(162 days)
Not Found
No
The description focuses on robotic control of a waterjet based on user input and pre-set parameters, with no mention of AI/ML for decision-making, image analysis, or autonomous control.
Yes
The device is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms, which is a therapeutic intervention.
No
The device is described as being for "resection and removal of prostate tissue," indicating a therapeutic rather than diagnostic purpose. It is used during surgical procedures to cut and remove tissue.
No
The device description explicitly lists multiple hardware components (Console, Motorpack, Foot pedal, Handpiece, Scope, etc.) and describes their physical functions (motor system, high-pressure pump system, articulating arms). It also mentions hardware verification testing.
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 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 control console used for surgical tissue removal. It does not describe any components or processes for analyzing biological samples (like blood, urine, or tissue samples).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or assays.
The AQUABEAM® Robotic System is clearly described as a surgical device used for a therapeutic procedure.
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
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
The AQUABEAM Console, Motorpack, Conformal Planning Unit, Foot Pedal, Roll Stand, Handpiece Articulating Arm and TRUS Articulating Arm are provided non-sterilization is required prior to each use. The Console, Conformal Planning Unit, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are cleaned after each use. The Console, Conformal Planning Unit, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are not designed to come in contact with the patient during the Aquablation procedure.
The Conformal Planning Unit is a reusable component of the AQUABEAM Robotic System, and it serves as the primary user interface of the System. The CPU is connected to the Console via a USB cable.
The AQUABEAM Console is a reusable component of the AquaBeam Robotic System that controls the functionality of the high-velocity waterjet delivered by the Handpiece.
The AQUABEAM Motorpack is a reusable component of the AQUABEAM Robotic System designed to dock, via a mechanical linkage, and connect with the disposable Handpiece. The Motorpack provides mechanical power to the Handpiece by means of DC motors, which enable both rotational and longitudinal movement of the Handpiece probe providing controlled and precise resection of the prostatic tissue in accordance with the CPU treatment plan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.
Anatomical Site
prostate tissue, prostatic urethra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The intended users are urologists and support staff who are trained and familiar with Transrectal Ultrasound (TRUS) and performing endoscopic surgical benign prostatic hyperplasia procedures and in recognizing and managing their complications.
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)
Non-clinical testing performed on the subject device, AQUABEAM Robotic System to demonstrate substantial equivalence includes verification and other testing. The non-clinical testing conducted are the same as those completed for the predicate device.
- Software and Firmware verification: Verification testing was performed on: CPU software, Operating system, MCU firmware, Updates to Console FPGA, Updates to Motorpack FPGA. The software and firmware performed as intended and all acceptance criteria were met demonstrating substantial equivalence.
- Hardware Verification: Verification testing was conducted on: Console, Motorpack, System. The Console, Motorpack and System performed as intended and all acceptance criteria were met demonstrating substantial equivalence.
- Electrical Safety and Electromagnetic Compatibility: All testing passed EMC per IEC 60601-1-2 4th edition requirements. All testing passed electrical safety per the standards listed.
- System Design Verification: Verification testing was performed on the AQUABEAM Robotic system to test the functional and simulated use and all acceptance criteria were met demonstrating substantial equivalence to the predicate device.
- System Design Validation: A design validation of the AQUABEAM Robotic System was conducted by performing a cadaver study and all acceptance criteria were met demonstrating substantial equivalence to the predicate device.
- Packaging Validation: Packaging and transportation validation was performed on the following components with design change: Console, Motorpack. There are no changes to packaging that are subject of this traditional 510(k). The components with design change passed all testing conducted.
- Reliability Testing: The reliability of the components with design changes were evaluated and the results are equivalent to the predicate device. The use life is documented in the table above and in the product labeling.
The following testing performed on the predicate device are still applicable to the subject device of this traditional 510(k):
- Biocompatibility: There are no changes to the AQUABEAM handpiece and AQUABEAM Scope subject of this traditional 510(k) that require a reassessment of biocompatibility.
- Sterilization: There are no changes to the AQUABEAM Handpiece subject of this traditional 510(k) that require a new sterilization validation.
- Clinical Trial data: Existing clinical trial data is sufficient to establish the safety and effectiveness of the subject device, AQUABEAM Robotic System with the changes in design subject of this traditional 510(k) do not change the mode of operation/mechanism of action of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 11, 2021
PROCEPT BioRobotics Corporation Sara Muddell Director, Global Regulatory Affairs 900 Island Drive, Suite 101 Redwood City, CA 94065
Re: K202961
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: February 1, 2021 Received: February 2, 2021
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 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 801and Part 809); 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, M.S. Acting 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) K202961
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)
X 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 symbol 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 symbol suggests that the company is involved in water-related technologies.
Traditional 510(k) application
510(k) SUMMARY
Date of submission:
November 04, 2020
Owner/Sponsor
| Owner/Sponsor | PROCEPT BioRobotics Corporation |
|---|---|
| 900 Island Drive, | |
| Suite 101 | |
| Redwood City, 94065 | |
| USA | |
| Contact Name: | Sara Muddell |
| Title: | Director of Global Regulatory Affairs |
| Address: | 900 Island Drive, Suite 101, Redwood City, CA, 94065, USA |
| Telephone: | (650) 232-7217 |
| Cell: | (669) 220-8583 |
| Fax: | (650) 232-5782 |
| Email: | s.muddell@procept-biorobotics.com |
Trade/Device Name
AQUABEAM® Robotic System
Device Common Name
- AQUABEAM
- AQUABEAM Robotic System
- Fluid jet system for prostate tissue removal ●
Device Classification Number and Classification Name
21 CFR 876.4350, Fluid jet system for prostate tissue removal
Regulatory Class: II
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.
Predicate Device
Trade Name: AQUABEAM System 510(k) Number: DEN170024 on 21 December 2017. Product Code: PZP Regulation Number: 876. 4350 Class II
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Image /page/4/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, gray letters. The "O" in "PROCEPT" is replaced with a blue water droplet. Below "PROCEPT" is the word "BioRobotics" in smaller, gray letters.
Submission Number: DEN170024
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.
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
The AQUABEAM Console, Motorpack, Conformal Planning Unit, Foot Pedal, Roll Stand, Handpiece Articulating Arm and TRUS Articulating Arm are provided non-sterilization is required prior to each use. The Console, Conformal Planning Unit, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are cleaned after each use. The Console, Conformal Planning Unit, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are not designed to come in contact with the patient during the Aquablation procedure.
The Conformal Planning Unit is a reusable component of the AQUABEAM Robotic System, and it serves as the primary user interface of the System. The CPU is connected to the Console via a USB cable.
The AQUABEAM Console is a reusable component of the AquaBeam Robotic System that controls the functionality of the high-velocity waterjet delivered by the Handpiece.
The AQUABEAM Motorpack is a reusable component of the AQUABEAM Robotic System designed to dock, via a mechanical linkage, and connect with the disposable Handpiece. The Motorpack provides mechanical power to the Handpiece by means of DC motors, which enable both rotational and longitudinal movement of the Handpiece probe providing controlled and precise resection of the prostatic tissue in accordance with the CPU treatment plan.
5
The AQUABEAM Foot Pedal is a reusable, purchased component of the AQUABEAM Robotic System that contains three foot-activated momentary switches. It is connected to the Console with a flexible cable. The Aquablate Pedal is the large center switch which must be depressed to enable Aquablation.
The AQUABEAM Roll Stand provides the main power source, via the isolation transformer, to the Console and serves as the chassis for the AQUABEAM Robotic System.
The AQUABEAM Handpiece Articulating Arm fixes the Handpiece/Motorpack assembly in position relative to the patient. The AQUABEAM TRUS Articulating Arm fixes the TRUS probe and stepper in position relative to the patient. The AQUABEAM Handpiece is a terminally sterilized, single-use disposable component of the AQUABEAM Robotic System
The AquaBeam Scope, a re-usable component of the AquaBeam Robotic System, needs to be reprocessed prior to each use per the AquaBeam Scope Reprocessing Instructions. The Scope is inserted into the central lumen of the Handpiece enabling direct visualization within the prostatic urethra during treatment.
| | Subject Device
AQUABEAM Robotic
System | Predicate Device
AQUABEAM System | Change | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------|
| Device Class | Class II | Class II | Same | |
| Product Code | PZP | PZP | Same | |
| Product Regulation
Number | 876.4350 | 876.4350 | Same | |
| 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 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. | Same | |
| Intended Patient
Population | The intended patient
population is males
suffering from LUTS
resulting from benign
prostatic hyperplasia
(BPH). | The intended patient
population is males
suffering from LUTS
resulting from benign
prostatic hyperplasia
(BPH). | Same | |
| Intended Users | The intended users are
urologists and support
staff who are trained and
familiar with Transrectal
Ultrasound (TRUS) and
performing endoscopic
surgical benign prostatic
hyperplasia procedures | The intended users are
urologists and support
staff who are trained and
familiar with Transrectal
Ultrasound (TRUS) and
performing endoscopic
surgical benign prostatic
hyperplasia procedures | Same | |
| | Subject Device
AQUABEAM Robotic
System | Predicate Device
AQUABEAM System | Change | Traditional 510(k) app |
| | and in recognizing and
managing their
complications. | and in recognizing and
managing their
complications. | | |
| Patient Contact | The AQUABEAM Robotic
System shall be used
endoscopically accessing
the prostate via the urethra
(external communicating
device, tissue/bone/dentin,
with limited exposure (