PVMED DDR 2520 DIGITAL IMAGING SYSTEM

K072766 · Portavision Medical · IXK · Dec 11, 2007 · Radiology

Device Facts

• Record ID: K072766
• Device Name: PVMED DDR 2520 DIGITAL IMAGING SYSTEM
• Applicant: Portavision Medical
• Product Code: IXK · Radiology
• Decision Date: Dec 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1630
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The PortaVision PVMed DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy. The system is not intended to be used for mammography. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This imager is intended for incorporation into a complete x-ray system by a qualified equipment manufacturer. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient

Device Story

PortaVision PVMed DDR 2520 is a solid-state digital X-ray imager; captures radiographic images of human anatomy. Components: amorphous silicon flat panel imager with gadolinium oxysulfide scintillator; Windows-based computer software for image display. Intended for integration into complete X-ray systems by qualified manufacturers. Operated by qualified medical personnel in clinical settings. Device transforms X-ray input into digital images displayed in <5 seconds. Benefits: replaces film/screen or computed radiography; provides high-quality digital imaging for general-purpose and extremity procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Amorphous silicon flat panel imager; gadolinium oxysulfide scintillator; Windows-based software for image display; digital X-ray imaging system; intended for integration into X-ray systems.

Indications for Use

Indicated for generating radiographic images of human anatomy in extremity and general-purpose procedures. Not for mammography. Contraindicated when physician deems procedure contrary to patient's best interest.

Regulatory Classification

Identification

An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Paxscan 4030 Medical Digital Imaging Systems (K024147)
• ADC-70 (K904519A)

Submission Summary (Full Text)

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## SECTION 5. 510(K) SUMMARY

K072766

| Submission<br>Correspondent: | Emergo Group, Inc.<br>1101 S. Capital of Texas Hwy, Suite F254<br>Austin, Texas, USA | | |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------------|
| | Phone: | 512.327.9997 | |
| | Fax: | 512.327.9998 | |
| | Email: | [e-mail] | |
| | Contact: | Ian Gordon<br>Sr. Vice President | DEC 1 1 2007 |
| Submission Sponsor: | PortaVision, LLC<br>5401 Cocos Plumosas Dr.<br>Kenner, LA 70065 | | |
| | Phone: | [phone] | |
| | Email: | [e-mail] | |
| | Contact: | Terry Ancar<br>President | |
| Date summary prepared: | April 10, 2007 | | |
| Device trade name: | The PortaVision Medical Digital Imaging System | | |
| Device common name: | Solid State X-ray Imager (Flat Panel/Digital Imager) | | |
| Device classification name: | Electrostatic x-ray imaging system (solid-state x-ray imaging system x-ray<br>system).<br>IXK at 21 CFR Part 892.1630 | | |
| Legally marketed devices<br>to which the device is<br>substantially equivalent: | K024147<br>Paxscan 4030 Medical Digital Imaging Systems<br>Varian Medial Systems, Inc. | K904519A<br>ADC-70<br>Agfa Medical Systems | |
| Description of the device: | The PortaVision PVMed DDR 2520 Digital Imaging System consists of two<br>components, an amorphous silicon digital x-ray imager and software for<br>viewing the captured images on a Windows-based computer.<br>The digital imager is composed of an amorphous silicon flat panel imager<br>which uses a large-area amorphous silicon sensor array with a gadolinium<br>oxysulfide scintillator. The PVMed DDR 2520 Digital Imaging System will<br>display high quality images in less that 5 seconds over a wide range of X-<br>Ray dose settings. The System is not intended to be use for<br>mammography. | | |

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| Intended use of the device: | The PortaVision PVMed DDR 2520 Digital Imaging System is intended for<br>use in generating radiographic images of human anatomy. The system is<br>not intended to be used for mammography. It is intended to replace<br>film/screen or computed radiography in extremity and general-purpose<br>procedures appropriate to the input field of view. This imager is intended<br>for incorporation into a complete x-ray system by a qualified equipment<br>manufacturer. This device is intended for use by qualified medical<br>personnel and is contraindicated when, in the judgment of the physician,<br>procedures would be contrary to the best interest of the patient |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>characteristics: | The technological characteristics between the predicate and proposed<br>devices are identical. There is no difference in fundamental scientific<br>technology. The only difference is the size. The proposed device is<br>smaller than the predicate device. |
| Conclusions: | By definition, a device is substantially equivalent when the device has the<br>same intended use and the same technological characteristics as the<br>predicate device.<br><br>There are no significant differences between the PortaVision PVMed DDR<br>2520 Digital Imaging System the predicate devices and therefore, the<br>PortaVision PVMed DDR 2520 Digital Imaging System does not raise any<br>questions regarding safety and effectiveness.<br><br>The PortaVision PVMed DDR 2520 Digital Imaging System, as designed,<br>is as safe and effective as the predicate device, and the device is<br>determined to be substantially equivalent to the referenced predicate<br>device currently on the market. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEC 1 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PortaVision Medical % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K072766

Trade/Device Name: PortaVision PVMed DDR 2520 Digital Imaging System Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: IXK Dated: November 21, 2007 Received: November 26, 2007

Dear Mr. Lehtonen:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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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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 Part 801); 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.

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4. INDICATIONS FOR USE STATEMENT

| 510(k) Number: | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PortaVision PVMed DDR 2520 Digital Imaging System |
| Indications for Use: | The PortaVision PVMed DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy. (The system is not intended to be use for mammography). It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This imager is intended for incorporation into a complete x-ray system by a qualified equipment manufacturer. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient. |

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Tzu M. Nhan

(Division Division of Reproductive, Abdominal and Radiological Devic 510(k) Number