(107 days)
Not Found
No
The device description focuses on the physical properties and chemical composition of a liquid spray/liquid for dry throat and mouth relief. There is no mention of any computational or data-driven components that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is intended for the immediate and effective relief of dry throat and dry mouth by coating, moistening, and lubricating, functioning as an artificial saliva device, which are characteristic therapeutic actions.
No
The device is intended for the immediate and effective relief of dry throat and dry mouth by coating, moistening, and lubricating, functioning as an artificial saliva device. It does not mention any diagnostic capabilities.
No
The device description clearly states it is a liquid product packaged in plastic bottles with dispensing mechanisms (spray pump or dispensing cup), 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 is for "immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating." This describes a physical action on the body to alleviate symptoms, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a liquid that is applied to the mouth and oropharynx to coat and lubricate the mucus membrane. This is a topical application for symptomatic relief.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a sample (like blood, urine, saliva, etc.) to provide diagnostic information.
- Comparison to Predicate Devices: The predicate devices listed (Moi-Stir, Throat Moi-Stir, Saliva Substitute) are all artificial saliva or dry mouth relief products, which are not typically classified as IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Vicks Powershot Dry Throat and Mouth Relief Spray - For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.
Vicks Powershot Dry Throat and Mouth Relief Liquid – For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.
Product codes
LFD
Device Description
Vicks Powershot Dry Throat and Mouth Relief is available for application cither as a spray or as a bulk liquid, the latter using a dispensing cup. It is a device intended for over-the-counter (OTC) consumer use. The device delivered as a spray form will be packaged in a 1.01 Fl.Oz. (30 mL) polyethylene tercphthalate (PET) plastic bottle and will be dispensed from the bottle via a positive displacement pump. The device delivered using a dispensing cup will be packaged in a 6 Fl.Oz (177mL) PET plastic bottle and will be dispensed via a polypropylene dispensing cup. The device is a clear liquid and contains polymers, including carboxymethylcellulose (CMC) that is known to coat and lubricate, as well as components that function as humectants and solvents. The device is preserved and lightly flavored for improved taste. Upon application the device coats and lubricates the mucus membrane of the mouth and oropharynx thereby providing immediate relief of dryness. The device thus functions as an artificial saliva device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mucus membrane of the mouth and oropharynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter (OTC) consumer 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness evaluations based on biocompatibility and performance data provided in this 510(k) demonstrate that Vicks Powershot Dry Throat and Mouth Relief device is substantially equivalent to the cited predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Premarket Notification [510(k)] Submission Vicks Powershot Dry Throat and Mouth Relief
5. 510(k) Summary
Submission Date:
12 May 2009
AUG 2 8 2009
Company Name: Company Address: The Procter and Gamble Company Mason Business Center 8700 Mason-Montgomery Road Mason, OH 45040
Contact Person: Richard J. Cooke, PhD
な
The Procter and Gamble Company Mason Business Center 8700 Mason-Montgomery Road Mason, OH 45040 Tel: (513) 622-0208 Fax: (866) 803-1842 Email: cooke.rj(a)pg.com
Device Information:
Trade Name: Vicks Powershot Dry Throat and Mouth Relief
Common Name: Artificial Saliva Device
Classification: Unclassified
Device Description:
Intended Use: Vicks Powershot Dry Throat and Mouth Relief is available for application cither as a spray or as a bulk liquid, the latter using a dispensing cup. It is a device intended for over-thecounter (OTC) consumer use. The device delivered as a spray form will be packaged in a 1.01 Fl.Oz. (30 mL) polyethylene tercphthalate (PET) plastic bottle and will be dispensed from the bottle via a positive displacement pump. The device delivered using a dispensing cup will be packaged in a 6 Fl.Oz (177mL) PET plastic bottle and will be dispensed via a polypropylene dispensing cup. The device is a clear liquid and contains polymers, including carboxymethylcellulose (CMC) that is known to coat and lubricate, as well as components that function as humectants and solvents. The device is preserved and lightly flavored for improved taste. Upon application the device coats and lubricates the mucus membrane of the mouth and oropharynx thereby providing immediate relief of dryness. The device thus functions as an artificial saliva device. See Table 3 for device component listing.
Vicks Powershot Dry Throat and Mouth Relief is intended to provide immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.
1
Premarket Notification [510(k)] Submission Vicks Powershot Dry Throat and Mouth Relief
Technological Characteristic:
Comparison to Predicate Device:
The Vicks Powershot Dry Throat and Mouth Relief device is applied to the mucus membrane of the mouth and oropharynx either as a spray or as a bulk liquid using a dispensing cup to coat and lubricate the surface. By coating, moistening and lubricating it treats dry mouth and dry throat and provides immediate relief.
Vicks Powershot Dry Throat and Mouth Relief device is similar to other medical devices. Like the Moi-Stir™, Throat Moi-StirTM and Saliva Substitute™ devices, Vicks Powershot Dry Throat and Mouth Relief is a ready to use spray or liquid and can be used as often as needed. Like the Moi-Stir, Throat Moi-Stir and Saliva Substitute devices, Vicks Powershot Dry Throat and Mouth Relief has the same intended use and the same or similar technological characteristics. All devices contain CMC, similar humectants and solvents. Upon application to the throat all devices coat, lubricate and moisten to provide immediate relief of dry mouth and dry throat.
The safety and effectiveness evaluations based on biocompatibility and performance data provided in this 510(k) demonstrate that Vicks Powershot Dry Throat and Mouth Relief device is substantially equivalent to the cited predicate devices.
| Product Name | Company | Class | Intended use |
|---|---|---|---|
| Moi-Stir, K810157 | Kingswood | ||
| Laboratories, Inc. | Unclassified | For the relief of dry | |
| mouth and dry throat | |||
| Throat Moi-Stir, | |||
| K840807 | Kingswood | ||
| Laboratories, Inc. | Unclassified | For the relief of dry | |
| throat | |||
| Saliva Substitute, | |||
| K822971 | Roxane Laboratories, | ||
| Inc. | Unclassified | For immediate and | |
| effective relief of dry | |||
| mouth and dry throat | |||
| by moistening and | |||
| lubricating |
Conclusion:
The data provided for Vicks Powershot Dry Throat and Mouth Rclief device support the conclusion that it is substantially equivalent to the cited predicate devices.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
The Procter & Gamble Company c/o Richard J. Cooke Senior Regulatory Affairs Manager Mason Business Center 8700 Mason-Montgomery Rd. Mason, OH 45040-9462
AUG 2 8 2009
Re: K091419
Trade/Device Name: Vicks Powershot Dry Throat and Mouth Relief Regulation Number: Unclassified Regulation Name: Saliva, Artificial Regulatory Class: Unclassified Product Code: LFD Dated: July 13, 2009 Received: July 23, 2009
Dear Mr. Cooke:
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 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.
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); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
Melvin R. Fudelman, M.D.
Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2091419
Premarket Notification [510(k)] Submission Vicks Powershot Dry Throat and Mouth Relief
4. Indications for Use Statement
TBD 510(k) Number (if known):
Device Name:
Vicks Powershot Dry Throat and Mouth Relief
Indications For Use:
Vicks Powershot Dry Throat and Mouth Relief Spray - For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.
Vicks Powershot Dry Throat and Mouth Relief Liquid – For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.
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
Ariatole
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091419