(74 days)
Not Found
No
The summary describes standard digital image processing and control systems for a mobile X-ray device. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The performance studies focus on traditional bench and system testing, electrical safety, and software verification, not on the performance metrics typically associated with AI/ML (e.g., AUC, sensitivity/specificity for classification tasks).
No
The device is an x-ray system used for imaging and diagnostic purposes, not for treating diseases or conditions.
No
The device is an X-ray system used to produce images that assist in clinical procedures; it does not itself provide a diagnosis.
No
The device description clearly states it is a "mobile fluoroscopy system" consisting of two mobile units: a mobile acquisition unit (with X-ray control, C-arm, generator/X-ray tube, Image Intensifier) and a monitor cart. This involves significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Cios Connect Function: The Cios Connect is an X-ray imaging system. It uses X-rays to create images of the inside of the body for diagnostic and procedural guidance purposes. It does not perform tests on biological samples.
- Intended Use: The intended use clearly describes its use in various clinical settings for imaging procedures, not for analyzing biological samples.
- Device Description: The device description details the components of an X-ray system (X-ray tube, image intensifier, displays, etc.), not equipment for laboratory testing.
Therefore, based on the provided information, the Cios Connect is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cios Connect is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Cios Connect can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Product codes
OWB, OXO, JAA
Device Description
The Siemens Cios Connect mobile fluoroscopy system is an imageintensified fluoroscopic X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station. The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the Image Intensifier, and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Image Processing System, user controls and image storage devices (DVD, USB).
Interfaces are provided for optional devices such as external monitors, thermal printers, MP3 players, connections for 2D navigation systems, lithotripters or injectors, as well as wired and wireless DICOM network interfaces.
Mentions image processing
Yes
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
Operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care, veterinary medicine.
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)
Bench Testing: Unit, Subsystem and System Integration testing was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
Non-Clinical Testing: Validation activities have been performed at the System test level on production prototype devices by appropriately trained and knowledgeable test personnel. System level validation and regression testing has been performed successfully, demonstrating that the device meets the acceptance criteria as noted in the system test plans.
Electrical Safety and Electromagnetic Compatibility (EMC): Electrical safety and EMC testing were conducted on the Cios Connect, consisting of the acquisition unit (C-arm system) and the image processing and display station. The system complies with the IEC 60601-1, IEC 60601-2-43 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction or latent design flaw in the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
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
§ 892.1650 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, flowing shape. The graphic is surrounded by a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
Siemens Medical Solutions USA, Inc. % Ms. Patricia D. Jones Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355
Re: K153147
Trade/Device Name: Cios Connect Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, JAA Dated: December 17, 2015 Received: December 18, 2015
Dear Ms. 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safety/ReportaProblem/default.htm for 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 Industry and Consumer Education 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.
Michael O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153147
Device Name Cios Connect
Indications for Use (Describe)
The Cios Connect is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Cios Connect can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------- |
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510(k) Summary: Cios Connect
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: December 17, 2015
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. General Information:
Importer / Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard; 65-1A Malvern, PA 19355 Establishment Reqistration Number: 2240869
Manufacturing Site:
Siemens AG / Siemens Healthcare GmbH Roentgenstrasse 19 - 21 95478 Kemnath, Germany Establishment Registration Number: 3002466018
Legal Manufacturer:
SIEMENS AG Wittelsbacherplatz 2 80333 Muenchen, Germany
2. Contact Person:
Mr. Darren Dorman Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard · Mail Code 65-1A Malvern, PA 19355, USA Phone: +1 610 448-6483 Email: darren.dorman@siemens.com
Alternate Contact Person :
Ms. Patricia D. Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail code 65-1A
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard Malvern, PA 19355-1406
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Malvern, PA 19355, USA Phone : +1-610-448-6474 Email : patricia.d.jones@siemens.com
-
- Subject Device Name and Classification: Trade Name: Cios Connect
Device: Regulation Medical Specialty: Review Panel: Product Code: Subsequent Product Codes: Submission Type: Regulation Number: Device Class
- Subject Device Name and Classification: Trade Name: Cios Connect
Image-intensified Fluoroscopic X-ray system, Mobile Radiology Radiology OWB OXO, JAA Traditional 510(k) 892.1650 2
-
- Legally Marketed Predicate Devices: Primary Predicate:
Trade Name: 510(k) Number: Device:
- Legally Marketed Predicate Devices: Primary Predicate:
Regulation Medical Specialty: Review Panel: Product Code: Subsequent Product Codes: Submission Type: Regulation Number: Device Class Recall Information:
Siremobil C-06 (renamed: Arcadis Varic) K040066 Image-intensified Fluoroscopic X-ray system, Mobile Radiology Radiology ОХО JAA Traditional 510(k) 892.1650 2 Z-0118-06; Z-0123-06; Z-0438/9-06
- Secondary Predicate: Trade Name: 510(k) Number: Device: Requlation Medical Specialty: Review Panel: Product Code: Subsequent Product Codes: Submission Type: Regulation Number: Device Class 2 Recall Information:
Cios Alpha K132094 Interventional Fluoroscopic X-Ray system Radiology Radiology OWB ОХО Traditional 510(k) 892.1650 Z-1958-2015
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5. Device Description:
The Siemens Cios Connect mobile fluoroscopy system is an imageintensified fluoroscopic X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station. The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the Image Intensifier, and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Image Processing System, user controls and image storage devices (DVD, USB).
Interfaces are provided for optional devices such as external monitors, thermal printers, MP3 players, connections for 2D navigation systems, lithotripters or injectors, as well as wired and wireless DICOM network interfaces.
6. Indications for Use:
The Cios Connect is a mobile x-rav system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Cios Connect can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
7. Substantial Equivalence:
The new device Cios Connect is within the same classification regulation for the same indication for use as the Primary predicate Siremobil C-06 (Arcadis Varic) (K040066, cleared 2/12/2004). Other comparable properties of the subject device to the Primary predicate include X-Ray technology, Mechanical design, and the Detector technology. Similarly, the Indication for Use, X-Ray technology, Image processing, and Mechanical design are compared to the Secondary predicate Cios Alpha (K132094, cleared 3/11/2014). Documentation is provided to support a claim of substantial equivalence to these Siemens' predicate devices.
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Devices:
The Siemens Cios Connect design is based on the Siemens Siremobil C 06 (ARCADIS Varic) (K040066) including the mechanical design, X-ray generator, the Image Intensifier, pulsed fluoroscopy, upgraded to integrate the latest control and image processing functions from the Siemens Cios Alpha (K132094).
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The subject device has the same fundamental scientific technologies as the predicate devices. The technological comparison table in below demonstrates the comparability of the technological characteristics of the new device and the currently cleared predicate devices. The modifications do not affect the intended use of the device.
The table below compares the main performance data of the subject device with the predicate devices to substantiate equivalence of the subject device and predicates.
| Features /
Technology | Subject Device :
Cios Connect | Primary Predicate:
Siremobil C-06
(renamed: Arcadis
Varic) K040066 | Secondary Predicate:
Cios Alpha K132094 |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Mobile fluoroscopic C-
arm | Yes | Yes | Yes |
| X-ray tube | Stationary Anode
0.6 mm focal spot | Stationary Anode
0.6 mm focal spot | Rotating Anode
0.3/0.5 mm focal spot |
| Tube housing assembly
with high frequency
generator | Yes | Yes | Yes |
| kV Range
40 kV to 110 kV | 40 kV to 110 kV | 40 kV to 110 kV | 40 kV to 125 kV |
| Max power output | 2.3 kW | 2.3 kW | 12 kW
25 kW (optional) |
| Pulsed fluoroscopy | 3 mA to 25 mA | up to 23 mA | 3 mA to 119 mA (12kW) |
| Beam limiting device | Yes, Iris collimator | Yes, Iris collimator | Yes, rectangular
collimator |
| X-Ray detector | Image Intensifier with
Optics and Digital
Video Imaging
system (CCD
technology) | lmage Intensifier with
Optics and TV System
(CCD technology) | Solid State Detector |
| Detector active field size | ø 23 cm | ø 23 cm | 20 cm × 20 cm
30 cm × 30 cm (optional) |
| Optional cassette holder | Yes | Yes | N/A |
| Optional integrated dose
measurement device | Yes | Yes | Yes |
| Matrix size | 1024 × 1024 | 1024 × 1024 | 1024 × 1024
(20 cm × 20 cm detector)
1536 × 1536
(30 cm × 30 cm detector) |
| Displays | 19" TFT Flat Screen
Color Display Panels | 19" TFT Flat Screen
Display Panels, B/W
or Color | 19" TFT Flat Screen
Display Panels, B/W or
Color |
| 2D Image post
processing | Yes | Yes | Yes |
| Dose optimization /
Siemens CARE program | Yes | Yes | Yes |
| User Interface | Yes, membrane
keyboards | Yes, membrane
keyboards | Yes, touch panels |
| NaviLink 2D integrated | Yes | Yes | No |
Siemens Medical Solutions USA, Inc.
Tel.: +1-888-826-9702 www.usa.siemens.com/healthcare
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| 510(k) Submission: Cios Connect |
|---|
| navigation interface | |||
|---|---|---|---|
| Lithotripsy interface | Yes | Yes | No |
| DICOM functionality | Yes | Yes | Yes |
9. Testing to Voluntary Consensus Standards
The Siemens Cios Connect has been tested to meet the requirements for conformity to multiple industry standards. Performance testing confirmed, that the Siemens Cios Connect complies with the following 21 CFR Federal Performance Standards
1020.30 Diagnostic X-Ray Systems and their major components
1020.31 Radiographic Equipment
1020.32 Fluoroscopic equipment
1040.10 Laser products
and with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below :
| Recog-
nition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Organization |
|----------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|--------------|
| 19-4 | General II
(ES/EMC) | Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance | 60601-1:2005 | AAMI
ANSI |
| 19-1 | General II
(ES/EMC) | Medical electrical equipment - Part 1-
2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests | 60601-1- 2:
2007 | IEC |
| 12-210 | Radiology | Medical electrical equipment - Part 1-
3: General requirements for basic
safety and essential performance -
Collateral Standard: Radiation
protection in diagnostic X-ray
equipment | 60601-1-3:
2008 | IEC |
| 12-204 | Radiology | Medical electrical equipment - Part 2-
28: Particular requirements for the
basic safety and essential
performance of X-ray tube assemblies
for medical diagnosis | 60601-2-28:
2010 | IEC |
| 12-202 | Radiology | Medical electrical equipment - Part 2-
43: Particular requirements for the
safety and essential performance of X-
ray equipment for interventional
procedures | 60601-2-43:
2010 | IEC |
| 12-274 | Radiology | Medical electrical equipment - Part 2-
54: Particular requirements for the
basic safety and essential
performance of X-ray equipment for
radiography and radioscopy | 60601-2-54:
2009 | IEC |
| 5-40 | General I | Medical devices - Application of risk | 14971:2007 | ISO |
Siemens Medical Solutions USA, Inc.
Tel.: +1-888-826-9702 www.usa.siemens.com/healthcare
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Healthcare
510(k) Submission: Cios Connect
| (QS/RM) | management to medical devices | |||
|---|---|---|---|---|
| 12-238 | Radiology | Digital Imaging and Communications | ||
| in Medicine (DICOM) Set | PS 3.1 - 3.20 | |||
| (2011) | NEMA | |||
| 12-273 | Radiology | Safety of laser products - Part 1: | ||
| Equipment classification, and | ||||
| requirements | 60825-1: | |||
| 2007 | IEC | |||
| 13-8 | Software/ | |||
| Informatics | Medical device software - Software life | |||
| cycle processes | 62304:2006 | IEC | ||
| 5-67 | General I | |||
| (QS/RM) | Medical devices - Application of | |||
| usability engineering to medical | ||||
| devices | 62366:2007 | AAMI | ||
| ANSI | ||||
| IEC | ||||
| 12-229 | Radiology | Medical electrical equipment - | ||
| Radiation dose documentation - Part | ||||
| 1: Equipment for radiography and | ||||
| radioscopy | PAS 61910-1: | |||
| 2007 | IEC |
10. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk Management is ensured via a Risk Analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards. Siemens adheres to recognized and established industry practice and relevant international standards.
The following performance data were provided in support of the substantial equivalence determination:
11. Bench Testing:
Bench testing in the form of Unit, Subsystem and System Integration testing was performed to evaluate the performance and functionality of the new features, hardware, and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
12. Non-Clinical Testing:
Validation activities have been performed at the System test level on production prototype devices by appropriately trained and knowledgeable test personnel. System level validation and regression testing has been performed successfully, demonstrating that the device meets the acceptance criteria as noted in the system test plans.
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The verification and validation activities within the meaning of the Quality Regulation (21 CFR 820.30) confirmed design requirements are fulfilled, system functions as intended and the Cios Connect performs as designed and does not raise new questions regarding safety and effectiveness. Therefore, when compared to the predicate devices the Cios Connect supports a determination of substantial equivalence to the predicate devices.
13. Electrical Safety and Electromagnetic Compatibility (EMC):
Electrical safety and EMC testing were conducted on the Cios Connect, consisting of the acquisition unit (C-arm system) and the image processing and display station. The system complies with the IEC 60601-1, IEC 60601-2-43 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC.
14. Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction or latent design flaw in the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
15. Conclusion as to Substantial Equivalence:
The Cios Connect has the same indications for use, operating environment, and mechanical design as the Primary and Secondary predicates. Siemens concludes via the documentation provided in this 510(k) submission that the Cios Connect does not introduce any new potential safety risks is substantially equivalent to, and performs as well as the predicate devices.