(88 days)
No
The summary describes standard image processing and calculation of parameters based on changes in image intensity over time, which are typical functions of medical imaging software and do not inherently indicate the use of AI/ML. There is no mention of AI, ML, deep learning, training data, or performance metrics commonly associated with AI/ML models.
No
The device is described as a diagnostic patient imaging tool intended to assist in generating information about changes in image intensity over time related to brain perfusion, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to assist the user by providing a diagnostic patient imaging tool".
No
The device is described as an "Option" that runs on a CT System's workspace. While it is software, it is an integral part of a larger hardware system (the CT scanner) and is not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Philips Medical Systems CT Brain Perfusion Option is a software tool that processes and analyzes imaging data obtained from a CT scan. It does not perform tests on biological samples.
- Input: The input is imaging data from a CT scanner, not a biological sample.
- Output: The output is processed imaging information and calculated parameters related to brain perfusion, displayed as images. It's not a diagnostic result derived from a biological test.
The device is clearly described as a diagnostic patient imaging tool that works with a CT system to analyze image intensity changes over time and calculate parameters from those images. This falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.
The Brain Perfusion Option is used in a Philips Medical Systems Brilliance ™ Workspace of a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Product codes
90JAK
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
FEB 2 0 2004
Brain Perfusion Option
K033 677 Pine 1/2
The following information is being supplied in accordance with 21CFR 807.92(a).
1. Submitter
| Submitter: | Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland, OH 44143
(440) 483-3000 | |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact | Robert L. Turocy
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland, OH 44143
Telephone: 440 483 3528
FAX: 440 483 2989 | |
| Date of Summary: | November 24, 2003 | |
2. Device Name
| (Proprietary Name): | Brain Perfusion Option |
|---|---|
| Classification Name: | Computed Tomography X-Ray System |
| Common Name: | Computed Tomography X-Ray System |
The FDA has classified the Brain Perfusion Option as Class II in 21 CFR 892.1750 (Product Code 90JAK)
3. Intended Use
The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to hrain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.
The Brain Perfusion Option is used in a Philips Medical Systems Brilliance ™ Workspace of a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
1
4. Predicate Device
K033677
Rogerofz
In the opinion of Philips Medical Systems (Cleveland) Inc., the Brain Perfusion Option is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009. Sce Appendix "G", Equivalent Device Comparison Matrix. This opinion is based on the fact that comparing the Image Processing Function on the Select CT/SP with the Brain Perfusion Option reveals that the devices comply with the same or equivalent standards and have the same or equivalent intended uses.
Functional specifications and operator's instructions (preliminary) are included in the Appendixes "B" and "C".
- Safety and Effectiveness
Philips Medical Systems (Cleveland), Inc. adhercs to FDA GMPs, 21 CFR 1020.30-33, and voluntary standards for safety/effectiveness (UL 2601) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). The Brain Perfusion Option is under the control of health care professionals who are trained and responsible for computed tomography examinations.
Philips has reviewed known information available and performed an investigation as to the causes of safety and effectiveness concerning the Brain Perfusion Option.
6. Substantial Equivalence Statement
The Brain Perfusion Option is substantially equivalent to legally marketed devices. The Brain Perfusion Option will be certified to comply with Federal Diagnostic X-Ray Performance Standards. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.
This opinion is based on the fact that comparing the Image Processing Function on the Select CT/SP and the Mx8000IDT to the Brain Perfusion Option reveals that the devices comply with the same or equivalent standards and have the same or equivalent intended uses.
The Brain Perfusion Option and the Image Processing Function on the Select CT/SP and Mx8000IDT CT Systems 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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 2004
Mr. Robert L. Turocy Regulatory Affairs Manager Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143
Re: K033677
Trade/Device Name: Brain Perfusion Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: November 24, 2003 Received: November 24, 2003
Dear Mr. Turocy:
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.
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.
3
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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
Page 2
to proceed to the market.
4
KO33677 510(k) Number (if known):
Brain Perfusion Option Device Name:
The Philips Medical Systems CT Brain Perfusion Option Indications for Use: is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.
The Brain Perfusion Option is used in a Philips Medical Systems Brilliance ™ Workspace of a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David R. Symm
(Division Sign-Off)
Brain Perfusion Option 510(k)
and Radiological Devices 510(k) Number.
Division of Reproductive, Abdominal.
11/24/03