(151 days)
Not Found
No
The summary describes a physical medical device (a catheter) that uses an air-filled bladder to enhance ultrasound visibility. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a urinary catheter intended for bladder/urinary tract drainage and to enhance visualization during prostate brachytherapy. It does not actively treat a disease or condition, but rather aids in a medical procedure.
No
The device is a urinary catheter designed for drainage and as an acoustic interface to enhance visualization of the prostatic urethra during TRUS-guided brachytherapy. It does not perform a diagnostic function itself, but rather aids in the visualization for diagnostic or therapeutic procedures.
No
The device description clearly details a physical, multi-lumen Foley catheter with a specific design for creating an acoustic interface using air, which is a hardware component. The performance studies also focus on bench tests related to the physical properties and performance of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Lighthouse™ Urinary Catheter is a physical device inserted into the body for drainage and to enhance visualization during a medical procedure (prostate brachytherapy). It does not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use is for bladder/urinary tract drainage and to aid in the visualization of the prostatic urethra during a procedure. This is a procedural aid, not a diagnostic test.
- Device Description: The description details the physical structure and function of the catheter, not a method for analyzing biological samples.
- Performance Studies: The performance studies described are bench tests related to the physical properties and functionality of the catheter (sterilization, biocompatibility, dimensions, echogenicity in a phantom model), not studies evaluating the accuracy of a diagnostic test on biological samples.
Therefore, the Lighthouse™ Urinary Catheter falls under the category of a medical device used in a procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
EZL, FGI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Transrectal Ultrasound (TRUS)
Anatomical Site
prostate, urethra, urinary bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
- ASTM F623-99 C.
- d. Echogenicity Testing in a Phantom Model
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Catheter | ||
| Manufacturer: | ||
| FDA 510(k) number: | ||
| Classification Code: | Fortune Medical Instrument Corp. | |
| K980919 | ||
| 78 EZL | ||
| (2) BeamCath, Urological Catheter Patient Positioning Device | ||
| Manufacturer: | ||
| FDA 510(k) number: | ||
| Classification Code: | Beampoint AB | |
| K042110 | ||
| 78 EZL |
1
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 Foley
Catheter (Fortune) | BeamCath
(Beampoint) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBA | K980919 | K042110 |
| 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 Silicone Foley Balloon
Catheters and Nelation
Catheter are intended for
use as urinary catheters to
pass fluids to and from the
urinary bladder. | The BeamCath is a
positioning device used
with external beam
conformal radiation
therapy for visualizing the
prostate position during
treatment of prostate
cancer. The BeamCath is
introduced into the urethra
as a sterile urological
catheter and is retained in
place by inflating the
balloon tip. Its radiopaque
markers aid in radiographic
visualization of the
prostate position for
planning, simulation and
treatment of prostate
cancer using dose
escalation radiotherapy |
2
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™
(Seedlings) | All Silicone Foley
Catheter (Fortune) | BeamCath
(Beampoint) |
|----------------------|-----------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------|
| Design | Urological catheter with Foley
balloon & echogenic 20Fr - 24Fr
air-filled bladder | Urological catheter with
Foley balloon | Urological catheter
with Foley balloon &
tantalum radiopaque
markers |
| Materials | Biocompatible silicone | Biocompatible silicone | PVC shaft & latex
balloon |
| Sterile, Patient Use | Sterile, Single-patient use | Sterile, Single-patient use | Sterile, Single-patient
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.
3
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
4
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
5
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