(160 days)
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No
The summary does not mention AI, ML, or any related concepts like training/test sets, performance metrics associated with AI/ML models, or image processing techniques that typically involve AI/ML in modern medical imaging devices. The description focuses on basic imaging and documentation functions.
No.
The device is an accessory imaging device used for assessment and communication, not for treating a disease or condition.
Yes
The device is intended to "assist in the assessment of the overall patient's dental health by providing magnified digital images of the oral cavity," which implies a diagnostic purpose.
No
The device description explicitly states it is an "accessory imaging device" and an "Intraoral Lens Option," which are hardware components used for capturing images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The SpectroShade intraoral lens option is described as an accessory imaging device that takes intraoral images of dental anatomy. It works by capturing images directly within the oral cavity.
- Intended Use: The intended uses listed are all related to visualizing and documenting the oral cavity for assessment, education, record-keeping, and procedure comparison. None of these involve analyzing specimens taken from the body.
Therefore, since the device operates by imaging the body directly and not by analyzing specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SpectroShade's intraoral lens option is an accessory imaging device, which is intended for use by dental professionals in taking intraoral images of dental anatomy in order to:
-
- Assist in the assessment of the overall patient's dental health by providing magnified digital images of the oral cavity.
-
- Provide visual educational information to the patient to more effectively communicate a treatment plan.
-
- Provide documented images for patient records, insurance companies, and other dental professionals.
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- Allow the practitioner to display before and after images of dental procedures.
Product codes (comma separated list FDA assigned to the subject device)
EIA
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
intraoral images
Anatomical Site
oral cavity
Indicated Patient Age Range
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Intended User / Care Setting
dental professionals
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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§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2002
Mr. Markus Angst MHT Optic Research AG Mandachstr. 50 Niederhasli, SWITZERLAND
Re: K012744
Trade/Device Name: Intraoral Lens Option To SpectroShade Regulation Number: 872.6640 Regulation Name: Dental Operative Unit Accessory Regulatory Class: I Product Code: EIA Dated: November 5, 2001 Received: November 7, 2001
Dear Mr. Angst:
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.
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.
1
Page 2 - Mr. Angst
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/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
2
510(k) Number: K012744
Intraoral Lens Option to SpectroShade Device Name:
Indications for Use:
SpectroShade's intraoral lens option is an accessory imaging device, which is intended for use by dental professionals in taking intraoral images of dental anatomy in order to:
-
- Assist in the assessment of the overall patient's dental health by providing magnified digital images of the oral cavity.
-
- Provide visual educational information to the patient to more effectively communicate a treatment plan.
-
- Provide documented images for patient records, insurance companies, and other dental professionals.
-
- Allow the practitioner to display before and after images of dental procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruscoe
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices KO12744 510(k) Number -
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Appendix A- 3