(183 days)
Not Found
No
The summary describes a physical oral appliance for treating sleep apnea and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated to treat a medical condition (mild to moderate Obstructive Sleep Apnea) and achieves this by actively moving the jaw to open airways, which directly impacts the patient's physiological function.
No
The device is described as an oral appliance used in the treatment of mild to moderate obstructive sleep apnea, not for diagnosis.
No
The device description clearly states it is an "oral appliance" made of "dental industry standard acrylic resins & metals," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat mild to moderate Obstructive Sleep Apnea (OSA) by physically moving the jaw forward. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The device is an oral appliance that physically interacts with the patient's anatomy to achieve a therapeutic effect. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Our devices are indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal
Indicated Patient Age Range
18 years of age or older.
Intended User / Care Setting
Not Found
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)
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.
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.
K150572 - Respire Pink Series-Herbst-EF
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 shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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.
1
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
2
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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3
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, LLC |
| 18 Bridge St. Suite #3J | |
| Brooklyn, NY 11201 | |
| Phone: 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 moderate |
| Obstructive Sleep Apnea (OSA) in patients, 18 years | |
| of 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.
4
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.
| Substantial
Equivalence Topic | Respire Pink EF | Respire Pink AT (Hard,
Hard/Soft, EF) |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Relationship | Predicate device | Current submission |
| 510(k) # | K150572 | K192127 |
| Device
Propriety/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 |
| Substantial
Equivalence 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 treat
mild to moderate OSA. | Our devices are indicated to
treat mild to moderate
Obstructive Sleep Apnea (OSA)
in patients, 18 years of age or
older. |
| Single or Multiple Use | Multiple Use | Multiple Use |
| Target Population | Adult Patients | Adult Patients |
| Prescription or OTC
Use | Prescription | Prescription |
| Design considerations:
• Risk Management | • Design Failure Mode and
Effect Analysis | • Design Failure Mode and
Effect Analysis |
| • Verification and
Validation | • Inspection of devices
according to Design Outputs | • Inspection of devices
according to Design Outputs,
and Third-Party Lab testing of
devices according to Design
Inputs |
| • Labeling
Considerations | • Labeling shall contain
adequate doctor and
patient directions | • Labeling shall contain
adequate doctor and patient
directions |
| • Use of Consensus
Standards | • ISO 7405
• ISO 10993-5
• ISO 10993-10
• ISO 10993-12 | • ISO 7405
• ISO 10993-5
• ISO 10993-10
• ISO 10993-12 |
| Description of the
design and operational
principles of the
device | -Customized oral appliance
-Allows for an increase in the
pharyngeal opening, and
improves the ability for the
patient to inhale and exhale
during sleep
-Upper and lower tray unhook
for easy removal from mouth | -Customized oral appliance
-Allows for an increase in the
pharyngeal opening, and
improves the ability for the
patient to inhale and exhale
during sleep
-Upper and lower tray unhook
for easy removal from mouth |
| Substantial
Equivalence Topic | Respire Pink EF | Respire Pink AT (Hard,
Hard/Soft, EF) |
| Relationship | Predicate device | Current submission |
| 510(k) # | K150572 | K192127 |
| | -Works by mandibular
advancement.
-Adjustable using titration keys. | -Works by mandibular
advancement.
-Adjustable using titration keys. |
| Maximum mandibular
Advancement 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.
5
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.
6
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.