(272 days)
Not Found
No
The summary describes a physical medical device (Foley catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device, a Foley catheter, is used for urine drainage and collection, which are management functions rather than direct therapeutic treatments for a disease or condition.
No
The device is a Foley catheter used for urine drainage and bladder management, not for diagnosing medical conditions.
No
The device description clearly states it is a physical catheter made from silicone with a hydrophilic coating, and the performance studies focus on physical properties and biocompatibility.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "bladder management including urine drainage, collection and measurement." This is a direct interaction with the patient's body for a therapeutic or management purpose.
- Device Description: The description details a physical catheter inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside of the body to diagnose a condition, monitor a disease, or screen for a condition. IVDs typically involve reagents, analyzers, or test kits used on biological specimens like blood, urine, or tissue.
This device is a medical device used for a clinical procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Well Lead Hydrophilic Silicone Foley Catheter is intended for use for bladder management including urine drainage, collection and measurement. The Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine. The Three-way Catheter provides a lumen that is used for bladder irrigation.
Product codes
EZL
Device Description
The Well Lead Hydrophilic Silicone Foley Catheter is sterile, single patient use, urinary drainage catheter that is made from silicone and with a hydrophilic coating. The Catheter is available in two types, Two-way and Three-way Silicone Foley Catheter, it is supplied in French size ranging from 6 to 26 and balloon size 1.5cc to 30cc. The 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bladder, urethra
Indicated Patient Age Range
The 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.
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
The Well Lead Hydrophilic Silicone Foley Catheters meet the following performance requirements per testing conducted according to ASTM F623-99, when appropriate, and/or Well Lead testing/ accepatance criteria:
- Flow Rate Through Drainage Lumen
- Balloon Integrity (Resistance to Rupture)
- Inflated Balloon Response to Pullout
- Balloon Volume Maintenance
- Balloon Size and Shaft Size
- Deflation Reliability (Failure to Deflate)
- Coefficients of Friction
Testing on aged product indicates that application of the coating has no adverse effect on the base material of the shaft or balloon. The Well Lead Hydrophilic Silicone Foley Catheter passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Implantation, Irritation, Sensitization, Systemic Toxicity)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Well Lead Hydrophilic Silicone Foley Catheters meet the following performance requirements per testing conducted according to ASTM F623-99, when appropriate, and/or Well Lead testing/ accepatance criteria:
- Flow Rate Through Drainage Lumen
- Balloon Integrity (Resistance to Rupture)
- Inflated Balloon Response to Pullout
- Balloon Volume Maintenance
- Balloon Size and Shaft Size
- Deflation Reliability (Failure to Deflate)
- Coefficients of Friction
Testing on aged product indicates that application of the coating has no adverse effect on the base material of the shaft or balloon. The Well Lead Hydrophilic Silicone Foley Catheter passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Implantation, Irritation, Sensitization, Systemic Toxicity)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2014
Well Lead Medical Co LTD Han Guang Yuan General Manager C-4* Jinhu Industrial Estate, Hualon, Panyu Guangzhou, 511434 P.R. China
Re: K140667
Trade/Device Name: Well Lead Hydrophilic Silicone Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: EZL
Dear Han Guang Yuan,
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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,
Benjamin R. Fisher -A
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
2
510(k) Number (if known): K140667
Device Name: Well Lead Hydrophilic Silicone Foley Catheter
Indications for Use:
The Well Lead Hydrophilic Silicone Foley Catheter is intended for use for bladder management including urine drainage, collection and measurement. The Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine. The Three-way Catheter provides a lumen that is used for bladder irrigation.
Prescription Use _ × (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 2014/03/14 |
|---|---|
| Submitter: | WELL LEAD MEDICAL CO., LTD. |
| Address:C-4 # Jinhu Industrial Estate, Hualong, Panyu, | |
| Guangzhou, 511434, P.R. China | |
| Contact Person: | Han Guang Yuan |
| General Manager | |
| WELL LEAD MEDICAL CO., LTD. | |
| Email: huangkg@welllead.com.cn | |
| Tel: +86-20-84758878 | |
| Fax:+86-20-84758224 | |
| Device Name: | |
| Regulation Number: | |
| Classification Name: | |
| Product Code: | |
| Regulatory Class: | Well Lead Hydrophilic Silicone Foley Catheter |
| 876.5130 | |
| Urological catheter and accessories | |
| EZL | |
| Class II | |
| Device Description: | The Well Lead Hydrophilic Silicone Foley Catheter is sterile, |
| single patient use, urinary drainage catheter that is made | |
| from silicone and with a hydrophilic coating. The Catheter is | |
| available in two types, Two-way and Three-way Silicone | |
| Foley Catheter, it is supplied in French size ranging from 6 to | |
| 26 and balloon size 1.5cc to 30cc. The 6Fr, 8Fr and 10Fr | |
| catheters are for pediatric, and others are for adult. | |
| Intended Use: | The Well Lead Hydrophilic Silicone Foley Catheter is |
| intended for use for bladder management including urine | |
| drainage, collection and measurement. The Catheter is | |
| passed through the urethra during urinary catheterization | |
| and into the bladder to drain urine. The Three-way Catheter | |
| provides a lumen that is used for bladder irrigation. | |
| Predicate Device(s): | K984084- Bardex® Lubri-Sil™ Foley Catheter |
| K002868-Bardex® Lubri-SilTM 3-way Foley Catheter | |
| K070508-Bardex® Lubri-Sil® All-Silicone Lubricious Coated | |
| Foley Catheter 6Fr |
4
- Substantial Equivalence: The Well Lead Hydrophilic Silicone Foley Catheters described in this 510(k) have similar technological and performance characteristics to the predicate devices. The proposed device are manufactured from silicone and have a hydrophilic outer coating. The predicate devices are manufactured from similar materials such as silicone and have a lubricious hydrophilic coating. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 12 of this submission. differences have no effect on safety and These effectiveness, or raise different questions of safety and effectiveness.
Test Data: The Well Lead Hydrophilic Silicone Foley Catheters meet the following performance requirements per testing conducted according to ASTM F623-99, when appropriate, and/or Well Lead testing/ accepatance criteria:
NOTE: ASTM F623-99 is applicable only to 2-way catheters, however, the test methods described therein will be utilized to test 3-way catheters.
- · Flow Rate Through Drainage Lumen
- · Balloon Integrity (Resistance to Rupture)
- flated Balloon Response to Pullout
- · Balloon Volume Maintenance
- · Balloon Size and Shaft Size
- · Deflation Reliability (Failure to Deflate)
- Coefficients of Friction
Testing on aged product indicates that application of the coating has no adverse effect on the base material of the shaft or balloon.
The Well Lead Hydrophilic Silicone Foley Catheter passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Implantation, Irritation, Sensitization, Systemic Toxicity)
Testing datas and results are included in this submission.