(89 days)
Not Found
No
The description focuses on robotic control, manual adjustments, and pre-set parameters, with no mention of AI or ML capabilities for decision-making, planning, or control.
Yes
The device is intended for the resection and removal of prostate tissue in males suffering from LUTS due to benign prostatic hyperplasia, directly treating a medical condition.
No
The device is described as a surgical system for resecting and removing prostate tissue, indicating its purpose is for treatment, not diagnosis. While it uses imaging to monitor treatment, it does not state that it is used to identify or characterize a disease.
No
The device description explicitly lists multiple hardware components (Console, Motorpack, Foot pedal, etc.) and describes a physical mechanism for tissue resection using a waterjet, indicating it is a hardware-based system with integrated software control.
Based on the provided information, the AQUABEAM Robotic System is not an In Vitro Diagnostic (IVD) 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 directly on the patient's body.
- Device Description: The description details a robotic system designed for surgical resection using a waterjet. It involves inserting components into the body (transurethral approach) to physically remove tissue.
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
The AQUABEAM Robotic System is a surgical device used for treatment, not for examining specimens outside the body to provide diagnostic information.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PZP
Device Description
The AQUABEAM® Robotic System is intended for use in patients suffering from lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH). The AQUABEAM Robotic System is designed for resecting of prostate tissue during minimally invasive surgical procedures. The AQUABEAM Handpiece and AQUABEAM Scope are inserted via transurethral approach and advanced into the prostatic urethra.
The AQUABEAM Robotic System is designed to utilize a high-velocity sterile saline wateriet as the cutting medium which is projected through a nozzle positioned within the prostatic urethra. The nozzle assembly motion is driven by a motor system, controlled by the user. The pressure is generated by a high-pressure pump system controlled by the AQUABEAM Console. The user is allowed to adjust the desired flow rates manually. All functions are displayed on the AQUABEAM Conformal Planning Unit. Pre-condition parameters are set on the AQUABEAM Conformal Planning Unit before operation.
The AQUABEAM Robotic System, consists of the following nine components:
- AQUABEAM Console
- AQUABEAM Motorpack
- AQUABEAM Foot pedal
- AQUABEAM Conformal Planning Unit ●
- AQUABEAM Roll Stand
- AQUABEAM Handpiece Articulating Arm
- AQUABEAM TRUS Articulating Arm
- AQUABEAM Handpiece
- . AQUABEAM Scope
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate / prostatic urethra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The new software and operating system verification and validation testing to ensure that the software and the operating system changes do not impact the safety and effectiveness of the subject device and the subject device software and OS works as intended. Apart from the software and the operating system changes, device's technological characteristics are unchanged, therefore no further non-clinical performance test data is required to support the subject device. The following pre-existing non-clinical data continues to be relied upon to support the safety and effectiveness of the subject device:
- Biocompatibility Sterilization ●
- Electrical Safety and EMC Compatibility
- . Usability
- . System Design Verification and Validation Reliability Testing, AQUABEAM Robotic System
- . Clinical Trial Data
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.
0
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 30, 2024
Procept BioRobotics Sara Muddell Sr. Director, Global Regulatory Affairs 150 Bavtech Drive San Jose, California 95134
Re: K241952 Trade/Device Name: AQUABEAM Robotic System (AB2000) Regulation Number: 21 CFR 876.4350 Regulation Name: Fluid Jet System For Prostate Tissue Removal Regulatory Class: II Product Code: PZP Received: September 3, 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 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 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.
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 Rue"). 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-device-advicecomprehensive-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-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,
Mark R. Kreitz -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
Submission Number (if known)
Device Name
AQUABEAM Robotic System (AB2000)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 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 water droplet design in shades of blue. Below the word "PROCEPT" is the text "BioRobotics" in a smaller, dark blue font.
K241952 Page 1 of 3
510(k) SUMMARY
Date Prepared
July 2, 2024
| Owner/Sponsor | PROCEPT BioRobotics Corporation
150 Baytech Dr.,
San Jose, 95134
USA |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Contact Name: Sara Muddell
Title: Sr. Director of Global Regulatory Affairs
Address: 150 Baytech Dr., San Jose, CA 95134, USA
Telephone: (650) 232-7217
Cell: (669) 220-8583
Email: s.muddell@procept-biorobotics.com |
| Trade Name | AquaBeam Robotic System |
| Classification | Class II |
| Classification Name | Fluid jet system for prostate tissue removal |
| Common Name | Fluid jet system for prostate tissue removal |
| Product Code | PZP: 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 (BPH). 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. |
| Regulation Number | 21 CFR 876. 4350 |
Predicate Device
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
Device Description
The AQUABEAM® Robotic System is intended for use in patients suffering from lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH). The AQUABEAM Robotic System is designed for resecting of prostate tissue during minimally invasive surgical procedures. The
5
Image /page/5/Picture/0 description: The image shows the logo for Procept BioRobotics. The logo is in blue and features the word "PROCEPT" in large, bold letters. The "O" in "PROCEPT" is replaced with a stylized water droplet design. Below the word "PROCEPT" is the text "BioRobotics" in a smaller font.
AQUABEAM Handpiece and AQUABEAM Scope are inserted via transurethral approach and advanced into the prostatic urethra.
The AQUABEAM Robotic System is designed to utilize a high-velocity sterile saline wateriet as the cutting medium which is projected through a nozzle positioned within the prostatic urethra. The nozzle assembly motion is driven by a motor system, controlled by the user. The pressure is generated by a high-pressure pump system controlled by the AQUABEAM Console. The user is allowed to adjust the desired flow rates manually. All functions are displayed on the AQUABEAM Conformal Planning Unit. Pre-condition parameters are set on the AQUABEAM Conformal Planning Unit before operation.
The AQUABEAM Robotic System, consists of the following nine components:
- AQUABEAM Console
- AQUABEAM Motorpack
- AQUABEAM Foot pedal
- AQUABEAM Conformal Planning Unit ●
- AQUABEAM Roll Stand
- AQUABEAM Handpiece Articulating Arm
- AQUABEAM TRUS Articulating Arm
- AQUABEAM Handpiece
- . AQUABEAM Scope
Intended Use/Indications for Use
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.
The intended use of the subject device is identical to the intended use of the predicate device.
Intended Patient Population
The intended patient population is males suffering from benign prostatic hyperplasia (BPH).
Technological Comparison as compared to the Predicate Device
This 510K is submitted for introduction of the new software and version for AQUABEAM Robotic System. All the other technological characteristics of the device are identical to the predicate device. The table below compares the predicate device and the subject device for the comparison -
| Device Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Software | SW0021-282 | |
| The software shall limit the user from | ||
| planning a cut in profile path beyond the | ||
| depth of the cut defined in the angle step | ||
| for mid prostate and bladder neck. Since | ||
| the user is now limited to exceed the | ||
| depth defined, the purple line indicator | ||
| flashing is removed. The median lobe | ||
| depth of cut is not limited. | ||
| The maximum depth constraint is | ||
| removed from the Profile Landmark | SW0021-281 | |
| The user has the option to | ||
| exceed the depth for bladder | ||
| neck, mid-prostate, and median | ||
| lobe. The purple lines on the | ||
| GUI blink when the depth is | ||
| exceeded. | ||
| The maximum depth | ||
| constraint could not let the |
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Image /page/6/Picture/0 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 word "PROCEPT" is the word "BioRobotics" in a smaller, sans-serif font. The logo is clean and modern, and the water droplet suggests that the company is involved in water-related technologies.
| step. The user is able to place the 4
landmark points beyond the 24.3 mm
depth. The maximum depth the user
can plan still is in 24.3mm | user place the markers
beyond the 24.3mm. |
| ------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------- |
|---|
Performance Data
The new software and operating system verification and validation testing to ensure that the software and the operating system changes do not impact the safety and effectiveness of the subject device and the subject device software and OS works as intended. Apart from the software and the operating system changes, device's technological characteristics are unchanged, therefore no further non-clinical performance test data is required to support the subject device. The following pre-existing non-clinical data continues to be relied upon to support the safety and effectiveness of the subject device:
- Biocompatibility Sterilization ●
- Electrical Safety and EMC Compatibility
- . Usability
- . System Design Verification and Validation Reliability Testing, AQUABEAM Robotic System
- . Clinical Trial Data
Conclusion:
The overall performance together with the prior non-clinical performance testing performed on the predicate device, supports that the AQUABEAM Robotic System with the new software and operating system version is as safe, as effective, and performs as well as the legally marketed predicate device. The materials provided in this special 510(k) premarket notification demonstrate compliance to the special controls prescribed in 21 CFR 876.4350.