(15 days)
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Detector is combined with a Philips XD-S workstation (K063781) which consists of a computer, keyboard, display, mouse. The complete X-ray system would further include other Philips subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. The XD-S workstation and the complete X-ray systems are not changed other than by replacing an Xray receptor with the Wireless Portable Detector FD-W17.
The provided text describes a 510(k) submission for the "Wireless Portable Detector FD-W17." However, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test sets or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies.
The submission focuses on:
- Device Identification: Manufacturer, submitter, product names, classification.
- Compliance with Standards: Federal X-Ray performance standards (CFR 1020.30, .31), electrical safety (UL 60601-1, IEC 60601-1), radiation protection (IEC 60601-1-3), Electromagnetic Compatibility (IEC-60601-1-2), and risk management (ISO 14971).
- System Description: How the detector integrates into a larger X-ray system.
- Intended Use: Acquiring digital radiographic images for routine, intensive care, trauma, and pediatric exams, excluding fluoroscopy, angiography, and mammography.
- Equivalence Information: Demonstrating substantial equivalence to a predicate device (Pixium 4600) and other existing Philips components for the workstation and pre-processing.
- Safety Information: Mature technology, compliance with standards, wireless transmission evaluation, and risk management.
- Conclusion: Stating substantial equivalence based on similar indications for use, technological characteristics, and no new hazards.
- FDA Clearance Letter: Confirming substantial equivalence based on the provided indications for use.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance studies based on the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.
{0}------------------------------------------------
Wireless Portable Detector FD-W17 510(k) Submission
MAR 2 4 2009
March Of
5 - 510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a Summary of Safety and Effectiveness.
| MANUFACTURER: | Philips Medical Systems DMC GmbHRoentgenstrasse 2422335 HamburgGermany |
|---|---|
| Establishment Registration No.: | 3003768251 |
| SUBMITTER: | Philips Medical Systems22100 Bothell Everett HighwayBothell, WA 98041-3003 |
| Establishment Registration No.:Contact: | 1217116Lynn Harmer425-487-7312 |
| Date Prepared: | March 06, 2009 |
| CLASSIFICATION NAME: | Solid State X-Ray Imager (Flat Panel/Digital Imager)Class IIMQB21 CFR 892.1650 |
| COMMON/USUAL NAME: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| TRADE/PROPRIETARY NAME: | Wireless Portable Detector FD-W17 |
PERFORMANCE STANDARDS:
This device complies with the federal X-Ray performance standards (CFR 1020.30, .31)
SYSTEM DESCRIPTION:
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images.
{1}------------------------------------------------
K090625
Page 2 of 3
Wireless Portable Detector FD-W17 510(k) Submission
October 20, 2008
The Detector is combined with a Philips XD-S workstation (K063781) which consists of a computer, keyboard, display, mouse.
The complete X-ray system would further include other Philips subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc.
The XD-S workstation and the complete X-ray systems are not changed other than by replacing an Xray receptor with the Wireless Portable Detector FD-W17.
INTENDED USE:
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
EQUIVALENCE INFORMATION:
The Wireless Portable Detector FD-W17 is considered substantially equivalent to the Pixium 4600 detector, which received FDA clearance on November 24, 1998, under the name Philips Bucky Vision in 510(k) Number K982795.
The grid supression pre-processing is equivalent to the pre-processing used by the Konica Minolta Regius Console CS 2000/CS-3000 (K051523).
The other parts of the workstation are equal to the Philips XD-S Direct Radiography Workstation/Package, which received FDA clearance on January 05, 2007, under 510(k) Number K063781.
SAFETY INFORMATION:
The Wireless Portable Detector FD-W17 uses mature technology. It is designed to be in compliance with relevant national and international standards for electrical safety (UL 60601-1, IEC 60601-1) , radiation protection (IEC 60601-1-3) and Electromagnetic Compatibility (IEC-60601-1-2).
The wireless transmission of data is evaluated in risk management and tested under worst case scenarios. The Center for Devices and Radiological Health (CDRH) draft guidance "Radio-Frequency Wireless Technology in Medical Devices" from January 3, 2007 was used in preparing tests and documentation for the wireless functionality.
{2}------------------------------------------------
K09C625
Page 3 of 3
Wireless Portable Detector FD-W17 510(k) Submission
October 20, 2008
A product risk mangement is executed according to ISO 14971 and all risks are reduced to an acceptable level by implementation and verification of appropriate measures.
CONCLUSION:
Philips Medical Systems believes that the Wireless Portable Detector FD-W17 is substantially equivalent to the currently legally marketed devices. It does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's name in blue, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written in a clear, sans-serif font. To the left of the text is a circular emblem featuring an abstract design, also in blue, which represents the department's mission and values.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K090625
Trade/Device Name: Wireless Portable Detector FD-W17 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 7, 2009 Received: March 9. 2009
AUG 2 3 2013
Dear Mr. Job:
This letter corrects our substantially equivalent letter of March 24, 2009.
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 r ou may, more, mains 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 or any I cieral statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
{4}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mouitements 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 whit anow you to ocgan mailsoming your available quivalence of your device to a legally marketed notication. THU PDF imaning of Scation 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 If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-007), promote note the regulation entitled, "Misbranding by reference to premarket 5 150. The stime not 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 Tou may 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
{5}------------------------------------------------
Wireless Portable Detector FD-W17 51Q(k) Submission Section 4
October 20, 2008
: 六
"
Indications for Use
K090625 510(k) Number (if known):
Device Name: Wireless Portable Detector FD-W17
Indications For Use:
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
ત્ત્વ
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.