(14 days)
Not Found
No
The 510(k) summary describes a mechanical device for treating BPH and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the treatment of symptoms due to urinary outflow obstruction, which indicates a therapeutic purpose.
No
The device is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) through the deployment of implants, not for diagnosing conditions.
No
The device description explicitly details physical components like a delivery handle, implant cartridges, and implants, which are hardware.
Based on the provided information, the UroLift 2 System (UL500) 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. IVD devices are used for the diagnosis or monitoring of diseases or conditions by examining specimens from the human body (like blood, urine, or tissue).
- Device Description: The device description details a system for physically implanting devices into the prostate to relieve obstruction. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic measurements.
Therefore, the UroLift 2 System (UL500) is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The UroLift 2 System (UL500) is intended for treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
PEW
Device Description
The UroLift 2 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 2 System (UL500) is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift 2 System (UL500) 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.
Users are now provided with an optional Scope Seal which enables them to examine the anatomy between implant deployments without removal of the telescope from the device handle. In addition, a Suture Support Tube has been incorporated into the device to provide additional support to the suture during Implant Cartridge assembly at NeoTract's manufacturing facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostatic urethra, prostatic tissue
Indicated Patient Age Range
men 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing conducted on the modified UroLift 2 System (UL500) demonstrated that the device meets the same performance requirements of the predicate device as well as the additional performance requirements for the Scope Seal. The changes made to the device do not affect the implant deployment procedure. Therefore, the modified UroLift 2 System (UL500) can be utilized in the same manner as the predicate device.
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.
Not Found
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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18. 2017
NeoTract, Inc. Louis-Pierre Marcoux Senior Director, Regulatory Affairs 4473 Willow Road. Suite 100 Pleasanton, CA 94588
Re: K172359
Trade/Device Name: UroLift 2 System (UL500) Regulation Number: 21 CFR§ 876.5530 Regulation Name: Implantable transprostatic tissue retractor system Regulatory Class: II Product Code: PEW Dated: August 4, 2017 Received: August 4, 2017
Dear Louis-Pierre Marcoux:
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.
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 (reporting of medical device-related 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.
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 (DICE) 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 (DICE) 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.
Image /page/1/Picture/9 description: The image shows the name "Benjamin R. Fisher -S" in a simple, sans-serif font. The text is black and appears to be against a white background. The letters are evenly spaced and the text is left-aligned.
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
Indications for Use
510(k) Number (if known)
Device Name UroLift 2 System (UL500)
Indications for Use (Describe)
The UroLift 2 System (UL500) is intended for 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)
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510 (k) Summary
Company Information
| Manufacturer: | NeoTract, Inc.
4473 Willow Road, Suite 100
Pleasanton, CA 94588
FDA Registration No.: 3005791775
NeoTract, Inc.
151 Lindbergh Ave., Suite H and I
Livermore, CA 94551
FDA Registration No: 3013163710
Tel: 925-201-8861
Fax: 925-401-0696 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Louis-Pierre Marcoux
Senior Director, Regulatory Affairs |
| Device Information | |
| Trade Name: | UroLift 2 System (UL500) |
| Common Name: | Implantable transprostatic tissue retractor sys |
| Trade Name: | UroLift 2 System (UL500) |
|---|---|
| Common Name: | Implantable transprostatic tissue retractor system |
| Class: | 2 |
| Regulation: | 21 CFR 876.5530 |
| Product Code: | PEW |
Intended Use
The UroLift 2 System (UL500) 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
UroLift 2 System (UL500), K162345, cleared to market by this Center on 21 September 2016.
Device Description
The UroLift 2 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 2 System (UL500) is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift 2 System (UL500) 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
4
| NeoTract, Inc. | August 4, 2017 |
|---|---|
| Special 510(k) | UroLift 2 System (UL500) |
approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant.
Comparison with the Predicate Device
Minor modifications have been made to the UroLift 2 System (UL500) to improve the device. The overall design, as well as the patient contacting materials, is substantially equivalent to the predicate device.
Users are now provided with an optional Scope Seal which enables them to examine the anatomy between implant deployments without removal of the telescope from the device handle. In addition, a Suture Support Tube has been incorporated into the device to provide additional support to the suture during Implant Cartridge assembly at NeoTract's manufacturing facility.
The UroLift 2 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 UroLift Implant is identical to the predicate device.
Performance Testing
Testing conducted on the modified UroLift 2 System (UL500) demonstrated that the device meets the same performance requirements of the predicate device as well as the additional performance requirements for the Scope Seal. The changes made to the device do not affect the implant deployment procedure. Therefore, the modified UroLift 2 System (UL500) can be utilized in the same manner as the predicate device.
Conclusion
The modified UroLift 2 System (UL500) is as safe and effective, has the same intended use, technological characteristics and principles of operation as the predicate device. The minor changes do not raise any new questions of safety or effectiveness. Therefore, the modified UroLift 2 System (UL500) is substantially equivalent.