(130 days)
No
The summary describes a standard CR acquisition scanner with software for image manipulation and enhancement. There is no mention of AI, ML, or related concepts, nor any description of training or test sets typically associated with such technologies.
No.
The device is described as a system for digital radiography, intended for creating diagnostic images, not for treating any condition.
Yes
Explanation: The device is intended for "standard radiographic diagnostic images," which implies its use in diagnosing medical conditions. It produces images that are used by healthcare professionals for diagnostic purposes.
No
The device description clearly outlines physical hardware components including a CR acquisition scanner, mechanical interface, Man Machine Interface panel, and a CR cassette. While it includes software for image manipulation, it is not solely software.
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 Vita Flex CR System is a digital radiography system that acquires and processes medical images from X-ray exposures. It works by scanning a phosphor storage screen that has been exposed to X-rays passing through the patient's body.
- Intended Use: The intended use is for "digital radiography using a phosphor storage screen for standard radiographic diagnostic images" and "Long Length Imaging examinations of long areas of anatomy such as the leg and spine." This clearly describes an imaging system used for visualizing internal structures of the body, not for analyzing biological samples.
- No Mention of Biological Samples: The description focuses entirely on the process of capturing and processing X-ray images from a screen, with no mention of handling or analyzing any biological samples from a patient.
Therefore, the Vita Flex CR System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Vita Flex CR System is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images. The LL is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Vita Flex CR System with LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
The Vita Flex CR system with LLI accepts an x-ray cassette with a screen. An X-ray cassette is a light-resistant container that protects the screen from exposure to daylight, and allows the passage of X-rays through the front cover on to the phosphor layer of the screen. When stroked by radiation the intensifying screen fluoresces emitting a light that creates the image.
Our Vita Flex CR system take a cassette as an input and it extracts an exposed screen and scans in the image off the screen. The image is stored on the computer system attached to the Vita Flex CR system. Once the scan is complete the screen data is erased and the screen is placed back inside the cassette to be used again by the customer.
When a cassette is properly inserted into the scanner, the scanner will lock the cassette in place. Once locked into place the cassette door can be opened to allow the scanner to feed the screen into the unit.
The operation of the scanning of the LLI cassette and screen will be done exactly as the predicate. Since the size of a long length imaging screen and cassette is large, the operation consists of 2 scans – scanning one half of the image, then turning the cassette around and scanning the second half of the image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Long areas of anatomy such as the leg and spine.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The modified Vita Flex CR System with LLI was evaluated by an OSHA approved, nationally recognized test lab, to verify conformance to the following standards: IEC 60825-1 Safety of Laser Products - Part 1: Equipment Classification and requirements; IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances requirements and tests.
The reports on these IEC standards testing confirm that the modified device meets the international/USA standards on laser safety, medical equipment safety and electromagnetic compliance. Bench testing was performed on the modified device and the results indicate that the Vita Flex CR System with LLI meet or exceed all the requirements in comparison with the predicate device. Given the differences from the predicate device, clinical testing is not necessary for the subject device. Bench testing alone is sufficient to demonstrate substantial equivalence.
The performance characteristics and operation / usability of the modified Vita Flex CR System with LLI were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, and reliability of the system software requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
0
February 18, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Carestream Health, Inc. % Duane Gutowski Manger Regulatory Affairs, Clearance and Surveillance 150 Verona Street ROCHESTER NY 14608
Re: K192894
Trade/Device Name: Vita Flex CR System with LLI Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 14, 2020 Received: January 21, 2020
Dear Duane Gutowski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192894
Device Name Vita Flex CR System with LLI
Indications for Use (Describe)
The Vita Flex CR System is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images. The LL is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
| 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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3
Carestream
"510(k) Summary"
K192894
| 510(k) Owner Name: | Carestream Health, Inc. |
|---|---|
| 510(k) Owner Address: | 150 Verona Street Rochester, NY, 14608 |
| 510(k) Owner Phone: | 585-627-8760 |
| 510(k) Owner Fax: | 585-323-7643 |
| Contact Person & Info: | Duane Gutowski Regulatory Affairs Manager duane.gutowski@carestream.com 585-627-8760 |
| Date Summary Prepared: | January 14, 2020 |
| Device Trade Name: | Vita Flex CR System with LLI Manufactured by: Carestream Health, Inc. Systems |
| Device Common Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Classification Name: | Stationary x-ray system |
| Device Class: | 2 |
| Device Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Predicate Device: | Point of care including LLI Manufactured by: Carestream Health, Inc. Systems 510(k) No.: K073670 (01/25/2008) |
| Predicate Device Class: | 2 |
| Predicate Device Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
Device Description:
The Vita Flex CR System with LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
4
The Vita Flex CR system with LLI accepts an x-ray cassette with a screen. An X-ray cassette is a light-resistant container that protects the screen from exposure to daylight, and allows the passage of X-rays through the front cover on to the phosphor layer of the screen. When stroked by radiation the intensifying screen fluoresces emitting a light that creates the image.
Our Vita Flex CR system take a cassette as an input and it extracts an exposed screen and scans in the image off the screen. The image is stored on the computer system attached to the Vita Flex CR system. Once the scan is complete the screen data is erased and the screen is placed back inside the cassette to be used again by the customer.
When a cassette is properly inserted into the scanner, the scanner will lock the cassette in place. Once locked into place the cassette door can be opened to allow the scanner to feed the screen into the unit.
The operation of the scanning of the LLI cassette and screen will be done exactly as the predicate. Since the size of a long length imaging screen and cassette is large, the operation consists of 2 scans – scanning one half of the image, then turning the cassette around and scanning the second half of the image.
The modified (subject) device is the previously cleared Point of care including LLI CR system which has been modified as follows:
- . The working environment of our customers was taken into account and components were selected to improve the conditions under which the system will operate.
- . The physical size dimensions have changed slightly as a result of an external appearance design refresh.
- The power module which was internal to the device is now external. Additionally, the power input for the predicate device had three separate power input profiles based on the model. The modified device uses one power input source.
- The laser module in the cleared device is reaching end of life and the replacement ● chosen has no impact to the functionality of the unit. The modified device has a slightly higher red light wave length, and a slight increase of output power. The negligible difference in the wave length and power output have no impact to the safety or effectiveness of the product.
- . The screen erase module in the cleared unit is reaching end of life. The modified device uses a monochromatic red LED light source with an aluminum radiator heatsink. The red LED functions more stable over a longer period of time reducing downtime and maintenance effort. The change to LED light source has no impact to the safety or effectiveness of the product.
5
Both the modified system and the previously cleared Point of Care including LLI CR system provided the optional console application software, Carestream Image Suite Software. Carestream Image Suite software was chosen for the modified device because it is a software platform that is common across Carestream products. Carestream Image Suite is a FDA cleared device, 510(k) number K100094, decision date on 03/11/2010. The optional Image Suite Software has no impact to the safety or effectiveness of the product.
Predicate Device Description:
The Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
Predicate Indications for Use / Intended Use:
The Point of care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images. The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Indications for Use / Intended Use:
The Indications for Use for the device, as described in its labeling, are: "The Vita Flex CR System is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images. The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine."
The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above. The Long Length Imaging software component provides the ability to perform operations related to image manipulation and enhancement of medical images.
The Indications for Use for the subject device is the identical to that of the predicate device and the intended use remains unchanged.
Substantial Equivalence:
With the information provided within this submission, we have compared the modified device. Vita Flex CR System with LLI, and the cleared device. Point of Care including LLI, and determined there is no impact to the intended use of the device, no impact to the safety
6
and effectiveness of the system, nor did we alter the fundamental scientific technology of the device.
In accordance with FDA Final Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2014, the critical decision points outlined in the proposed 510(k) Decision-Making Flowchart in Appendix A have been considered. The proposed predicate device, Point of care including LLI, has been found substantially equivalent by FDA through the 510(k) process (K073670) and is legally marketed. The Indications for Use for the subject device are identical to the predicate indications and can therefore be considered for substantial equivalence.
A comparison of the modified device Vita Flex CR System with LLL, and the Point of Care including LLI (K073670) is provided in Table 1 below:
Risk assessment of the modifications to the Vita Flex CR System with LLI described in this submission has not identified any new unmitigated risks for the system. Testing to recognized prevailing consensus standards and bench testing have indicated equivalent safety and performance of the modified device. We believe that the modifications to the Vita Flex CR system with LLI do not raise new issues of safety and effectiveness and therefore support a substantial equivalence determination.
7
| Table 1 | ||||||
|---|---|---|---|---|---|---|
| 1. Product Modification Comparison | ||||||
| Point of Care Including LLI | ||||||
| (cleared device) | Vita Flex with LLI | |||||
| (modified device) | ||||||
| Model Type: | POC120 | POC140 | POC260 | Vita Flex | ||
| 30PPH with | ||||||
| LLI | Vita Flex | |||||
| 45PPH with | ||||||
| LLI | Vita Flex | |||||
| 60PPH with | ||||||
| LLI | ||||||
| Product classification: | Medical device class II | Medical device class II | ||||
| Product safety classification: | CLASS 1 LASER PRODUCT, and IEC/EN | |||||
| 60825-1. | ||||||
| CLASS 1 EQUIPMENT | CLASS 1 LASER PRODUCT, and IEC/EN | |||||
| 60825-1. | ||||||
| CLASS 1 EQUIPMENT | ||||||
| Product Picture: | Image: POC120 | Image: Vita Flex | ||||
| Working environment: | Ambient temperature: +10 to + 40°C | |||||
| Relative humidity: 30 - 70% | Ambient temperature: +5 to + 45°C | |||||
| Relative humidity: 25 - 81% | ||||||
| Atmospheric pressure: 700 - 1060 hPa | ||||||
| Physical Size: | 658mm x 735mm x 358mm with 45KG | |||||
| Weight | 668mm x 675mm x 385mm with 30KG Weight |
8
| Power input: | 90~
250VAC,
50/60Hz,UP
S-online
700VA | 90~
250VAC,
50/60Hz,UPS
-online
700VA | 110~
250VAC,
50/60Hz,2.5
A | 100~240VAC, 50/60Hz,1.5A |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Module | Internal AC/DC converter | | | External AC/DC converter |
| Cassette Loading | Manual loading | | | Manual loading |
| Screen Access | Autofeed by Driving Roller in Screen
Transportation unit | | | Autofeed by Driving Roller in Screen
Transportation Unit |
| Imaging Module | Laser Platen Scanning:
Vertical Direction - Fast Scan: Laser Beam
Line
Horizontal Direction - Slow Scan: Linear
Motor Moving
Image: Imaging Module | | | Laser Platen Scanning:
Vertical Direction - Fast Scan: Laser Beam
Line
Horizontal Direction - Slow Scan: Linear
Motor Moving
Image: Imaging Module |
| Laser Beam Wave Length: | Red Light Wave Length: 655 $\pm$ 10 nm | | | Red Light Wave Length: 660 $\pm$ 7nm |
| Laser output power(mW): | 22~25 | | | 30 $\pm$ 2 |
| Laser Level: | Class 3B | | | Class 3B |
9
| Screen Erase Module | Achromatic Light Eraser
Fluorescent Lamps Light Source
Heatsink: N/A | Monochromatic Light Eraser
Red LED Light Source
Heatsink: Aluminum Radiator | |
|---------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------|
| Console Connector: | USB 2.0 | USB 2.0 | |
| Software Development Kit | Ultra Lite SDK | Ultra Lite SDK | |
| Long Length Imaging Software | CR Long-Length Imaging System (K021829) | DR Long Length Imaging Software (K130567) | |
| DICOM: | 3.0 | 3.0 | |
| Image Pixel Depth(Bit): | 12 | 12 | |
| Phosphor screen
and cassette
specification: | 14" x
17"(Standard
configuration) | Supported | Supported |
| | 10" x 12" | Supported | Supported |
| | 8"x 10" | Supported | Supported |
| | 24 x 30cm | Supported | Supported |
| | 14" x 14" | Supported | Supported |
| | 14"x 33"(LLI) | Supported | Supported |
| | 10"x 10"(Dental
Vet) | Not Supported | Supported |
| | 15 x 30cm(Dental
Panoramic) HR | Supported | Supported |
| | 9.5" x9.5" | Not
Supported | Not Supported |
| Throughput
tolerance ±5%
(PPH): | 14" x
17"(Standard
configuration) | 21 | 30 |
| | 14" x 33"(LLI) | 2.5 | 2.5 |
| Max Spatial
Resolution
(LP/mm): | 8"x 10" | 4.2 | 4.2 |
| | 10" x 12" | 3.5 | 4.2 |
| | 14" x 14" | 4.2 | 4.2 |
| | 14" x 17" | 4.2 | 4.2 |
| | | | |
10
| 3.5 | 3.5 | 4.2 | 4.2 | ||
|---|---|---|---|---|---|
| 24 x 30cm | 3.5 | 3.5 | 4.2 | 4.2 | |
| 10"x 10"(Dental | |||||
| Vet) | Not Supported | 4.2 | |||
| 15 x 30cm(Dental | |||||
| Panoramic) | 4.2 | 4.2 | 4.2 | 4.2 | |
| 9.5" x 9.5" | Not | ||||
| Supported | Not | ||||
| Supported | 4.2 | Not Supported | |||
| Min Pixel | |||||
| Pitch(um): | 14" x 33"(LLI) | 173 | 173 | 160 | 160 |
| 8"x 10" | 100 | 100 | 86 | 86 | |
| 10" x 12" | 125 | 125 | 86 | 86 | |
| 14" x 14" | 86 | 86 | 86 | 86 | |
| 14" x 17" | 86 | 86 | 86 | 86 | |
| 24 x 30cm | 125 | 125 | 86 | 86 | |
| 10"x 10"(Dental | |||||
| Vet) | Not Supported | 86 | |||
| 15 x 30cm(Dental | |||||
| Panoramic) | 100 | 100 | 86 | 86 | |
| 9.5" x 9.5" | Not | ||||
| Supported | Not | ||||
| Supported | 86 | Not Supported | |||
| Safety Standard | IEC60601-1 | IEC60601-1 | |||
| EMC Standard | IEC60601-1-2 | IEC60601-1-2 |
11
Discussion of Testing
The modified Vita Flex CR System with LLI was evaluated by an OSHA approved. nationally recognized test lab, to verify conformance to the following standards: · IEC 60825-1 Safety of Laser Products - Part 1: Equipment Classification and requirements.
• IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
· IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances requirements and tests.
The reports on these IEC standards testing confirm that the modified device meets the international/USA standards on laser safety, medical equipment safety and electromagnetic compliance. Bench testing was performed on the modified device and the results indicate that the Vita Flex CR System with LLI meet or exceed all the requirements in comparison with the predicate device. Given the differences from the predicate device, clinical testing is not necessary for the subject device. Bench testing alone is sufficient to demonstrate substantial equivalence.
Conclusion
The performance characteristics and operation / usability of the modified Vita Flex CR System with LLI were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, and reliability of the system software requirements. Non-clinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.