(153 days)
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.
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.
The provided text describes the 510(k) submission for the iSR'obot Biopsy Kit, which consists of a needle guide, a probe sheath, and a drape. It establishes substantial equivalence to predicate devices rather than presenting a study proving performance against acceptance criteria for an AI-powered device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving an AI device meets them cannot be fully provided from the given text.
However, I can extract the information related to the device itself and its testing, and then explain why a full answer to your prompt is not possible with the provided document.
Based on the provided document, here's what can be extracted regarding acceptance criteria and device testing:
This document is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria for a novel AI device through a clinical study with detailed statistical outcomes.
The testing described is primarily for the physical components of the iSR'obot Biopsy Kit (probe sheath, needle guide, drape) and their functionality, biocompatibility, and sterility, which are typical for consumable medical devices. It does not describe an AI device, an AI-powered component, or an MRMC study.
Here's a breakdown of the requested information, adapted to what is (and isn't) available in the text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the format typically seen for AI device performance (e.g., sensitivity, specificity, AUC thresholds). Instead, it discusses the functional and safety requirements for a physical medical device kit and reports on non-clinical tests to meet these.
| Component | Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|---|
| Probe Sheath | - Mechanical safety (withstand stress) - Effective ultrasound imaging through the sheath - Biocompatibility (ISO 10993-01) - Environmental, packaging, shipping, shelf-life, and sterilization requirements | - Laboratory stress tests demonstrated mechanical safety. - Performance testing showed effective ultrasound imaging of the prostate gland through the probe sheath using a phantom. - Reviewed images obtained during the clinical trial of the main device (iSR'obot Mona Lisa, K130944) for imaging effectiveness. - 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. |
| Needle Guide | - Allow 18-gauge needle passage - Needle deflection within specified tolerance - Biocompatibility (ISO 10993-01) - Environmental, packaging, shipping, shelf-life, and sterilization requirements | - Physical dimensions were verified to ensure an 18-gauge needle can pass through. - Any deflection of the needle was within the specified tolerance. - 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. |
| Drape | - Sterility maintenance over shelf-life | - Microbial barrier test on the Tyvek film pouch showed it can maintain sterility for the 3-year shelf-life if packaging integrity is not compromised. |
| Overall Kit | - Designed and manufactured under Quality System Regulations (21 CFR 820 and ISO 13485) | - Risk Analysis conducted - Requirements Reviews completed - Design Reviews completed - Usability Analysis performed - Performance testing (Verification) completed |
2. Sample size used for the test set and the data provenance:
- Test Set: The document does not specify a "test set" in the context of an AI algorithm's performance validation.
- For the probe sheath, testing involved a phantom and a "review of images obtained during the clinical trial conducted for the main device - iSR'obot Mona Lisa (K130944)". The sample size for this review is not specified.
- For the needle guide, "physical dimensions were verified," implying a small sample or inspection.
- Data Provenance: Not applicable as this is not a study on a data-driven AI device. The images reviewed for the probe sheath came from the clinical trial of the associated Mona Lisa device, but no further details on origin (e.g., country) or retrospective/prospective nature are provided for those images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a submission for a physical medical device kit, not an AI device requiring expert-established ground truth for a diagnostic task.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No such adjudication method is mentioned or relevant for this type of device submission.
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, an MRMC study was NOT done. This document pertains to a physical medical device kit, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI device ground truth. The "ground truth" for this device's performance relates to its physical properties:
- Mechanical safety: Direct observation against stress.
- Imaging effectiveness: Comparison of ultrasound images (with and without the sheath) using a phantom and potentially clinical images from the associated device's trial.
- Sterility: Microbial barrier tests.
- Biocompatibility: Adherence to ISO 10993-01 standards.
8. The sample size for the training set:
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
In summary: The provided document is a 510(k) premarket notification for a physical medical device kit. It focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing of its components (probe sheath, needle guide, drape), rather than detailing the performance metrics or clinical study results of an AI-powered diagnostic system. Therefore, most of the questions pertaining to AI device validation (e.g., acceptance criteria for AI, training/test set details, expert ground truth, MRMC studies) are not addressed in this document.
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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.
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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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Image /page/3/Picture/1 description: The image shows the logo for Biobot Analytics. The logo features the word "biobot" in a stylized font. The "bio" portion is in orange and the "bot" portion is in blue. 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 Ltd79, Ayer Rajah Crescent,#04-06, Singapore 139955 |
| Primary Contact: | Lai Chee LiewHead of Quality and Regulatory AffairsBiobot Surgical Pte LtdTelephone: +65 63511868E-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 /ITX21 CFR 892.1560, Ultrasonic pulsed echo imagingsystem / OIJ (Biopsy Needle Guide Kit) |
| Predicate Device(s): | K970515 CIVCO Latex Ultrasound Transducer Cover(Primary Predicate) |
| K971115 Transrectal Needle/Biopsy Guide (ReferenceDevice) | |
| K844472 Civco Scan Drape (Reference Device) | |
| Manufacturer/Design Location: | Biobot Surgical Pte Ltd79 Ayer Rajah Crescent, #04-06Singapore 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
| 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(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.
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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:CIVCO LatexUltrasoundTransducer Cover | Proposed Device:iSR'obot Biopsy Kit | DiscussionofSimilarities | |
|---|---|---|---|
| Manufacturer | Civco | Biobot | |
| 510(k) number | K970515 | Pending | |
| Where Used | Hospital | Hospital | Same |
| Intended Use | Protective cover orsheath placed overdiagnostic transducer/probe instruments | The probe sheathprovide a protectivecover system for theultrasound transducer. | Same |
| Material | Natural rubber latex | Medical grade TPX(polymethylpentene) | - |
| Manufacturing | Dip-molding | Injection molding | |
| Sterility | ETO | ETO | Same |
| Biocompatibility | ISO10993 | ISO10993. | Same |
| Disposition | Disposable | Disposable | Same |
| Human Factor | No Known AdverseEffects | No Known AdverseEffects | Same |
| Chemical Safety | Latex materialformulations conform toUS FDA CFR, Title 21,Section 177.2600 | No HazardousComponents29CFR1910, 1200 | |
| Mechanical Safety | Material strength andelasticity is adequate toallow use without tearingor pinholing the cover | Material strength andelasticity is adequate toallow use withoutbreaking or crackingthe sheath | Same |
| Anatomical site | Body surface, endocavitywhere ultrasound is used | Rectum whereultrasound probe goesin to scan the prostate | Similar |
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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:TransrectalNeedle/Biopsy Guide | Proposed Device:iSR'obot Biopsy Kit | DiscussionofSimilarities | |
|---|---|---|---|
| Manufacturer | Protek Medical ProductsInc. | Biobot | |
| 510(k) number | K041637 | Pending | |
| Where Used | Hospital | Hospital | Same |
| Intended Use | Ultrasound transducerneedle guide | Biopsy needle guide | Similar |
| Materials | Stainless Steel;Medical Grade Plastic | Medical Grade PP(Polypropylene) | - |
| Sterility | ETO | ETO | Same |
| Biocompatibility | ISO10993 | ISO10993 | Same |
| Chemical Safety | No HazardousComponents29CFR1910,1200 | No HazardousComponents29CFR1910,1200 | Same |
| Anatomical Sites | Where Ultrasound isUsed | Perineal Area (Skin) | - |
| ManufacturingMethod | Injection molded clips | Injection molded | Same |
| Human Factor | No Known AdverseEffects | No Known AdverseEffects | Same |
3. Drape
| Predicate Device:Civco Scan Drape | Proposed Device:iSR'obot Biopsy Kit | DiscussionofSimilarities | |
|---|---|---|---|
| Manufacturer | Civco | Biobot | |
| 510(k) number | K844472 | Pending | |
| Where Used | Hospital | Hospital | Same |
| Intended Use | Protective Cover orsheath placed overequipment to helpprevent transfer ofmicroorganisms, bodyfluids, etc | Cover for the iSR'obotMona Lisa for thepurpose of prevention ofcontamination | Same |
| Materials | Polyethylene | Low DensityPolyethylene | Same |
| Sterility | ETO | ETO | Same |
| Human Factor | No Known AdverseEffects | No Known AdverseEffects | Same |
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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.
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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:1. CIVCO Latex UltrasoundTransducer Cover2. Transrectal Needle/ Biopsy Guide3. Civco Scan Drape | Proposed Device: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.
§ 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.