(434 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard urethral catheter, with no mention of AI or ML capabilities.
Yes
The device is described as being used for "clean intermittent catheterization-CIC treatment" for patients with "chronic urine retention" and is inserted to "empty the bladder," indicating a direct therapeutic action to manage a medical condition.
No
The device is a urethral catheter used to drain urine from the bladder in patients with chronic urine retention. It is a therapeutic device, not a diagnostic one.
No
The device description clearly indicates it is a physical, disposable catheter made of PVC with a hydrophilic coating, and includes a water sachet and connectors. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the urethra for emptying the bladder." This describes a procedure performed directly on the patient to drain urine, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: The description details a physical device (a catheter) used for a physical procedure (inserting it into the urethra to drain the bladder). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in samples
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The testing described (bench testing, biocompatibility) is typical for a medical device that comes into contact with the body, not for an IVD which focuses on the performance of the diagnostic test itself.
Therefore, the Well Lead PVC Hydrophilic Urethral Catheter is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 urethra for emptying the bladder.
Product codes
EZD
Device Description
The device is a urethral catheter used for intermittent catheterization. The device is a flexible single use urinary catheter inserted through the urethra to drain the bladder. The device is a disposable polyvinyl chloride (PVC) catheter coated with a hydrophilic coating (polyacrylamide) and an optional water sachet is included, which can activate the lubricant coating on the PVC. The device is generally for use in professional medical facilities and home environments.
The catheters come in sizes from 6Fr – 22Fr for the Male Model, 6Fr – 22Fr for the Female Model and 10Fr – 22Fr for the Tiemann Model. The catheter can connect to two different shapes of connector (called connector I and connector II) provided with the device. The connector enables the catheter to be connected to a urine bag or other collection apparatus. Urine can also be drained directly into the toilet.
The catheter is intended to be used for less than 24 hours based on the biocompatibility information provided. It is expected that patients will use a new intermittent catheter multiple times a day (each time urine needs to be drained).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
Indicated Patient Age Range
The sizes 6-10 Fr are indicated for pediatric patients. Adult sizes are also listed.
Intended User / Care Setting
professional medical facilities and home environments.
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
PVC Hydrophilic Urethral Catheter has been evaluated for safety and performance by lab bench testing as follows:
- ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within A Risk Management Process
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation;
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity;
- ISO 10993-18: 2020, "Biological Evaluation of Medical Devices -Part 18: Chemical characterization of medical device materials within a risk management process"
- Surface finish
- Outer diameter
- Catheter length
- Strength
- Connector security
- Flow rate
- Kink stability
- Peak tensile force
- Coefficient of Friction
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and biocompatibility testing was conducted to show that the device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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May 22, 2023
Well Lead Medical Co., Ltd. Jenny Zhu RA Specialist No. 47 Guomao Avenue South, Hualong, Panyu Guangzhou, Guangdong 511434 China
Re: K220722
Trade/Device Name: Wellead® PVC Hydrophilic Urethral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: April 21, 2022 Received: April 24, 2022
Dear Jenny Zhu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica K. Nguyen -S
Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220722
Device Name Wellead® PVC Hydrophilic Urethral Catheter
Indications for Use (Describe)
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 urethra for emptying the bladder.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summarv
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- 510(k) Owner's Name: Well Lead Medical Co., Ltd. �
- Address: No.47, Guomao Avenue South, Hualong, Panyu, Guangzhou, China � 511434
- Tel: 86 20 8475 8878-8628 �
- Contact Person (including title): Miss. Zhiqin Liang (RA Specialist); Ms. Jenny Zhu � (RA Supervisor)
- � E-mail: liangzhigin@welllead.com.cn ; jenny zhu@welllead.com.cn
2. Subject Device Information
- Type of 510(k) submission: Traditional �
- � Common Name: Urethral Catheter
- � Trade Name: Wellead® PVC Hydrophilic Urethral Catheter
- � Device: Catheter, Urological
- Requlation Name: Urological catheter and accessories �
- � Regulation Medical Specialty: Gastroenterology/Urology
- Review Panel: Gastroenterology/Urology �
- Product Code: EZD �
- Regulation Number: 876.5130 �
- Regulation Class: 2 �
4
| Predicate Device | Reference Device | |
|---|---|---|
| Sponsor | WELL LEAD MEDICAL CO. | |
| LTD | OASIS MEDIKAL URUNLER | |
| KIMYA SANAYI VE TIC A.S. | ||
| Device | ||
| Name | Well Lead PVC Hydrophilic | |
| Urethral Catheter | Urinary Catheter for | |
| Intermittent Use | ||
| 510(k) | ||
| Number | K133615 | K062444 |
| Product | ||
| Code | EZD | EZD |
| Regulation | ||
| Number | 876.5130 | 876.5130 |
| Regulation | ||
| Class | 2 | 2 |
3. Predicate Device and Reference Device Information
The predicate device has not been subject to a design related recall.
4. Device Description
The device is a urethral catheter used for intermittent catheterization. The device is a flexible single use urinary catheter inserted through the urethra to drain the bladder. The device is a disposable polyvinyl chloride (PVC) catheter coated with a hydrophilic coating (polyacrylamide) and an optional water sachet is included, which can activate the lubricant coating on the PVC. The device is generally for use in professional medical facilities and home environments.
The catheters come in sizes from 6Fr – 22Fr for the Male Model, 6Fr – 22Fr for the Female Model and 10Fr – 22Fr for the Tiemann Model. The catheter can connect to two different shapes of connector (called connector I and connector II) provided with the device. The connector enables the catheter to be connected to a urine bag or other collection apparatus. Urine can also be drained directly into the toilet.
The catheter is intended to be used for less than 24 hours based on the biocompatibility
5
information provided. It is expected that patients will use a new intermittent catheter multiple times a day (each time urine needs to be drained).
5. Indications for 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.
6. Test Summary
PVC Hydrophilic Urethral Catheter has been evaluated for safety and performance by lab bench testing as follows:
- ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical � Packaging by Dye Penetration
- � ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
- � ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems � for Medical Devices
- ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation and � Testing Within A Risk Management Process
- � ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for � irritation and skin sensitization
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for � irritation;
- ♦ ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity;
6
- ISO 10993-18: 2020, "Biological Evaluation of Medical Devices -Part 18: Chemical � characterization of medical device materials within a risk management process"
- � Surface finish
- Outer diameter �
- � Catheter length
- � Strength
- Connector security �
- Flow rate �
- Kink stability �
- Peak tensile force �
- � Coefficient of Friction
| Elements of
| Comparison | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| Device Name | ||||
| and Model | Well Lead PVC | |||
| Hydrophilic | ||||
| Urethral | ||||
| Catheter | Well Lead PVC | |||
| Hydrophilic Urethral | ||||
| Catheter | Urinary Catheter for | |||
| Intermittent Use | -- | |||
| 510 (K) | ||||
| Number | K220722 | K133615 | K062444 | -- |
| Regulation | ||||
| number | 21 CFR | |||
| 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | SE | |
| Regulation | ||||
| description | Urological | |||
| Catheter and | ||||
| Accessories | Urological Catheter | |||
| and Accessories | Urological Catheter | |||
| and Accessories | SE | |||
| Product code | EZD | EZD | EZD | SE |
| Class | II | II | II | SE |
| Indication for | ||||
| Use | The Well Lead | |||
| PVC Hydrophilic | ||||
| Urethral | ||||
| Catheter is | ||||
| launched for | ||||
| clean | ||||
| intermittent | The Well Lead PVC | |||
| Hydrophilic Urethral | ||||
| Catheter is | ||||
| launched for clean | ||||
| intermittent | ||||
| catheterization-CIC | ||||
| treatment and | Hi-Slip, Hi-Slip Plus | |||
| and Hi-Slip Kit are | ||||
| all launched for | ||||
| Clean Intermittent | ||||
| Catheterization-CIC | ||||
| treatment and | ||||
| indicated for use by | SE | |||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Reference Device | Remark |
| 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. | indicated for use by | |||
| patients with | ||||
| chronic urine | ||||
| retention. The | ||||
| catheter is inserted | ||||
| into the bladder | ||||
| through the urethra | ||||
| for emptying the | ||||
| bladder. | patients with | |||
| chronic urine | ||||
| retention. The | ||||
| catheter is inserted | ||||
| into the bladder | ||||
| through the urethra | ||||
| for emptying the | ||||
| bladder | ||||
| Prescription | ||||
| use | Yes | Yes | Yes | SE |
| Sterility | Sterile | Sterile | Sterile | SE |
| Sterilization | ||||
| Method | Water sachet is | |||
| irradiation | ||||
| sterilized, and | ||||
| the final product | ||||
| is EO sterilized. | EO sterilized | EO sterilized | SE | |
| Note 1 | ||||
| Use | Single Use | Single Use | Single Use | SE |
| Type and Size | Standard | |||
| Pediatric (6Fr, | ||||
| 8Fr, 10Fr) | ||||
| Adult (12Fr, | ||||
| 14Fr, 16Fr, | ||||
| 18Fr, 20Fr, | ||||
| 22Fr) | Male (12Fr, 14Fr, | |||
| 16Fr, 18Fr, 20Fr, | ||||
| 22Fr, 24Fr) | Hi-Slip (urinary | |||
| catheter) | ||||
| (Male 40 cm, | ||||
| CH08-24; | ||||
| Female 20 cm, | ||||
| CH08-18; | ||||
| Boys/Pediatric 30 | ||||
| cm, CH06-10; | ||||
| Girls/Pediatric 20 | ||||
| cm, CH06-10, | ||||
| Tiemann 40 cm, | ||||
| CH10-18) | SE | |||
| Note 2 | ||||
| Female | ||||
| Pediatric (6Fr, | ||||
| 8Fr, 10Fr) | ||||
| Adult (12 Fr, 14 | ||||
| Fr, 16Fr, 18Fr, | ||||
| 20 Fr, 22Fr) | Female (12Fr, | |||
| 14Fr, 16Fr, 18Fr, | ||||
| 20Fr, 22Fr, 24Fr) | Hi-Slip Plus | |||
| (urinary catheter | ||||
| and water sachet) | ||||
| (Male 40 cm, | ||||
| CH08-24; | ||||
| Female 20 cm, | ||||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Reference Device | Remark |
| CH08-18; | ||||
| Boys/Pediatric 30 | ||||
| cm, H06-10; | ||||
| Girls/Pediatric 20 | ||||
| cm, CH06-10) | ||||
| Pediatric (6Fr, 8Fr, | ||||
| 10Fr) | Hi-Slip Kit (urinary | |||
| catheter, water | ||||
| sachet, Urine bag | ||||
| and Iodine swab) | ||||
| Tiemann (10Fr, | ||||
| 12 Fr, 14Fr, | ||||
| 16Fr, 18Fr, | ||||
| 20Fr, 22Fr) | Tiemann (6Fr, 8Fr, | |||
| 10Fr, 12Fr, 14Fr, | ||||
| 16Fr, 18Fr, 20Fr, | ||||
| 22Fr, 24Fr) | (Male 08-18CH; | |||
| Female CH08- | ||||
| 16CH; | ||||
| Pediatric Girls 06- | ||||
| 10 CH; | ||||
| Pediatric Boys 06- | ||||
| 10 CH; | ||||
| Tiemann 10-18 CH) | ||||
| Catheter | ||||
| Materials | Polyvinylchloride | |||
| catheter coated | ||||
| with | ||||
| polyacrylamide | Polyvinylchloride | |||
| catheter coated | ||||
| with | ||||
| polyvinylpyrrolidone | Polyvinyl chloride | |||
| catheter coated | ||||
| with | ||||
| polyvinylpyrrolidone | SE | |||
| Note 3 | ||||
| Components | Water sachet | None | Water sachet | |
| Urine bag | ||||
| Iodine swab | SE | |||
| Note 4 |
7. Substantial Equivalence Discussion
7
8
Comparison in Detail(s):
Note 1:
The terminal sterilization method of the subject device is EO Sterilization, just like the predicate device according to standard ISO 11135:2014 and has a sterility assurance level (SAL) of 10^-6. The water sachet is sterilized through radiation prior to final assembly.
Note 2:
9
The subject device adds - 6, 8, and 10 Fr- for the Male and Female catheter. The predicate device also has 6, 8, and 10 Fr. The reference device covers the 8-10 Fr Male and Female catheters, as well as the Tiemann tips. FDA has cleared 6Fr catheters in previous submissions, so it does not present different questions of safety and effectiveness. The sizes 6-10 Fr are indicated for pediatric patients, just like the predicate device.
Note 3:
The hydrophilic coating of subject device is polyacrylamide (PAM), while the predicate device is polyvinylpyrrolidone (PVP). Performance and biocompatibility testing was conducted to show that the device is substantially equivalent to the predicate device.
Note 4:
The subject device has an optional water sachet accessory. The water can lubricate the PVC catheter which has hydrophilic-coating, so it is easier for the catheter to pass through the urethra during urinary catheterization and into the bladder to drain urine. The water sachet of subject device are same as the Hi-Slip Plus Type (the reference device). The water sachet are sterilized via radiation. There are no different questions of safety or effectiveness raised.
Final Conclusion:
The technological characteristics and indication for use of the Wellead PVC Hydrophilic Urethral Catheter is substantially equivalent to the predicate device. The differences between the subject device and predicate devices do not raise different questions of safety or effectiveness.