(90 days)
Not Found
No
The device description and intended use focus on a gel formulation with milk proteins and enzymes for moisturizing the mouth, with no mention of AI or ML technology.
Yes
The device is indicated for the symptomatic relief of dry mouth (xerostomia), which can be caused by various medical conditions, medications, or treatments. It aims to replace the feel of missing saliva, moisturize, lubricate, and refresh the mouth, thereby alleviating symptoms and improving patient comfort. These actions align with the definition of a therapeutic device which is intended to treat or alleviate a condition.
No
The device is a moisturizing gel intended for symptomatic relief of dry mouth, not for diagnosing medical conditions.
No
The device description clearly states it is a gel supplied in an aluminum tube, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of BioXtra® Moisturizing Gel is to provide symptomatic relief from dry mouth by temporarily substituting the feel of natural saliva. It is applied directly to the oral cavity to alleviate discomfort, difficulty swallowing, etc.
- Mechanism of Action: The device works by physically moisturizing and lubricating the mouth with its gel formulation containing milk proteins and salivary enzymes. It does not analyze or test any biological samples (like blood, urine, or saliva) to diagnose a condition or provide information about a patient's health status.
- Device Description: The description confirms it's a gel applied topically.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. BioXtra® Moisturizing Gel is used in vivo (within the body) for symptomatic relief.
N/A
Intended Use / 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.
Product codes
LFD
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.
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
Healthcare professional (for Rx)
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)
BioXtra® Moisturizing Gel has been shown in laboratory and human tests to be safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062653, K061331, K981693, K030802, K024148
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 |
1
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 | ||||
| liquid | Ready to use | |||||
| gel and liquid | Ready to use | |||||
| liquid spray | Mix Parts A & | |||||
| B ampoules | Ready to use | |||||
| liquid | ||||||
| # Applications | ||||||
| per day | As needed | As needed | As needed | As needed | As needed | As needed |
| Claim | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| 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.
2
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
4
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: