(6 days)
No
The description focuses on basic imaging capture and display functionalities, with no mention of AI/ML terms, image processing beyond simple display modes, or performance metrics typically associated with AI/ML algorithms.
No
The device is used for imaging and viewing purposes to assist the dentist in describing procedures and showing results, not for treating any condition.
No
The device is an intraoral camera system that provides a view of the mouth to assist the dentist in describing procedures and showing results. It captures images but does not analyze or interpret them to identify diseases or conditions, which is characteristic of diagnostic devices.
No
The device description explicitly details hardware components such as a handpiece, light, focusing mechanism, capture button, cable, and multi-docking system.
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 of the mouth to the dentist and patient for viewing before and after procedures and assisting in describing procedures and showing results. This is a direct visualization tool, not a device that performs tests on biological samples (like blood, urine, tissue, etc.) to diagnose or monitor a condition.
- Device Description: The description details a camera system for capturing images of the inside of the mouth. It doesn't mention any components or processes related to analyzing biological samples.
- Input Imaging Modality: The input is an intraoral camera, which captures visual images, not data from a biological sample analysis.
- Anatomical Site: The anatomical site is the mouth, which is being directly visualized.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for visual inspection and communication.
N/A
Intended Use / Indications for Use
Win-100D 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
EIA
Device Description
Our device comprises of a light (0.6Kg), small (230mmX12mm), compact design and ergonomic handpiece along with a multi-docking system.
The handpiece consists of a focusing mechanism and a capture button to assist the The nanapless intraoral or full face images of the patient.
The handpiece connects to a multi-docking system via a cable.
The multi-docking system in turn can connect directly to a monitor and PC via a standard composite connection (RCA).
It uses high definition imaging (460 TV-lines) to capture images at 80 degrees field of view.
It can make the screen in 4 frames or full screen mode via a multi-docking system. It can change the side of the captured image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 2 3 2004
510(k) Summary As Required by 21 section 807.92 ( c )
1-Submitter Name: WIN-US TECHNOLOGY CO., LTD
2-Address: 3F Younbg-Pung B/D, #225-1 Poi-Dong
Kangnam-Ku, Seoul, Korea
3-Phone: 82-2-529-3785
4-Fax: 82-2-572-3784
4-Fax: 82-2-372-3704
5-Contact Person: (on behalf of the submitter) Jay Mansour, Mansour Consulting LLC
5-Contact Person: (on behalf of the Submitter) Jay Mansour, Mansour Co 5-Contact Person: (on behalf of the Submiter) buy Manocal, Marioun, Marines (678) 623-3765
1308 Morningside Park Dr Alpharetta, GA 30022 USA (770) 777-4146 Fax (678) 623-376 6-Date summary prepared: January 9th, 2004
7-Device Trade or Proprietary Name: Win-100D
7-Device Trade of Proprietary Nation in the 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 technical specifications, refer to the user manual) 11-DeSCH(ption of the Devices (rec: (rol technour spotheaters) in refer to User Manual)
Our device comprises of a light (0.6Kg), small (230mmX12mm), compact design and ergonomic handpiece along with a multi-docking system.
The handpiece consists of a focusing mechanism and a capture button to assist the The nanapless intraoral or full face images of the patient.
The handpiece connects to a multi-docking system via a cable.
The multi-docking system in turn can connect directly to a monitor and PC via a standard composite connection (RCA).
It uses high definition imaging (460 TV-lines) to capture images at 80 degrees field of view.
It can make the screen in 4 frames or full screen mode via a multi-docking system. It can change the side of the captured image.
12-Intended use of the device: (refer to FDA form attached)
Win-100D intra oral camera system and accessories is indicated for use to provide the ville 100D intra oral camora cystem atta before and after the dental procedure, dentist and the pations with a vieribing 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)
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1
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially r lease in a below a tablated compansement of 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 | Not Applicable |
| 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 | Not Applicable |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.
MAR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Win-US Technology Company Limited C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K040691
Trade/Device Name: Intra-Oral Camera System and Accessories, WIN-100D Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 16, 2004 Received: March 17, 2004
Dear Mr. Lehtonen:
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 -- Ms. Rivkowich
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) 594-5613. 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 vours.
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
510(k) Number (if known): |(0 \0(0(0)
Device Name: Intra-Oral Camera System and Accessories, WIN-100D
Indications For Use:
Win-100D 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 ﻟﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ (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 Runny
Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number: K040691
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