(208 days)
The HYDROS™ Robotic System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
The HYDROS™ Robotic System has three components - the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece.
- HYDROS Robotic System: consists of the HYDROS Tower, Touchscreen Interfaces Monitor, HYDROS Software, HYDROS Operating System, Embedded Software, Motorpack, Handpiece Arm, TRUS Probe Arm, and Foot Pedal. It is provided non-sterile and reprocessed per instructions. It does not contact patients during the procedure.
- HYDROS TRUS Probe: a biplane transrectal ultrasound probe used with the HYDROS Robotic System and HYDROS Handpiece to provide ultrasound imaging for the AQUABLATION procedure. It is re-usable, provided non-sterile, and reprocessed prior to each use.
- HYDROS Handpiece: a single-use sterile surgical device introduced through the urethra to visualize, resect and remove prostatic tissue. It is integrated with a digital CMOS Scope and terminally sterilized by EtO.
Here's a summary of the acceptance criteria and study information for the HYDROS™ Robotic System, HYDROS™ Handpiece, and HYDROS™ TRUS Probe, based on the provided text:
Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about a clinical study or performance metrics specifically for AI functionality, as the AI feature seems to be an optional "FirstAssist AI™" feature that aids in planning rather than directly dictating treatment. Therefore, many of the requested clinical study-related details are not available in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily reports "Pass" for all non-clinical bench tests, indicating that the device met the requirements of the specified standards and guidance documents. Specific quantitative acceptance criteria or performance metrics beyond a "Pass" result are not provided in this summary.
| Non-Clinical Bench Test Category | Guidance/Standard ID & Name | Reported Device Performance |
|---|---|---|
| System Verification | FDA Guidance for BPH Device Investigation | Pass |
| Usability | IEC 62366-1:2015/COR1:2016, ANSI/AAMI HE75:2009 (R2018) | Pass |
| Electromagnetic Compatibility | IEC60601-1-2:2020, IEC TR 60601-4-2 | Pass |
| Basic Safety | IEC 60601-1:2020, IEC 60601-2-37 Ed. 2.1 2015, EC 60601-1-6:2020, IEC 60601-2-18: 2009, IEC 80601-2-77: 2019 | Pass |
| Wireless | AAMI TIR69:2017/(R2020), FDA Guidance | Pass |
| Sterilization | EN ISO 11135:2014 + AMD 1: 2019, ISO 10993-7:2008 + AMD 1:2019, ISO 11138-1: 2017, ISO 11138-2: 2017, BS EN 556-1: 2001, ISO11737-1: 2018+AMD1:2021, ISO 11737-2: 2019, ISO 11139: 2018, ISO 14937:2009, AAMI TIR 14: 2016, AAMI TIR 15: 2016, AAMI TIR 16: 2017, AAMI TIR 28: 2016/(R)2020, ISO 11135 Second edition 2014-07-15, ISO 11737-2 Third edition 2019-12 | Pass |
| Biocompatibility | ISO 10993-1:2018, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-9: 2019, ISO 10993-10:2021, ISO 10993-11: 2017, ISO 10993-12:2021, ISO 10993-13:2010, ISO 10993-14:2001, ISO 10993-15:2019, ISO 10993-18:2020, ISO 10993-23:2021 | Pass |
| Packaging and Transit | ISTA 3B: 2017, ASTM D4332-22, ASTM D4169-22, ASTM F1886/F1886M-16, ASTM F2096-11 (2019), ISO 11607-1: 2019, ISO 11607-2: 2019 | Pass |
| Shelf Life | ASTM F88/F88-2023, ASTM F1980-21 | Pass |
| Reliability | MIL-STD-721C | Pass |
| Labeling | ISO 15223-1:2021, ISO 20417:2021, ISO 7000:2019, ISO 7010 Third edition 2019-07, ISO 17664-2 First edition 2021-02, IEC/TR 60878 Ed. 4.0 2022-11, ISO 17664-1:2021, FDA Guidance (Blue Book Memo), FDA Guidance (89-4203) | Pass |
| Reprocessing | ANSI AAMI ST98:2022, AAMI TIR 12:2020, ASTM F3208-20, AAMI TIR 99:2024 | Pass |
| Corrosion | ASTM F1089-18 | Pass |
| Cystoscope Imaging | ISO 8600-5:2020, ISO 8600-3:2019, ISO 8600-1: 2015, ISO 80369-7:2021, ISO CIE 11664-4, First Edition 2019-06, ISO CIE 11664-6, First Edition 2014-02-01, IEC 61966-2-1:1999-10 | Pass |
| Ultrasound Imaging | IEC 62127-1:2022, IEC 61391-1:2006+AMD1:2017, FDA Guidance | Pass |
| Cybersecurity | ISO IEC 29147 First edition 2014-02-15, IEC 80001-1 Edition 1.0 2010-10, AAMI TIR57:2016, ANSI NEMA HN 1-2019, FDA Guidance | Pass |
| Software | FDA Guidance (Premarket Submissions Software), Draft FDA Guidance (Device Software Functions), FDA Guidance (Software Validation) | Pass |
| AI/ML | FDA Guidance (Clinical Performance CADe), FDA Guidance (CADe Premarket Notification), FDA Guidance (Good Machine Learning Practice) | Pass |
Non-Clinical Testing Details:
- Study Type: Design validation included simulated use testing and cadaver testing. The summary primarily lists compliance with various national and international standards and FDA guidance documents.
- Sample Size (Test Set): Not explicitly stated in the provided text for each specific test. The "Pass" results suggest that the tests were conducted with sufficient samples to meet the requirements of the standards.
- Data Provenance: Not specified, but implied to be from laboratory and cadaver testing within the manufacturer's control, as it's non-clinical performance data.
- Number of Experts for Ground Truth & Qualifications: Not applicable for non-clinical bench testing.
- Adjudication Method: Not applicable for non-clinical bench testing.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned in this non-clinical summary. The AI feature ("FirstAssist AI™") is described as "optional" and assists in planning by providing handpiece nozzle position and prostate capsule boundary, and placing profile landmarks for adjustment by the surgeon. This suggests it's a decision-support tool rather than an autonomous diagnostic or treatment device requiring MRMC studies for performance comparison against human readers.
- Standalone (Algorithm Only) Performance: The AI/ML entry indicates compliance with FDA guidance documents for CADe devices and good machine learning practice. This suggests standalone performance testing for the AI component was likely conducted to meet these guidelines, but specific metrics are not detailed in this summary. The AI assists in planning rather than directly performing the procedure.
- Type of Ground Truth (for AI): The AI feature provides "handpiece nozzle position and the prostate capsule boundary" and places "4 landmarks - treatment start (TS), bladder neck (BN), mid-prostate (MP) and treatment end (TE)." The implication is that these are derived from anatomical structures visible on TRUS imaging, and the ground truth for these would typically be established by expert review/annotations of such images.
- Sample Size for Training Set (for AI): Not specified in the provided text.
- How Ground Truth for Training Set was Established (for AI): Not explicitly stated. For AI in medical imaging, ground truth is typically established by expert annotation (e.g., urologists or radiologists marking anatomical structures or disease boundaries on medical images).
Conclusion from the document:
"The overall performance data in this submission supports that the HYDROS Robotic System and its components are substantially equivalent to the predicate device when utilized for its intended use." This statement confirms that all acceptance criteria relevant to demonstrating substantial equivalence through non-clinical means were met.
§ 876.4350 Fluid jet system for prostate tissue removal.
(a)
Identification. A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate the following:
(i) All adverse events associated with the device, and
(ii) Improvement in lower urinary tract symptoms (LUTS).
(2) Physician training must be provided that includes:
(i) Information on key aspects and use of the device, and
(ii) Information on how to override or stop resection.
(3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.
(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and
(ii) High pressure fluid jet verification testing at target and non-target tissues.
(5) Software verification, validation, and hazard analysis must be performed.
(6) The patient-contacting elements of the device must be demonstrated to be biocompatible.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.
(8) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(9) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(10) Performance data must validate the instructions for reprocessing and reliability of reusable components.
(11) Labeling must include the following:
(i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;
(ii) A shelf life for single use components;
(iii) A use life for reusable components; and
(iv) Reprocessing instructions for reusable components.