Rx: Under the supervision of a healthcare professional, BioXtra® Moisturizing Gel is indicated for relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. Relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste and replaces missing saliva feel.

OTC: BioXtra® Moisturizing Gel is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.

Device Description

BioXtra® Moisturizing Gel contains a patented formulation of milk proteins and salivary enzymes which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth. The product is supplied in a 1.4 fl. oz aluminum tube.

AI/ML Overview

The BioXtra® Moisturizing Gel is a device intended for the symptomatic relief of dry mouth (xerostomia). The provided 510(k) summary (K072306) indicates that the device met its acceptance criteria based on laboratory and human tests demonstrating safety and effectiveness for its intended use. However, the document does not provide specific quantitative acceptance criteria or detailed performance metrics from these studies.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for K072306 does not contain a table of explicit, quantitative acceptance criteria or specific reported device performance metrics (e.g., quantifiable relief duration, percentage of symptom reduction). The summary states:

"BioXtra® Moisturizing Gel has been shown in laboratory and human tests to be safe and effective for its intended use."

This is a general statement of conclusion rather than a presentation of specific performance data against predefined criteria.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary mentions "human tests," but it does not specify the sample size used for these tests.
Furthermore, the document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature) for these human tests.

3. Number of Experts Used to Establish the Ground Truth and Their Qualifications

The 510(k) summary does not mention the number of experts used to establish a ground truth for the test set, nor does it detail their qualifications. For a device like BioXtra® Moisturizing Gel, ground truth might relate to patient-reported symptom relief or clinical assessment of dry mouth symptoms by healthcare professionals, but these details are not provided.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe any adjudication method (e.g., 2+1, 3+1) used for the test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Because this is a Class I, unclassified medical device (artificial saliva) and not a diagnostic imaging AI algorithm, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and therefore not mentioned in the submission. The device is a therapeutic product, not an interpretative aid.

6. Standalone (Algorithm Only) Performance

The device is a moisturizing gel for dry mouth relief, not a standalone algorithm. Therefore, standalone (i.e., algorithm only without human-in-the-loop performance) is not applicable and not evaluated in the context of this device.

7. Type of Ground Truth Used

The 510(k) summary generally refers to "human tests" to establish "safety and effectiveness." While not explicitly stated as "ground truth," for a product like a moisturizing gel, effectiveness would typically be assessed based on:

Patient-reported outcomes: Symptom relief (e.g., difficulties in swallowing, speech, taste changes, mouth discomfort, mouth odors).
Clinical assessment: Evaluation of oral dryness by healthcare professionals.
Laboratory tests: Potentially, in-vitro or ex-vivo tests related to the formulation's properties or interaction with oral tissues.

The document does not specify which of these were used as primary indicators for "effectiveness."

8. Sample Size for the Training Set

As the BioXtra® Moisturizing Gel is a medical product (not an AI/ML algorithm), there is no concept of a "training set" in the typical machine learning sense. The product's development would involve formulation, in-vitro testing, and clinical studies for safety and efficacy. The sample sizes for formulation development or initial in-vitro tests are not described in the 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

Similarly, since there is no "training set" for an AI/ML model, the concept of establishing ground truth for it is not applicable to this device.

Summary

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K072306

510(k) SUMMARY

Submission Applicant Information and Correspondent: A.

Bio-X Healthcare S.A., 21 Rue Herman Meganck B-5032 Les Isnes Belgium

NOV 1 5 2007

Registration Number: TBA

Contact:

Dr. Jean-Paul Perraudin PhD Email: jp.perraudiin@biopole.com Telephone : 011-32- 81- 723- 460

US Agent and Correspondent:

Emalee G. Murphy Kirkpatrick & Lockhart Preston Gates Ellis LLP 1601 K Street, NW Washington, DC 20006

Email: emalee.murphy@klgates.com Telephone: (202) 778-9428 (Direct) Fax: (202) 778-9100

B. BioXtra® Moisturizing Gel Name of Device:

Trade Name:	BioXtra® Moisturizing Gel
Common or Usual Name:	BioXtra® Moisturizing Gel
Classification Name:	Saliva, Artificial

C. Regulatory Information:

Product Code:	LFD
Classification:	Unclassified
Panel:	Dental

D. Devices to Which New Device is Substantially Equivalent:

Parnell Pharmaceuticals Inc.	Mouthkote Oral Moisturizer, cleared K062653
Laclede Inc.	Oralbalance Gel and Liquid, cleared in K061331
Gebauer Company:	Salivart Spray, cleared in K981693
Inpharma AB:	Caphasol cleared in K030802
Sinclair Pharmaceuticals	Salinum or Oraclair, cleared in K024148

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E. Device Description:

F. Intended Use:

Rx: Under the supervision of a healthcare professional, for relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. Relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste and replaces missing saliva feel.
OTC: BioXtra® is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.

G. Summary of Technological Characteristics of the Device Compared to the Predicate Devices

Product Name	BioXtra®	Mouthkote	Oralbalance	Salivart	Caphosol	Salinum
Method of use	Ready to use gel	Ready to useliquid	Ready to usegel and liquid	Ready to useliquid spray	Mix Parts A &B ampoules	Ready to useliquid
# Applicationsper day	As needed	As needed	As needed	As needed	As needed	As needed
Claim	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia
Area of use	Oral cavity	Oral cavity	Oral cavity	Oral cavity	Oral cavity	Oral cavity
Disease state	Xerostomia	Xerostomia	Xerostomia	Xerostomia	Xerostomia	Xerostomia
Product Type	Solution	Solution	Solution	Solution	Solution	Solution
Presentation	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Rx/OTC	Rx/OTC	OTC	OTC	Rx	Rx	Rx/OTC

Substantial Equivalence Comparison Chart

BioXtra® Moisturizing Gel is intended for the same indications and uses the same methods of use as predicate products.

H. Tests and Conclusions

BioXtra® Moisturizing Gel has been shown in laboratory and human tests to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's stylized logo, which consists of three horizontal lines that curve upwards, resembling a stylized human figure. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2007

Bio-X Healthcare S.A. C/O Ms. Emalee G. Murphy Attorney Kirkpatrick & Lockhart Preston Gates Ellis L.L.P. 1601 K Street, NW Washington, DC 20006

Re: K072306

Trade/Device Name: BioXtra® Moisturizing Gel Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LFD Dated: October 31, 2007 Received: November 1, 2007

Dear Ms. Murphy:

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.

If your device is classified (see above) into either 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 - Ms. Murphy

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/cdrh/industry/support/index.html.

Sincerely yours,

Nul Rp Ople
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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SECTION V

Indications for Use

510(k) Number (if known):

Device Name:

BioXtra® Moisturizing Gel

Indications for Use:

Rx:

Under the supervision of a healthcare professional, BioXtra® Moisturizing Gel is indicated for relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. Relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste and replaces missing saliva feel.

OTC:

BioXtra® Moisturizing Gel is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kim

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

DC-963837 v1

510(k) Number:

Regulation Number and Section

N/A