(128 days)
Not Found
No
The document describes standard X-ray and tomosynthesis techniques (Filtered Back-Projection and Shift Addition) and mentions software validation and safety testing, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an X-ray radiography system intended to generate diagnostic images for examination purposes, not for treating or curing a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended to generate "diagnostic images" by converting x-rays into electronic signals.
No
The device description explicitly states it consists of hardware components such as an X-ray high voltage generator, X-ray tube support, collimator, and can be configured with a radiographic table, stand, and digital radiography system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The FDR Visionary Suite is an X-ray radiography system. It generates images of the internal structures of the human body by passing X-rays through the patient. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) diagnostic test.
- Intended Use: The intended use clearly states it's for generating radiographic images of various body parts for routine radiography examinations. It does not mention analyzing biological specimens.
Therefore, the FDR Visionary Suite falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB
Device Description
The FDR Visionary Suite is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The FDR Visionary Suite can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The FDR Visionary Suite consists of an X-ray high voltage generator, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by two different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed. This description is the same as our predicate. Key technological characteristics of the main components: X-Ray Generators: Available in 80 kW, 65 kW, and 50 kW versions. Image receptor panels: More recently cleared versions of Fujifilm panels are now employed. Tomography remains completely unchanged, including the digital receptor panel DR-ID 911SE.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray radiography
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies
Indicated Patient Age Range
all ages including pediatric patients
Intended User / Care Setting
hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained 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)
The radiation safety aspects of the device have not changed. The device remains compliant with the FDA Radiation Safety Standards. The following activities were performed as a result of the modifications to the device:
- The User Manuals were modified to reflect the changes detailed above.
- Software Validation was performed according to the FDA Guidance Documents: Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff (Basic Documentation Level) AND Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff.
- EMC and Electrical Safety Testing was performed according to these IEC Standards: Test Specification: EN 60601-1-2:2015 +A1:2021, IEC 60601-1-2:2014 +A1:2020; EN 60601-2-54:2009 +A1:2015 +A2:2019 clause 202; IEC 60601-2-54:2009 +A1:2015 +A2:2018 clause 202. Test Specification: IEC 60601-2-54:2009+A1+A2, IEC 60601-1-3:2008+A1, IEC 60601-1-3:2008+A1, IEC 60601-1-6:2010+A1, plus a Test Report for National Differences.
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
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
March 28, 2024
Shimadzu Corporation % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES, FL 34114
Re: K233719
Trade/Device Name: FDR Visionary Suite Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MQB Dated: January 26, 2024 Received: January 26, 2024
Dear Daniel Kamm:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
FDR Visionary Suite
Indications for Use (Describe)
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.
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
Image /page/3/Picture/0 description: The image shows the Shimadzu logo and the text "510(k) Summary K233719". The text is located above the logo. The Shimadzu logo is a black square with a white cross inside, followed by the company name in bold, black letters.
SHIMADZU CORP. 1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto City, JAPAN 604-8511 Date submitted: February 12, 2024 Prepared by: Koichi Kataoka, General Manager, Quality Assurance Department, Medical Systems Division k_koichi@shimadzu.co.jp; Tel +81-75-8231305
-
- Identification of the Device: Trade/Device Names: FDR Visionary Suite Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR, MQB
-
- Equivalent legally marketed device: K152294 Trade/Device Name: FDR Visionary Suite Manufacturer: Shimadzu. Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: II Product Code: KPR, MQB
-
- Purpose of Submission: Modified Device. The fundamental technological features are the same for the subject and the predicate systems.
-
- Device Description: The FDR Visionary Suite is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The FDR Visionary Suite can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The FDR Visionary Suite consists of an Xray high voltage generator, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by two different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed. This description is the same as our predicate. Key technological characteristics of the main components: X-Ray Generators: Available in 80 kW, 65 kW, and 50 kW versions. Image receptor panels: More recently cleared versions of Fujifilm panels are now employed. Tomography remains completely unchanged, including the digital receptor panel DR-ID 911SE. Details are in the comparison table below.
4
Software Description: These functions are unchanged:
- DICOM Connection Software,
- Basic Grayscale Print Management o
- Media Storage о
- Image Processing Software
- o Multi-objective Frequency Processing
- Grid Removal Processing o
- o Shuttering Processing
- o Gradation Processing
- o Dynamic Range Control Processing
- Tomographic Artifact Suppression Processing o
- Flexible Noise Control o
- Function Software
- o Retake Analysis Software
But the fundamental technological features are the same for the subject and the predicate systems. The changes are described in Section 6, below.
-
- Indications for Use: The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.
- Comparison of Technological Characteristics with the predicate device: At a high level, new device and its predicate device is based on the following same technological elements: Energy emission to the patient - X-ray Power requiremental requirement; Mechanism to generate X-ray; Mechanism to acquire, process and store image data; Use of the hardware components. The imaging components were replaced by more recently cleared digital x-ray receptor panels made by FUJIFILM. A detailed list is provided in the comparison table below.
The following technological differences exist between modified and its predicate device:
A larger LCD display is employed in the collimator.
A larger LCD display is employed in the generator control.
A video camera has been added to the collimator to assist in patient positioning. Functions include: movie display, rotation, zooming, guideline overlay.
A wireless remote control collimator control has been added.
A wireless remote exposure control has been added.
The software for the two touchscreens (Collimator and Generator Control) has been updated.
Infrastructure: Change programming language (C => C, Golang, JavaScript)
5
Architecture: Port to new OS (Real-time OS => Linux)
The software functionality remains unchanged.
The generator technical characteristics have not changed (kW, kV, mA, exposure times) Imaging components: The updated versions of the FUJIFILM X-ray receptor panels (since 2015) have been employed except for the tomography digital panel which remains unchanged. All the imaging panels have 510(k) clearance as shown in the table below. The panels all use the same integration software which comes with the panel. The integration software, although updated, has the identical functionality to the predicate.
In conclusion, the main technological characteristics have not changed. The modified system has a more modern, updated "look."
| Name of
Modified
Item | Predicate Device FDR Visionary Suite
K152294 | Modified Device FDR Visionary Suite
K233719 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The FDR Visionary Suite is intended to generate
digital or conventional radiographic images of the
skull, spinal column, chest, abdomen, extremities,
and other body parts of human anatomies in all
routine radiography examinations. The FDR
Visionary Suite enables radiographic or tomographic
exposures of the whole body of all ages including
pediatric patients. Exposures may be taken with the
patient sitting, standing, or lying in the prone or
supine position. The FDR Visionary Suite uses
portable or integrated flat panel detectors to
generate diagnostic images by converting x-rays into
electronic signals. The device is also designed to be
used with conventional film/screen or computed
radiography (CR) cassettes. The Tomosynthesis
option is intended to generate tomographic images
of human anatomies. Tomosynthesis technique is
used to produce a specific cross-sectional plane of
the body by reconstruction of tomographic
acquisition. The device is intended to be used in
hospitals, clinics, imaging centers, and/or other
healthcare facilities by qualified/trained
professionals. The device is not intended for
mammographic applications | The FDR Visionary Suite is intended to generate digital
or conventional radiographic images of the skull,
spinal column, chest, abdomen, extremities, and other
body parts of human anatomies in all routine
radiography examinations. The FDR Visionary Suite
enables radiographic or tomographic exposures of the
whole body of all ages including pediatric patients.
Exposures may be taken with the patient sitting,
standing, or lying in the prone or supine position. The
FDR Visionary Suite uses portable or integrated flat
panel detectors to generate diagnostic images by
converting x-rays into electronic signals. The device is
also designed to be used with conventional
film/screen or computed radiography (CR) cassettes.
The Tomosynthesis option is intended to generate
tomographic images of human anatomies.
Tomosynthesis technique is used to produce a specific
cross-sectional plane of the body by reconstruction of
tomographic acquisition. The device is intended to be
used in hospitals, clinics, imaging centers, and/or
other healthcare facilities by qualified/trained
professionals. The device is not intended for
mammographic applications. UNCHANGED |
| Name of
Modified
Item | Predicate Device FDR Visionary Suite
K152294 | Modified Device FDR Visionary Suite
K233719 |
| Over-head
Tube crane
control | Image: Predicate Device FDR Visionary Suite K152294 Over-head Tube crane control | CH-200(L) Touch screen now rectangular 12"
instead of square 7"
Image: Modified Device FDR Visionary Suite K233719 Over-head Tube crane control |
| Generator
Console | 6.7" x 5" display, 640 x 480 pixels
Image: Predicate Device FDR Visionary Suite K152294 Generator Console | 8.5"d x 5.4" display, 1280 x 800 pixels
Image: Modified Device FDR Visionary Suite K233719 Generator Console
Larger display, but same content |
| Name of
Modified
Item | Predicate Device FDR Visionary Suite
K152294 | Modified Device FDR Visionary Suite
K233719 |
| Added
Camera
Option
in Colli-
mator | R-300 Collimator Before Modification, no camera port
Bottom View Shown
Image: [R-300 Collimator Before Modification, no camera port Bottom View Shown] | Video Camera (HD resolution, 1280x720) added
On front of R-300 Collimator, now called RC-300
Bottom View shown
Camera Functions Patient position, patient
movement, plus: The following guide lines are
superimposed on the camera image: Gridline,
Exposure field, FPD effective area (Described in
Section 10 of the System Users Manual)
Image: [Camera and Control unit in cover] |
| Remote
Controller | Wired
Image: [Wired Remote Controller] | Wireless Remote Controller (Page 127 and 139 of
the Tube Support User Manual)
Shown in holder Closeup View
Image: [Wireless Remote Controller Shown in holder Closeup View] |
| Name of
Modified
Item | Predicate Device FDR Visionary Suite
K152294 | Modified Device FDR Visionary Suite
K233719 |
| Exposure
switch, part
of Generator
assembly | Wired
Wired, shown attached to control panel | Wireless Option: Battery operated Exposure
Switch with holder, Described in Generator User
Manual |
| SOFTWARE | X | The software for the two touchscreens:
(Colllimator and Generator Control) has been
updated.
Infrastructure: Change programming language
(C ⇒ C, Golang, JavaScript)
Architecture: Port to new OS , (Real-time OS ⇒
Linux)
The software functionality remains unchanged. |
| Tomography
Modes | SA mode : Reconstruction is performed using
the standard back projection method.
FBP mode : Reconstruction is performed using
the Filtered Back Projection method | UNCHANGED |
| X-Ray
Generator
Power | Three available models:
50 kW (100 kV, 500 mA)
65 kW (100 kV, 650 mA)
80 kW (100 kV, 800 mA) | UNCHANGED |
| Generator
kV | 40 to 150 kV | UNCHANGED |
| Exposure
Times | 81 positions, 0.001 to 10 sec | UNCHANGED |
| Current | (Depending on model)
10-500 mA (12 positions)
10-630 mA (12 positions)
10-800 mA (12 positions) | UNCHANGED |
| Name of
Modified
ltem | Predicate Device FDR Visionary Suite
K152294 | Modified Device FDR Visionary Suite
K233719 |
| Filtration | Minimum total filtration
IEC 60601-2-28:2017
1.7 mm Al/75 kV (Including added filter) | UNCHANGED |
| DR System | DR-ID 900. | UNCHANGED |
| FPD Flat panel
detectors | For Tomography: DR-ID 911SE
For radiography:
DR-ID 601SE
DR-ID 602SE
DR-ID 611SE | For Tomography: DR-ID 911SE (SAME)
For radiography:
DR-ID 1201SE (K142003)
DR-ID 1202SE (K142003)
DR-ID 1211SE (K142003)
DR-ID 1212SE (K142003)
DR-ID 1831SE (K192932)
DR-ID 1832SE (K192932)
DR-ID 1811SE (K192932)
DR-ID 1812SE (K192932)
(All FPD models have previous clearance) |
6
7
8
9
-
- Performance Testing Information: The radiation safety aspects of the device have not changed. The device remains compliant with the FDA Radiation Safety Standards. The following activities were performed as a result of the modifications to the device:
- The User Manuals were modified to reflect the changes detailed above. a.
- b. Software Validation was performed according to the FDA Guidance Documents: Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff (Basic Documentation Level) AND Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff.
- c. EMC and Electrical Safety Testing was performed according to these IEC Standards: Test Specification: EN 60601-1-2:2015 +A1:2021, IEC 60601-1-2:2014 +A1:2020; EN 60601-2-54:2009 +A1:2015 +A2:2019 clause 202; IEC 60601-2-54:2009 +A1:2015 +A2:2018 clause 202. Test Specification: IEC 60601-2-54:2009+A1+A2, IEC 60601-1-3:2008+A1, IEC 60601-1-3:2008+A1, IEC 60601-1-6:2010+A1, plus a Test Report for National Differences.
-
- Conclusion: The non-clinical data supports the safety of the device and the hardware verification and validation demonstrate that new device should performs as intended in the specified use. Based on our risk analysis and bench testing, the differences do not affect its clinical safety or effectiveness. From the result of our risk analysis, software verification and validation, and nonclinical testing discussed above, it is our conclusion that, - New device is substantially equivalent to the legally marketed predicate devices K152294. The fundamental technological features are the same for the subject and the predicate systems. Therefore, new device is as safe, as effective, and performs as well as or better than the predicate device.