TGO SPRAY

K051812 · Laboratoires Carilene S.A.S. · LFD · Oct 21, 2005 · DE

Device Facts

• Record ID: K051812
• Device Name: TGO SPRAY
• Applicant: Laboratoires Carilene S.A.S.
• Product Code: LFD · DE
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the supervision of a healthcare professional, TGO Spray® is intended to provide 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. TGO Spray® relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste.

Device Story

TGO Spray is an oral artificial saliva solution containing oxygenated triglycerides from corn oil. It provides lubrication and moisture to the oral cavity. The device is supplied in a 40 mL glass spray bottle with a pump mechanism that delivers a metered dose of 0.100 mL per spray. It is intended for use by patients under the supervision of a healthcare professional to alleviate symptoms of xerostomia, such as swallowing difficulties, speech impairment, and taste changes. The device is applied topically to the oral cavity as needed.

Clinical Evidence

Bench testing only. Studies included acute oral toxicity, skin and mucous membrane irritation, and skin sensitization testing to demonstrate safety for the intended use.

Technological Characteristics

Lipid-based artificial saliva solution containing oxygenated triglycerides from corn oil. Supplied in a 40 mL glass spray bottle with a metered-dose pump (0.100 mL/spray). Non-sterile. No electronic components or software.

Indications for Use

Indicated for patients suffering from chronic or temporary xerostomia (dry mouth) caused by Sjögren's Syndrome, oral inflammation, medication, chemo/radiotherapy, stress, or aging. Relieves symptoms including difficulty swallowing, speech impairment, and taste changes. Requires supervision of a healthcare professional.

Predicate Devices

• Caphasol (K030802)
• Salivart (K981693)
• Salinum or Oraclair (K024148)

Submission Summary (Full Text)

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SECTION VI

## PREMARKET NOTIFICATION SUMMARY

OCT 2 1 2005

812

- Submission Applicant and & Correspondent: A. Laboratoires Carilene S.A. S. Name: 7, rue de Chants des Oiseaux Address: BP 52 78360 Montesson France Tel: [phone] US Agent and Emalee Murphy Correspondent: Kirkpatrick & Lockhart Nicholson Graham LLP 1800 Massachusetts Avenue, NW Washington, DC 20036 Telephone: [phone] TGO Spray® B. Name of Device: TGO Spray® Trade Name: Saliva, Artificial Common or Usual Name: Saliva, Artificial Classification Name: Regulatory Information: C. LFD Product Code: Class II Classification: .. Dental
#### Devices to Which New Device is Substantially Equivalent: D.

| Inpharma AB: | Caphasol cleared in K030802 |
|---------------------------|----------------------------------------|
| Gebauer Company: | Salivart cleared in K981693 |
| Sinclair Pharmaceuticals: | Salinum or Oraclair cleared in K024148 |

- Device Description E.
Panel:

TGO Spray® is an oral artificial saliva that contains oxygenated triglycerides from corn oil that have lubricating and moisturizing properties. The product is preserved, and supplied in a glass spray bottle containing 40 mL (1.35 fl.oz.). The spray pump delivers a metered dose of 0.100 mL per spray or approximately 400 sprays.

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#### Indications for Use: F.

- Use.
Under supervision of a healthcare professional, TGOTM Spray has Rx: Onder supervision of a neatined of chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren's (di y mouth), willen may be a research, chemo or radiotherapy, Syllurome, oral minantoms include difficulties in swallowing, stress of aging. "Dymptome more and more symptoms may also be Specon, and chairgerse, stress, aging or medication.
- Summary of Technological Characteristics of the Device Compared to the G. Predicate Devices

| Product | TGO Spray® | Caphasol | Salivart | Salinum/Oraclair |
|--------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|
| Intended Uses | Symptomatic<br>Treatment of<br>xerostomia | Symptomatic<br>Treatment of<br>xerostomia | Symptomatic<br>Treatment of<br>xerostomia | Symptomatic<br>Treatment of<br>xerostomia |
| Method of Use | Ready to use<br>spray | Mix parts A &<br>B ampoules | Ready to use<br>spray | Ready to use<br>ampoules |
| Applications per<br>Day | As needed | As needed | As needed | As needed |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use<br>Type of Product | Oral cavity<br>Lipid<br>Solution | Oral cavity<br>Electrolyte<br>Solution | Oral cavity<br>Electrolyte<br>Solution | Oral cavity<br>Lipid Solution |
| Presentation | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |

Substantial Equivalence Comparison Chart

#### Tests and Conclusions: H.

The TGO Spray® formulation has been shown in studies, including tests for acute oral toxicity, skin and mucous membrane irritation, skin sensitization, acute eye irritation,
oral toxicity, skin and mucous membrane irritation, skin sensitization its in oral toxicity, skin and inucous membrand infriduent sim sective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 2005

Laboratoires Carilene S.A.S. C/O Ms. Emalee G. Murphy Kirkpatrick & Lockhart Nicholson Graham, LLP 1800 Massachusetts Avenue, NW WASHINGTON, DC 20036

Re: K051812

Trade/Device Name: TGO SPRAY Regulation Number: NONE Regulation Name: NONE Regulatory Class: UNCLASSIFIED Product Code: LFD Dated: September 20, 2005 Received: September 21, 2005

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard) the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). and Cosmetic 71ct (71ct) that ac novice, subject to the general controls provisions of the Act. The I ou may, mercrore, market the Act include requirements for annual registration, listing, of general controls provisions of use tice, 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 If your device is classified (500 abor of the Existing major regulations affecting your device can inay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oods or enents 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 I loase oc advisod that I Dr o tasan that your device complies with other requirements of the Act that I DA has made a acterimismations administered by other Federal agencies. You must or ally it cacial statutes and regaraments, including, but not limited to: registration and listing (21 Comply with an the Ace Stequirements, and manufacturing practice requirements as set CITY art 6077, adomig (21 CFR Part 820); and if applicable, the electronic form in the quality byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050. Product laulation control pro hereins (setions (se seting your device as described in your Section 510(k) This letter will anow you to begin mailing of substantial equivalence of your device to a legally prematicated predicated. The allessification 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 If you desire specific advice 10. Job 276-0115. Also, please note the regulation entitled, Colinect the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormational 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,

Susan Runnes

f
C

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): Kb51812

Device Name: TGO Spray® Artificial Saliva

Indications for Use:

Rx:

Under the supervision of a healthcare professional, TGO Spray® is intended to provide relief. Under the supervision of a neamicale protessional; 1 coo open of a result of disease such as
from chronic and temporary xerostomia (dry mouth), which areas or anno from chronic and temporary xcrostoma (dry movement), chemo or radiotherspy, stress or aging.
Sjögren's Syndrome, oral inflammation, medication, chemo in swallowing, speech, a Sjögren's Syndrome, oral inflammation, medication, memore of the 1977.
TGO Spray® relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runnes

Page 1 of 1

( "ivision Sign-Off) ( . Wision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

000010