TGO SPRAY

• K Number: K051812
• Device Name: TGO SPRAY
• Manufacturer: LABORATOIRES CARILENE S.A.S.
• Date Cleared: 2005-10-21 ( 108 days)
• Product Code: LFD CLA
• Regulation Number: N/A

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 Description

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.

Predicate Devices

K030802, K981693, K024148

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on the chemical composition and physical properties of the spray, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

Yes
The device is intended to provide relief from chronic and temporary xerostomia, which is a medical condition, and it aims to relieve symptoms such as difficulties in swallowing and speech, indicating a therapeutic purpose.

Diagnostic

No
The device is intended to relieve symptoms of dry mouth (xerostomia), not to diagnose any condition.

SaMD (Software as a Medical Device)

No

The device description clearly states that TGO Spray® is an oral artificial saliva supplied in a glass spray bottle, indicating it is a physical product and not software.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use of TGO Spray® is to provide relief from the symptoms of dry mouth (xerostomia) by lubricating and moisturizing the oral cavity. This is a therapeutic and symptomatic relief function, not a diagnostic one.
• Device Description: The device is an oral artificial saliva. It is applied directly to the oral cavity to alleviate symptoms.
• Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a disease or condition. IVDs are designed to perform tests in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.

The information provided clearly describes a device intended for direct application to the body for symptomatic relief, which is characteristic of a medical device, but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

LFD

Device Description

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.

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 supervision

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

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, to be safe and effective for its intended use.

Key Metrics

Not Found

Predicate Device(s)

K030802, K981693, K024148

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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.

1

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
Treatment of
xerostomia	Symptomatic
Treatment of
xerostomia	Symptomatic
Treatment of
xerostomia	Symptomatic
Treatment of
xerostomia
Method of Use	Ready to use
spray	Mix parts A &
B ampoules	Ready to use
spray	Ready to use
ampoules
Applications per
Day	As needed	As needed	As needed	As needed
Disease State	Xerostomia	Xerostomia	Xerostomia	Xerostomia
Area of Use
Type of Product	Oral cavity
Lipid
Solution	Oral cavity
Electrolyte
Solution	Oral cavity
Electrolyte
Solution	Oral cavity
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.

2

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.

3

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

4

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