(95 days)
No
The device description focuses on multispectral light technology for direct visualization and does not mention any computational analysis, algorithms, or learning processes.
No.
The document states that the device is intended for "identification and visualization of oral mucosal abnormalities" and to "help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision." It performs diagnostic functions and aids in surgical planning, but does not directly treat or cure any condition.
Yes
The device is intended to "enhance the identification and visualization of oral mucosal abnormalities" and to "help identify diseased tissue around a clinically apparent lesion," which are diagnostic purposes.
No
The device description clearly states it is a "AA" battery operated, hand-held, multispectral oral examination light, which is a hardware device. It also includes accessories like safety glasses and disposable mirrors, further indicating it is not software-only.
Based on the provided information, the OCS 3000® is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The OCS 3000® is a device that is used on the body (specifically, the oral mucosal) to visualize tissue characteristics in situ. It does not involve the collection or analysis of biological samples like blood, urine, tissue biopsies, etc.
- The device description and intended use focus on direct visualization. The device uses light to enhance the visualization of tissue fluorescence, reflectance, and vasculature. This is a form of in vivo examination, not in vitro analysis.
- The predicate devices are also visualization tools. The listed predicate devices (VELscope and ViziLite) are also light-based systems for oral examination and visualization, not IVDs.
Therefore, the OCS 3000® falls under the category of a medical device used for in vivo examination and visualization, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
OCS 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.
OCS 3000® allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescence and reflectance, and vasculature.
OCS 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. OCS 3000 eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000 eyewear has been designed to allow transmission of 430-580 nm light.
Product codes (comma separated list FDA assigned to the subject device)
NXV, HQY, KAI
Device Description
The TRIMIRA™ OCS 3000® is a "AA" battery operated, hand-held, multispectral oral examination light used in conventional and specialized oral examination. Accessories include safety glasses and disposable mirrors.
OCS 3000® eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000® eyewear has been designed to allow transmission of 430-580 nm light.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for Remicalm LLC. The logo consists of a stylized four-petal flower-like design to the left of the text "REMIICALM LLC". The text is in a simple, sans-serif font.
952 Echo Lane, Suite 333 Houston, TX 77024 Voice: 713-984-8550 Fax: 713-984-9232
V. 510(k) SUMMARY
- Submitted by:
TRIMIRA LLC 952 Echo Lane Houston, TX 77024 Phone: (713) 984-8550 Fax: (713)984-9232
DEC 1 2 2008
| Contact Person: | David B. Jones |
|---|---|
| ----------------- | ---------------- |
August 22, 2008
Proprietary Name:
Date Prepared:
Oral Examination Light and Accessories
Ultraviolet Detector - NXV (EAQ)
Photosensitive glasses - HQY (Exempt)
TRIMIRA™ OCS 3000®
Classification:
Common Name:
Class II: 21 CFR § 872.6350
Class I: (Exempt) 21 CFR § 874.4420 Class I: (Exempt) 21 CFR § 886.5850
ENT manual surgical instrument (Mirrors) - KAI (Exempt)
Classification Name:
Predicate Devices:
VELscope (K070523) LED Medical Diagnostics 201-15047 Marine Drive White Rock, BC, Canada V4B 1C5
ViziLite (K033033 & K080043) The Trylon Corporation 970 West 190th Street, Suite 850 Torrance, CA 90502-1037
Device Description:
The TRIMIRA™ OCS 3000® is a "AA" battery operated, hand-held, multispectral oral examination light used in conventional and specialized oral examination. Accessories include safety glasses and disposable mirrors.
Intended Use:
OCS 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.
OCS 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescence and reflectance, and vasculature.
OC'S 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.
Confidentially claimed per 21 CFR 807.95
OCS 3000 510(k) Vol. 1
1
952 Echo Lane, Suite 333 Houston, TX 77024 Voice: 713-984-8550 Fax: 713-984-9232
EMICALM LLC
08760
272
OCS 3000® eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000® eyewear has been designed to allow transmission of 430-580 nm light.
Technological Characteristics:
The OCS 3000 with multispectral identifi™ technology (Patent No. 7,365,844 and patents pending) uses "AA" batteries to operated 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 light, and specialized or enhanced visual examinations of tissue using violet and amber lights.
The OCS 3000 violet light enhances normal tissue's natural fluorescence. Visual examination under violet light shows healthy tissues in fluorescing green (when using filtered glasses) while suspicious tissue appears dark because of its loss of fluorescence. Amber light enhances the tissue's natural reflectance 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 fluorescence and reflectance can identify subclinical high-risk fields with cancerous and precancerous changes Clinical Cancer Research Vol. 12, 6716-6722. November 15, 2006.
Substantial Equivalence
The OCS 3000 has the same intended use and technological characteristics as the approved predicate devices (K033033, K070523, and K080043); each uses fluorescence and/or reflectance as the primary mode for enhanced visualization of tissue for determining oral tissue abnormalities.
Predicate K070523 uses 120v AC to power a metal halide light to produce a single blue light and views fluorescence through a connected handpiece with a green filtered lens. In addition, the predicate for the original VELscope (K060920) was the ViziLite (K033033).
Predicate, K033033, uses two "AA" batteries to power high-intensity LEDs to produce white light. However, predicate K033033 uses a 1% acetic acid rinses and metachromatic vital tissue dye (tolonium chloride), a post-dye decolorized filtered eyewear (K080043) with diffuse chemiluminescent white-blue light to observe abnormalities by reflectance.
The OCS 3000 "s patented multispectral identifi™ technology use LEDs produce three different light wave lengths (white, violet and amber), and polarized filtered eyewear (K080043) to enhance the fluorescence and reflectance (K070523) contrast of normal and neoplastic epithelial tissue. By filtering a selected band of autofluoresced or reflected light, the OCS 3000® allows the clinician to see enhanced contrast between normal and abnormal tissue within the overall range of white light spectra (K033033).
Unlike the predicates, the clinician may use the multispectral OCS 3000® with white light for conventional oral examinations, and violet and amber lights for visualization of the natural tissue fluorescence and reflectance. Other devices or chemicals are not required. In addition, the OCS 3000 amber light enhances visualization of the vasculature through reflectance.
The design, materials, method of operation, and labeling are substantially equivalent.
The TRIMIRA™ OCS 3000® is substantially equivalent to the approved predicate devices.
Confidentially claimed per 21 CFR 807.95
OCS 3000 510(k) Vol. 1
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized with thick, black lines, giving it a modern and authoritative appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2008
Mr. David B. Jones Vice President, Regulatory Affairs and Quality Assurance Remicalm L.L.C. 952 Echo Lane, Suite 333 Houston, Texas 77024
Re: K082603
Trade/Device Name: TRIMIRA™ OCS 3000 Regulation Number: 21 CFR 872.6350 Regulation Name: Ultraviolet Detector Regulatory Class: II Product Code: NXV Dated: December 8, 2008 Received: December 10, 2008
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 provisions 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 yours,
Anthony D. Watson for
Chiu S. Lin, Ph. D Division 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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Image /page/4/Picture/0 description: The image shows the logo for REMICALM LLC. The logo consists of a stylized atom symbol above the company name. The text "REMICALM LLC" is written in a simple, sans-serif font. The logo is black and white.
952 Echo Lane, Suite 333 Houston, TX 77024 Voice: 713-984-8550 Fax: 713-984-9232
IV. Indications for Use
Applicant:
TRIMIRA LLC 952 Echo Lane, Suite 333 Houston, TX 77024 Phone: (713) 984-8550 Fax: (713) 984-9232
510(k) Number (if Known): KA8221053
Device Name:
TRIMIRA™ OCS 3000®
Indications For Use:
OCS 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.
OCS 3000® allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescence and reflectance, and vasculature.
OCS 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. OCS 3000 eyewear is reusable polarized filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. OCS 3000 eyewear has been designed to allow transmission of 430-580 nm light.
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 Rumer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: R082603
Confidentially claimed per 21 CFR 807.95