/disinfection | Wash with warm water and
detergent followed by surface
disinfection (See Instruction for
Use) | Similar |
| Manufacturer | Stevenson Industries, Inc. | Same |
■ Conclusion
The primary difference is the use of Advantage™, the oral appliance for minimizing mouth-breathing. Previously a dental appliance held the nasal CPAP cannula. Which, positions jaw and holds nasal CPAP cannula (including upper mouthpiece). The results of the testing support the claim that the Advantage™ is substantially equivalent to the predicate.
The device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties remain similar as the predicate. The Advantage™ is substantially equivalent to its predicate and reference devices.