(30 days)
No Reference Device(s) K/DEN number was explicitly identified in the text. The section for "Reference Device(s)" explicitly states "Not Found".
No
The description focuses on a mechanical device for treating BPH and does not mention any AI/ML components or functionalities.
Yes
The device is used to treat symptoms of benign prostatic hyperplasia (BPH) by maintaining an expanded urethral lumen and reducing fluid obstruction, which directly addresses a medical condition and its symptoms.
No
The device is described as a treatment for symptoms due to urinary outflow obstruction, and its function involves delivering implants to expand the urethral lumen. It does not mention any diagnostic capabilities.
No
The device description clearly outlines physical components (Delivery Device, Implants) and a procedure involving insertion and deployment of these components within the body. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the UroLift System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- UroLift System Function: The UroLift System is a surgical device used to physically treat a condition (BPH) by implanting devices into the prostate to relieve urinary obstruction. It does not analyze biological specimens.
The description clearly outlines a mechanical intervention within the body, not a diagnostic test performed on a sample outside the body.
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 UL400 (most recently cleared in K173087), 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.
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, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical design verification testing was required to assure that the modifications of the proposed device did not impact the safe and effective use of the device. Non-clinical testing included deployment testing, needle depth testing, Urethral End-piece to Suture Joint Strength testing, and Needle Spool to Right Case wall gap testing. The testing was performed on devices which had undergone worst case sterilization, accelerated aging, and transit testing. The test methods were equivalent to the 510(k) cleared UroLift System (K173087), and all acceptance criteria were met.
The UroLift System has been tested for biocompatibility and passed the relevant tests according to ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The modification addressed in this Special 510(k) submission is manufactured using materials already used in the 510(k) cleared UroLift System (K173087). No new materials were introduced. In addition, the device modifications do not impact parts in the fluid pathway and there are no changes to the implant.
The UroLift System has been validated to determine the minimum gamma irradiation dose to ensure a 10 ° Sterility Assurance Level (SAL). The modification addressed in the Special 510(k) submission does not impact the product sterility. The modified component utilizes already cleared materials which do not introduce a higher level of geometric complexity or clearance. These materials are manufactured, processed, and handled similarly to the predicate UroLift device. Sterility testing was performed as required, and confirmed that the modification did not impact product sterility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5530 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.
March 21, 2019
NeoTract, Inc. Brian Gall Regulatory Affairs Manager 4473 Willow Road, Suite 100 Pleasanton, CA 94588
Re: K190377
Trade/Device Name: UroLift System UL400 Regulation Number: 21 CFR 876.5530 Regulation Name: Implantable Transprostatic Tissue Retractor System Regulatory Class: Class II Product Code: PEW Dated: February 15, 2019 Received: February 19, 2019
Dear Brian Gall:
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. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Glenn B. Bell -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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K190377 |
|---|---|
| Device Name | UroLift System (UL400) |
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (7/17)
Page 1 of 1
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Image /page/2/Picture/14 description: The image shows the logos for "neotract" and "Teleflex". Below the logos, the text "INTERVENTIONAL UROLOGY" is displayed. The logos are in blue and black, and the text is in a smaller font size.
Confidential
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K190377 Page 1 of 3 UroLift® System UL400
510(k) SUMMARY
COMPANY INFORMATION
NeoTract, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 94588 Registration Number: 3005791775
SUBMISSION CORRESPONDENT
Brian Gall Requlatory Affairs Manager, Interventional Urology NeoTract, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 94588
Telephone - 925.329.6547 E-mail - brian.gall@teleflex.com
DATE PREPARED
15 February 2019
DEVICE INFORMATION
| Trade Name: | NeoTract® UroLift® System (UL400) |
|---|---|
| Common Name: | Implantable transprostatic tissue retractor system |
| Classification Name: | Implantable transprostatic tissue retractor system |
| Product Code: | PEW |
| Regulation Number: | 876.5530 |
| Classification: | II |
| Classification Panel: | Office of Device Evaluation (ODE) – Division of Reproductive, |
| Gastro-Renal, and Urological Devices (DRGUD) Urology and | |
| Lithotripsy Devices Branch (ULDB) |
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 UL400 (most recently cleared in K173087), 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.
Image /page/3/Picture/13 description: The image shows the logos for "NeoTract" and "Teleflex", separated by a vertical line. Below the logos, the text "INTERVENTIONAL UROLOGY" is displayed. The NeoTract logo is in blue and black, while the Teleflex logo is in blue.
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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.
CONTRAINDICATIONS
The UroLift System should not be used if the patient has:
- · Prostate volume of >80 cc
- · A urinary tract infection
- Urethra conditions that may prevent insertion of delivery system into bladder
- · Urinary incontinence due to incompetent sphincter
- Current gross hematuria
PREDICATE DEVICE
The predicate device is the UroLift System by NeoTract (K173087).
| Trade Name: | NeoTract UroLift System (UL400) |
|---|---|
| Common Name: | Implantable transprostatic tissue retractor system |
| Product Code: | PEW |
| Regulation Number: | 876.5530 |
| Classification: | II |
| Classification Panel: | Office of Device Evaluation (ODE) – Division of |
| Reproductive, Gastro-Renal, and Urological Devices | |
| (DRGUD) Urology and Lithotripsy Devices Branch (ULDB) |
COMPARISON WITH THE PREDICATE DEVICE
The UroLift System (UL400) described in this submission is substantially equivalent to the previously cleared generations of the device. The UL400 was previously cleared in K173087. Minor device modifications have been made to UL400 that do not affect the overall safety and effectiveness.
PERFORMANCE TESTING
The design requirements for the UroLift System were reviewed and non-clinical design verification testing was required to assure that the modifications of the proposed device did not impact the safe and effective use of the device. Non-clinical testing included deployment testing, needle depth testing, Urethral End-piece to Suture Joint Strength testing, and Needle Spool to Right Case wall gap testing. The testing was performed on devices which had undergone worst case sterilization, accelerated aging, and transit testing. The test methods were equivalent to the 510(k) cleared UroLift System (K173087), and all acceptance criteria were met.
BIOCOMPATIBILITY TESTING
The UroLift System has been tested for biocompatibility and passed the relevant tests according to ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The modification addressed in this Special 510(k) submission is manufactured using materials already used in the 510(k) cleared UroLift System (K173087). No new materials were introduced. In addition, the device modifications do not impact parts in the fluid pathway and there are no changes to the implant.
Image /page/4/Picture/19 description: The image shows the logos for "NeoTract" and "Teleflex" side by side. The "NeoTract" logo is on the left, and the "Teleflex" logo is on the right. Below the logos, the text "INTERVENTIONAL UROLOGY" is written in a smaller font. The logos and text are all in blue and black.
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K190377 Page 3 of 3 UroLift® System UL400
STERILIZATION AND SHELF-LIFE TESTING
The UroLift System has been validated to determine the minimum gamma irradiation dose to ensure a 10 ° Sterility Assurance Level (SAL). The modification addressed in the Special 510(k) submission does not impact the product sterility. The modified component utilizes already cleared materials which do not introduce a higher level of geometric complexity or clearance. These materials are manufactured, processed, and handled similarly to the predicate UroLift device. Sterility testing was performed as required, and confirmed that the modification did not impact product sterility.
CONCLUSION
The testing demonstrated the NeoTract UroLift System is as safe and effective, has the same intended use, technological characteristics and principles of operation as the predicate device. Therefore, the NeoTract UroLift System is substantially equivalent to the predicate devices.
Image /page/5/Picture/5 description: The image shows the logos for "NeoTract" and "Teleflex" side by side. The "NeoTract" logo is on the left, and the "Teleflex" logo is on the right. Underneath the logos, the text "INTERVENTIONAL UROLOGY" is written in a smaller font. The logos and text are all in a sans-serif font.