(140 days)
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 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.
The provided document indicates that the Biobot Surgical Pte Ltd iSRobot Mona Lisa 2.0is being submitted for 510(k) clearance based on its substantial equivalence to a legally marketed predicate device,iSRobot Mona Lisa 2.0 (K213411). The submission does not include clinical data, and therefore, no study proving device meets acceptance criteria based on clinical performance with human subjects. Instead, it relies on non-clinical testing to demonstrate that modifications to the device do not raise new questions of safety or effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics of the device as if it were a new device seeking initial clearance. Instead, it states that
All verification and validation activities were performed, and the results demonstrated substantial equivalence.
The acceptance criteria are implicitly tied to meeting the specifications and intended purpose of the modified components and software, and ensuring safety and effectiveness as compared to the predicate.
The reported device performance is described as:
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](https://510k.innolitics.com/device/K213411)).
Specific non-clinical testing performed includes:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Design and System Verification (Meet specifications and intended purpose) | Ensure new modification meets the specifications and its intended purpose |
| Software Verification and Validation (Meet specifications and intended purpose; IEC 62304:2006+A1:2015 Ed 1.1 compliant) | 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 (Compliance with ANSI UL 2900-1 and ANSI UL 2900-2-1) | Testing conducted in accordance with ANSI UL 2900-1 and ANSI UL 2900-2-1 |
| Non-clinical System Performance Testing (Accurate needle positioning with new components) | 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 (Compliance with ISO 10993-1:2018) | Evaluation and testing conducted in accordance with ISO 10993-1:2018 |
| Sterilization Validation (Compliance with ISO 11135:2014) | Validation conducted in accordance with ISO 11135:2014 |
| Compatible Evaluation for New Ultrasound Transducers (Image quality, acoustic output, physical integrity) | Compatibility evaluation conducted with the new ultrasound transducers (e.g., image quality, acoustic output, physical integrity with the holder) |
| Accelerated Aging (To demonstrate 2-year shelf life, compliance with ASTM standards) | Accelerated aging, post-packaging and functional test conducted for the kit to demonstrate shelf life of 2 years (ASTM F1980-21, ASTM F1886/F1886M-16, ASTM F2906-11 (2019), ASTM F1929-15, ASTM F88/F88M-21) |
| Other Non-Clinical Tests (Compliance with ISO 14971:2019, ISTA 3A 2018) | ISO 14971:2019, ISTA 3A 2018 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The submission explicitly states:
No clinical data is submitted in support of this submission.
Therefore, there is no clinical test set, sample size, or data provenance provided from human subjects. The non-clinical testing was performed on physical components (e.g., phantom for system performance, materials for biocompatibility, packaging for aging) and software. The document does not specify the sample sizes of these non-clinical tests (e.g., how many phantoms were used, how many samples of materials were tested).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since no clinical data was submitted, there was no human-established ground truth for a clinical test set in this submission. The ground truth for non-clinical testing would typically be engineering specifications, established scientific principles, or recognized standards. The document does not specify if external experts were used for these non-clinical tests or their qualifications, beyond stating that testing was done using "well-established methods based on FDA recognized standards."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No clinical studies, including MRMC studies, were conducted or submitted. The device is a "user-controlled, stereotaxic accessory" for guidance during procedures, not a diagnostic AI tool that assists human readers in image interpretation for which an MRMC study would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an algorithm-only device. It is a "user-controlled" system intended "to guide physicians." Its performance is inherently linked to human interaction. The non-clinical system performance testing used a phantom, which could be considered a form of standalone technical performance evaluation of the robot's accuracy in positioning, but it's not a standalone diagnostic algorithm performance as typically meant in AI contexts.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical system performance testing, the "ground truth" would have been the known, precise target locations within the phantom or the expected trajectory accuracy as per engineering specifications. The document states: Testing conducted to demonstrate that system is able to accurately position the needle with the new needle guide holder and iSR’obot Biopsy Kit. This implies comparison against a predefined accurate position.
For other non-clinical tests (biocompatibility, sterilization, aging, cybersecurity, software), the ground truth is adherence to the specified technical standards (e.g., ISO 10993-1:2018, ISO 11135:2014, IEC 62304:2015, ANSI UL 2900-1, etc.) or internal design specifications.
8. The sample size for the training set
Not applicable in the context of this 510(k) submission. While the device involves "software updates" and "application software" with functions like "segmentation" and "image registration" (which often use machine learning requiring training data), the document does not discuss the development of new AI algorithms or models that would necessitate a training set in this submission. The modifications described are primarily mechanical (needle guide holder material, stabilizer), software updates for existing functionalities, and compatibility expansions, rather than the introduction of new AI-driven diagnostic or analytical capabilities that would typically require a training set discussion.
9. How the ground truth for the training set was established
Not applicable, as no training set details were provided.
{0}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 ShinRegulatory ManagerBiobot Surgical Pte LtdCell: +65 97263992E-mail: limyanshin@biobotsurgical.com |
| Secondary Contact: | Georgiann Keyport, Regulatory Consultant, U.S.Email: gkeyport@canopyregulatory.comCell: 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 system892.1570 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
{4}------------------------------------------------
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;
{5}------------------------------------------------
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.
{6}------------------------------------------------
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 | ||
|---|---|---|
| TechnologicalCharacteristic | 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 accessoryintended to guide physicians in theplanning and positioning ofinsertion tools, such as a third-party needle or a probe, duringimage-guided diagnostic andinterventional procedures inconjunction with the guidance oftransrectal ultrasound involving theprostate gland in a clinical setting.Examples of such proceduresinclude, but are not limited to,image fusion for diagnostic clinicalexaminations and procedures, softtissue biopsies, and soft tissueablations.The iSR'obot Mona Lisa 2.0provides 2D and 3D visualizationof Ultrasound images and theability to fuse and register theseimages with those from otherimaging modalities such asMagnetic Resonance, etc. It alsoprovides the ability to display asimulated image of an insertiontool on a computer monitor screen,the target organ, and the currentand projected future path of theinsertion tool taking into accountpatient movement. Other softwarefeatures include multi-planarreconstruction, segmentation,image measurements, 2D/3Dimage 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 | ||
| TechnologicalCharacteristic | 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 procedurePatients for an interventionalprocedure | Same |
| Clinical Utility | Soft tissue biopsiesSoft tissue ablations | Same |
| Software | ||
| Window OS | Yes | Same |
| Medical ImagingSoftware | Yes | Same |
| Compliance with FDACybersecurity | Yes | Yes (Updated Non-significantChange) |
| Image Display | ||
| Multi-ModalitySupport | Yes | Same |
| General Image 2D/3DReview | 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-PlanarReformatting | Yes | Same |
| Connectivity | ||
| DICOM Import/Export | Yes | Same |
| Review Tools | ||
| Comparison Between Subject Device and Predicate Device | ||
| TechnologicalCharacteristic | Predicate Device:iSR'obot Mona Lisa 2.0(K213411) | Submitted Device:iSR'obot Mona Lisa 2.0(K232320) |
| Standard ImageViewing 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.gneedles and probes) | Yes | Same |
| Ultrasound Systems | Yes | Same |
| List of compatibleultrasound systems | B-K MEDICAL - BK 8848 | Expanded list of compatibleultrasound:• B-K MEDICAL - BK 8848• B-K MEDICAL - BK 0948• Shenzhen Mindray - 6L7Bs• Hitachi - CL4416R |
| Hardware | ||
| Workstation | Yes | Same |
| Mechanical Arm forPositioning of InsertionTool | 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 thedisposables) |
| Comparison Between Subject Device and Predicate Device | ||
| TechnologicalCharacteristic | 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 HolderMaterial | Stainless Steel 316 L | Polycarbonate and stainless steel304 |
{7}------------------------------------------------
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.
{8}------------------------------------------------
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.
{9}------------------------------------------------
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
{10}------------------------------------------------
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.
§ 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.