(171 days)
The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older.
The Oral Device-S is intended to reduce night time snoring for adults 18 and older.
Passion for Life Healthcare UK Limited is offering two devices: 1) the Oral Device-S is an OTC device intended as an aid for the reduction of snoring; and 2) the Oral Device-OA is a Rx device intended as an aid for the reduction of mild to moderate obstructive sleep apnea, and/or snoring.
Both the Oral Device-S and Oral Device-OA are an oral appliance design concept based upon the use of a standard set of upper and lower trays of one size.
The Oral Device-OA is fitted by a dentist to act as a Mandibular Repositioning Device (MRD).
Whereas the Oral Device-S, an OTC device, is fitted by the user at home and any adjustments can be made without clinician interaction.
The provided text describes a 510(k) summary for two oral devices, the Oral Device-OA and Oral Device-S, and their substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria for an AI/ML powered medical device.
The document focuses on demonstrating substantial equivalence to existing medical devices based on:
- Indications for Use: Both the proposed devices and predicates are for reducing snoring and/or mild to moderate obstructive sleep apnea (Oral Device-OA) or just snoring (Oral Device-S).
- Technology/Principle of Operation: Both types of devices use upper and lower trays to advance the mandible.
- Environment of Use: Home and clinical settings for OA; Home for S.
- Patient Population: Adults 18 years and older.
- Non-clinical performance testing: This includes durability (180 days), flexural strength/fracture toughness, water absorption/solubility, mechanical/tensile testing, and drop testing.
- Biocompatibility of Materials: Adherence to ISO 10993 standards (cytotoxicity, sensitization, irritation).
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML powered device, a study proving it meets those criteria, sample sizes, expert ground truth, or MRMC studies, as none of this information is present in the provided text.
The document details the device's physical and functional equivalency to its predicates, not its performance in an AI/ML context.
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Image /page/0/Picture/0 description: The image contains 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" and "ADMINISTRATION" in blue text.
Passion for Life Healthcare (UK) Limited Paul Dryden Consultant Pioneer House, Pioneer Business Park North Road Ellesmere Port, CH65 1AD GB
November 16, 2018
Re: K181396
Trade/Device Name: Oral Device OA. Oral Device S 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: October 16, 2018 Received: October 17, 2018
Dear Paul Dryden:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2018.11.16
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181396
Device Name Oral Device-OA
Indications for Use (Describe)
The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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PDF Page 19 of 28
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181396
Device Name Oral Device-S
Indications for Use (Describe)
The Oral Device-S is intended to reduce night time snoring for adults 18 and older.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| 510(k) Summary9-Nov-18 | |
|---|---|
| Official Contact: | Passion for Life Healthcare (UK) LimitedPioneer House, Pioneer Business Park North RoadEllesmere Port, CH65 1AD, United Kingdom |
| Paul Earps - Quality ControllerTel - +44 151 550 4708E-mail - paul.earps@passionforlife.com | |
| Submission Correspondent: | Paul DrydenTel - (239) 307-6061E-mail - paul.dryden@promedic.cc |
| Proprietary or Trade Name: | Oral Device-OA and Oral Device-S |
| Common/Usual Name: | Intra-oral appliance |
| Product Code:Product Classification Name: | LRKDevice, anti-snoring, Intraoral devices for snoringand intraoral devices for snoring and obstructive sleep apnea |
| CFR Number:Class: | 21 CFR 872.55702 |
| Predicate Devices: | Oral Device-OA - K113569 – ApneaRxOral Device-S - K170825 - SnoreRx |
Device Description
Passion for Life Healthcare UK Limited is offering two devices: 1) the Oral Device-S is an OTC device intended as an aid for the reduction of snoring; and 2) the Oral Device-OA is a Rx device intended as an aid for the reduction of mild to moderate obstructive sleep apnea, and/or snoring.
Both the Oral Device-S and Oral Device-OA are an oral appliance design concept based upon the use of a standard set of upper and lower trays of one size.
The Oral Device-OA is fitted by a dentist to act as a Mandibular Repositioning Device (MRD).
Whereas the Oral Device-S, an OTC device, is fitted by the user at home and any adjustments can be made without clinician interaction.
Indications for Use
Oral Device-OA
The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older.
Oral Device-S
The Oral Device-S is intended to reduce night time snoring for adults 18 and older.
Environment of Use Oral Device-OA Home and clinical settings
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Oral Device-S Home
Cautions, Warning, and Contraindications Oral Device-OA
Warnings
Use of this device may cause:
- Tooth movement or changes in dental occlusion ●
- Dental sensitiveness after removing the Oral Device
- Gingival (gum) or dental soreness
- Pain or soreness of the jaw
- . Obstruction of oral breathing
- Excessive salivation ●
Contraindications
The device is contraindicated for patients who:
- Suffer with central sleep apnea ●
- Have a severe respiratory disorder, such as asthma or emphysema
- Are under 18 years old
- . Have been diagnosed with a joint disorder related to the jaw
- Have severe jaw pain, loose teeth or periodontal disease
- Have full dentures that are removed at night
- Wear fixed braces or a retainer at night ●
- Have had an implant less than 1 year ago
Cautions, Warning, and Contraindications Oral Device-S
Warnings
Use of this device may cause:
- Tooth movement or changes in dental occlusion
- Dental sensitiveness after removing the Oral Device
- Gingival (gum) or dental soreness ●
- Pain or soreness of the jaw ●
- Obstruction of oral breathing ●
- Excessive salivation .
Contraindications
The device is contraindicated for patients who:
- . You suffer with central sleep apnea
- You have a severe respiratory disorder, such as asthma or emphysema ●
- . You are under 18 years old
- You have been diagnosed with a joint disorder related to the jaw .
- You have severe jaw pain, loose teeth or periodontal disease ●
- You have full dentures that are removed at night
- You wear fixed braces or a retainer at night ●
- You had a dental implant less than 1 year ago
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510(k) Summary 9-Nov-18
Comparison of Oral Device-OA to Predicate
We present in Table 1 a comparison of the subject device, Oral Device-OA compared to the predicate ApneaRx - K113569.
| Proposed DeviceOral Device-OA | Predicate DeviceApneaRxK113569 | |
|---|---|---|
| Attributes | ||
| Indications for Use | The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older. | 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. |
| Environments of use | Home and clinical settings | Home and clinical settings |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | Suffer with central sleep apnea Have a severe respiratory disorder, such as asthma or emphysema Are under 18 years old Have been diagnosed with a joint disorder related to the jaw Have severe jaw pain, loose teeth or periodontal disease Have full dentures that are removed at night Wear fixed braces or a retainer at night Have had an implant less than 1 year ago | Suffer with central sleep apnea Have a severe respiratory disorder, such as asthma or emphysema Are under 18 years old Have been diagnosed with a joint disorder related to the jaw Have severe jaw pain, loose teeth or periodontal disease Have full dentures that are removed at night Wear fixed braces or a retainer at night Have had an implant less than 1 year ago |
| Prescription | Prescription use | Prescription use |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |
| Principle of operation / means ofmandibular advancement | Adjustment of the relative position of the trays by the use of screw adjustment to obtain a fixed advancement. | Adjustment of the relative position of the trays by the use of a latch adjustment to obtain a fixed advancement. |
| Design | ||
| Tray Design | Pre-formed and fixed | Customized trays |
| Method to advance the mandible | Adjustable upper / lower tray for mandible repositioning | Adjustable upper / lower tray for mandible repositioning |
| Allows lateral and vertical movement | Allows for lateral and vertical movement | Allows for lateral and vertical movement |
| Maximum adjustment by the user | Up to 10 mm | Up to 10 mm |
| How it opens airway | Holds mandible / lower jaw forward | Holds mandible / lower jaw forward |
| Method of cleaning | Cleaned by simple rinsing with water and toothbrush | Cleaned by simple rinsing with water and toothbrush |
| Proposed DeviceOral Device-OA | Predicate DeviceApneaRxK113569 | |
| Performance Testing | ||
| Biocompatibility and Patient contact | ISO 10993CytotoxicitySensitizationIrritation | ISO 10993CytotoxicitySensitizationIrritation |
| Durability testing | 180 days | Not available |
| Performance testing | • Functional testing for durabilityafter multiple cleanings equivalentto 180 days use• Flexural strength / FractureToughness• Water absorption / solubility• Mechanical / Tensile testing• Drop testing | Testing not available |
Table 1 – Oral Device-OA vs. K113569 - ApneaRx
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510(k) Summarv 9-Nov-18
Discussion of Substantial Equivalence for Oral Device-OA
The Oral Device-OA is viewed as substantially equivalent to the predicate device because:
Indications - Similar to predicate - ApneaRx - K113569; indicated for treating snoring and mild to moderate obstructive sleep apnea (OSA).
Discussion - The indications for use between the subject device and predicate are similar and therefore they can be found as substantially equivalent.
Technology / Principle of Operation - Similar to predicate - ApneaRx - K113569. Both devices use upper and lower trays with a means to advance the mandible / lower jaw.
Discussion - Both devices use separate upper and lower trays with a means to advance the mandible / lower jaw are similar. The predicate uses customized trays while the proposed device uses preformed trays. Both utilize an impression material to mold to the individual's teeth and to keep the trays in place. There is a difference in the trays is only related to sizing and the mechanism of advancing the trays with the proposed device using screws and the predicate a latch and lock mechanism.
Environment of Use - Similar to predicate - ApneaRx - K113569. They are used in Home and clinical settings.
Discussion - Both devices have similar environments of use and therefore they can be found as substantially equivalent.
Patient Population - Similar to predicate - ApneaRx - K113569. 18 years and older Discussion - The patient population is similar and therefore they can be found as substantially equivalent.
Non-clinical performance testing
The Oral Device underwent the following testing:
- Functional testing for durability after multiple cleanings equivalent to 180 days use ●
- . Flexural strength / Fracture Toughness
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510(k) Summary 9-Nov-18
- Water absorption / solubility
- Mechanical / Tensile testing
- . Drop testing
Biocompatibility of Materials
All the materials are considered per ISO 10993-1 per FDA Guidance Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA dated 11/12/2002
- Cytotoxicity ●
- Sensitization
- . Irritation
Comparison of Oral Device-S to Predicate
Table 2 – Oral Device-S vs. K170825 – SnoreRx OTC
| Proposed DeviceOral Device-S | Predicate DeviceSnoreRx OTCK170825 | |
|---|---|---|
| Attributes | ||
| Indications for Use | The Oral Device-S is intended toreduce night time snoring for adults18 and older. | The SnoreRx is intended for use onadult patients 18 years of age or olderas an aid for the reduction of snoring. |
| Environments of use | Home | Home |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | • You suffer with central sleepapnea• You have a severe respiratorydisorder, such asasthma or emphysema• You are under 18 years old• You have been diagnosed with ajoint disorderrelated to the jaw• You have severe jaw pain, looseteeth or periodontal disease• You have full dentures that areremoved at night• You wear fixed braces or aretainer at night• You had a dental implant less than1 year ago | • You suffer with central sleepapnea• You have a severe respiratorydisorder, such asasthma or emphysema• You are under 18 years old• You have been diagnosed with ajoint disorderrelated to the jaw• You have severe jaw pain, looseteeth or periodontal disease• You have full dentures that areremoved at night• You wear fixed braces or aretainer at night• You had a dental implant lessthan 1 year ago |
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510(k) Summary 9-Nov-18
| Proposed DeviceOral Device-S | Predicate DeviceSnoreRx OTCK170825 | |
|---|---|---|
| OTC | OTC | OTC |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |
| Principle of operation / means ofmandibular advancement | Adjustment of the relative position ofthe trays by the use of screwadjustment to obtain a fixedadvancement. | Adjustment of the relative position ofthe trays by the use of latchadjustment to obtain a fixedadvancement. |
| Design | ||
| Tray Design | Pre-formed and fixed | Pre-formed and fixed |
| Method to advance the mandible | Adjustable upper / lower tray formandible repositioning | Adjustable upper / lower tray formandible repositioning |
| Allows lateral and vertical movement | Allows for lateral and verticalmovement | Allows for lateral and verticalmovement |
| Maximum adjustment by the user | Up to 6 mm | Up to 6 mm |
| How it opens airway | Holds mandible / lower jaw forward | Holds mandible / lower jaw forward |
| Method of cleaning | Cleaned by simple rinsing with waterand toothbrush | Cleaned by simple rinsing with waterand toothbrush |
| Performance Testing | ||
| Biocompatibility and Patient contact | ISO 10993CytotoxicitySensitizationIrritation | ISO 10993CytotoxicitySensitizationIrritation |
| Durability testing | 180 days | Not available |
| Performance testing | • Functional testing for durabilityafter multiple cleanings equivalentto 180 days use• Flexural strength / FractureToughness• Water absorption / solubility• Mechanical / Tensile testing• Drop testing | Testing not available |
Discussion of Substantial Equivalence for Oral Device-S
The Oral Device-S is viewed as substantially equivalent to the predicate device because:
Indications - Similar to predicate - SnoreRx OTC - K170825; indicated for reducing night-time snoring.
Discussion - The indications for use between the subject device and predicate are similar and therefore they can be found as substantially equivalent.
Technology / Principle of Operation - Similar to predicate - SnoreRx OTC - K170825. Both devices use upper and lower trays with a means to advance the mandible / lower jaw. Discussion - Both devices use separate pre-formed trays with a means to advance the mandible / lower jaw that are similar. Both utilize an impression material to the individual's teeth and to keep the trays in place. They use a screw or a latch and lock mechanism to advance and hold the trays in their advanced position.
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510(k) Summarv 9-Nov-18
Environment of Use - Similar to predicate - SnoreRx OTC - K170825. They are used in Home settings.
Discussion - Both devices have similar environments of use and therefore they can be found as substantially equivalent.
Patient Population - Similar to predicate - SnoreRx OTC - K170825. 18 years and older Discussion - The patient population is similar and therefore they can be found as substantially equivalent.
Non-clinical performance testing
The Oral Device underwent the following testing:
- . Functional testing for durability after multiple cleanings
- Flexural strength / Fracture Toughness ●
- . Water absorption / solubility
- . Mechanical / Tensile testing
- . Drop testing
Biocompatibility of Materials
All the materials are considered per ISO 10993-1 per FDA Guidance Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA dated 11/12/2002
- Cytotoxicity ●
- . Sensitization
- Irritation
Discussion of Differences
The differences between the Oral Device - OA predicate - ApneaRx - K113569 and the Oral Device-S and the predicate SnoreRx - K170825 are:
- For the Oral Device-OA the predicate trays are customized but the principle of a boil and bite . tray with impression material is similar.
- . The mechanism for advancing the trays is a set of screws for the Oral Device while the predicate uses clips on the side to latch and hold the trays in the advanced position.
Substantial Equivalence Conclusion
Based upon the performance testing and comparison to the legally marketed predicate device for indications for use, technology, and performance we believe we have demonstrated that the Oral Device-OA is substantially equivalent to the predicate ApneaRx - K113569 and the Oral Device-S is substantially equivalent to the predicate SnoreRx OTC - K170825.
§ 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.”