(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.
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August 20, 2024
Procept BioRobotics Sara Muddell Sr. Director, Global Regulatory Affairs 150 Bavtech Drive San Jose, California 95134
Re: K240200
Trade/Device Name: HYDROS™ Robotic System: HYDROS™ Handpiece: HYDROS™ TRUS Probe Regulation Number: 21 CFR 876.4350 Regulation Name: Fluid jet system for prostate tissue removal Regulatory Class: II Product Code: PZP Received: July 19, 2024
Dear Sara Muddell:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -S
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240200
Device Name HYDROS™ Robotic System HYDROS™ Handpiece HYDROS™ TRUS Probe
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced by a blue water drop symbol. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
510(k) SUMMARY
Date Prepared: August 19, 2024
| Owner/Sponsor | PROCEPT BioRobotics Corporation150 Baytech Drive,San Jose, 95134USA |
|---|---|
| Submitter | Contact Name: Sara MuddellTitle: Sr. Director of Global Regulatory AffairsAddress: 150 Baytech Drive, San Jose, CA 95134, USATelephone: (650) 232-7217Cell: (669) 220-8583Email: s.muddell@procept-biorobotics.com |
| Trade Name | 1. HYDROS™ Robotic System2. HYDROS™ TRUS Probe3. HYDROS™ Handpiece |
| Classification | Class II |
| Classification Name | Fluid jet system for prostate tissue removal |
| Product Code | PZP |
| Regulation Number | 21 CFR 876.4350 |
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Image /page/5/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, dark blue letters. The "O" in "PROCEPT" is replaced with a stylized image of a water droplet in shades of blue. Below the word "PROCEPT" is the word "BioRobotics" in smaller, dark blue letters.
Predicate Device
-
- Primary Predicate1
Trade Name - AQUABEAM ROBOTIC System 510(k) Number - K231024 cleared on August 30, 2023. Product Code - PZP Regulation Number: 876. 4350 Device Classification - Class II
- Primary Predicate1
Device Description
The HYDROS™ Robotic System has three components - the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece.
1. HYDROS Robotic System
The HYDROS Robotic System, consists of the following nine components:
- HYDROS Tower ●
- Touchscreen Interfaces Monitor that supports the Tower Monitor (Tmon) and ● Surgeon Monitor (Smon)
- HYDROS Software ●
- HYDROS Operating System
- Embedded Software
- Motorpack
- Handpiece Arm
- TRUS Probe Arm
- Foot Pedal .
The HYDROS Robotic System is provided non-sterilization is required prior to each use. The Tower, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are reprocessed per instructions provided with the device after each use. The HYDROS Robotic System does not come in contact with the patients during the procedure.
2. HYDROS TRUS Probe
The HYDROS TRUS Probe is a biplane transrectal ultrasound probe that is used in the conjunction with the HYDROS Robotic System and HYDROS Handpiece to provide ultrasound imaging to deliver the AQUABLATION procedure. The HYDROS TRUS Probe is re-usable and provided non-sterile. It is reprocessed prior to each use as per the instructions provided in the IFU.
3. HYDROS Handpiece
The HYDROS Handpiece is the single-use sterile surgical device introduced to the surgical site within the prostate through the urethra to visualize, resect and remove prostatic tissue. The HYDROS Handpiece is integrated with a digital CMOS Scope and is terminally sterilized by EtO.
1 The predicate device has not been subject to any design related recall.
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Image /page/6/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, dark blue letters. The "O" in Procept is a stylized water droplet. Below the word "PROCEPT" is the phrase "BioRobotics" in a smaller, dark blue font.
Intended Use/Indications for Use
The HYDROS Robotic System is indicated for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
Intended Patient Population
The intended patient population is males suffering from LUTS resulting from benign prostatic hyperplasia (BPH).
Intended Users
The intended user shall be a urologist, supported by OR staff, trained and familiar with performing endoscopic surgical procedures for BPH, such as TURP, and in recognizing and managing their complications. The intended user shall also be trained and familiar with TRUS imaging.
Technological Comparison as compared to the Predicate Device
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| HYDROS ROBOTIC SYSTEM | ||
| Device Trade Name | HYDROS® RoboticSystem | AQUABEAM® RoboticSystem (P1G2) |
| Manufacturer | PROCEPT BioRoboticsCorporation | PROCEPT BioRoboticsCorporation |
| REF/Model Number | HY1000 | AB2000 |
| Pre-Market Notification Type | Traditional 510(k) | Traditional 510(k) |
| 510(k) number | K240200 | K231024 |
| Regulation Number | 21 CFR 876.4350 | 21 CFR 876.4350 |
| Regulation Name | Fluid jet system forprostate tissue removal | Fluid jet system for prostatetissue removal |
| Product Classification | Class II | Class II |
| Product Code | PZP | PZP |
| Intended Use/Indications for Use | The HYDROS RoboticSystem is indicated for theresection and removal ofprostate tissue in malessuffering from lowerurinary tract symptoms(LUTS) due to benignprostatic hyperplasia. | The AquaBeam RoboticSystem is intended for theresection and removal ofprostate tissue in malessuffering from lower urinarytract symptoms (LUTS) dueto benign prostatichyperplasia. |
| Intended User | The intended user shall bea urologist supported by | Urologists and support staffwho are trained and familiar |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS ROBOTIC SYSTEM | ||
| OR staff, trained andfamiliar with performingendoscopic surgicalprocedures for BPH, suchas TURP, and inrecognizing and managingtheir complications. Theintended user shall also betrained and familiar withTRUS imaging. | with performing endoscopicsurgical benign prostatichyperplasia procedures andin recognizing andmanaging theircomplications. Users mustpossess a thoroughunderstanding of thetechnical principles, clinicalapplication, and risksassociated with theAQUABEAM RoboticSystem and complete thePROCEPT BioRoboticsCorporation trainingprogram prior to use. | |
| Patient Population | Males suffering fromLUTS resulting frombenign prostatichyperplasia (BPH). | Males suffering from LUTSresulting from benignprostatic hyperplasia (BPH). |
| Intended Body/Tissue Interaction | The HYDROS RoboticSystem is not patientcontacting. | The AquaBeam RoboticSystem is not patientcontacting. |
| Operating Environment | Temperature: 10° to 30° CHumidity: 20% to 80%,non-condensingAtmospheric Pressure: 70kPA to 101 kPA | Temperature: 0° to 35° CHumidity: 0% to 90%, non-condensingAtmospheric Pressure: 70kPA to 107 kPA |
| Storage Environment | Temperature: 10° to 30°Humidity: 20% to 80%,non-condensingAtmospheric Pressure: 70kPA to 101 kPA | Temperature: 0° to 35° CHumidity: 0% to 90%, non-condensingAtmospheric Pressure: 70kPA to 107 kPA |
| Transportation Environment | Temperature: -18° to 60°CHumidity: 15% to 90%,non-condensingAtmospheric Pressure: 60kPA to 106 kPA | Temperature: -18° to 60° CHumidity: 15% to 90%,non-condensingAtmospheric Pressure: 60kPA to 106 kPA |
| Cleaning and Disinfection Method | Clean using quaternaryammonium -based cleanerand disinfect using | Clean using quaternaryammonium -based cleanerand disinfect using |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS ROBOTIC SYSTEM | ||
| Use Life | intermediate leveldisinfectant.1 year | intermediate leveldisinfectant.3 Years |
| Surgeon Interface | Two monitors for display – one surgeonmonitor (Smon) for use in the sterileenvironment and the tower monitor (Tmon)which can be used by support staff.- Portrait view- Interaction is throughtouchscreen.- Physician authorizationis enabled only on thesurgeon monitor. | Single monitor for display for use by boththe surgeon and the support staff- landscape view- Interaction is throughthe keyboard and thetrackball on thekeyboard.- Physician authorizationis enabled by pressingthe “+” button on themotorpack. |
| Ultrasound | Integrated ultrasound and acompatible TRUS probe isprovided with theHYDROS RoboticSystem. | A third-party ultrasoundsystem and a third-partycompatible ultrasound probeis used with the AquaBeamRobotic System per itsindications for use. |
| Cystoscope Imaging | The CMOS scope connectsto the HYDROS RoboticSystem and specificallythe camera control unit(CCU) located within thetower infrastructure of thedevice for cystoscopeimage processing. | The AquaBeam Scopewhich is part of theAquaBeam Robotic Systemwas connected to a third-party cystoscopy unit forproviding the livecystoscope imaging duringthe Aquablation therapy. |
| Maximum angle rotation | 225 degrees | 225 degrees |
| Maximum depth of penetration | 24.3 mm | 24.3 mm |
| Network Connection Capability | The HYDROS RoboticSystem component (PC)includes a Wi-Fi card thatcreates network connectioncapability. | The AquaBeam RoboticSystem and its componentsdo not include a Wi-Fi cardand there is no networkconnection capability. |
| Cloud Connection + Wi-Ficonnection | The software allowsenabling and disabling the | AquaBeam RoboticSystems do not provide anyoptions for connected |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS ROBOTIC SYSTEM | ||
| cloud connection on theWi-Fi connected systems.Users have the option tochoose a disconnectedsystem. | systems and/or options forconnection to Cloud servers. | |
| FirstAssist AI™ (previously AssistedPlanning) Feature | Optional FirstAssist AIfeature available duringthe PLAN step.FirstAssist AI ,Transverse: When theFirstAssist AI togglebutton is enabled in thetransverse view at theangle and depth step, thesoftware provides thehandpiece nozzle positionand the prostate capsuleboundary.FirstAssist AI , Sagittal:When the FirstAssist AItoggle button is enabled atthe profile landmark stepthe software will place the4 landmarks - treatmentstart (TS), bladder neck(BN), mid-prostate (MP)and treatment end (TE).The surgeon has the optionto adjust the landmarks asneeded. | No Optional FirstAssist AIfeature present in the PLANstep |
| Workflow Enhancement | GUI Steps:• Setup – includesTRUS, Handpiece andAlign• Plan -includes Manualand optionalFirstAssist AITransverse Angle andDepth planning | GUI Steps:• Setup - includes TRUS,Handpiece and Align• Plan -includes ManualTransverse Angle andDepth planning,registration, Manualprofile for Sagittal Plane |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS ROBOTIC SYSTEM | ||
| Manual and OptionalFirstAssist AI profileoptions for SagittalPlane and Contour.Treat – includes treatment with the options for starting an additional pass or completing the procedure. | Treat - includes treatment with the options for starting an additional pass or completing the procedure. | |
| Manual Aspiration Flow Rate | During Resection:Nominal Waterjet Flow +10ml/minManual: $360\pm75$ ml/min =[285, 435] | During Resection: NominalWaterjet Flow + 10ml/minManual: 317ml/min +/- 10%= [285,349] |
| Verumontanum protectionorientation | Transverse Plane - The user cannot modify the default orientation of the verumontanum protection zone. Sagittal Plane - The user has the ability to modify the length of the verumontanum protection zone. | Transverse Plane - The user has the ability to modify the default orientation of the verumontanum protection zone. Sagittal Plane - The user has the ability to modify the length of the verumontanum protection zone. |
| COMPARISONELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| Device Trade Name | HYDROS TRUS Probe | AQUABEAM ROBOTIC SYSTEM |
| Manufacturer | PROCEPT BioRoboticsCorporation | PROCEPT BioRoboticsCorporation |
| REF/Model Number | HU1000 | AB2000 |
| Pre-MarketNotificationInformation | Traditional 510(k) | Traditional 510(k) |
| 510(k) number | K240200 | K231024 |
| Regulation Number | 21 CFR 876.4350 | 21 CFR 876.4350 |
| Regulation Name | Fluid jet system for prostatetissue removal | Fluid jet system for prostate tissueremoval |
| Product Classification | Class II | Class II |
| Product Code | PZP | PZP |
| IntendedUse/Indications for Use | The HYDROS Robotic System isindicated for the resection andremoval of prostate tissue inmales suffering from lowerurinary tract symptoms (LUTS)due to benign prostatichyperplasia. | The AquaBeam Robotic System isindicated for the resection andremoval of prostate tissue in malessuffering from lower urinary tractsymptoms (LUTS) due to benignprostatic hyperplasia. |
| Intended User | The intended user shall be aurologist, supported by OR staff,trained and familiar withperforming endoscopic surgicalprocedures for BPH, such asTURP, and in recognizing andmanaging their complications.The intended user shall also betrained and familiar with TRUSimaging. | Urologists and support staff whoare trained and familiar withperforming endoscopic surgicalbenign prostatic hyperplasiaprocedures and in recognizing andmanaging their complications.Users must possess a thoroughunderstanding of the technicalprinciples, clinical application, andrisks associated with theAQUABEAM Robotic System andcomplete the PROCEPTBioRobotics Corporation trainingprogram prior to use |
| Patient Population | Males suffering from LUTSresulting from benign prostatichyperplasia (BPH). | Males suffering from LUTSresulting from benign prostatichyperplasia (BPH). |
| COMPARISONELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS TRUS Probe | ||
| Intended Body/Tissueinteraction | The HYDROS TRUS probe maycome in contact with the rectaltissue.Tissue/Bone/Dentin per ISO10993-1:2018, Table A.1 | The AquaBeam Robotic Systemuses a third-party ultrasound probe,SIUI'S ECBP-1 and the intendedbody/tissue interaction is identicalbetween the subject device andpredicate device. |
| Duration of Contact | The HYDROS TRUS probe isconsidered an Externallycommunicating medical device.The HYDROS TRUS probe isused as part of the Aquablationprocedure which lasts about 30minutes, so the TRUS probe hasLimited Exposure (≤24hr). | The AquaBeam Robotic Systemuses a third-party ultrasound probe,SIUI'S ECBP-1 and the duration ofcontact is the same as the subjectdevice as the manner in which theTRUS probe is used remainsidentical between subject deviceand predicate device. |
| Mode of Action | B mode | The AquaBeam Robotic Systemuses a third-party ultrasound probe,SIUI'S ECBP-1 and the mode ofaction is the same as the subjectdevice as the manner in which theTRUS probe is used remainsidentical between subject deviceand predicate device. |
| Surface Area (patientcontacting portion ofthe probe only) | ~276 Sq.cm | The AquaBeam Robotic Systemuses a third-party ultrasound probe,SIUI'S ECBP-1 and the surfacearea of ECBP-1 is 264 Sq. cm. |
| Plane Switching | The handle interface of theHYDROS TRUS probe providesa button to switch ultrasoundvisualization planes betweentransverse and sagittal planes | The AquaBeam Robotic Systemuses a third-party ultrasound probe,SIUI'S ECBP-1 which does notinclude a plane switching button. |
| Connection | Probe is plugged into theHYDROS Robotic System withone connector | The AquaBeam Robotic Systemuses a third-party ultrasoundsystem, SIUI's Apogee 2300 andultrasound probe, SIUI's ECBP-1.The ultrasound system connects tothe AquaBeam Robotic System viaan ethernet cable and theultrasound probe connects to the |
| COMPARISONELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS TRUS Probe | ||
| Length of the connectorcable | ~220 cm | ultrasound system with twoconnectors.The AquaBeam Robotic systemuses a third-party ultrasound probe,SIUI's ECBP-1 and the length ofthe connector cable is ~220 cmwhich is identical to the subjectdevice. |
| Materials | HYDROS TRUS probe materialinformation:- Hard Shell: ABS Plastic- Transducer portion of theprobe: Silicone- Plane Switching Button:Silicone | The AquaBeam RoboticSystem uses a third-partyultrasound probe, SIUI'sECBP-1 and the material ofthis probe is identical to thesubject device andadditionally manufacturedby the same company, SIUI |
| Reprocessing | Reprocessing is required prior toeach use and instructions areprovided in the instructions foruse (IFU) shipped with device. | The AquaBeam Robotic systemuses a third-party ultrasoundsystem, SIUI's Apogee 2300 andultrasound probe, SIUI's ECBP-1and has its individual IFU with thereprocessing instructions providedby SIUI. |
| OperatingEnvironment | Temperature: 10° to 30° CHumidity: 20% to 80%, non-condensingAtmospheric Pressure: 70kPA to101kPA | The AquaBeam Robotic systemuses a third-party ultrasound probe,SIUI's ECBP-1 and the operatingenvironment for subject device andECBP-1 are similar since theintended use environment of thesubject and predicate devices areidentical. |
| Storage Environment | Temperature: 10° to 30° CHumidity: 20% to 80%, non-condensingAtmospheric Pressure: 70kPA to101kPA | The AquaBeam Robotic systemuses a third-party ultrasound probe,SIUI's ECBP-1 and the storageenvironment for subject device andECBP-1 are similar since theintended use environment of thesubject and predicate devices areidentical. |
| COMPARISONELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS TRUS Probe | ||
| TransportationEnvironment | Temperature: -18° to 60° CHumidity: 15% to 90%, non-condensingAtmospheric Pressure: 60kPA to106kPA | The AquaBeam Robotic systemuses a third-party ultrasound probe,SIUI's ECBP-1 and thetransportation environment forsubject device and ECBP-1 aresimilar since the intended useenvironment of the subject andpredicate devices are identical. |
| Use Life | The users are instructed toperform visual and functionalinspection post reprocessing andprior to each use however, thedevice is validated for 25 cyclesof reprocessing. | The AquaBeam Robotic systemuses a third-party ultrasound probe,SIUI's ECBP-1 and has a use lifeof 100 cycles. The use-life of thesubject device falls within the uselife of the ultrasound probe usedwith the predicate device. |
HYDROS ROBOTIC SYSTEM
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Image /page/7/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, dark blue letters. The "O" in "PROCEPT" is replaced by a stylized image of a water droplet. Below the word "PROCEPT" is the word "BioRobotics" in a smaller, less bold font.
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Image /page/8/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is stylized as a water droplet. Below the word "PROCEPT" is the word "BioRobotics" in a smaller font.
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Image /page/9/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced with a blue water droplet. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
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Image /page/10/Picture/1 description: The image shows the logo for Procept BioRobotics. The logo is in dark blue and features the word "PROCEPT" in large, bold letters. The "O" in "PROCEPT" is stylized to look like a water droplet. Below the word "PROCEPT" is the word "BioRobotics" in a smaller font.
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Image /page/11/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced with a blue water droplet. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
HYDROS TRUS PROBE
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Image /page/12/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in a large, bold, sans-serif font, with a stylized water droplet replacing the "O". Below "PROCEPT" is the word "BioRobotics" in a smaller, sans-serif font. The logo is clean and modern, with a focus on the company's name and branding.
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Image /page/13/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in a bold, sans-serif font, with a stylized water droplet replacing the "O". Below the main wordmark, in a smaller font, is the word "BioRobotics".
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Image /page/14/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced with a blue water droplet. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
HYDROS HANDPIECE
| COMPARISONELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| HYDROS HANDPIECE | ||
| Device Trade Name | HYDROS Handpiece | AQUABEAM® Robotic System |
| Manufacturer | PROCEPT BioRoboticsCorporation | PROCEPT BioRobotics Corporation |
| REF/Model Number | HH1000 | HP2000SC2000 |
| Pre-MarketNotificationInformation | Traditional 510(k) | Traditional 510(k) |
| 510(k) number | K240200 | K231024 |
| Regulation Number | 21 CFR 876.4350 | 21 CFR 876.4350 |
| Regulation Name | Fluid jet system for prostatetissue removal | Fluid jet system for prostate tissueremoval |
| Product Classification | Class II | Class II |
| Product Code | PZP | PZP |
| IntendedUse/Indications forUse | The HYDROS Robotic Systemis indicated for the resectionand removal of prostate tissuein males suffering from lowerurinary tract symptoms (LUTS) | The AquaBeam Robotic System isintended for the resection and removalof prostate tissue in males sufferingfrom lower urinary tract symptoms(LUTS) due to benign prostatichyperplasia. |
| COMPARISONELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS HANDPIECEdue to benign prostatichyperplasia. | ||
| Intended User | The intended user shall be aurologist, supported by ORstaff, trained and familiar withperforming endoscopic surgicalprocedures for BPH, such asTURP, and in recognizing andmanaging their complications.The intended user shall also betrained and familiar with TRUSimaging. | Urologists and support staff who aretrained and familiar with performingendoscopic surgical benign prostatichyperplasia procedures and inrecognizing and managing theircomplications. Users must possess athorough understanding of thetechnical principles, clinicalapplication, and risks associated withthe AQUABEAM Robotic System andcomplete the PROCEPT BioRoboticsCorporation training program prior touse |
| Patient Population | Males suffering from LUTSresulting from benign prostatichyperplasia (BPH) | Males suffering from LUTS resultingfrom benign prostatic hyperplasia(BPH) |
| Intended Body/TissueInteraction | The HYDROS Handpiece shallbe used endoscopicallyaccessing the prostate via theurethra (externalcommunicating device,tissue/bone/dentin, with limitedexposure (<24 hours). | The AQUABEAM Handpiece shall beused endoscopically accessing theprostate via the urethra (externalcommunicating device,tissue/bone/dentin, with limitedexposure (<24 hours). |
| Biocompatibility | The device was tested forbiocompatibility as per the ISO10993-1 standard and it wasreported to be biocompatible. | The device was tested forbiocompatibility as per the ISO 10993-1 standard and it was reported to bebiocompatible. |
| Sterilization method | Ethylene Oxide Sterilization(ETO)SAL 10-6 | Ethylene Oxide Sterilization (ETO)SAL 10-6 |
| OperatingEnvironment | Temperature: 10° to 30° CHumidity: 20% to 80%, non-condensingAtmospheric Pressure: 70 kPAto 101 kPA | Temperature: 0° to 35° CHumidity: 0% to 90%, non-condensingAtmospheric Pressure: 70 kPA to 107KPA |
| Storage Environment | Temperature: 10° to 30° CHumidity: 20% to 80%, non-condensingAtmospheric Pressure: 70 kPAto 101 kPA | Temperature: 0° to 35° CHumidity: 0% to 90%, non-condensingAtmospheric Pressure: 70 kPA to 107KPA |
| COMPARISONELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS HANDPIECE | ||
| TransportationEnvironment | Temperature: -18° to 60° CHumidity: 15% to 90%, non-condensingAtmospheric Pressure: 60 kPAto 106 kPA | Temperature: -18° to 60° CHumidity: 15% to 90%, non-condensingAtmospheric Pressure: 60 kPA to 106kPA |
| Shelf Life of theHandpiece | 6 months | 2 Years |
| Use Life of the scope | Single use | At least 10 cycles (reusable scope) |
| Scope | The CMOS Scope is a digitalscope and comes pre-loaded inthe HYDROS Handpiece. ThisCMOS Scope is a single-usedevice and provided sterile. | The AquaBeam Scope is a reusabledevice and requires to be loaded intothe AquaBeam Handpiece during thesetup of the device. |
| Maximum anglerotation | 225 degrees | 225 degrees |
| Maximum depth ofpenetration | 24.3 mm | 24.3 mm |
| Resolving Power | (MTF )• >80% contrast at 80 lp/ph (8lp/mm object space) @5mm• >80% contrast at 80 lp/ph(5.3 lp/mm object space)@8mm | (USAF 1951 target)Group 3 Element 6 on axis at 5mm andGroup 3 Element 2 on axis at 8mm |
| Field of View | Minimum of 60° FoV | Minimum of 60° FoV |
| Working Length | 24.5cm ≥ working length ≤27.0cmMaximum = 24 Fr | 24.5cm ≥ working length ≤ 27.0cmMaximum = 24 Fr |
| Packaging | HYDROS Handpiece will bepackaged in a thermoformedTray and Retainermanufactured using PETG.The tray and the retainer areheat sealed using a Tyvek lid. | The AQUABEAM Handpiece ispackaged on a White high-densitypolyethylene (HDPE) packaging cardin Tyvek pouch. The sealed pouchesare then placed into shelf cartons |
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Image /page/15/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced by a blue water droplet. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
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Image /page/16/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in a dark blue sans-serif font, with a stylized water droplet in place of the "O". Below the word "PROCEPT" is the word "BioRobotics" in a smaller, dark blue sans-serif font with a trademark symbol.
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Image /page/17/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced by a blue water droplet. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
Non-Clinical Performance Data
Design validation included simulated use testing and cadaver testing.
Please see table below for testing conducted in accordance with applicable standards and guidance documents on the HYDROS Robotic System and its components.
Summary of non-clinical testing in accordance with applicable standards and guidance documents
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
|---|---|---|---|
| SystemVerification | FDA Guidance | Guidance for the Non-Clinical and ClinicalInvestigation of DevicesUsed for the Treatment ofBenign Prostatic Hyperplasia(BPH) | Pass |
| Usability | IEC 62366-1:2015/COR1:2016ANSI/AAMIHE75:2009 (R2018) | Medical devices - Part 1:Application of usabilityengineering to medicaldevicesHuman Factors Engineering- Design Of Medical Devices | Pass |
| ElectromagneticCompatibility | IEC60601-1-2:2020IEC TR 60601-4-2 | Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances- Requirements and testsMedical electrical equipment- Part 4-2: Guidance andinterpretation -Electromagnetic immunity:performance of medicalelectrical equipment andmedical electrical systems | Pass |
| Basic Safety | IEC 60601-1:2020IEC 60601-2-37 Edition2.1 2015 | Medical electrical equipment- Part 1: Generalrequirements for basic safetyand essential performanceMedical electrical equipment- Part 1: Generalrequirements for basic safetyand essential performance | Pass |
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| EC 60601-1-6:2020 | Medical electrical equipmentPart 1-6: Generalrequirements for basic safetyand essential performance –Collateral standard:Usability | ||
| IEC 60601-2-18: 2009 | Medical electrical equipment - Part 2-18: Particularrequirements for the basicsafety and essentialperformance of endoscopicequipment | ||
| IEC 80601-2-77: 2019 | Medical electrical equipment - Part 2-77: Particularrequirements for the BasicSafety and essentialperformance of RoboticallyAssisted Surgical Equipment(RASE) | ||
| Wireless | AAMITIR69:2017/(R2020) | Technical InformationReport Risk Management ofradio-frequency wirelesscoexistence for medicaldevices and systems | |
| FDA Guidance | Radio Frequency WirelessTechnology in MedicalDevices | ||
| Sterilization | EN ISO 11135:2014 +AMD 1: 2019 | Sterilization of health-careproducts — Ethylene oxide— Requirements for thedevelopment, validation androutine control of asterilization process formedical devices | |
| ISO 10993-7:2008 +AMD 1:2019 | Biological evaluation ofmedical devices — Part 7:Ethylene oxide sterilizationresiduals | ||
| ISO 11138-1: 2017 | Sterilization of health careproducts — Biologicalindicators — Part 1: Generalrequirements | ||
| ISO 11138-2: 2017 | Sterilization of health careproducts — Biological | ||
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| BS EN 556-1: 2001 | indicators – Part 2:Biological indicators forethylene oxide sterilizationprocesses | ||
| Sterilization of medicaldevices – Requirements formedical devices to bedesignated “STERILE” –Part 1: Requirements forterminally sterilized medicaldevices | |||
| ISO11737-1:2018+AMD1:2021 | Sterilization of health careproducts — Microbiologicalmethods — Part 1:Determination of apopulation ofmicroorganisms on products | ||
| ISO 11737-2: 2019 | Sterilization of health careproducts — Microbiologicalmethods — Part 2: Tests ofsterility performed in thedefinition, validation, andmaintenance of a sterilizationprocess | ||
| ISO 11139: 2018 | Sterilization of health careproducts — Vocabulary ofterms used in sterilizationand related equipment andprocess standards | ||
| ISO 14937:2009 | Sterilization of health careproducts - Generalrequirements forcharacterization of asterilizing agent and thedevelopment, validation, androutine control of asterilization process formedical devices | ||
| AAMI TIR 14: 2016 | Contract sterilization usingethylene oxide | ||
| AAMI TIR 15: 2016 | Physical aspects of ethyleneoxide sterilization | ||
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| AAMI TIR 16: 2017 | Microbiological aspects ofethylene oxide sterilization | ||
| ISO 14937:2009 | Sterilization of health careproducts - Generalrequirements forcharacterization of asterilizing agent and thedevelopment, validation androutine control of asterilization process formedical devices | ||
| AAMI TIR 28:2016/(R)2020 | Product adoption and processequivalence for ethyleneoxide sterilization | ||
| ISO 11135 Secondedition 2014-07-15 | Sterilization of health-careproducts - Ethylene oxide -Requirements for thedevelopment, validation androutine control of asterilization process formedical devices [Including:Amendment 1 (2018)] | ||
| ISO 11737-2 Thirdedition 2019-12 | Sterilization of medicaldevices - Microbiologicalmethods - Part 2: Tests ofsterility performed in thedefinition, validation andmaintenance of a sterilizationprocess | ||
| Biocompatibility | ISO 10993-1:2018 | Biological evaluation ofmedical devices - Part1:Evaluation and testing withina risk management process | |
| ISO 10993-4:2017 | Biological evaluation ofmedical devices - Part 4:Selection of tests forinteractions with blood | ||
| ISO 10993-5:2009 | Biological evaluation ofmedical devices - Part5:Tests for in vitro cytotoxicity | ||
| ISO 10993-9: 2019 | Biological evaluation ofmedical devices – Part 9:Framework for identification | ||
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| and quantification ofpotential degradationproducts | |||
| ISO 10993-10:2021 | Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization | ||
| ISO 10993-11: 2017 | Biological evaluation ofmedical devices - Part 11:Tests for Systemic Toxicity | ||
| ISO 10993-12:2021 | Biological evaluation ofmedical devices - Part 12:Sample preparation andreference materials | ||
| ISO 10993-13:2010 | Biological evaluation ofmedical devices - Part 13:Identification andquantification of degradationproducts from polymericmedical devices | ||
| ISO 10993-14:2001 | Biological evaluation ofmedical devices - Part 14:Identification andquantification of degradationproducts from ceramics | ||
| ISO 10993-15:2019 | Biological evaluation ofmedical devices - Part 15:Identification andquantification of degradationproducts from metals andalloys | ||
| ISO 10993-18:2020 | Biological evaluation ofmedical devices - Part 18:Chemical characterization ofmedical device materialswithin a risk managementprocess | ||
| ISO 10993-23:2021 | Biological evaluation ofmedical devices - Part 23:Tests for Irritation | ||
| Packaging andTransit | ISTA 3B: 2017 | Packaged-Products for Less-Than-Truckload (LTL)Shipment | Pass |
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| ASTM D4332-22 | Standard Practice forConditioning Containers,Packages, or PackagingComponents for Testing | ||
| ASTM D4169-22 | Standard Practice forPerformance Testing ofShipping Containers andSystems | ||
| ASTM F1886/F1886M-16 | Standard test method fordetermining integrity of sealsfor flexible packaging visualinspection | ||
| ASTM F2096-11 (2019) | Standard test method fordetecting gross leaks inpackaging by internalpressurization (bubble test) | ||
| ISO 11607-1: 2019 | Packaging for terminallysterilized medical devices —Part 1: Requirements formaterials, sterile barriersystems and packagingsystems | ||
| ISO 11607-2: 2019 | Packaging for terminallysterilized medical devices —Part 2: Validationrequirements for forming,sealing and assemblyprocesses | ||
| Shelf Life | ASTM F88/F88-2023 | Standard test method for sealstrength of flexible barriermaterials | Pass |
| ASTM F1980-21 | Standard guide forAccelerated Aging of SterileBarrier Systems and MedicalDevices | ||
| Reliability | MIL-STD-721C | Military StandardsDefinitions of Terms forReliability andMaintainability | Pass |
| Labeling | ISO 15223-1:2021 | Medical devices - Symbolsto be used with medicaldevice labels, labelling and | Pass |
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| information to be supplied - | |||
| Part 1: General requirements | |||
| ISO 20417:2021 | Medical devices - | ||
| Information to be provided | |||
| by the manufacturer | |||
| ISO 7000:2019 | Graphical symbols for use on | ||
| equipment - Registered | |||
| symbols | |||
| ISO 7010 Third edition | Graphical symbols - Safety | ||
| 2019-07 | colours and safety signs - | ||
| Registered safety signs | |||
| ISO 17664-2 First | Processing of health care | ||
| edition 2021-02 | products - Information to be | ||
| provided by the medical | |||
| device manufacturer for the | |||
| processing of medical | |||
| devices - Part 2: Non-critical | |||
| medical devices. | |||
| IEC/TR 60878 Ed. 4.0 | Graphical symbols for | ||
| 2022-11 | electrical equipment in | ||
| medical practice | |||
| ISO 17664-1:2021 | Processing of health care | ||
| products - Information to be | |||
| provided by the medicaldevice manufacturer for the | |||
| processing of medical | |||
| devices | |||
| Part 1: Critical and semi- | |||
| critical medical devices | |||
| FDA Guidance | Device Labeling Guidance | ||
| #G91-1 (Blue Book Memo) | |||
| FDA Guidance | Labeling - Regulatory | ||
| Requirements for Medical | |||
| Devices (FDA 89-4203) | |||
| Reprocessing | ANSI AAMI ST98:2022 | Cleaning validation of health | Pass |
| care products - Requirements | |||
| for development and | |||
| validation of a cleaning | |||
| process for medical devices | |||
| AAMI TIR 12:2020 | Designing, Testing, And | ||
| Labeling Medical Devices | |||
| Intended For Processing By | |||
| Health Care Facilities: A | |||
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| ASTM F3208-20 | Guide For DeviceManufacturers | ||
| Standard Guide for SelectingTest Soils for Validation ofCleaning Methods forReusable Medical Devices | |||
| AAMI TIR 99:2024 | Processing of dilators,transesophageal andultrasound probes in healthcare facilities | ||
| Corrosion | ASTM F1089-18 | Standard Test Method forCorrosion of SurgicalInstruments | |
| CystoscopeImaging | ISO 8600-5:2020 | Optics and photonics -Medical endoscopes andendotherapy devices - Part 5:Determination of opticalresolution of rigidendoscopes with optics | |
| ISO 8600-3:2019 | Endoscopes - Medicalendoscopes and endotherapydevices - Part 3:Determination of field ofview and direction of view ofendoscopes with optics | ||
| ISO 8600-1: 2015 | Endoscopes – medical andendotherapy devices – Part1: General Requirements | ||
| ISO 80369-7:2021 | Small-bore connectors forliquids and gases inhealthcare applications – Part7: Connectors forintravascular or hypodermicapplications | ||
| ISO CIE 11664-4, FirstEdition 2019-06 | Colorimetry - Part 4: CIE1976 Lab colour space | ||
| ISO CIE 11664-6, FirstEdition 2014-02-01 | Colorimetry - Part 6:CIEDE2000 colourdifference formula | ||
| IEC 61966-2-1:1999-10 | Multimedia systems andequipment - Colourmeasurement andmanagement - Part 2-1: | ||
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| Colour management -Default RGB colour space -sRGB | |||
| UltrasoundImaging | IEC 62127-1:2022 | Ultrasonics - Hydrophones -Part 1: Measurement andcharacterization of medicalultrasonic fields | Pass |
| IEC 61391-1:2006+AMD1:2017 | CSV Consolidated versionUltrasonics - Pulse-echoscanners - Part 1: Techniquesfor calibrating spatialmeasurement systems andmeasurement of point-spreadfunction response | ||
| FDA Guidance | Marketing Clearance ofDiagnostic UltrasoundSystems and Transducers | ||
| Cybersecurity | ISO IEC 29147 Firstedition 2014-02-15 | Information technology -Security techniques -Vulnerability disclosure | Pass |
| IEC 80001-1 Edition1.0 2010-10 | Application of riskmanagement for IT-networksincorporating medicaldevices - Part 1: Roles,responsibilities and activities | ||
| AAMI TIR57:2016 | Principles for medical devicesecurity - Risk management. | ||
| ANSI NEMA HN 1-2019 | American National StandardManufacturer DisclosureStatement for MedicalDevice Security | ||
| FDA Guidance | Cybersecurity in MedicalDevices: Quality SystemConsiderations and Contentof Premarket Submissions | ||
| FDA Guidance | Cybersecurity for NetworkedMedical Devices ContainingOff-the-Shelf (OTS)Software | ||
| Software | FDA Guidance | Guidance for the Content ofPremarket Submissions forSoftware Contained inMedical Devices | Pass |
| Non-ClinicalBench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| Draft FDA Guidance | Draft Guidance - Content ofPremarket Submissions forDevice Software Functions | ||
| FDA Guidance | General Principles ofSoftware Validation | ||
| AI/ML | FDA Guidance | Clinical PerformanceAssessment: Considerationsfor Computer-AssistedDetection Devices Appliedto Radiology Images andRadiology Device Data inPremarket Notification(510(k)) Submissions | Pass |
| FDA Guidance | Computer-Assisted DetectionDevices Applied to RadiologyImages and Radiology DeviceData - Premarket Notification[510(k)] Submissions | ||
| FDA Guidance | Good Machine LearningPractice for Medical DeviceDevelopment: GuidingPrinciples |
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Image /page/18/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced with a blue water droplet. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
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Image /page/19/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, dark blue letters. The "O" in Procept is a stylized water droplet. Below the word "PROCEPT" is the word "BioRobotics" in a smaller font.
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Image /page/20/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in a dark blue sans-serif font, with a stylized water droplet replacing the "O". Below the word "PROCEPT" is the word "BioRobotics" in a smaller, sans-serif font. The logo is clean and modern, and the water droplet suggests a connection to water or fluids.
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Image /page/21/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced with a blue water droplet. Underneath "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
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Image /page/22/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, dark blue letters. The "O" in Procept is stylized as a water droplet. Underneath the word "PROCEPT" is the word "BioRobotics" in a smaller, dark blue font.
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Image /page/23/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, blue letters. The "O" in Procept is replaced with a blue water droplet. Underneath the word "PROCEPT" is the phrase "BioRobotics" in smaller, blue letters.
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Image /page/24/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced with a blue water droplet. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
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Image /page/25/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, blue letters, with a stylized water droplet in place of the "O". Below the main wordmark, in smaller letters, is the phrase "BioRobotics" with a registered trademark symbol.
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Image /page/26/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, dark blue letters. To the left of the "C" is a stylized water droplet design in shades of blue. Below the word "PROCEPT" is the phrase "BioRobotics" in a smaller, lighter font.
Conclusion:
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.
§ 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.