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K Number
K181396
Device Name
Oral Device OA, Oral Device S
Manufacturer
Passion for Life Healthcare (UK) Limited
Date Cleared
2018-11-16

(171 days)

Product Code
LRK
Regulation Number
872.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 Oral Device-S is intended to reduce night time snoring for adults 18 and older.
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.
More Information

K113569, K170825

Not Found

No
The summary describes a physical oral appliance for sleep apnea and snoring, with no mention of software, algorithms, or AI/ML terms.

Yes.
The device is intended to reduce night-time snoring and/or mild to moderate obstructive sleep apnea (OSA), which are conditions related to health and functioning, fitting the definition of a therapeutic device.

No

The device is an oral appliance intended to reduce night-time snoring and/or mild to moderate obstructive sleep apnea, not to diagnose these conditions.

No

The device description clearly states it is an "oral appliance design concept" and mentions physical components like "upper and lower trays" and fitting by a dentist, indicating it is a physical medical device, not software-only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Device Function: The Oral Device-OA and Oral Device-S are physical appliances worn in the mouth. Their function is to reposition the mandible (lower jaw) to reduce snoring and/or obstructive sleep apnea. They do not analyze any biological samples.
  • Intended Use: The intended use is to reduce snoring and/or sleep apnea, not to diagnose or monitor these conditions through the analysis of biological samples.

The provided information clearly describes a physical medical device used for mechanical intervention, not a diagnostic test performed on biological specimens.

N/A

Intended Use / 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 Oral Device-S is intended to reduce night time snoring for adults 18 and older.

Product codes (comma separated list FDA assigned to the subject device)

LRK

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.

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 18 and older

Intended User / Care Setting

Oral Device-OA: Home and clinical settings
Oral Device-S: Home

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:
The Oral Device underwent the following testing:

  • Functional testing for durability after multiple cleanings equivalent to 180 days use
  • 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

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.

K113569, K170825

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

§ 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

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

1

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

2

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.

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."

PDF Page 19 of 28

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

3

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."

4

| | 510(k) Summary
9-Nov-18 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Passion for Life Healthcare (UK) Limited
Pioneer House, Pioneer Business Park North Road
Ellesmere Port, CH65 1AD, United Kingdom |
| | Paul Earps - Quality Controller
Tel - +44 151 550 4708
E-mail - paul.earps@passionforlife.com |
| Submission Correspondent: | Paul Dryden
Tel - (239) 307-6061
E-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: | LRK
Device, anti-snoring, Intraoral devices for snoring
and intraoral devices for snoring and obstructive sleep apnea |
| CFR Number:
Class: | 21 CFR 872.5570
2 |
| Predicate Devices: | Oral Device-OA - K113569 – ApneaRx
Oral 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

5

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

6

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 Device
Oral Device-OA | Predicate Device
ApneaRx
K113569 |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 of
mandibular 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 Device
Oral Device-OA | Predicate Device
ApneaRx
K113569 |
| Performance Testing | | |
| Biocompatibility and Patient contact | ISO 10993
Cytotoxicity
Sensitization
Irritation | ISO 10993
Cytotoxicity
Sensitization
Irritation |
| Durability testing | 180 days | Not available |
| Performance testing | • Functional testing for durability
after multiple cleanings equivalent
to 180 days use
• Flexural strength / Fracture
Toughness
• Water absorption / solubility
• Mechanical / Tensile testing
• Drop testing | Testing not available |

Table 1 – Oral Device-OA vs. K113569 - ApneaRx

7

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

8

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 Device
Oral Device-S | Predicate Device
SnoreRx OTC
K170825 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attributes | | |
| Indications for Use | The Oral Device-S is intended to
reduce night time snoring for adults
18 and older. | The SnoreRx is intended for use on
adult patients 18 years of age or older
as 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 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 | • 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 |

9

510(k) Summary 9-Nov-18

| | Proposed Device
Oral Device-S | Predicate Device
SnoreRx OTC
K170825 |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| OTC | OTC | OTC |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |
| Principle of operation / means of
mandibular 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 latch
adjustment to obtain a fixed
advancement. |
| Design | | |
| Tray Design | Pre-formed and fixed | Pre-formed and fixed |
| 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 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 water
and toothbrush | Cleaned by simple rinsing with water
and toothbrush |
| | Performance Testing | |
| Biocompatibility and Patient contact | ISO 10993
Cytotoxicity
Sensitization
Irritation | ISO 10993
Cytotoxicity
Sensitization
Irritation |
| Durability testing | 180 days | Not available |
| Performance testing | • Functional testing for durability
after multiple cleanings equivalent
to 180 days use
• Flexural strength / Fracture
Toughness
• 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.

10

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.