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.

AI/ML Overview

The provided text describes a premarket notification for the TGO Spray® device, an artificial saliva intended for the symptomatic treatment of xerostomia (dry mouth). However, it does not contain a study that proves the device meets specific acceptance criteria.

The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices. It mentions that TGO Spray® has undergone certain safety studies, but these are not presented as having specific acceptance criteria or performance metrics in the context of a clinical study.

Therefore, many of the requested sections regarding acceptance criteria, study details, and performance are not present in the provided text.

Here's an breakdown of the information that can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not mentioned for performance effectiveness. The document states "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." This indicates safety testing, but no specific performance acceptance criteria (e.g., a certain percentage reduction in dry mouth symptoms or duration of relief) are provided.
Reported Device Performance: Not explicitly stated in terms of quantitative performance metrics. The document claims the device is "effective for its intended use" based on the safety studies listed, and that it "relieves symptoms of dry mouth," but no data points are given to support this.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not provided.
Data Provenance: The studies mentioned are described generally (e.g., "studies, including tests for acute oral toxicity"). There is no information on the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable / Not provided. The document does not describe a study involving expert assessment to establish ground truth for performance. The studies mentioned are toxicology and irritation tests, which typically don't involve "experts establishing ground truth" in the way clinical performance studies do.

4. Adjudication Method for the Test Set:

Not Applicable / Not provided. No such method is described as there's no clinical performance test set with ground truth adjudication mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No such study was done or reported. The document does not describe any comparative effectiveness study with human readers (or users in this context) to evaluate the device's performance with or without AI assistance. The device itself is a spray, not an AI-powered diagnostic tool.

6. Standalone Performance Study (Algorithm Only):

Not Applicable. The device is a physical product (artificial saliva spray), not an algorithm.

7. Type of Ground Truth Used:

Not Applicable / Not provided for performance. For the safety tests mentioned (toxicity, irritation, sensitization), the "ground truth" would be established by standard laboratory procedures and observations for adverse reactions. There's no clinical performance "ground truth" (like pathology or outcomes data) described in the provided text as part of a performance study.

8. Sample Size for the Training Set:

Not Applicable / Not provided. There is no "training set" mentioned, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable / Not provided.

Summary of available information related to the device:

The document serves as a 510(k) premarket notification, primarily focusing on demonstrating substantial equivalence to predicate devices for its intended use. It confirms that the device is a non-sterile, lipid solution spray for symptomatic treatment of xerostomia, to be used in the oral cavity as needed. Safety tests for acute oral toxicity, skin and mucous membrane irritation, and skin sensitization were performed, and the formulation was found to be effective for its intended use based on these studies. However, detailed performance acceptance criteria or a clinical study proving performance against such criteria are not included in this document.

Summary

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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: 011-331-30-15-58-90 US Agent and Emalee Murphy Correspondent: Kirkpatrick & Lockhart Nicholson Graham LLP 1800 Massachusetts Avenue, NW Washington, DC 20036 Telephone: 202-778-9428 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:

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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	SymptomaticTreatment ofxerostomia	SymptomaticTreatment ofxerostomia	SymptomaticTreatment ofxerostomia	SymptomaticTreatment ofxerostomia
Method of Use	Ready to usespray	Mix parts A &B ampoules	Ready to usespray	Ready to useampoules
Applications perDay	As needed	As needed	As needed	As needed
Disease State	Xerostomia	Xerostomia	Xerostomia	Xerostomia
Area of UseType of Product	Oral cavityLipidSolution	Oral cavityElectrolyteSolution	Oral cavityElectrolyteSolution	Oral cavityLipid 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

N/A