(113 days)
CEREC Opti Spray, K080882
No
The device is a coating spray, not a software or hardware system that processes data. The 510(k) summary describes its physical properties and performance in aiding optical impressions, with no mention of AI/ML.
No
The device is a coating medium for optical impressions and does not directly treat or prevent a disease or condition.
No
The IOS FastScan Spray is a coating medium that aids in capturing optical impressions. It does not analyze patient data or provide a medical diagnosis itself. Its function is to facilitate the diagnostic process by improving the quality of the optical impression.
No
The device description clearly states it is a "coating medium" consisting of a "pigment suspension in ethanol with a fluorinated hydrocarbon propellant," which is a physical substance, not software.
Based on the provided information, the IOS FastScan Spray is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- IOS FastScan Spray's Function: The IOS FastScan Spray is a coating medium applied directly to the teeth and gums within the patient's mouth. Its purpose is to aid in the optical capture of a 3D impression of the dentition. It is not used to analyze a specimen taken from the body.
- Intended Use: The intended use clearly states it's a "coating medium for optical impressions" to aid in "intraoral topographical recordings." This is a physical aid for imaging, not a diagnostic test performed on a biological sample.
Therefore, the IOS FastScan Spray falls under the category of a dental device used for imaging purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IOS FastScan Spray is indicated as a coating medium for optical impressions with the IOS FastScan System. 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 IOS FastScan Spray is a coating medium applied by a dentist, by spraying onto the area of interest on the teeth and gums. After the coating application, the IOS FastScan System is used to optically capture a 3D impression of the coated dentition. Once the dentir hys completed the optical impression, the patient's mouth is rinsed and suctioned thes IOS FastScan Spray. The IOS FastScan Spray consists of a pigment suspension in ethanol with a fluorinated hydrocarbon propellant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical impressions
Anatomical Site
teeth and gums / intraoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist / dental practice
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
Non-clinical studies: A master typodont model was repeatedly coated with the subject device and the predicate device and then spirally scanned to capture an optical impression. Comparison of the optical impressions captured with the IOS FastScan Spray showed no statistically significant difference in the accuracy of the 3D digital models derived from the impressions captured with the IOS FastScan Spray versus the impressions captured using the predicate CEREC Opti Spray.
Clinical studies: 20 dentists participated. Each dentist took an in-vitro digital optical impression of the same master typodont dental model test specimen and an in-vivo digital optical impression of the same section of dentition of a volunteer subject. The volunteer subject was a 59 year old male. The digital optical impression data for each dentist and each spray were saved and compared for validation of precision and to compare the partisy IOS FastScan Spray device against the performance of the predicate CEREC Opti Spray device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing: Non-clinical studies were performed to assess the performance characteristics of the IOS FastScan Spray in comparison to the performance characteristics of the predicate device CEREC Opti Spray. The studies involved the repeated applications of the Freuncate cevice of the predicate CEREC Opti Spray to a master typodont model which was then spirally scanned to capture an optical impression of the typodont model. Comparison of the optical impressions captured with the IOS FastScan Spray showed no statistically significant difference in the accuracy of the 3D digital models derived from the impressions captured with the IOS FastScan Spray versus the impressions captured using the predicate CEREC Opti Spray. Biocompatibility testing (cytotoxicity, irritation, sensitivity, acute oral toxicity) found no expected cytotoxic, irritative, sensitizing effects, nor signs of toxicity or mortality.
Clinical testing: Clinical studies were performed, involving 20 dentists with clinical testing taking place at the dental practice of each of the participating dentists. The study involved testing the performance of the IOS FastScan Spray in comparison to the CEREC Opti Spray by having each dentist take an in-vitro digital optical ionspression of the Same master typodont dental model test specimen and an in-vivo digital optical impression of the same section of dentition of a volunteer subject. The same volunteer subject, a 59 year old male, was involved with the clinical in-vivo testing at all 20 sites. The clinical in-vitro and in-vivo impression 3D model accuracy data show that the 20 dentists involved in the study achieved essentially the same accuracy result with the IOS FastScan Spray as was achieved with the CEREC Opti Spray. There were no adverse events or complications experienced during the clinical testing.
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 exactly as they appear in the text.
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
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
A. SUBMITTER INFORMATION
| Company Name: | IOS Technologies, Inc. | |
|---|---|---|
| Company Address: | 3978 Sorrento Valley Blvd. Suite 200 | |
| San Diego, CA 92121 | ||
| Company Phone: | ||
| Company FAX: | (858) 202-3363 | |
| (858) 552-8516 | ||
| Contact Person: | Duane M. Durbin (858) 202-3363 |
Date Summary Prepared: January 26, 2011
B. DEVICE IDENTIFICATION
| Trade/Proprietary Name: | IOS FastScan Spray |
|---|---|
| 21 CFR Reference: | 872.3660 |
| 21 CFR Common Name: | ImpressionMaterial |
| Classification: | Class II |
| Panel: | Dental EL W |
C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name: CEREC Opti Spray, K080882 (4/11/2008)
D. DEVICE DESCRIPTION
The IOS FastScan Spray is a coating medium applied by a dentist, by spraying onto the area of interest on the teeth and gums. After the coating application, the IOS FastScan System is used to optically capture a 3D impression of the coated dentition. Once the dentir hys completed the optical impression, the patient's mouth is rinsed and suctioned thes IOS FastScan Spray. The IOS FastScan Spray consists of a pigment suspension in ethanol with a fluorinated hydrocarbon propellant.
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E. INDICATIONS FOR USE
The IOS FastScan Spray is indicated as a coating medium for optical impressions with the IOS FastScan System. It aids in intraoral topographical recordings of prepossions and unprepared teeth and their surroundings.
F. TECHNOLOGICAL CHARACTERISTICS:
The IOS FastScan Spray consists of a pigment suspension in ethanol with a fluorinated hydrocarbon propellant. The contents are mixed together and packaged in 50mL spray cans. Disposable extension tubes and nozzles are used to apply the spray to the dentition.
G. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Characteristic | IOS FastScan Spray | Predicate CEREC Opti Spray |
|---|---|---|
| Principles of Operation | Spray can with a fluorinated | |
| hydrocarbon propellant used to | ||
| expel a pigment suspension | ||
| comprised principally of titanium | ||
| oxide and ethanol through a | ||
| nozzle | Spray can with a fluorinated | |
| hydrocarbon propellant used to | ||
| expel a pigment suspension | ||
| comprised principally of titanium | ||
| oxide and ethanol through a | ||
| nozzle | ||
| Predicate Device | CEREC Opti Spray | Unknown |
| Volume of Spray | ||
| Can | 50mL | 50mL |
| Extension Tube | ||
| Length | 85mm | 85mm |
| Nozzle design | Rotates to allow direct aim of spray | |
| at dentition | Rotates to allow direct aim of spray at | |
| dentition | ||
| Patient | ||
| Contamination | ||
| Control | Discard extension tube and nozzle | |
| after each use | Discard extension tube and nozzle | |
| after each use | ||
| Shelf Life | 36 months | 36 months |
| Indication for Use | The IOS FastScan Spray is indicated | |
| as a coating medium for optical | ||
| impressions with the IOS FastScan | ||
| System. It aids in intraoral | ||
| topographical recordings of prepared | ||
| and unprepared teeth and their | CEREC Opti Spray is indicated as a | |
| coating medium for optical | ||
| impressions with the | ||
| CEREC system. It aids in intraoral | ||
| topographical recordings of prepared | ||
| and unprepared |
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Reference 510(K) Number: K103586
H. SUMMARY OF NON-CLINICAL TESTING DATA
Non-clinical studies were performed to assess the performance characteristics of the IOS FastScan Spray in comparison to the performance characteristics of the predicate device CEREC Opti Spray. The studies involved the repeated applications of the Freuncate cevice of the predicate CEREC Opti Spray to a master typodont model which was then spirally scanned to capture an optical impression of the typodont model. Comparison of the optical impressions captured with the IOS FastScan Spray showed no statistically significant difference in the accuracy of the 3D digital models derived from the impressions captured with the IOS FastScan Spray versus the impressions captured using the predicate CEREC Opti Spray.
To evaluate the biocompatibility of the IOS FastScan Spray materials, cytotoxicity testing as per EN ISO 10993-5, and irritation and sensitivity testing per EN ISO 10993-10 was performed. The testing found that "no cytotoxic, irritative and sensitizing effects should be expected".
To assess Acute Systemic Toxicity, an Acute Oral Toxicity study was also performed. The study found that there were no signs of toxicity or mortality from an acute oral dose of the IOS FastScan Spray.
SUMMARY OF CLINICAL TESTING DATA I.
Clinical studies were performed, involving 20 dentists with clinical testing taking place at the dental practice of each of the participating dentists. The study involved testing the performance of the IOS FastScan Spray in comparison to the CEREC Opti Spray by having each dentist take an in-vitro digital optical ionspession of the Same master typodont dental model test specimen and an in-vivo digital optical impression of the same section of dentition of a volunteer subject. The digital optical impression data for each dentist and each spray were saved and compared for validation of precision and to compare the partisy IOS FastScan Spray device against the performance of the predicate CEREC Opti Spray device.
The same volunteer subject, a 59 year old male, was involved with the clinical in-vivo testing at all 20 sites.
The clinical in-vitro and in-vivo impression 3D model accuracy data show that the 20 dentists involved in the study achieved essentially the same accuracy result with the IOS FastScan Spray as was achieved with the CEREC Opti Spray.
There were no adverse events or complications experienced during the clinical testing.
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J. CONCLUSION, SUBSTANTIAL EQUIVALENCE
The IOS FastScan Spray is substantially equivalent to the CEREC Opti Spray. These devices are both comprised of a spray can with a fluorinated hydrocarbon procellant used to experi a pigment suspension comprised principally of titanium oxide and ethanol through a nozzle. Both devices are indicated as a coating medium for optical impressions to aid in intraoral topographical recordings of prepared and unprepared teeth and their surrounding,
The IOS FastScan Spray performance was assessed in non-clinical and clinical studies and found to have a performance substantially equivalent to that of the predicated device, the CEREC Opti Spray.
Biocompatibility and toxicity studies conducted with the IOS FastScan Spray have found that no cytotoxic, irritative, sensitization, or acute systemic toxicity effects should be expected and it is concluded that the safety of the IOS FastScan Spray device for the intended use is substantially equivalent to the predicate device.
IOS Technologies is claiming substantial equivalence of the IOS FastScan Spray to other currently marketed coating mediums for optical impressions, specifically, the CEREC Onti Spray which was cleared under K080882 in April, 2008.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring. MD 20993-0002
Mr. Duane Durbin President IOS Technologies, Incorporated 3978 Sorrento Valley Boulevard, Suite 200 San Diego, California 92121
MAR 3 0 2011
Re: K103586
Trade/Device Name: IOS FastScan Spray Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: February 14, 2011 Received: February 17, 2011
Dear Mr. Durbin:
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. Durbin
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 licderal 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/CentersOflices/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 yours,
Wh for
Anthony 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 Form (Text Version)
Indications for Use
510(k) Number (if known): K103586
Device Name: IOS FastScan Spray
Indications for Use:
The IOS FastScan Spray is indicated as a coating medium for optical impressions with the IOS FastScan System. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
$10(k) Number: R835086
CONFIDENTIAL
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