(10 days)
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.
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.
The provided text describes a medical device called "Arges Imaging Contrast Spray" and its 510(k) submission. However, it does not include detailed information about acceptance criteria, a specific study proving the device meets those criteria, or most of the other requested elements. This submission focuses on demonstrating substantial equivalence to a predicate device (CEREC Opti Spray) rather than providing extensive performance data against specific, quantitative acceptance criteria.
Here's an analysis based on the information available in the text, with significant gaps for the parts not provided:
Acceptance Criteria and Device Performance Study Analysis
The provided 510(k) summary for the "Arges Imaging Contrast Spray" focuses on establishing substantial equivalence to a predicate device, the CEREC Opti Spray (K080882). As such, it does not present a typical study design with explicit, quantitative acceptance criteria and detailed performance results in the way one might expect for a novel high-risk device or an AI/software as a medical device.
Instead, the "acceptance criteria" are implicitly met by demonstrating that the device has comparable technological characteristics, indications for use, and performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission, explicit quantitative acceptance criteria for performance are not provided. The document states that the device "performed as intended with acceptable results" which points to qualitative assessment and comparison rather than specific numerical thresholds.
| Acceptance Criterion (Implicitly derived from predicate comparison) | Reported Device Performance (from text) |
|---|---|
| Biocompatibility | "biocompatible for its intended use" |
| Dimensional verification | "performed as intended with acceptable results" |
| Functional testing | "performed as intended with acceptable results" |
| Substantial equivalence in: | "substantially equivalent in intended use, principal of operation and technological characteristics" |
| - Indications for Use | "same technological characteristics" and "Substantially Equivalent To" predicate |
| - Basic design/configuration | "same technological characteristics" and "Substantially Equivalent To" predicate |
| - Where used | "same technological characteristics" and "Substantially Equivalent To" predicate |
| - Target population | "same technological characteristics" and "Substantially Equivalent To" predicate |
| - Delivery method | "same technological characteristics" and "Substantially Equivalent To" predicate |
2. Sample size used for the test set and the data provenance
Not provided. The document mentions "Bench testing, including dimensional verification and functional testing" but does not specify sample sizes for these tests or the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies). For a coating medium, ground truth would likely be established through physical measurements or chemical analyses rather than expert consensus on diagnostic interpretations. The document does not mention any expert involvement in establishing "ground truth" for the testing performed.
4. Adjudication method for the test set
Not applicable/Not provided. Similar to point 3, adjudication methods are usually applied in human-based evaluations (e.g., clinical trials or reading studies). This information is not relevant or provided for the bench testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not an AI/software as a medical device. The device is a contrast spray. Therefore, an MRMC study is not relevant and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software as a medical device.
7. The type of ground truth used
The document states "Bench testing, including dimensional verification and functional testing was completed". This implies that the ground truth for these tests would be objective physical or chemical measurements/specifications (e.g., coating thickness, spray uniformity, material properties) rather than expert consensus, pathology, or outcomes data. However, the specific type of ground truth is not explicitly detailed. For biocompatibility, the ground truth would be established by the principles of ISO 10993-1, which involves standardized biological assessments.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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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 Pine129 N Hill AvePasadena, CA 91106Phone: 760.809.5178Fax: 760.290.3216 |
| TRADE NAME: | Arges Imaging Contrast Spray |
| CLASSIFICATIONNAME: | Impression Material |
| DEVICECLASSIFICATION: | Class II |
| REGULATIONNUMBER | 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.
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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.
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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
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- 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
§ 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).