(154 days)
K191320- Slow Wave DS8
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical function and custom design based on anatomical scans, not algorithmic processing of data for diagnosis or treatment adjustment.
Yes
The device is indicated to treat a medical condition (Obstructive Sleep Apnea) and achieves this by physically altering the patient's oral anatomy to open airways.
No
The Respire Clear is described as a device used in the treatment of Obstructive Sleep Apnea (OSA) by moving the jaw forward to open airways, not for diagnosing the condition. It functions as a therapeutic oral appliance.
No
The device description explicitly states it is an "oral appliance" made of "3D printed resins & metals," indicating it is a physical hardware device.
Based on the provided information, the Respire Clear is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to treat mild to moderate Obstructive Sleep Apnea (OSA) by physically repositioning the jaw. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an oral appliance that mechanically alters the patient's anatomy to improve breathing. It doesn't analyze biological samples.
- Lack of IVD Characteristics: The description doesn't mention any analysis of blood, urine, tissue, or other bodily fluids or substances. It doesn't perform any tests to diagnose a condition based on these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Respire Clear's function is purely mechanical and therapeutic.
N/A
Intended Use / Indications for Use
The Respire Clear is 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, LQZ
Device Description
The Respire Clear 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 Clear is made out of dental industry standard 3D printed resins & metals, and is custom designed to 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
Not Found
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)
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 Clear 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.
K192127 - Respire Pink AT (Hard, Hard/Soft, 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.
K191320- Slow Wave DS8
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.”
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2022
Respire Medical, LLC David Walton CEO 18 Bridge St. Brooklyn, New York 11201
Re: K214096
Trade/Device Name: Respire Clear 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, LQZ Dated: February 8, 2022 Received: February 11, 2022
Dear David Walton:
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 mediation-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.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K214096
Device Name Respire Clear
Indications for Use (Describe)
The Respire Clear is 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)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k): Respire Clear
K214096
510(k) Summary
Form 21 CFR Part 807.92:
| (a) (1) - (3) | |
|---|---|
| Device Common Name: | Device, Anti-Snoring |
| Device Proprietary Name: | The Respire Clear |
| Submitter: | Respire Medical, LLC |
| 18 Bridge St. | |
| Suite 3J, Brooklyn, NY 11201 | |
| Contact: | Walton David |
| Date Prepared: | May 28, 2022 |
| Classification Regulation: | 21 CFR 872.5570, |
| Class II - Device Anti-Snoring | |
| Panel: | Dental |
| Product Code: | LRK |
| Predicate Device: | K192127 - Respire Pink AT (Hard, Hard/Soft, 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. | |
| Reference Device: | K191320- Slow Wave DS8 |
| Indication for Use: | Intended to reduce or alleviate snoring, mild to |
| moderate Obstructive Sleep Apnea (OSA) while | |
| sleeping in adults. |
(4) The Respire Clear 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 Clear is made out of
4
dental industry standard 3D printed resins & metals, and is custom designed to fit each patients' unique oral anatomy.
(5) The intended use of the Respire Clear 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 Clear 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 Clear have always been ordered by medical professionals for adult patients only.
(6) The subject of this Traditional 510(k) submission is a change to the Respire Pink AT (Hard, Hard/Soft, EF) (hereinafter referred to as Pink AT) to make the Respire Clear. This change will remove the materials, the standard acrylic resin (Product Code: KMY) and use the 3D Printed resin (Product Code: KMY), as an alternative material to produce trays. Accordingly, the design process will change from hand-fabrication only to the use of additive manufacturing and handfabrication processes. After the trays are produced using the additive manufacturing process, the trays are adjusted by hand fabrication and stainless-steel parts are added to the trays. The dimensions have not changed as a result of the modifications.
| | Respire Clear | Respire Pink AT
(Hard, Hard/Soft, EF) | Slow Wave DS8 | |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Relationship | Current submission | Predicate device | Reference Device | - |
| 510(k) # | K214096 | K192127 | K191320 | - |
| Device Propriety /
Trade name | Respire Clear | Respire Pink AT
(Hard, Hard/Soft, EF) | Slow Wave DS8 | - |
| Company name | Respire Medical, LLC | Respire Medical, LLC | Slow Wave Inc. | IDENTICAL to
the predicate |
| Product Code | LRK | LRK | LQZ, LRK | IDENTICAL to
the predicate |
| Classification | Class II | Class II | Class II | IDENTICAL |
| Indication for Use | Our devices are
indicated to | Our devices are
indicated to | Intended to reduce or
alleviate snoring, mild
to moderate | IDENTICAL to
the predicate |
| | Respire Clear | Respire Pink AT
(Hard, Hard/Soft, EF) | Slow Wave DS8 | |
| Relationship | Current submission | Predicate device | Reference Device | - |
| 510(k) # | K214096 | K192127 | K191320 | - |
| | treat mild to moderate
Obstructive Sleep
Apnea (OSA)
in patients, 18 years of
age or
older. | treat mild to moderate
Obstructive Sleep
Apnea (OSA)
in patients, 18 years of
age or
older. | Obstructive Sleep
Apnea (OSA) while
sleeping in adults. | |
| Single or Multiple
Use | Multiple Use | Multiple Use | Multiple Use | IDENTICAL |
| Target Population | 18 years of age or older | 18 years of age or older | Adult Patients | Identical to the
predicate |
| Material of Tray | 3D printed resin | Acrylic resin | 3D printed resin | IDENTICAL to
the reference |
| Tray's material
Biocompatibility | • ISO 7405
• ISO 10993-5
• ISO 10993-10
• ISO 10993-12 | • ISO 7405
• ISO 10993-5
• ISO 10993-10
• ISO 10993-12 | ISO 7405 and ISO
10993 compliant
biocompatibility
assessment on 3D
printed material
based on the risk
assessment | IDENTICAL to
the predicate |
| 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 | -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 | DS8 consists of two
trays worn on the
maxilla and
mandible. The device
is manufactured at
Slow
Wave facilities using
additive
manufacturing,
specifically, on a
Formlabs 3D Printer
utilizing
stereolithography
(SLA) using
biocompatible | IDENTICAL to
the predicate |
| | Respire Clear | Respire Pink AT (Hard, Hard/Soft, EF) | Slow Wave DS8 | |
| Relationship | Current submission | Predicate device | Reference Device | - |
| 510(k) # | K214096 | K192127 | K191320 | - |
| | for easy removal from mouth
-Works by mandibular advancement.
-Adjustable using titration keys. | for easy removal from mouth
-Works by mandibular advancement.
-Adjustable using titration keys. | material.
The trays are designed to be an exact custom fit by a trained dental technician, using a 3Shape intraoral scanning device, or comparable intraoral scanner such as the iTero, or Cerec, registering one's full impressions of the upper teeth, lower teeth. A bite scan registration with a gap (typically 8 mm), which is a crucial design feature. The gap results from the design of the lower and upper trays. The upper and lower trays, the molars, premolars, and canines, are covered by the device. However, the lateral or central incisors are not | |
| | Respire Clear | Respire Pink AT
(Hard, Hard/Soft, EF) | Slow Wave DS8 | |
| Relationship | Current submission | Predicate device | Reference Device | - |
| 510(k) # | K214096 | K192127 | K191320 | - |
| | | | covered, which effectively leaves eight teeth (four maxillary incisors and four mandibular incisors)
uncovered. The trays are shaped like arch because
the covered portion of the device is connected to
each other by two palatal bands one connecting the upper left and upper tray, and the other connecting the lower tray.
Additionally, the trays are built with ramps that
guide the mandible forward and downward, thus
maintaining advancement, enlarging the airway,
allowing more room for the tongue to migrate
forward naturally. The vertical opening of the jaw is | |
| | Respire Clear | Respire Pink AT
(Hard, Hard/Soft, EF) | Slow Wave DS8 | |
| Relationship | Current submission | Predicate device | Reference Device | - |
| 510(k) # | K214096 | K192127 | K191320 | - |
| | | | not fixed in a single
position. DS8 is a
tractionbased
mandibular
repositioning
device
that allows
nasal
and/or
oral
breathing. | - |
| Maximum
Mandibular
Advancement
range | 7 mm | 7 mm | 15 mm | IDENTICAL to
the predicate |
Table1.
5
6
7
8
- (b) (1) In order to demonstrate the substantial equivalence of the Respire Clear, 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 Clear 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:
- · "uses designs dissimilar from designs previously cleared under a 510(k)"
o (the design for the Respire Clear is similar to the design for the Respire Pink-AT)
- "uses new technology, i.e., technology different from that used in legally marketed
intraoral devices for snoring and/or obstructive sleep apnea"
o (the technology used for the Respire Clear is still mandibular adjustment via titration and this technology is almost same as Slow Wave DS8)
- · "makes changes in the indication for use."
- o (the indication for use has not changed)
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(3) The conclusions drawn from the nonclinical tests demonstrate that the Respire Clear is as safe, as effective, and performs as well as the legally marketed predicate device and reference device. The mechanical safety, performance validation, and biocompatibility tests criteria were all evaluated thoroughly, and passed successfully.