(183 days)
Not Found
No
The summary describes computer-assisted navigation, image processing for 3D modeling, and automated control of a biopsy needle platform based on user-defined plans. While it uses computational methods, there is no mention of AI, ML, or related terms, nor is there any description of training or test data sets typically associated with AI/ML development. The functions described appear to be based on traditional algorithms and control systems.
No
The device is a surgical navigation system and needle guide for biopsy procedures, which assists in treatment planning and guidance but does not directly deliver therapy.
No
This device is described as a "Minimally Invasive Prostate Surgery Navigation System" and is intended for "treatment planning and guidance for prostate surgical procedures." It acts as a "needle guide" to aid in biopsy and other needling procedures, providing navigation and guidance rather than diagnosing a condition.
No
The device description explicitly states it is a "platform-hosted motorized device integrating a probe-driving system for 3D image collection and a precise biopsy guidance mechanism (biopsy needle platform)". This indicates the device includes significant hardware components beyond just software.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They perform tests outside the body.
- Device Function: The Minimally Invasive Prostate Surgery Navigation System (AmaKris SR1-A-1) is a surgical navigation and guidance system. It assists the physician in performing a procedure (biopsy) on the patient's body. It uses imaging modalities (MRI and Ultrasound) and provides guidance for needle insertion.
- No Specimen Testing: The device does not perform any tests on biological specimens. It facilitates the collection of a specimen (biopsy), but the device itself is not analyzing that specimen.
Therefore, while it is a medical device used in a diagnostic process (biopsy is often used for diagnosis), its function is not that of an In Vitro Diagnostic device. It is a surgical guidance system.
N/A
Intended Use / Indications for Use
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for use by the trained physician or urologist to perform the computer-assisted procedures through transperineal skin under real-time transrectal ultrasound guidance. It provides the capability to register and fuse with MRI medical images in DICOM format. It provides real-time 3D visualization for prostate, biopsy needle, and probe. It also provides the ability to display an image coordinates and guidewire that means the projected future path of the biopsy needle. Other software feature include patient data management, prostate and tumor modeling, 3D image registration.
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for treatment planning and guidance for prostate surgical procedures in a clinical setting.
Product codes
LLZ
Device Description
To help physician or urologist to perform needling procedures on prostate, AmaKris SR1-A-1 serves as a needle guide, which enables the needling procedures safer, faster and more precision with lesser side effects such as infection and internal hemorrhage.
AmaKris SR1-A-1 is a computer-assisted medical device to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle guide only. Different from the conventional hand-held probe guidance and operator-dependent manual biopsy targeting, AmaKris SR1-A-1 is a platform-hosted motorized device integrating a probe-driving system for 3D image collection and a precise biopsy guidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture. This system is intended to be used with adult patients.
The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians. The system allows users to draw contour curves of the organ/tumor referring to the transversal images, then the software performs contour fitting and generates the 3D model, based on which the prostate volume is calculated, and the systematic biopsy plan is made. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture.
The device is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. It shall be used in conjunction with a third-party ultrasound machine and endorectal probe that supports type-B ultrasound, and a third-party prostate biopsy gun and needle. The device services as a biopsy needle guide only. The insertion of biopsy needle will be done by the urologist.
AmaKris SR1-A-1 is composed of two modules: Navigation Manipulator and Intelligent Surgical Console.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, Transrectal Ultrasound
Anatomical Site
Prostate
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Trained physician or urologist / Clinical setting
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
Verification of Accuracy and Precision:
- Sample size: 325 sample points tested (needle pen experiment)
- Data source: Needle pen inserted into the end effector of the manipulator, targeting a template with 25 target circles (radius 0.5mm, 1.0mm, 1.5mm) on a target sheet.
- Annotation protocol: Not explicitly stated, but includes statistical analysis using SPSS 16.0.
Simulation Testing for Verifying Accuracy and Precision:
- a. Egg Phantom Test:
- Sample size: Punctures on eight random target points for three cycles.
- Data source: Shelled hard-boiled pigeon egg suspended in gelatin within a transparent plastic cylindrical box, simulating human prostate.
- Annotation protocol: Ultrasound images of the egg were acquired, margins delineated, and a 3D model generated. Tester identified eight random target points within the egg boundary. The test goal was to observe if the directional needle was outside the egg.
- b. Metal Needle Phantom Test:
- Sample size: 16 metal needles inserted and measurement repeated 5 times for repeatability (total 80 punctures).
- Data source: Gelatin phantom box with 16 puncture sites (10 mm matrix) on its top surface. Metal needles (1 mm diameter) inserted perpendicular to the ultrasound probe.
- Annotation protocol: Metal needle tip identified by software. A marker placed at the metal needle tip on the software planning screen to guide the navigation system. Biopsy needle inserted, and distance between biopsy needle tip and metal needle tip measured with electronic vernier calipers. Statistical analysis using SPSS 16.0.
Verification of Accuracy and Precision of Model Fusion:
- Sample size: 4 cases, 18 typical directions of divergence from the O-point (center of mass of the fusion model) for testing.
- Data source: MRI model and ultrasound model.
- Annotation protocol: Distances between O-points and intersection points on the surfaces of MRI and ultrasound models measured with software. Statistical analysis using SPSS 16.0.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical bench performance testing and simulation testing for accuracy and precision. No clinical testing was required.
Verification of Accuracy and Precision (Needle Pen):
- Sample Size: 325 sample points
- Key Results:
- Mean value of overall positioning accuracy: 0.404 mm
- Mean value of total variance: 0.2243
- Positioning accuracy is within 1.0 mm radius and meets biopsy specification.
- Positioning accuracy influenced by position of target points and moving pattern of end effector (P-values
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows 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.
Augment Intelligent Medical System (China) Co., Ltd. % Chen Lihong Chief Clinical Application Officer 1801-1812, Floor18, Block B, Kechuang No.1 Building, No.320 Pubin Road, Jiangpu Sub-District, Pukou District Nanjing, Jiangsu 211808 CHINA
November 22, 2022
Re: K221499
Trade/Device Name: Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-1) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 20, 2022 Received: October 27, 2022
Dear Chen Lihong:
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/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.
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221499
Device Name
Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-1)
Indications for Use (Describe)
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for use by the trained physician or urologist to perform the computer-assisted procedures through transperineal skin under realtime transrectal ultrasound guidance. It provides the capability to register and fuse with MRI medical images in DICOM format. It provides real-time 3D visualization for prostate, biopsy needle, and probe. It also provides the ability to display an image coordinates and guidewire that means the projected future path of the biopsy needle. Other software feature include patient data management, prostate and tumor modeling, 3D image registration.
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for treatment planning and guidance for prostate surgical procedures in a clinical setting.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows a logo with a circular design on the left and text on the right. The circular design has a gold and silver gradient and appears to contain the letter 'G'. To the right of the circle, there are four Chinese characters in gray, stacked above the English text "ZHONG YI ZHI CHUANG", also in gray. The text is simple and clear.
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
K221499
Prepared Date: Oct 20,2022
Submitter's Information
The submitter of this pre-market notification is:
| Name: | Augment Intelligent Medical System (China) Co., Ltd. |
|---|---|
| Address: | 1801-1812, Floor 18, Block B, Kechuang No.1 Building, No.320 |
| Pubin Road, Jiangpu Sub-District, Pukou District, Nanjing, | |
| Jiangsu 211808 China | |
| Contact person: | Chen Lihong |
| Title: | Chief Clinical Application officer |
| E-mail: | chenlh@aimsrobots.com |
| Tel: | 86-025-58600482 |
Device Identification
| 510(K) number: | K221499 |
|---|---|
| Trade/Device Name: | Minimally Invasive Prostate Surgery Navigation System |
| Models: | AmaKris SR1-A-1 |
| Common name: | System, Image Processing, Radiological |
| Regulation Number: | 892.2050 |
| Regulation Name: | Picture archiving and communications system |
| Regulation Class: | Class 2 |
| Panel: | Radiology |
| Product Code: | LLZ |
Predicate Device
| 510(K) number: | K162474 |
|---|---|
| Device Name: | Artemis |
| Manufacturer: | Eigen |
| Common name | System, Image Processing, Radiological |
| Regulation Number: | 892.2050 |
| Regulation Name: | Picture archiving and communications system |
| Regulation Class: | Class 2 |
| Panel: | Radiology |
| Product Code: | LLZ |
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Image /page/4/Picture/1 description: The image shows a logo with a stylized letter "G" on the left and Chinese characters and English text on the right. The letter "G" is in a circle with a gold and silver gradient. To the right of the "G" are the Chinese characters "中奕智创" in gray. Below the Chinese characters is the English text "ZHONG YI ZHI CHUANG" also in gray.
4. Indication for Use
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for use by the trained physician or urologist to perform the computer-assisted prostate surgical procedures through transperineal skin under real-time transrectal ultrasound quidance. It provides the capability to register and fuse with MRI medical images in DICOM format. It provides real-time 3D visualization and localization for prostate, biopsy needle, and probe. It also provides the ability to display an image coordinates and guidewire that means the current and the projected future path of the biopsy needle. Other software features include patient data management, prostate and tumor modeling,3D image registration.
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures.
5. Device Description
To help physician or urologist to perform needling procedures on prostate, AmaKris SR1-A-1 serves as a needle guide, which enables the needling procedures safer, faster and more precision with lesser side effects such as infection and internal hemorrhage.
AmaKris SR1-A-1 is a computer-assisted medical device to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle quide only. Different from the conventional hand-held probe quidance and operator-dependent manual biopsy targeting, AmaKris SR1-A-1 is a platform-hosted motorized device integrating a probe-driving system for 3D image collection and a precise biopsy quidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture. This system is intended to be used with adult patients.
The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians. The system allows users to draw contour curves of the organ/tumor referring to the transversal images, then the software performs contour fitting and generates the 3D model, based on which the prostate volume is calculated, and the systematic biopsy plan is made. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture.
The device is intended for use by a trained urologist or physician to perform the computerassisted transperineal prostate biopsy under transrectal ultrasound guidance. It shall be used in conjunction with a third-party ultrasound machine and endorectal probe that supports type-B ultrasound, and a third-party prostate biopsy gun and needle. The device services as a biopsy needle guide only. The insertion of biopsy needle will be done by the urologist.
AmaKris SR1-A-1 is composed of two modules:
Navigation Manipulator 510(k) Summary
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Image /page/5/Picture/1 description: The image shows a logo with a stylized letter "G" on the left, rendered in gold and silver gradient. To the right of the "G" are Chinese characters in gray, followed by the English transliteration "ZHONG YI ZHI CHUANG" also in gray. The overall design appears to represent a company or brand identity.
Navigation manipulator is a computer-controlled surgical manipulator. There are 3 servo mote controlled by both magnetic encodes and potentiometers to provide higher position accuracy and quick location responses. A nine axes Inertia Measurement Unit (IMU) has been integrated into this system to measure the movement of pitch, yaw, rotation and acceleration.
Intelligent Surgical Console
The intelligent surgical console is the core platform of the system, the software operating platform for medical imaging processing, biopsy planning and execution, as well as a mobile platform for surgery. The intelligent surgical console has a built-in IPC, on which runs the AmaKris software. The software acquires real-time ultrasound images from the ultrasound diagnostic apparatus and controls the navigation manipulator. The navigation manipulator is a portable device for prostate biopsy execution. It is fixed into the intelligent surgical controlled by the intelligent surgical console. The intelligent surgical consisted of main components including the base, main body, mobile surgical table, and touch screen monitor.
6. Compared to Predicate Device
The design, function, and specifications of AmaKris SR1-A-1 are similar to the identified legally marketed predicate devices Artemis (K162474). AmaKris SR1-A-1 and Artemis (K162474) similarly provide image-guided interventional planning and navigation for prostate procedures, the ability to view and capture live 2D ultrasound data to create reconstructed 3D ultrasound images/models, and the ability to fuse and register these images with the imaqes acquired and imported from other modalities like Magnetic Resonance Imaging, and Ultrasound.
AmaKris SR1-A-1 and Artemis (K162474) also similarly perform other viewing and imageprocessing functions such as image registration, multi-planar reformats and includes tools to segment, measure and annotate images. AmaKris SR1-A-1 and Artemis (K162474) can import data from other DICOM based imaging devices and also output selected image views, processed data and user-defined reports.
AmaKris SR1-A-1 and Artemis (K162474) similarly utilize a mechanical arm with encoders to determine the location of the ultrasound probe.
The main difference between AmaKris SR1-A-1 and Artemis (K162474) is the physical form. This difference does not impact device safety or effectiveness.
Other differences between AmaKris SR1-A-1 and Artemis (K162474) include minor user interface variations such as GUI icons, screen colors and image viewing layouts. These differences are cosmetic in nature do not significantly affect the use of the device, nor do they raise new or additional safety risks. These differences between AmaKris SR1-A-1 and the legally marketed predicate device do not impact device safety or effectiveness.
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Image /page/6/Picture/1 description: The image contains a logo with the text "ZHONG YI ZHI CHUANG" written in both Chinese and English. To the left of the text is a circular graphic with a stylized letter "G" inside. The circular graphic is colored with gold and silver. The text is written in a simple, sans-serif font.
AmaKris SR1-A-1 is a diagnostic and interventional software accessory to perform the computer-assisted prostate surgical procedures through transperineal skin under real-time transrectal ultrasound quidance. It provides convenient options for visualizing diagnostic and interventional information in support of routine clinical procedures of the prostate gland. The device does not directly contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the AmaKris SR1-A-1 system but by Radiologists, Clinicians and referring Physicians.
A physician, providing ample opportunity for competent human interprets the images and information being displayed and maintains control of the clinical procedure at all times.
The AmaKris SR1-A-1 utilizes the same technological characteristics as the predicate devices Artemis (K162474).
Both:
-
are PC based software applications that provide 2D and 3D medical image acquisition including ultrasound video image acquisition arid visualization of the prostate gland
-
use Windows operating systems
-
allow registration of live ultrasound images to previously created 3D image sets based on previously collected ultrasound image sets or DICOM images sets
-
include image enhancements such as zoom and pan capabilities
-
provide patient and clinical data management features
-
deal with live ultrasound images received from commercially available imaging devices.
-
use graphic overlays to define segmentations
-
calibrate ultrasound video images
-
create a report
-
allow multi-planar reformatting
-
allow manual planning of instrument positioning including biopsy needle placement and planning
-
allow the user to plan and mark the reached positions of the biopsies and instruments
-
are only intended for use on the prostate gland
-
utilize a mechanical arm with encoders to determine the location of the ultrasound probe.
Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table
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Image /page/7/Picture/1 description: The image contains a logo with the letters 'gi' in a gold and silver gradient on the left. To the right of the logo are Chinese characters in gray, with the English translation 'ZHONG YI ZHI CHUANG' written below in a smaller font, also in gray. The overall design appears to represent a company or brand identity.
| SE
Comparisons | Proposed Device
Minimally Invasive Prostate
Surgery Navigation System
(Model: AmaKris SR1-A-1) | Primary Predicate Device
Artemis (K162474) | Similarities/
Differences |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | Minimally Invasive Prostate
Surgery Navigation System
(Model: AmaKris SR1-A-1) is
intended for use by the trained
physician or urologist to
perform the computer-assisted
prostate surgical procedures
through transperineal skin
under real-time transrectal
ultrasound guidance. It
provides the capability to
register and fuse with MRI
medical images in DICOM
format. It provides real-time 3D
visualization and localization
for prostate, biopsy needle,
and probe. It also provides the
ability to display an image
coordinates and guidewire that
means the current and the
projected future path of the
biopsy needle. Other software
features include patient data
management, prostate and
tumor modeling,3D image
registration.
Minimally Invasive Prostate
Surgery Navigation System
(Model: AmaKris SR1-A-1) is
intended for treatment
planning and guidance for
clinical, interventional and/or
diagnostic procedures. | Artemis along with the Needle
Guide Attachment is used for
image-guided interventional and
diagnostic procedures of the
prostate gland. It provides 2D
and 3D visualization of
Ultrasound (US) images and the
ability to fuse and register these
images with those from other
imaging modalities such as
Ultrasound, Magnetic
Resonance, Computed
Tomography, etc. It also
provides the ability to display a
simulated image of a tracked
insertion tool such as a biopsy
needle, guidewire or probe on a
computer monitor screen that
shows images of the target
organ and the current and the
projected future path of the
interventional instrument taking
patient movement into account.
The software also provides a
virtual grid on the live ultrasound
for performing systematic
sampling of the target organ.
Other software features include
patient data management, multi-
planar reconstruction,
segmentation, image
measurements, 2D/3D image
registration, reporting, and
pathology management.
Artemis is intended for
treatment planning and
guidance for clinical,
interventional and/or diagnostic
procedures. The device is
intended to be used in
interventional and diagnostic
procedures in a clinical setting.
Example procedures include but
are not limited to image fusion
for diagnostic clinical
examinations and procedures. | The main
function of
the subject
device and
predicate
device is that
help doctor
conduct
biopsy of
prostate by
providing
real-time 3D
visualization
and
localization
for prostate,
biopsy
needle, and
probe. |
| SE
Comparisons | Proposed Device
Minimally Invasive Prostate
Surgery Navigation System
(Model: AmaKris SR1-A-1) | Primary Predicate Device
Artemis (K162474) | Similarities/
Differences |
| | | soft tissue biopsies, soft tissue
ablations and placement of
fiducial markers. Artemis is also
intended to be used for patients
in active surveillance to keep
track of previous procedures
information and outcomes. | |
| Product code | LLZ | LLZ | Same |
| Class | II | II | Same |
| Target anatomy | Prostate | Prostate | Same |
| Anatomy
access | Transperineal | Transrectal & Transperineal | The subject
device only
provides
Transperineal
needle
guidance
procedures.
There is no
risk raise. |
| Software | | | |
| Windows OS | Yes | Yes | Same |
| Medical
Imaging
Software | Yes | Yes | Same |
| Image display | | | |
| General Image
2D/3D Review | Yes | Yes | Same |
| 3D Rendering
View | Yes | Yes | Same |
| Live 2D
Ultrasound | Yes | Yes | Same |
| Image Process | | | |
| Gland
Segmentation | Yes | Yes | Same |
| Image
Registration | Yes | Yes | Same |
| Rigid
Registration | Yes | Yes | Same |
| Elastic
Registration | Yes | Yes | Same |
| SE
Comparisons | Proposed Device
Minimally Invasive Prostate
Surgery Navigation System
(Model: AmaKris SR1-A-1) | Primary Predicate Device
Artemis (K162474) | Similarities/
Differences |
| Multi-Planar
Reformation | Yes | Yes | Same |
| Connectivity | | | |
| DICOM
Import/Export | Yes | Yes | Same |
| Ultrasound
Video | Yes | Yes | Same |
| Review Tools | | | |
| Standard
Image Viewing
Tools | Yes | Yes | Same |
| Measurement
Tools | Yes | Yes | Same |
| Annotation
Tools | Yes | Yes | Same |
| Segmentation
Tools | Yes | Yes | Same |
| Reporting
Tools | Yes | Yes | Same |
| Video Capture | Yes | Yes | Same |
| Image
Overlays | Yes | Yes | Same |
| Planning & Navigation | | | |
| Import Prior
Plan | Yes | Yes | Same |
| Import/Add
Targets | Yes | Yes | Same |
| Plan/Mark
Locations | Yes | Yes | Same |
| Navigation
Type | Mechanical | Mechanical | Same |
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Image /page/8/Picture/1 description: The image contains a logo with both graphic and text elements. On the left, there is a stylized, circular graphic in shades of gold and gray, resembling a letter 'G' or a stylized swirl. To the right of the graphic, there are three bold, gray Chinese characters, followed by the English transliteration "ZHONG YI ZHI CHUANG" in smaller, gray font.
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Image /page/9/Picture/1 description: The image contains a logo with the text "ZHONG YI ZHI CHUANG" written in gray letters. Above the text is the same phrase written in Chinese characters. To the left of the text is a circular logo with a gold and silver design.
The new device and predicate devices are substantially equivalent in the areas of technological characteristics such as basic design, features, energy source, method of operation, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
8. Performance Data
Clinical test:
Clinical testing is not required.
510(k) Summary
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Image /page/10/Picture/1 description: The image shows a logo with a stylized letter 'G' on the left, rendered in silver and gold. To the right of the 'G' are Chinese characters in gray, followed by the English transliteration "ZHONG YI ZHI CHUANG" in a smaller, gray font. The overall design appears to represent a company or brand identity, with a combination of visual and textual elements.
Safety and Effectiveness
The AmaKris SR1-A-1 labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via the product (software and hardware) development process, verification and validation testing.
Non-clinical data
-Safety
IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
-EMC
IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic Disturbances-Requirements and tests
-Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Performance Testing:
- Verification of Accuracy and Precision
In the test, a needle pen is designed as such a pen refill is secured to the needle sheath guide and then inserted to the end effector of the manipulator. A template is created on a piece of target sheet. The template consists of 25 target circles, each of which consists of three concentric circles with radius of 0.5mm, 1.0mm, and 1.5mm, respectively, with the target point as the center of the circle. There are a total of 5 different patterns to verify the accuracy and precision of various movement mode.The navigation system of the device will guide the manipulator from the home position P0 to the designate target position. The manipulator will move through a series of position patterns preset by the software.
Based on the raw data, we used SPSS 16.0 analysis software to analyze the positioning accuracy and precision of each testing point on the target sheet. The analysis results shows that the total number of sample points tested is 325, and the mean value of the overall positioning accuracy is 0.404 (mm) with the mean value of total variance 0.2243, which means the positioning accuracy is within 1.0 mm radius and meets the biopsy specification.
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Image /page/11/Picture/1 description: The image contains a logo with text in both Chinese and English. On the left, there is a stylized circular logo with gold and silver colors. To the right of the logo, there are three Chinese characters in gray, followed by the English text "ZHONG YI ZHI CHUANG" also in gray. The text appears to be the name of a company or organization.
In addition, it was analyzed whether the positioning accuracy was influenced by the position of target points or the moving pattern of the end effector of the manipulator. The analysis method used was a two-factor ANOVA model. The results show that the P-values of the tests for the effects of the position of target points and the moving pattern of the end effector of the manipulator are less than 0.001, indicating that both are statistically significant. The positioning accuracy is higher in the lower left region of the target sheet (with lower deviation value from the target), and lower in the upper right corner and the rest of the outer boundary of the target sheet. The positioning accuracy is higher for moving pattern 1 and 2 and lower for moving pattern 3 and 4.
-Simulation Testing for Verifying Accuracy and Precision
a. Egg Phantom Test
A shelled hard-boiled pigeon egg was used to simulate the shape, size, and texture of human prostate. The egg was suspended in gelatin to allow for conductance to ultrasound waves. The container was a transparent plastic cylindrical box.
The standard protocol began with the acquisition of the ultrasound images of the suspended egg. After delineation of its margins, a 3D model is generated by the software to be verified. In target planning, the tester identified eight random target points, with two in each quadrant within the egg boundary. The software did not allow placement of any target points outside the verified 3D model, which was consistent with the clinical safety requirements defined by the urologists. The test goal is to observe whether the directional needle is outside the egg. According to the test, all punctures on eight random target points for three cycles are placed inside the egg boundary. This test verified that the device system is able to navigate biopsy needles to targets within a defined boundary.
b. Metal Needle Phantom Test
Prepare the gelatin phantom box as described previously without the egg. The top surface of the box has 16 puncture sites spaced in 10 mm matrix for inserting the metal needles. The box is placed where the nearest row of puncture sites is 99 mm from the needle holder on the guider. 16 metal needles with a diameter of 1 mm be inserted in sequence from the top surface of the box perpendicular to the ultrasound probe, whose tips randomly placed within a radius of 2-5 cm of the center of the ultrasound probe. Set the area to be where the prostate is normally located and within the detection range of the ultrasound. After the ultrasound images were collected, the metal needle tip (target points) was identified by the software. A marker was placed at the point of the metal needle tip shown on the software planning screen to guide the navigation system to that position. Next, the biopsy needle was inserted through the needle sheath until the biopsy needle tip reaches the position of the metal needle tip in longitudinal depth. Measure and recorde the distance (mm) between the biopsy needle tip to the mental needle tip with the electronic vernier calipers. Same procedure was repeated for all metal needles. To validate repeatability, the biopsy needle was returned to each Page 9 of Page 11 510(k) Summary
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Traditional 510(k) Submission of Minimally Invasive Prostate Surgery Navigation System position of all metal needle tips for a total of 5 times with the same methods of measurement
Based on the raw data, we used SPSS 16.0 analysis software to analyze the accuracy and precision of robotic-navigated puncture under TRUS quidance was analyzed by experimental data of the distance between the biopsy needle tip and the metal needle tip (target point). The mean value of the distance of the two needle tips is 0.435 mm, the mean variance is 0.1903, and the total number of punctures is 80.
In addition, the mean value of the distance between the biopsy needle tip and the metal needle tip (target point), which shows the navigation accuracy of the device, was further analyzed to see if it was influenced by the position of the target point. The analysis method used was a one-way ANOVA model.The results showed that the P-value for the test of the position effect was less than 0.001, indicating statistical significance. The closer the target point position to the needle holder on the guider, the higher the navigation accuracy is, and the farther the target point position to the needle holder on the guider, the lower the navigation accuracy is.
- Verification of Accuracy and Precision of Model Fusion
Selected 18 typical directions of divergence from the O-point (with serial number 1 to 18), the center of mass of the fusion model, for testing, including 8 target directions along the Z-axis; 6 target directions along the X-axis that do not coincide with the Z-axis direction: and 4 target directions along the Y-axis that do not coincide with the Z- and X-axis directions.
The distances between the O points in these 18 directions and the intersection points on the surfaces of the MRI model and ultrasound model, were measured with the software, and the accuracy and precision of the model fusion were statistically analyzed on this basis.
Based on the raw data, we used SPSS 16.0 analysis software to analyze the accuracy and precision of model fusion, according to the analysis of 4 cases, the mean value of the distance is 1.2801 mm with a mean variance 0.92556. Furthermore, the difference of target direction does not have statistically significant effect on model fusion accuracy.
9. Conclusion
The 510(k) Pre-Market Notification for Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) contains adequate information, data, and nonclinical test results to enable FDA-CDRH to determine substantial equivalence to the predicate device. We have determined that our device, Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1), is substantially equivalent to the identified predicate device Artemis (K162474). A comparison with the legally marketed predicate device indicates that it is substantially equivalent to this device, and that it does not raise any new safety or efficacy concerns. new safety or efficacy concerns. The results of
510(k) Summary
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Image /page/13/Picture/0 description: The image contains a logo with a stylized letter "G" in gold and silver on the left. To the right of the logo are Chinese characters in gray, followed by the English text "ZHONG YI ZHI CHUANG" in a smaller font size. The logo and text appear to represent a company or organization, with the Chinese characters likely being the name of the company.
Traditional 510(k) Submission of Minimally Invasive Prostate Surgery Navigation System comparing the intended use, function, technological characteristics, mode of operation, and specifications of Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) with the predicate devices demonstrate that Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is substantially equivalent to predicate device Artemis (K162474).