(72 days)
Not Found
No
The summary describes a software package for 3D reconstruction from 2D images, a standard image processing technique, and does not mention AI, ML, or related terms.
No
The device is described as an "x-ray imaging software option" intended to "assist the physician in diagnosis and treatment," indicating a diagnostic rather than therapeutic function. While it assists in treatment, it does not directly treat the condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to assist the physician in diagnosis and treatment of vessel malformations". The word "diagnosis" directly indicates it is a diagnostic device.
Yes
The device is described as a "software option" that performs image reconstruction. It explicitly states it works with a "standard angiographic C-arm device," implying it is a software component that processes data from existing hardware, rather than being a hardware device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The 3D-Angio package is a software option that processes x-ray images acquired from a standard angiographic C-arm device. It reconstructs 2D images into a 3D format to assist physicians in diagnosing and treating vessel malformations.
- No Biological Samples: The device does not analyze biological samples from the patient. Its input is imaging data, not biological material.
Therefore, the 3D-Angio package falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.
Product codes
90JAA
Device Description
The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray imaging, angiographic C-arm device
Anatomical Site
Vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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
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
510(K) SUMMARY FOR THE 3D-ANGIO SOFTWARE OPTION
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
December 28, 1998
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
-
- Contact Person:
Ms. Malgorzata Stanek Phone: (732) 321-3950 Fax: (732) 321-4841
- Contact Person:
2. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
3D-Angio Accessory to Angiographic X-Ray System Radiology 21 CFR §892.1600 Class I.I. 90JAA
3. Substantial Equivalence:
The 3D-Angio software option is designed for three-dimensional evaluation of data acquired with a standard angiographic C-arm devices. The package is substantially equivalent to the following device:
| Siemens Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| GE Advantage 3D XR | K974715 | 7/6/98 |
4. Device Description:
The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
1
Intended Use of the Device: 5.
The resulting images of the 3D-Angio package are intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.
Summary of Technological Characteristics of the Devices Compared to the 6. Predicate:
Both the Siemens 3D-Angio software option and GE Advantage 3D XR allow construction of a three-dimensional model from images acquired during rotational angiography.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 1999
Malgorzata Stanek Technical Specialist Siemens Medical Systems, Inc. 186 Wood Ave. South Iselin, NJ 08830
Re:
K984634 3D-Angio (3D Angiographic Accessory) Dated: December 28, 1998 Received: December 30, 1998 Regulatory class: II 21 CFR 892.1600/Procode: 90 JAA
Dear Ms. Stanek:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements; as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CARL T. HART, D.O., M.D.
CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
| 510(k) Number (if known): | K984634 |
|---|---|
| Device Name: | 3D-Angio |
Indications For Use:
The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Yhind h. Lyan
(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological De 510(k) Number
Prescription Use ✗ OR Over-The-Counter Use __
(Per 21 CFR 801.109)