TRIMIRA IDENTAFI 3000

K090135 · Remicalm, LLC · NXV · Feb 17, 2009 · Dental

Device Facts

• Record ID: K090135
• Device Name: TRIMIRA IDENTAFI 3000
• Applicant: Remicalm, LLC
• Product Code: NXV · Dental
• Decision Date: Feb 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6350
• Device Class: Class 2

Intended Use

Identafi™ 3000 is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. Identafi™ 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescene and reflectance, and vasculature. Identafi™ 3000 is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision. Identafi™ 3000 eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. Identafi™ 3000 eyewear has been designed to allow transmission of 430-580 nm light.

Device Story

Identafi 3000 is a hand-held, battery-operated multispectral oral examination light. Device emits white, violet, and amber light to excite oral tissue. Healthcare providers use the device during oral exams while wearing filtered eyewear (430-580 nm transmission). Violet light induces natural tissue fluorescence; healthy tissue appears blue, while suspicious tissue appears dark due to loss of fluorescence. Amber light enhances visualization of tissue vasculature. Surgeons use the device to identify diseased tissue margins around lesions for excision. Output is direct visual observation of tissue fluorescence and reflectance. Device aids clinical decision-making by identifying suspicious areas requiring further investigation or biopsy.

Clinical Evidence

No clinical data provided. The device relies on the principle of natural tissue fluorescence and reflectance for visualization, supported by literature references regarding tissue fluorescence in cancerous and precancerous fields.

Technological Characteristics

Hand-held, battery-operated (AA) device using high-intensity LEDs. Emits white, violet, and amber light. Includes reusable filtered eyewear (430-580 nm transmission). Multispectral technology. No software or complex algorithms; purely optical/visual enhancement.

Indications for Use

Indicated for use by qualified healthcare providers to enhance identification and visualization of oral mucosal abnormalities (e.g., oral cancer, premalignant dysplasia) not apparent to the naked eye; also indicated for surgeons to assist in identifying diseased tissue margins around clinically apparent lesions.

Regulatory Classification

Identification

An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.

Predicate Devices

• Trimira OCS 3000 (K082603)

Submission Summary (Full Text)

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# EMICALM LLC

952 Echo Lane, Suite 333 Houston, TX 77024 Voice: 713-984-8550 Fax: [phone]

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| V.<br>510(k) SUMMARY | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | TRIMIRA LLC<br>952 Echo Lane<br>Houston, TX 77024<br>Phone: [phone]<br>Fax: [phone]<br><br>FEB 1 7 2009 |
| Contact Person: | David B. Jones |
| Date Prepared: | January 20, 2009 |
| Proprietary Name: | TRIMIRA™ Identafi™ 3000 |
| Common Name: | Oral Examination Light and Accessories |
| Classification: | Class II:<br>21 CFR § 872.6350<br>Class I: (Exempt)<br>21 CFR § 874.4420<br>Class I: (Exempt)<br>21 CFR § 886.5850 |
| Classification Name: | Ultraviolet Detector - NXV (EAQ)<br>ENT manual surgical instrument (Mirrors) – KAI (Exempt)<br>Filtered glasses - HQY (Exempt) |
| Predicate Devices: | Trimira OCS 3000 (K082603)<br>952 Echo Lane #333 Houston, TX 77024 |

# Device Description:

The TRIMIRA™ IDENTAFI 3000® is a "AA" battery operated, hand-held, multispectral oral examination light used in conventional and specialized oral examination. Accessories outli oldi glasses and disposable mirrors.

## Intended Use:

Identaff™ 3000 is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.

Identafi™ 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescene and reflectance, and vasculature.

Identaff™ 3000 is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision.

Identaff™ 3000 eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. Identafi™ 3000 eyewear bacbeen designed to allow transmission of 430-580 nm light.

#### Technological Characteristics:

The Identaff™ 3000, with multispectral identifi™ technology (patents pending), uses "AA" batteries to operate high-intensity LEDs to produce white, violet and amber light. These safe, visible lights allow health professional to perform Conventional Oral Examination (COE) using white ight, and specialized or enhanced visual examinations of tissue using violet and amber lights.

The Identafi™ 3000 violet light enhances normal tissue's natural fluorescence. Visual examination under violet light shows healthy tissues fluorescing blue (when using rose colored filtered glasses)

Confidentially claimed per 21 CFR 807,95

IDENTAFI 3000 Special 510(k)

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952 Ecno Lane, Suite 333 mousion, Fax: [phone] Voice: 713-984-8550

Image /page/1/Picture/1 description: The image shows the logo for REMICALM LLC. The logo consists of a stylized atom symbol to the left of the company name. The text "REMICALM LLC" is written in a simple, sans-serif font. The overall design is clean and professional.

K090135

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while suspicious tissue appears dark because of its loss of fluorescence. Amber light enhances the withio suspicious assus app and makes visualization of the vasculature possible.

The direct visualization of fluorescent and reflective tissues is using the body's natural system to identify suspicious tissue quickly that may require further investigation. The loss of natural tissue Identify suspicious tissue quietly that that the fields with cancerous and précancerous Hooresoenes and Cancer Research Vol. 12, 6716-6722, November 15, 2006.

# Substantial Equivalence

The Identafi™ 3000 has the same intended use and technological characteristics as the approved The Identan- - 3000 has the sune meeting as and results of therescence and/or reflectance as the primary mode for enhanced visualization of tissue for determining oral tissue abnormalities.

The design, materials, method of operation, and labeling are substantially equivalent.

The TRIMIRA™ Identati™ 3000 is substantially equivalent to the approved predicate device.

# Confidentially claimed per 21 CFR 807.95

## IDENTAFI 3000 Special 510(k)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 7 2009

Mr. David B. Jones Vice President, Regulatory Affairs and Quality Assurance Remicalm, LLC 952 Echo Lane, Suite 333 Houston, Texas 77024

K090135 Re:

> Trade/Device Name: TRIMIRA™ Identafi™ 3000 Regulation Number: 21 CFR 872.6350 Regulation Name: Ultraviolet Detector Regulatory Class: II Product Code: NXV Dated: February 10, 2009 Received: February 11, 2009

Dear Mr. Jones:

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 mavisions 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 such 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.

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# Page 2 - Mr. Jones

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 syours,

Anthony D. natar br
Ginette Y. Michaud, M.D.

Acting 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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# REMICALM LLC

952 Echo Lane, Suite 333 Houston, TX 77024 Voice: 713-984-8550 Fax: [phone]

/J/

IV. Indications for Use

Applicant:

TRIMIRA LLC 952 Echo Lane, Suite 333 Houston, TX 77024 Phone: [phone] Fax: [phone]

090135

510(k) Number (if Known):

Device Name:

## TRIMIRA™ Identafi 3000™

Indications For Use:

Identafi™ 3000 is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.

Identafi™ 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluo essence and reflectance, and vasculature.

Identall™ 3000 is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision.

Identafi™ 3000 eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. Identator™ 3000 eyewear has been designed to allow transmission of 430-580 nm light. I

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (Per 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)

Susan Dunne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Confidentially claimed per 21 CFR 807.95

IDENTAFI 3000 Special 510(k)

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