(140 days)
Not Found
No
The summary describes image processing, registration, and robotic control, but does not mention AI or ML algorithms or capabilities.
No
Explanation: The device is described as an accessory to guide physicians in planning and positioning insertion tools, and it provides visualization and image fusion capabilities. It does not directly provide therapy. The therapy is administered by the physician using insertion tools.
No
The device is described as an accessory to guide physicians in the planning and positioning of insertion tools during image-guided diagnostic and interventional procedures, but it does not perform the diagnosis itself. Its function is to aid in the procedure by providing visualization, image fusion, and guidance for tools, which can be for diagnostic clinical examinations (e.g., biopsies), but it is not the diagnostic device.
No
The device description explicitly states the system consists of a workstation, robotic navigation module (comprising a motorized mechanical robotic arm, bed rail stabilizer or floor stand stabilizer), and disposables, in addition to the application software. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the iSR'obot Mona Lisa 2.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "stereotaxic accessory intended to guide physicians in the planning and positioning of insertion tools... during image-guided diagnostic and interventional procedures... involving the prostate gland." It facilitates procedures like biopsies and ablations, which are performed in vivo (within the living body).
- Device Description: The description details a system involving a robotic arm, workstation, and software for image processing, planning, and guiding the insertion of tools. This is consistent with a surgical or interventional guidance system, not a device that analyzes samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens such as blood, tissue, or other body fluids in vitro to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The iSR'obot Mona Lisa 2.0's function is to assist in procedures performed directly on the patient using imaging guidance.
N/A
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 multiplanar reconstruction, segmentation, image measurements, 2D/3D image registration, and reporting.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX, LLZ, OIJ
Device Description
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, Magnetic Resonance
Anatomical Site
Prostate gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Design and System Verification
- Software Verification and Validation
- Cybersecurity Testing
- Non-clinical System Performance Testing (system level testing using phantom)
- Biological evaluation and biocompatibility testing
- Sterilization validation
- Compatible evaluation for the new ultrasound transducers
- Accelerated Aging
- Other Non-Clinical Tests
No clinical data is submitted in support of this submission.
The subject device iSR'obot Mona Lisa 2.0 did not require clinical study, since substantial equivalence to the legally marketed predicate device iSR'obot Mona Lisa 2.0 (K213411) was demonstrated with the following attributes:
- Design features; .
- Intended Use; •
- . Indications for use;
- Fundamental scientific technology;
- . Non-clinical performance testing; and
- Safety and effectiveness. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
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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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| 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 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, |
| Singapore 139955 | |
| Primary Contact: | Lim Yan Shin |
| Regulatory Manager | |
| Biobot Surgical Pte Ltd | |
| Cell: +65 97263992 | |
| E-mail: limyanshin@biobotsurgical.com | |
| Secondary Contact: | Georgiann Keyport, Regulatory Consultant, U.S. |
| Email: gkeyport@canopyregulatory.com | |
| 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 |
| 892.1570 Diagnostic ultrasonic transducer | |
| Product Code: | IYO, ITX, LLZ, OIJ |
| Manufacturer / Design | Biobot Surgical Pte Ltd |
| Location: | 79 Ayer Rajah Crescent, #04-05, |
| 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 | ||
| Characteristic | Predicate Device: | |
| iSR'obot Mona Lisa 2.0 | ||
| (K213411) | Submitted Device: | |
| iSR'obot Mona Lisa 2.0 | ||
| (K232320) | ||
| 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. | Same |
| Product Code | IYO, ITX, LLZ, OIJ | Same |
| Class | II | Same |
| Target Anatomy | Prostate | Same |
| Comparison Between Subject Device and Predicate Device | | |
| Technological
Characteristic | Predicate Device:
iSR'obot Mona Lisa 2.0
(K213411) | Submitted Device:
iSR'obot Mona Lisa 2.0
(K232320) |
| Anatomy Access | Transperineal | Same |
| Patient population | Patients for a biopsy procedure
Patients for an interventional
procedure | Same |
| Clinical Utility | Soft tissue biopsies
Soft tissue ablations | Same |
| Software | | |
| Window OS | Yes | Same |
| Medical Imaging
Software | Yes | Same |
| Compliance with FDA
Cybersecurity | Yes | Yes (Updated Non-significant
Change) |
| Image Display | | |
| Multi-Modality
Support | Yes | Same |
| General Image 2D/3D
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
Reformatting | Yes | Same |
| Connectivity | | |
| DICOM Import/Export | Yes | Same |
| Review Tools | | |
| Comparison Between Subject Device and Predicate Device | | |
| Technological
Characteristic | Predicate Device:
iSR'obot Mona Lisa 2.0
(K213411) | Submitted Device:
iSR'obot Mona Lisa 2.0
(K232320) |
| Standard Image
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 | Same |
| Third-Party Devices Compatibility | | |
| Insertion Tools (e.g
needles and probes) | Yes | Same |
| Ultrasound Systems | Yes | Same |
| List of compatible
ultrasound systems | B-K MEDICAL - BK 8848 | Expanded list of compatible
ultrasound:
• B-K MEDICAL - BK 8848
• B-K MEDICAL - BK 0948
• Shenzhen Mindray - 6L7Bs
• Hitachi - CL4416R |
| Hardware | | |
| Workstation | Yes | Same |
| Mechanical Arm for
Positioning of Insertion
Tool | Yes. Robotic. | Same |
| Stabilizer | Bed Rail Stabilizer | • Bed Rail Stabilizer
• Floor Stand Stabilizer (New) |
| Accessory & Disposable | | |
| Needle Guide Holder | Yes | No (removed and added in the
disposables) |
| Comparison Between Subject Device and Predicate Device | | |
| Technological
Characteristic | Predicate Device:
iSR'obot Mona Lisa 2.0
(K213411) | Submitted Device:
iSR'obot Mona Lisa 2.0
(K232320) |
| Proprietary Disposables | iSR'obot Kit | iSR'obot Kit (updated)iSR'obot Biopsy Kit
(K163502) |
| Needle Guide Holder
Material | Stainless Steel 316 L | Polycarbonate and stainless steel
304 |
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Image /page/7/Picture/1 description: The image shows the word "biobot" in a stylized font. The "bio" part of the word is in orange and the "bot" part is in blue. There is an orange oval shape behind the word "bio" that fades into the background.
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Image /page/8/Picture/1 description: The image shows the logo for Biobot Analytics. The logo features the word "biobot" in a lowercase, sans-serif font. The "bio" portion of the word is colored in a gradient that transitions from orange to yellow, while the "bot" portion is colored in blue. The logo has a clean and modern design.
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Image /page/9/Picture/1 description: The image shows the logo for Biobot Analytics. The logo features the word "biobot" in lowercase letters. The "bio" portion of the word is in orange, while the "bot" portion is in blue. The "bio" portion is also slightly larger than the "bot" portion. The logo is simple and modern.
The technological characteristics such as intended use, indications for use, method of operation, general function, and application of the subject device iSR 'obot Mona Lisa 2.0 are equivalent to the cleared predicated device iSR'obot Mona Lisa 2.0 (K213411). Risk analysis was conducted to evaluate the modifications and features update in iSR 'obot Mona Lisa 2.0. All verification and validation activities were performed, and the results demonstrated substantial equivalence.
Safety and Effectiveness
The 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 Biobot Surgical's Risk Management procedure, which is used to identify potential hazards as a result of the proposed changes. These potential hazards are controlled through the product development process, verification, and validation testing to ensure the safe profile of iSR'obot Mona Lisa 2.0.
Non-Clinical Testing
Biobot performed the following testing to ensure the safety and effectiveness of iSR'obot Mona Lisa 2.0 using well-established methods based on FDA recognized standards:
- . Design and System Verification - To ensure new modification meets the specifications and its intended purpose
- Software Verification and Validation - To ensure all software updates meets the specifications and the intended purpose. Software life cycle process is in accordance with IEC 62304:2006+A1:2015 Ed 1.1
- . Cybersecurity Testing - Testing conducted in accordance with ANSI UL 2900-1 and ANSI UL 2900-2-1
- . Non-clinical System Performance Testing (system level testing using phantom) -Testing conducted to demonstrate that system is able to accurately position the needle with the new needle guide holder and iSR'obot Biopsy Kit.
- Biological evaluation and biocompatibility testing - Evaluation and testing conducted in accordance with ISO 10993-1:2018.
- . Sterilization validation - Validation conducted in accordance with ISO 11135:2014
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Image /page/10/Picture/1 description: The image shows the word "biobot" in a stylized font. The "bio" part of the word is in a darker blue color, while the "bot" part is in a lighter blue. There is an orange oval shape behind the word, which gives the impression of a sun or a planet. The overall design is clean and modern.
- . Compatible evaluation for the new ultrasound transducers – compatibility evaluation conducted with the new ultrasound transducers (eg image quality, acoustic output, physical integrity with the holder)
- . Accelerated Aging - accelerated aging, post-packaging and functional test conducted for the kit to demonstrate shelf life of 2 years
- ASTM F1980-21 O
- ASTM F1886/F1886M-16 O
- O ASTM F2906-11 (2019)
- ASTM F1929-15 O
- o ASTM F88/F88M-21
- Other Non-Clinical Tests
- ISO 14971:2019 O
- ISTA 3A 2018 o
●
Clinical Performance
No clinical data is submitted in support of this submission.
The subject device iSR'obot Mona Lisa 2.0 did not require clinical study, since substantial equivalence to the legally marketed predicate device iSR'obot Mona Lisa 2.0 (K213411) was demonstrated with the following attributes:
- Design features; .
- Intended Use; •
- . Indications for use;
- Fundamental scientific technology;
- . Non-clinical performance testing; and
- Safety and effectiveness. .
Conclusion
Comparison of the intended use, indications for use, technological characteristics, and performance specifications demonstrate the functional equivalence of subject device iSR 'obot Mona Lisa 2.0 to the legally marketed predicate device, iSR 'obot Mona Lisa 2.0 (K213411).
Based on the conformance to standards, development under Biobot's quality system, and the successful verification and non-clinical testing, iSR 'obot Mona Lisa 2.0 does not raise different questions of safety and/or effectiveness. Biobot believes that the iSR'obot Mona Lisa 2.0 performs substantially equivalent to the predicate device.