(90 days)
Not Found
No
The description focuses on the mechanical aspects of the device and its delivery system, with no mention of AI or ML.
Yes
The device is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to BPH and works by maintaining an expanded urethral lumen, reducing fluid obstruction, and improving lower urinary tract symptoms (LUTS). This directly addresses a medical condition, which is the definition of a therapeutic device.
No
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) and is described as delivering implants to secure a retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms. This describes a therapeutic device, not a diagnostic one.
No
The device description clearly details physical components like a delivery device, implants, handle, and cartridges, indicating it is a hardware-based medical device.
Based on the provided information, the UroLift System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- UroLift System Function: The UroLift System is a surgical device used to physically treat the symptoms of BPH by implanting devices that retract prostatic tissue and open the urethra. It is used within the body to modify anatomy, not to analyze specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any collection or analysis of biological specimens. It focuses on the mechanical action of the device and the physical placement of implants.
Therefore, the UroLift System falls under the category of a therapeutic medical device, specifically a surgical implant system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
Product codes
PEW
Device Description
The UroLift System is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction.
The UroLift System includes two generations of the device, the UL400 and the UL500. Both generations use the same UroLift Implant. The only differences are in the delivery device.
The UL400 (cleared in K133281), consists of two main components, the UroLift® Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.
The UL500 (UroLift 2 System, cleared in K172359) is comprised of the UroLift® Delivery Handle (single patient reusable), the UroLift Implant Cartridges (single-use) and the UroLift Implants (one implant per cartridge). Each cartridge is pre-loaded with one UroLift Implant. The cartridges fit into the delivery handle. Each patient procedure will use one dedicated handle and the number of cartridges/implants necessary to perform a typical procedure (estimated 2-6 implants). For the UL500, users are also provided with an optional Scope Seal which enables them to examine the anatomy between implant deployments without removal of the telescope from the Delivery Handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Prostatic urethra, prostate
Indicated Patient Age Range
45 years of age or older
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: Prospective, multicenter, non-blinded, single arm (non-randomized) study.
Sample size: 45 subjects were enrolled.
Key results:
Effectiveness Endpoint: At 6 months, the 95% lower confidence limit of the mean percent improvement in subject's International Prostatic Symptom Score (IPSS) over baseline for the UroLift System must be $\ge$ 25%. Results: At 6 months, the 95% lower confidence limit of the mean percent improvement in subject's International Prostatic Symptom Score (IPSS) over baseline for the UroLift System was 50.8% (substantially above the goal of $\ge$ 25%). The mean percent change at 6 months was 57.7%.
Safety Endpoint: The composite observed rate of post-procedure device related serious complications $\le$15% at 3 months. Composite device related serious complications for this endpoint are 1) de Novo (new) severe urinary retention lasting more than 21 consecutive days post procedure, 2) device related formation of fistula between the rectum and urethra, 3) perforation of the rectum or GI tract, 4) damage to ureter or ureteral orifices, 5) damage to the trigone requiring surgical repair or 6) de novo, sustained erectile dysfunction. Results: The CEC adjudicated the adverse events and relevant subject questionnaires to evaluate against the safety endpoint. The safety endpoint was achieved with 0% (5.7% CI upper limit) meeting criteria within the composite. In addition, from 3 to 6 months, there were no reported events that would meet the endpoint criteria.
Adverse Events (AE) observed through 6 months were mostly mild and occurred within the first week after procedure. The most common AEs included hematuria, dysuria, and urinary urgency.
Key Metrics
IPSS, Safety Endpoint (composite of device related serious complications, specific criteria listed)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5530 Implantable transprostatic tissue retractor system.
(a)
Identification. An implantable transprostatic tissue retractor system is a prescription use device that consists of a delivery device and implant. The delivery device is inserted transurethrally and deploys the implant through the prostate. It is designed to increase prostatic urethral patency by providing prostate lobe tissue retraction while preserving the potential for future prostate procedures and is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia in men.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(3) Performance data must support shelf life by demonstrating continued sterility of the device (of the patient-contacting components), package integrity, and device functionality over the requested shelf life.
(4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing must be conducted.
(ii) Mechanical strength must be conducted.
(iii) Resistance-to-degradation testing must be conducted.
(5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance environment.
(6) In vivo testing must demonstrate safe and effective use, assess the impact of the implants on the ability to perform subsequent treatments, document the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing must be conducted.
(ii) Implant migration must be conducted.
(7) Labeling must bear all information required for safe and effective use of the device, and must include:
(i) Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
(ii) Information on the patient population for which the device has been demonstrated to be effective.
(iii) A detailed summary of the device technical parameters.
(iv) Information on how the device operates and the typical course of treatment.
(v) An expiration date/shelf life.
(vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.
0
December 28, 2017
NeoTract, Inc. Louis-Pierre Marcoux Senior Director, Regulatory Affairs 4473 Willow Road, Suite 100 Pleasanton, CA 94588
Re: K173087
Trade/Device Name: UroLift System (UL400 and UL500) Regulation Number: 21 CFR§ 876.5530 Regulation Name: Implantable Transprostatic Tissue Retractor System Regulatory Class: II Product Code: PEW Dated: September 29, 2017 Received: September 29, 2017
Dear Louis-Pierre Marcoux:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name UroLift System (UL400 and UL500)
Indications for Use (Describe)
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY 5
COMPANY INFORMATION
| Manufacturer: | NeoTract, Inc.
4473 Willow Road, Suite 100
Pleasanton, CA 94588
Tel: 925-201-8861
Fax: 925-401-0696
FDA Registration No.: 3005791775 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Louis-Pierre Marcoux
Senior Director, Regulatory Affairs |
DATE PREPARED
29 September 2017
DEVICE INFORMATION
| Trade Name: | NeoTract® UroLift® System (UL400 and UL500) |
|---|---|
| Common Name: | Implantable transprostatic tissue retractor system |
| Class: | II |
| Regulation: | 21 CFR 876.5530 |
| Product Code: | PEW |
INTENDED USE
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
PREDICATE DEVICE
The predicate device is the UroLift System, which includes two generations of the device, the UL400 and the UL500. The UL400 was previously cleared under K133281. The UL500 was previously cleared under K172359.
DEVICE DESCRIPTION
The UroLift System is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile
4
orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction.
The UroLift System includes two generations of the device, the UL400 and the UL500. Both generations use the same UroLift Implant. The only differences are in the delivery device.
The UL400 (cleared in K133281), consists of two main components, the UroLift® Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.
The UL500 (UroLift 2 System, cleared in K172359) is comprised of the UroLift® Delivery Handle (single patient reusable), the UroLift Implant Cartridges (single-use) and the UroLift Implants (one implant per cartridge). Each cartridge is pre-loaded with one UroLift Implant. The cartridges fit into the delivery handle. Each patient procedure will use one dedicated handle and the number of cartridges/implants necessary to perform a typical procedure (estimated 2-6 implants). For the UL500, users are also provided with an optional Scope Seal which enables them to examine the anatomy between implant deployments without removal of the telescope from the Delivery Handle.
CLINICAL DATA
Median lobe clinical study:
NeoTract conducted a prospective, multicenter, non-blinded, single arm study to demonstrate the safety and effectiveness of the UroLift System for subjects with symptomatic benign prostatic hyperplasia with an enlarged median lobe. Study design and results are shown below:
| Study Title: | Median Lobe Prostatic UroLift System Procedure (MedLift) |
|---|---|
| Study Objectives: | Evaluate the safety and effectiveness of the UroLift® System when |
| used in symptomatic benign prostatic hyperplasia (BPH) subjects with | |
| an enlarged median lobe. | |
| Study Design: | Prospective, multicenter, non-blinded, single arm (non-randomized) |
| study. | |
| Sample Size: | 45 subjects were enrolled. |
| Subject Population: | Males 50 years or older diagnosed with symptomatic benign prostatic |
| hyperplasia (BPH). | |
| Number of Centers: | 9 investigational sites located in the US. |
5
UroLift System
| Follow-up | 1, 3, 6, and 12 months. For this submission, the report primarily
presents results through 6 months of follow-up. A partial subset of
subjects who have returned for the 12 month follow-up are included
where noted (18 of 45 at time of submission). |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Effectiveness
Endpoint: | At 6 months, the 95% lower confidence limit of the mean percent
improvement in subject's International Prostatic Symptom Score
(IPSS) over baseline for the UroLift System must be $\geq$ 25%. |
| | Results: At 6 months, the 95% lower confidence limit of the mean
percent improvement in subject's International Prostatic Symptom
Score (IPSS) over baseline for the UroLift System was 50.8%
(substantially above the goal of $\geq$ 25%). The mean percent change at 6
months was 57.7%. |
| Safety Endpoint: | The composite observed rate of post-procedure device related serious
complications ≤15% at 3 months. Composite device related serious
complications for this endpoint are 1) de Novo (new) severe urinary
retention lasting more than 21 consecutive days post procedure, 2)
device related formation of fistula between the rectum and urethra, 3)
perforation of the rectum or GI tract, 4) damage to ureter or ureteral
orifices, 5) damage to the trigone requiring surgical repair or 6) de
novo, sustained erectile dysfunction. |
| | A Clinical Events Committee (CEC) will adjudicate adverse events
and relevant subject questionnaires to evaluate against safety endpoint. |
| | Results: The CEC adjudicated the adverse events and relevant subject
questionnaires to evaluate against the safety endpoint. The safety
endpoint was achieved with 0% (5.7% CI upper limit) meeting criteria
within the composite. In addition, from 3 to 6 months, there were no
reported events that would meet the endpoint criteria. |
Adverse Events (AE) observed through 6 months were mostly mild and occurred within the first week after procedure. The most common AEs included hematuria, dysuria, and urinary urgency. Comparison of 6 month effectiveness outcomes (IPSS, QOL, and BPHII) show similar magnitude of improvement between median lobe subjects and lateral lobe subjects (data originally presented in DEN130023), which indicates that the median lobe anatomy does not negatively impact outcomes.
The clinical study data demonstrates that treatment of the enlarged median lobe with the UroLift System is as safe and effective as treatment of the lateral lobe. As such, the UroLift System is substantially equivalent to the predicate devices (K133281 and K172359).
Reduction of Age in Indication:
The FDA Guidance for Industry and Food and Drug Administration Staff entitled "Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)" was issued on August 17, 2010 and recommended that the patient selection protocol criteria for enrollment include men over 50 "because BPH is generally
6
NeoTract, Inc. Traditional 510(k)
29 September 2017 UroLift System
confined to older men." Approximately one month later in September 2010, the AUA released the 2010 update to the AUA Guideline on the Management of Benign Prostatic Hyperplasia. In this guideline, the index patient was updated to be a male > 45 years of age who is consulting a qualified healthcare provider for his lower urinary tract symptoms (LUTS). The AUA panel lowered the age for inclusion in this Guideline from age 50 to age 45, as this lower age group can commonly present with LUTS. Literature data demonstrates that the prevalence of BPH in ages 40-49 are not dramatically different compared to ages 50-59. The estimated difference in prevalence of histopathologic BPH is