NeoTract UroLift System UL500

K153584 · Neotract, Inc. · PEW · Mar 15, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153584
• Device Name: NeoTract UroLift System UL500
• Applicant: Neotract, Inc.
• Product Code: PEW · Gastroenterology, Urology
• Decision Date: Mar 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5530
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

The UroLift System UL500 is a mechanical surgical device used by urologists to treat BPH. It consists of a reusable delivery handle and single-use implant cartridges containing permanent implants. During a transurethral procedure, the physician inserts the device through the penile orifice into the prostatic urethra. The device displaces the obstructive prostatic tissue laterally toward the prostatic capsule. The system then deploys a permanent implant transversely through the prostate tissue, anchoring the urethral tissue to the capsule. This retraction maintains an expanded urethral lumen, reducing obstruction and improving lower urinary tract symptoms (LUTS). The procedure is performed in a clinical setting. The device provides a minimally invasive alternative to traditional surgical resection by mechanically holding the prostate lobes open.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including design verification, transit testing, joint strength testing, and packaging/labeling integrity. Biocompatibility testing was conducted per ISO 10993. Design validation was performed using a cadaveric model to confirm the device met customer requirements.

Technological Characteristics

Mechanical transprostatic tissue retractor system. Components: reusable delivery handle, single-use implant cartridges, and permanent implants. Biocompatibility per ISO 10993. Sterilization validated for handle and cartridges. Shelf-life testing performed for sterility and functionality. No software or electronic components.

Indications for Use

Indicated for men 50+ years of age with urinary outflow obstruction symptoms secondary to benign prostatic hyperplasia (BPH).

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the UroLift® System is subject to the following special controls: - (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: - (A) Deployment testing must be conducted - (B) Mechanical strength must be conducted - (C) Resistance-to-degradation testing must be conducted - (5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance (MR) 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: - (A) Deployment testing must be conducted - (B) Implant migration must be conducted - (7) Labeling must bear all information required for safe and effective use of the device, and must include: - (A) Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device - (B) Information on the patient population for which the device has been demonstrated to be effective - (C) A detailed summary of the device technical parameters - (D) Information on how the device operates and the typical course of treatment - (E) An expiration date/shelf life - (F) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.

*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.

Predicate Devices

• UroLift System UL400 (DEN 130023, K133281)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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| 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) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services [phone] EF

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#### 5 510(k) SUMMARY

#### COMPANY INFORMATION

| Manufacturer: | NeoTract, Inc.<br>4473 Willow Road, Suite 100<br>Pleasanton, CA 94588<br>Tel: [phone]<br>Fax: [phone]<br>FDA Registration No.: 3005791775 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nancy E. Isaac, JD, MPH<br>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.

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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.