K Number
K163502
Device Name
iSR'obot Biopsy Kit
Date Cleared
2017-05-16

(153 days)

Product Code
Regulation Number
892.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
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: 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 (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.
More Information

No
The device description focuses on the physical components of a biopsy kit (sheath, needle guide, drape) and their material properties and sterilization. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML. The performance studies described are related to mechanical safety, imaging through the sheath, and needle guide dimensions, not algorithmic performance.

No
The device is described as a biopsy kit, which includes components for guiding a needle and covering an ultrasound probe during a prostate biopsy. A biopsy is a diagnostic procedure, not a therapeutic one. The kit's function is to facilitate the collection of tissue for diagnosis (biopsy), not to treat a condition.

No

Explanation: The device description clearly states that the iSR'obot Biopsy Kit is a "consumables pack" including a probe sheath, needle guide, and drape, designed to be used with the iSR'obot Mona Lisa for performing biopsies. It facilitates the biopsy procedure and imaging but does not perform diagnostic functions itself.

No

The device description clearly outlines physical components (needle guide, probe sheath, drape) made of materials like polymethylpentene and polypropylene, and mentions sterilization and packaging. This indicates a hardware-based medical device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for performing image-guided transperineal biopsies of the prostate. This is a procedure to collect a tissue sample from the prostate.
  • Device Description: The components of the kit (needle guide, probe sheath, drape) are all accessories used during the biopsy procedure itself. They facilitate the collection of the sample.
  • Lack of In Vitro Function: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic purposes. This device does not perform any analysis or examination of a specimen in vitro. It is used in vivo (within the body) to obtain the specimen.
  • Biopsy Papers: While biopsy papers are mentioned, they are explicitly stated as "not considered a medical device" and are for collecting the specimen after it has been obtained.

The device is a medical device used in a surgical/interventional procedure, but it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes

ITX, OIJ

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

ItemDescription
Probe SheathNon-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 (

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

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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.

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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

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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)

Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
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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
79, Ayer Rajah Crescent,
#04-06, Singapore 139955
Primary Contact:Lai Chee Liew
Head of Quality and Regulatory Affairs
Biobot Surgical Pte Ltd
Telephone: +65 63511868
E-mail: laichee@zicomgroup.com

Product Identification

Device Trade Name:iSR'obot Biopsy Kit
Common / Usual Name:Biopsy Kit
Classification Names/:
Product Code:21 CFR 892.1570, Diagnostic Ultrasound Transducer /
ITX
21 CFR 892.1560, Ultrasonic pulsed echo imaging
system / OIJ (Biopsy Needle Guide Kit)
Predicate Device(s):K970515 CIVCO Latex Ultrasound Transducer Cover
(Primary Predicate)
K971115 Transrectal Needle/Biopsy Guide (Reference
Device)
K844472 Civco Scan Drape (Reference Device)
Manufacturer/Design Location:Biobot Surgical Pte Ltd
79 Ayer Rajah Crescent, #04-06
Singapore 139955

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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

ItemDescription
Probe SheathNon-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 (