(247 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI or ML.
Yes
The ApneaRx Pro is a therapeutic device because its intended use is to aid in the reduction of mild to moderate obstructive sleep apnea (OSA) and/or snoring by repositioning the jaw to increase pharyngeal space, which is a direct treatment or mitigation of a medical condition.
No
The device is described as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA) and/or snoring by repositioning the jaw. Its function is to alleviate symptoms, not to diagnose a condition.
No
The device description clearly states it is an "intraoral device" consisting of "two custom fabricated liners" and a "polycarbonate chassis," indicating it is a physical hardware device.
Based on the provided information, the ApneaRx Pro is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to aid in the reduction of mild to moderate obstructive sleep apnea (OSA) and/or snoring by repositioning the jaw. This is a physical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is an intraoral appliance that physically alters the position of the jaw. 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 biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The ApneaRx Pro is a medical device, specifically a mandibular advancement device, used for the treatment of sleep apnea and snoring. It falls under the category of devices that physically interact with the body for therapeutic purposes, not diagnostic ones.
N/A
Intended Use / Indications for Use
The ApneaRx Pro is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.
Product codes
LRK
Device Description
The ApneaRx Pro is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space and minimizing air obstruction and turbulence. The device consists of two custom fabricated liners that fit separately over the upper and lower dental arches and engage in the posterior area of the mouth. The lower liner is snapfitted to a polycarbonate chassis that enables mandibular repositioning in 1 mm increments. The upper liner employs a hinged design to enable vertical movement of the jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space, jaw, dental arches
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Home use
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)
Nonclinical Testing: The ApneaRx Pro materials were tested for cytotoxicity, irritation, and sensitization and were determined to be biocompatible in accordance with ISO 10993. The material utilized for the custom-fabricated liners was previously cleared under K203000.
Device materials were tested for various physical properties. The tray material was tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62). The liner material was tested for flexure strength (ASTM D790), and shore hardness (ASTM D2240). All materials met device specifications. The device was tested to failure under increasing strain in the medial and lateral directions and the force required to cause integrity failure exceeds the natural jaw forces expected under anticipated use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
September 1, 2023
Apnea Sciences Coporation % James Smith Regulatory Consultant Apnea Sciences Corporation 28591 Springfield Drive Laguna Niguel, California 92677
Re: K223901
Trade/Device Name: ApneaRX Pro Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: August 3, 2023 Received: August 4, 2023
Dear James Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bobak Shirmohammadi -5
For Michael E. Adjodha, M. ChE., COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name ApneaRx Pro
Indications for Use (Describe)
The ApneaRx Pro is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for Apnea Sciences. The logo consists of the words "APNEA" and "SCIENCES" on either side of a crescent moon shape, all in white text on a gold background. Below the logo is the tagline "Advancing the Science of Sleep Medicine" in a smaller, italicized font.
510(k) SUMMARY
Submitted by:
| Owner's Name: | Apnea Sciences Corporation |
|---|---|
| Address: | 27121 Aliso Creek Road, Ste. 140 |
| Aliso Viejo, CA 92656 | |
| Contact: | James Fallon, President/CEO |
| Telephone: | (949) 680-2770 |
| Fax: | (928) 569-5974 |
| E-mail: | jfallon@apneasciences.com |
Contact Person:
Name Address
Telephone E-mail:
Date Prepared:
March 13, 2023
949-422-1512
James Smith, Ph.D.
28591 Springfield Drive Laguna Niguel, CA 92677
Trade Name: ApneaRx Pro
Common Name: Classification Name: Device Class: Product Code: Regulation No.
Predicate Device: Predicate 510(k) #: Reference Device 1 Reference Device 2
Mandibular repositioning device Device, Anti-Snoring Class II LRK 21 CFR 872.5570
ApneaRx (Apnea Sciences Corporation) (Primary predicate) K113569 K203000 (KeyPrint KeySplint Hard; Keystone Industries) K170825 (SnoreRx; Apnea Sciences Corporation)
Device Description:
The ApneaRx Pro is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space and minimizing air obstruction and turbulence. The device consists of two custom fabricated liners that fit separately over the upper and lower dental arches and engage in the posterior area of the mouth. The lower liner is snapfitted to a polycarbonate chassis that enables mandibular repositioning in 1 mm increments. The upper liner employs a hinged design to enable vertical movement of the jaws.
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Image /page/4/Picture/0 description: The image shows the logo for Apnea Sciences. The logo consists of the word "APNEA" on the left and "SCIENCES" on the right, with a crescent moon in between. Below the logo is the tagline "Advancing the Science of Sleep Medicine."
- Intended Use: The ApneaRx Pro is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.
- Both the ApneaRx Pro and its predicate consist of intraoral Technology Comparison: mouth pieces that are molded to the patient's teeth and allows slight adjustment of the anterior positioning of the jaw to the patient's comfort. The ApneaRx Pro utilizes customfabricated liners and incorporates design changes to slightly increase freedom of movement of the upper liner. The ApneaRx Pro is provided non-sterile and uses a similar packaging system as the predicate device. The table below compares the technological aspects of the new and predicate devices.
| Subject Area | New Device | Predicate | Differences |
|---|---|---|---|
| Product Code | - LRK | - LRK | |
| Product | |||
| Classification | - Class II | - Class II | |
| Classification Name | - Anti-Snoring | ||
| Device | - Anti-Snoring | ||
| Device | |||
| Proprietary Name | ApneaRx Pro | ApneaRx | |
| Technological | |||
| Features | Mandibular | ||
| repositioning | |||
| device that | |||
| advances the lower | |||
| jaw to increase | |||
| pharyngeal space. | Mandibular | ||
| repositioning | |||
| device that | |||
| advances the lower | |||
| jaw to increase | |||
| pharyngeal space. | |||
| Intended Use | The ApneaRx Pro | ||
| is intended for use | |||
| on adult patients | |||
| 18 years of age or | |||
| older as an aid for | |||
| the reduction of | |||
| mild to moderate | |||
| obstructive sleep | |||
| apnea (OSA), | |||
| and/or snoring. | The Apnea | ||
| Sciences | |||
| Corporation | |||
| "ApneaRx" is | |||
| intended for use | |||
| on adult patients | |||
| 18 years of age or | |||
| older as an aid for | |||
| the reduction of | |||
| mild to moderate | |||
| obstructive sleep | |||
| apnea (OSA), | |||
| and/or snoring. |
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Image /page/5/Picture/0 description: The image shows the logo for Apnea Sciences. The logo consists of the words "APNEA" and "SCIENCES" in white letters on a gold background, separated by a white crescent moon. Below the logo is the tagline "Advancing the Science of Sleep Medicine" in a smaller, elegant font.
| Subject Area | New Device | Predicate | Differences |
|---|---|---|---|
| Materials | - Polycarbonate resin |
- KeyPrint KeySplint
- Hard | - Copolyester Plastic
- Ethylene vinyl
acetate copolymer | The polycarbonate resin
is the same as used in a
510(k) cleared device of
similar design and
intended use. The
ApneaRx Pro
incorporates custom-
fabricated liners utilizing
an FDA-cleared material
indicated for this
purpose. |
| Desirable
Characteristics | - Home use - Adjustable jaw
advancement
position - Custom-fabricated
liners - Enhanced jaw
mobility | - Home use - Adjustable jaw
advancement
position - Heat sensitive /
moldable liners | The ApneaRx Pro retains
the same essential
adjustable tray design,
but incorporates custom-
fabricated liners and
enables modest jaw
mobility. |
| Specifications: - Physical:
- Mechanical:
- Single use: | - Custom-fitted
intraoral device - Repositions
mandible anteriorly
up to 10 mm - Reusable
- Upper liner allows
vertical jaw
movement. | - Custom-fitted
intraoral device - Repositions
mandible anteriorly
up to 10 mm - Reusable | The upper tray design to
enhance range of motion
does not create new risks
and mitigates issues of
discomfort and
dislodging. |
| Sterility | Non-sterile | Non-sterile | |
| Biocompatibility | ISO 10993 | ISO 10993 | |
Nonclinical Testing: The ApneaRx Pro materials were tested for cytotoxicity, irritation, and sensitization and were determined to be biocompatible in accordance with ISO 10993. The material utilized for the custom-fabricated liners was previously cleared under K203000.
Device materials were tested for various physical properties. The tray material was tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62). The liner material was tested for flexure strength (ASTM D790), and shore hardness (ASTM D2240). All materials met device specifications. The device was tested to failure under increasing strain in the medial and lateral directions and the force required to cause integrity failure
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Image /page/6/Picture/0 description: The image shows the logo for Apnea Sciences. The logo consists of the words "APNEA" and "SCIENCES" in white letters on a gold background, with a crescent moon shape in between the two words. Below the logo is the tagline "Advancing the Science of Sleep Medicine" in a smaller font.
exceeds the natural jaw forces expected under anticipated use conditions.
- Conclusion of Comparison: ApneaRx Pro and its predicate are technologically equivalent. The ApneaRx is fitted by the 'boil-and-bite' method that is equivalent to that used for multiple OTC devices while the ApneaRx assembled to a molded polycarbonate chassis. The slight design changes to enable a slightly greater degree of freedom in upper-liner movement does not raise substantial new questions of safety or effectiveness. Therefore, the new device (ApneaRx Pro) is determined to be substantially equivalent to the predicate device.