(66 days)
The Philips Integris Allura 9 system with FD Option is intended for use in cardiac x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies) pacemaker implantations, and electrophysiology.
The Philips Integris Allura 9 system with FD Option is an angiographic x-ray system with a solid state x-ray imaging device for cardiovascular diagnostic and interventional procedures. The monoplane system can be configured as either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintillator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are detected with a flat dynamic x-ray detector (FD) and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on film (video or laser hardcopy) or on digital storage media.
This Philips Medical Systems 510(k) summary (K020055) describes the PHILIPS Integris Allura 9 system with FD Option, an angiographic x-ray system. The document focuses on regulatory submission and substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria. As such, information on specific acceptance criteria and detailed study results is not provided in the given text.
However, based on the provided text, we can infer some general information about safety and effectiveness, which would typically be supported by testing and data:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria or specific reported device performance metrics (e.g., spatial resolution, contrast-to-noise ratio, dose reduction, or clinical accuracy). Instead, it states that the device:
- "will comply with the applicable requirements of 21 CFR, Subchapter J - Radiological Health, parts 1020.30, .31, and .32."
- "will comply with applicable requirements of the Underwriters Laboratories Standard for Safety, X-ray Equipment (UL 187 and UL 2601) and be classified by Underwriters Laboratories."
- "will also comply with the ACR/NEMA DICOM digital imaging communication standard."
These are regulatory and interoperability compliance statements rather than performance metrics with specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical study with a "test set" and therefore does not provide information on sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no specific clinical performance study with a test set is described, there is no information about expert involvement in establishing ground truth.
4. Adjudication Method:
No adjudication method is mentioned as there is no specific clinical performance study described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not described in this document. The device itself is an angiographic x-ray system, not an AI-powered diagnostic tool in the sense of computer-aided detection (CADx) or diagnosis (CADx) that would typically involve a human-AI comparison study.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study for an algorithm is not applicable or described, as this device is a complete x-ray imaging system, not a software algorithm for diagnostic interpretation in isolation.
7. Type of Ground Truth Used:
As no specific clinical performance study is described, no information on the type of ground truth (e.g., expert consensus, pathology, outcomes data) is provided.
8. Sample Size for the Training Set:
The device is a hardware imaging system, not a machine learning algorithm that requires a "training set." Therefore, this information is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
Summary of what the document does provide:
- Predicate Devices: Philips Integris H5000 system (K984545) and GE Medical Systems' solid state digital detector (K993037).
- Substantial Equivalence Argument: The Philips Integris Allura 9 system with FD Option does not introduce any new indications for use or new potential hazards compared to the predicate devices.
- Compliance with Standards: The device is stated to comply with relevant sections of 21 CFR Subchapter J (Radiological Health), UL Standards (UL 187 and UL 2601), and ACR/NEMA DICOM standard.
- Indications for Use: Cardiac x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP).
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Image /page/0/Picture/0 description: The image shows the Philips logo, which is a shield shape with the word "PHILIPS" at the top. Inside the shield, there is a globe-like symbol with a wavy line across the middle and a star-like shape in the upper left and lower right quadrants. The logo is black and white.
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MAR 1 5 2002
Philips Medical Systems
510(k) SUMMARY
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Company Name:Address: | Philips Medical Systems North America Company22100 Bothell Everett HighwayP.O. Box 3003Bothell, WA 98041-3003 |
|---|---|
| Registration No .: | 1217116 |
| Contact Person:Telephone No .: | Lynn Harmer(425) 487-7312 |
| Date Prepared: | January 7, 2002 |
| Device (Trade) Name: | PHILIPS Integris Allura 9 system with FD Option |
| Classification Name: | Angiographic x-ray system, Class II, 90 IZISolid x-ray Imager, Class II, 90 MBQ |
Predicate Devices:
The Philips Integris Allura 9 System with FD Option is substantially equivalent to the Philips Integris H5000 system manufactured by Philips Medical Systems. The Integris H5000 received a 510(k) substantially equivalent determination in K984545 on February 25, 1999.
The FD option is also substantially equivalent to GE Medical Systems' solid state digital detector cleared by FDA on February 14, 2000, under 510(k) K993037.
Device Description:
The Philips Integris Allura 9 system with FD Option is an angiographic x-ray system with a solid state x-ray imaging device for cardiovascular diagnostic and interventional procedures. The monoplane system can be configured as either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintillator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are
22100 Bothell Everett Highway
Bothell, Washington 98021-8431
(425) 487 7000
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detected with a flat dynamic x-ray detector (FD) and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on film (video or laser hardcopy) or on digital storage media.
Indications for Use:
The Philips Integris Allura 9 system with FD Option is intended for use in cardiac x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies) pacemaker implantations, and electrophysiology.
General Safety and Effectiveness:
The devices and their labeling will comply with the applicable requirements of 21 CFR, Subchapter J - Radiological Health, parts 1020.30, .31, and .32.
The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety, X-ray Equipment (UL 187 and UL 2601) and be classified by Underwriters Laboratories. The Integris Allura 9 system with FD Option will also comply with the ACR/NEMA DICOM digital imaging communication standard.
Conclusion:
The Phillips Integris Allura 9 system with FD Option does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Integris Allura 9 system with FD Option to be substantially equivalent with the predicate devices.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in blue and is centered in the image. The font is sans-serif and the text is in all caps. There is a logo to the left of the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Hwy. BOTHELL WA 98041-3003
AUG 20 2043
Re: K020055
Trade/Device Name: Philips Integris Allura 9 System with FD Option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and IZI Dated: January 7, 2002 Received: January 8. 2002
Dear Ms. Harmer:
This letter corrects our substantially equivalent letter of March 15, 2002.
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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Philips Integris Allura 9 system with FD Option Device Name:
Indications for Use:
The Philips Integris Allura 9 system with FD Option is intended for use in cardiac imaging applications including diagnostic, interventional procedures (such as PTCA, maging approaded mores,) pacemaker implantations, and electrophysiology (EP.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Toriel A. Skynner
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K020055
510(k) Number
L Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
§ 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.