(47 days)
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.
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 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.
This document, a 510(k) summary for the Lighthouse™ Urinary Catheter, describes the device and its intended use, but it does not contain acceptance criteria for device performance or a study demonstrating that it meets those criteria in the way typically required for AI/software-as-a-medical-device (SaMD) clearances.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical characteristics and biocompatibility.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing in the context of an AI/SaMD performance study:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Sterilization and Shelf Life | Performed with results demonstrating substantial equivalence |
| Biocompatibility | Performed with results demonstrating substantial equivalence |
| Device Performance Specifications | Performed with results demonstrating substantial equivalence (e.g., Visual Inspection, Dimensional Analysis, ASTM F623-99, Echogenicity Testing in a Phantom Model) |
Important Note: These "acceptance criteria" are not performance metrics like accuracy, sensitivity, or specificity that would be used to evaluate an AI algorithm's diagnostic or predictive capabilities. They are standard engineering and material science tests for a physical medical device. The "device performance specifications" are general claims, not quantifiable criteria with thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a clinical performance study with a test set. The described "tests" are bench tests on the physical catheter.
- Data Provenance: Not applicable for the type of tests described. The "echogenicity testing" was done "in a phantom model," which is not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No human expert "ground truth" was established for a clinical test set because no clinical performance study involving human data or interpretations was conducted or reported here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study was not done. The device is a physical catheter, not an AI or software assistant for human readers. Its function is to create an acoustic interface for TRUS imaging, not to interpret images or assist human interpretation in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device. Its "performance" is its physical characteristics and how it appears on TRUS, not an independent interpretation of data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical ground truth. The "ground truth" for the bench tests would be the measurement standards (e.g., ASTM F623-99) and the physical properties of the materials and design. For echogenicity, the "ground truth" is whether it effectively creates an acoustic interface in a phantom model.
8. The sample size for the training set
- Not applicable. There is no AI algorithm to train.
9. How the ground truth for the training set was established
- Not applicable. There is no AI algorithm requiring a training set with established ground truth.
Summary of the Study Proving Device Meets Acceptance Criteria:
The provided document describes a technical and bench testing study designed to demonstrate the substantial equivalence of the Lighthouse™ Urinary Catheter to legally marketed predicate devices. The "study" (series of tests) focused on:
- Sterilization and Shelf Life: Not detailed, but claims results demonstrated substantial equivalence.
- Biocompatibility: Not detailed, but claims results demonstrated substantial equivalence.
- Device Performance Specifications: Evaluated through:
- Visual Inspection: To confirm the device's physical appearance and integrity.
- Dimensional Analysis: To ensure the catheter's dimensions (e.g., 24F max OD for the UIB) meet design specifications and are comparable to predicates.
- ASTM F623-99: A standard for urological catheters, indicating testing against established physical performance requirements (e.g., balloon inflation, flow rates).
- Echogenicity Testing in a Phantom Model: This is the most "performance-oriented" test related to its unique feature. It demonstrated the catheter's ability to create an acoustic interface for TRUS imaging in a simulated environment.
The conclusion of the submission is that these bench tests, along with the device's design and intended use, establish its substantial equivalence to the predicate devices, not that it met specific quantitative diagnostic performance criteria in a clinical setting with human data. The submission asserts that the risks are outweighed by benefits and do not raise new questions of safety and effectiveness, based on comparison to existing devices and the nature of the bench tests.
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510(k) SUMMARY
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| Life • Science • Ventures • LLC230 East 15th Street, Suite 1-ANew 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: | ken@seedlings.net |
| 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 CatheterManufacturer:FDA 510(k) number:Classification Code: | Seedlings Life Science Ventures, LLCK13165578 EZL |
| (2) BeamCath, Urological Catheter Patient Positioning DeviceManufacturer: | Beampoint AB |
| FDA 510(k) number: | K042110 |
| Classification Code: | 78 EZL |
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| K140099 | |
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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™(Seedlings) | Lighthouse™(Seedlings) | BeamCath™(Beampoint) |
|---|---|---|---|
| 510(k) number | K140099 | K131655 | K042110 |
| Intended Use | The Lighthouse™ UrinaryCatheter is intended forbladder/urinary tract drainageduring prostate biopsy andbrachytherapy procedureswhere transrectal ultrasound(TRUS) imaging is used tovisualize the prostate. Thecatheter additionally enhancesidentification of the course ofthe posterior aspect of theprostatic urethra during TRUS-guided prostate biopsy andbrachytherapy procedures bycreating an acoustic interface(i.e., air) between the catheterand the urethral wall via itsurethral identification bladder. | The Lighthouse™ UrinaryCatheter is intended forbladder/urinary tractdrainage during prostatebrachytherapy procedureswhere transrectalultrasound (TRUS) imagingis used to visualize theprostate. The catheteradditionally enhancesidentification of the courseof the posterior aspect ofthe prostatic urethraduring TRUS-guidedbrachytherapy by creatingan acoustic interface (i.e.,air) between the catheterand the urethral wall via itsurethral identificationbladder. | The BeamCath is apositioning device usedwith external beamconformal radiationtherapy for visualizingthe prostate positionduring treatment ofprostate cancer. TheBeamCath is introducedinto the urethra as asterile urologicalcatheter and is retainedin place by inflating theballoon tip. Itsradiopaque markers aidin radiographicvisualization of theprostate position forplanning, simulationand treatment ofprostate cancer usingdose escalationradiotherapy |
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™(Seedlings) | Lighthouse™(Seedlings) | BeamCath(Beampoint) |
|---|---|---|---|
| 510(k) number | K140099 | K131655S | K042110 |
| Design | Urological catheter with Foleyballoon & echogenic 24Fr air-filled bladder | Urological catheter withFoley balloon & echogenic24Fr air-filled bladder | 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 | 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 (800) 638-2041 or (301) 796-7100 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.
§ 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.