(34 days)
The Philips MX 16-slice CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating x-ray tube and detector array with multislice capability up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.
The MX 16-slice CT System, phase II is a Whole Body Computed Tomography X-Rav System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports. components and accessories.
The provided document is a 510(k) summary for the Philips MX 16-slice CT System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, performance studies (other than general quality assurance), sample sizes for testing or training, expert ground truth establishment, or any information about AI assistance or standalone algorithm performance.
Therefore, I cannot fulfill your request for this input based on the provided text. The document focuses on regulatory compliance and equivalence to an existing device, rather than detailed performance study results.
Here's an explanation of why the requested information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance: The document states that "meeting the specifications and functional requirements is demonstrated via testing," but it does not specify what those specifications or functional requirements are, nor does it provide any quantitative performance data.
- Sample Size for Test Set and Data Provenance: This information is completely absent.
- Number of Experts and Qualifications: This information is not mentioned.
- Adjudication Method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication of such a study. The product is a CT scanner, not an AI-powered diagnostic tool.
- Standalone Performance (Algorithm Only): The device is a physical CT scanner, not an AI algorithm, so this concept does not apply in the context of this document.
- Type of Ground Truth Used: Not applicable or mentioned, as there are no diagnostic AI algorithms being evaluated.
- Sample Size for Training Set: Not applicable, as there's no mention of an AI model or training.
- How Ground Truth for Training Set Was Established: Not applicable.
The submission focuses on substantiating that the MX 16-slice CT System is substantially equivalent to a previously cleared device (Brilliance CT 16-slice, K012009) by demonstrating similar technological characteristics and adherence to general safety standards (GMP, ISO, IEC, 21 CFR Subchapter J). This type of submission generally does not require detailed clinical performance studies beyond what was established for the predicate device, unless significant changes impacting safety or effectiveness are introduced.
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MAY 27 2009
510(k) Summary Philips Medical Systems (Cleveland) Inc. "Brilliance Volume"
This summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter
Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000
Contact:
| Michael A. Chilbert, Ph.D., P.E. | |
|---|---|
| Telephone: | 440 483 3284 |
| FAX: | 440 483 4918 |
| Email: | Michael.chilbert@philips.com |
Date of Summary: February 25, 2009
2. Device Name and Classification
| Device Name: | MX 16-slice CT System, phase II |
|---|---|
| Classification Name: | Computed Tomography X-Ray System |
The FDA has classified the Computed Tomography X-Ray System and its accessories as Class II in 21 CFR 892.1750 (Product Code 90 JAK)
3. Predicate Device Information
In the opinion of Philips Medical Systems Inc., the MX 16-slice CT System, phase II is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: the Brilliance CT 16-slice in K012009 (a.k.a. MX8000 IDT CT Scanner). It expands the capabilities of the MX 16-slice CT system (K083498).
Device Description 4.
The MX 16-slice CT System, phase II is a Whole Body Computed Tomography X-Rav System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports. components and accessories.
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5. Intended Use of the device
The MX 16-slice CT system can be used as a Whole Body Computed Tomography X-ray System featuring a continuously rotating x-ray tube and detector array with multislice capability up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.
6. Comparison to Predicate Devices
In the opinion of Philips Medical Systems (Cleveland), Inc., the "Philips MX 16-slice" CT scanner is of comparable type and substantially equivalent to the legally marketed devices because it has the similar technological characteristics and sub-assemblies as the current commercial distribution of Brilliance CT 16-slice (K012009).
The safety and effectiveness of the "Philips MX 16-slice" is assured by adherence to Good Manufacturing Practices (GMP) 21 CFR 820 and to International Standards ISO 13485:2003. Potential hazards are identified in a hazard analysis and controlled in the following manner:
Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements is demonstrated via testing.
Electrical and Mechanical safety is assured by adherence to IEC 60601-1 Standards.
Radiation safety is assured by compliance with 21 CFR. Subchapter J Performance Standards.
Based on the above considerations, it is Philips's opinion that the MX 16-slice CT Scanner is substantially equivalent in safety and effectiveness to the predicate device: Brilliance CT 16-slice with 510(k) Number K012009.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or birds in flight. The overall design is simple and conveys a sense of government authority and public service.
Public Health Service
27 2009 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems (Cleveland), Inc. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
Re: K091195
Trade/Device Name: Philips MX 16-slice CT system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 8, 2009 Received: May 12, 2009
Dear Mr. Devine:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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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.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)
(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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510(k) Number (if known):
Page 1 of 1
Philips MX 16-slice CT system Device Name:
Indications for Use:
The Philips MX 16-slice CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating x-ray tube and detector array with multislice capability up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hels Remm
(Division Sign Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.