(26 days)
Not Found
No
The summary describes a standard intraoral camera with image capture and storage capabilities, with no mention of AI/ML features or image processing beyond basic capture.
No.
The device is used to provide a view of the mouth before and after a dental procedure and to assist in describing and showing results; it does not explicitly state that it treats or prevents a disease or condition.
No
Explanation: The device is described as an intra-oral camera system used to provide a view of the mouth before and after procedures to assist the dentist in describing procedures and showing results. There is no indication that it is used to diagnose any disease or condition.
No
The device description explicitly details a physical handpiece with a light, focusing mechanism, and capture button, which connects to a computer via a USB port. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visual information (images) of the mouth to assist the dentist in describing procedures and showing results. This is a visual aid for clinical examination and communication, not a test performed on biological samples in vitro (outside the body).
- Device Description: The device is an intraoral camera system that captures digital images. It does not involve the analysis of biological specimens like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Claris i310D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
Claris i310D comprises of a light (0.1 Ibs), small (8.3" x 0.85"), and ergonomic handpiece.
The handpiece consists of a focusing mechanism and a capture button to assist the doctor in taking intraoral or full face images of the patient.
The handpiece connects to the computer via USB 2.0 port.
A cradle is provided to allow for on-off functions.
Claris i310D has a digital resolution (720x480 pixels) to capture images at 60 degrees field of view. Images may be stored using third party software vendors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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)
This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 19 below)
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.
Not Found
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
§ 872.6640 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
K061175.
p. 1 of 2
510(k) Summary
As Required by 21 section 807.92 ( c )
SOTA PRECISION OPTICS, INC. 1-Submitter Name:
1073 NORTH BATAVIA STREET, ORANGE, CA 92867 2-Address:
(714) 532-6100 3-Phone:
(714) 532-6107 4-Fax:
5-Contact Person:
6-Date summary prepared: April 14th, 2006
- 7 Official Correspondent for this 510k submission: Jay Mansour, Mansour Consulting LLC
- 8- Address: 845 Aronson Lake Court, Roswell, GA 30075
- 9- Phone: 678-908-8180
10- Fax: 678-623-3765
- 11- Contact Person: Jay Mansour, President
12-Device Trade or Proprietary Name: Claris i310D
13-Device Common or usual name: Intraoral camera system and accessories
-
14-Device Classification Name: Unit, Operative, Dental
15-Substantial Equivalency is claimed against the following device: -
Claris i310 from SOTA PRECISION OPTICS, INC. . 510k# K032341
16-Description of the Device: (For technical specifications, refer to the user manual) (Full listing and photos of accessories is available within this submission- refer to user manual)
Claris i310D comprises of a light (0.1 Ibs), small (8.3" x 0.85"), and ergonomic handpiece.
The handpiece consists of a focusing mechanism and a capture button to assist the doctor in taking intraoral or full face images of the patient.
The handpiece connects to the computer via USB 2.0 port.
A cradle is provided to allow for on-off functions.
Claris i310D has a digital resolution (720x480 pixels) to capture images at 60 degrees field of view. Images may be stored using third party software vendors.
17-Intended use of the device: (refer to FDA form attached)
Claris i310D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.
18-Safety and Effectiveness of the device:
This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 19 below)
PAGE II
1
19-Summary comparing technological characteristics with predicate device:
Please find below a tabulated comparison supporting that this device is substantially r lease lind bother medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission.
| FDA file reference number | 510k # K032341 |
|---|---|
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Similar |
| Sterility | Identical (being not applicable as well) |
| Biocompatibility | Identical |
| Mechanical safety | Similar |
| Chemical safety | Identical (being not applicable as well) |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Similar |
| Radiation safety | Similar |
Refer to the submission for more details.
PAGE 12
2
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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2006
Sota Precision Optics, Incorporated C/O Jay Mansour Mansour Consulting, LLC 845 Aronson Lake Court Roswell, Georgia 30075
Re: K061175
Trade/Device Name: Claris i310D Intra Oral Camera System and Accessories Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: April 14, 2006 Received: April 27, 2006
Dear Mr. Mansour:
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. Mansour
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,
Sujite Y. Mchair Omd.
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
4
Indications for Use
K061175 510(k) Number (if known):
Device Name: Claris i310D Intra Oral Camera System and accessories
Indications For Use:
Claris i310D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Raaser
.. Sa-Citi) -n of Anesthesiology, General Hospital, Jon Control, Dental Devices
inter K061175
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