(114 days)
The ExtraXtender Film Processor is an automatic film processor used by dental offices to develop X-ray films. The Extra Xtender 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 xray films. The Sprint Film Processor processes all sizes of intra-oral film. Films may be viewed wet after 2 1/2 minutes.
Automatic Film processor
The provided text is a 510(k) summary for the Velopex ExtraXtender Film Processor and Sprint Film Processor. It focuses on establishing substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or specific studies proving a device meets
these criteria. This document is a regulatory submission, not a scientific study report.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets them based on the provided text. The document does not include information on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts used or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness studies or effect sizes for AI assistance.
- Standalone (algorithm only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily provides:
- Device names and regulatory information.
- Contact details for the 510(k) holder.
- Predicate devices for demonstrating substantial equivalence.
- Indications for Use for both film processors.
To answer your questions, a different type of document, such as a validation study report or a different section of a regulatory submission (e.g., performance data), would be needed.
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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: 407-957-3900 407-957-3927 Fax: Email: tony@velopexusa.com
510 (k) Summary
Device Name:
ExtraXtender Film Processor Sprint Film Processor
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Trade Name: Xtender Film Processor, Sprint Film Processor
- a Common Name: Automatic Film processor
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Classification name: Processor, Radiographic-Film, Automatic
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Device Class 2
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Regulation Number: 892,1900
Legally marketed device to which we are claiming equivalence:
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Velopex IntraX Film Processor #K093503
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Air Techniques Inc. (Registered Establishment # 2428225) A/T 2000 Automatic Film Processor
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Dent-X Co., Model 410 Dental X-Ray Film Processor #K874118
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Air Techniques Inc. (Registered Establishment # 2428225) Peri-Pro Film Processor
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Air Techniques Inc. (Registered Establishment # 2428225) All-Pro 2010 Film Processor
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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
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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
Page 1 of
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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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§ 892.1900 Automatic radiographic film processor.
(a)
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.(b)
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.