(74 days)
No
The summary describes a topical oral gel/liquid with moisturizing properties and enzymes, with no mention of AI/ML technology or related concepts like data processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended to diminish symptoms of a dry mouth, which is a therapeutic purpose. It is also described as a saliva substitute containing ingredients for lubricating and moistening, and performance studies mention it as safe and effective for its intended use.
No
The device is described as an artificial saliva substitute that provides moisture and relief for dry mouth symptoms. It does not mention any function for diagnosing a medical condition. Its intended use is to diminish symptoms, not to identify a disease.
No
The device description clearly states it is a gel and liquid product supplied in a bottle and tube, indicating it is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to alleviate symptoms of dry mouth (discomfort, odors). This is a therapeutic or palliative purpose, not a diagnostic one.
- Device Description: The description details the composition and form of an artificial saliva substitute. It does not mention any components or functions related to testing biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, saliva, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies mentioned focus on safety and effectiveness for its intended use (alleviating dry mouth symptoms), not on diagnostic accuracy.
- Predicate Devices: The listed predicate devices are also artificial saliva substitutes, which are not IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This device does not fit that definition.
N/A
Intended Use / Indications for Use
A Restreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors, and other symptoms of a Dry Mouth.
Product codes
LFD
Device Description
Oral Balance is an artificial saliva substitute which contains moisturizers, amino acids, milk proteins that have lubricating and moistening properties, it also contains patented salivary enzymes. Product is supplied in 1.5 oz PI.T bottle and tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
Indicated Patient Age Range
Not Found
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)
Oral Balance formulation has been shown in studies, including tests for acute oral toxicity, Oral Balance formulation has book chown the eve inritation and preservative effectiveness to be safe and effective for its indented use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991938, K981693, K024148, K051812
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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HEALTHCARE PRODUCTS DIVISION
East University Drive, Rancho Domir guez, CA 90220 Fax: (310) 605-4288 • http: //www.laclede.com Phone: (310) 605-4280 ·
510(k) Summary
May 8, 2006
-
- Submission Applicant & Correspondent: Name: Address:
Phone No .: Contact Person: Laclede, Inc.
- Submission Applicant & Correspondent: Name: Address:
2103 E. University Dr. Rancho Dominguez, Ca 90220
(310) 605-4280 Michael Pellico, President
2. Name of Device:
ORAL BALANCE GEL AND LIQUID
Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:
ORAL BALANCE GEL AND LIQUID Dental: Saliva, Artificial Dental: Saliva, Artificial
- Regulatory Information: Device Class: Product Code:
Unclassified LFD
- Devices to which new device is substantially equivalent:
Inpharma AB: Gebauer Company: Sinclair Pharmaceuticals Laboratoires Carilene S.A.S. Caphasol cleared in K991938 Salivart cleared in K981693 Salinum or Oraclair cleared in K024148 TGC Spray cleared in K051812
- Device Description:
Oral Balance is an artificial saliva substitute which contains moisturizers, amino acids, milk proteins that have lubricating and moistening properties, it also contains patented salivary enzymes. Product is supplied in 1.5 oz PI.T bottle and tube.
K18
DE
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HEALTHCARE PRODUCTS DIVISION
2103 East University Drive, Rancho Dominguez, CA 90220 2103 East University Drive, Ranono Bomings222 • • http: //www.laclede.com
- Intended Use of the Device:
A refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors and other symptoms of a dry mouth.
- Summary of Technological Characteristics of the Device compared to the Predicate Devices:
Substantial Equivalence Comparison Chart
| Product | Oral Balance | TGO Spray | Caphasol | Salivart | Salinum/Oraclair |
|---|---|---|---|---|---|
| Intended Use | Symptomatic Treatment of xerostomia | Symptomatic Treatment of xerostomia | Symptomatic Treatment of xerostomia | Symptomatic Treatment of xerostomia | Symptomatic Treatment of xerostomia |
| Method of Use | Ready to use liquid and Gel | Ready to use spray | Mix parts A &B ampoules | Ready to use spray | Ready to use ampoules |
| Applications per Day | As needed | As needed | As needed | As needed | As needed |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity |
| Type of Product | Lipid solution | Lipid solution | Electrolyte solution | Electrolyte solution | Lipid solution |
| Presentation | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
- Tests and conclusion:
Oral Balance formulation has been shown in studies, including tests for acute oral toxicity, Oral Balance formulation has book chown the eve inritation and preservative effectiveness to be safe and effective for its indented use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo consists of a circular border with the words "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael A. Pellico President Laclede, Incorporated 2103 East University Drive Rancho Domingucz, California 90220
Re: K061331
Trade/Device Name: Oral Balance Liquid and Gel Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: May 8, 2006 Received: May 12, 2006
Dear Mr. Pellico:
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.
JUL 25 2006
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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
Page 2 - Mr. Pellico
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely vours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Oral Balance Liquid and Gel
Indications For Use:
A Refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors, and other symptoms of a Dry Mouth.
Prescription Use -(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(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)
Robert J. Betz DDS for Dr. Susan Runner
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Control, Dental Devices
Number K061331
PAGE 3.1