BIOXTRA MOISTURIZING GEL

K072306 · Bio-X Healthcare S.A. · LFD · Nov 15, 2007 · DE

Device Facts

• Record ID: K072306
• Device Name: BIOXTRA MOISTURIZING GEL
• Applicant: Bio-X Healthcare S.A.
• Product Code: LFD · DE
• Decision Date: Nov 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

BioXtra® Moisturizing Gel is a topical oral gel containing milk proteins and salivary enzymes. It functions as an artificial saliva substitute to moisturize, lubricate, and refresh the oral cavity. Supplied in a 1.4 fl. oz aluminum tube, it is applied topically by the patient or under professional supervision. By mimicking natural saliva, the gel provides symptomatic relief for xerostomia, aiding in swallowing, speech, and comfort. It is used in clinical or home settings.

Clinical Evidence

The device underwent laboratory and human testing to demonstrate safety and effectiveness. No specific clinical trial metrics (e.g., p-values, sensitivity) are provided in the summary document.

Technological Characteristics

Non-sterile gel formulation containing milk proteins and salivary enzymes. Supplied in 1.4 fl. oz aluminum tube. Ready-to-use topical application.

Indications for Use

Indicated for symptomatic relief of chronic or temporary xerostomia (dry mouth) and associated symptoms (swallowing/speech difficulty, taste changes, discomfort, odors) in patients of any age experiencing dry mouth due to Sjögren's Syndrome, oral inflammation, medication, chemo/radiotherapy, stress, or aging.

Predicate Devices

• Mouthkote Oral Moisturizer (K062653)
• Oralbalance Gel and Liquid (K061331)
• Salivart Spray (K981693)
• Caphasol (K030802)
• Salinum or Oraclair (K024148)

Submission Summary (Full Text)

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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: [e-mail] Telephone : [phone]

### US Agent and Correspondent:

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

Email: [e-mail] Telephone: [phone] (Direct) Fax: [phone]

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:

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.

#### 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 use<br>liquid | Ready to use<br>gel and liquid | Ready to use<br>liquid spray | Mix Parts A &<br>B ampoules | Ready to use<br>liquid |
| # Applications<br>per day | As needed | As needed | As needed | As needed | As needed | As needed |
| Claim | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia | Symptomatic<br>treatment of<br>xerostomia |
| 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 [phone]. 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 [phone] or [phone] 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: