The Respire Pink AT (Hard, Hard/Soft, EF) is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Pink AT (Hard, Hard/Soft, EF) is made out of dental industry standard acrylic resins & metals, and is custom designed to comfortably fit each patients' unique oral anatomy.

AI/ML Overview

The provided FDA 510(k) summary for the “Respire Pink AT (Hard, Hard/Soft, EF)” device focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report for the device's performance against specific clinical or technical metrics for disease treatment. This summary primarily relies on bench testing and a comparison to its predicate device to show safety and effectiveness.

Therefore, many of the requested details, such as specific acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, or results from MRMC or standalone studies, are not available in the provided text. The device is an oral appliance for treating Obstructive Sleep Apnea (OSA), not a diagnostic tool where "acceptance criteria and reported device performance" as typically understood in AI/imaging devices would apply.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance in treating OSA (e.g., AHI reduction, oxygen saturation). Instead, it relies on demonstrating substantial equivalence to a predicate device and successful completion of non-clinical tests.

Topic	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Safety & Performance	Not explicitly stated as quantitative metric; assumed to meet industry standards for durability, functionality, etc.	"Performs as well as the predicate device"
Biocompatibility	Not explicitly stated; assumed to meet ISO 10993 standards.	"Passed successfully"
Shipping Validation	Not explicitly stated; assumed to ensure device integrity during transport.	"Passed successfully"
Mandibular Advancement Range (Key change from predicate device)	Predicate: 6mm Submitted Device: 7mm (allows for slightly more titration, consistent with other cleared devices)	Achieved 7mm maximum mandibular advancement range.
Clinical Efficacy (Indirect)	Assumed to be equivalent to the predicate device in treating mild to moderate OSA.	No direct clinical efficacy data provided for the submitted device; equivalence is based on similar design and mechanism of action to predicate.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not applicable/not provided. The "testing" mentioned is non-clinical bench testing.
Data provenance: Not applicable. The testing is laboratory-based, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/not provided. Ground truth in the context of diagnostic performance (e.g., expert consensus on images) is not relevant to this type of device and testing. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

4. Adjudication method for the test set:

Not applicable/not provided. Adjudication typically applies to multi-reader studies for diagnostic devices.

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. This is not an AI-assisted diagnostic device, and no MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests (mechanical, biocompatibility, shipping validation), the "ground truth" implicitly refers to established engineering standards, material safety specifications (e.g., ISO 10993), and regulatory requirements for medical devices. The device was assessed against these benchmarks.

8. The sample size for the training set:

Not applicable. This is not an AI device that uses a training set of data.

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

Not applicable.

Summary

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February 5, 2020

Respire Medical Holdings Madubuike Okafor Quality Assurance Manager 18 Bridge St. Suite 3J Brooklyn, New York 11201

Re: K192127

Trade/Device Name: Respire Pink AT (Hard, Hard/Soft, EF) 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: January 8, 2020 Received: January 9, 2020

Dear Madubuike Okafor:

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192127

Device Name Respire Pink AT (Hard, Hard/Soft, EF)

Indications for Use (Describe)

Our devices are indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Whole You"

Special 510(k): Respire Pink AT (Hard, Hard/Soft, EF)

K192127

510(k) Summary

From 21 CFR Part 807.92:

(a) (1) (3)

Device Common Name:	Device, Anti-Snoring
Device Proprietary Name:	The Respire Pink AT (Hard, Hard/Soft, EF)
Submitter:	Respire Medical Holdings, LLC18 Bridge St. Suite #3JBrooklyn, NY 11201Phone: 718-360-9209
Contact:	Madubuike Okafor
Date Prepared:	January 8, 2020
Classification Regulation:	21 CFR 872.5570,Class II - Device Anti-Snoring
Panel:	Dental
Product Code:	LRK
Predicate Device:	K150572 - Respire Pink Series-Herbst-EF
Indication for Use:	Our devices are indicated to treat mild to moderateObstructive Sleep Apnea (OSA) in patients, 18 yearsof age or older.

Image /page/3/Picture/7 description: The image shows the logo and contact information for Respire. The logo features a green circle with a person with outstretched arms inside. Below the logo is the name "RESPIRE" in large letters, with the tagline "breathe easy again" in smaller letters. The contact information includes the address 18 Bridge St Suite 3J Brooklyn, NY 11201, phone number 718-643-7326, fax number 718-643-7322, email address info@RespireMedical.com, and website www.RespireMedical.com.

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Whole You"

(4), The Respire Pink AT (Hard, Hard/Soft, EF) is an oral appliance used in the treatment of mild to moderate obstructive sleep apnea. This device helps move a patient's jaw forward, thus opening their airways, and allowing them to breathe more easily throughout the night. The Respire Pink AT (Hard, Hard/Soft, EF) is made out of dental industry standard acrylic resins & metals, and is custom designed to comfortably fit each patients' unique oral anatomy.

(5) The intended use of the Respire Pink AT (Hard, Hard/Soft, EF) is "Our devices are indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.". Obstructive sleep apnea (or OSA) is a sleep disorder that occurs when a patient's throat muscles intermittently relax and block their airway during sleep. The intended used for the Respire Pink AT (Hard, Hard/Soft, EF) has the phrase "in adult patients" replaced and clarified with the phrase "18 years of age or older". This is not a new indication, rather just a clarification since both of the devices shown in the below comparison chart. Are for adult patients. This addition is not critical to the intended therapeutic use of the device, and does not affect the safety and effectiveness of the device when used as labeled because both the predicate devices, and Respire Pink AT (Hard/Soft, EF) have always been ordered by medical professionals for adult patients only.

(6) Respire Medical has developed its own custom telescopic arm, and this arm is the technological difference between the Respire Pink AT (Hard, Hard/Soft, EF), and its legally marketed predicate device; the Respire Pink (Hard, Hard/Soft, EF). This new arm was developed in order to create a hinge with more self-contained features, allow for more ease of titration, and more accurate titration/mandibular advancement readings. The below comparison chart summarizes features of the Respire Pink AT (Hard/Soft, EF), and its predicate; the Respire Pink (Hard, Hard/Soft, EF). The chart also further demonstrates the substantially equivalence of the Respire Pink AT (Hard, Hard/Soft, EF) to the Respire Pink (Hard, Hard/Soft, EF). The 1mm increase of the "Maximum mandibular Advancement range" identified in Figure 1. is meant to allow for slightly more titration. The extra millimeter (7mm) maximum advancement of the MIM Hinge allows adjustment consistent with other cleared devices.

SubstantialEquivalence Topic	Respire Pink EF	Respire Pink AT (Hard,Hard/Soft, EF)
Relationship	Predicate device	Current submission
510(k) #	K150572	K192127
DevicePropriety/Trade name	Respire Pink Series-Herbst-EF	Respire Pink AT (Hard, Hard/Soft, EF)
Company Name	Respire Medical	Respire Medical
Product Code	LRK	LRK
Classification	Class II	Class II
SubstantialEquivalence Topic	Respire Pink EF	Respire Pink AT (Hard,Hard/Soft, EF)
Relationship	Predicate device	Current submission
510(k) #	K150572	K192127
Indications For Use	The Respire Pink Series –Herbst - EF is indicated to treatmild to moderate OSA.	Our devices are indicated totreat mild to moderateObstructive Sleep Apnea (OSA)in patients, 18 years of age orolder.
Single or Multiple Use	Multiple Use	Multiple Use
Target Population	Adult Patients	Adult Patients
Prescription or OTCUse	Prescription	Prescription
Design considerations:• Risk Management	• Design Failure Mode andEffect Analysis	• Design Failure Mode andEffect Analysis
• Verification andValidation	• Inspection of devicesaccording to Design Outputs	• Inspection of devicesaccording to Design Outputs,and Third-Party Lab testing ofdevices according to DesignInputs
• LabelingConsiderations	• Labeling shall containadequate doctor andpatient directions	• Labeling shall containadequate doctor and patientdirections
• Use of ConsensusStandards	• ISO 7405• ISO 10993-5• ISO 10993-10• ISO 10993-12	• ISO 7405• ISO 10993-5• ISO 10993-10• ISO 10993-12
Description of thedesign and operationalprinciples of thedevice	-Customized oral appliance-Allows for an increase in thepharyngeal opening, andimproves the ability for thepatient to inhale and exhaleduring sleep-Upper and lower tray unhookfor easy removal from mouth	-Customized oral appliance-Allows for an increase in thepharyngeal opening, andimproves the ability for thepatient to inhale and exhaleduring sleep-Upper and lower tray unhookfor easy removal from mouth
SubstantialEquivalence Topic	Respire Pink EF	Respire Pink AT (Hard,Hard/Soft, EF)
Relationship	Predicate device	Current submission
510(k) #	K150572	K192127
	-Works by mandibularadvancement.-Adjustable using titration keys.	-Works by mandibularadvancement.-Adjustable using titration keys.
Maximum mandibularAdvancement range	6mm	7mm

Image /page/4/Picture/5 description: The image shows the logo and contact information for Respire. The logo features a green arch with a person in the center with their arms raised. Below the logo is the name "RESPIRE" in a sans-serif font, with the tagline "breathe easy again" in a smaller font. The contact information includes the address 18 Bridge St Suite 3J Brooklyn, NY 11201, phone number 718-643-7326, fax number 718-643-7322, email address info@RespireMedical.com, and website www.RespireMedical.com.

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Whole You"

Image /page/5/Picture/2 description: The image shows the logo and contact information for Respire. The logo features a stylized figure with arms raised above a green rectangle. Below the logo is the name "RESPIRE" in large letters, with the tagline "breathe easy again" in smaller letters. The contact information includes the address 18 Bridge St Suite 3J Brooklyn, NY 11201, phone number 718-643-7326, fax number 718-643-7322, email address info@RespireMedical.com, and website www.RespireMedical.com.

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Figure 1.

(b) (1) In order to demonstrate the substantial equivalence of the Respire Pink AT (Hard, Hard/Soft, EF), bench testing was conducted on the device in order to ensure that it safely & effectively performs as intended. This testing included mechanical safety & performance validation, biocompatibility tests, and shipping validation tests. The results indicated that the Respire Pink AT (Hard, Hard/Soft, EF) performs as well as the predicate device.
(2) N/A (Clinical Testing is not required per "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea – Guidance for Industry and FDA". This is due to the fact that none of the below criteria requiring clinical testing apply:
o "uses designs dissimilar from designs previously cleared under a 510(k)"
- (the design for the Respire Pink AT (Hard, Hard/Soft, EF) is similar to the റ design for the Respire Pink (Hard, Hard/Soft, EF)
o "uses new technology, i.e., technology different from that used in leqally marketed intraoral devices for snoring and/or obstructive sleep apnea"
- (the technology used for the Respire Pink AT (Hard, Hard/Soft, EF) is still O mandibular adjustment via titration)
o "makes changes in the indication for use."
- (the intended use has not changed) O

(3) The conclusions drawn from the nonclinical tests demonstrate that the Respire Pink AT (Hard, Hard/Soft, EF) is as safe, as effective, and performs as well as the legally marketed predicate device. The mechanical safety & performance validation, biocompatibility tests, and shipping validation tests criteria were all evaluated thoroughly, and passed successfully.

Image /page/6/Picture/12 description: The image shows the logo and contact information for Respire Medical. The logo features a green circle with a person inside, and the text "RESPIRE breathe easy again" is below the logo. The contact information includes the address 18 Bridge St Suite 3J Brooklyn, NY 11201, phone number 718-643-7326, fax number 718-643-7322, email address info@RespireMedical.com, and website www.RespireMedical.com.

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.”