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.

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.

AI/ML Overview

The provided document describes a 510(k) submission for the UroLift System (UL400) by NeoTract, Inc. This submission focuses on minor device modifications and asserts substantial equivalence to a previously cleared predicate device (K173087).

Crucially, this document focuses on non-clinical performance testing and does not describe a study involving patient data, ground truth establishment, or clinical outcomes that would typically be associated with AI/ML device performance. The acceptance criteria and "device performance" discussed here pertain to engineering and material testing, not diagnostic or predictive accuracy.

Therefore, many of the requested sections (sample size for test/training sets, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, type of ground truth) are not applicable to the information provided in this regulatory submission.

Here is the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Mechanical Performance	Deployment Testing	Not explicitly stated, but implied to ensure safe and effective deployment.	"All acceptance criteria were met."
	Needle Depth Testing	Not explicitly stated, but implied to ensure correct tissue penetration.	"All acceptance criteria were met."
	Urethral End-piece to Suture Joint Strength	Not explicitly stated, but implied to ensure structural integrity.	"All acceptance criteria were met."
	Needle Spool to Right Case wall gap testing	Not explicitly stated, but implied to ensure proper assembly and function.	"All acceptance criteria were met."
Biocompatibility	General Biocompatibility Testing	Compliance with ISO 10993-1: Biological evaluation of medical devices.	"Passed the relevant tests according to ISO 10993-1."
Sterility	Sterilization Validation	Minimum gamma irradiation dose to ensure a 10⁻⁶ Sterility Assurance Level (SAL).	"Confirmed that the modification did not impact product sterility."
Aging/Transit	Impact of sterilization, accelerated aging, and transit	Not explicitly stated, but implied that all mechanical tests were performed on devices subjected to these conditions, and acceptance criteria were met after these conditions.	"All acceptance criteria were met" even after worst case sterilization, accelerated aging, and transit testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The described tests are non-clinical engineering and material tests, not clinical studies with patient data. Therefore, there is no "test set" in the context of diagnostic performance or patient data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth in the context of expert consensus for diagnostic performance is not relevant to this type of device modification submission. The "ground truth" here would be the physical properties and performance metrics defined in engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are used in clinical studies for resolving discrepancies in expert interpretations, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This document pertains to a medical device (UroLift System) for treating BPH, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. The UroLift System is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed would be defined by engineering specifications, international standards (e.g., ISO 10993-1 for biocompatibility), and established test methods (e.g., for mechanical strength, sterility assurance). This is not related to clinical "ground truth" derived from patient data.

8. The sample size for the training set

Not Applicable. This submission does not involve an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. This submission does not involve an AI/ML device.

Summary

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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

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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

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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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (701) 443-6740 EF

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Confidential

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K190377 Page 1 of 3 UroLift® System UL400

510(k) SUMMARY

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 andLithotripsy Devices Branch (ULDB)

DEVICE DESCRIPTION

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INTENDED USE

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 ofReproductive, 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.

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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.

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Regulation Number and Section

§ 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.