ORAL BALANCE LIQUID/ GEL by LACLEDE, INC.

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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or the sample size and ground truth establishment for a training set in the context of a medical device study.

The document is a 510(k) summary for "Oral Balance Gel and Liquid," an artificial saliva substitute. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific performance metrics against acceptance criteria.

Here's a breakdown of what is available and what is missing:

Available Information (Limited to what's provided):

Device Performance: The document states, "Oral Balance formulation has been shown in studies, including tests for acute oral toxicity, Oral Balance formulation has been shown to be effective and safe...to be safe and effective for its intended use." However, it does not provide specific quantitative performance metrics (e.g., success rates, percentage reduction in symptoms, specific scores) or a table of acceptance criteria.
Study Details: It vaguely mentions "studies" and "tests for acute oral toxicity, eye irritation and preservative effectiveness." It does not specify:
- Sample sizes for these studies.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance (this is not an AI/algorithm-based device).
- Type of ground truth used (though implied to be clinical assessment for effectiveness given the intended use).
- Sample size for training set (not applicable for this type of device).
- How ground truth for training set was established (not applicable).

Missing Information (Required by the prompt):

A table of acceptance criteria and the reported device performance: This is absent. The document only makes a general statement about safety and effectiveness.
Sample sized used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method for the test set: Not specified.
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, as this is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
The type of ground truth used: Indirectly implied to be clinical observation for effectiveness, but not explicitly stated or detailed.
The sample size for the training set: Not applicable, as this is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Conclusion:

Based on the provided text, it is not possible to fill out the requested table and answer the detailed questions regarding acceptance criteria and study particulars. The document focuses on regulatory approval through substantial equivalence, and while it states the device is "safe and effective," it does not provide the granular study data needed for your request.

Summary

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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 ·

K061331

510(k) Summary

May 8, 2006

1. Submission Applicant & Correspondent: Name: Address:
  Phone No .: Contact Person: Laclede, Inc.

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:

K18

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whelessifier

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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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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.

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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

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Indications for Use

510(k) Number (if known):

K041331

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

Regulation Number and Section

N/A