(74 days)
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.
The PortaVision PVMed DDR 2520 Digital Imaging System consists of two components, an amorphous silicon digital x-ray imager and software for viewing the captured images on a Windows-based computer. The digital imager is composed of an amorphous silicon flat panel imager which uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The PVMed DDR 2520 Digital Imaging System will display high quality images in less that 5 seconds over a wide range of X-Ray dose settings. The System is not intended to be use for mammography.
"The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. Instead, it focuses on the device's substantial equivalence to a predicate device. Therefore, I cannot extract the requested information directly.
However, I can infer from the text that the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed devices. The study proving this "acceptance criterion" is the 510(k) submission itself, which presents a comparison of the technological characteristics and intended use of the PortaVision PVMed DDR 2520 Digital Imaging System with those of predicate devices.
Here's an attempt to answer your questions based on the available text, highlighting what's explicitly stated and what cannot be determined:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The PortaVision PVMed DDR 2520 Digital Imaging System has the same intended use and the same technological characteristics (amorphous silicon digital x-ray imager and software for viewing images on a Windows-based computer) as the predicate device (Paxscan 4030 Medical Digital Imaging Systems, Varian Medial Systems, Inc.). The only difference noted is the size, with the proposed device being smaller than the predicate. |
| Safety and Effectiveness | The submission concludes that "the PortaVision PVMed DDR 2520 Digital Imaging System does not raise any questions regarding safety and effectiveness" and "is as safe and effective as the predicate device." |
| Image Display Quality and Speed | The device "will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings." (This is a performance characteristic but not explicitly framed as an acceptance criterion in the provided text.) |
| Intended Use | Intended for use in generating radiographic images of human anatomy (excluding mammography), replacing film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This matches the intended use of the predicate device implicitly. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The provided text does not mention a specific test set, its sample size, or data provenance related to a performance study. The submission focuses on a comparison of technical specifications and intended use against a predicate device for substantial equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The provided text does not mention a test set, ground truth establishment, or experts for such a purpose.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The provided text does not mention a test set or any adjudication method.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- The provided text does not indicate that an MRMC comparative effectiveness study was done. The device described is a digital imaging system, not an AI-assisted diagnostic tool, so such a study would not be expected in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The provided text does not describe a standalone algorithm performance study. The device is an imaging system designed for use by qualified medical personnel.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The provided text does not mention a specific ground truth type as no performance study with a test set is detailed. The "ground truth" for this 510(k) submission is essentially the legally marketed status and established safety/effectiveness of the predicate device.
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The sample size for the training set
- The provided text does not mention a training set sample size. This type of information is typically relevant for machine learning or AI-based devices, which this imaging system is not described as.
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How the ground truth for the training set was established
- The provided text does not mention a training set or how a ground truth for it would be established.
In summary: The provided 510(k) summary is for an imaging system seeking substantial equivalence to a predicate device. It primarily relies on demonstrating that the new device shares the same intended use and technological characteristics as the already-cleared predicate, rather than presenting a detailed clinical performance study with a test set, ground truth, or expert evaluations in the manner typically seen for AI/ML-driven diagnostic aids."
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SECTION 5. 510(K) SUMMARY
| SubmissionCorrespondent: | Emergo Group, Inc.1101 S. Capital of Texas Hwy, Suite F254Austin, Texas, USA | ||
|---|---|---|---|
| Phone: | 512.327.9997 | ||
| Fax: | 512.327.9998 | ||
| Email: | igordon@emergogroup.com | ||
| Contact: | Ian GordonSr. Vice President | DEC 1 1 2007 | |
| Submission Sponsor: | PortaVision, LLC5401 Cocos Plumosas Dr.Kenner, LA 70065 | ||
| Phone: | (504) 883-4133 | ||
| Email: | tancar@angiovision.com | ||
| Contact: | Terry AncarPresident | ||
| 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-raysystem).IXK at 21 CFR Part 892.1630 | ||
| Legally marketed devicesto which the device issubstantially equivalent: | K024147Paxscan 4030 Medical Digital Imaging SystemsVarian Medial Systems, Inc. | K904519AADC-70Agfa Medical Systems | |
| Description of the device: | The PortaVision PVMed DDR 2520 Digital Imaging System consists of twocomponents, an amorphous silicon digital x-ray imager and software forviewing the captured images on a Windows-based computer.The digital imager is composed of an amorphous silicon flat panel imagerwhich uses a large-area amorphous silicon sensor array with a gadoliniumoxysulfide scintillator. The PVMed DDR 2520 Digital Imaging System willdisplay high quality images in less that 5 seconds over a wide range of X-Ray dose settings. The System is not intended to be use formammography. |
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:
| Intended use of the device: | The PortaVision PVMed DDR 2520 Digital Imaging System is intended foruse in generating radiographic images of human anatomy. The system isnot intended to be used for mammography. It is intended to replacefilm/screen or computed radiography in extremity and general-purposeprocedures appropriate to the input field of view. This imager is intendedfor incorporation into a complete x-ray system by a qualified equipmentmanufacturer. This device is intended for use by qualified medicalpersonnel and is contraindicated when, in the judgment of the physician,procedures would be contrary to the best interest of the patient |
|---|---|
| Technologicalcharacteristics: | The technological characteristics between the predicate and proposeddevices are identical. There is no difference in fundamental scientifictechnology. The only difference is the size. The proposed device issmaller than the predicate device. |
| Conclusions: | By definition, a device is substantially equivalent when the device has thesame intended use and the same technological characteristics as thepredicate device.There are no significant differences between the PortaVision PVMed DDR2520 Digital Imaging System the predicate devices and therefore, thePortaVision PVMed DDR 2520 Digital Imaging System does not raise anyquestions regarding safety and effectiveness.The PortaVision PVMed DDR 2520 Digital Imaging System, as designed,is as safe and effective as the predicate device, and the device isdetermined to be substantially equivalent to the referenced predicatedevice currently on the market. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of three stylized human profiles facing to the right, stacked on top of each other.
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 (800) 638-2041 or (240) 276-3150 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
§ 892.1630 Electrostatic x-ray imaging system.
(a)
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.(b)
Classification. Class II.