(56 days)
Not Found
No
The description focuses on a mechanical device and surgical technique, with no mention of AI/ML terms or data processing related to learning or prediction.
Yes
The device is intended for the treatment of symptoms due to urinary outflow obstruction, which indicates a therapeutic purpose.
No
The device is described as a treatment for BPH symptoms, not for diagnosis. Its operation involves deploying implants to treat the condition, which is a therapeutic function.
No
The device description clearly outlines physical components (UroLift Delivery Device and UroLift Implant) that are inserted into the body, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 test performed on samples from the body.
- Device Description: The device is a physical implant and delivery system used to mechanically alter the prostate and urethra. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any components or processes typical of IVDs, such as reagents, assays, sample collection, or analysis of biological markers.
In summary, the UroLift System is a surgical device used for treatment, not a diagnostic device used for testing biological samples.
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 NeoTract UroLift System comprises two main components, the UroLift Delivery Device and UroLift Implant. Each delivery device comes pre-loaded with one UroLift Implant. The insertion of the UroLift Delivery Device into the male urethra is performed under direct visualization using standard surgical technique, using a standard cystoscopy sheath and telescope.
The UroLift Delivery Device is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift Delivery Device is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. A 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, urethra
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Transit and functionality testing conducted on the modified NeoTract UroLift System demonstrate that the device meets the same performance requirements as the unmodified predicate device. Usability test results confirm that the modified device does not affect the usability of the device and that it can be utilized in the same manner as the unmodified predicate device.
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.
0
| NeoTract, Inc.
Special 510(k) | | October 24, 2013
NeoTract UroLift System |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| | 510 (k) Summary | K133281
pg 1 of 2 |
| 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 | DEC 2 0 2013 |
| Contact: | Nancy E. Isaac, JD, MPH
Vice President, Clinical & Regulatory Affairs, Quality Assurance | |
Device Information
| Trade Name: | NeoTract® UroLift® System |
|---|---|
| Common Name: | Implantable transprostatic tissue retractor system |
| Class: | 2 |
| 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
NeoTract UroLift System, K130651
Device Description
The NeoTract UroLift System comprises two main components, the UroLift Delivery Device and UroLift Implant. Each delivery device comes pre-loaded with one UroLift Implant. The insertion of the UroLift Delivery Device into the male urethra is performed under direct visualization using standard surgical technique, using a standard cystoscopy sheath and telescope.
1
The UroLift Delivery Device is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift Delivery Device is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. A 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
Minor modifications have been made to the UroLift Delivery Device to improve usability and reliability. The materials used remain the same, as well as the manner in which the implant is deployed from the delivery device. The UroLift Implant component is identical to that of the predicate device.
The modified UroLift System shares the same intended use and employs the same fundamental scientific technology as the legally marketed predicate device.
Performance Testing
Transit and functionality testing conducted on the modified NeoTract UroLift System demonstrate that the device meets the same performance requirements as the unmodified predicate device. Usability test results confirm that the modified device does not affect the usability of the device and that it can be utilized in the same manner as the unmodified predicate device.
Conclusion
The modified NeoTract UroLift System is as safe and effective, has the same intended use, technological characteristics and principles of operation as the unmodified predicate device. The minor technological differences between the modified and unmodified predicate device do not raise any new questions of safety or effectiveness. Therefore, the modified NeoTract UroLift System is substantially equivalent.
2
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Neotract, Inc. Nancy Isaac, J.D., M.P.H. VP, Clinical Affairs, Regulatory and Quality 4473 Willow Road, Suite 100 Pleasanton, CA 94588
Re: K133281
Trade/Device Name: NeoTract UroLift® System Regulation Number: 21 CFR 876.5530 Regulation Name: Implantable Transprostatic Tissue Retractor System Regulatory Class: Class II Product Code: PEW Dated: December 4, 2013 Received: December 5, 2013
Dear Nancy Isaac,
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 [OIR/IVD OPTION] and Part 809); medical device
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Page 2 - Nancy Isaac, J.D., M.P.H.
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 |OIR/IVD OPTION] and Part 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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
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Indications for Use Statement
510(k) Number K133281
NeoTract UroLift® System Device Name
Indications UroLift System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia for Use (BPH) in men 50 years of age or older.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Cleared by CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801. 109)
: '' '' ''
ﮩ
OR
Over-The-Counter Use