(272 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the patch, with no mention of AI or ML.
Yes
The device is intended to promote lubrication of the oral mucosa and provide temporary relief for dry mouth, addressing symptoms of medical conditions or treatments. This aligns with the definition of a therapeutic device as it is treating or alleviating a medical condition.
No
The device, OraMoist Patches for Dry Mouth, is intended to promote lubrication and provide temporary relief for dry mouth. Its purpose is to alleviate a symptom, not to identify, detect, or monitor a medical condition or disease.
No
The device description clearly states it is an "oral tablet" consisting of physical components (electrolytes, lubricants, polymers, etc.) and is packaged in foil, indicating a physical, non-software 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 promote lubrication and provide temporary relief for dry mouth. This is a therapeutic or palliative function, not a diagnostic one.
- Device Description: The device is an oral tablet that adheres to and moisturizes the oral cavity. It does not analyze biological samples (like blood, urine, or saliva) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic to diagnose a disease or condition.
- Over-The-Counter Use: The intended user is the general public for OTC use, which is typical for devices providing symptomatic relief rather than diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for therapeutic relief.
N/A
Intended Use / Indications for Use
OraMoist® Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist® Patches for Dry Mouth provides temporary relief for dry mouth.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
OraMoist® Patches for Dry Mouth is formulated as an oral tablet that adheres to soft tissues of the mouth and dissolves slowly moisturizing the buccal cavity for hours. The tablets are packaged individually in low density polyethylene foil. Each tablet consists of a mixture of electrolytes, natural lubricants, flavoring agents, and enzymes, and an adherent polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa, buccal cavity, oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter (OTC) use
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 Vitro erosion time (standard USP dissolution test) and clinical investigations in patients with xerostomia have been conducted with OraMoists Patches for Dry Mouth.
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.
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
N/A
0
ડ. 510(k) Summary
Submission Application and Correspondence
| Name of Device: | OraMoistR Patches for Dry Mouth |
|---|---|
| Trade/Proprietary/Model Name: | OraMoistR Patches for Dry Mouth |
| Common or Usual Name: | Saliva, Artificial |
| Classification Names: | Dental; Saliva, Artificial |
Devices to Which New Device is Substantially Equivalent
| Company | Device | K Number |
|---|---|---|
| Scandinavian Formulas | SalivaSure Tablets | K051409 |
Device Description
OraMoist® Patches for Dry Mouth is formulated as an oral tablet that adheres to soft tissues of the mouth and dissolves slowly moisturizing the buccal cavity for hours. The tablets are packaged individually in low density polyethylene foil. Each tablet consists of a mixture of electrolytes, natural lubricants, flavoring agents, and enzymes, and an adherent polymer.
Statement of Intended Use
OraMoist® Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist® Patches for Dry Mouth provides temporary relief for dry mouth.
OraMoists Patches for Dry Mouth is intended for Over-The-Counter (OTC) use
Summary of Technological Characteristics of the Device Compared to the Predicate Devices
The subject device (OraMoist® Patches for Dry Mouth) is a time-released patch that adheres to the oral mucosa. The adhesion is achieved by the addition of an approved biodegradable polymer to the surface of one side of the patch (tablet). The inactive ingredients of the patch provide a means for slow dissolution of the active ingredients (electrolytes, natural lubricants, flavoring agents, and enzymes) responsible for promoting lubrication of the oral mucosa. The predicate device (SalivaSure) consists of similar components to promote lubrication of the oral mucosa, however, the delivery is in the form of a lozenge which is unfixed in the oral cavity. OraMoist® Patch for Dry Mouth dissolves slowly moisturizing the buccal cavity for hours compared to the predicate device whose label recommends 1 lozenge per hour for severe dry mouth.
1
Revised 501(K) Notification Submission, K122663/S001 Device Name: OraMoist® Patches for Dry Mouth Divke Framer - Ruantum, Inc., 754 Washington Street, Eugene, Oregon 97401
Substantial Equivalence Comparison Chart
| Product Name | OraMoistR | SalivaSure |
|---|---|---|
| Method Of Use | Ready to Use | Ready to Use |
| No. Applications/day | Take as needed | Take as needed |
| Claim | Symptomatic Relief | Symptomatic Relief |
| Area of Use | Oral Cavity | Oral Cavity |
| Disease State | Xerostomia | Xerostomia |
| Type of Product | Lozenge | Time-release patch |
| Presentation | Non-sterile | Non-sterile |
Tests and Conclusions
In Vitro erosion time (standard USP dissolution test) and clinical investigations in patients with xerostomia have been conducted with OraMoists Patches for Dry Mouth.
In conclusion, OraMoist® Patches for Dry Mouth is substantially equivalent to the predicate device based on components, claims, and intended use with the mechanism of action (adherence device based on components, and mrifferentiating OraMoist® Patches for Dry Mouth from the predicate device lozenge form.
Correspondence
Quantum, Inc. 754 Washington Street Eugene, Oregon 97401 541-345-5556 Eve McClure, President Contact Person:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2013
Quantum, Incorporated C/O Mr. Fred Ma Medical Quality International, Limited Liability Company 7195 Longview Drive CLEVELAND OH 44139
Re: K122663
Trade/Device Name: OraMoist® Patches for Dry Mouth Regulation Number: Unclassified Regulation Name: Artificial Saliva Regulatory Class: Unclassified Product Code: LFD Dated: January 14, 2013 Received: April 22, 2013
Dear Mr. Ma:
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, 1Drug, 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.
3
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
Susan Runner, DDS, MA cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=13000879
Date: 2013.05.30 15:05:21 -04'00'
Anthony D. Watson, B.S., M.S., M.B.A.
Director
Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Revised 501(K) Notification Submission, K122663/S001 Device Name: OraMoist® Patches for Dry Mouth 510(k) Submitter: Quantum, Inc., 754 Washington Street, Eugene, Oregon 97401
- Indications for Use Statement
OraMoist Patches for Dry Mouth Device Name:
Indications for Use:
OraMoist" Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist Patches for Dry Mouth provides temporary relief for dry mouth.
Prescription Use
AND/OR
Over-The-Counter Use X
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Mary S. Runner
-5
DN: c=US, o=U.S. Government,
au=HHS, ou=FDA, ou=People,
Susan Runner, DOS, MA cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=13000
87950
Date: 2013.05.17 09:52:55 -04'00'
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: