XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT

K111167 · Velopex International, Inc. · IXW · Aug 18, 2011 · Radiology

Device Facts

• Record ID: K111167
• Device Name: XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
• Applicant: Velopex International, Inc.
• Product Code: IXW · Radiology
• Decision Date: Aug 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1900
• Device Class: Class 2

Intended Use

The ExtraXtender Film Processor is an automatic film processor used by dental offices to develop X-ray films. The ExtraXtender processes all film sizes of intra-oral and extra oral film. High quality archivable radiographs are delivered dry in 5 minutes. Films may be viewed wet after 2 1/2 minutes. The Sprint Film Processor is an automatic film processor used by dental offices to develop x-ray films. The Sprint Film Processor processes all sizes of intra-oral film. Films may be viewed wet after 2 1/2 minutes.

Device Story

The ExtraXtender and Sprint Film Processors are automatic, electromechanical devices used in dental clinical settings to develop exposed X-ray films. The devices automate the chemical processing cycle, transforming exposed film into developed, archivable radiographs. The ExtraXtender handles both intra-oral and extra-oral film sizes, while the Sprint is limited to intra-oral film. Operation is performed by dental office staff. The devices provide dry, processed radiographs in 5 minutes (ExtraXtender) or allow for wet viewing after 2.5 minutes. This automation streamlines the diagnostic workflow, enabling clinicians to obtain physical X-ray images for patient assessment and treatment planning.

Clinical Evidence

Bench testing only.

Technological Characteristics

Automatic radiographic film processor; electromechanical design; processes intra-oral and extra-oral dental X-ray films; utilizes standard chemical development process; standalone unit for dental office use.

Indications for Use

Indicated for use in dental offices for the development of intra-oral and extra-oral X-ray films.

Regulatory Classification

Identification

An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Velopex IntraX Film Processor (K093503)
• A/T 2000 Automatic Film Processor (Air Techniques Inc.)
• Dent-X Co., Model 410 Dental X-Ray Film Processor (K874118)
• Peri-Pro Film Processor (Air Techniques Inc.)
• All-Pro 2010 Film Processor (Air Techniques Inc.)
• All-Pro 100 Plus Film Processor (Air Techniques Inc.)

Submission Summary (Full Text)

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KM1167

AUG 18 2011

Image /page/0/Picture/2 description: The image shows the logo for VELOPEX INTERNATIONAL. The word "VELOPEX" is in large, bold, black letters at the top of the image. The word "INTERNATIONAL" is in smaller, bold, black letters at the bottom of the image. The logo is simple and easy to read.

105 East 17th Street St. Cloud, FL 34769 1-888-835-6739

Date: April 21, 2011

510(k) Holder: Velopex International Inc Establishment Registration # 3003697084 Device Name: ExtraXtender Film Processor, Sprint Film Processor Contact: Anthony Urella Phone: [phone] Fax: Email: [e-mail]

## 510 (k) Summary

Device Name:

ExtraXtender Film Processor Sprint Film Processor

- > Trade Name: Xtender Film Processor, Sprint Film Processor
- a Common Name: Automatic Film processor
- > Classification name: Processor, Radiographic-Film, Automatic
- > Device Class 2
- > Regulation Number: 892,1900

Legally marketed device to which we are claiming equivalence:

- > Velopex IntraX Film Processor #K093503
- > Air Techniques Inc. (Registered Establishment # 2428225) A/T 2000 Automatic Film Processor
- > Dent-X Co., Model 410 Dental X-Ray Film Processor #K874118
- > Air Techniques Inc. (Registered Establishment # 2428225) Peri-Pro Film Processor
- > Air Techniques Inc. (Registered Establishment # 2428225) All-Pro 2010 Film Processor
- > Air Techniques Inc. (Registered Establishment # 2428225) All-Pro 100 Plus Film Processor

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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

Velopex International Inc. % Mr. Anthony Urella Vice President. Sales & Marketing 105 East 17th Street SAINT CLOUD FL 34769

AUG 1 8 2011

Re: K111167

Trade/Device Name: ExtraXtender Film Processor, Sprint Film Processor Regulation Number: 21 CFR 892.1900 Regulation Name: Automatic radiographic film processor Regulatory Class: II Product Code: IXW Dated: April 21, 2011 Received: June 6, 2011

Dear Mr. Urella:

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 your 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,

Mary S Pastel

Mary Pastel, ScD. 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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## Indications for Use Form

k) Number (if known): KIII/67 traxtender Film Processor Indications for Use

The Extracter Film Processor is an automatic tilmprocessor used by dental offices to develop X-ray films. The Extra Kender processes all film sizes of intra-oral and extra oral Im. High quality archivable radiographs are slelivered dry in 5 minutes . Films may be viewed wet after 21/2 minutes

scription Use ________________________________________________________________________________________________________________________________________________________________ Prescription Use

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

urrence of CDRH, Office of In Vitro Diagnostic Devices (OIV

Mary S. Pastel
Division Sigh Off

of In Vitro Diagnostic D tion and Safe

510(k) K111167

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## Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Spurt Film Processor Indications for Use:

The Sprint Film Processor is an automatic film processor used by dental offices to Sevelop xray films. The Sprint Film Sursson processes all sizes of intra-oral film, Films may be viewed wet after 2"/z minutes.

Prescription Use Over-The-Counter Us (Part 21 CFR 801 Subpart D) AND (21 CFR 801 Subpart

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

rrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K. 111167

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