(78 days)
Not Found
No
The device description and the absence of mentions of AI, DNN, or ML, along with the lack of information on training or test sets, indicate that this is a physical product (a dissolving disc) and not a software-based device incorporating AI/ML.
Yes
The device is intended for the relief of chronic and temporary xerostomia (dry mouth), which is a medical condition, and is used under the supervision of a healthcare professional (for Rx use), indicating a therapeutic purpose.
No
Explanation: The device is intended for the relief of dry mouth symptoms by providing lubrication and does not perform any diagnostic function such as identifying, measuring, or analyzing medical conditions or states.
No
The device description clearly states it is a "disc that is allowed to dissolve slowly in the mouth" and contains a "lubricating polymer," indicating a physical, non-software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of dry mouth symptoms (xerostomia). This is a therapeutic or palliative use, addressing a physical symptom within the body.
- Device Description: The device is a disc that dissolves in the mouth to provide lubrication. This is a physical interaction within the oral cavity.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Anatomical Site: The anatomical site is the oral cavity, where the device is applied directly for symptomatic relief.
- No Mention of Diagnostic Processes: The description does not involve any processes related to analyzing biological samples or generating diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stess or aging.
OTC labeling stipulates that OASIS® mouth moisturizing discs have been specially formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.
Product codes
LFD
Device Description
OASIS® is a disc that is allowed to dissolve slowly in the mouth. The product contains a lubricating polymer, with other ingredients to produce a pleasant flavored disc. The discs are presented in containers of various counts.
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 prescription use), Over-the-counter (for self-use)
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
Functional and performance evaluation has been conducted to assess the safety and effectiveness of OASIS® discs. All results are satisfactory.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG 2 7 2004
H. 510(k) Summary
-
- Submission Applicant & Correspondent:
| Name: | GlaxoSmithKline Consumer Healthcare, L.P. | ||
|---|---|---|---|
| Address: | 1500 Littleton Road | ||
| Parsippany, NJ 07054-3884 | |||
| Phone No .: | (973) 889-2566 | ||
| Contact Person: | Anthony Amitrano, U.S. Director Regulatory Affairs | ||
| anthony.g.amitrano@gsk.com |
| 2. Name of Device: | OASIS® |
|---|---|
| Trade/Proprietary/Model Name: | OASIS® Dry Mouth Relief Discs OR |
| OASIS® Mouth Moisturizing Discs |
| 3. Devices to Which New Device is Substantially Equivalent: | |
|---|---|
| Gebauer Company: | Salivart cleared in 510(k) K981693 |
| Sinclair Pharmaceuticals: | SST cleared in 510(k) K023046 |
| Sinclair Pharmaceuticals: | Salinum or Oraclair cleared in 510(k) K024148 |
-
- Device Description:
OASIS® is a disc that is allowed to dissolve slowly in the mouth. The product contains a lubricating polymer, with other ingredients to produce a pleasant flavored disc. The discs are presented in containers of various counts.
- Device Description:
1
- Intended Use of the Device:
Rx:
Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stess or aging.
Over-the-counter:
OTC labeling stipulates that OASIS® mouth moisturizing discs have been specially formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.
-
- Summary of the Technological Characteristics of the Device Compared to the Predicate Devices:
OASIS® has the same intended use/indications as the predicate devices Gebauer Company Salivart, Sinclair Pharmaceuticals SST, and Sinclair Pharmaceuticals Salinum or Oraclair and is described in the following table.
- Summary of the Technological Characteristics of the Device Compared to the Predicate Devices:
2
| Product Name | OASIS | Salivart | SST | Salinum or
Oraclair |
|---------------------------------|-------------------------------------------|-------------------------------------------|--------------------------------------------------|-------------------------------------------|
| Method of Use | Ready to use | Ready to use | Ready to use | Ready to use |
| # of
Applications
per Day | Take as
needed | Take as
needed | Take as
needed up to
16 tablets per
day | Take as
needed |
| Claim | 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 |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Type of
Product | Disc | Solution | Tablet | Solution |
| Presentation | Non sterile | Non sterile | Non sterile | Non sterile |
7. Tests and Conclusions:
Functional and performance evaluation has been conducted to assess the safety and effectiveness of OASIS® discs. All results are satisfactory.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing the human services aspect. The eagle is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2004
Mr. Anthony G. Amitrano Director, U.S. Regulatory Affairs GlaxoSmithKline Consumer Healthcare, L.P. 1500 Littleton Road Parsippany, New Jersey 07054-3884
Re: K041563
K041505
Trade/Device Name: OASIS® Dry Mouth Relief Discs OR Mouth Moisturizing Discs Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: June 9, 2004 Received: June 11, 2004
Dear Mr. Amitrano:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases on and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the ensiesary, to the enactment date of the Medical Device Interstate connineree prior to ria, 25, 20, 20, 20, 2017 11:42 pm accordance with the provisions of Amendinents, or to devroos that have a ct (Act) that do not require approval of a premarket the rederal Pood, Drug, and Coment , therefore, market the device, subject to the general approval application (1 Mr.). - The general controls provisions of the Act include Controls provisions of the rion 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 If your device is classified (boo as a 107.07) in a controls. Existing major regulations affecting (FMA), it may of subjoct to back adding the casing the 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
4
Page 2 -- Ms. Amitrano
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that ITDA s Issualled of a backance complies with other requirements mean that FDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal status in of the Act of any rederal statues and reguirements . including, but not limited to: registration .
You must comply with all the Act's requirements . . . . . . . . . . . . . . You must comply with an the Tec s requirements) in CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laboling (21 CFR Part 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set forth in the quality Systems (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 5 10(k) I his letter will anow you to begin malibating , butantial equivalence of your device to a a
nd the premarket notification. The PDA initing of substants of the results 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), If you desire specific advice for your de room at (301) 594-4613. Also, please note the regulation
N please contact the Office of Comphanos as (50%) - 10% - 10% Part 807.97). You
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 may obtain other general miorination on your itsp. I spistance at its toll-free Division of Binan 2001 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
5
Indications for Use
510(k) Number (if known): K041563
OASIS® Dry Mouth Relief Discs OR Mouth Moisturizing Discs Device Name:
Indications For Use:
Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (drv mouth), which may be a result of diseases such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging.
OASIS® mouth moisturizing discs have been formulated for relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.
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)
Susan Runge
Page 1 of
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K041561