(1 days)
The airVata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
The airVata™ sleep appliance is a mandibular advancement device. It holds the mandible in a protrusive position as determined by a trained dentist. The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin. Connectors, made of a biocompatible synthetic polymer with injection molding technology attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 1.0 mm increments by using different lower trays supplied with the device. The connectors are attached after the upper and lower splints (trays) are manufactured. The Subject device is a single patient, non-sterile, prescription-only device. It is to be used only by the patient for whom it is custom designed. It is to be worn during sleep and may be removed by the patient at any time.
This document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device (airVata™) to a legally marketed predicate device (EndSnorZ™ Sleep Appliance). It does not describe a study proving the new device meets acceptance criteria in the way a clinical trial or algorithm performance study would. Instead, it focuses on non-clinical testing and comparison to an existing device to demonstrate similar safety and effectiveness.
Therefore, many of the requested criteria for an AI/algorithm-based device cannot be fully answered or are not applicable to the information provided in this 510(k) summary. The document explicitly states: "No clinical or animal testing data is included in this submission."
However, I can extract information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.
Here's an attempt to address your prompts based on the provided text, indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported performance in the typical format of an algorithm's diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the new device (airVata™) is "substantially equivalent" to a predicate device (EndSnorZ™ Sleep Appliance) based on its intended use, technological characteristics, and non-clinical performance testing.
The "acceptance criteria" here implicitly relate to demonstrating that the airVata™ device functions similarly and is as safe and effective as the predicate device.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance and Substantiation (as per 510(k)) |
|---|---|
| Indications for Use Equivalence: The device should have highly similar indications for use as the predicate device. | Achieved: "The airVata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient." This is nearly identical to the predicate. |
| Technological Characteristics Equivalence: The device's technological characteristics (product code, device type, regulation, class, intended use, method of use/operation, biocompatibility, OTC/Rx, sterility, environment, and core design elements like rigid trays, material, mode of action) should be largely the same or highly similar to the predicate. Any differences must be mitigated through testing. | Achieved: Demonstrated through comparison table. Minor differences (e.g., product code, specific advancement mechanism, maximum adjustment/advancement) were identified. |
| Safety and Performance of Differences: Where technological differences exist (e.g., advancement mechanism, titration method, maximum adjustment/advancement), these differences must not raise new questions of safety or effectiveness and be mitigated by non-clinical testing. | Achieved: "Any differences in material composition and number of connector attachments for the Subject device and the impact on Subject device performance have been mitigated by means of clinical product validation performance testing." (Note: The document later clarifies "No clinical or animal testing data is included," implying "clinical" here refers to real-world context for mechanical/performance testing.) "Technological differences between the Subject and Predicate devices have been evaluated through validation performance testing of the Subject device. The results of the tests performed show that the Subject device is suitable for its intended use and confirms that the Subject device performs similarly to Predicate which has the same intended use." |
| Manufacturing Process Validation: The manufacturing process should be validated to ensure consistency. | Achieved: "Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input." |
| Physical Property Compliance: The device materials should meet relevant physical property standards. | Achieved: "Physical property testing according to ISO 20795-2, Dentistry - Base polymers - Part 2: Orthodontic base polymers was leveraged from the sponsor's material supplier." |
| Biocompatibility: Device materials must be biocompatible as per relevant standards. | Achieved: "Biocompatibility testing for the Subject device, was conducted in accordance with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. ... Testing was performed according to ISO 10993-5 and ISO 10993-10." |
| MR Safety Assessment (if applicable): The device should be assessed for safety in an MR environment if intended for such use or if components might interact with MRI. | Achieved: "An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance..." |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This 510(k) submission relies on non-clinical performance testing and comparison to a predicate device, not a clinical test set of patient data. The non-clinical tests would have their own sample sizes (e.g., number of material samples for physical property testing, number of devices for manufacturing validation), but these are not detailed in terms of patient data.
- Data Provenance: Not applicable for patient data. The non-clinical testing data would typically originate from the manufacturer's labs or contracted testing facilities. Given the US-based manufacturer and FDA submission, it's implied the testing would follow international standards recognized by the US, potentially performed in the US or by certified labs elsewhere.
- Retrospective or Prospective: Not applicable for patient data. The non-clinical tests would be prospective in nature, designed and executed for the premarket submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable as this is not an AI/algorithm performance study requiring ground truth derived from expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The document explicitly states: "No clinical or animal testing data is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical appliance, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For a physical device, "ground truth" would relate to its physical properties, biocompatibility, and functional performance based on engineering specifications and intended use, rather than a diagnostic 'truth' established from patient data. The "truth" evaluated here is whether the device meets material, manufacturing, and safety standards to be considered equivalent to a legally marketed device.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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February 14, 2024
Gelb Practice Solutions, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K240427
Trade/Device Name: airVata™ 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, LOZ Dated: September 29, 2023 Received: February 13, 2024
Dear Prithul Bom:
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.
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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 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 mediation-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).
Sincerelv.
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name airVata™
Indications for Use (Describe)
The air Vata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
| 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) |
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K240427 510(k) Summary Gelb Practice Solutions, Inc. airVata™ 1/26/2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Gelb Practice Solutions, Inc.52 Woodedge DriveDix Hills, NY 33472Telephone: +1 888-427-7671 | Consultant: | Aclivi, LLC3250 Brackley DriveAnn Arbor, Michigan 48105Telephone: +1 810 360-9773 |
|---|---|---|---|
| Official Contact: | Layne Martin – CEOlmartin@gpsfordental.com | Chris Brown - Manageracliviconsulting@gmail.com | |
| Email: |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | airVata™ |
|---|---|
| Device: | Device, Anti-Snoring |
| Regulation Name/Number: | 21 CFR 872.5570 |
| Device Class: | Class II |
| Product Code: | LRK, LQZ |
| Review Panel: | Dental |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The Subject device in this submission is substantially equivalent in indications, use and design principles to the following Predicate device.
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K211069 | EndSnorZTM Sleep Appliance | Prismatik Dentalcraft, Inc. |
INDICATIONS FOR USE
The airVata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
DEVICE DESCRIPTION
The airVata™ sleep appliance is a mandibular advancement device. It holds the mandible in a protrusive position as determined by a trained dentist. The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin. Connectors, made of a biocompatible synthetic polymer with injection molding technology attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 1.0 mm increments by using different lower trays supplied with the device. The connectors are attached after the upper and lower splints (trays) are manufactured.
The Subject device is a single patient, non-sterile, prescription-only device. It is to be used only by the patient for whom it is custom designed. It is to be worn during sleep and may be removed by the patient at any time.
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EQUIVALENCE TO MARKETED DEVICE
The Subject device is highly similar to the Predicate device with respect to Indications for Use and Technological Characteristics. The comparison tables below compare the Indications for Use and Technological Characteristics of the Subject and Predicate devices.
| Device | Indications for Use Statement |
|---|---|
| Subject DeviceairVataTMGelb Practice Solutions, Inc. | The airVataTM sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVataTM sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient. |
| Predicate DeviceEndSnorZTM Sleep Appliance (K211069)Prismatik Dentalcraft, Inc. | EndSnorZTM Sleep Appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. EndSnorZTM Sleep Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient. |
Indications For Use Statement Comparison
The Subject and Predicate Indications for Use Statement (IFUS) are highly similar differing in the specific device names. The slight differences in the wording related to the device name within Indications for Use Statements do not change the intended use of the Subject and Predicate devices to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Technological Characteristics
| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| airVata™ | EndSnorZ™ Sleep Appliance (K211069) | ||
| Gelb Practice Solutions, Inc. | Prismatik Dentalcraft, Inc. | ||
| Reason for Predicate/Reference | n/a | IFUS, Technological Characteristics | n/a |
| Product Code | LRK, LQZ | LRK | Highly Similar |
| Device | Device, Anti-Snoring | Device, Anti-Snoring | Same |
| Regulation | 21 CFR 872.5570 | 21 CFR 872.5570 | Same |
| Regulatory Class | Class II | Class II | Same |
| Intended Use | Reduce snoring and mild to moderate obstructive sleepapnea in patients 18 years of age or older. | Reduce snoring and mild to moderate obstructive sleepapnea in patients 18 years of age or older. | Same |
| Method of Use: | Single patient user, removable and reusable appliance. | Single patient user, removable and reusable appliance. | Same |
| Method of Operation | Support the lower jaw in a forward position. | Support the lower jaw in a forward position. | Same |
| Biocompatible | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Environment | During sleep at home or in sleep laboratory. | During sleep at home or in sleep laboratory. | Same |
| Design | |||
| Rigid Trays | Upper and lower | Upper and lower | Same |
| Tray material | Methacrylate-based light cured polymer resin(additively manufactured) | Methacrylate-based light cured polymer resin(additively manufactured) | Same |
| Mode of Action | Mandibular advancement | Mandibular advancement | Same |
| Advancement mechanism (connector) | Synthetic polymer, three-point attachment | Synthetic polymer nylon, two-point attachment | Highly Similar |
| Adjustable / Titration of arch position | Yes, different trays | Yes, different connectors | Similar |
| Connector length range | 19.9 mm | 20.5mm to 26 mm | Similar |
| Maximum adjustment | 3.0 mm, increments of 1.0 mm | 5.5mm; increments of 0.5 mm | Similar |
| Maximum mandibular advancement | 8 mm | Approximately 10 mm | Similar |
| Biocompatibility Testing | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
The above table identifies the Technological Characteristic endpoints which are the same. Technological characteristic endpoints which are not the same are described below.
Product Code – Both the Subject and Predicate devices have Primary Product code. Both the Subject and Predicate devices operate as Jaw Repositioning Devices (Mandibular Advancement Devices), where the LQZ product code is applicable. The lack of use of the LQZ Product code in the Predicate device premarket does not change the same Mode of Operation or Mode of Action of both devices.
Advancement mechanism (connector) – Both the Subject and Predicate devices advancement mechanism are connectors fabricated of a synthetic polymer material and are therefore highly similar. Slight differences of material composition and the two-point design do not impact the intended use of the device. No specific performance claims are made related to differences in the number of points of attachment. Any differences in material composition and number of connector attachments for the Subject device and the impact on Subject device performance have been mitigated by means of clinical product validation performance testing.
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Adjustable / Titration of arch position - Both the Subject and Predicate devices support similarly adjustable advancement or titration of the lower tray and arch position of the upper tray and arch. The Subject device accomplishes titration by means of different lower trays with connector attachments positioned to result in 1 mm increment of the lower tray position. The Predicate device accomplishes titration by means of different connector lengths. To increase the advancement of the lower arch, a shorter length connector is attached to the device. The ability to titrate arch position in the Subject and Predicate devices is similar but accomplished by different means. Slight differences of method of titration does not impact the intended use of the device. Any differences in titration method and performance of the Subject device have been mitigated by means of clinical product validation performance testing.
Connector length range – Both the Subject and Predicate devices have similar defined connector lengths. The Subject device has a fixed connector length of 19.9 mm and accomplishes titration by means of different lower trays with connector attachments positioned to result in 1 mm increment of the lower tray position. The Predicate device accomplishes titration by means of different connector lengths ranging from 20.5 mm to 26 mm. The different approach to titration results in different approach to connector length and device design. Slight differences of method of titration and connector lengths does not impact the intended use of the device. Any differences in titration method and performance of the different approach to titration have been mitigated by means of clinical product validation performance testing.
Maximum adjustment – Both the Subject and Predicate devices support similarly adjustable advancement or titration of the lower tray and arch position relative to the upper tray and arch. The Subject device offers a maximum 3 mm adjustment while the Predicate device offers a maximum adjustment of 5.5 mm. Slight differences in the maximum titration adjustment does not impact the intended use of the device. Any differences in titration method and performance of the Subject device using the different approach to titration have been mitigated by means of clinical product validation performance testing.
Maximum mandibular advancement – Both the Subject and Predicate devices similarly support mandibular advancement or titration of the lower tray and arch position of the upper tray and arch. The Subject device accomplishes titration by means of different lower trays with connector attachments positioned to result in a maximum 2 mm advancement of the lower tray position for typical cases (0-, 1- and 2-mm advancement). The Predicate device accomplishes titration by means of different connector lengths. Based on position of connectors and attachments, the Predicate device offers a maximum mandibular advancement of approximately 10 mm. The Subject device allows for a maximum mandibular advancement of 8 mm (one of three different lower trays with sequential one mm titration positions) when directed by the prescribing doctor. Differences of maximum mandibular advancement and approach they are implemented does not impact the intended use of the device. Any differences in performance of the Subject device have been mitigated by means of clinical product validation performance testing.
Biocompatibility - The Subject and Predicate devices are the same in the standards and biological endpoints the devices were evaluated to.
Overall, the Technological Characteristics of the Subject and Predicate devices are the Same, Highly Similar or Similar. Technological differences between the Subject and Predicate devices have been evaluated through validation performance testing of the Subject device. The results of the tests performed show that the Subject device is suitable for its intended use and confirms that the Subject device performs similarly to Predicate which has the same intended use.
CLINICAL AND ANIMAL TESTING
No clinical or animal testing data is included in this submission.
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NON-CLINICAL PERFORMANCE TESTING
Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input.
Physical property testing according to ISO 20795-2, Dentistry - Base polymers - Part 2: Orthodontic base polymers was leveraged from the sponsor's material supplier.
Biocompatibility testing for the Subject device, was conducted in accordance with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Consideration was given to the Subject device materials, manufacturing process and packaging. Testing was performed according to ISO 10993-5 and ISO 10993-10.
An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use.
CONCLUSION
Overall, the Indications for Use statements for the Subject and Predicate devices are highly similar differing only in device name. Overall, the Technological Characteristics of the Subject device is the same, highly similar, or similar to the Predicate device with any differences mitigated through non-clinical performance testing.
Overall, these similarities between the Subject and Predicate devices support a determination of substantial equivalence.
§ 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.”