HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

K251082 · Procept Biorobotics · PZP · Oct 10, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K251082
• Device Name: HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
• Applicant: Procept Biorobotics
• Product Code: PZP · General, Plastic Surgery
• Decision Date: Oct 10, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4350
• Device Class: Class 2
• Attributes: AI/ML, Therapeutic

Intended 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.

Device Story

HYDROS Robotic System is a fluid jet system for prostate tissue removal. System components include a tower with touchscreen interfaces, motorpack, articulating arms, foot pedal, reusable TRUS probe, and single-use sterile handpiece with integrated CMOS scope. Used in OR by urologists to perform Aquablation. Input includes real-time TRUS imaging and cystoscope video. Software provides 'FirstAssist AI' for planning: identifies nozzle position, prostate capsule boundary, and landmarks (treatment start, bladder neck, mid-prostate, treatment end). Surgeon reviews and adjusts landmarks on touchscreen. System controls robotic handpiece to resect tissue via waterjet. Output is visual guidance and automated tissue removal. Benefits include precise, image-guided prostate tissue resection for BPH symptom relief.

Clinical Evidence

Bench testing only. Performance validated through system verification, usability engineering (IEC 62366-1), electromagnetic compatibility (IEC 60601-1-2), sterilization validation (ISO 11135), biocompatibility (ISO 10993-1), and software/AI/ML validation per FDA guidance. No clinical data presented.

Technological Characteristics

Fluid jet system for prostate tissue removal. Components: Tower (PC, touchscreen, motorpack), TRUS probe (ABS plastic, silicone), Handpiece (single-use, CMOS scope, EtO sterilized). Connectivity: Wi-Fi enabled, cloud-capable. Software: Embedded OS, AI-assisted planning. Reprocessing: Quaternary ammonium-based cleaner, intermediate disinfectant, CIDEX OPA, or STERIS V-Pro maX. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993, ISO 11135.

Indications for Use

Indicated for resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the fluid jet system for prostate tissue removal is subject to the following special controls:

*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.

Predicate Devices

• HYDROS Robotic System (K240200)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 10, 2025

Procept BioRobotics
Bijesh Chandran
Senior Vice President, Regulatory Affairs and Quality Assurance
150 Baytech Drive
San Jose, California 95134

Re: K251082
Trade/Device Name: HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
Regulation Number: 21 CFR 876.4350
Regulation Name: Fluid Jet System For Prostate Tissue Removal
Regulatory Class: Class II
Product Code: PZP, ITX
Dated: September 14, 2025
Received: September 15, 2025

Dear Bijesh Chandran:

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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251082 - Bijesh Chandran
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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).

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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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Additionally, you may contact the 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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

**MARK J. ANTONINO -S**

Mark 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251082 | |
| Device Name HYDROS Robotic System (HY1000) HYDROS Handpiece (HH1000) HYDROS TRUS Probe (HU1000) | |
| Indications for Use (Describe) 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. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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PROCEPT
BIOROBOTICS
K251082
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# 510(k) SUMMARY

Date Prepared: Sep 12, 2025

| Owner/Sponsor | PROCEPT BioRobotics Corporation
150 Baytech Drive,
San Jose, 95134
USA |
| --- | --- |
| Submitter | Contact Name: Bijesh Chandran
Title: SVP, Regulatory Affairs and Quality Assurance
Address: 150 Baytech Drive, San Jose, CA 95134, USA
Telephone: [phone]
Email: [e-mail] |
| Trade Name | 1. HYDROS™ Robotic System
2. HYDROS™ TRUS Probe
3. HYDROS™ Handpiece |
| Classification | Class II |
| Classification Name | Fluid jet system for prostate tissue removal |
| Product Code | PZP |
| Regulation Number | 21 CFR 876.4350 |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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BIOROBOTICS
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# Predicate Device

1. **Primary Predicate¹**
Trade Name - HYDROS™ Robotic System
510(k) Number - K240200 cleared on August 20, 2024.
Product Code – PZP
Regulation Number: 876.4350
Device Classification - Class II

# 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-sterile, and no 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.

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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BIOROBOTICS
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# 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

HYDROS ROBOTIC SYSTEM

| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS ROBOTIC SYSTEM | | |
| Device Trade Name | HYDROS® Robotic System | HYDROS® Robotic System |
| Manufacturer | PROCEPT BioRobotics Corporation | PROCEPT BioRobotics Corporation |
| REF/Model Number | HY1000 | HY1000 |
| Pre-Market Notification Type | Traditional 510(k) | Traditional 510(k) |
| 510(k) number | K251082 | K240200 |
| Regulation Number | 21 CFR 876.4350 | 21 CFR 876.4350 |
| Regulation Name | Fluid jet system for prostate tissue removal | Fluid jet system for prostate tissue removal |
| Product Classification | Class II | Class II |
| Product Code | PZP | PZP |
| 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. | 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 User | The intended user shall be a urologist, supported by | The intended user shall be a urologist, supported by OR |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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BIOROBOTICS
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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS ROBOTIC SYSTEM | | |
| | 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. | 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. |
| Patient Population | Males suffering from LUTS resulting from benign prostatic hyperplasia (BPH). | Males suffering from LUTS resulting from benign prostatic hyperplasia (BPH). |
| Intended Body/Tissue Interaction | The HYDROS Robotic System is not patient contacting. | The HYDROS Robotic System is not patient contacting. |
| Operating Environment | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70 kPa to 101 kPa | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70 kPa to 101 kPa |
| Storage Environment | Temperature: 10° to 30°
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70 kPa to 101 kPa | Temperature: 10° to 30°
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70 kPa to 101 kPa |
| Transportation Environment | Temperature: -18° to 60° C
Humidity: 15% to 90%, non-condensing
Atmospheric Pressure: 60 kPa to 106 kPa | Temperature: -18° to 60° C
Humidity: 15% to 90%, non-condensing
Atmospheric Pressure: 60 kPa to 106 kPa |
| Cleaning and Disinfection Method | Clean using quaternary ammonium –based cleaner and disinfect using intermediate level disinfectant. | Clean using quaternary ammonium –based cleaner and disinfect using intermediate level disinfectant. |
| Use Life | 1 year | 1 year |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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BIOROBOTICS
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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS ROBOTIC SYSTEM | | |
| Surgeon Interface | - Two monitors for display – one surgeon monitor (Smon) for use in the sterile environment and the tower monitor (Tmon) which can be used by support staff.
- Portrait view
- Interaction is through touchscreen.
- Physician authorization is enabled on the surgeon monitor or by pressing the + button on the motorpack. | - Two monitors for display – one surgeon monitor (Smon) for use in the sterile environment and the tower monitor (Tmon) which can be used by support staff.
- Portrait view
- Interaction is through touchscreen.
- Physician authorization is enabled only on the surgeon monitor. |
| Ultrasound | Integrated ultrasound and a compatible TRUS probe is provided with the HYDROS Robotic System. | Integrated ultrasound and a compatible TRUS probe is provided with the HYDROS Robotic System. |
| Cystoscope Imaging | The CMOS scope connects to the HYDROS Robotic System and specifically the camera control unit (CCU) located within the tower infrastructure of the device for cystoscope image processing. | The CMOS scope connects to the HYDROS Robotic System and specifically the camera control unit (CCU) located within the tower infrastructure of the device for cystoscope image processing. |
| Maximum angle rotation | 225 degrees | 225 degrees |
| Maximum depth of penetration | 24.3 mm | 24.3 mm |
| Network Connection Capability | The HYDROS Robotic System component (PC) includes a Wi-Fi card that creates network connection capability. | The HYDROS Robotic System component (PC) includes a Wi-Fi card that creates network connection capability. |
| Cloud Connection + Wi-Fi connection | The software allows enabling and disabling the cloud connection on the Wi-Fi connected systems. | The software allows enabling and disabling the cloud connection on the Wi-Fi connected systems. |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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BIOROBOTICS
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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS ROBOTIC SYSTEM | | |
| | Users have the option to choose a disconnected system. | Users have the option to choose a disconnected system. |
| FirstAssist AI™ (previously Assisted Planning) Feature | Optional FirstAssist AI feature available during the PLAN step.
FirstAssist AI, Transverse: When the FirstAssist AI toggle button is enabled in the transverse view at the angle and depth step, the software provides the handpiece nozzle position and the prostate capsule boundary.

FirstAssist AI, Sagittal: When the FirstAssist AI toggle button is enabled at the profile landmark step the software will place the 4 landmarks – treatment start (TS), blader neck (BN), mid-prostate (MP) and treatment end (TE). The surgeon has the option to adjust the landmarks as needed. The subject device has an updated AI model for the same functionality of landmark identification. | Optional FirstAssist AI feature available during the PLAN step.
FirstAssist AI, Transverse: When the FirstAssist AI toggle button is enabled in the transverse view at the angle and depth step, the software provides the handpiece nozzle position and the prostate capsule boundary.

FirstAssist AI, Sagittal: When the FirstAssist AI toggle button is enabled at the profile landmark step the software will place the 4 landmarks – treatment start (TS), blader neck (BN), mid-prostate (MP) and treatment end (TE). The surgeon has the option to adjust the landmarks as needed. |
| Workflow Optimization | GUI Steps:
• Setup – includes TRUS, Handpiece and Align
– Plan -includes Manual and optional FirstAssist AI Transverse | GUI Steps:
• Setup – includes TRUS, Handpiece and Align
• Plan -includes Manual and optional FirstAssist AI Transverse Angle and Depth planning options, registration, |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS ROBOTIC SYSTEM | | |
| | Angle and Depth planning options, registration, Manual and Optional FirstAssist AI profile options for Sagittal Plane and Contour.
• Treat – includes treatment with the options for starting an additional pass or completing the procedure. | Manual and Optional FirstAssist AI profile options for Sagittal Plane and Contour.
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/min
Manual: 360±75ml/min = [285, 435] | During Resection: Nominal Waterjet Flow + 10ml/min
Manual: 360±75ml/min = [285, 435] |
| Verumontanum protection orientation | • 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 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. |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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BIOROBOTICS
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HYDROS TRUS PROBE

| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS TRUS Probe | | |
| Device Trade Name | HYDROS TRUS Probe | HYDROS TRUS Probe |
| Manufacturer | PROCEPT BioRobotics Corporation | PROCEPT BioRobotics Corporation |
| REF/Model Number | HU1000 | HU1000 |
| Pre-Market Notification Information | Traditional 510(k) | Traditional 510(k) |
| 510(k) number | K251082 | K240200 |
| Regulation Number | 21 CFR 876.4350 | 21 CFR 876.4350 |
| Regulation Name | Fluid jet system for prostate tissue removal | Fluid jet system for prostate tissue removal |
| Product Classification | Class II | Class II |
| Product Code | PZP, ITX | PZP. ITX |
| 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. | 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 User | 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. | 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. |
| Patient Population | Males suffering from LUTS resulting from benign prostatic hyperplasia (BPH). | Males suffering from LUTS resulting from benign prostatic hyperplasia (BPH). |
| Intended Body/Tissue interaction | The HYDROS TRUS probe may come in contact with the rectal tissue. Tissue/Bone/Dentin per ISO 10993-1:2018, Table A.1 | The HYDROS TRUS probe may come in contact with the rectal tissue. Tissue/Bone/Dentin per ISO 10993-1:2018, Table A.1 |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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BIOROBOTICS
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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| **HYDROS TRUS Probe** | | |
| Duration of Contact | The HYDROS TRUS probe is considered an Externally communicating medical device. The HYDROS TRUS probe is used as part of the Aquablation procedure which lasts about 30 minutes, so the TRUS probe has Limited Exposure (≤24hr). | The HYDROS TRUS probe is considered an Externally communicating medical device. The HYDROS TRUS probe is used as part of the Aquablation procedure which lasts about 30 minutes, so the TRUS probe has Limited Exposure (≤24hr). |
| Mode of Action | B mode | B mode |
| Surface Area (patient contacting portion of the probe only) | ~276 Sq.cm | ~276 Sq.cm |
| Plane Switching | The handle interface of the HYDROS TRUS probe provides a button to switch ultrasound visualization planes between transverse and sagittal planes | The handle interface of the HYDROS TRUS probe provides a button to switch ultrasound visualization planes between transverse and sagittal planes |
| Connection | Probe is plugged into the HYDROS Robotic System with one connector | Probe is plugged into the HYDROS Robotic System with one connector |
| Length of the connector cable | ~220 cm | ~220 cm |
| Materials | HYDROS TRUS probe material information:
- Hard Shell: ABS Plastic
- Transducer portion of the probe: Silicone
- Plane Switching Button: Silicone | HYDROS TRUS probe material information:
- Hard Shell: ABS Plastic
- Transducer portion of the probe: Silicone
- Plane Switching Button: Silicone |
| Reprocessing | Reprocessing is required prior to each use and instructions are provided in the instructions for use (IFU) shipped with device.
Addition of two reprocessing methods to the TRUS Probe IFU:
1. Disinfection using CIDEX™ OPA (ASP™). | Reprocessing is required prior to each use and instructions are provided in the instructions for use (IFU) shipped with device. |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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BIOROBOTICS
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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS TRUS Probe | | |
| | 2. Sterilization using STERIS V-Pro maX Non-Lumen cycle. | |
| Operating Environment | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70kPa to 101kPa | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70kPa to 101kPa |
| Storage Environment | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70kPa to 101kPa | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70kPa to 101kPa |
| Transportation Environment | Temperature: -18° to 60° C
Humidity: 15% to 90%, non-condensing
Atmospheric Pressure: 60kPa to 106kPa | Temperature: -18° to 60° C
Humidity: 15% to 90%, non-condensing
Atmospheric Pressure: 60kPa to 106kPa |
| Use Life | The users are instructed to perform visual and functional inspection post reprocessing and prior to each use however, the device is validated for 71 cycles of reprocessing. | The users are instructed to perform visual and functional inspection post reprocessing and prior to each use however, the device is validated for 25 cycles of reprocessing. |

## HYDROS HANDPIECE

| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS Handpiece | | |
| Device Trade Name | HYDROS Handpiece | HYDROS Handpiece |
| Manufacturer | PROCEPT BioRobotics Corporation | PROCEPT BioRobotics Corporation |
| REF/Model Number | HH1000 | HH1000 |
| Pre-Market Notification Information | Traditional 510(k) | Traditional 510(k) |
| 510(k) number | K251082 | K240200 |
| Regulation Number | 21 CFR 876.4350 | 21 CFR 876.4350 |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS HANDPIECE | | |
| Regulation Name | Fluid jet system for prostate tissue removal | Fluid jet system for prostate tissue removal |
| Product Classification | Class II | Class II |
| Product Code | PZP | PZP |
| 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. | 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 User | 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. | 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. |
| Patient Population | Males suffering from LUTS resulting from benign prostatic hyperplasia (BPH) | Males suffering from LUTS resulting from benign prostatic hyperplasia (BPH) |
| Intended Body/Tissue Interaction | The HYDROS Handpiece shall be used endoscopically accessing the prostate via the urethra (external communicating device, tissue/bone/dentin, with limited exposure (<24 hours). | The HYDROS Handpiece shall be used endoscopically accessing the prostate via the urethra (external communicating device, tissue/bone/dentin, with limited exposure (<24 hours). |
| Biocompatibility | The device was tested for biocompatibility as per the ISO 10993-1 standard and it was reported to be biocompatible. | The device was tested for biocompatibility as per the ISO 10993-1 standard and it was reported to be biocompatible. |
| Sterilization method | Ethylene Oxide Sterilization (ETO) SAL 10-6 | Ethylene Oxide Sterilization (ETO) SAL 10-6 |
| Operating Environment | Temperature: 10° to 30° C | Temperature: 10° to 30° C |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| **HYDROS HANDPIECE** | | |
| | Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70 kPA to 101 kPA | Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70 kPA to 101 kPA |
| Storage Environment | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70 kPA to 101 kPA | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-condensing
Atmospheric Pressure: 70 kPA to 101 kPA |
| Transportation Environment | Temperature: -18° to 60° C
Humidity: 15% to 90%, non-condensing
Atmospheric Pressure: 60 kPA to 106 kPA | Temperature: -18° to 60° C
Humidity: 15% to 90%, non-condensing
Atmospheric Pressure: 60 kPA to 106 kPA |
| Shelf Life of the Handpiece | 24 months | 6 months |
| Use Life of the scope | Single use | Single use |
| Scope | The CMOS Scope is a digital scope and comes pre-loaded in the HYDROS Handpiece. This CMOS Scope is a single-use device and provided sterile. | The CMOS Scope is a digital scope and comes pre-loaded in the HYDROS Handpiece. This CMOS Scope is a single-use device and provided sterile. |
| Maximum angle rotation | 225 degrees | 225 degrees |
| Maximum depth of penetration | 24.3 mm | 24.3 mm |
| Resolving Power | (MTF)
• >80% contrast at 80 lp/ph (8 lp/mm object space) @5mm
• >80% contrast at 80 lp/ph (5.3 lp/mm object space) @8mm | (MTF)
• >80% contrast at 80 lp/ph (8 lp/mm object space) @5mm
• >80% contrast at 80 lp/ph (5.3 lp/mm object space) @8mm |
| Field of View | Minimum of 60° FoV | Minimum of 60° FoV |
| Working Length | 24.5cm ≥ working length ≤ 27.0cm
Maximum = 24 Fr | 24.5cm ≥ working length ≤ 27.0cm
Maximum = 24 Fr |
| Packaging | HYDROS Handpiece will be packaged in a thermoformed Tray and Retainer manufactured using PETG. | HYDROS Handpiece will be packaged in a thermoformed Tray and Retainer manufactured using PETG. |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| --- | --- | --- |
| HYDROS HANDPIECE | | |
| | The tray and the retainer are heat sealed using a Tyvek lid. | The tray and the retainer are heat sealed using a Tyvek lid. |

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]

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# 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-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| System Verification | FDA Guidance | Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) | Pass |
| Usability | IEC 62366-1:2015/COR1:2016 | Medical devices – Part 1: Application of usability engineering to medical devices | Pass |
| | ANSI/AAMI HE75:2009 (R2018) | Human Factors Engineering - Design Of Medical Devices | |
| Electromagnetic Compatibility | IEC60601-1-2:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests | Pass |
| | IEC TR 60601-4-2 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | |
| Basic Safety | IEC 60601-1:2020 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Pass |
| | IEC 60601-2-37 Edition 2.1 2015 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | |

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| Non-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| | EC 60601-1-6:2020 | Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard:Usability | |
| | IEC 60601-2-18: 2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | |
| | IEC 80601-2-77: 2019 | Medical electrical equipment - Part 2-77: Particular requirements for the Basic Safety and essential performance of Robotically Assisted Surgical Equipment (RASE) | |
| Wireless | AAMI TIR69:2017/(R2020) | Technical Information Report Risk Management of radio-frequency wireless coexistence for medical devices and systems | Pass |
| | FDA Guidance | Radio Frequency Wireless Technology in Medical Devices | |
| Sterilization | EN ISO 11135:2014 + AMD 1: 2019 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | Pass |
| | ISO 10993-7:2008 + AMD 1:2019 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals | |
| | ISO 11138-1: 2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements | |
| | ISO 11138-2: 2017 | Sterilization of health care products — Biological | |

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| Non-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| | | indicators — Part 2: Biological indicators for ethylene oxide sterilization processes | |
| | BS EN 556-1: 2001 | Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices | |
| | ISO11737-1: 2018+AMD1:2021 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products | |
| | ISO 11737-2: 2019 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process | |
| | ISO 11139: 2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards | |
| | ISO 14937:2009 | Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices | |
| | AAMI TIR 14: 2016 | Contract sterilization using ethylene oxide | |
| | AAMI TIR 15: 2016 | Physical aspects of ethylene oxide sterilization | |

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| Non-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| | AAMI TIR 16: 2017 | Microbiological aspects of ethylene oxide sterilization | |
| | ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | |
| | AAMI TIR 28: 2016/(R)2020 | Product adoption and process equivalence for ethylene oxide sterilization | |
| | ISO 11135 Second edition 2014-07-15 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] | |
| | ISO 11737-2 Third edition 2019-12 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | |
| Biocompatibility | ISO 10993-1:2018 | Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process | Pass |
| | ISO 10993-4:2017 | Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood | |
| | ISO 10993-5:2009 | Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity | |
| | ISO 10993-9: 2019 | Biological evaluation of medical devices — Part 9: Framework for identification | |

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| Non-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| | | and quantification of potential degradation products | |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11: 2017 | Biological evaluation of medical devices – Part 11: Tests for Systemic Toxicity |
| ISO 10993-12:2021 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-15:2019 | Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys |
| ISO 10993-18:2020 | Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process |
| ISO 10993-23:2021 | Biological evaluation of medical devices – Part 23: Tests for Irritation |
| Packaging and Transit | ISTA 3B: 2017 | Packaged-Products for Less-Than-Truckload (LTL) Shipment | Pass |

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| Non-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| | ASTM D4332-22 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing | |
| | ASTM D4169-22 | Standard Practice for Performance Testing of Shipping Containers and Systems | |
| | ASTM F1886/F1886M-16 | Standard test method for determining integrity of seals for flexible packaging visual inspection | |
| | ASTM F2096-11 (2019) | Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test) | |
| | ISO 11607-1: 2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems | |
| | ISO 11607-2: 2019 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes | |
| Shelf Life | ASTM F88/F88- 2023 | Standard test method for seal strength of flexible barrier materials | Pass |
| | ASTM F1980-21 | Standard guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices | |
| Reliability | MIL-STD-721C | Military Standards Definitions of Terms for Reliability and Maintainability | Pass |
| Labeling | ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labelling and | Pass |

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| Non-Clinical Bench 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 2019-07 | Graphical symbols - Safety colours and safety signs - Registered safety signs | |
| | ISO 17664-2 First edition 2021-02 | Processing of health care 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 2022-11 | Graphical symbols for electrical equipment in medical practice | |
| | ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device 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) | |
| | FDA Guidance | Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) | |
| Reprocessing | ANSI AAMI ST98:2022 | Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices | Pass |
| | AAMI TIR 12:2020 | Designing, Testing, And Labeling Medical Devices Intended For Processing By Health Care Facilities: A | |

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| Non-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| | | Guide For Device Manufacturers | |
| | ASTM F3208-20 | Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices | |
| | AAMI TIR 99:2024 | Processing of dilators, transesophageal and ultrasound probes in health care facilities | |
| Corrosion | ASTM F1089-18 | Standard Test Method for Corrosion of Surgical Instruments | Pass |
| Cystoscope Imaging | ISO 8600-5:2020 | Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics | Pass |
| | ISO 8600-3:2019 | Endoscopes – Medical endoscopes and endotherapy devices – Part 3: Determination of field of view and direction of view of endoscopes with optics | |
| | ISO 8600-1: 2015 | Endoscopes – medical and endotherapy devices – Part 1: General Requirements | |
| | ISO 80369-7:2021 | Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications | |
| | ISO CIE 11664-4, First Edition 2019-06 | Colorimetry - Part 4: CIE 1976 L*a*b colour space | |
| | ISO CIE 11664-6, First Edition 2014-02-01 | Colorimetry - Part 6: CIEDE2000 colour difference formula | |
| | IEC 61966-2-1:1999-10 | Multimedia systems and equipment - Colour measurement and management - Part 2-1: | |

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| Non-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| | | Colour management - Default RGB colour space - sRGB | |
| Ultrasound Imaging | IEC 62127-1:2022 | Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields | Pass |
| | IEC 61391-1:2006+AMD1:2017 | CSV Consolidated version Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of point-spread function response | |
| | FDA Guidance | Marketing Clearance of Diagnostic Ultrasound Systems and Transducers | |
| Cybersecurity | ISO IEC 29147 First edition 2014-02-15 | Information technology - Security techniques - Vulnerability disclosure | Pass |
| | IEC 80001-1 Edition 1.0 2010-10 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities | |
| | AAMI TIR57:2016 | Principles for medical device security - Risk management. | |
| | ANSI NEMA HN 1-2019 | American National Standard Manufacturer Disclosure Statement for Medical Device Security | |
| | FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | |
| | FDA Guidance | Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software | |
| Software | FDA Guidance | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | Pass |

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| Non-Clinical Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| --- | --- | --- | --- |
| | Draft FDA Guidance | Draft Guidance - Content of Premarket Submissions for Device Software Functions | |
| | FDA Guidance | General Principles of Software Validation | |
| AI/ML | FDA Guidance | Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions | Pass |
| | FDA Guidance | Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions | |
| | FDA Guidance | Good Machine Learning Practice for Medical Device Development: Guiding Principles | |

**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.

PROCEPT BioRobotics Corporation · 150 Baytech Drive · San Jose, CA 95134
office: +1.650.232.7200 · [e-mail]