(114 days)
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No
The summary describes a light-based device for enhanced visualization and does not mention any computational analysis, image processing, or AI/ML terms.
No
The device is described as an oral examination light used to enhance visualization of oral mucosal abnormalities and help identify diseased tissue. It is a diagnostic tool, not a therapeutic one that treats or cures a condition.
Yes
The device is intended to enhance the visualization of oral mucosal abnormalities such as oral cancer or pre-malignant dysplasia, which falls under the definition of diagnosing a condition. It also helps surgeons identify diseased tissue to determine surgical margins, which is a diagnostic aid.
No
The description explicitly states the device is an "oral examination light," which implies a hardware component (a light source) is integral to its function. The summary does not mention any software-only functionality.
Based on the provided information, the Sapphire O/E oral examination light is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Sapphire O/E Function: The description clearly states the Sapphire O/E is an "oral examination light" used directly on the patient's oral mucosa to enhance visualization. It is a tool for in vivo examination, not for testing samples in vitro.
Therefore, the Sapphire O/E oral examination light falls under the category of a medical device used for direct examination of the patient, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional oral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
Product codes
NXV
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral mucosal
Indicated Patient Age Range
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Intended User / Care Setting
dentist or qualified health-care provider, surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan Matthews Quality Assurance Manager Den-Mat Holdings, LLC 2727 Skyway Drive Santa Maria, California 93455
APR - 3 2008
Re: K073483
Trade/Device Name: Sapphire™ O/E Oral Examination System Regulation Number: 872.6350 Regulation Name: Ultraviolet Detector Regulatory Class: II Product Code: NXV Dated: December 7, 2007 Received: January 10, 2008
Dear Mr. Matthews:
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.
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Page 2 - Mr. Matthews
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sina Rames
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 4. Den-Mat Sapphire O/E 510(k) Premarket Notification
510(k) Number (if known): pending
Sapphire™ O/E Oral Examination System Device Name:
Indications for use:
The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional oral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
Prescription Use x_
and/or
OTC Use __
(Per 21 CFR 801 subpart D)
(Per 21 CFR 801 subpart C)
Susan Runne
(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073483