The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

Device Description

The BluePro® oral appliance design concept is based upon the use of a standard set of upper and lower trays, referred also as splints in documentation, that are then customized for fit by a dentist. The design is commonly referred to as a Mandibular Repositioning Device (MRD).

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the BluePro®, by the FDA. However, it does not include detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the typical sense of a clinical trial with performance metrics like sensitivity, specificity, accuracy, or reduction in AHI.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (ApneaRx - K113569), which is a common pathway for FDA clearance for Class II devices. This means the device is being cleared because it is similar enough to an already legally marketed device, not necessarily because it has met specific, pre-defined performance thresholds in a clinical study presented in this document.

Here's an attempt to answer your questions based only on the provided text, acknowledging that many details you requested are not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of performance metrics (e.g., "device must achieve X accuracy"). Instead, the acceptance criteria for regulatory clearance appear to be based on demonstrating substantial equivalence to the predicate device in terms of indications for use, technology/principle of operation, environment of use, patient population, and safety (biocompatibility).

Acceptance Criteria Category (Derived from Substantial Equivalence Comparison)	Reported Device Performance (as claimed by Bluesom)	Source of Evidence (if mentioned)
Indications for Use Similarity	Intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.	510(k) Summary, Indications for Use section
Technology / Principle of Operation Similarity	Uses separate pre-formed trays with a means to advance the mandible/lower jaw; boil and bite design.	510(k) Summary, Technology / Principle of Operation section
Environment of Use Similarity	Home, Dental offices, Physician offices, Sleep laboratories.	510(k) Summary, Environment of Use section
Patient Population Similarity	Adult patients 18 years and older.	510(k) Summary, Patient Population section
Contraindications Similarity	Similar list of contraindications (central sleep apnea, severe respiratory disorders, loose teeth/periodontal disease, under 18).	K162192 510(k) Summary table
Biocompatibility	Materials are Surface Contacting, Mucosal membrane, prolonged use >24 hours <30 days. Tested for Cytotoxicity, Sensitization, Irritation per ISO 10993-1.	510(k) Summary, Biocompatibility of Materials section
Mechanical & Durability	Supports mechanical and durability after real-time use plus simulated 1 year use via Braem testing.	K162192 510(k) Summary, Non-clinical performance testing
Real-time clinical experience (safety/performance)	"Real-time clinical experience from sales outside the US" supports substantial equivalence.	K162192 510(k) Summary, Non-clinical performance testing
Cleaning	Effective via rinsing with water and use of a toothbrush.	K162192 510(k) Summary, Non-clinical performance testing

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states "No clinical testing" was performed for the 510(k) submission. Therefore, there is no "test set" in the sense of a clinical study cohort with a defined sample size for performance evaluation.

The closest substitute mentioned is "Commercial experience" ("The BluePro® has been marketed outside the US since October 2014. The results of this experience support the substantial equivalence of the BluePro® for the intended use..."). This is a form of real-world data, retrospective in nature, but no specific sample size, country of origin data breakdown, or detailed analysis is provided in this document.

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 no clinical test set with ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set or adjudication process is mentioned.

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

Not applicable. The device is a physical intraoral appliance, not an AI/software device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical intraoral appliance, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical test set with ground truth is mentioned. The "evidence" primarily relies on demonstrating similarity to a predicate device and existing commercial experience (outcomes data in a very general sense, without specific metrics).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI/machine learning algorithm.

Summary of Device Safety and Performance Evidence for Substantial Equivalence:

The primary "study" or evidence presented in this 510(k) submission is a comparison to a legally marketed predicate device (ApneaRx - K113569). Bluesom argues that the BluePro® is substantially equivalent based on:

Indications for Use: Identical to the predicate.
Technology / Principle of Operation: Similar (both use pre-formed trays to advance the mandible, both employ boil and bite design).
Environment of Use: Similar.
Patient Population: Similar.
Contraindications: Similar.
Non-clinical Performance Testing:
- Commercial experience: The device has been marketed outside the US since October 2014, and this general "real-time clinical experience" is cited to support its substantial equivalence. No specific outcomes data or sample size from this experience is provided.
- Biocompatibility: Testing was performed on finished devices for Cytotoxicity, Sensitization, and Irritation according to ISO 10993-1, consistent with FDA guidance for intraoral devices with prolonged mucosal contact.
- Mechanical and Durability: Supported by real-time use and simulated 1-year use via "Braem testing."
- Cleaning: Demonstrated effectiveness via rinsing and toothbrushing.

In essence, the submission relies on the established safety and effectiveness of the predicate device and demonstrates that the BluePro® shares sufficient similarities and appropriate non-clinical testing (biocompatibility, durability) to warrant the same regulatory classification and market access. No new clinical trials proving specific performance metrics were required or conducted for this 510(k) clearance.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2016

Bluesom Paul Dryden Consultant BlueSom 24 Rue Leon Gaumont Orvault, 44700 FR

Re: K162192 Trade/Device Name: BluePro® 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: November 14, 2016 Received: November 15, 2016

Dear Mr. 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

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)

K162192

Device Name

BluePro®

Indications for Use (Describe)

The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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BLUESOM

24 rue Léon Gaumont 44700 Orvault FRANCE Tel - +33 2 28 25 61 43

Official Contact:	Erwan Floch - General Manager
Proprietary or Trade Name:	BluePro®
Common/Usual Name:	Intra-oral appliance
Classification Name:	LRK - Device, anti-snoring, Intraoral devices for snoringand intraoral devices for snoring and obstructive sleep apnea21 CFR 872.5570, Class 2
Predicate Device:	K113569 – Apnea Sciences – ApneaRx
	PredicateApneaRx	Subject DeviceBluePro®
	K113569	K162192
Indications for Use	The Apnea Sciences Corporation"ApneaRx" is intended for use onadult patients 18 years of age or olderas an aid for the reduction of mild tomoderate obstructive sleep apnea(OSA), and/or snoring.	The BluePro® is a mandibularrepositioning device intended toreduce or alleviate night-time snoringand mild to moderate obstructivesleep apnea in adult patients 18 yearsor older.
Environments of use	Home, dental and Physician offices,Sleep laboratories	Home, dental and Physician offices,Sleep laboratories
Patient Population	Adult patients 18 years and older	Adult patients 18 years and older
Contraindications	• have central sleep apnea• have severe respiratory disorders• have loose teeth or advancedperiodontal disease• are under 18 years of age	• have central sleep apnea• have severe respiratory disorders• have loose teeth or advancedperiodontal disease• are under 18 years of age
Prescription	Prescription use	Prescription use
Single patient, multi-use	Yes	Yes
Limitation of duration of use	No limitation	No limitation
Principle of operation / means ofmandibular advancement	Adjustment of the relative position ofthe trays by the use of fixedadvancement.	Adjustment of the relative position ofthe trays by the use of fixedadvancement.
Fixed tray sizes	Yes	Yes
Method to advance the mandible	Integral interlocking advancementmethod	Integral interlocking advancementmethod
Allows lateral and vertical movement	Yes	Yes
Employs boil and bite design	Yes	Yes
Maximum adjustment by the user	10 mm	10 mm
Works by holding lower jaw forward	Yes	Yes
Cleaned by simple rinsing with water	Yes	Yes
Cleaning with toothbrush	Yes	Yes
Biocompatibility and Patient contact	Surface Contacting, Mucosalmembrane, with duration of useprolonged > 24 hours < 30 days, perFDA Guidance Class II SpecialControls Guidance Document:Intraoral Devices for Snoring and/orObstructive Sleep Apnea; Guidancefor Industry and FDA dated11/12/2002	ISO 10993CytotoxicitySensitizationIrritationSurface Contacting, Mucosalmembrane, with duration of useprolonged > 24 hours < 30 days, perFDA Guidance Intraoral Devices forSnoring and/or Obstructive SleepApnea dated 11/12/2002
Age testing		Yes
Real-time clinical experience		Yes

Device Description

The principle of advancing a lower or upper tray so that it advances the mandible for the treatment of snoring and / or mild to moderate obstructive sleep apnea is well known and there are a number of predicate devices.

Indications for Use

The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

Contraindications

The device is contraindicated for patients who:

. have central sleep apnea
. have severe respiratory disorders
. have loose teeth or advanced periodontal disease
. have loose dental work, dentures, or other oral conditions which would be adversely affected by wearing dental appliances
. are under 18 years of age

Warnings

Use of this device may cause:

tooth movement or changes in dental occlusion
gingival or dental soreness
. pain or soreness to the temporomandibular joint
. obstruction of oral breathing
. excessive salivation
. excessive dry mouth
. loosening of dental restorations
. loosening of teeth

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Environment of Use

Home, Dental and Physician offices, and Sleep laboratories

Predicate Device Comparison:

Table 1 compares the predicate and the subject device.

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K162192 510(k) Summary 7-Dec-16

The BluePro® 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 separate pre-formed 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 are similar and therefore they can be found as substantially equivalent.

Environment of Use - Similar to predicate - ApneaRx - K113569. They are used in Home, Dental offices, Physician offices, Sleep laboratories.

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

Commercial experience

The BluePro® has been marketed outside the US since October 2014. The results of this experience support the substantial equivalence of the BluePro® for the intended use, as compared to the predicate device.

The observations support:

Cleaning via rinsing with water and use of a toothbrush ●
. Real-time clinical experience from sales outside the US
. Mechanical and durability after real-time use plus simulated 1 year use via the Braem testing

Biocompatibility of Materials

All the materials are considered per FDA G95-1 as Surface Contacting, Mucosal membrane, with duration of use prolonged > 24 hours < 30 days, 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

Based upon the Guidance the ISO 10993-1 testing would be:

Cytotoxicity .
Sensitization .
. Irritation

Testing was performed on finished, final devices.

Clinical No clinical testing.

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K162192 510(k) Summary 7-Dec-16

Discussion of Differences and Conclusion

The subject and predicate devices share equivalent intended use. that of treating snoring and mild to moderate obstructive sleep apnea (OSA). Both the subject and predicate devices share equivalent technology, in that they both use separate pre-formed trays with a means to advance the mandible / lower jaw. Both the subject and predicate devices employ a boil and bite design to provide a custom impression for each patient. Both devices have similar environments of use, patient populations and biocompatibility.

Any differences between the subject and predicate devices are not significant and does not affect the substantial equivalence of the proposed device to the predicate device.

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 BluePro® is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.”