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.

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 dentist has completed the optical impression, the patient's mouth is rinsed and suctioned to remove the IOS FastScan Spray. The IOS FastScan Spray consists of a pigment suspension in ethanol with a fluorinated hydrocarbon propellant.

AI/ML Overview

The provided document describes the IOS FastScan Spray and its substantial equivalence to the CEREC Opti Spray. It outlines non-clinical and clinical studies conducted to demonstrate its performance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IOS FastScan Spray were to demonstrate substantial equivalence to the predicate device, CEREC Opti Spray, specifically showing no statistically significant difference in accuracy for 3D digital models derived from impressions.

Acceptance Criterion	Reported Device Performance
Functional Equivalence: No statistically significant difference in the accuracy of 3D digital models derived from optical impressions compared to the predicate device.	Non-clinical study: "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 study: "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."
Biocompatibility: No cytotoxic, irritative, or sensitizing effects.	"The testing found that 'no cytotoxic, irritative and sensitizing effects should be expected'."
Acute Systemic Toxicity: No signs of toxicity or mortality from acute oral dose.	"The study found that there were no signs of toxicity or mortality from an acute oral dose of the IOS FastScan Spray."
Absence of Adverse Events/Complications in Clinical Use.	"There were no adverse events or complications experienced during the clinical testing."

2. Sample Size and Data Provenance

Test Set Sample Size:
- Non-clinical: Not explicitly stated, but involved "repeated applications" to a master typodont model.
- Clinical: 20 dentists, each performing an in-vitro and in-vivo digital optical impression. The same volunteer subject was used for all 20 in-vivo tests.
Data Provenance:
- Non-clinical: In-vitro lab setting, using a master typodont model.
- Clinical: Prospective clinical testing, taking place at the dental practice of each of the 20 participating dentists. The country of origin is not specified but given the submitter information (San Diego, CA), it is likely the USA.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention "experts" being solely responsible for establishing ground truth in the traditional sense of diagnostic interpretation. Instead, the ground truth for accuracy appears to be established by comparing the 3D digital models generated by the device to those generated by the predicate device (which is assumed to be accurate).

For the clinical study, 20 dentists were involved in taking the impressions and evaluating performance. Their qualifications are not specified beyond being "dentists." It's stated they compared the data for "validation of precision" and "comparison of performance."

4. Adjudication Method

The document does not describe an adjudication method in the context of multiple expert readers interpreting images or data. The comparison methodology involved statistically comparing the accuracy of 3D digital models from the test device against the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study as typically understood in AI performance evaluation (comparing human readers with and without AI assistance to measure effect size) was not performed. The clinical study involved 20 dentists directly comparing the performance of the IOS FastScan Spray to the predicate CEREC Opti Spray, not measuring improvement of human readers using the AI (the spray itself is not an AI).

6. Standalone Performance

Yes, a form of standalone performance was implicitly evaluated. The non-clinical studies specifically focused on the "performance characteristics of the IOS FastScan Spray in comparison to the performance characteristics of the predicate device CEREC Opti Spray" by scanning a master typodont model. This indicates the device's ability to capture accurate 3D models on its own, independent of variable human factors in some aspects (though humans apply the spray and use the system). The clinical studies then validated this performance in a real-world setting with dentists.

7. Type of Ground Truth Used

The ground truth for evaluating the accuracy of the 3D digital models was an established reference model.

Non-clinical: A "master typodont model" served as the reference for accurate 3D geometry which was then spirally scanned to capture an optical impression. The accuracy of the generated 3D digital models was compared against impressions from this known reference model, and against the performance of the predicate device on the same model.
Clinical: The "same master typodont dental model test specimen" for in-vitro tests and "the same section of dentition of a volunteer subject" for in-vivo tests served as the subject for comparison, again implying that the objective was to match the performance of the predicate device when applied to these 'ground truth' dentitions.

8. Sample Size for the Training Set

The document does not mention a training set, as the device (IOS FastScan Spray) is a medical device (coating medium) and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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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 200San 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 fluorinatedhydrocarbon propellant used toexpel a pigment suspensioncomprised principally of titaniumoxide and ethanol through anozzle	Spray can with a fluorinatedhydrocarbon propellant used toexpel a pigment suspensioncomprised principally of titaniumoxide and ethanol through anozzle
Predicate Device	CEREC Opti Spray	Unknown
Volume of SprayCan	50mL	50mL
Extension TubeLength	85mm	85mm
Nozzle design	Rotates to allow direct aim of sprayat dentition	Rotates to allow direct aim of spray atdentition
PatientContaminationControl	Discard extension tube and nozzleafter each use	Discard extension tube and nozzleafter each use
Shelf Life	36 months	36 months
Indication for Use	The IOS FastScan Spray is indicatedas a coating medium for opticalimpressions with the IOS FastScanSystem. It aids in intraoraltopographical recordings of preparedand unprepared teeth and their	CEREC Opti Spray is indicated as acoating medium for opticalimpressions with theCEREC system. It aids in intraoraltopographical recordings of preparedand 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:

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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Regulation Number and Section

§ 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).