(91 days)
The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
The Well Lead PVC Hydrophilic Urethral Catheter is a flexible tubular single use urinary catheter that is inserted through the urethra to allow drainage of the bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds it becomes slippery and ready to use.
The catheters come in sizes from 12Fr-24Fr for Male, 12Fr-24Fr for Female and 6Fr-10Fr for Pediatric.
The provided text describes the regulatory submission for the Well Lead PVC Hydrophilic Urethral Catheter. However, it does not contain information about a study comparing the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop system. The document is primarily a 510(k) summary demonstrating substantial equivalence to a predicate device for a medical catheter, focusing on non-clinical performance and biocompatibility.
Therefore, many of the requested categories related to AI models, clinical studies, ground truth establishment, and expert involvement are not applicable to the provided information.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests with the standard they were tested to and the result ("Complies"). These can be considered the acceptance criteria for those specific physical and material properties.
| Acceptance Criteria (Test Performed) | Standard Tested To | Reported Device Performance (Result) |
|---|---|---|
| Tensile Seal Strength Test | ISO 11607 | Complies |
| Impermeability and Continuity of Seals formed by fusion test | ISO 11607 | Complies |
| Vacuum Leak Test | ISO 11607 | Complies |
| Agar contact-attack test | ISO 11607 | Complies |
| Analysis of Flow Rate | EN1616:1997/A1:1999 | Complies |
| Analysis of Strength of the Catheter | EN1616:1997/A1:1999 | Complies |
| Analysis of Connector Security | EN1616:1997/A1:1999 | Complies |
| Analysis of Coefficients of Friction | EN1616:1997/A1:1999 | Complies |
| Sterility Assurance Level | ISO 11135-1 | SAL 10^-6^* |
| Ethylene oxide residual | EN ISO 10993 part 7 | Complies (within 4mg/day for ETO and 9mg/day for ECH)* |
| Shelf life | Accelerated aging | 5 years |
| In Vitro Cytotoxicity | ISO 10993-5:2009 and ISO 10993-12:2012 | Performed (implies compliance for approval)* |
| Delayed Contact Sensitization Study | ISO 10993-10:2010 and ISO 10993-12:2012 | Performed (implies compliance for approval)* |
| Penile Irritation Test | ISO 10993-10:2010 and ISO 10993-12:2012 | Performed (implies compliance for approval)* |
*Note: For sterility, ETO residual, and biocompatibility, the document states the validation method or that the tests were performed, which implies the results met the criteria for approval, even if the exact "Complies" is not explicitly stated in the table for every test as it is for others.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For the non-clinical performance testing (Flow Rate, Strength, Connector Security, Coefficients of Friction), testing was completed on 3 different size catheters: 8Fr (pediatric size), 14Fr, and 24Fr. The document doesn't specify the number of units per size.
For other tests like packaging and biocompatibility, the sample size is not explicitly stated.
The data provenance (country of origin, retrospective/prospective) is not mentioned for these tests. This is a medical device submission, not a clinical trial or AI study, so standard data provenance details for patient data are not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document is about the physical and chemical properties of a medical device, not an AI model requiring expert-established ground truth from images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI model evaluation study involving human adjudication of results.
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
Not applicable. This document does not describe an AI device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document does not describe an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the standards (e.g., ISO 11607, EN1616) they were tested against. The physical and chemical properties of the catheter (e.g., flow rate, strength, seal integrity, biocompatibility) are measured against these established engineering and biological safety standards.
8. The sample size for the training set
Not applicable. This document does not describe an AI model with a training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI model.
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510(k) SUMMARY (as required by 807.92)
FEB 2 4 2014
| Regulatory Correspondent: | AJW Technology Consultants, Inc.445 Apollo Beach Blvd.Apollo Beach, FL 33572 USAJohn O'BrienEmail: jobrien@ajwtech.com |
|---|---|
| Submitter of 510(k): | WELL LEAD MEDICAL CO. LTDC-4 JINHU INDUSTRIAL ESTATE, HUALONG,PAN YUGUANGZHOU, 511434, CHINAHan Guang YuanEmail: info@welllead.com.cnPhone: 86-20-84758878Fax: 86-20-84758224 |
| Date of Summary: | 10/18/2013 |
| Trade/Proprietary Name: | Well Lead PVC Hydrophilic Urethral Catheter |
| Common/Usual Name: | Catheter, Straight |
| Classification Name: | Class II |
| Product Code: | EZD |
Intended Use:
The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
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Device Description:
The Well Lead PVC Hydrophilic Urethral Catheter is a flexible tubular single use urinary catheter that is inserted through the urethra to allow drainage of the bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds it becomes slippery and ready to use.
The catheters come in sizes from 12Fr-24Fr for Male, 12Fr-24Fr for Female and 6Fr-10Fr for Pediatric.
Sizes 6Fr - 10Fr are for Children ages 2 years old to less than 12 years old, Sizes 12Fr -24Fr are for 12 years old and over.
| Predicate Device: | K062444 – Hi-Slip Single Use Hydrophilic UrinaryCatheter. |
|---|---|
| ------------------- | --------------------------------------------------------------- |
Substantial Equivalence:
The Well Lead PVC Hydrophilic Urethral Catheters are substantially equivalent in intended use and technological characteristics to the HI-Slop Single Use Hydrophilic Urethral Catheters. Any difference that exists between the Well Lead PVC Hydrophilic Urethral Catheters and the predicate device do not affect safety or effectiveness, or raise different questions of safety and effectiveness.
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| ComparisonElements | Applicant Device | Predicate Device |
| 510k Number | K062444 | |
| Device Name | Well Lead PVC Hydrophilic UrethralCatheters | Hi-Slip Single UseHydrophilic Urinary Catheter |
| Technical Data | ||
| Device Composition | Polyvinyl Chloride catheter coated withpolyvinyl pyrrolidone | Polyvinyl Chloride cathetercoated with polyvinylpyrrolidone |
| Sizes | Male (12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr,24Fr) | Male 40cm, CH08-24 |
| Female (12Fr, 14Fr. 16Fr. 18Fr. 20Fr, 22Fr.24Fr) | Female 20cm, CH08-18 | |
| Pediatric (6Fr, 8Fr, 10Fr) | Boys/Pediatric 30cm, CH06-10 | |
| Tiemann (6Fr-24Fr) | Girls/Pediatric 20cm, CH06-10Tiemann 40cm, CH10-18 | |
| Design Features | Single lumen shaft, multi-port adaptor, 1cuff | Double lumen shaft, multi-port adaptor, 1 cuff |
| Function of the Device | Intermittent Catheterization | Intermittent Catheterization |
| Features of the device | Hydrophilic Coated, slippery surface. Lowfriction between catheter and urethralmucosa | Hydrophilic Coated, slipperysurface. Low friction betweencatheter and urethral mucosa |
| Sterility | EO | EO |
| Packaging | Peel Pack | Peel Pack |
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Sterilization and Shelf-Life
Sterilization was completed using the ethylene oxide process. The validation was completed according to ISO 11135-1. The sterility assurance level is SAL 106. Ethylene oxide residual is validated according to EN ISO 10993 part 7 for Limited Exposure Devices of 4mg/day for ETO and 9mg/day for ECH.
The packaging material complies with requirements of ISO 11607-1. sealing validation per ISO 11607-2 and GHTF-SG3-N99-10:2004. Accelerated aging was completed to validate a shelf life of 5 years.
| Packaging Testing | |||
|---|---|---|---|
| Test Performed | Standard Tested to | Result | |
| Tensile Seal Strength Test | ISO 11607 | Complies | |
| Impermeability and Continuity ofSeals formed by fusion test | ISO 11607 | Complies | |
| Vacuum Leak Test | ISO 11607 | Complies | |
| Agar contact-attack test | ISO 11607 | Complies |
Performance /Non-Clinical Testing:
| Non-Clinical Testing | ||
|---|---|---|
| Test Performed | Standard Tested to | Result |
| Analysis of Flow Rate | EN1616:1997/A1:1999 | Complies |
| Analysis of Strength of theCatheter | EN1616:1997/A1:1999 | Complies |
| Analysis of Connector Security | EN1616:1997/A1:1999 | Complies |
| Analysis of Coefficients ofFriction | EN1616:1997/A1:1999 | Complies |
Testing was completed on 3 different size catheters, 8Fr (pediatric size), 14Fr and 24Fr, based on the data generated from the testing on it can be concluded that the Well Lead PVC Hydrophilic Urethral Catheters are substantially equivalent to the Hi-Slip Single Use Hydrophilic Urinary Catheters.
Biocompatibility Testing:
Based on ISO 10993-1:2009 Annex A Table A.I - Well Lead PVC Hydrophilic Urethrai Catheters Category is considered a Surface Device that comes in contact with the Mucosal Membrane at for limited exposure. The following tests were performed:
In Vitro Cytotoxicity - ISO 10993-5:2009 and ISO 10993-12:2012 Delayed Contact Sensitization Study - ISO 10993-10:2010 and ISO 10993-12:2012 Penile Irritation Test -- ISO 10993-10:2010 and ISO 10993-12:2012
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2014
Well Lead Medical CO., LTD. % John O'Brien Consultant Level I AJW Technology Consultants, Inc. 445 Apollo Beach Blvd. Apollo Beach, FL 33572
Re: K133615
Trade/Device Name: Well Lead PVC Hydrophilic Urethral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: January 27, 2014 Received: January 31, 2014
Dear John O'Brien,
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 - John O'Brien
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 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/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 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.
Herbert P. Lerner -S
for 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
510(k) Number (if known): K133615
Device Name: Well Lead PVC Hydrophilic Urethral Catheter
Indications for use:
The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization -ClC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
2014.02.24 14:52:33 -05'00'
Page 1 Of 1
K 133615 - PVC Hydrophilic Urethral Catheter - Supplementary Response 1
§ 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.