(295 days)
No
The summary describes a system for measuring, displaying, and calculating biophysiological signals. It mentions standard data interfaces and communication with other medical devices. There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The calculations mentioned are based on user input and measured signals, not on learned patterns.
No
The device is described as a "diagnostic and administrative tool," and its functions involve "measurement, display, and printout of biophysiological events" and enabling users to "monitor and assess" various signals. It does not mention any therapeutic capabilities or interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The AXIOM Sensis system is intended for use as a diagnostic and administrative tool..."
No
The device description explicitly states it is a "multi-channel computer-based stationary system for the measurement, display, and printout of biophysiological events," indicating it includes hardware components for signal acquisition and display, not just software.
Based on the provided information, the AXIOM Sensis system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a "diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies." This involves measuring and displaying physiological signals directly from the patient's body (intracardiac pressure, ECG, ICEG).
- Device Description: The description confirms that the system "measures, displays, and printouts of biophysiological events" and "monitors and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG)." These are measurements taken in vivo (within the living organism).
- Lack of In Vitro Activities: There is no mention of the system being used to examine specimens (like blood, urine, tissue) outside of the body, which is the defining characteristic of an IVD.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AXIOM Sensis system is designed to acquire and process physiological signals directly from the patient during a medical procedure.
N/A
Intended Use / Indications for Use
The AXIOM Sensis system is intended for use as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools. Many of the components used in AXIOM Sensis are either commercially available with current Siemens systems or include minor modifications to existing components.
Product codes
DQK
Device Description
AXIOM Sensis is a multi-channel computer-based stationary system for the measurement, display, and printout of biophysiological events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. AXIOM Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG). With the AXIOM Sensis system the user can perform a number of calculations based on the input signals and other hemodynamic parameter values entered by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
Indicated Patient Age Range
Adult and pediatric populations
Intended User / Care Setting
Trained healthcare professional
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)
K993414, K002137, K930786, K982776, K003004, K980882
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY
Submitted by: Siemens Medical Solutions USA, Inc. 186 Wood Avenue South Iselin, NJ 08830
DEC 0 3 2002
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.
| 1. | Contact Person | |
|---|---|---|
| Sandra Robinson | ||
| Technical Specialist | ||
| Phone (732) 321-3243 | Fax: (732) 321-4841 |
2. Device Name and Classification
Trade Name: Internal name of R&D: Classification name: Classification Panel Classification Number Classification class
AXIOM Sensis NEWCOR Programmable diagnostic computer 21 CFR § 870.1425 DQK II
3. Intended Use
The AXIOM Sensis system is intended for use as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools. Many of the components used in AXIOM Sensis are either commercially available with current Siemens systems or include minor modifications to existing components.
4. Substantial Equivalence
AXIOM Sensis system is substantially equivalent to the following legally market devices:
| GE PRUCKA CARDIOLAB® 7000 | K993414, cleared on April 7, 2000 |
|---|---|
| Siemens CATHCOR LX Desktop | K002137, cleared on Oct 5, 2000 |
| Siemens EPCOR option | K930786, cleared on Sept 26, 1996 |
| Nonin Neonatal/Adult Vital Sign Monitor (SpO2) | K982776, cleared on Aug 9, 1998 |
| SunTech Oscar II BP Monitor (NIBP) | K003004, cleared on Oct 25, 2000 |
| SC9000 Infinity Monitor (HR & CO) | K980882, cleared on June 5, 1998 |
Information that substantiates this claim of equivalence is provided throughout this 510(k) submission and specific equivalence information is provided in section M.
ડ. Device Description
AXIOM Sensis is a multi-channel computer-based stationary system for the measurement, display, and printout of biophysiological events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. AXIOM Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG). With the AXIOM Sensis system the user can perform a number of calculations based on the input signals and other hemodynamic parameter values entered by the user.
1
Summary of Technological Characteristics of the Principal Device as Compared with the 6. Predicate Device
AXIOM Sensis goes one-step beyond the currently available systems to create modular units with component commonality, streamlined user interface and use, and performance and reliability improvement.
Technological Characteristics:
The Axiom Sensis described supports a subset of DICOM and HL 7 communication interfaces, communication with Siemens X-ray systems via HICOR and Axiom Artis communication protocols, and communication of parameter data from Medtronic Model 4803 Atake® II RF Power Generator, Boston Scientific EP Technologies EPT-100 TC and Stockert EP-Shuttle ablation devices.
AXIOM Sensis is based on the Syngo platform, which received FDA 510(k) clearance K010938 on June 25, 2001.
7. General Safety and Effectiveness Concerns
Instructions for use are included within the device labelling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. Furthermore the operators are health care professionals familiar with and responsible for the 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.
8. Substantial Equivalence
In the opinion of Siemens Medical Systems, Inc., the hardware and software documentation and the substantial equivalence comparison matrix proves that the AXIOM Sensis Electrophysiological and Hemodynamic Recording System is substantially equivalent to the Siemens Medical Systems, Inc. predicate Cathcor LX Desktop System, with EPCOR option and the General Electric Inc. Prucka Cardiolab 7000 system.
AXIOM Sensis is substantial equivalent on parameter level with Nonin Neonatal/Adult Vital Sign Monitor (SpO2), SunTech Oscar II BP Monitor (NIBP) and Siemens SC9000 Infinity Monitor (HR & CO).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is blurry and difficult to make out any details. It appears to show some text, but the text is not legible. It is not possible to provide a more detailed description of the image.
DEC 0 3 2002
od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Systems, Inc. c/o Ms. Kathleen Rutherford Manager, Regulatory Submissions 186 Wood Avenue South Iselin, NJ 08830
Re: K020440 Trade Name: AXIOM Sensis Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: Undated Received: September 5, 2002
Dear Ms. Rutherford:
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 vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FI > Part publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Kathleen Rutherford
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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), 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 vours.
Kaitlin
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Spetion 11
510(k) Number (if known):
Device Name: AXIOM Sensis
Indications For Use: ·
The AXIOM Sensis system is intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the data using the administrative tools.
The AXIOM Sensis system has functions for:
- External communication via the DICOM interface by using Siemens Medical Platform 1. syngo ™and AXIOM Sensis VC00A DICOM Conformance Statement
- External Communication via the HL7 interface by using AXIOM Sensis Interface description 2: · HL7 Interface.
-
- Local communication by using the Siemens HICOR interface
- Local communication by using the Siemens AXIOM Artis FC/BC interface 4.
- Local communication with Medtronic Model 4803, Atakr® II RF Power Generator, Boston ર. Scientific EP Technologies EPT-100 TC. and Stockert EP-Shuttle Ablator devices
The device is intended to be used on either or both of the following populations:
- Adult and pediatric populations requiring intracardiac electrophysiology examinations, typically 1 . when the patient is suffering from cardiac arrhythmias.
- Adult and pediations requiring intracardiac hemodynamic examinations, typically when 2. the patient has a heart disease resulting in insufficient hemodynamic functionality.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. OR
Over-The-Counter Use_
Division of Cardiovascular & Respiratory Devices
510(k) Number
510(K) for Siemens AXIOM Sensis Siemens Medical Solutions USA, Inc. Section H, Page I of 1