(10 days)
Not Found
No
The summary describes a contrast spray used for optical impressions and does not mention any AI or ML components in its function or processing.
No
The device aids in obtaining optical impressions for topographical recordings and does not treat or prevent disease, which are characteristics of therapeutic devices.
No
Explanation: The device is described as a coating medium for optical impressions to aid in topographical recordings. Its purpose is to facilitate image capture for CAD/CAM systems, not to diagnose a medical condition or disease. It is a tool for obtaining an impression, not for diagnostic interpretation.
No
The device description clearly states it is a "pigment suspension in ethanol with a fluorinated hydrocarbon propellant" and is applied as a spray, indicating it is a physical substance, not software.
Based on the provided information, the Arges Imaging Contrast device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in intraoral topographical recordings of teeth and their surroundings by providing a coating medium for optical impressions. This is a physical process applied directly to the patient's mouth to improve imaging, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a spray applied to the teeth. It's a coating medium, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), detection of specific analytes, or diagnostic purposes.
IVDs are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Arges Imaging Contrast device's function is purely to enhance the quality of optical impressions for dental procedures.
N/A
Intended Use / Indications for Use
Arges Imaging Contrast is indicated as a coating medium for optical impressions. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
The Arges Imaging Contrast Spray is a pigment suspension in ethanol with a fluorinated hydrocarbon propellant. The Arges Imaging Contrast Spray is a coating medium which is applied to teeth and surrounding areas. A 3D impression of the coated dentition is taken using a commercially available CAD/CAM system. Upon completion of the impression scan, the patient's mouth if rinsed and suctioned to remove the Arges Imaging Contrast Spray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral (teeth and their surroundings)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The biocompatibility of the Arges Imaging Contrast Spray materials was evaluated following the principles of ISO 10993-1.
Bench testing, including dimensional verification and functional testing was completed to support substantial equivalence of the Arges Imaging Contrast Spray. In all cases the Arges Imaging Contrast Spray performed as intended with acceptable results.
Conclusion: The Arges Imaging Contrast Spray was found to be biocompatible for its intended use and substantially equivalent in performance characteristics when compared to the predicate devices.
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.
CEREC Opti Spray (K080882)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list precisely 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
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
Section 6
510(k) Summary
6. 510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Arges Imaging, Inc. |
|---|---|
| DATE PREPARED: | September 9, 2011 |
| CONTACT PERSON: | Rebecca K Pine |
| 129 N Hill Ave | |
| Pasadena, CA 91106 | |
| Phone: 760.809.5178 | |
| Fax: 760.290.3216 | |
| TRADE NAME: | Arges Imaging Contrast Spray |
| CLASSIFICATION | |
| NAME: | Impression Material |
| DEVICE | |
| CLASSIFICATION: | Class II |
| REGULATION | |
| NUMBER | 872.3660 |
| PRODUCT CODE | ELW |
| PREDICATE DEVICES: | CEREC Opti Spray (K080882) |
Substantially Equivalent To:
The Arges Imaging Contrast Spray is substantially equivalent in intended use, principal of operation and technological characteristics to the CEREC Opti Spray.
Description of the Device Subject to Premarket Notification:
The Arges Imaging Contrast Spray is a pigment suspension in ethanol with a fluorinated hydrocarbon propellant. The Arges Imaging Contrast Spray is a coating medium which is applied to teeth and surrounding areas. A 3D impression of the coated dentition is taken using a commercially available CAD/CAM system. Upon completion of the impression scan, the patient's mouth if rinsed and suctioned to remove the Arges Imaging Contrast Spray.
Indication for Use:
Arges Imaging Contrast is indicated as a coating medium for optical impressions. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.
1
4
Technological Characteristics:
The Arges Imaging Contrast Spray has the same technological characteristics and is similar in overall design, materials and configuration compared to the predicate device. It is substantially equivalent to the predicate in terms of:
- . Indications for Use
- . Basic design/configuration
- Where used
- Target population
- . Delivery method
Testing and Performance Data:
The biocompatibility of the Arges Imaging Contrast Spray materials was evaluated following the principles of ISO 10993-1.
Bench testing, including dimensional verification and functional testing was completed to support substantial equivalence of the Arges Imaging Contrast Spray. In all cases the Arges Imaging Contrast Spray performed as intended with acceptable results.
Conclusion: The Arges Imaging Contrast Spray was found to be biocompatible for its intended use and substantially equivalent in performance characteristics when compared to the predicate devices.
Basis for Determination of Substantial Equivalence:
Upon reviewing and comparing intended use, design, materials, principle of operation and overall technological characteristics, the Arges Imaging Contrast Spray is determined by Arges Imaging, Inc. to be substantially equivalent to existing legally marketed devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized, curved shapes that resemble abstract human figures or waves.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
NOV 1 4 2011
Arges Imaging, Inc. C/O Mr. Mark Job Regulatory Technology Services, LLC 1394 25" Street, NW Buffalo, MN 55313
Re: K113263
Trade/Device Name: Arges Imaging Contrast Spray Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 3, 2011 Received: November 4, 2011
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Job
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. 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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Arges Imaging Contrast Spray
Indications for Use:
Arges Imaging Contrast is indicated as a coating medium for optical impressions. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.
OR
Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
of Page Page
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113263