Minimally Invasive Prostate Surgery Navigation System

K221499 · Augment Intelligent Medical System (China) Co., Ltd. · LLZ · Nov 22, 2022 · Radiology

Device Facts

• Record ID: K221499
• Device Name: Minimally Invasive Prostate Surgery Navigation System
• Applicant: Augment Intelligent Medical System (China) Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Nov 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended 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 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.

Device Story

System acts as needle guide for transperineal prostate biopsy; integrates with third-party ultrasound machines, endorectal probes, and biopsy guns. Device comprises navigation manipulator (3 servo motors, magnetic encoders, potentiometers, 9-axis IMU) and intelligent surgical console (IPC, touch screen, software). Inputs: real-time ultrasound video, imported DICOM MRI/ultrasound images. Software performs image registration, segmentation, 3D prostate/tumor modeling, and biopsy planning. Manipulator controls needle insertion orientation and depth. Physician uses GUI to view 3D prostate model, plan needle path, and monitor real-time guidance. System provides visual coordinates and projected needle path. Enhances safety, speed, and precision of biopsy; reduces manual targeting variability. Used in clinical settings by urologists/physicians.

Clinical Evidence

No clinical data. Bench testing only. Accuracy and precision verified using target sheet templates (n=325, mean accuracy 0.404 mm) and metal needle phantom tests (n=80, mean distance 0.435 mm). Model fusion accuracy tested on 18 directions (mean distance 1.2801 mm). Egg phantom test confirmed navigation to targets within defined boundaries.

Technological Characteristics

PC-based software with mechanical manipulator arm. Manipulator uses 3 servo motors, magnetic encoders, potentiometers, and 9-axis IMU. Connectivity: DICOM import/export, real-time ultrasound video acquisition. Software features: 3D rendering, rigid/elastic registration, multi-planar reformatting, segmentation, and biopsy planning. Operates on Windows OS. Class II device, Product Code LLZ.

Indications for Use

Indicated for trained physicians or urologists performing computer-assisted transperineal prostate biopsy procedures under real-time transrectal ultrasound guidance in adult patients. Used for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Artemis (K162474)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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<br>Pubin Road, Jiangpu Sub-District, Pukou District, Nanjing,<br>Jiangsu 211808 China |
| Contact person: | Chen Lihong |
| Title: | Chief Clinical Application officer |
| E-mail: | [e-mail] |
| 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<br>Comparisons | Proposed Device<br>Minimally Invasive Prostate<br>Surgery Navigation System<br>(Model: AmaKris SR1-A-1) | Primary Predicate Device<br>Artemis (K162474) | Similarities/<br>Differences |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | Minimally Invasive Prostate<br>Surgery Navigation System<br>(Model: AmaKris SR1-A-1) is<br>intended for use by the trained<br>physician or urologist to<br>perform the computer-assisted<br>prostate surgical procedures<br>through transperineal skin<br>under real-time transrectal<br>ultrasound guidance. It<br>provides the capability to<br>register and fuse with MRI<br>medical images in DICOM<br>format. It provides real-time 3D<br>visualization and localization<br>for prostate, biopsy needle,<br>and probe. It also provides the<br>ability to display an image<br>coordinates and guidewire that<br>means the current and the<br>projected future path of the<br>biopsy needle. Other software<br>features include patient data<br>management, prostate and<br>tumor modeling,3D image<br>registration.<br>Minimally Invasive Prostate<br>Surgery Navigation System<br>(Model: AmaKris SR1-A-1) is<br>intended for treatment<br>planning and guidance for<br>clinical, interventional and/or<br>diagnostic procedures. | Artemis along with the Needle<br>Guide Attachment is used for<br>image-guided interventional and<br>diagnostic procedures of the<br>prostate gland. It provides 2D<br>and 3D visualization of<br>Ultrasound (US) images and the<br>ability to fuse and register these<br>images with those from other<br>imaging modalities such as<br>Ultrasound, Magnetic<br>Resonance, Computed<br>Tomography, etc. It also<br>provides the ability to display a<br>simulated image of a tracked<br>insertion tool such as a biopsy<br>needle, guidewire or probe on a<br>computer monitor screen that<br>shows images of the target<br>organ and the current and the<br>projected future path of the<br>interventional instrument taking<br>patient movement into account.<br>The software also provides a<br>virtual grid on the live ultrasound<br>for performing systematic<br>sampling of the target organ.<br>Other software features include<br>patient data management, multi-<br>planar reconstruction,<br>segmentation, image<br>measurements, 2D/3D image<br>registration, reporting, and<br>pathology management.<br>Artemis is intended for<br>treatment planning and<br>guidance for clinical,<br>interventional and/or diagnostic<br>procedures. The device is<br>intended to be used in<br>interventional and diagnostic<br>procedures in a clinical setting.<br>Example procedures include but<br>are not limited to image fusion<br>for diagnostic clinical<br>examinations and procedures. | The main<br>function of<br>the subject<br>device and<br>predicate<br>device is that<br>help doctor<br>conduct<br>biopsy of<br>prostate by<br>providing<br>real-time 3D<br>visualization<br>and<br>localization<br>for prostate,<br>biopsy<br>needle, and<br>probe. |
| SE<br>Comparisons | Proposed Device<br>Minimally Invasive Prostate<br>Surgery Navigation System<br>(Model: AmaKris SR1-A-1) | Primary Predicate Device<br>Artemis (K162474) | Similarities/<br>Differences |
| | | soft tissue biopsies, soft tissue<br>ablations and placement of<br>fiducial markers. Artemis is also<br>intended to be used for patients<br>in active surveillance to keep<br>track of previous procedures<br>information and outcomes. | |
| Product code | LLZ | LLZ | Same |
| Class | II | II | Same |
| Target anatomy | Prostate | Prostate | Same |
| Anatomy<br>access | Transperineal | Transrectal & Transperineal | The subject<br>device only<br>provides<br>Transperineal<br>needle<br>guidance<br>procedures.<br>There is no<br>risk raise. |
| Software | | | |
| Windows OS | Yes | Yes | Same |
| Medical<br>Imaging<br>Software | Yes | Yes | Same |
| Image display | | | |
| General Image<br>2D/3D Review | Yes | Yes | Same |
| 3D Rendering<br>View | Yes | Yes | Same |
| Live 2D<br>Ultrasound | Yes | Yes | Same |
| Image Process | | | |
| Gland<br>Segmentation | Yes | Yes | Same |
| Image<br>Registration | Yes | Yes | Same |
| Rigid<br>Registration | Yes | Yes | Same |
| Elastic<br>Registration | Yes | Yes | Same |
| SE<br>Comparisons | Proposed Device<br>Minimally Invasive Prostate<br>Surgery Navigation System<br>(Model: AmaKris SR1-A-1) | Primary Predicate Device<br>Artemis (K162474)…