LIGHTHOUSE(TM) URINARY CATHETER

K131655 · Seedings Life Science Ventures, LLC · EZL · Nov 4, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K131655
• Device Name: LIGHTHOUSE(TM) URINARY CATHETER
• Applicant: Seedings Life Science Ventures, LLC
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Nov 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate 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 brachytherapy 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; includes standard drainage and balloon inflation lumens plus a third lumen for a 4-cm Urethral Identification Bladder (UIB). UIB holds 0.1cc–1.0cc of air; creates acoustic interface between catheter and urethral wall; provides echogenic marker under TRUS imaging. Used in clinical settings during prostate brachytherapy; operated by physicians. Provides enhanced visualization of posterior prostatic urethra course; assists in TRUS-guided brachytherapy planning and procedure. Benefits patient by improving anatomical identification during radiation therapy.

Clinical Evidence

Bench testing only. Testing included sterilization and shelf-life validation, biocompatibility, and device performance specifications (visual inspection, dimensional analysis, ASTM F623-99 compliance, and echogenicity testing in a phantom model).

Technological Characteristics

Biocompatible silicone construction; 3-lumen design; 16Fr size; air-filled Urethral Identification Bladder (UIB) for echogenicity; Foley balloon for retention. Complies with ASTM F623-99. Sterile, single-patient use.

Indications for Use

Indicated for patients undergoing prostate brachytherapy 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

• All Silicone 3-way Foley Balloon Catheter (K980919)
• BeamCath, Urological Catheter Patient Positioning Device (K042110)

Submission Summary (Full Text)

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# 510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows a company logo with the text "seedlings" and the phrase "Life, Science, Ventures, LLC". The logo also includes the text "230 East 15th Street, Suite 1-A, New York, NY 10003", which is likely the company's address. The image also includes the text "K131655 pg. 1 of 3" at the top.

| 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: | November 4, 2013 | NOV 04 2013 |
| 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) All Silicone 3-way Foley Balloon Catheter<br>Manufacturer:<br>FDA 510(k) number:<br>Classification Code: | Fortune Medical Instrument Corp.<br>K980919<br>78 EZL | |
| (2) BeamCath, Urological Catheter Patient Positioning Device<br>Manufacturer:<br>FDA 510(k) number:<br>Classification Code: | Beampoint AB<br>K042110<br>78 EZL | |

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Image /page/1/Picture/0 description: The image shows a logo with the text "seedlings" in a stylized font. Below the word "seedlings" is the text "Life * Science * Ventures LLC". The image also contains the address "230 East 15th Street, Suite 1-A". The text "K131655 pg 2 of 3" is also present in the image.

New York. NY 10003

## 510(k) SUMMARY

- System The Lighthouse™ Urinary Catheter is a 3-lumen Foley catheter. In addition to Description a lumen for inflating the Foley balloon and a urine drainage lumen, the Lighthouse 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.
- Intended Use The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate 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 brachytherapy by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.

The Lighthouse is substantially equivalent to the following predicate devices: the All Silicone 3-way Foley Catheter (Fortune Medical Instrument Corp.) and the BeamCath Urological Catheter Positioning Device (Beampoint).

| Characteristic | Lighthouse™<br>(Seedlings) | All Silicone Foley<br>Catheter (Fortune) | BeamCath<br>(Beampoint) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBA | K980919 | K042110 |
| Intended Use | The Lighthouse™ Urinary<br>Catheter is intended for<br>bladder/urinary tract drainage<br>during prostate brachytherapy<br>procedures where transrectal<br>ultrasound (TRUS) imaging is<br>used to visualize the prostate.<br>The catheter additionally<br>enhances identification of the<br>course of the posterior aspect<br>of the prostatic urethra during<br>TRUS-guided brachytherapy 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 Silicone Foley Balloon<br>Catheters and Nelation<br>Catheter are intended for<br>use as urinary catheters to<br>pass fluids to and from the<br>urinary bladder. | The BeamCath is a<br>positioning device used<br>with external beam<br>conformal radiation<br>therapy for visualizing the<br>prostate position during<br>treatment of prostate<br>cancer. The BeamCath is<br>introduced into the urethra<br>as a sterile urological<br>catheter and is retained in<br>place by inflating the<br>balloon tip. Its radiopaque<br>markers aid in radiographic<br>visualization of the<br>prostate position for<br>planning, simulation and<br>treatment of prostate<br>cancer using dose<br>escalation radiotherapy |

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## K131655

pg 3 of 3

Image /page/2/Picture/2 description: The image shows the word "seedlings" in a sans-serif font. Above the word, there are two stylized drawings of trees. The tree on the left is tall and thin, while the tree on the right is shorter and bushier. The word "seedlings" is underlined with a thin line.

## 510(k) SUMMARY

Life · Science · Ventures · LLC 230 East 15th Street, Suite 1-A New York, NY 10003

| Characteristic | Lighthouse™<br>(Seedlings) | All Silicone Foley<br>Catheter (Fortune) | BeamCath<br>(Beampoint) |
|----------------------|-----------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------|
| Design | Urological catheter with Foley<br>balloon & echogenic 20Fr - 24Fr<br>air-filled bladder | Urological catheter with<br>Foley balloon | 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 | 12 - 26Fr | 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
- ف Dimensional Analysis
- ASTM F623-99 C.
- 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 Lighthouse does Equivalence 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 4. 2013

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

Re: K131655

> Trade/Device Name: Lighthouse™ Urinary Catheter Regulation Number: 21 CFR § 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Codes: EZL and FGI Dated: October 16, 2013 Received: October 18, 2013

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 fiability 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

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Page 2 - Ken Solovay

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/7 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The letters "R" and "F" are stylized with a geometric design that appears to be layered or outlined. The name is horizontally oriented and appears to be a logo or signature.

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): K131655 (To be assigned)

Device Name: Lighthouse™ Urinary Catheter

Indications for Use: The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate 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 TRUSguided brachytherapy 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) Over-The-Counter Use No (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beniamin 2013.11