(141 days)
Not Found
No
The description focuses on the mechanical and hydraulic aspects of the robotic system and does not mention any AI or ML components for control, planning, or analysis.
Yes.
Explanation: The device is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia, which is a therapeutic intervention.
No
The device is described as a system for resecting and removing prostate tissue, indicating a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly lists and describes multiple hardware components, including a console, motorpack, foot pedal, planning unit, roll stand, articulating arms, handpiece, and scope. It also describes mechanical actions (motor system, high-pressure pump) and physical components (nozzle, handpiece, scope). This clearly indicates it is a hardware-based system with integrated software, not a software-only medical device.
Based on the provided information, the AQUABEAM® 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 body.
- Device Description: The description details a robotic system with a handpiece, scope, waterjet, and console used for surgical intervention. It does not describe a device that analyzes biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The AQUABEAM® Robotic System is a surgical device used for treatment.
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 waterjet 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 tissue, 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 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 nonclinical data continues to be relied upon to support the safety and effectiveness of the subject device:
- Biocompatibility .
- . Sterilization
- . Software and Firmware Verification
- . Electrical Safety and EMC Compatibility
- . Usabilitv
- . System Design Verification and Validation
- Reliability Testing, AQUABEAM Robotic System .
The clinical performance data provided in the submission supports that the contraindication is not required, because the risk of use does not clearly outweigh any possible benefit to patients with diagnosed or suspected prostate cancer.
Previously unsuspected prostate cancer is routinely diagnosed incidentally to surgery for benign prostatic hyperplasia, therefore the existing clinical data generated with the device includes such patients whose prostate cancer was not diagnosed in advance of treatment. A sub-group analysis is performed for participants in the Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) study (NCT02505919) without previously diagnosed prostate cancer at the study initiation who went on to be diagnosed with prostate cancer during the study follow-up period.
The clinical performance data also includes a study enumerating circulating tumor cells (CTCs) introduced to the bloodstream secondary to Aquablation in patients with prostate cancer, finding no sustained increase in CTCs following treatment.
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 shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
August 30, 2023
PROCEPT BioRobotics Corporation Sara Muddell Senior Director, Global Regulatory Affairs 900 Island Drive. Suite 101 Redwood City, CA 94065
Re: K231024
Trade/Device Name: AQUABEAM® Robotic System Regulation Number: 21 CFR§ 876.4350 Regulation Name: Fluid Jet System For Prostate Tissue Removal Regulatory Class: II Product Code: PZP Dated: July 31, 2023 Received: August 1, 2023
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 (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 located 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.
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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 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 J. Antonino -S
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
2
Indications for Use
510(k) Number (if known) K231024
Device Name AQUABEAM® Robotic System
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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Procept BioRobotics. The logo consists of the word "PROCEPT" in a sans-serif font, with a stylized water droplet in place of the "O". Below the word "PROCEPT" is the word "BioRobotics" in a smaller sans-serif font. The logo is simple and modern, and the water droplet suggests that the company is involved in water-related technologies.
K231024 Page 1 of 3
510(k) Summary
1. Submitter
PROCEPT BioRobotics Corporation 900 Island Drive Suite 101 Redwood City, 94065 USA
Contact: Sara Muddell Senior Director, Global Regulatory Affairs Telephone: (650) 232-7217 Email: s.muddell(@procept-biorobotics.com
Date Prepared: April 10, 2023
2. Device
| Trade Name: | AQUABEAM® Robotic System |
|---|---|
| Common Name: | Fluid jet system for prostate tissue removal |
| Classification Name: | Fluid jet system for prostate tissue removal |
| Regulation Number: | 21 CFR 876. 4350 |
| Product Code: | PZP |
| Classification: | Class II |
3. Predicate Devices
| Trade Name | AQUABEAM® System | AQUABEAM® Robotic
System |
|------------------|------------------|-----------------------------|
| Clearance Number | DEN170024 | K212835 |
| Product Code | PZP | PZP |
4. 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.
4
Image /page/4/Picture/0 description: The image shows the logo for Procept BioRobotics. The logo consists of the word "PROCEPT" in a dark gray sans-serif font, with a stylized water droplet symbol in place of the "O". Below the word "PROCEPT" is the word "BioRobotics" in a smaller, lighter gray sans-serif font.
The AQUABEAM Robotic System is designed to utilize a high-velocity sterile saline waterjet 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
5. 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.
6. Technological Characteristics
This 510(k) is submitted for changes to the device labeling. The device's technological characteristics are unchanged relative to the predicate device.
7. Device Comparison
The AQUABEAM Robotic System subject device includes the following changes to the device labeling:
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Contraindications | Do not use the AQUABEAM Robotic | |
| System in patients who do not meet the | ||
| indication for the system's intended | ||
| use. In addition, do not use the system | ||
| in patients with: | Do not use the AQUABEAM Robotic | |
| System in patients who do not meet the | ||
| indication for the system's intended | ||
| use. In addition, do not use the system | ||
| in patients with: | ||
| • Active urinary tract or | ||
| systemic infection | • Active urinary tract or | |
| systemic infection | ||
| • Inability to safely stop | ||
| anticoagulant or antiplatelet | ||
| agents perioperatively | • Unable to safely stop | |
| anticoagulant or antiplatelet | ||
| agents perioperatively | ||
| • Diagnosed or suspected cancer | ||
| of the prostate |
5
Image /page/5/Picture/0 description: The image shows the logo for Procept BioRobotics. The logo consists of the word "PROCEPT" in a dark gray sans-serif font, with a stylized water droplet in blue and white replacing the "O". Below the word "PROCEPT" is the word "BioRobotics" in a smaller, lighter gray sans-serif font. The logo is clean and modern, and the water droplet suggests a connection to water or fluids, which may be relevant to the company's products or services.
8. Performance Data
The 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 nonclinical data continues to be relied upon to support the safety and effectiveness of the subject device:
- Biocompatibility .
- . Sterilization
- . Software and Firmware Verification
- . Electrical Safety and EMC Compatibility
- . Usabilitv
- . System Design Verification and Validation
- Reliability Testing, AQUABEAM Robotic System .
9. Clinical Data Summary
The clinical performance data provided in the submission supports that the contraindication is not required, because the risk of use does not clearly outweigh any possible benefit to patients with diagnosed or suspected prostate cancer.
Previously unsuspected prostate cancer is routinely diagnosed incidentally to surgery for benign prostatic hyperplasia, therefore the existing clinical data generated with the device includes such patients whose prostate cancer was not diagnosed in advance of treatment. A sub-group analysis is performed for participants in the Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) study (NCT02505919) without previously diagnosed prostate cancer at the study initiation who went on to be diagnosed with prostate cancer during the study follow-up period.
The clinical performance data also includes a study enumerating circulating tumor cells (CTCs) introduced to the bloodstream secondary to Aquablation in patients with prostate cancer, finding no sustained increase in CTCs following treatment.
10. Conclusion:
The data provided in this submission, together with the prior non-clinical performance testing performed on the predicate device, supports that the AQUABEAM Robotic System with modified labeling is as safe, as effective, and performs as well as the legally marketed predicate device.
The materials provided in this 510(k) premarket notification demonstrate compliance to the special controls prescribed in 21 CFR 876.4350.