(37 days)
Not Found
No
The description focuses on facilitating communication and workflow between a CT scanner and an injector, not on image analysis or decision-making using AI/ML. There are no mentions of AI, ML, or related concepts, nor are there descriptions of training or test sets typically associated with AI/ML development.
No.
The device facilitates contrast-enhanced CT examinations by connecting a CT scanner and an injector, which is used for diagnostic imaging rather than directly treating a condition.
No
Explanation: The device is described as an interface to facilitate contrast-enhanced CT examinations by connecting a CT scanner and an injector. It does not perform any analysis, interpretation, or diagnosis of medical conditions. Its function is to streamline the workflow of existing diagnostic equipment.
No
The device description explicitly states that CARE Contrast CT includes both hardware and software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "facilitate contrast enhanced CT examinations by connecting CT and injector." This describes a device that manages the workflow and communication between two medical devices used for imaging, not a device that performs tests on biological samples (in vitro).
- Device Description: The description reinforces the intended use, stating it "implements an interface between CT scanners and an injector." This is a connectivity and workflow management function, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
CARE Contrast CT is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. If CARE Contrast CT is activated, the contrast-enhanced examination can be started by pressing one single start button, either at the CT scanner or at the injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
CARE Contrast CT for the SOMATOM CT Systems includes both hardware and software components. CARE Contrast CT is an optional extension to the functionality of Siemens SOMATOM Emotion and Sensation CT scanners and is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. The addition of the CARE Contrast CT option to the SOMATOM scanners simply implements an interface between CT scanners and an injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K04 3087
DEC 1 5 2004
510(K) SUMMARY FOR SIEMENS CARE CONTRAST CT
Submitted by:
Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355
November 3, 2004
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Contact Person:
Ms. Debbie Peacock Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 Malvern, PA 19355 Phone: (610) 448-1773 Fax: (610) 448-1787 Email: debra.peacock(@siemens.com
2. Device Name and Classification
| Product Name: | SOMATOM CARE Contrast CT |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
3. Importer/Distributor Establishment:
Registration Number: 2240869 Siemens Medical Solutions, Inc. USA 51 Valley Stream Pkwy Malvern, PA 19355
1
Manufacturing Facility:
Siemens AG Wittelsbacherplatz 2 DE- 80333 Muenchen Germany
4. Substantial Equivalence
The CARE Contrast CT package, addressed in this premarket notification, is substantially equivalent to the following commercially available software package:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens SOMATOM Emotion 6 (P10F) | K023687 | 11/22/2002 |
| Siemens SOMATOM Sensation 64 | ||
| (P30F) | K040665 | 04/02/2004 |
| Siemens SOMATOM Sensation Open | ||
| (P30L) | K040577 | 03/22/2004 |
ર્ડ. Device Description
CARE Contrast CT for the SOMATOM CT Systems includes both hardware and software components. CARE Contrast CT is an optional extension to the functionality of Siemens SOMATOM Emotion and Sensation CT scanners and is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. The addition of the CARE Contrast CT option to the SOMATOM scanners simply implements an interface between CT scanners and an injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.
6. Indications for Use
CARE Contrast CT is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. If CARE Contrast CT is activated, the contrast-enhanced examination can be started by pressing one single start button, either at the CT scanner or at the injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the agency's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2004
Ms. Debbie Peacock Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K043087 Trade/Device Name: CARE Contrast CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray sytem Regulatory Class: II Product Code: 90 JAK Dated: November 3, 2004 Received: November 8, 2004
Dear Ms. Peacock:
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 (Premarket Approval), 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 to proceed to the market.
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.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
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Indications for Use
510(k) Number (if known): _ Ko Y Jo8 7
Device Name:
CARE Contrast CT
CARE Contrast CT is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. If CARE Contrast CT is activated, the contrast enhanced examination can be started by pressing one single start button, either at the CT scanner or at the injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.
(Please do not write below this line - continue on another page if needed)
============================================================================================================================================================================== Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR §801.109)
OR
Over-The-Counter Use
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices ROH 308 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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