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.

Device Description

The Lighthouse™ Urinary Catheter is a 3-lumen Foley catheter. In addition to 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Lighthouse™ Urinary Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Specification	Acceptance Criteria	Reported Device Performance
1.) Sterilization	Not explicitly stated, but implied to meet standards for a sterile medical device.	Performed. Results demonstrate substantial equivalence.
2.) Shelf Life	Not explicitly stated, but implied to meet standards for device effectiveness and sterility over time.	Performed. Results demonstrate substantial equivalence.
3.) Biocompatibility	Not explicitly stated, but implied to meet standards for materials used in medical devices with patient contact.	Performed. Results demonstrate substantial equivalence.
4.) Device Performance Specifications (General)	Not explicitly stated but implied to meet relevant performance and safety standards for urinary catheters and visualization. This would include aspects addressed by ASTM F623-99.	Performed. Results demonstrate substantial equivalence. Specific tests include:
Visual Inspection	Not explicitly stated, but generally involves confirming the device's physical appearance, integrity, and absence of defects.	Performed.
Dimensional Analysis	Not explicitly stated, but would involve verifying the dimensions (e.g., catheter size, UIB outer diameter) against design specifications. Specifically, UIB max outer diameter 24F.	Performed. 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.
ASTM F623-99	Compliance with ASTM F623-99 (Standard Specification for Foley Catheter).	Performed. The text states the Lighthouse UIB is "smaller than other urinary catheters that meet ASTM F623-99" directly implying compliance with, or exceeding requirements of, this standard for overall catheter size.
Echogenicity Testing (UIB)	The UIB provides echogenicity when viewed by Transrectal Ultrasound (TRUS) and creates an acoustic interface during TRUS-guided brachytherapy to enhance identification of the posterior aspect of the prostatic urethra.	Performed "in a Phantom Model." 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 study concluded that "enhanced visualization of Substantial under external imaging is equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size for any of the bench tests (Sterilization and Shelf Life, Biocompatibility, Device Performance, Visual Inspection, Dimensional Analysis, ASTM F623-99, Echogenicity Testing).
Data Provenance: Not specified. The tests are described as "bench tests," implying they were conducted in a laboratory setting. There is no mention of human subject data, country of origin, or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The performance testing appears to be primarily bench testing against engineering specifications and industry standards rather than an assessment requiring clinical expert interpretation or a "ground truth" derived from expert consensus. For the Echogenicity Testing, while it involved a "Phantom Model" and aimed to demonstrate "enhanced visualization," it doesn't specify if expert radiologists/urologists were involved in establishing a ground truth for "enhanced visualization."

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the tests described are bench tests with objective outcomes (e.g., meeting dimensional specs, compliance with ASTM standards, visual confirmation of echogenicity in a phantom). Adjudication methods are typically relevant for clinical studies involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted or described. The study focuses on demonstrating substantial equivalence through bench testing, comparing the device's characteristics and performance to predicate devices and industry standards. There is no mention of human readers or AI assistance in the context of this submission.
Effect Size of AI vs. Without AI Assistance: Not applicable, as no MRMC study or AI component is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this device is a physical urinary catheter, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

For most tests, the "ground truth" was based on engineering specifications, industry standards (e.g., ASTM F623-99), and objective measurements.
For Echogenicity Testing, the ground truth was the observable "echogenic marker" and "acoustic interface" within a "Phantom Model." This relies on basic physics and the known properties of air creating acoustic impedance differences visible on ultrasound.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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:	ken@seedlings.net
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 CatheterManufacturer:FDA 510(k) number:Classification Code:	Fortune Medical Instrument Corp.K98091978 EZL
(2) BeamCath, Urological Catheter Patient Positioning DeviceManufacturer:FDA 510(k) number:Classification Code:	Beampoint ABK04211078 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™(Seedlings)	All Silicone FoleyCatheter (Fortune)	BeamCath(Beampoint)
510(k) number	TBA	K980919	K042110
Intended Use	The Lighthouse™ UrinaryCatheter is intended forbladder/urinary tract drainageduring prostate brachytherapyprocedures where transrectalultrasound (TRUS) imaging isused to visualize the prostate.The catheter additionallyenhances identification of thecourse of the posterior aspectof the prostatic urethra duringTRUS-guided brachytherapy bycreating an acoustic interface(i.e., air) between the catheterand the urethral wall via itsurethral identification bladder.	The Silicone Foley BalloonCatheters and NelationCatheter are intended foruse as urinary catheters topass fluids to and from theurinary bladder.	The BeamCath is apositioning device usedwith external beamconformal radiationtherapy for visualizing theprostate position duringtreatment of prostatecancer. The BeamCath isintroduced into the urethraas a sterile urologicalcatheter and is retained inplace by inflating theballoon tip. Its radiopaquemarkers aid in radiographicvisualization of theprostate position forplanning, simulation andtreatment of prostatecancer using doseescalation radiotherapy

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K131655

pg 3 of 3

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510(k) SUMMARY

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

Characteristic	Lighthouse™(Seedlings)	All Silicone FoleyCatheter (Fortune)	BeamCath(Beampoint)
Design	Urological catheter with Foleyballoon & echogenic 20Fr - 24Frair-filled bladder	Urological catheter withFoley balloon	Urological catheterwith Foley balloon &tantalum radiopaquemarkers
Materials	Biocompatible silicone	Biocompatible silicone	PVC shaft & latexballoon
Sterile, Patient Use	Sterile, Single-patient use	Sterile, Single-patient use	Sterile, Single-patientuse
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.