(200 days)
Not Found
Not Found
No
The summary describes a computer-controlled therapeutic device using ultrasound for planning, monitoring, and ablation. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on the physical mechanism of HIFU ablation and real-time ultrasound imaging.
Yes
The device is indicated for "ablation of prostatic tissue" and uses "thermal ablation" to "destroy regions of unwanted prostatic tissue," which are therapeutic actions directed at treating a medical condition.
No
The Sonablate® 450 is described as a device for the ablation of prostatic tissue, which is a therapeutic function, even though it uses integrated ultrasound imaging for real-time monitoring and planning, this imaging is an aid to the therapeutic procedure, not for diagnosis.
No
The device description clearly outlines multiple hardware components (Sonasource Console, Sonablate Probe, Sonachill, Stepper, etc.) that are integral to the device's function of delivering HIFU energy. While it is computer-controlled, it is not solely software.
Based on the provided information, the Sonablate® 450 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue." This describes a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for delivering energy to ablate tissue. While it uses imaging for guidance and monitoring, its primary function is therapeutic.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
- Performance Studies: The performance studies focus on the device's ability to ablate tissue safely and effectively, and the resulting clinical outcomes in patients. They do not evaluate diagnostic accuracy metrics like sensitivity, specificity, PPV, or NPV, which are relevant to IVD performance.
In summary, the Sonablate® 450 is a therapeutic device that uses ultrasound energy to treat prostatic tissue. It does not perform diagnostic testing on in vitro samples.
N/A
Intended Use / Indications for Use
The Sonablate® 450 is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
Product codes
PLP
Device Description
The Sonablate® 450 is a computer-controlled device designed for transrectal delivery of high intensity focused ultrasound (HIFU) energy to the prostate to ablate regions of unwanted prostatic tissue via thermal ablation. The device makes use of integrated biplanar ultrasound imaging for real-time monitoring, planning, and pre- and post-ablation imaging of the prostate. The system consists of the following main components: Sonasource Console, Sonablate Probe 30/40, Sonachill, Sonablate Multi-Axis Stepper and Probe Arm, and Single Use Components (Probe Tip Kit and Water Path Kit).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Prostate
Indicated Patient Age Range
Men (40-85 years of age)
Intended User / Care Setting
Prescribed and administered under the direct supervision of a qualified and trained physician, after appropriate urologic patient evaluation.
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
Performance Testing - Bench:
- Study Type: Ultrasound characterization and output performance tests.
- Transducer Characterization: Schlieren test (n=7), Electrostatic test (n=7), Force balance test (n=7).
- Imaging Verification: Phantom testing using a standard ATS Labs phantom (n=1), Imaging frame rate test (n=1), Image display test (n=1).
- HIFU Verification/Safety: Ex vivo tissue phantom tests (n=1), HIFU ON-time/OFF-time Verification Testing (n=1).
- Key Results: All test samples met the acceptance criteria for transducer characterization, imaging verification, and HIFU verification/safety tests. This supports targeting accuracy, reproducibility of HIFU output, sufficient resolution for tissue differentiation, and adequate frame rate for physician feedback. The system is capable of targeting a tissue volume of up to 40 cm³, at a depth of up to 40 mm, and creating single and volume lesions as specified.
Performance Testing - Animal:
- Study Type: In vivo animal studies to demonstrate thermal ablation in a controlled manner without unsafe heating or ablation of adjacent tissues.
- Study 1 ("Safety and Effectiveness of Tissue Ablation"): Dog prostate model (n=5).
- Study 2 ("Efficacy Improvement Software Test Report Localization and Ablation"): Dog prostate model (n=4).
- Study 3 ("Treatment Volume and Accuracy Study Report"): Preliminary dog study.
- Study 4 ("Thermocouple Response to Treatment Test"): Preliminary dog study.
- Study 5 ("Safety of HIFU Energy Application to Adjacent Tissues"): Preliminary dog study.
- Key Results: Study 1 demonstrated effective prostate tissue destruction without rectal wall injury or ablation outside planned target zones; target tissue temperature reached above 60°C for 3 seconds without rectal wall temperatures exceeding 43°C. Studies 2-5 supported safety and effectiveness aspects, including accurate spatial localization and prevention of coagulative necrosis in non-target tissue.
Clinical Information (US Salvage Study):
- Study Design: Multi-center, non-randomized, prospective, single arm study.
- Sample Size: Initial 117 patients enrolled (116 underwent HIFU application); 73 patients had prostate volumes determined pre- and post-ablation.
- Data Source: Patients with histologically confirmed, organ-confined, recurrent, non-metastatic prostatic adenocarcinoma, who had documented disease relapse two or more years following external beam radiation therapy (EBRT).
- Effectiveness Endpoints: PSA nadir of ≤ 0.5 ng/mL within 12 months, and negative prostate biopsy at 12 months.
- Safety Endpoints: Rate of adverse event occurrence by type and severity.
- Key Results (Effectiveness):
- Mean reduction in prostate volume was 11.8 cm³ (46% reduction from baseline) among 73 patients.
- 83% of 117 patients had a reduction in PSA post-ablation.
- 61% of 117 patients had a negative post-ablation biopsy (30 patients without 12-month biopsy considered "positive").
- Key Results (Safety):
- 99% of patients experienced some type of application-related complication.
- Serious adverse events (SAEs) reported in 21 subjects included urinary retention (n=6), hematuria (n=5), rectal/urinary fistula (n=5), UTI/urosepsis (n=5), osteomyelitis (n=3), urinary incontinence (n=1), urethral stricture (n=1), and small intestinal obstruction (n=1). All resolved.
- Common non-serious adverse events: Erectile Dysfunction (71%), Urinary Tract Infection (50%), Urinary Incontinence (leak) (47%), Hematuria (43%), Urinary Retention (43%), Urinary Frequency (35%), Urinary Incontinence (pads) (32%), Urinary Urgency (29%), Urinary Tract Obstruction (20%), Dysuria (18%), Urethral Stricture (15%), Epididymitis/Orchitis (8%), Bladder Neck Contracture (5%), Rectal Fistula (4%), Urinary Fistula (2.6%), Osteomyelitis (2.6%).
Key Metrics
Effectiveness:
- Mean reduction in prostate volume: 11.8 cm³ (46% reduction from baseline).
- % reduction in PSA post-ablation: 83% (95% confidence limits = 74.6, 89.0).
- % negative post-ablation biopsy: 61% (95% confidence limits = 51.2, 69.5).
Safety (Adverse Events):
- Erectile Dysfunction (n=51 potent at baseline): 71%
- Urinary Tract Infection: 50%
- Urinary Incontinence (leak): 47%
- Hematuria: 43%
- Urinary Retention: 43%
- Urinary Frequency: 35%
- Urinary Incontinence (pads): 32%
- Urinary Urgency: 29%
- Urinary Tract Obstruction: 20%
- Dysuria: 18%
- Urethral Stricture: 15%
- Epididymitis/Orchitis: 8%
- Bladder Neck Contracture: 5%
- Rectal Fistula: 4%
- Urinary Fistula: 2.6%
- Osteomyelitis: 2.6%
Serious Adverse Events (SAEs) (reported in % of subjects):
- Urinary retention: 5%
- Hematuria: 4%
- Rectal fistula: 4%
- Urinary tract infection: 4%
- Osteomyelitis: 3%
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4340 High intensity ultrasound system for prostate tissue ablation.
(a)
Identification. A high intensity ultrasound system for prostate tissue ablation is a prescription device that transmits high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance. This classification does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate non-prostatic tissues/organs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) 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) Characterization of acoustic pressure and power output at clinically relevant levels;
(ii) Measurement of targeting accuracy and reproducibility of high intensity ultrasound output;
(iii) Ultrasound-induced heating verification testing at target and non-target tissues;
(iv) Electrical safety testing; and
(v) Electromagnetic compatibility testing.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The elements of the device that may contact the patient's mucosal tissue must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components that contact the patient's mucosal tissue.
(5) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.
(6) Performance data must support the instructions for reprocessing all reusable components.
(7)
In vivo testing must demonstrate that the device thermally ablates targeted tissue in a controlled manner without thermal injury to adjacent, non-target tissues.(8) Clinical testing must document the adverse event profile, provide evidence of prostatic ablation, and demonstrate that the device performs as intended under anticipated conditions of use.
(9) Training must be provided so that upon completion of the training program, the physician can:
(i) Use all safety features of the device;
(ii) Accurately target the high intensity ultrasound energy within the desired region of the prostate; and
(iii) Perform the ablation procedure in a manner that minimizes damage to non-target tissues.
(10) Labeling must include:
(i) A section that summarizes the clinical testing results, including the adverse event profile and evidence of prostate ablation achieved; and
(ii) An expiration date or shelf life for single use components.
0
DE NOVO CLASSIFICATION REQUEST FOR SONABLATE® 450
REGULATORY INFORMATION
FDA identifies this generic type of device as:
High intensity ultrasound system for prostate tissue ablation. A high intensity ultrasound system for prostate tissue ablation is a prescription device that transmits high intensity therapeutic ultrasound (HITU) energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance. This classification does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate nonprostatic tissues/organs.
NEW REGULATION NUMBER: 21 CFR 876.4340
CLASSIFICATION: II
PRODUCT CODE: PLP
BACKGROUND
DEVICE NAME: SONABLATE® 450
SUBMISSION NUMBER: DEN150011
DATE OF DE NOVO: MARCH 24, 2015
- SONACARE MEDICAL, LLC CONTACT: DAWN BURLESON, RN, MBA, CCRA VICE PRESIDENT OF CLINICAL AFFAIRS 10130 PERIMETER PARKWAY, SUITE 250 CHARLOTTE, NC 28216
REQUESTER'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
The Sonablate® 450 is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
LIMITATIONS
The sale, distribution, and use of the Sonablate® 450 is limited to prescription use only.
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Use of the Sonablate® 450 must be prescribed and administered under the direct supervision of a qualified and trained physician, after appropriate urologic patient evaluation.
Limitations on device use are also achieved through the following statements included in the Instructions for Use:
Contraindications:
- Large (> 10 mm) cysts or calcifications in the planned ablation zone ●
- Metal implants or stents in the urethra
- Brachytherapy seeds in the planned ablation zone ●
- . Pre-existing inflammatory disease of the colon or rectum (such as proctitis or ulcerative colitis)
- Prior significant rectal surgery
- Inability to insert or tolerate a transrectal ultrasound probe
- Active urinary tract infection
- Urethral stricture
- Latex allergy ●
Warnings:
The effectiveness of the Sonablate® 450 in treating any specific prostate disease has not been established.
The safety and effectiveness of the Sonablate® 450 have not been established in patients with the following conditions:
- . interest in future fertility.
- I bleeding disorders,
- l clinical or histological evidence of urinary bladder cancer,
- l renal impairment,
- I functional bladder problems, including neurological disorders that might affect bladder function,
- I post-void residual urine > 250 mL、
- I urinary retention requiring an indwelling catheter,
- I enlarged medial lobe of the prostate protruding into the urinary bladder,
- I clinical evidence of prostatitis within 6 months prior to HIFU.
- bladder calculus, and
- I prostates > 40 cm3.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
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DEVICE DESCRIPTION
The Sonablate® 450 is a computer-controlled device designed for transrectal delivery of high intensity focused ultrasound (HIFU) energy to the prostate to ablate regions of unwanted prostatic tissue via thermal ablation. The device makes use of integrated biplanar ultrasound imaging for real-time monitoring, planning, and pre- and post-ablation imaging of the prostate. The system consists of the following main components:
Sonasource Console:
Image /page/2/Picture/3 description: The image shows a Sonablate machine, which is a medical device used for non-invasive ablation of tissue. The machine is mounted on wheels and has a monitor and keyboard attached to an arm. The monitor displays medical images, and the keyboard is used to control the machine. The side of the machine has the word "Sonablate" written on it.
The Sonasource Console contains the system computer and electronics for HIFU planning and delivery. The monitor displays all system, patient, imaging, and HIFU delivery information via a graphical user interface. The keyboard and trackball are used for data and user-command entry. The trackball allows the operator to define the dimensions of the target zone and to measure the tissue distance from the rectal wall to the center of the target zone.
Planning is performed under physician control, while HIFU delivery is automatically performed by the system under physician monitoring.
Key system features:
- . Rectal Wall Distance (RWD) monitor: A feature used by the system to continually measure the distance between the therapy transducer and the rectal wall, to maintain a safe distance.
- . Reflectivity Index Monitor (RIM): A feature used by the system to detect undesired/excessive cavitation bubble formation at the rectal wall.
- . Dual Stack: A visual aid tool for the physician to use during planning, which allows rapid view of sequential transverse and linear images.
- . MR/US Fusion: Fuses the ultrasound image with a prior magnetic resonance (MR) image.
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Sonablate Probe 30/40:
Image /page/3/Figure/1 description: The image contains three different pictures. The first picture shows a Sonablate device in a black case. The second picture shows a diagram of the device and how it is used to create transverse and sagittal planes. The third picture shows a diagram of the device being used to treat the prostate with a focal point.
The Sonablate Probe 30/40 (probe) is designed to provide gray-scale ultrasound images of the prostate and to deliver HIFU pulses to targeted tissue while minimizing damage to intervening tissue. Prior to HIFU application, the probe is inserted into the patient's rectum, with the ultrasound transducers positioned at the level of the prostate. The probe has a dual-sided piezoelectric transducer, with different curvatures (i.e., 30 mm and 40 mm focal lengths) on opposite sides. The dual-sided transducer allows focal HIFU application of the entire volume of prostate tissue using only one transrectal probe (30 mm transducer for the posterior region of the gland, 40 mm probe for the anterior region).
The probe is connected to the Sonasource Console via a cable. Prior to insertion in the patient, the tip of the probe is covered with a single use probe sheath (an off the shelf condom), which is secured by O-rings.
The probe incorporates two motors (linear and sector) to guide transducer movement, dedicated, closed loop coolant water path, and a thermistor for temperature control. To reduce the possibility of thermal injury to the rectal wall, HIFU application is automatically terminated if the probe temperature exceeds 30°C.
In the Imaging Mode, the transducer moves in a longitudinal direction to provide linear images of the prostate and oscillates in the transverse plane for sector images. In the Therapy Mode, the transducer sequentially moves to pre-specified positions (determined during HIFU planning), and stays at each position while the energy is delivered to the tissue. Each thermal lesion created in the prostate is 10-12 mm in length and 1-2 mm wide. Multiple lesions must be sequentially positioned within the prostate to fill the intended tissue volume.
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Key technical specifications:
- . Two piezoelectric crystals of different curvatures - 30 mm and 40 mm focal lengths on opposite sides
- Focal lengths: 30 mm +2.0/-1.0 mm, 40 mm +2.0/-1.0 mm
- Site intensity in the focal zone 1200 to 2000 W/cm-
- Pulse ON/OFF durations: 3 s ON/6s OFF ●
- HIFU application mode frequency 4.0 MHz ●
- Imaging mode frequency 6.5 MHz ●
Sonachill:
Image /page/4/Picture/8 description: This image shows a medical device on a stand. The device is labeled "Senachtill" on the front. The stand has a five-legged base with wheels, allowing it to be easily moved. A power cord is visible, indicating the device requires electricity to operate.
The Sonachill circulates degassed cold water to the probe tip (flow contained within the probe sheath). The circulating water functions to cool the rectal wall and HIFU transducer surface, and to provide ultrasound coupling between the transducer and tissue. To prevent contaminated coolant water from the patient entering and contaminating the internal fluid pathways of the Sonachill device (which could occur if the probe sheath breaks), there are two independent fluid pathways. The first fluid path is through the probe and the single use components of the Water Path Kit. The second fluid path is isolated from the probe (i.e., within the Sonachill), and circulates between the heat exchanger and the pump.
Sonablate Multi-Axis Stepper and Probe Arm:
Image /page/4/Picture/11 description: The image shows two different medical devices. The device on the left is a metallic surgical instrument with multiple adjustable parts and knobs, set against a blue background. The device on the right is a metallic arm with a black headpiece, also featuring adjustable knobs, and is set against a white background. Both devices appear to be designed for precise positioning and fixation during medical procedures.
After the probe is inserted in the patient's rectum. the Multi-Axis Stepper and Probe Arm are locked to hold the probe in a fixed position for the duration of the procedure. Adjustments are made to the stepper to optimize the position of the probe in relationship to the probe arm.
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Single Use Components:
Single use, disposable components used during a Sonablate® 450 HIFU application are provided in (i) a Probe Tip Kit, and (ii) a Water Path Kit. The Probe Tip Kit contains the single use components to cover and prepare the probe tip for insertion (i.e., probe sheaths (legally marketed condoms), packets of ultrasound transmission gel, O-rings, and O-ring applicator). The Water Path Kit contains the tubing, reservoir, syringe, and other disposable components used to set up and establish coolant water flow between the probe and the Sonachill.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
HIFU application time ranges from 2 to 4 hours, and all patient contact is limited to the rectum. Therefore, components that contact the patient have limited ( 60℃), and that tissue outside of the focal zone (including the rectal wall) do not reach temperatures capable of coagulative necrosis.
- . Study 4 ("Thermocouple Response to Treatment Test"): This preliminary dog study compared the accuracy of the planned HIFU application zones versus actual target tissue volume.
- . Study 5 ("Safety of HIFU Energy Application to Adjacent Tissues"): This preliminary dog study was performed to verify that energy delivery to prostatic tissue does not damage adjacent structures, and that the use of the Sonachill cooling system during HIFU cools the rectal wall tissue.
Study 1 (primary study) was performed using the Sonablate® 450, whereas Studies 2, 3, 4, and 5 (supporting studies) were performed using a different device version that has several additional features.
SUMMARY OF CLINICAL INFORMATION
Data to support that the Sonablate® 450 safely and effectively ablates prostatic tissue were obtained from the US Salvage Study. In this study, a population of post-radiation patients
15
received whole gland ablation using the Sonablate® 450 as a treatment for recurrent prostate cancer. While the oncological outcomes from this study are inconclusive, the results provide reasonable assurance of safety and effectiveness of the device in the context of prostate tissue ablation.
The design of the US Salvage Study is briefly summarized below:
- Study Design: Multi-center, non-randomized, prospective, single arm study involving . 20 sites (U.S. and Canada) and 200 subjects. Sixteen sites actively enrolled subjects.
- . Patient Population: Men (40-85 years of age) with histologically confirmed, organconfined, recurrent, non-metastatic prostatic adenocarcinoma. All participants had documented disease relapse two or more years following external beam radiation therapy (EBRT). All participants had a prostate specific antigen (PSA) level > 0.5 ng/mL and 10 mm) cysts or calcifications in the planned ablation zone, O
- metal implants or stents in the urethra. O
- brachytherapy seeds in the planned ablation zone, о
- pre-existing inflammatory disease of the colon or rectum (such as proctitis or O ulcerative colitis).
- prior significant rectal surgery. O
- inability to insert or tolerate a transrectal ultrasound probe, O
- active urinary tract infection. o
- urethral stricture, and O
- latex allergy; o
- . warning and precaution statements to mitigate potential risks in the clinical setting, such as:
- the Sonablate® 450 is not capable of ablating anterior prostate tissue > 4 cm from o the transducer (due to physical limitations of the device);
- in patients who have previously received radiation to the pelvic region, the o Denonvillers' fascia should not be included within the targeted ablation zone, and the manufacturer's recommended values of total acoustic power should be followed:
- the effectiveness of the device in treating any specific prostate disease has not о been established:
- the safety and effectiveness of the Sonablate® 450 have not been established in o patients with the following conditions:
- interest in future fertility, ■
- I bleeding disorders.
- l clinical or histological evidence of urinary bladder cancer,
- l renal impairment,
- functional bladder problems, including neurological disorders that might affect bladder function,
- . post-void residual urine > 250 mL,
- I urinary retention requiring an indwelling catheter,
- l enlarged medial lobe of the prostate protruding into the urinary bladder,
- I clinical evidence of prostatitis within 6 months prior to HIFU,
- l bladder calculus, and
- prostates > 40 cm3.
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RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of the high intensity ultrasound system for prostate tissue ablation and the measures necessary to mitigate these risks.
| Identified Risk | Mitigation Measure |
|---|---|
| Thermal injury from high intensity | |
| ultrasound exposure to non-target tissue: | |
| -erectile dysfunction | |
| -urinary incontinence | |
| -rectal fistula | |
| -osteomyelitis pubis | Non-clinical performance testing Software verification, validation, and hazard analysis In vivo testing Clinical testing Labeling Physician training |
| Thermal injury from high intensity | |
| ultrasound exposure to target tissue: | |
| -urethral stricture | |
| -bladder neck contracture | |
| -urinary retention | |
| -tissue debris/obstruction | |
| -voiding dysfunction | |
| -dysuria | |
| -hematuria | |
| -ejaculation disorder | Clinical testing Labeling Physician training |
| Mechanical injury from unintentional | |
| movement of ultrasound components: | |
| -patient rectal injury | |
| -operator hand injury | Software verification, validation, and hazard analysis Clinical testing Labeling Physician training |
| Infection | Sterilization validation Reprocessing validation Shelf life validation Labeling |
| Electrical shock/Electromagnetic | |
| interference | Electrical safety testing Electromagnetic compatibility testing Labeling |
| Adverse tissue reaction | Biocompatibility testing |
SPECIAL CONTROLS :
In combination with the general controls of the FD&C Act, the high intensity ultrasound system for prostate tissue ablation is subject to the following special controls:
- (1) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (A) Characterization of acoustic pressure and power output at clinically relevant levels.
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- (B) Measurement of targeting accuracy and reproducibility of high intensity ultrasound output.
- (C) Ultrasound-induced heating verification testing at target and non-target tissues.
- (D) Electrical safety testing.
- (E) Electromagnetic compatibility testing.
- (2) Software verification, validation, and hazard analysis must be performed.
- (3) The elements of the device that may contact the patient's mucosal tissue must be demonstrated to be biocompatible.
- (4) Performance data must demonstrate the sterility of the device components that contact the patient's mucosal tissue.
- (5) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.
- (6) Performance data must support the instructions for reprocessing all reusable components.
- (7) In vivo testing must demonstrate that the device thermally ablates targeted tissue in a controlled manner without thermal injury to adjacent, non-target tissues.
- (8) Clinical testing must document the adverse event profile, provide evidence of prostatic ablation, and demonstrate that the device performs as intended under anticipated conditions of use.
- (9) Training must be provided so that upon completion of the training program, the physician can:
- (A) Use all safety features of the device:
- (B) Accurately target the high intensity ultrasound energy within the desired region of the prostate;
- (C) Perform the ablation procedure in a manner that minimizes damage to non-target tissues;
- (10) Labeling must include:
- (A) A section that summarizes the clinical testing results, including the adverse event profile and evidence of prostate ablation achieved.
- (B) An expiration date or shelf life for single use components.
BENEFIT/RISK DETERMINATION
The risks of the device are based on the non-clinical laboratory studies, as well as data collected in a clinical study described above. The pivotal study indicated that nearly all (i.e., 99%) subjects experienced a HIFU application-related complication. Serious adverse events (SAEs) occurring in the population included urinary retention (5%), hematuria (4%), rectal fistula (4%), urinary tract infection (4%), and osteomyelitis (3%). Non-serious adverse events primarily consisted of erectile dysfunction (71%), UTI (50%), urinary incontinence (leak) (47%), hematuria (43%), urinary retention (43%), urinary obstruction (20%), and urethral stricture (15%). The duration of a harmful event was dependent on the indication for prostate ablation and current disease status. Some of the harmful events such as voiding symptoms resolve on their own over weeks to months, and some such as infections resolve with medical therapies. Of the three patients with osteomvelitis, one patient underwent cystectomy and ileal conduit diversion. Some of the patients with urinary incontinence and erectile dysfunction resolve spontaneously over a period of months while a significant percentage have lifelong symptoms
21
requiring medical and surgical intervention. These include placement of an artificial urinary sphincter for treatment of incontinence and medications or devices for treatment of erectile dysfunction.
The probable benefits of the device are also based on the non-clinical laboratory studies as well as the data collected in a clinical study described above. For this de novo, effectiveness was defined as evidence that Sonablate® 450 ablates prostate tissue within the targeted region, as demonstrated by reductions in prostate volume and PSA level, and increase in the rate of negative biopsy, between baseline and 12 months post-HIFU. Ninety percent (90%) of the perprotocol population had a decrease in prostate size. The average reduction was approximately 50%. Across the entire population, 83% had a reduction in PSA at 12 months. Sixty-one percent (61%) of the intent to treat protocol population had a negative biopsy 12 months post-HIFU.
Additional factors to be considered in determining probable risks and benefits for the high intensity ultrasound system for prostate tissue ablation include:
- Robustness was enhanced by the use of objective endpoints for safety and documentation . of tissue ablation. However, robustness was challenged by the reliance on a single-arm study and by missing data.
- It is likely that the device can ablate prostate tissue in a range of clinical settings.
- Post-radiation patients have limited options for removal or ablation of unwanted prostate . tissue.
- The submission did not include patient perspective information: however, prior input ● from the advisory panel indicates that there is a low tolerance for risks since the majority of patients with this condition are currently observed.
- . An extensive physician training program is in place to mitigate risks. Limitations in the labeling also mitigate risks.
- . The technology is a novel strategy for ablating prostate tissue.
- . The effectiveness of the device in ablating prostate tissue appears to be similar to that of existing methods, with comparable safety.
In conclusion, given the available information above, the data support that, for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue. the probable benefits outweigh the probable risks for the high intensity ultrasound system for prostate tissue ablation. The device provides substantial benefits and the risks can be mitigated by the use of general and the identified special controls.
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CONCLUSION
The de novo for the high intensity ultrasound system for prostate tissue ablation is granted and the device is classified under the following:
Product Code: PLP Device Type: High intensity ultrasound system for prostate tissue ablation Class: II Regulation: 21 CFR 876.4340