iSR`obot Mona Lisa 2.0

K232320 · Biobot Surgical Pte., Ltd. · IYO · Dec 21, 2023 · Radiology

Device Facts

• Record ID: K232320
• Device Name: iSR`obot Mona Lisa 2.0
• Applicant: Biobot Surgical Pte., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

iSR'obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations. The iSR'obot Mona Lisa 2.0 provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance, etc. It also provides the ability to display a simulated image of an insertion tool on a computer monitor screen, the target organ, and the current and projected future path of the insertion tool taking into account patient movement. Other software multiplanar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.

Device Story

System comprises workstation, robotic navigation module (motorized arm), and disposables; used by urologists/physicians for prostate procedures. Inputs include transrectal ultrasound and external imaging (e.g., MRI). Software (UroFusion, UroBiopsy, UroTherapy) performs image segmentation, 2D/3D registration, and fusion; displays simulated needle trajectory, target organ, and path relative to patient movement. Robotic arm positions needle guidance mechanism based on physician-planned trajectory. UroReview provides post-procedure data; UroConnect handles PACS connectivity. System improves needle placement accuracy during biopsies and ablations; benefits include precise targeting of lesions and reduced procedural variability.

Clinical Evidence

No clinical data submitted. Substantial equivalence demonstrated via bench testing, including system performance testing with phantoms, software verification/validation, biocompatibility (ISO 10993-1), sterilization validation (ISO 11135), and cybersecurity testing (ANSI UL 2900).

Technological Characteristics

Workstation-based robotic navigation system. Materials: Polycarbonate and stainless steel 304 (needle guide holder). Sensing: Transrectal ultrasound. Connectivity: PACS (DICOM). Software: Multi-planar reconstruction, segmentation, 2D/3D registration. Standards: IEC 62304 (software), ISO 10993-1 (biocompatibility), ISO 11135 (sterilization), ASTM F1980, F1886, F2906, F1929, F88 (packaging/aging).

Indications for Use

Indicated for use by physicians to guide planning and positioning of insertion tools (needles/probes) during image-guided diagnostic and interventional prostate procedures (biopsies, ablations) using transrectal ultrasound in a clinical setting.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.

Predicate Devices

• iSR'obot Mona Lisa 2.0 (K213411)

Reference Devices

• iSR'obot Biopsy Kit (K163502)
• BK 8848 (K132335)
• BK 0948 (K173569, K180737, K223830)
• 6L7Bs (K171579)
• CL4416R (K171708, K181376)

Submission Summary (Full Text)

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December 21, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.

Biobot Surgical Pte Ltd % Lim Yan Shin Regulatory Affairs 79 Ayer Rajah Crescent, #04-05 Singapore 139955 SGP SINGAPORE

Re: K232320

Trade/Device Name: iSR`obot Mona Lisa 2.0 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, LLZ, OIJ Dated: December 7, 2023 Received: December 7, 2023

Dear Lim Yan Shin:

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).

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Your device is also subject to, among other requirements, the Quality System (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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#### Indications for Use

510(k) Number (if known) K232320

Device Name iSR'obot Mona Lisa 2.0

#### Indications for Use (Describe)

iSR'obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations.

The iSR'obot Mona Lisa 2.0 provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance, etc. It also provides the ability to display a simulated image of an insertion tool on a computer monitor screen, the target organ, and the current and projected future path of the insertion tool taking into account patient movement. Other software multiplanar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.

Type of Use (Select one or both, as applicable)

| <span></span> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|--------------------------------------------------------------------------------------|
| <span></span> | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the word "biobot" in a stylized font. The "bio" part of the word is in orange, with a gradient effect that makes it appear brighter at the top and darker at the bottom. The "bot" part of the word is in blue. The two parts of the word are connected, forming a single brand name.

### 510(k) Summary K232320 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).

| Date: | August 30, 2023 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | 79 Ayer Rajah Crescent, #04-05,<br>Singapore 139955 |
| Primary Contact: | Lim Yan Shin<br>Regulatory Manager<br>Biobot Surgical Pte Ltd<br>Cell: [phone]<br>E-mail: [e-mail] |
| Secondary Contact: | Georgiann Keyport, Regulatory Consultant, U.S.<br>Email: [e-mail]<br>Cell: 952-994-8267 |

#### Product Identification

| Device Trade Name: | iSR'obot Mona Lisa 2.0 |
|-----------------------|---------------------------------------------------------------------------------------------|
| Common / Usual Name: | System, image processing, radiological |
| Classification Names: | 892.1560 Ultrasonic pulsed echo imaging system<br>892.1570 Diagnostic ultrasonic transducer |
| Product Code: | IYO, ITX, LLZ, OIJ |
| Manufacturer / Design | Biobot Surgical Pte Ltd |
| Location: | 79 Ayer Rajah Crescent, #04-05,<br>Singapore 139955 |

#### Device Description

#### System Overview

The iSR'obot Mona Lisa 2.0 system consists of a workstation, robotic navigation module (comprising of a motorized mechanical robotic arm, bed rail stabilizer or floor stand stabilizer) and disposables. The workstation is installed with application software that provides functions for image processing, image segmentation, 2D/3D visualization to support urologists or physicians in planning needle positions for procedures. The application software (UroBiopsy / UroTherapy) interfaces and controls the robotic arm to position its needle guidance mechanism at a trajectory to allow needle insertion by the physician. Another application software (UroFusion) provides an interface for users to perform contouring of the prostate gland and marking of suspected lesion regions, which can be imported into UroBiopsy or UroTherapy for image fusion during the procedure. The physician is able to review procedural data such as

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Image /page/4/Picture/1 description: The image shows the word "biobot" in a stylized font. The "bio" part of the word is in a bold, rounded font and is colored in a gradient from yellow to orange. The "bot" part of the word is in a similar font but is colored in blue. The word is slightly tilted to the left, and the overall design is clean and modern.

prostate information and model, needle positioning plan and trajectories, number of needles executed, etc., using a utility software (UroReview). A utility software (UroConnect) provides the connectivity solution to a picture archiving and communication system (PACS) server for downloading/uploading DICOM-compatible data. The bed rail stabilizer and floor stand stabilizer provide support for the robotic arm. They are to be attached to the bed rail or mounted on the floor respectively. Sterile disposables are used with iSR'obot Mona Lisa 2.0 during prostate procedures.

The system is compatible with commercially available ultrasound systems, transrectal ultrasound bi-plane probes, and commercially available needle devices.

#### Predicate Device Information and Comparison

| Predicate Device Name | Predicate 510(k) Submission Reference |
|------------------------|---------------------------------------|
| iSR'obot Mona Lisa 2.0 | K213411 |

#### Intended Use / Indications for Use

iSR'obot Mona Lisa 2.0 is a user-controlled, stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools, such as a third-party needle or a probe, during image-guided diagnostic and interventional procedures in conjunction with the guidance of transrectal ultrasound involving the prostate gland in a clinical setting. Examples of such procedures include, but are not limited to, image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, and soft tissue ablations.

The iSR'obot Mona Lisa 2.0 provides 2D and 3D visualization of Ultrasound images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance, etc. It also provides the ability to display a simulated image of an insertion tool on a computer monitor screen, the target organ, and the current and projected future path of the insertion tool, taking into account patient movement. Other software features include multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.

#### Technology Characteristics Compared to Predicate Device

iSR 'obot Mona Lisa 2.0 employs the same fundamental scientific technology (design, function, and specifications) as its original device, iSR 'obot Mona Lisa 2.0 (K213411).

Similarities in technology characteristics include:

- . Platform-hosted motorized devices are able to provide 2D and 3D views of the prostate gland;
- . Use the same technology to acquire a transrectal ultrasound image to plan and guide a needle for diagnostic and interventional procedures;

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Image /page/5/Picture/1 description: The image shows the logo for Biobot. The logo features the word "biobot" in blue, with the "bio" portion in a slightly larger and bolder font than the "bot" portion. To the left of the word "biobot" is an orange oval shape, which appears to be a stylized representation of a sun or a cell. The logo is simple and modern, with a focus on the company name and a visual element that suggests biology or technology.

- Control the trajectory and depth for needle placement via needle guiding mechanism;
- Fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland;
- . Re-positioning of subsequent needle insertion for the same target lesion after the user has indicated the actual needle landing position from the prior insertion;
- . Visualization of simulated images in an interventional procedure of 1) the lesions and their margins and 2) the treatment zone;
- Patient movement adjustment function for re-alignment of the prostate model with the liveultrasound image in the event that prostate shifts due to patient movement during a procedure;
- . Connectivity to picture archiving and communication system (PACS) to download DICOM images and download/upload of procedure case; and
- Provide an offline post-procedure review

#### Modification to iSR'obot Mona Lisa 2.0

iSR'obot Mona Lisa 2.0 is modified:

- . Material change to the needle guide holder accessory from stainless steel 316L (intended to be reusable) to polycarbonate and stainless steel 304 (intended to be disposable).
- Needle guide holder is included as new component in the disposable kit. ●
- A new list of ultrasound transducers tested as compatible to iSR'obot Mona Lisa 2.0:

| Manufacturer | Compatible Transducer | 510(k) Number |
|----------------------------------------------------|-----------------------|---------------------------|
| B-K MEDICAL APS | BK 8848 | K132335 |
| B-K MEDICAL APS | BK 0948 | K173569, K180737, K223830 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 6L7Bs | K171579 |
| Hitachi Healthcare Americas Corporation | CL4416R | K171708, K181376 |

- Other minor changes such as the software updates, the inclusion of a Floor Stand Stabilizer, ● and an iSR'obot Biopsy Kit (K163502) in the system. These changes do not significantly affect the use of the device, nor do they raise new or additional safety risks. These changes are being implemented as a product improvement effort and not due to a corrective action or field action.

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Image /page/6/Picture/1 description: The image shows the logo for Biobot. The word "biobot" is written in lowercase letters. The "bio" part of the word is in orange, and the "bot" part of the word is in blue. The orange part of the word is also slightly larger than the blue part of the word.

# Substantial Equivalence

| Comparison Between Subject Device and Predicate Device | | |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristic | Predicate Device:<br>iSR'obot Mona Lisa 2.0<br>(K213411) | Submitted Device:<br>iSR'obot Mona Lisa 2.0<br>(K232320) |
| Intended Use /<br>Indications for Use | iSR'obot Mona Lisa 2.0 is a user-<br>controlled, stereotaxic accessory<br>intended to guide physicians in the<br>planning and positioning of<br>insertion tools, such as a third-<br>party needle or a probe, during<br>image-guided diagnostic and<br>interventional procedures in<br>conjunction with the guidance of<br>transrectal ultrasound involving the<br>prostate gland in a clinical setting.<br>Examples of such procedures<br>include, but are not limited to,<br>image fusion for diagnostic clinical<br>examinations and procedures, soft<br>tissue biopsies, and soft tissue<br>ablations.<br><br>The iSR'obot Mona Lisa 2.0<br>provides 2D and 3D visualization<br>of Ultrasound images and the<br>ability to fuse and register these<br>images with those from other<br>imaging modalities such as<br>Magnetic Resonance, etc. It also<br>provides the ability to display a<br>simulated image of an insertion<br>tool on a computer monitor screen,<br>the target organ, and the current<br>and projected future path of the<br>insertion tool taking into account<br>patient movement. Other software<br>features include multi-planar<br>reconstruction, segmentation,<br>image measurements, 2D/3D<br>image registration, and reporting. | Same |
| Product Code | IYO, ITX, LLZ, OIJ | Same |
| Class | II | Same |
| Target Anatomy | Prostate | Same |
| Comparison Between Subject Device and Predicate Device | | |
| Technological<br>Characteristic | Predicate Device:<br>iSR'obot Mona Lisa 2.0<br>(K213411) | Submitted Device:<br>iSR'obot Mona Lisa 2.0<br>(K232320) |
| Anatomy Access | Transperineal | Same |
| Patient population | Patients for a biopsy procedure<br>Patients for an interventional<br>procedure | Same |
| Clinical Utility | Soft tissue biopsies<br>Soft tissue ablations | Same |
| Software | | |
| Window OS | Yes | Same |
| Medical Imaging<br>Software | Yes | Same |
| Compliance with FDA<br>Cybersecurity | Yes | Yes (Updated Non-significant<br>Change) |
| Image Display | | |
| Multi-Modality<br>Support | Yes | Same |
| General Image 2D/3D<br>Review | Yes | Same |
| 3D Rendering View | Yes | Same |
| Live 2D Ultrasound | Yes | Same |
| Image Processing | | |
| Gland Segmentation | Yes | Same |
| Image Registration | Yes | Same |
| Rigid Registration | Yes | Same |
| Elastic Registration | Yes | Same |
| Multi-Planar<br>Reformatting | Yes | Same |
| Connectivity | | |
| DICOM Import/Export | Yes | Same |
| Review Tools | | |
| Comparison Between Subject Device and Predicate Device | | |
| Technological<br>Characteristic | Predicate Device:<br>iSR'obot Mona Lisa 2.0<br>(K213411) | Submitted Device:<br>iSR'obot Mona Lisa 2.0<br>(K232320) |
| Standard Image<br>Viewing Tools | Yes | Same |
| Measurement Tools | Yes | Same |
| Annotation Tools | Yes | Same |
| Segmentation Tools | Yes | Same |
| Reporting Tools | Yes | Same |
| Image Overlays | Yes | Same |
| Post Procedure Review | Yes | Same |
| Planning & Navigation | | |
| Import Prior Plans | Yes | Same |
| Import/Add Targets | Yes | Same |
| Plan / Mark Locations | Yes | Same |
| Navigation Type | Electromechanical…