MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

K041385 · Schick Technologies, Inc. · EAP · Jun 7, 2004 · Dental

Device Facts

• Record ID: K041385
• Device Name: MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
• Applicant: Schick Technologies, Inc.
• Product Code: EAP · Dental
• Decision Date: Jun 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1810
• Device Class: Class 2

Intended Use

The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.

Device Story

The Computed Oral Radiology System is a digital imaging receptor used as an alternative to dental x-ray film. The device captures intra-oral x-ray images; the modified version allows image acquisition to be triggered via a hardwire connection to the x-ray tube, improving ergonomics and response time by eliminating the need for a standalone remote module. The system is operated by dental professionals in a clinical setting. The output consists of instant digital images of the patient's mouth, which are used by the clinician to support diagnostic decision-making. The device benefits patients by reducing the required x-ray dosage compared to traditional film.

Clinical Evidence

Bench testing and third-party safety testing were conducted to validate the device modification. No clinical data was required or presented.

Technological Characteristics

Solid state x-ray imager; digital imaging receptor. Modification includes hardwire interface to x-ray source. Firmware updated to support hardware integration. Operates as an intraoral source x-ray system (21 CFR 892.1810).

Indications for Use

Indicated for patients undergoing intra-oral dental x-ray examinations.

Regulatory Classification

Identification

An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Computed Oral Radiology System (K933455)

Submission Summary (Full Text)

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# JUN - 7 2004

# Exhibit IV: 510(k) Summary Schick Computed Oral Radiology System

Common/Classification Name: Solid State X-ray Imager 21 CFR892.1650

Schick Technologies, Inc. 30-00 47th Avenue Long Island City, NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: May 24, 2004

### A. Legally Marketed Predicate Devices

The original Computed Oral Radiology System notification was cleared on January 318, 1994 (K933455). The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film.

## B. Modification Description

The new control mechanism differs from the predicate in that image acquisition may additionally be triggered through a hardwire to an x-ray tube. This modification allows for a quicker x-ray response time and may improve ergonomics as it eliminates the need for a standalone remote module.

The existing firmware has been altered to support the modified and additional hardware. The new remote module may be housed within a specified x-ray source. The modification in no way effects the fundamental technology governing image acquisition.

### C. Indications for Use

The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was originally cleared in K933455.

### D. Substantial Equivalence Summary

A risk analysis established the areas of concern. The principal risk is unintended x-ray exposure. These areas have been evaluated following bench, and thirdparty safety testing. All validation activities have demonstrated that the

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predetermined acceptance criteria were met. Where appropriate, warnings have been incorporated within the user manual.

# E. Conclusions

Schick Technologies has demonstrated through a risk analysis and validation studies that the device modification is substantially equivalent to the already cleared and marketed device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Daniel Michaeli Director of Science Development Schick Technologies, Inc. 30-30 47th Avenue LONG ISLAND CITY NY 11101

AUG 23 2013

Re: K041385

Trade/Device Name: Computed Oral Radiology System Regulation Number: 21 CFR 892.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP and MOB Dated: May 24, 2004 Received: May 25, 2004

Dear Mr. Michaeli:

This letter corrects our substantially equivalent letter of June 7, 2004.

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 vour device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K041385

Computed Oral Radiology System Device Name:

Indications For Use:

The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Nancy C Langdon

and Radiological Devic 510(k) Numl

*Prescription Use*