(69 days)
The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use.
The DRF 4343 is Intended to capture digital images from a radiographic/fluoroscopic system through a dynamic digital flat panel, to digitalize, archive and review images and to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices which uses a device.
This 510(k) submission for the DRF 4343, an Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems, does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on shared indications for use and technological characteristics.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what can be inferred or what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- No specific acceptance criteria or reported device performance metrics are provided in the document. The submission relies on demonstrating substantial equivalence to predicate devices, implying that if it functions similarly to already approved devices, its performance is acceptable.
2. Sample size used for the test set and the data provenance:
- Not applicable. The document does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth establishment is described.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No MRMC comparative effectiveness study is mentioned. The submission focuses on device characteristics and substantial equivalence, not comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an operator console and imaging workstation for X-ray systems, not an AI algorithm performing diagnostic tasks. Its function is to capture, digitalize, archive, and review images, which implicitly involves human interaction.
7. The type of ground truth used:
- Not applicable. As there is no performance study or ground truth establishment described.
8. The sample size for the training set:
- Not applicable. This submission does not describe an AI model or a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI model or training set described.
Summary of available information related to the device and its approval:
- Device Name: DRF 4343
- Common Name: Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems
- Indication for Use: "The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use."
- Predicate Devices: Nical NDR+/DIVA-D (K053029), Siemens AXIOM Luminos dRF (K062623), Shimadzu DAR7000 RADspeed SAFIRE (K050925).
- Rationale for Substantial Equivalence: The DRF 4343 has the same indication for use and similar technological characteristics as the predicate devices, with minor differences not raising new questions regarding safety or effectiveness.
In conclusion, this 510(k) submission establishes substantial equivalence through comparison to existing predicate devices rather than through a dedicated performance study with acceptance criteria and a test set. Therefore, the specific details requested regarding acceptance criteria and study data are not present in the provided document.
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Ko80859
JUN - 4 2008
510 (k) Summary
This summary of safety and effectiveness information is submitted in accordance with the
requirements of 21 CFR 807.92.
| Submitter: | Villa Sistemi Medicali S.p.A.via delle Azalea 320090 Buccinasco (MI)ITALYRegistration # 8021091 |
|---|---|
| Contact Person: | Paolo Casagrande SantinQA ManagerPhone: +39 02 48859 239Fax: +39 02 48859 303Email: p.casagrande@villasm.com |
| Designated Agent: | Bill KostecklDol Medical ImagingQA/RA ManagerRegistration # 9027610 |
| Date Prepared: | March 14, 2008 |
| Trade Name: | DRF 4343 |
| Common Name: | Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems |
| Classification Name: | 892.1630 Solid State x-ray Imaging system |
| Predicate Devices: | The DRF 4343 is compared with the following predicate devices:• Nical NDR+/DIVA-D (K053029),• Siemens AXIOM Luminos dRF (K062623),• Shimadzu DAR7000 RADspeed SAFIRE (K050925). |
| Product Description: | The DRF 4343 is Intended to capture digital images from a radiographic/fluoroscopicsystem through a dynamic digital flat panel, to digitalize, archive and review imagesand to provide a network connection via DICOM protocol to various output (e.g.hardcopy, softcopy and archive) devices which uses a device. |
| Indication for Use: | The DRF 4343 is a digital image acquisition system to be used in conjunctionwith a solid-state detector during radiography or fluoroscopy x-ray examination tocapture, digitalize, review images and format images according to DICOMprotocol to be sent through network connection.This device is not intended for mammography use. |
| Rationale forSubstantial Equivalence: | The DRF 4343 has the same indication for use as the predicate devices. It shares thesame technological characteristics as the predicate devices. Minor technologicaldifferences do not raise any new questions regarding safety or effectiveness of thedevice. |
510(k) for DRF 4343 - rev. 3
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Page 8 of 11
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March 25, 2008
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol with stylized human figures and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The symbol is on the left side of the text.
· Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Paolo Casagrande Santin Quality Assurance Manager Villa Sistemi Medicali S.p.A. Via delle Azalee 3 BUCCINASCO (MI) 20090 ITALY
AUG - 9 2013
Re: K080859 Trade/Device Name: DRF 4343 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified Fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and MQB Dated: March 25, 2008 Received: March 28, 2008
Dear Mr. Santin:
This letter corrects our substantially equivalent letter of June 4, 2008.
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,
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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Indication for Use Statement
510k Number: (if known):
Device Name: DRF 4343
Indications for Use:
The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection.
This device is not intended for mammography use.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use X(Per 21 CFR 801.109) | OR | Over-The-Counter |
(Optional Format 1-2-96)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K080859 |
510(k) for DRF 4343 - rev. 1
: :
March 25, 2008
Page 7 of 11
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.