K231024 · Procept Biorobotics, Corporation · PZP · Aug 30, 2023 · General, Plastic Surgery
Device Facts
Record ID
K231024
Device Name
AquaBeam Robotic System
Applicant
Procept Biorobotics, Corporation
Product Code
PZP · General, Plastic Surgery
Decision Date
Aug 30, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.4350
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
AQUABEAM Robotic System performs minimally invasive prostate tissue resection. System utilizes high-velocity sterile saline waterjet as cutting medium; nozzle assembly motion driven by motor system; pressure generated by high-pressure pump. User controls system via AQUABEAM Console and Conformal Planning Unit; pre-condition parameters set on Planning Unit. Handpiece and scope inserted transurethrally into prostatic urethra. System provides automated, image-guided tissue removal; surgeon monitors procedure via console. Output is resection of prostate tissue, relieving LUTS. Used in clinical/surgical settings by physicians. Benefits include precise, controlled tissue removal for BPH patients.
Clinical Evidence
Clinical evidence includes sub-group analysis of the WATER study (NCT02505919) involving patients with incidentally diagnosed prostate cancer post-treatment. Additionally, a study on circulating tumor cells (CTCs) in patients with prostate cancer undergoing Aquablation showed no sustained increase in CTCs following treatment. Data supports safety and effectiveness of the device with modified labeling.
Technological Characteristics
Fluid jet system for prostate tissue removal. Components: console, motorpack, foot pedal, conformal planning unit, roll stand, articulating arms, handpiece, and scope. High-velocity sterile saline waterjet cutting medium. Motor-driven nozzle assembly. High-pressure pump system. Software-controlled parameters. Class II device per 21 CFR 876.4350.
Indications for Use
Indicated for resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
Regulatory Classification
Identification
A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.
Special Controls
In combination with the general controls of the FD&C Act, the fluid jet system for prostate tissue removal is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate the following:
(i) All adverse events associated with the device, and
(ii) Improvement in lower urinary tract symptoms (LUTS).
(2) Physician training must be provided that includes:
(i) Information on key aspects and use of the device, and
(ii) Information on how to override or stop resection.
(3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.
(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and
(ii) High pressure fluid jet verification testing at target and non-target tissues.
(5) Software verification, validation, and hazard analysis must be performed.
(6) The patient-contacting elements of the device must be demonstrated to be biocompatible.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.
(8) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(9) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(10) Performance data must validate the instructions for reprocessing and reliability of reusable components.
(11) Labeling must include the following:
(i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;
(ii) A shelf life for single use components;
(iii) A use life for reusable components; and
(iv) Reprocessing instructions for reusable components.
{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) | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <table style="border:none;"><tr><td><span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr></table> | <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <table style="border:none;"><tr><td><span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | |
| <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | | |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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<br>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<br>System in patients who do not meet the<br>indication for the system's intended<br>use. In addition, do not use the system<br>in patients with: | Do not use the AQUABEAM Robotic<br>System in patients who do not meet the<br>indication for the system's intended<br>use. In addition, do not use the system<br>in patients with: |
| | • Active urinary tract or<br>systemic infection | • Active urinary tract or<br>systemic infection |
| | • Inability to safely stop<br>anticoagulant or antiplatelet<br>agents perioperatively | • Unable to safely stop<br>anticoagulant or antiplatelet<br>agents perioperatively |
| | | • Diagnosed or suspected cancer<br>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.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
