LIGHTHOUSE URINARY CATHETER

K140099 · Seedings Life Science Ventures, LLC · EZL · Mar 4, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140099
• Device Name: LIGHTHOUSE URINARY CATHETER
• Applicant: Seedings Life Science Ventures, LLC
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Mar 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate biopsy and brachytherapy procedures where transrectal ultrasound (TRUS) imaging is used to visualize the prostate. The catheter additionally enhances identification of the course of the posterior aspect of the prostatic urethra during TRUS-guided prostate biopsy and brachytherapy procedures by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.

Device Story

Lighthouse™ Urinary Catheter is a 3-lumen Foley catheter designed for use during prostate biopsy and brachytherapy. It features a standard Foley balloon lumen, a urine drainage lumen, and a third lumen connected to a Urethral Identification Bladder (UIB). The UIB is a 4-cm bladder along the shaft that holds 0.1cc–1.0cc of air. When inserted, the air-filled UIB creates an acoustic interface between the catheter and the urethral wall, providing an echogenic marker visible under TRUS imaging. This allows clinicians to identify the posterior aspect of the prostatic urethra during procedures. The device is used in clinical settings by physicians. It benefits patients by improving visualization of the urethra, potentially reducing complications associated with prostate biopsy and brachytherapy procedures.

Clinical Evidence

Bench testing only. Evidence includes sterilization and shelf-life validation, biocompatibility testing, and device performance specifications. Performance testing included visual inspection, dimensional analysis, adherence to ASTM F623-99 standards, and echogenicity testing in a phantom model to verify the acoustic interface functionality.

Technological Characteristics

3-lumen Foley catheter; materials: biocompatible silicone; dimensions: 16Fr; Urethral Identification Bladder (UIB) capacity: 0.1cc–1.0cc air; sensing principle: acoustic interface (air-filled bladder) for TRUS echogenicity; sterilization: sterile, single-patient use; connectivity: none.

Indications for Use

Indicated for patients undergoing prostate biopsy or brachytherapy procedures requiring bladder/urinary tract drainage and visualization of the prostatic urethra via transrectal ultrasound (TRUS).

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Lighthouse Urinary Catheter (K131655)
• BeamCath, Urological Catheter Patient Positioning Device (K042110)

Submission Summary (Full Text)

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MAR 0 4 2014 .

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## 510(k) SUMMARY

| K140099<br>pg 1 of 3 |
|------------------------------------------------------------------------------------------|
| seedlings |
| Life • Science • Ventures • LLC<br>230 East 15th Street, Suite 1-A<br>New York, NY 10003 |

| 510(k) Owner: | Seedlings Life Science Ventures |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Address: | 230 East 15th Street, Suite 1-A, New York, NY, 10003 |
| Phone: | 954.336.0777 |
| FAX: | 866-277-3269 |
| Contact: | Ken Solovay, Chief Operating Officer |
| Email: | [e-mail] |
| Date Prepared: | March 3, 2014 |
| Device Trade name: | Lighthouse™ Urinary Catheter |
| Common name: | Urinary Catheter |
| Classification name: | Catheter, Retention Type, Balloon |
| Classification Product Code: | EZL, FGI |
| Regulation Number: | 21 CFR 876.5130 |
| Predicate Devices: | |
| (1) Lighthouse Urinary Catheter<br>Manufacturer:<br>FDA 510(k) number:<br>Classification Code: | Seedlings Life Science Ventures, LLC<br>K131655<br>78 EZL |
| (2) BeamCath, Urological Catheter Patient Positioning Device<br>Manufacturer: | Beampoint AB |
| FDA 510(k) number: | K042110 |
| Classification Code: | 78 EZL |

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| | K140099 |
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| | pg 2 of 3 |

seedlings

Life · Science · Ventures · LLC

230 East 15th Street, Suite 1-A

New York, NY 10003

### 510(k) SUMMARY

- The Lighthouse™ Urinary Catheter is a 3-lumen Foley catheter. In addition to a System lumen for inflating the Foley balloon and a urine drainage lumen, the Lighthouse Description has a third lumen for filling 0.1cc - 1cc of air in a 4-cm length bladder along the shaft of the catheter. The Urethral Identification Bladder (UIB) has a maximum outer diameter of 24F (i.e. smaller than other urinary catheters that meet ASTM F623-99) when filled with a maximum 1cc volume described in the instructions for use (IFU) and provides echogenicity when viewed by a Transrectal Ultrasound (TRUS). The non-inflated UIB contains a narrow air space between the catheter shaft and the urethra, which provides an echogenic marker under TRUS and when necessary can be increased by adding 0.1cc - 1.0cc of volume via syringe.
- The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage Intended Use during prostate biopsy and brachytherapy procedures where transrectal ultrasound (TRUS) imaging is used to visualize the prostate. The catheter additionally enhances identification of the course of the posterior aspect of the prostatic urethra during TRUS-guided prostate biopsy and brachytherapy procedures by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.

| Characteristic | Lighthouse™<br>(Seedlings) | Lighthouse™<br>(Seedlings) | BeamCath™<br>(Beampoint) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K140099 | K131655 | K042110 |
| Intended Use | The Lighthouse™ Urinary<br>Catheter is intended for<br>bladder/urinary tract drainage<br>during prostate biopsy and<br>brachytherapy procedures<br>where transrectal ultrasound<br>(TRUS) imaging is used to<br>visualize the prostate. The<br>catheter additionally enhances<br>identification of the course of<br>the posterior aspect of the<br>prostatic urethra during TRUS-<br>guided prostate biopsy and<br>brachytherapy procedures by<br>creating an acoustic interface<br>(i.e., air) between the catheter<br>and the urethral wall via its<br>urethral identification bladder. | The Lighthouse™ Urinary<br>Catheter is intended for<br>bladder/urinary tract<br>drainage during prostate<br>brachytherapy procedures<br>where transrectal<br>ultrasound (TRUS) imaging<br>is used to visualize the<br>prostate. The catheter<br>additionally enhances<br>identification of the course<br>of the posterior aspect of<br>the prostatic urethra<br>during TRUS-guided<br>brachytherapy by creating<br>an acoustic interface (i.e.,<br>air) between the catheter<br>and the urethral wall via its<br>urethral identification<br>bladder. | The BeamCath is a<br>positioning device used<br>with external beam<br>conformal radiation<br>therapy for visualizing<br>the prostate position<br>during treatment of<br>prostate cancer. The<br>BeamCath is introduced<br>into the urethra as a<br>sterile urological<br>catheter and is retained<br>in place by inflating the<br>balloon tip. Its<br>radiopaque markers aid<br>in radiographic<br>visualization of the<br>prostate position for<br>planning, simulation<br>and treatment of<br>prostate cancer using<br>dose escalation<br>radiotherapy |

The Lighthouse is substantially equivalent to the following predicate devices: the Lighthouse Urinary Catheter (Seedlings Life Science Ventures) with its original

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# 510(k) SUMMARY

Image /page/2/Picture/1 description: The image shows the logo for Seedlings Life Science Ventures LLC. The logo includes the word "seedlings" in a stylized font, with the words "Life, Science, Ventures, LLC" underneath. The address "230 East 15th Street, Suite 1-A, New York, NY 10003" is printed below the logo.

| Characteristic | Lighthouse™<br>(Seedlings) | Lighthouse™<br>(Seedlings) | BeamCath<br>(Beampoint) |
|----------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k) number | K140099 | K131655S | K042110 |
| Design | Urological catheter with Foley<br>balloon & echogenic 24Fr air-<br>filled bladder | Urological catheter with<br>Foley balloon & echogenic<br>24Fr air-filled bladder | Urological catheter<br>with Foley balloon &<br>tantalum radiopaque<br>markers |
| Materials | Biocompatible silicone | Biocompatible silicone | PVC shaft & latex<br>balloon |
| Sterile, Patient Use | Sterile, Single-patient use | Sterile, Single-patient use | Sterile, Single-patient<br>use |
| Sizes | 16Fr | 16Fr | 14Fr |

#### Performance The following bench tests have been performed to verify the Lighthouse performance specifications, with results demonstrating substantial equivalence:

- 1.) Sterilization and Shelf Life
- 2.) Biocompatibility
- 3.) Device Performance Specifications

### Data

- a. Visual Inspection
- Dimensional Analysis ف
- C. ASTM F623-99
- d. Echogenicity Testing in a Phantom Model

Determination Based on the comparison above, the urine drainage and enhanced visualization of Substantial under external imaging is equivalent to the predicate devices. The small risk of Equivalence using a urinary catheter during prostate biopsy is overwhelmingly outweighed by the benefits of using the Lighthouse Catheter. The risk of urethral complication from prostate biopsy without using the Lighthouse Catheter is much greater than the risk of a complication due to use of the Lighthouse Catheter and, as such, the device does not raise new questions of safety and effectiveness.

Conclusion We believe the Lighthouse Catheter is substantially equivalent based on the indications for use and the performance testing results.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2014

Seedlings Life Science Ventures Ken Solovay Chief Operating Officer 230 East 15th Street, Suite 1-A New York, NY 10003

K140099 Re:

> Trade/Device Name: Lighthouse™ Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL, FGI Dated: January 15, 2014 Received: January 16, 2014

Dear Ken Solovay,

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.

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Page 2 - Ken Solovay

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the text "Benjamin Fisher-S". The text is written in a simple, sans-serif font. The letters are black and the background is white. The letters "FDA" are in the middle of the text, and they are larger than the other letters.

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): K140099 (To be assigned)

Device Name: Lighthouse™ Urinary Catheter

Indications for Use: The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate biopsy and brachytherapy procedures where transrectal ultrasound (TRUS) imaging is used to visualize the prostate. The catheter additionally enhances identification of the course of the posterior aspect of the prostatic urethra during TRUS-guided prostate biopsy and brachytherapy procedures by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.

Prescription Use __ Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/9 description: The image shows the text "Benjamin R. Fisher -S 2014.03.04 11:59:24 -05'00'". The text appears to be a name, followed by a date and time stamp. The name is "Benjamin R. Fisher", and the date and time stamp is "2014.03.04 11:59:24 -05'00'". The text is black and is on a white background.