(24 days)
No
The description focuses on a mechanical device and procedure for treating BPH, with no mention of AI or ML capabilities.
Yes
The device is indicated for the treatment of symptoms due to urinary outflow obstruction, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a treatment for BPH symptoms by displacing the urethra and securing it with implants, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components (Delivery Device, Implants) and a mechanical procedure, indicating it is a hardware-based medical device, not software-only.
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 derived from the human body (like blood, urine, tissue) to provide information 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 laboratory test or analysis of samples.
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
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)
The modification of the contraindication does not impact the performance testing of the existing UroLift System. As such, the performance testing data provided with the predicate device (K173087) is applicable for the proposed device with a modified contraindication. The minor device modifications discussed were tested using test methods equivalent to the predicate device.
The basis for increasing the maximum prostate volume indicated in the contraindication for the UroLift System is based on clinical review of both sponsored and independent clinical studies that included men with prostate volumes greater than 80cc. These studies show that the symptom response, quality of life, uroflowmetry, adverse events, and catheterization rates are equivalent to the outcomes of patients with prostate volumes less than 80cc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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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 & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
December 20, 2019
Neotract, Inc. Brian Gall Regulatory Affairs Manager 4155 Hopyard Rd. Pleasanton, CA 94588
Re: K193269
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: November 25, 2019 Received: November 26, 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.
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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 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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.
Jessica K. Nguyen, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K193269
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.
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 Rd. Pleasanton, CA 94588 Registration Number: 3015181082
SUBMISSION CORRESPONDENT
Brian Gall Requlatory Affairs Manager, Interventional Urology NeoTract, Inc. 4155 Hopvard Rd. Pleasanton, CA 94588
Telephone - 925.329.6547 E-mail - brian.gall@teleflex.com
DATE PREPARED
25 November 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: | Gastroenterology/Urology |
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/14 description: The image features the logos of NeoTract and Teleflex, two companies in the interventional urology field. The NeoTract logo is on the left, while the Teleflex logo is on the right. Below the logos, the words "INTERVENTIONAL UROLOGY" are written in a smaller font, indicating the area of specialization for these companies.
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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.
CONTRAINDICATIONS
The UroLift 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 System by NeoTract (K173087).
| 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: | Gastroenterology/Urology |
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. This submission concerns the modification of a contraindication of the device and does not impact the device itself. The modification is to change one contraindication from "The UroLift System is contraindicated for men with Prostate volume of >80 cc" to "The UroLift System is contraindicated for men with Prostate volume of >100 cc". This is based on a clinical literature review. The indications for use and remaining contraindications do not change as a result of this submission. Minor device modifications which were determined to not require a pre-market submission based on Deciding When to Submit a 510(k) for a Change to an Existing Device Guidance for Industry and Food and Drug Administration Staff are included in this submission.
PERFORMANCE TESTING
The modification of the contraindication does not impact the performance testing of the existing UroLift System. As such, the performance testing data provided with the predicate device (K173087) is applicable for the proposed device with a modified contraindication. The minor device modifications discussed were tested using test methods equivalent to the predicate device.
The basis for increasing the maximum prostate volume indicated in the contraindication for the UroLift System is based on clinical review of both sponsored and independent clinical studies that included men with prostate volumes greater than 80cc. These studies show that the symptom response, quality of life, uroflowmetry, adverse events,
Image /page/4/Picture/19 description: The image features the logos of two companies, "neotract" and "Teleflex", along with the text "INTERVENTIONAL UROLOGY". The "neotract" logo is on the left, with the company name in blue and black. The "Teleflex" logo is on the right, with the company name in blue. The text "INTERVENTIONAL UROLOGY" is centered below the two logos.
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and catheterization rates are equivalent to the outcomes of patients with prostate volumes less than 80cc.
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 manaqement process. The modification of the contraindication does not impact the biocompatibility of the existing UroLift System. As such, the data provided with the predicate device (K173087) is applicable for the proposed device with a modified contraindication.
STERILIZATION AND SHELF-LIFE TESTING
The modification of the contraindication does not impact the sterilization or shelf life of the existing UroLift System. As such, the data provided with the predicate device (K173087) is applicable for the proposed device with a modified contraindication.
CONCLUSION
The data provided demonstrated the NeoTract UroLift System with a modified contraindication 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/9 description: The image features the logos of two companies, "NeoTract" and "Teleflex", side by side. The "NeoTract" logo is on the left, while the "Teleflex" logo is on the right, both in a dark blue color. Below the logos, the text "INTERVENTIONAL UROLOGY" is displayed in a smaller font size, indicating the field of expertise or focus of these companies.