The Aromatic and Flavored Tongue Depressor is intended to displace the tongue to facilitate examination of the surrounding organs. They are available in the following colors: Yellow. blue, orange, magenta, pink. green and red.

Device Description

The Aromatic and Flavored Tongue Depressor is for medical use which is comprised of a non-toxic thermoplastic material and an aromatic sweetener. The device is molded through a process of injection molding originating an article of vibrant colors, with taste and smell, 8 to 20 cm. long; 1 to 4 cm wide and 0.1 to 0.3 cm thick.

AI/ML Overview

The provided 510(k) summary for the "Aromatic and Flavored Tongue Depressor" (K992995) does not describe a study that uses acceptance criteria in the typical sense of a performance study for a medical imaging or AI device.

This device is a basic medical instrument, and the regulatory submission focuses on material safety and equivalence to a predicate device, rather than quantifiable performance metrics like sensitivity, specificity, or accuracy. Therefore, many of the requested categories are not applicable to this document.

Here's the information that can be extracted, and an explanation of why other categories are not present:

Acceptance Criteria and Device Performance Study for K992995: Aromatic and Flavored Tongue Depressor

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Safety	Non-toxic thermoplastic material.	Material Testing Certifications were supplied, confirming the plastic (polypropylene), pigments/colors, aroma, and flavor/taste meet safety standards.
Biocompatibility	Patient-contacting materials must be biocompatible.	Biocompatibility testing results revealed "passing data."
Functional Equivalence	Ability to displace the tongue to facilitate examination of surrounding organs, comparable to predicate.	("Discussion of Non-Clinical Tests Performed"): No specific functional tests are detailed, but the submission implicitly relies on the mechanical similarity of the device to the predicate for functional equivalence. The description states it is "molded through a process of injection molding originating an article of vibrant colors, with taste and smell, 8 to 20 cm. long; 1 to 4 cm wide and 0.1 to 0.3 cm thick."
Physical Dimensions	Similar size range to predicate device.	"similar" sizes reported in the comparison table: 8 to 20 cm. long; 1 to 4 cm wide and 0.1 to 0.3 cm thick.
Intended Use	Same as predicate device (displace tongue for examination).	"same" intended use as predicate.
Manufacturing Quality	Compliance with Good Manufacturing Practice (GMP) regulation (implied for all medical devices).	The FDA's letter states: "A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions."

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

Sample Size: Not applicable. The document describes material and biocompatibility testing, not a clinical "test set" in the context of imaging or AI. The material testing certifications and biocompatibility assessments would have involved specific test samples as per relevant standards (e.g., ISO 10993 for biocompatibility), but the exact number of samples or data provenance (country, retrospective/prospective) for these lab tests are not detailed in this summary.
Data Provenance: Not specified, as it pertains to internal lab testing, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. This device does not generate diagnostic interpretations requiring expert ground truth establishment. Biocompatibility testing is assessed against established standards by laboratory professionals.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" requiring adjudication in this context.

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

Not applicable. This is not an AI or imaging device, and therefore, no MRMC study was performed or is relevant.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

Material Safety: Ground truth is based on established materials science standards, chemical analyses, and regulatory guidelines for non-toxicity, colorants, flavorings, and aroma additives.
Biocompatibility: Ground truth is established by recognized international standards for biocompatibility testing (e.g., ISO 10993 series), using in-vitro or in-vivo models to assess biological responses.
Intended Use/Functionality: Ground truth for functional equivalence is based on the predicate device's established safe and effective use through manual physical displacement of the tongue.

8. Sample Size for the Training Set:

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. There is no "training set" or "ground truth" establishment in the AI/machine learning sense for this device.

Summary

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510(K) SUMMARY

K992995

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

1. Submitter's Identification:

AGAPlastic Ind. Com. Ltda. Rua Conde de Agrolongo, 362 Penha 21020-190 Rio De Janeiro-RJ BRAZIL

Date Summary Prepared: August 1999

Mr. Cezar Reis, Contact: Tel: 55 21 260-5753 Fax: 55 21 266-5130

2. Name of the Device:

Aromatic and Flavored Tongue Depressor

3. Predicate Device Information:

The Torrent Corporation, Tongue Depressor, K# 842461

4. Device Description:

5. Intended Use:

The Aromatic and Flavored Tongue Depressor is intended to displace the tongue to facilitate examination of the surrounding organs.

6. Comparison to Predicate Devices:

Company	Device	Material	Size(s)	Intended Use
The Torrent Corp.	Tongue Depressor	wood	similar	same
AGAPlastic	Tongue Depressor	polypropylene	similar	same

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7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the Aromatic and Flavored in the intended environment of use is supported by testing that was conducted for the plastic, piqments/colors, aroma and flavor/taste.

Material Testing Certifications were supplied with the 510(k) submission.

8. Discussion of Clinical Tests Performed:

A biocompatibility assessment was conducted for patient-contacting materials, and biocompatibility testing results revealed passing data.

9. Conclusions:

Based on the similarities of the two devices and supporting test data for both the polypropylene and the additives, the Aromatic and Flavored Tongue Depressor is as safe and effective as the predicate device. Furthermore, it does not raise any new questions regarding safety and effectiveness from the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1999

AGA Plastic Incorporated Ms. Susan D. Goldstein-Falk Official Correspondent for AGA Plastic Incorporated c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021

Re : K992995 Aromatic and Flavored Tongue Depressor Trade Name: Regulatory Class: I Product Code: FMA Dated: November 16, 1999 Received: November 19, 1999

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Goldstein-Falk

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit

Page イ of of 1 -

510(k) Number (if known): K992295

Device Name Aromatic and Flavored Tongue Depressor

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__ (Optional Format 1-2-96)

Patoux Cuente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .

Regulation Number and Section

§ 880.6230 Tongue depressor.

(a)
Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.