(47 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and echogenicity of the catheter, with no mention of AI or ML for image analysis or other functions.
No
The device is intended for drainage and identification during procedures, which are supportive functions, not therapeutic treatment.
No
The device is a urinary catheter designed to facilitate bladder/urinary tract drainage and enhance the visualization of the prostatic urethra during prostate biopsy and brachytherapy procedures using TRUS imaging. Its primary function is therapeutic/interventional support and visualization enhancement, not diagnosing a medical condition.
No
The device description clearly details a physical catheter with multiple lumens and a bladder, indicating it is a hardware device, not software only.
Based on the provided information, the Lighthouse™ Urinary Catheter 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.
- Lighthouse Catheter Function: The Lighthouse catheter is a medical device inserted into the body (in vivo) for drainage and to enhance visualization during a medical procedure (prostate biopsy and brachytherapy). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a procedural aid for drainage and imaging, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the physical structure and function of the catheter within the body.
- Performance Studies: The performance studies described are bench tests related to the physical properties and functionality of the device, not analytical performance on biological samples.
Therefore, the Lighthouse™ Urinary Catheter falls under the category of a medical device used in a clinical 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 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.
Product codes (comma separated list FDA assigned to the subject device)
EZL, FGI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
transrectal ultrasound (TRUS)
Anatomical Site
bladder/urinary tract, prostate, prostatic urethra
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key results from data obtained:
- Visual Inspection
- Dimensional Analysis
- ASTM F623-99
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 0 4 2014 .
← ۶۰
510(k) SUMMARY
| K140099
| pg 1 of 3 |
|---|
| seedlings |
| Life • Science • Ventures • LLC |
| 230 East 15th Street, Suite 1-A |
| 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: | 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 Catheter | |
| Manufacturer: | |
| FDA 510(k) number: | |
| Classification Code: | Seedlings Life Science Ventures, LLC |
| K131655 | |
| 78 EZL | |
| (2) BeamCath, Urological Catheter Patient Positioning Device | |
| Manufacturer: | Beampoint AB |
| FDA 510(k) number: | K042110 |
| Classification Code: | 78 EZL |
.
:
·
:
/
1
| K140099 | |
|---|---|
| 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™
(Seedlings) | Lighthouse™
(Seedlings) | BeamCath™
(Beampoint) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K140099 | K131655 | K042110 |
| Intended 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. | 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 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 |
The Lighthouse is substantially equivalent to the following predicate devices: the Lighthouse Urinary Catheter (Seedlings Life Science Ventures) with its original
2
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 Foley
balloon & echogenic 24Fr air-
filled bladder | Urological catheter with
Foley balloon & echogenic
24Fr air-filled bladder | 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 | 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.
3
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.
4
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
5
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.