(208 days)
Not Found
Yes
The summary explicitly mentions an "Optional FirstAssist AI feature" and describes its function in providing nozzle position, prostate capsule boundary, and landmark placement. It also includes an "AI/ML section in Non-Clinical Performance Data table."
Yes
The device is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms due to benign prostatic hyperplasia, which is a therapeutic intervention.
No
The device is a surgical robotic system intended for the resection and removal of prostate tissue. While it uses imaging and has an optional AI feature to assist with planning, its primary function is therapeutic (surgical tissue removal), not diagnostic (identifying or characterizing disease).
No
The device is a complex robotic system with multiple hardware components (tower, arms, handpiece, probe, foot pedal, etc.) in addition to software. While software is a critical part of the system, it is not a standalone software-only medical device.
Based on the provided information, the HYDROS™ Robotic System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the resection and removal of prostate tissue in males with LUTS due to BPH. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The components are described as a robotic system, a TRUS probe for imaging, and a surgical handpiece for tissue resection. These are all tools used in a surgical intervention.
- Function: The system facilitates a surgical procedure (resection and removal of tissue) using imaging guidance and robotic assistance. It does not perform any diagnostic testing on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) to provide diagnostic information. The imaging is used for guidance during the surgical procedure, not for diagnosing the condition itself.
While the device uses imaging and potentially AI for planning and guidance during the surgical procedure, its primary function is a therapeutic intervention (tissue removal), not a diagnostic test performed on a sample.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PZP
Device Description
The HYDROS™ Robotic System has three components - the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece.
-
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.
-
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. -
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.
Mentions image processing
Yes, "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."
Mentions AI, DNN, or ML
Yes, "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), bladder neck (BN), mid-prostate (MP) and treatment end (TE). The surgeon has the option to adjust the landmarks as needed."
Input Imaging Modality
Ultrasound, Cystoscope Imaging
Anatomical Site
Prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design validation included simulated use testing and cadaver testing.
Summary of non-clinical testing in accordance with applicable standards and guidance documents listed in the table provided. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
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).
1
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
2
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
3
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 Corporation
150 Baytech Drive,
San Jose, 95134
USA |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Contact Name: Sara Muddell
Title: Sr. Director of Global Regulatory Affairs
Address: 150 Baytech Drive, San Jose, CA 95134, USA
Telephone: (650) 232-7217
Cell: (669) 220-8583
Email: s.muddell@procept-biorobotics.com |
| 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 |
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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® Robotic | |
| System | AQUABEAM® Robotic | |
| System (P1G2) | ||
| Manufacturer | PROCEPT BioRobotics | |
| Corporation | PROCEPT BioRobotics | |
| Corporation | ||
| 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 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 AquaBeam 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. | ||
| Intended User | The intended user shall be | |
| a urologist supported by | Urologists and support staff | |
| who are trained and familiar | ||
| 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. | with performing endoscopic | |
| surgical benign prostatic | ||
| hyperplasia procedures and | ||
| in recognizing and | ||
| managing their | ||
| complications. Users must | ||
| possess a thorough | ||
| understanding of the | ||
| technical principles, clinical | ||
| application, and risks | ||
| associated with the | ||
| AQUABEAM Robotic | ||
| System and complete the | ||
| PROCEPT BioRobotics | ||
| Corporation training | ||
| program prior to use. | ||
| 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 AquaBeam 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: 0° to 35° C | |
| Humidity: 0% to 90%, non- | ||
| condensing | ||
| Atmospheric Pressure: 70 | ||
| kPA to 107 kPA | ||
| Storage Environment | Temperature: 10° to 30° | |
| Humidity: 20% to 80%, | ||
| non-condensing | ||
| Atmospheric Pressure: 70 | ||
| kPA to 101 kPA | Temperature: 0° to 35° C | |
| Humidity: 0% to 90%, non- | ||
| condensing | ||
| Atmospheric Pressure: 70 | ||
| kPA to 107 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 | Clean using quaternary | |
| ammonium -based cleaner | ||
| and disinfect using | ||
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS ROBOTIC SYSTEM | ||
| Use Life | intermediate level | |
| disinfectant. | ||
| 1 year | intermediate level | |
| disinfectant. | ||
| 3 Years | ||
| 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 only on the
surgeon monitor. | Single monitor for display for use by both
the surgeon and the support staff - landscape view
- Interaction is through
the keyboard and the
trackball on the
keyboard. - Physician authorization
is enabled by pressing
the “+” button on the
motorpack. |
| Ultrasound | Integrated ultrasound and a
compatible TRUS probe is
provided with the
HYDROS Robotic
System. | A third-party ultrasound
system and a third-party
compatible ultrasound probe
is used with the AquaBeam
Robotic System per its
indications for use. |
| 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 AquaBeam Scope
which is part of the
AquaBeam Robotic System
was connected to a third-
party cystoscopy unit for
providing the live
cystoscope imaging during
the Aquablation therapy. |
| 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 AquaBeam Robotic
System and its components
do not include a Wi-Fi card
and there is no network
connection capability. |
| Cloud Connection + Wi-Fi
connection | The software allows
enabling and disabling the | AquaBeam Robotic
Systems do not provide any
options for connected |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| | HYDROS ROBOTIC SYSTEM | |
| | cloud connection on the
Wi-Fi connected systems.
Users have the option to
choose a disconnected
system. | systems and/or options for
connection to Cloud servers. |
| 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), bladder neck
(BN), mid-prostate (MP)
and treatment end (TE).
The surgeon has the option
to adjust the landmarks as
needed. | No Optional FirstAssist AI
feature present in the PLAN
step |
| Workflow Enhancement | GUI Steps:
• Setup – includes
TRUS, Handpiece and
Align
• Plan -includes Manual
and optional
FirstAssist AI
Transverse Angle and
Depth planning | GUI Steps:
• Setup - includes TRUS,
Handpiece and Align
• Plan -includes Manual
Transverse Angle and
Depth planning,
registration, Manual
profile for Sagittal Plane |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS ROBOTIC SYSTEM | | |
| | 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. | 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: $360\pm75$ ml/min =
[285, 435] | During Resection: Nominal
Waterjet Flow + 10ml/min
Manual: 317ml/min +/- 10%
= [285,349] |
| 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 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. |
| COMPARISON
ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| Device Trade Name | HYDROS TRUS Probe | AQUABEAM ROBOTIC SYSTEM |
| Manufacturer | PROCEPT BioRobotics
Corporation | PROCEPT BioRobotics
Corporation |
| REF/Model Number | HU1000 | AB2000 |
| Pre-Market
Notification
Information | 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 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 AquaBeam 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. | Urologists and support staff who
are trained and familiar with
performing endoscopic surgical
benign prostatic hyperplasia
procedures and in recognizing and
managing their complications.
Users must possess a thorough
understanding of the technical
principles, clinical application, and
risks associated with the
AQUABEAM Robotic System and
complete the PROCEPT
BioRobotics Corporation training
program prior to use |
| Patient Population | Males suffering from LUTS
resulting from benign prostatic
hyperplasia (BPH). | Males suffering from LUTS
resulting from benign prostatic
hyperplasia (BPH). |
| COMPARISON
ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS TRUS Probe | | |
| 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 AquaBeam Robotic System
uses a third-party ultrasound probe,
SIUI'S ECBP-1 and the intended
body/tissue interaction is identical
between the subject device and
predicate device. |
| 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 AquaBeam Robotic System
uses a third-party ultrasound probe,
SIUI'S ECBP-1 and the duration of
contact is the same as the subject
device as the manner in which the
TRUS probe is used remains
identical between subject device
and predicate device. |
| Mode of Action | B mode | The AquaBeam Robotic System
uses a third-party ultrasound probe,
SIUI'S ECBP-1 and the mode of
action is the same as the subject
device as the manner in which the
TRUS probe is used remains
identical between subject device
and predicate device. |
| Surface Area (patient
contacting portion of
the probe only) | ~276 Sq.cm | The AquaBeam Robotic System
uses a third-party ultrasound probe,
SIUI'S ECBP-1 and the surface
area of ECBP-1 is 264 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 AquaBeam Robotic System
uses a third-party ultrasound probe,
SIUI'S ECBP-1 which does not
include a plane switching button. |
| Connection | Probe is plugged into the
HYDROS Robotic System with
one connector | The AquaBeam Robotic System
uses a third-party ultrasound
system, SIUI's Apogee 2300 and
ultrasound probe, SIUI's ECBP-1.
The ultrasound system connects to
the AquaBeam Robotic System via
an ethernet cable and the
ultrasound probe connects to the |
| COMPARISON
ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS TRUS Probe | | |
| Length of the connector
cable | ~220 cm | ultrasound system with two
connectors.
The AquaBeam Robotic system
uses a third-party ultrasound probe,
SIUI's ECBP-1 and the length of
the connector cable is ~220 cm
which is identical to the subject
device. |
| Materials | HYDROS TRUS probe material
information: - Hard Shell: ABS Plastic
- Transducer portion of the
probe: Silicone - Plane Switching Button:
Silicone | The AquaBeam Robotic
System uses a third-party
ultrasound probe, SIUI's
ECBP-1 and the material of
this probe is identical to the
subject device and
additionally manufactured
by the same company, SIUI |
| Reprocessing | Reprocessing is required prior to
each use and instructions are
provided in the instructions for
use (IFU) shipped with device. | The AquaBeam Robotic system
uses a third-party ultrasound
system, SIUI's Apogee 2300 and
ultrasound probe, SIUI's ECBP-1
and has its individual IFU with the
reprocessing instructions provided
by SIUI. |
| Operating
Environment | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-
condensing
Atmospheric Pressure: 70kPA to
101kPA | The AquaBeam Robotic system
uses a third-party ultrasound probe,
SIUI's ECBP-1 and the operating
environment for subject device and
ECBP-1 are similar since the
intended use environment of the
subject and predicate devices are
identical. |
| Storage Environment | Temperature: 10° to 30° C
Humidity: 20% to 80%, non-
condensing
Atmospheric Pressure: 70kPA to
101kPA | The AquaBeam Robotic system
uses a third-party ultrasound probe,
SIUI's ECBP-1 and the storage
environment for subject device and
ECBP-1 are similar since the
intended use environment of the
subject and predicate devices are
identical. |
| COMPARISON
ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS TRUS Probe | | |
| Transportation
Environment | Temperature: -18° to 60° C
Humidity: 15% to 90%, non-
condensing
Atmospheric Pressure: 60kPA to
106kPA | The AquaBeam Robotic system
uses a third-party ultrasound probe,
SIUI's ECBP-1 and the
transportation environment for
subject device and ECBP-1 are
similar since the intended use
environment of the subject and
predicate devices are identical. |
| 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 25 cycles
of reprocessing. | The AquaBeam Robotic system
uses a third-party ultrasound probe,
SIUI's ECBP-1 and has a use life
of 100 cycles. The use-life of the
subject device falls within the use
life of the ultrasound probe used
with the predicate device. |
HYDROS ROBOTIC SYSTEM
7
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.
9
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.
10
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.
11
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
12
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.
13
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".
14
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
| COMPARISON
| ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| HYDROS HANDPIECE | ||
| Device Trade Name | HYDROS Handpiece | AQUABEAM® Robotic System |
| Manufacturer | PROCEPT BioRobotics | |
| Corporation | PROCEPT BioRobotics Corporation | |
| REF/Model Number | HH1000 | HP2000 |
| SC2000 | ||
| Pre-Market | ||
| Notification | ||
| Information | 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 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) | The AquaBeam 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. | ||
| COMPARISON | ||
| ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS HANDPIECE | ||
| 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. | Urologists and support staff who are | |
| trained and familiar with performing | ||
| endoscopic surgical benign prostatic | ||
| hyperplasia procedures and in | ||
| recognizing and managing their | ||
| complications. Users must possess a | ||
| thorough understanding of the | ||
| technical principles, clinical | ||
| application, and risks associated with | ||
| the AQUABEAM Robotic System and | ||
| complete the PROCEPT BioRobotics | ||
| Corporation training program prior to | ||
| use | ||
| 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 (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 | (USAF 1951 target) | |
| Group 3 Element 6 on axis at 5mm and | ||
| Group 3 Element 2 on axis at 8mm | ||
| Field of View | Minimum of 60° FoV | Minimum of 60° FoV |
| Working Length | 24.5cm ≥ working length ≤ | |
| 27.0cm | ||
| 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. | ||
| The tray and the retainer are | ||
| heat sealed using a Tyvek lid. | The AQUABEAM Handpiece is | |
| packaged on a White high-density | ||
| polyethylene (HDPE) packaging card | ||
| in Tyvek pouch. The sealed pouches | ||
| are then placed into shelf cartons |
15
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.
16
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.
17
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-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 |
ANSI/AAMI
HE75:2009 (R2018) | Medical devices - Part 1:
Application of usability
engineering to medical
devices
Human Factors Engineering
- Design Of Medical Devices | Pass |
| Electromagnetic
Compatibility | IEC60601-1-2:2020
IEC TR 60601-4-2 | Medical electrical equipment
- Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic disturbances - Requirements and tests
Medical electrical equipment
- Part 4-2: Guidance and
interpretation -
Electromagnetic immunity:
performance of medical
electrical equipment and
medical electrical systems | Pass |
| Basic Safety | IEC 60601-1:2020
IEC 60601-2-37 Edition
2.1 2015 | Medical electrical equipment
- Part 1: General
requirements for basic safety
and essential performance
Medical electrical equipment
- Part 1: General
requirements for basic safety
and essential performance | Pass |
| 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 |
| | | 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 |
| | 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 | |
| Non-Clinical
Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| | BS EN 556-1: 2001 | indicators – Part 2:
Biological indicators for
ethylene oxide sterilization
processes | |
| | | 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 | |
| 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 |
| | | 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 |
| 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 |
| 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 |
| 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 | 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 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) | |
| 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-Clinical
Bench Tests | Guidance/Standard ID | Guidance/Standard Name | Results |
| | ASTM F3208-20 | Guide For Device
Manufacturers | |
| | | 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 |
| | 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 |
| | | 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 Lab 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: |
| 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 |
| 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 | |
18
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.
19
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.
20
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.
21
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.