iSR'obot Biopsy Kit

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profile graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 16, 2017 Biobot Surgical Pte Ltd % Ms. Lai Chee Liew Head of Quality and Regulatory Affairs 79, Ayer Rajah Crescent #04-06, Singapore 139955 SINGAPORE Re: K163502 Trade/Device Name: iSR'obot Biopsy Kit Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: II Product Code: ITX, OIJ Dated: April 25, 2017 Received: May 1, 2017 Dear Ms. Liew: 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. 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. 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163502 Device Name iSR'obot Biopsy Kit #### Indications for Use (Describe) The iSR'obot Biopsy Kit (consisting of a needle guide, a probe sheath and a drape) is intended to be used with the iSR'obot Mona Lisa (K130944) for performing image guided transperineal biopsies of the prostate. Type of Use (Select one or both, as applicable) | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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. 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The orange portion is also slightly larger and has a rounded shape, resembling a sun or a drop of liquid. # 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 807.92. | Date: | May 16, 2017 | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Biobot Surgical Pte Ltd<br>79, Ayer Rajah Crescent,<br>#04-06, Singapore 139955 | | Primary Contact: | Lai Chee Liew<br>Head of Quality and Regulatory Affairs<br>Biobot Surgical Pte Ltd<br>Telephone: +65 63511868<br>E-mail: laichee@zicomgroup.com | ### Product Identification | Device Trade Name: | iSR'obot Biopsy Kit | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Common / Usual Name: | Biopsy Kit | | Classification Names/:<br>Product Code: | 21 CFR 892.1570, Diagnostic Ultrasound Transducer /<br>ITX<br>21 CFR 892.1560, Ultrasonic pulsed echo imaging<br>system / OIJ (Biopsy Needle Guide Kit) | | Predicate Device(s): | K970515 CIVCO Latex Ultrasound Transducer Cover<br>(Primary Predicate) | | | K971115 Transrectal Needle/Biopsy Guide (Reference<br>Device) | | | K844472 Civco Scan Drape (Reference Device) | | Manufacturer/Design Location: | Biobot Surgical Pte Ltd<br>79 Ayer Rajah Crescent, #04-06<br>Singapore 139955 | {4}------------------------------------------------ 510(k) Premarket Notification Submission - iSR'obot Biopsy Kit Image /page/4/Picture/2 description: The image shows the word "biobot" in a stylized font. The "bio" part of the word is in orange and is partially obscured by an oval shape. The "bot" part of the word is in blue. The logo appears to be for a company or organization named Biobot. ## Device Description The iSR'obot Biopsy Kit is a consumables pack consisting of three (3) separate singleuse items designed to be used with the iSR'obot Mona Lisa (K130944). #### Contents of the Biopsy Kit | Item | Description | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Probe Sheath | Non-active invasive device made of medical grade TPX (polymethylpentene). The open end of the sheath is intended to be connected to the end of the probe platform of Mona Lisa and its closed end is to be inserted into the patient's rectum for transient use (< 1 hour) during the prostate biopsy process. The device functions as a sheath to an ultrasound probe providing a stabilized channel for ultrasound scanning of the prostate organ. | | Needle Guide<br>(for 18G needle) | Non-active non-invasive device medical grade PP (Polypropylene). It is to be mounted on the Mona Lisa, functioning as a channel for a biopsy needle. The head of the needle guide will touch the pivot point (puncture hole) on the patient's perineal skin during the biopsy process | | Drape | An accessory made of plastic (Low Density Polyethylene - Titanlene) with silicone rings. It is intended to be used as a cover for the iSR'obot Mona Lisa during the biopsy process for the purpose of prevention of contamination. | The components are assembled into a Tyvek Film Pouch which is made up of Tyvek 1059B and a PET/PE laminated 52µm transparent film. The Tyvek 1059B is highly resistant to penetration by bacterial spores and other contaminating microorganisms. Microbial barrier test conducted on the Tyvek film pouch showed that the pouch can maintain sterility for the 3 years shelf-life of the Biopsy kit if packaging integrity is not compromised. The final kit assembled in a cleanroom is sterilized using ethylene oxide. Biopsy Papers (not considered a medical device) are included with the kit as a convenience to the user. The hospital has the option of using biopsy specimen collection products generally supplied in the hospital. ## Hardware Description There is no hardware component in the Biopsy Kit ## Intended Use The iSR'obot Biopsy Kit is intended to be used with the iSR'obot Mona Lisa (K130944). The probe sheath provide a protective cover system for the ultrasound transducer usage in the rectum to prevent microbial and other contamination. The needle guide serves as a guidance for a biopsy needle during the procedure. {5}------------------------------------------------ 510(k) Premarket Notification Submission - iSR'obot Biopsy Kit Image /page/5/Picture/2 description: The image shows the logo for Biobot. The logo features the word "biobot" in a lowercase, sans-serif font. The "bio" portion of the word is in a bright orange color and is tilted slightly upwards, while the "bot" portion is in a darker blue color. The orange part of the logo is also shaped like a rounded oval, giving it a dynamic and modern appearance. #### Indications for Use The iSR'obot Biopsy Kit (consisting of a needle guide, probe sheath and drape) is intended to be used with the iSR'obot Mona Lisa (K130944) for performing image guided transperineal biopsies of the prostate. ## Technology The subject and predicate devices are designed for secure and aligned fit to the transducer and biopsy needle while not altering transducer nor biopsy needle design integrity nor function. The table below outlines the major subsystem differences andsimilarities. #### 1. Probe Sheath | | Predicate Device:<br>CIVCO Latex<br>Ultrasound<br>Transducer Cover | Proposed Device:<br>iSR'obot Biopsy Kit | Discussion<br>of<br>Similarities | |-------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------| | Manufacturer | Civco | Biobot | | | 510(k) number | K970515 | Pending | | | Where Used | Hospital | Hospital | Same | | Intended Use | Protective cover or<br>sheath placed over<br>diagnostic transducer/<br>probe instruments | The probe sheath<br>provide a protective<br>cover system for the<br>ultrasound transducer. | Same | | Material | Natural rubber latex | Medical grade TPX<br>(polymethylpentene) | - | | Manufacturing | Dip-molding | Injection molding | | | Sterility | ETO | ETO | Same | | Biocompatibility | ISO10993 | ISO10993. | Same | | Disposition | Disposable | Disposable | Same | | Human Factor | No Known Adverse<br>Effects | No Known Adverse<br>Effects | Same | | Chemical Safety | Latex material<br>formulations conform to<br>US FDA CFR, Title 21,<br>Section 177.2600 | No Hazardous<br>Components<br>29CFR1910, 1200 | | | Mechanical Safety | Material strength and<br>elasticity is adequate to<br>allow use without tearing<br>or pinholing the cover | Material strength and<br>elasticity is adequate to<br>allow use without<br>breaking or cracking<br>the sheath | Same | | Anatomical site | Body surface, endocavity<br>where ultrasound is used | Rectum where<br>ultrasound probe goes<br>in to scan the prostate | Similar | {6}------------------------------------------------ Image /page/6/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. The "bio" part is also slightly larger than the "bot" part. The word is slightly tilted to the right. 510(k) Premarket Notification Submission - iSR'obot Biopsy Kit #### 2. Needle Guide | | Predicate Device:<br>Transrectal<br>Needle/Biopsy Guide | Proposed Device:<br>iSR'obot Biopsy Kit | Discussion<br>of<br>Similarities | |-------------------------|---------------------------------------------------------|----------------------------------------------|----------------------------------| | Manufacturer | Protek Medical Products<br>Inc. | Biobot | | | 510(k) number | K041637 | Pending | | | Where Used | Hospital | Hospital | Same | | Intended Use | Ultrasound transducer<br>needle guide | Biopsy needle guide | Similar | | Materials | Stainless Steel;<br>Medical Grade Plastic | Medical Grade PP<br>(Polypropylene) | - | | Sterility | ETO | ETO | Same | | Biocompatibility | ISO10993 | ISO10993 | Same | | Chemical Safety | No Hazardous<br>Components<br>29CFR1910,1200 | No Hazardous<br>Components<br>29CFR1910,1200 | Same | | Anatomical Sites | Where Ultrasound is<br>Used | Perineal Area (Skin) | - | | Manufacturing<br>Method | Injection molded clips | Injection molded | Same | | Human Factor | No Known Adverse<br>Effects | No Known Adverse<br>Effects | Same | ## 3. Drape | | Predicate Device:<br>Civco Scan Drape | Proposed Device:<br>iSR'obot Biopsy Kit | Discussion<br>of<br>Similarities | |---------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------| | Manufacturer | Civco | Biobot | | | 510(k) number | K844472 | Pending | | | Where Used | Hospital | Hospital | Same | | Intended Use | Protective Cover or<br>sheath placed over<br>equipment to help<br>prevent transfer of<br>microorganisms, body<br>fluids, etc | Cover for the iSR'obot<br>Mona Lisa for the<br>purpose of prevention of<br>contamination | Same | | Materials | Polyethylene | Low Density<br>Polyethylene | Same | | Sterility | ETO | ETO | Same | | Human Factor | No Known Adverse<br>Effects | No Known Adverse<br>Effects | Same | {7}------------------------------------------------ 510(k) Premarket Notification Submission - iSR'obot Biopsy Kit Image /page/7/Picture/2 description: The image shows the logo for Biobot. The logo consists of the word "biobot" in lowercase letters. 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". #### Determination of Substantial Equivalence #### Summary of Non-Clinical Tests Testing on the probe sheath in the iSR'obot Biopsy Kit involved laboratory stress test to demonstrate mechanical safety. Performance testing to demonstrate effective ultrasound imaging of the prostate gland through the probe sheath was done using a phantom (comparison of ultrasound images with and without the probe sheath); as well as a review of images obtained during the clinical trial conducted for the main device - iSR'obot Mona Lisa (K130944). The needle quide only serves as a channel for an 18 gauge biopsy needle. The physical dimensions were verified to ensure that an 18 gauge needle can pass through and any deflection of the needle is within the specified tolerance. Additionally both the probe sheath and needle guide met biocompatibility requirements specified by ISO 10993-01. Environmental, packaging, shipping, shelf-life and sterilization requirements were met through validations performed by a certified laboratory. The iSR'obot Biopsy Kit consists of accessories which are the same as devices being marketed legally by several companies. The Biopsy Kit complies with voluntary standards as detailed in this premarket notification submission. It also successfully completed all testing per our quality system and it was designed and manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system: - . Risk Analysis - Requirements Reviews ● - Design Reviews ● - Usability Analysis . - Performance testing (Verification) . Biobot believes that the Biopsy Kit is of comparable type and substantially equivalent to the predicate devices identified. {8}------------------------------------------------ 510(k) Premarket Notification Submission - iSR'obot Biopsy Kit Image /page/8/Picture/2 description: The image shows the logo for Biobot Analytics. The logo features the word "biobot" in a stylized font. The "bio" part of the word is in orange, while the "bot" part is in blue. The orange portion is also slightly larger and bolder than the blue portion. The logo has a clean and modern design. | | Predicate Devices:<br>1. CIVCO Latex Ultrasound<br>Transducer Cover<br>2. Transrectal Needle/ Biopsy Guide<br>3. Civco Scan Drape | Proposed Device:<br>iSR'obot Biopsy Kit | Discussion | |--------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Intended Use | 1. Protective cover or sheath placed over diagnostic transducer/ probe instruments | 1. The probe sheath provide a protective cover system for the ultrasound transducer | The intended use of the iSR'obot Biopsy Kit is substantially equivalent to the predicate devices | | | 2. Ultrasound transducer needle guide | 2. The needle guide serves as a guidance for a biopsy needle during the procedure | | | | 3. Protective Cover or sheath placed over equipment to help prevent transfer of microorganisms, body fluids, etc | 3. The drape is a cover for the iSR'obot Mona Lisa during the biopsy process for the purpose of prevention of contamination | | #### Conclusion Biobot Surgical Pte Ltd believes that the iSR'obot Biopsy Kit is substantially equivalent with regard to Intended use and other key features including safety and effectiveness to the predicate devices.