(29 days)
No
The description focuses on the mechanical delivery system and implants, with no mention of AI/ML terms or functions.
Yes
The UroLift 2 System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) and is designed to improve lower urinary tract symptoms, which are therapeutic effects.
No
Explanation: The device is indicated for the treatment of symptoms due to urinary outflow obstruction, not for diagnosis. It is designed to deliver implants to open the urethra, which is a therapeutic action.
No
The device description clearly outlines physical components like a Delivery Handle, Implant Cartridges, and Implants, indicating it is a hardware-based medical device.
Based on the provided information, the UroLift 2 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, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- UroLift 2 System Function: The UroLift 2 System is a surgical device used to physically treat symptoms of BPH by implanting devices that retract prostatic tissue and open the urethra. It directly interacts with the patient's anatomy during a procedure.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens. The device is used to perform a physical intervention within the body.
Therefore, the UroLift 2 System falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The UroLift 2 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 2 System (UL2), most recently cleared in K173087 under the marketing model number of UL500, is comprised of the UroLift Delivery Handle (single patient use), the UroLift Implant Cartridges (singleuse) and the UroLift Implants (one implant per cartridge). Each Implant Cartridge is preloaded with one UroLift Implant. The Implant Cartridges fit into the Delivery Handle. Each patient procedure will use one dedicated Delivery Handle and the number of Implant Cartridges/implants necessary to perform a typical procedure (estimated 2-6 implants). The UroLift 2 System is also provided with an optional Scope Seal which enables a clinician 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, urethral lumen
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)
The design requirements for the UroLift 2 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 product performance testing, compatibility testing, and deployment testing. The testing was performed on devices which had undergone worst case sterilization and transit testing. The test methods were equivalent to the previously cleared UroLift System, and all acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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July 31, 2020
NeoTract, Inc. Brian Gall Regulatory Affairs Manager 4155 Hopyard Road Pleasanton, CA 94588
Re: K201837
Trade/Device Name: NeoTract® UroLift® 2 System (UL2) Regulation Number: 21 CFR§ 876.5530 Regulation Name: Implantable transprostatic tissue retractor system Regulatory Class: II Product Code: PEW Dated: June 30, 2020 Received: July 2, 2020
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.
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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and 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 DICE (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe website assistance/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,
for Martha W. Betz, 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) K201837
Device Name NeoTract® UroLift® 2 System (UL2)
Indications for Use (Describe)
The UroLift 2 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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510(k) SUMMARY
COMPANY INFORMATION
NeoTract, Inc. 4155 Hopyard Road Pleasanton, CA 94588 Registration Number: 3015181082
SUBMISSION CORRESPONDENT
Brian Gall Requlatory Affairs Manager, Interventional Urology NeoTract, Inc. 4155 Hopvard Road Pleasanton, CA 94588
Telephone - 925.329.6547 E-mail - brian.gall@teleflex.com
DATE PREPARED
30 June 2020
DEVICE INFORMATION
| Trade Name: | NeoTract® UroLift® 2 System (UL2) |
|---|---|
| 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) |
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 2 System (UL2), most recently cleared in K173087 under the marketing model number of UL500, is comprised of the UroLift Delivery Handle (single patient use), the UroLift Implant Cartridges (singleuse) and the UroLift Implants (one implant per cartridge). Each Implant Cartridge is preloaded with one UroLift Implant. The Implant Cartridges fit into the Delivery Handle. Each patient procedure will use one dedicated Delivery Handle and the number of Implant Cartridges/implants necessary to perform a typical procedure (estimated 2-6
Image /page/3/Picture/13 description: The image shows the logos for neotract and Teleflex. 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 are both in blue and white.
4
implants). The UroLift 2 System is also provided with an optional Scope Seal which enables a clinician to examine the anatomy between implant deployments without removal of the telescope from the Delivery Handle.
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 >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 UL500 System by NeoTract (K173087).
| Trade Name: | NeoTract UroLift System (UL500) |
|---|---|
| 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) |
A reference device is included in this s ion as well. The reference device UroLift UL400 System by NeoTract (K193269)
| 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: | Gastrorenal, ObGyn, General Hospital, and Urology |
| Devices (OHT3) Reproductive, Gynecology and Urology | |
| Devices (DHT3B) |
COMPARISON WITH THE PREDICATE DEVICE
The UroLift 2 System (formerly UL500) described in this submission is substantially equivalent to the previously cleared generations of the device. The UroLift 2 System was most recently cleared in K173087; previous clearances included K172359, K162345, and K153584. Minor device modifications have been made to the UL2 Delivery System (Delivery Handle and Implant Cartridge) that do not affect the overall safety and effectiveness of the UroLift procedure. No modifications have been made to the UroLift Implant.
Image /page/4/Picture/19 description: The image features the logos of "neoTract" and "Teleflex" side-by-side, with the text "INTERVENTIONAL UROLOGY" centered below. The "neoTract" logo is in black and white, while the "Teleflex" logo is in blue. The text "INTERVENTIONAL UROLOGY" is in a smaller, lighter font, providing additional context to the brands.
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COMPARISON WITH THE REFERENCE DEVICE
The UroLift 2 System described in this submission utilizes the cleared UroLift System UL400 for some of the changes to the design of the device including the redesigned distal tip of the proposed device to match the UL400 geometry, as well as the expanded contraindication to increase the prostate size limitation from 80cc to 100cc. The device parameters relevant to the placement of the UroLift implant are identical between the UroLift 2 System and the UroLift System UL400.
PERFORMANCE TESTING
The design requirements for the UroLift 2 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 product performance testing, compatibility testing, and deployment testing. The testing was performed on devices which had undergone worst case sterilization and transit testing. The test methods were equivalent to the previously cleared UroLift System, and all acceptance criteria were met.
BIOCOMPATIBILITY TESTING
The UroLift 2 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 and the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The modifications addressed in this Special 510(k) submission do not impact the UroLift Implant cleared previously. Parts of the Delivery Device (Delivery Handle and Implant Cartridge) are patient contacting. They are considered externally communicating: tissue, bone, dentin with limited (