(207 days)
No
The document describes a wireless footswitch and voice control system for an angiography system. While voice control involves processing, the description does not mention AI, ML, or any related technologies like neural networks or deep learning. The focus is on basic voice command recognition and RF communication.
No
This device is described as an angiography system for diagnostic imaging and interventional procedures, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that AXIOM Artis is "developed for single and biplane diagnostic imaging and interventional procedures." It also lists various diagnostic procedures like "cardiac angiography, neuro-angiography, general angiography," and "radiographic/fluoroscopic procedures e.g. gastro-intestinal imaging, skeletal imaging."
No
The device description explicitly mentions "Additional hardware (independent of microcontroller)" for the Wireless Footswitch and describes it as a "transmitter" communicating with a "receiver" on the AXIOM Artis system, indicating hardware components beyond just software.
Based on the provided text, the AXIOM Artis system, including the wireless footswitch and voice control, is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The AXIOM Artis is an angiography system that uses X-rays to image the inside of the body directly. It does not analyze biological samples.
- The intended use describes diagnostic imaging and interventional procedures performed directly on the patient. This is consistent with an in-vivo imaging system, not an in-vitro diagnostic device.
- The device description focuses on the hardware and control mechanisms for the angiography system. It does not mention any components or processes related to handling or analyzing biological specimens.
Therefore, the AXIOM Artis is an in-vivo diagnostic and interventional imaging system, not an IVD.
N/A
Intended Use / Indications for Use
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. gastro-intestinal imaging, skeletal imaging etc.
AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the AXIOM Artis with wireless footswitch and with voice control as described in its labeling have not changed from its predicate device the AXIOM Artis Modular Angiographic System.
Product codes (comma separated list FDA assigned to the subject device)
90 JAA, 90 IZI
Device Description
The Wireless Footswitch uses RF technology in order to establish a short-range, low-power radio communication link between the footswitch (transmitter) and AXIOM Artis system (receiver). Additional hardware (independent of microcontroller) and Siemens own communication protocol layers will provide a safety-oriented signal transmission.
The Voice Control for the AXIOM Artis family allows for the control of selected functions by voice commands. The primary focus will be on image processing functions. Safety relevant functions such as X-ray release and movement control will not be included in the voice control functions.
Both Wireless Footswitch and Voice Control will be made available on the currently marketed Siemens AXIOM Artis family of products.
Mentions image processing
The primary focus will be on image processing functions.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals familiar with and responsible for the X-ray examinations
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.
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
§ 892.1650 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.
0
MAR 7 2006 510(K) SUMMARY FOR
SIEMENS AXIOM ARTIS
WIRELESS FOOTSWITCH AND VOICE CONTROL
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
August 1, 2005
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:
Mr. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions USA, Inc 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(601) 448-1778 Fax: (610) 448-1787
2. Device Name and Classification
| Product Name: | AXIOM Artis - Modular Angiographic System |
|---|---|
| Classification Name: | Angiographic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1600 |
| Device Class: | Class II |
| Product Code: | 90 JAA (90 IZI with flat Panel Detector) |
3. Intended Use:
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. gastro-intestinal imaging, skeletal imaging etc.
1
AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the AXIOM Artis with wireless footswitch and with voice control as described in its labeling have not changed from its predicate device the AXIOM Artis Modular Angiographic System.
4. Device Description:
The Wireless Footswitch uses RF technology in order to establish a short-range, low-power radio communication link between the footswitch (transmitter) and AXIOM Artis system (receiver). Additional hardware (independent of microcontroller) and Siemens own communication protocol layers will provide a safety-oriented signal transmission.
The Voice Control for the AXIOM Artis family allows for the control of selected functions by voice commands. The primary focus will be on image processing functions. Safety relevant functions such as X-ray release and movement control will not be included in the voice control functions.
Both Wireless Footswitch and Voice Control will be made available on the currently marketed Siemens AXIOM Artis family of products.
ട്. Substantial Equivalence:
The Wireless Footswitch and Voice Control are designed for use with the commercially available AXIOM Artis Modular Angiographic systems.
The Siemens wireless footswitch is substantially equivalent to the Stryker Wireless footswitch, 510(k) K033135 with a clearance date of August 9, 2004.
Siemens Voice Control is substantially equivalent to the voice control used on the SIOS -Siemens Integrated Operation System discussed in 510(k) K994231 "cleared on August 10, 2000 and the Philips iU22 Ultrasound System, 510(k) W0425401 with a clearance date of October 04, 2004.
These systems will be incorporated for use with SIEMENS AXIOM Artis Modular Angiographic System cleared via 510(k), K010721 on March 30, 2001 and the SIEMENS AXIOM Artis with FD, 510(k) K021021 with a clearance date of June 6, 2002. The Indication for use of the AXIOM Artis does not change with the above-mentioned additions.
2
Summary of Technological Characteristics of the Principal Device as compared with 6. the Predicate Device:
A Wireless Footswitch and a Voice Control will be made available for the AXIOM Artis family. Many of the components used in AXIOM Artis with the Wireless Footswitch and Voice Control are either commercially available with current Siemens systems or include minor modifications to existing components.
General Safety and Effectiveness Concerns: 7.
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the AXIOM Artis Modular Angiography System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards. Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
3
Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread, depicted in a simple, abstract design. The image is in black and white.
Public Health Service
MAR 7 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary Johnson Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway E-50 MALVERN PA 19355-1406
Re: K052202
Trade/Device Name: AXIOM Artis with Wireless Footswitch and Voice Control Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI and JAA Dated: February 16, 2006 Received: February 17, 2006
Dear Mr. Johnson:
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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
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 (o 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/industry/support/index.html.
Sincerely yours.
Nancy C. Bigelow
Nanev C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 3 INDICATION FOR USE
510(k) Number (if known): KOS 2202____________________________________________________________________________________________________________________________________________________________________
AXIOM Artis with Wireless Footswitch and Voice Control Device Name:
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. gastro-intestinal imaging, skeletal imaging etc.
AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the AXIOM Artis with wireless footswitch and with voice control as described in its labeling have not changed from its predicate device the AXIOM Artis Modular Angiographic System.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _
Over-The-Counter Use
(Per 21 CFR §801.109)
Nancy Brogdon
(Division Sian-Off Division of Reproductive, A bdominal and Radiological Devices 510(k) Number