(27 days)
Not Found
No
The summary describes a standard intraoral camera system for capturing and displaying images, with no mention of AI or ML capabilities for image analysis, diagnosis, or other functions.
No
The device is described as an intraoral camera system used to view the mouth and assist in describing dental procedures and showing results, not to treat or diagnose any disease or condition.
No
The device is an intra oral camera system used to provide a view of the mouth before and after a dental procedure, primarily for descriptive and demonstrative purposes, not for diagnosing conditions.
No
The device description explicitly details hardware components such as a handpiece, docking station, cable, and optional footswitch. It is not solely software.
Based on the provided information, the Claris i310 intra oral camera system 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.
- Claris i310 Function: The Claris i310 is an intraoral camera system. Its intended use is to capture images of the inside of the mouth to assist the dentist in visualizing and explaining procedures and results. It does not perform any tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the Claris i310 falls under the category of a medical device used for visualization and documentation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Claris i310 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 i310 comprises of a light (0.1 lbs), small (8"x0.86"), and ergonomic handpiece along with a docking station.
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 a docking station via a cable. The docking station in turn can connect directly to a monitor. PC, or a printer via a S-Video or a standard composite connection.
Claris i310 is also available in a wireless option.
It uses high definition imaging (494 lines/inch) to capture images at 60 degrees field of view.
Images may be stored using third party software vendors.
Claris i310 includes also an optional footswitch.
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 other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 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
AUG 2 5 2003
510(k) Summary As Required by 21 section 807.92 ( c )
| 1-Submitter Name: | Sota Precision optics, Inc |
|---|---|
| 2-Address: | 1073 North Batavia Street |
| Orange, CA 92867 | |
| 3-Phone: | 714-532-6100 |
| 4-Fax: | 714-532-6107 |
| 5-Contact Person: | Jay Mansour of Mansour Consulting LLC, on behalf of submitter |
| 1308 Morningside Park Dr. Alpharetta, GA 30022. 770-777-4146 | |
| 6-Date summary prepared: | July 22nd, 2003 |
| 7-Device Trade or Proprietary Name: | Claris i310 |
8-Device Common or usual name: Intra Oral Camera system and accessories
-
9-Device Classification Name: Unit, Operative, Dental
10-Substantial Equivalency is claimed against the following device: -
DIGITAL DOC from Digital Doc. Inc. . 510k # K981663
11-Description of the Device: (For tochnical specifications, refer to the user manual) (Full listing and photos of accessories is available within this submission- refer to User Manual pages 22 and 23)
Claris i310 comprises of a light (0.1 lbs), small (8"x0.86"), and ergonomic handpiece along with a docking station.
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 a docking station via a cable. The docking station in turn can connect directly to a monitor. PC, or a printer via a S-Video or a standard composite connection.
Claris i310 is also available in a wireless option.
It uses high definition imaging (494 lines/inch) to capture images at 60 degrees field of view.
Images may be stored using third party software vendors.
Claris i310 includes also an optional footswitch.
12-Intended use of the device: (refer to FDA form attached)
Claris i310 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.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
1
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially r loase find b other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Refer to the detailed explanations within the main submission.
| FDA file reference number | 510k # K981663 |
|---|---|
| Attachments inside notification submission file | 510k FDA website print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Not Applicable |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Similar |
| Radiation safety | Similar |
2
Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of a bird with three lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2003
Sota Precision Optics. Incorporated C/O Mr. Donald J Sherratt Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779
Re: K032341
Trade/Device Name: Claris i310 Intra Oral Camera System and Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 15, 2003 Received: August 18, 2003
Dear Mr. Sherratt:
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 vour 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. Sherratt
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
SusaRuroer
Susan Runner, DDS, MA Interim 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 statement
510(k) Number (if known): K032341 Claris i310 Intra Oral Camera System and Accessories Device Name:
Indications For Use:
Claris i310 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
Kein Mulvey for MSN
nesthesiology, General Hospital, Control. Dental D
510(k) Number: K032341
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)