(30 days)
No
The description focuses on mechanical modifications and the physical mechanism of action, with no mention of AI or ML components or functions.
Yes
The device is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) and functions by securing the retracted position of the urethra to maintain an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms, which are all therapeutic actions.
No
The device is described as a system for treating symptoms of benign prostatic hyperplasia by deploying implants to secure and expand the urethral lumen. Its function is interventional and involves a physical procedure to alleviate symptoms, rather than to diagnose a condition.
No
The device description clearly details a physical medical device (UroLift System) with components like a delivery handle, implant cartridge, and implants, designed for a surgical procedure. It is not solely software.
Based on the provided information, the UroLift System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of symptoms due to urinary outflow obstruction secondary to BPH. This is a therapeutic intervention, not a diagnostic one.
- Device Description: The device is described as a system that delivers implants to physically displace prostatic tissue and maintain an expanded urethral lumen. This is a mechanical intervention, not a test performed on biological samples in vitro.
- No mention of biological samples: The description does not mention the collection or analysis of any biological samples (like blood, urine, tissue, etc.) which is a hallmark of IVD devices.
- No mention of diagnostic purpose: The device is used to treat a condition, not to diagnose it or provide information about a patient's health status based on the analysis of biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The UroLift System does not fit this description.
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 (comma separated list FDA assigned to the subject device)
PEW
Device Description
The UroLift 2 ATC Advanced Tissue Control System is a modification of the UroLift 2 System (last cleared in K201837). The primary difference is the addition of a wing component on the distal tip of the UroLift 2 ATC Advanced Tissue Control System which provides a larger footprint. This design feature is intended to provide better mobilization of tissue when performing the UroLift System procedure.
The UroLift System (both the UroLift 2 and UroLift 2 ATC) is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift 2 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 2 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 2 ATC Advanced Tissue Control System consists of two main components, the UL2 Delivery Handle and the UroLift 2 ATC Implant Cartridge (single use). Each UroLift 2 ATC Implant Cartridge comes pre-loaded with one UroLift Implant. The Delivery Handle with the Implant Cartridge installed is known as the Delivery Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, prostatic urethra, urethra
Indicated Patient Age Range
men 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)
Performance Testing: 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, compatibility with accessories, and implant, shaft, and wing performance testing. The testing was performed on devices which had undergone worst case sterilization, accelerated aging, and transit testing. The majority of the test methods were equivalent to the testing for the 510(k) cleared UroLift 2 System (K201837), and all acceptance criteria were met.
Biocompatibility Testing: The UroLift 2 ATC Advanced Tissue Control 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 510(k) submission introduces new materials and, therefore additional biocompatibility testing was performed. Biocompatibility testing was performed on worst case sterilized patient contact components and included: Cytotoxicity testing per ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity, Sensitization Reactivity testing per ISO 10993-10:2021, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization, Systemic Toxicity testing per ISO 10993-11:2017, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity, Intracutaneous Reactivity testing per ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation, Material Mediated Pyrogenicity and Acute Systemic Toxicity per ISO 10993-. 11:2017 - Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity.
Sterilization and Shelf Life Testing: The UroLift 2 ATC Advanced Tissue Control System has been validated to determine the minimum gamma irradiation dose to ensure a 10° Sterility Assurance Level (SAL).
Key Result: The testing demonstrated the NeoTract UroLift 2 ATC Advanced Tissue Control 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 2 ATC Advanced Tissue Control System is substantially equivalent to the UroLift 2 System.
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 22, 2023
NeoTract, Inc. % Kelsey Krische Senior Manager, Regulatory Affairs Product Management Teleflex Medical, Inc. 3015 Carrington Mill Boulevard Morrisville, NC 27560
Re: K232558
Trade/Device Name: UroLift 2 ATC Advanced Tissue Control System Regulation Number: 21 CFR§ 876.5530 Regulation Name: Implantable Transprostatic Tissue Retractor System Regulatory Class: II Product Code: PEW Dated: August 23, 2023 Received: August 23, 2023
Dear Kelsey Krische:
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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232558
Device Name
UroLift 2 ATC Advanced Tissue Control System
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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03 510(k) SUMMARY
COMPANY INFORMATION
NeoTract, Inc. 4155 Hopyard Road Pleasanton, CA 94588 Registration Number: 3015181082
SUBMISSION CORRESPONDENT
Kelsey Krische Senior Manager, Requlatory Affairs, Product Management Teleflex Medical, Inc. 3015 Carrington Mill Blvd. Morrisville, NC 27560
Telephone - 303.775.6821 E-mail - IUBU.requlatory@teleflex.com
DATE PREPARED
22 August 2023
DEVICE INFORMATION
| Trade Name: | UroLift 2 ATC Advanced Tissue Control System |
|---|---|
| Common Name: | Implantable Transprostatic Tissue Retractor System |
| Regulation Name: | Implantable Transprostatic Tissue Retractor System |
| Product Code: | PEW |
| Regulation Number: | 876.5530 |
| Classification: | II |
| Classification Panel: | Reproductive, Gastro-Renal, Urological, General Hospital |
| Device and Human Factors (OHT3) | |
| Reproductive and Urology Devices (DHT3B) |
DEVICE DESCRIPTION
The UroLift 2 ATC Advanced Tissue Control System is a modification of the UroLift 2 System (last cleared in K201837). The primary difference is the addition of a wing component on the distal tip of the UroLift 2 ATC Advanced Tissue Control System which provides a larger footprint. This design feature is intended to provide better mobilization of tissue when performing the UroLift System procedure.
The UroLift System (both the UroLift 2 and UroLift 2 ATC) is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift 2 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 2 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
NeoTract, Inc.
CONFIDENTIAL
4
the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UroLift 2 ATC Advanced Tissue Control System consists of two main components, the UL2 Delivery Handle and the UroLift 2 ATC Implant Cartridge (single use). Each UroLift 2 ATC Implant Cartridge comes pre-loaded with one UroLift Implant. The Delivery Handle with the Implant Cartridge installed is known as the Delivery Device.
INTENDED USE
The UroLift 2 ATC Advanced Tissue Control 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 2 ATC Advanced Tissue Control System should not be used if the patient has:
- Prostate volume of >100 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 2 System from NeoTract (K201837).
| Trade Name: | UroLift 2 System |
|---|---|
| Common Name: | Implantable Transprostatic Tissue Retractor System |
| Regulation Name: | Implantable Transprostatic Tissue Retractor System |
| Product Code: | PEW |
| Regulation Number: | 876.5530 |
| Classification: | II |
| Classification Panel: | Reproductive, Gastro-Renal, Urological, General Hospital |
| Device and Human Factors (OHT3) | |
| Reproductive and Urology Devices (DHT3B) |
A reference device is included in this submission as well. The reference device is the UroLift Advanced Tissue Control (ATC) System from NeoTract (K200441)
| Trade Name: | NeoTract UroLift System Advanced Tissue Control (ATC) System |
|---|---|
| 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: | Gastrorenal, ObGyn, General Hospital, and Urology |
| Devices (OHT3) Reproductive, Gynecology and Urology | |
| Devices (DHT3B) |
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COMPARISON WITH THE PREDICATE DEVICE
The UroLift 2 ATC Advanced Tissue Control System is based on the UroLift 2 System platform cleared in K201837. The UroLift 2 ATC System device leverages the same platform design as the UroLift 2 System and includes a modification to the distal tip, with the addition of the ATC wings, qiving the tip a larger footprint during the procedure and allowing for effective mobilization of tissue when needed.
The remainder of the device is substantially equivalent to the UroLift 2 System. The implant components, including the materials, specifications and methods of manufacture are unchanged relative to the predicate device. The system mechanics and delivery is substantially equivalent.
COMPARISON WITH THE REFERENCE DEVICE
The UroLift 2 ATC Advanced Tissue Control System described in this submission utilizes the cleared UroLift Advanced Tissue Control (ATC) System for some of the changes to the design of the UroLift 2 ATC Advanced Tissue Control System device including the redesigned distal tip of the proposed device to match the UroLift Advanced Tissue Control (ATC) geometry. The device parameters relevant to the placement of the UroLiff implant are identical between the UroLift 2 ATC Advanced Tissue Control System and the UroLift Advanced Tissue Control (ATC) System.
DESIGN CONTROLS
The NeoTract Product Development Process specifies the activities and deliverables to be completed to ensure that changes do not raise any new issues of safety and/or effectiveness. The procedure includes risk management, development planning, the development of design inputs, the creation of design outputs, design verification and validation activities, design reviews, design transfer and post-market surveillance.
An analysis of all risks related to the subject device in this submission was conducted. The UroLift 2 ATC Advanced Tissue Control System does not compromise the clinical condition or safety of patients or the safety and health of users. The subject device does not affect the safety or efficacy of the UroLift Implant once delivered to the patient. The subject device does not present any new clinical risks or undesirable side-effects.
PERFORMANCE TESTING
The design requirements for the UroLift 2 ATC Advanced Tissue Control 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, compatibility with accessories, and implant, shaft, and wing performance testing. The testing was performed on devices which had undergone worst case sterilization, accelerated aging, and transit testing. The majority of the test methods were equivalent to the testing for the 510(k) cleared UroLiff 2 System (K201837), and all acceptance criteria were met.
6
BIOCOMPATIBILITY TESTING
The UroLift 2 ATC Advanced Tissue Control 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 510(k) submission introduces new materials and, therefore additional biocompatibility testing was performed.
Biocompatibility testing was performed on worst case sterilized patient contact components and included:
- Cytotoxicity testing per ISO 10993-5:2009 Biological evaluation of medical ● devices Part 5: Tests for in vitro cytotoxicity
- . Sensitization Reactivity testing per ISO 10993-10:2021, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization
- Systemic Toxicity testing per ISO 10993-11:2017, Biological Evaluation of ● Medical Devices - Part 11: Tests for Systemic Toxicity
- Intracutaneous Reactivity testing per ISO 10993-23:2021, Biological evaluation of ● medical devices - Part 23: Tests for irritation
- Material Mediated Pyrogenicity and Acute Systemic Toxicity per ISO 10993-. 11:2017 - Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity
STERILIZATION AND SHELF LIFE TESTING
The UroLift 2 ATC Advanced Tissue Control System has been validated to determine the minimum gamma irradiation dose to ensure a 10° Sterility Assurance Level (SAL). The modification addressed in the 510(k) submission may impact the product sterility because the modified component utilizes new materials and adds some geometric complexity to the device. These materials are manufactured, processed, and handled similarly to the predicate UroLift 2 device.
CONCLUSION
The testing demonstrated the NeoTract UroLift 2 ATC Advanced Tissue Control 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 2 ATC Advanced Tissue Control System is substantially equivalent to the UroLift 2 System.