(64 days)
Not Found
Unknown
The description mentions an "automatic surface detection" tool for prostate segmentation. While this could be implemented using traditional image processing techniques, it is also a common application for AI/ML. Without further detail or explicit mention of AI/ML, it's impossible to definitively confirm its presence.
No
The device serves as a biopsy needle guide only and assists the surgeon in performing a biopsy, which is a diagnostic procedure, not a therapeutic one. The device description explicitly states it is for "targeted transperineal prostate biopsy."
No
The device is described as a "biopsy needle guide only" and focuses on assisting in the physical act of performing a biopsy, not on interpreting or analyzing medical data to determine a diagnosis. Its function is to guide the needle for tissue collection, which is then typically analyzed for diagnosis elsewhere.
No
The device description explicitly states it is a "platform-hosted motorized device integrating a probe-driving system" and a "precise biopsy guidance mechanism (biopsy needle platform)," indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The iSR'obot Mona Lisa is a robotic system designed to assist a physician in performing a transperineal prostate biopsy. It acts as a needle guide and provides imaging assistance.
- Nature of the Procedure: A biopsy is a surgical procedure where a tissue sample is physically removed from the body. The device facilitates this surgical procedure.
- Lack of Sample Analysis: The device itself does not analyze any biological samples. It assists in the collection of a sample, but the analysis of that sample (which would be the IVD part) is done separately in a laboratory.
The device is a surgical assist device or a medical device for image-guided intervention, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
iSR'obot Mona Lisa is intended for use by a trained urologist or physician to perform the computerassisted 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 BMode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.
Product codes
IYO, ITX
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 quide 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
transrectal ultrasound
Anatomical Site
prostate
Indicated Patient Age Range
adult males
Intended User / Care Setting
trained urologist or physician
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: 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
iSR'obot Mona Lisa (K111347)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
iSR'obot Mona Lisa
Special 510k Premarket Application
Section 5: 510(k) Summary
JUN 0 7 2013
The following information is provided as required by 21 CFR § 807.87 for the iSR'obot Mona Lisa 510(k) premarket notification.
- BioBot Surgical Pte Ltd. Sponsor: 2 Woodlands Spectrum #03-10 Woodlands Sector1, Singapore 738068 Establishment Registration: Pending
Contact: Quality Systems and Solutions Pte Ltd 20 Maxwell Road, #09-17,Maxwell House Singapore 069113
Phone: +65 31507191 +65 6507 0368 (Attn: Biobot Surgical Pte Ltd) Fax: Email: john@quasys.net
Date of Submission: April 2, 2013 Proprietary Name: iSR'obot Mona Lisa Common Name: system, image processing, radiological Regulatory Class: II Regulation(s): 892.1560 Ultrasonic pulsed echo imaging system
892.1570 Diagnostic ultrasonic transducer
Product Codes: IYO, ITX
Panel: Radiology
Predicate Device: iSR'obot Mona Lisa (K111347)
pg. 10
1
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 quide 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.
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 BMode, 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 compared to those of predicate device: Like iSR'obot Mona Lisa (K111347), the modified device utilizes similar technology to acquire transrectal ultrasound image to plan and guide a prostate biopsy procedure. Both devices are platform hosted motorized device and are able to provide transverse view, sagittal view and 3D view of prostate gland. Regarding to the needle guiding mechanism, both iSR and modified device can identify the direction and depth for biopsy needle. Thus the fundamental scientific technology of both iSR'obot Mona Lisa (K111347) and the modified device are the same.
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.
pg. 11
2
iSR'obot Mona Lisa
pg. 12
Clinical Performance: No clinical data is submitted in support of this submission.
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. «
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
Biobot Surgical Pte Ltd. % Mr. John Baby Chief Consultant Quality Systems and Solutions Pte Ltd. 20 Maxwell Road, #09-17, Maxwell House SINGAPORE 069113
Re: K130944
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, ITX Dated: May 22, 2013 Received: May 31, 2013
Dear Mr. Baby:
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. Jisting.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 mav 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
4
Page 2 - Mr. Baby
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely vours.
for
Janine M. Morris Director, Division of Radiological Health Office of In-Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130944
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 computerassisted 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 BMode, and a third party prostate biopsy gun and needle. The insertion of biopsy needle will be done by urologist.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sm.h.7)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
K130944 510(k) _
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