(272 days)
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.
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.
The provided text describes the 510(k) premarket notification for the "Well Lead Hydrophilic Silicone Foley Catheter." It details the device, its intended use, and substantial equivalence to predicate devices. Crucially, it outlines the performance requirements and testing conducted to demonstrate compliance.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow Rate Through Drainage Lumen | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Balloon Integrity (Resistance to Rupture) | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Inflated Balloon Response to Pullout | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Balloon Volume Maintenance | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Balloon Size and Shaft Size | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Deflation Reliability (Failure to Deflate) | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Coefficients of Friction | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Coating effect on base material after aging | Application of the coating has no adverse effect on the base material of the shaft or balloon. |
| Biocompatibility | Passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Implantation, Irritation, Sensitization, Systemic Toxicity). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the performance tests. It states that "Testing datas and results are included in this submission," but doesn't elaborate on the number of catheters tested for each criterion.
The data provenance is from Well Lead Medical Co. LTD (the manufacturer) and is part of their 510(k) submission to the FDA. It is prospective testing conducted by the manufacturer specifically to demonstrate compliance for their device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and testing. The acceptance criteria are based on objective physical and material properties, defined by industry standards (ASTM F623-99, ISO 10993-1) and the manufacturer's internal criteria, not on expert interpretations of medical images or conditions.
4. Adjudication method for the test set
This information is not applicable. The tests performed are objective, measurable physical properties, not subjective assessments requiring adjudication by multiple experts.
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
This information is not applicable. This device is a urological catheter, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance refers to the physical and material properties of the catheter itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by objective physical measurements and adherence to recognized industry standards.
- For performance criteria like "Flow Rate Through Drainage Lumen" or "Balloon Volume Maintenance," the ground truth is defined by the numerical specifications and limits set by ASTM F623-99 and/or Well Lead's internal acceptance criteria.
- For biocompatibility, the ground truth is determined by the results of specific assays as mandated by ISO 10993-1 (e.g., cell viability for cytotoxicity, inflammatory response for implantation, etc.).
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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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
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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
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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)
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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 YuanGeneral ManagerWELL LEAD MEDICAL CO., LTD.Email: huangkg@welllead.com.cnTel: +86-20-84758878Fax:+86-20-84758224 |
| Device Name:Regulation Number:Classification Name:Product Code:Regulatory Class: | Well Lead Hydrophilic Silicone Foley Catheter876.5130Urological catheter and accessoriesEZLClass II |
| Device Description: | The Well Lead Hydrophilic Silicone Foley Catheter is sterile,single patient use, urinary drainage catheter that is madefrom silicone and with a hydrophilic coating. The Catheter isavailable in two types, Two-way and Three-way SiliconeFoley Catheter, it is supplied in French size ranging from 6 to26 and balloon size 1.5cc to 30cc. The 6Fr, 8Fr and 10Frcatheters are for pediatric, and others are for adult. |
| Intended Use: | The Well Lead Hydrophilic Silicone Foley Catheter isintended for use for bladder management including urinedrainage, collection and measurement. The Catheter ispassed through the urethra during urinary catheterizationand into the bladder to drain urine. The Three-way Catheterprovides a lumen that is used for bladder irrigation. |
| Predicate Device(s): | K984084- Bardex® Lubri-Sil™ Foley CatheterK002868-Bardex® Lubri-SilTM 3-way Foley CatheterK070508-Bardex® Lubri-Sil® All-Silicone Lubricious CoatedFoley Catheter 6Fr |
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- 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.
§ 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.