(91 days)
iSR'obot Mona Lisa is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports B-Mode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.
iSR'obot Mona Lisa is a platform-hosted motorized device integrating a probe-driving system for 3-D image collection and a precise biopsy guidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle guide only.
The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians by hands-free image acquisition. The prostate segmentation tool allows a manual or automatic surface detection from the 3D image, based on which the prostate volume is calculated and the systematic biopsy plan is generated. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture.
The provided text describes the iSR'obot Mona Lisa device and its 510(k) submission but does not include specific acceptance criteria or an explicit study proving performance against those criteria. The document states that "No clinical data is submitted in support of this submission." and that substantial equivalence is based on "comparison of the regulatory characteristics, product technical characteristics, and performance." It primarily highlights non-clinical testing.
Therefore, for many of your questions, the information is not available in the provided text.
Here's what can be extracted based on the given document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in the document. The submission focuses on substantial equivalence to predicate devices and non-clinical testing. | Bench and simulated use testing, including phantom testing, confirm that the subject device performs as intended and is substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. The document states, "No clinical data is submitted in support of this submission." and refers to "bench and simulated use testing, including phantom testing." The sample size for these non-clinical tests is not specified.
- Data provenance: Not applicable/Not provided. Since no clinical data was submitted, there is no information on country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. As no clinical data with human expert-adjudicated ground truth was submitted, this information is not available.
4. Adjudication method for the test set
- Not applicable/Not provided. No clinical test set requiring adjudication is mentioned.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "No clinical data is submitted in support of this submission."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies that non-clinical testing (bench and simulated use, including phantom testing) was performed to assess the device's performance "as intended." However, it doesn't explicitly describe a "standalone" algorithmic performance in the context of image analysis (e.g., sensitivity/specificity of an automated detection system), but rather the mechanical and functional performance of the robotic system as a biopsy guide. The "prostate segmentation tool allows a manual or automatic surface detection from the 3D image" suggesting an algorithmic component, but no performance metrics for this specific function are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical "bench and simulated use testing, including phantom testing," the ground truth would typically be established by the known physical properties and design specifications of the phantoms and the expected mechanical outputs of the device. This is generally a physical truth rather than a clinical one. No clinical ground truth (like pathology or outcomes) was used as no clinical data was submitted.
8. The sample size for the training set
- Not applicable/Not provided. No information is given about a "training set" in the context of machine learning. While the device has an "automatic surface detection" tool, no details about its development or training data are provided.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as no information on a training set or its ground truth establishment is given.
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Section 5: 510(k) Summary
AUG 1 2 2011
The following information is provided as required by 21 CFR § 807.87 for the iSR'oboot Mona Lisa 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
Sponsor: BioBot Surgical Pte Ltd. Blk 55, Ayer Rajah Crescent #06-09 Singapore 139949 Establishment Registration: not yet assigned
Contact: M Squared Associates, Inc. Cherita James 901 King Street, Suite 200 Alexandria, VA 22314 Ph. 703-562-9800 Ext 257 Fax. 703-562-9797 Clames@MSquaredAssociates.com
Date of Submission: May 11, 2011
Proprietary Name: iSR'obot Mona Lisa
Common Name: system, irrage processing, radiological
Regulatory Class: II
Regulation(s): 892.1560 Ultrasonic pulsed echo imaging system
892.1570 Diagnostic ultrasonic transducer
Product Codes: IYO, ITX
Predicate Device(s): Envisioneering, LLC TargetScan Transrectal Ultrasound System K041639 and TargetScan Biopsy needle guide K041637
Device Description: iSR'obot Mona Lisa is a platform-hosted motorized device integrating a probe-driving system for 3-D image collection and a precise biopsy guidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle guide only.
The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians by hands-free image acquisition. The prostate segmentation tool
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allows a manual or automatic surface detection from the 3D image, based on which the prostate volume is calculated and the systematic biopsy plan is generated. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture.
Indications for Use: iSR'obot Mona Lisa is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under transrectal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports B-Mode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.
Intended Use: iSR'obot Mona Lisa serves as a biopsy needle guide to assist the surgeon in performing targeted transperineal prostate biopsy in adult males in conjunction with the guidance of transrectal ultrasound.
Technological Characteristics: Like TargetScan Transrectal Ultrasound System (K041639), the iSR'obot Mona Lisa utilizes similar technology to acquire transrectal ultrasound image to plan and guide a prostate biopsy procedure. Both devices provide transverse view, sagittal view and 3D view of prostate gland.
Regarding to the needle guiding mechanism, both iSR'obot Mona Lisa and TargetScan Biopsy needle guide (K041637) can identify the direction and depth for biopsy needle. Unlike TargetScan Biopsy needle guide (K041637) to adjust the direction and depth rranually, iSR'obot Mona Lisa employs a 4-degree-of-freedom robotic guiding mechanism to identify the direction and depth of the biopsy needle.
Non-clinical Testing: Bench and simulated use testing, including phantom testing, confirm that the subject device performs as intended and is substantially equivalent to the predicate devices.
Clinical Performance: No clinical data is submitted in support of this submission.
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Substantial Equivalence/Conclusions:
The claim of substantial equivalence of iSR'obot Mona Lisa to the products identified above is based on the comparison of the regulatory characteristics, product technical characteristics, and performance.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
BioBot Surgical PTE Ltd. % Ms. Cherita James Regulatory Consultant M Squared Associates, Inc. 901 King St., Suite 200 ALEXANDRÍA VA 22314
AUG 1 2 2011
Re: K111347
Trade/Device Name: iSR'obot Mona Lisa Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: May 11, 2011 Received: May 16, 2011
Dear Ms. James:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K111347
Device Name: iSR'obot Mona Lisa
Indications for Use: iSR'obot Mona Lisa is intended for use by a trained urologist or physician to perform the computer-assisted transperineal prostate biopsy under trivitise cal ultrasound guidance. The device serves as a biopsy needle guide only. It shall be used in conjunction with a third party ultrasound machine and endorectal probe that supports B-Mode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Mury Slattl
(Division Sign-Off)
Division of the Office of In
510K
§ 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.