VICKS POWERSHOT DRY THROAT & MOUTH RELIEF

K091419 · The Procter & Gamble Co. · LFD · Aug 28, 2009 · DE

Device Facts

• Record ID: K091419
• Device Name: VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
• Applicant: The Procter & Gamble Co.
• Product Code: LFD · DE
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for 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.

Device Story

Artificial saliva device for OTC consumer use; provides immediate relief of dry mouth and throat. Device consists of clear liquid containing carboxymethylcellulose (CMC), humectants, and solvents. Delivered via two formats: spray (30 mL PET bottle with positive displacement pump) or bulk liquid (177 mL PET bottle with polypropylene dispensing cup). User applies liquid/spray directly to oral and oropharyngeal mucosa. Coating/lubricating action mimics natural saliva to moisten tissues. No complex electronics or software; purely mechanical delivery of chemical formulation.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and comparison of technological characteristics/formulation to legally marketed predicate devices.

Technological Characteristics

Clear liquid formulation containing carboxymethylcellulose (CMC), humectants, and solvents. Packaging: PET plastic bottles. Delivery: positive displacement pump (spray) or polypropylene dispensing cup (liquid). Non-sterile, OTC device. No electronic components or software.

Indications for Use

Indicated for the immediate and effective relief of dry throat and dry mouth by coating, moistening, and lubricating the mucus membranes of the mouth and oropharynx in consumers.

Predicate Devices

• Moi-Stir (K810157)
• Throat Moi-Stir (K840807)
• Saliva Substitute (K822971)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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.

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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<br>Laboratories, Inc. | Unclassified | For the relief of dry<br>mouth and dry throat |
| Throat Moi-Stir,<br>K840807 | Kingswood<br>Laboratories, Inc. | Unclassified | For the relief of dry<br>throat |
| Saliva Substitute,<br>K822971 | Roxane Laboratories,<br>Inc. | Unclassified | For immediate and<br>effective relief of dry<br>mouth and dry throat<br>by moistening and<br>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.

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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.

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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 [phone] or [phone] 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

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# 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