(91 days)
DEN 130023, K133281
Not Found
No
The device description focuses on mechanical components and their function in treating BPH. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended for the treatment of symptoms due to urinary outflow obstruction, which directly addresses a medical condition to improve the patient's health.
No
The device description states that the UroLift® System is intended for the "treatment of symptoms due to urinary outflow obstruction" and "to access the prostatic urethra and deliver one UroLiff Implant through a lateral lobe of the prostate", which are therapeutic actions, not diagnostic.
No
The device description clearly outlines physical components (Delivery Handle, Implant Cartridges, Implants) and their mechanical function in treating BPH, indicating it is a hardware-based medical device.
Based on the provided information, the UroLift® System is not an IVD (In Vitro Diagnostic) 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 performed directly on the patient's body.
- Device Description: The device is a system of instruments and implants designed to be inserted into the urethra and prostate to physically alter the tissue and improve urine flow. This is a surgical/interventional device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status. IVD devices are specifically designed for in vitro examination of specimens.
Therefore, the UroLift® System is a medical device used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The UroLift® System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
Product codes
PEW
Device Description
The UroLift® System UL500 is comprised of the UroLift® Delivery Handle (single patient reusable), the UroLift® Implant Cartridges (single-use) and the UroLift® Implants (one implant per cartridge). Each patient procedure will use one dedicated sterile handle and the number of cartridges/implants necessary to perform a successful procedure (estimated 2-6 implants). The cartridges fit into the delivery handle.
The UroLift Delivery Handles (UL500-H) and UroLift Implant Cartridges (UL500-C) will be sold separately. The UroLift System UL500 Delivery Handles will be sold two per carton and the UroLift System UL500 Implant Cartridges will be sold eight per carton. Both cartons will contain the same UroLift System UL500 Instructions for Use (IFU).
The UroLift System UL500 is designed to access the prostatic urethra and deliver one UroLiff Implant through a lateral 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. The implants secure the retracted position of the urethra thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving 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.
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
50 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
Bench testing, including design verification and transit testing, performed for the NeoTract UroLift System UL500 demonstrated that the device meets the same performance requirements as the predicate device. Testing included the verification of packaging and labeling integrity as well as bench verification testing of the devices, and joint strength testing. All acceptance criteria were met. Design validation was performed in a cadaveric model and demonstrated that the UroLift System UL500 met the customer requirements.
Key Metrics
Not Found
Predicate Device(s)
DEN 130023, K133281
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2016
Neotract, Inc. Nancy Isaac Vice President, Regulatory Affairs 4473 Willow Road, Suite 100 Pleasanton, CA 94588
K153584 Trade/Device Name: Neotract® Urolift® System UL500 Regulation Number: 21 CFR 876.5530 Regulation Name: Implantable Transprostatic Tissue Retractor System Regulatory Class: Class II Product Code: PEW Dated: December 15, 2015 Received: December 16, 2015
Dear Nancy Isaac,
Re:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -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
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K153584 |
|---|---|
| Device Name | NeoTract UroLift® System UL500 |
| Indications for Use (Describe) | UroLift® System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 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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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
3
5 510(k) SUMMARY
COMPANY INFORMATION
| Manufacturer: | NeoTract, Inc.
4473 Willow Road, Suite 100
Pleasanton, CA 94588
Tel: 650 269 2552
Fax: 925 401 0683
FDA Registration No.: 3005791775 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nancy E. Isaac, JD, MPH
Vice President, Regulatory Affairs |
DATE PREPARED
14 December 2015
DEVICE INFORMATION
| Trade Name: | NeoTract® UroLift® System UL500 |
|---|---|
| Common Name: | Implantable transprostatic tissue retractor system |
| Class: | II |
| Regulation: | 21 CFR 876.5530 |
| Product Code: | PEW |
INTENDED USE
The UroLift System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
PREDICATE DEVICE
The predicate device is the UroLift System UL400, DEN 130023 and K133281, which were cleared to market by this Center on 13 September 2013 and 13 December 2013, respectively.
DEVICE DESCRIPTION
The UroLift® System UL500 is comprised of the UroLift® Delivery Handle (single patient reusable), the UroLift® Implant Cartridges (single-use) and the UroLift® Implants (one implant per cartridge). Each patient procedure will use one dedicated sterile handle and the number of cartridges/implants necessary to perform a successful procedure (estimated 2-6 implants). The cartridges fit into the delivery handle.
4
The UroLift Delivery Handles (UL500-H) and UroLift Implant Cartridges (UL500-C) will be sold separately. The UroLift System UL500 Delivery Handles will be sold two per carton and the UroLift System UL500 Implant Cartridges will be sold eight per carton. Both cartons will contain the same UroLift System UL500 Instructions for Use (IFU).
The UroLift System UL500 is designed to access the prostatic urethra and deliver one UroLiff Implant through a lateral 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. The implants secure the retracted position of the urethra thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving 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.
COMPARISON WITH THE PREDICATE DEVICE
The UroLift System UL500 described in this submission is substantially equivalent to the predicate device in that they share the same intended use and employ the same technology characteristics. The implant is identical to the predicate device.
PERFORMANCE TESTING
Bench testing, including design verification and transit testing, performed for the NeoTract UroLift System UL500 demonstrated that the device meets the same performance requirements as the predicate device. Testing included the verification of packaging and labeling integrity as well as bench verification testing of the devices, and joint strength testing. All acceptance criteria were met. Design validation was performed in a cadaveric model and demonstrated that the UroLift System UL500 met the customer requirements.
BIOCOMPATIBILITY TESTING
Testing was conducted in accordance with ISO 10993 to assure the elements of the device that are patient contacting are biocompatible.
STERILIZATION AND SHELF-LIFE TESTING
Sterility has been demonstrated for the UroLift System UL500 Delivery Handle and Implant Cartridge. Shelf-life testing was performed and supports the continued sterility of the device, packaging integrity and device functionality over the shelf-life of the device.
CONCLUSION
The testing demonstrated the NeoTract UroLift System UL500 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 UL500 is substantially equivalent to the predicate device.