(27 days)
No
The description focuses on multispectral light technology for direct visualization and does not mention any computational analysis, algorithms, or learning processes.
No
The device is used for identification and visualization of abnormalities, not for treatment. Its purpose is diagnostic, to help identify diseased tissue and determine surgical margins, not to provide therapy itself.
Yes
Explanation: The "Identafi™ 3000 is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities...such as oral cancer or premalignant dysplasia." This device directly assists in identifying and visualizing medical conditions, which is the core function of a diagnostic device.
No
The device description explicitly states it is a "AA" battery operated, hand-held, multispectral oral examination light, indicating it is a hardware device.
Based on the provided information, the Identafi™ 3000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information about a person's health.
- Identafi™ 3000's Function: The Identafi™ 3000 is a hand-held light source used for direct visualization of oral mucosal tissue within the body. It enhances the visual examination performed by a healthcare provider. It does not analyze samples taken from the patient.
The device is a diagnostic aid that assists the healthcare provider in their visual assessment, but it does not perform an in vitro test on a biological specimen.
N/A
Intended Use / 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 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.
Product codes
NXV
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.
The Identafi™ 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) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral mucosal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified health-care providers, surgeon
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Trimira OCS 3000 (K082603)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6350 Ultraviolet detector.
(a)
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.(b)
Classification. Class II.
0
EMICALM LLC
952 Echo Lane, Suite 333 Houston, TX 77024 Voice: 713-984-8550 Fax: 713-984-9232
1072
| V.
| 510(k) SUMMARY | |
|---|---|
| Submitted by: | TRIMIRA LLC |
| 952 Echo Lane | |
| Houston, TX 77024 | |
| Phone: (713) 984-8550 | |
| Fax: (713) 984-9232 |
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:
21 CFR § 872.6350
Class I: (Exempt)
21 CFR § 874.4420
Class I: (Exempt)
21 CFR § 886.5850 |
| Classification Name: | Ultraviolet Detector - NXV (EAQ)
ENT manual surgical instrument (Mirrors) – KAI (Exempt)
Filtered glasses - HQY (Exempt) |
| Predicate Devices: | Trimira OCS 3000 (K082603)
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: 713-984-9232 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.
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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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
REMICALM LLC
952 Echo Lane, Suite 333 Houston, TX 77024 Voice: 713-984-8550 Fax: 713-984-9232
/J/
IV. Indications for Use
Applicant:
TRIMIRA LLC 952 Echo Lane, Suite 333 Houston, TX 77024 Phone: (713) 984-8550 Fax: (713) 984-9232
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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