(36 days)
Not Found
No
The summary describes a system for measuring, displaying, and calculating bio-physiological events (hemodynamic and electrophysiological signals). It mentions manual input and calculations based on input signals and other parameter values, but there is no mention of AI, ML, or related concepts like image processing, DNNs, or training/test sets for algorithmic learning. The description focuses on signal acquisition, display, and user-driven calculations.
No
The device is described as a diagnostic and administrative tool for measuring, displaying, and printing bio-physiological events, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Sensis recording system is "intended to be used as a diagnostic and administrative tool." It is used for hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies for specific conditions like cardiac arrhythmias and heart disease with insufficient hemodynamic functionality. This clearly indicates its role in diagnosing medical conditions based on the collected physiological data.
No
The device description explicitly states it is a "further SW and HW development" and a "multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events," indicating the presence of hardware components for signal acquisition and display.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Sensis recording system is described as a system for the measurement, display, and printout of bio-physiological events like intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG). It's used during procedures (cardiac catheterizations and electrophysiology studies) to monitor and assess signals directly from within the body.
- Lack of Specimen Analysis: The description does not mention the analysis of any specimens (blood, tissue, etc.) derived from the body outside of the body. The measurements are taken in vivo.
Therefore, the Sensis recording system falls under the category of a medical device used for physiological monitoring and recording during invasive cardiac procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sensis recording 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 administrative tools.
The device is intended to be used on either or both of the following populations:
- Adult and pediatric populations requiring intracardiac electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
- Adult and pediatric populations requiring intracardiac hemodynamic examinations, typically when the patient has a heart disease resulting in insufficient hemodynamic functionality.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The Sensis Electrophysiological and Hemodynamic Recording System with software VC12 is a further SW and HW development of the commercially available Siemens AXIOM Sensis K020440.
The Sensis is a multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG) The user can perform a number of calculations based on manual input and / or on the input signals and other hemodynamic parameter values from the Sensis system.
For more flexibility in the department, additional post processing and reporting workplaces can always be connected to the network.
The software and hardware modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
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
Adult and pediatric populations
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)
Non clinical tests (integration and functional) were conducted on the Sensis software during product development. The Risk Analysis was completed and risk control implemented to mitigate identifed hazards. The testing results supports that all software specifications have met the acceptance criteria.
Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify to conformance Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation have been completed.
Clinical testing was not applicable as Sensis has no new indications for use nor new clinical applications were introduced to the system.
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
§ 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
JUL 2 5 2013
SIEMENS
Special 510(k) Submission: Sensis
510(k) Summary: Sensis
Siemens Medical Systems, Inc. Company: 51 Valley Stream Parkway Malvern, PA 19355
June 25, 2013 Date Prepared:
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.
-
- General Information:
Importer / Distributor: Siemens Medical Systems, Inc. 51 Valley Stream Parkway Malvern, PA 19355
- General Information:
Establishment Registration Number: 2240869
Manufacturing Site: SIEMENS AG Sector Healthcare Siemensstraße 1 D-91301 Forchheim, Germany
Establishment Registration Number: 3004977335
2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 Malvern, PA 19355 Fax: (610) 448-1787 Phone: (610) 448 -3536 Email: patricia.d.jones@siemens.com
Device Name and Classification: 3.
Trade Name: Classification Name: Classification Panel: CFR Section:
Sensis Programmable diagnostic computer Cardiovascular Diagnostic Devices 21 CFR §870.1425
1
Special 510(k) Submission: Sensis
| Device Class: | Class II |
|---|---|
| Product Code: | DQK |
| Legally Marketed Predicate Device | |
| Trade Name: | AXIOM Sensis |
| 510(k) #: | K020440 |
| Clearance Date: | December 3, 2002 |
| Classification Name: | Programmable diagnostic computer |
| Classification Panel: | Cardiovascular Diagnostic Devices |
| Classification Regulation: | 21 CFR §870.1425 |
| Device Class: | Class II |
| Product Code: | DQK |
-
- Device Description:
The Sensis Electrophysiological and Hemodynamic Recording System with software VC12 is a further SW and HW development of the commercially available Siemens AXIOM Sensis K020440.
- Device Description:
The Sensis is a multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG) The user can perform a number of calculations based on manual input and / or on the input signals and other hemodynamic parameter values from the Sensis system.
For more flexibility in the department, additional post processing and reporting workplaces can always be connected to the network.
The software and hardware modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
ട. Indication for Use:
The Sensis recording 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 device is intended to be used on either or both of the following populations:
2
-
- Adult and pediatric populations requiring intracardiac electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
-
- Adult and pediatic populations requiring intracardiac hemodynamic examinations, typically when the patient has a heart disease resulting in insufficient hemodynamic functionality.
Substantial Equivalence: 6.
The Sensis Electrophysiological and Hemodynamic Recording System with software VC12 is substantially equivalent to the commercially available Siemens AXIOM Sensis which was described in premarket notification K020440 which received 510(k) clearance on December 03, 2002.
- Summary of Technological Characteristics of the Subject Device as 7. Compared with the Predicate Device:
The Sensis Electrophysiological and Hemodynamic Recording System with software VC12 is a further SW and HW development of the commercially available Siemens AXIOM Sensis K020440.
The Sensis features the same Indications for use. Acquisition, Monitoring, Recording, Imaging and Administrative Functions as the predicate AXIOM Sensis. It interfaces with Angiograhy X-ray systems e.q. Artis Q zen, Artis zee / zeego. The user function is similar to the predicate AXIOM Sensis device.
Performance Testing: 8.
Siemens claims conformance to a signed statements of conformance to This submission contains performance data to performance standards. demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted on the Sensis software during product development. The Risk Analysis was completed and risk control implemented to mitigate identifed hazards. The testing results supports that all software specifications have met the acceptance criteria.
Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify to conformance Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation have been completed.
Clinical testing was not applicable as Sensis has no new indications for use nor new clinical applications were introduced to the system.
3
The Sensis uses the same sensors applied to the patients as the predicate device. These sensors are provided by OEM manufacturer and have their own 510(k) clearances.
All Sensis components do not come into direct contact with patients. For those accessories which come into direct contact with patient, it is ensured that legal manufacturing and supplier provides this biocompatibility and stellization (where applicable) before integration or use with Sensis itself does not have any parts which would require sterilization
ರ್. General Safety and Effectiveness Concerns:
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.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, and mechanical hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.
10. Conclusion as to Substantial Equivalence:
The Sensis Electrophysiological and Hemodynamic Recording System with software VC12 is intended for the same indications as cleared in the predicate AXIOM Sensis. The predicate device hardware has 2 PC's. The subject device has only one PC and a nurse workstation with the same functionality as the Sensis PC. It allows a faster, more efficient workflow directly in the examination room.
The functionality of Sensis VC12 is similar to the predicate device. It is Siemens opinion, that the Sensis VC12 is substantially equivalent to the AXIOM Sensis (K020440).
4
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
July 25, 2013
Siemens Medical Solutions, Inc. Patricia Jones 51 Valley Stream Parkway Malven, PA 19355 US
Re: K131812 Trade/Device Name: Sensis and Sensis Lite Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 18, 2013 Received: June 24, 2013
Dear Patricia Jones:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Feli Aguel Felipe Aguel
for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Special 510(k) Submission: Sensis
Indications for Use Statement
510(k) Number (if known): K131812
Device Name: Sensis
Indications for Use:
The Sensis recording 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 administrative tools.
The device is intended to be used on either or both of the following populations:
- Adult and pediatric populations requiring intracardiac electrophysiology 1. examinations, typically when the patient is suffering from cardiac arrhythmias.
- Adult and pediatric populations requiring intracardiac hemodynamic 2. examinations, typically when the patient has a heart disease resulting in insufficient hemodynamic functionality.
Prescription Use _ × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Feli Aguel for BDZ
2013.07.25 15:45:33
-04'00'
Concurrence of CDRH: Office of Device Evaluation (ODE)
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