(254 days)
No
The device description and performance studies focus on the physical properties and standard testing of a conventional Foley catheter, with no mention of AI or ML.
No
The device is used for drainage and irrigation, not for treating a disease or condition. While it assists in managing a bodily function, it does not directly provide therapy.
No
The device is described as being used for "routine urine drainage or for routine post-operative drainage and bladder irrigation," which are therapeutic or management functions, not diagnostic ones.
No
The device description clearly outlines physical components made of latex with silicone coating, such as a shaft, drainage funnel, inflation funnel, balloon, and valve. The performance studies also include biocompatibility and sterilization testing, which are relevant to physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "routine urine drainage or for routine post-operative drainage and bladder irrigation." This is a direct intervention on the body for therapeutic or management purposes.
- Device Description: The description details a physical device inserted into the body (catheter) to facilitate drainage.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for drainage.
N/A
Intended Use / Indications for Use
Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.
Product codes (comma separated list FDA assigned to the subject device)
EZL
Device Description
The Latex Foley Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of a shaft, a drainage funnel, an inflation funnel, an irrigation funnel (if present), a balloon and a valve. The device is made from latex with silicone coating and available in different types (e.g., straight, Tiemann, female etc.) and sizes for adult and pediatric use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder through urethra
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
Health care facilities
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)
- Biocompatibility testing according to ISO 10993-1:2018 Biological evaluation of medical . devices Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- The EO sterilization process was validated in accordance with ANSI/AAMI/ISO 11135:2014.
- The following bench performance testing were conducted per ASTM F623-19 and the FDA guidance document, 'Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway'-
- Flow Rate through Drainage Lumen
- Balloon Integrity (Resistance to Rupture)
- Inflated Balloon Response to Traction
- Balloon Volume Maintenance
- Balloon Size and Shaft Size
- Deflation Reliability (Failure to Deflate)
- For 6-10Fr. and 28-30 Fr. catheters, the bench performance testing was conducted per BS EN 1616:1997 as theses French sizes are outside of the scope of ASTM F623-19.
All pre-determined acceptance criteria were met.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
June 6, 2024
Well Lead Medical (Hainan) Co., Ltd. Irene Zhang RA Specialist No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park Haikou, Hainan 571157 CHINA
Re: K233094
Trade/Device Name: Wellead® Latex Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: May 8, 2024 Received: May 8, 2024
Dear Irene Zhang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Angel A. Soler-garcia -S
For. 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
3
Indications for Use
510(k) Number (if known) K233094
Device Name Wellead® Latex Foley Catheter
Indications for Use (Describe)
Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.
| 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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4
TRADITIONAL 510(K) SUMMARY
1. SUBMITTER INFORMATION
| Applicant | Well Lead Medical (Hainan) Co., Ltd,
No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park
571157, Haikou, Hainan, China, |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Ms. Jenny Zhu (RA Supervisor),
E-mail: jenny_zhu@welllead.com.cn
Miss. Irene Zhang (RA Specialist),
E-mail: zhangshanshan@welllead.com.cn |
| Date Prepared | June 04, 2024 |
2. DEVICE NAME
| Trade Name of the Device | Wellead® Latex Foley Catheter |
|---|---|
| Common Name: | Foley Catheter |
| Classification Name: | Urological Catheter and Accessories |
| Classification Regulation: | 21 CFR 876.5130 |
| Device Class: | II |
| Product Code: | EZL |
| Panel: | Gastroenterology/Urology |
Predicate device was not subjected to any design related recall.
4. DEVICE DESCRIPTION:
IDENTIFICATION
The Latex Foley Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of a shaft, a drainage funnel, an inflation funnel, an irrigation funnel (if present), a balloon and a valve. The device is made from latex with silicone coating and available in different types (e.g., straight, Tiemann, female etc.) and sizes for adult and pediatric use.
5
5. INDICATIONS FOR USE:
Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
| | K233094 (Subject
Catheter) | K082815 (Predicate
Device) | K071423(Reference) |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Well Lead Latex
Foley Catheter | Well Lead Latex Foley
Catheters | Medline Latex Foley
Catheter |
| Indication For
use | Latex Foley Catheter is
inserted into the bladder
through urethra and are
indicated for routine
urine drainage or for
routine post-operative
drainage and bladder
irrigation. | Two-Way Catheter
urethral catheterization for
bladder drainage for
urological use only.
Three-Way Catheter
urethral catheterization for
bladder drainage and
bladder irrigation for
Urological use only. | The Medline Latex Foley
Catheter is intended to be
used as a urological
catheter inserted through
the urethra for the
purpose of draining urine
and other fluids from the
urinary tract. |
| Device Type | 2-Way and 3-way
Foley Catheter | 2-Way and 3-way Foley
Catheter | 2-Way and 3-way
Foley Catheter |
| Catheter tube
Material | Latex | Latex | Latex |
| Catheter French
Size (Fr.) | 6-30Fr. | 6-30Fr. | 6-30Fr. |
| Catheter Shaft
Effective Length
(mm) | $180\pm25$ to $300\pm25$ | $180\pm25$ to $300\pm25$ | 240 to 380 |
| Balloon Volume | 3mL, 3-5mL, 5ml, 5-
10ml, 10ml, 5-15ml, 15ml,
15-30mL, 20ml, 30ml | 3ml, 5ml, 30ml | 3ml, 5ml, 30ml |
| Stylet | Present | None | Present |
| Catheter Tip | Straight and Coude | Straight | Straight and Coude |
| Duration of Use | less than 30 days | up to 30 days | Not provided |
| Use
environment | Health care facilities | Health care facilities | Health care facilities |
| Surface Coating | Silicon Coating | Silicon Coating | Silicon Elastomer |
| Sterile and
Single Use | Yes | Yes | Yes |
As evidenced by the above table, both the subject and the predicate devices have same intended use but differ in technological characteristics. Performance testing was conducted on the subject device, and it was established that the differences in technological characteristics do not raise different questions of safety or effectiveness.
6
7. SUMMARY OF NONCLINICAL TESTING:
The reference device was used to justify the Coude tip and the use of a stylet with the pediatric models of the subject catheter.
Below is a list of the tests that were performed and successfully completed for the subject device per the specified guidance and standards:
-
Biocompatibility testing according to ISO 10993-1:2018 Biological evaluation of medical . devices
-
Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
-
The EO sterilization process was validated in accordance with ANSI/AAMI/ISO 11135:2014.
-
. The following bench performance testing were conducted per ASTM F623-19 and the FDA guidance document, 'Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway'-
- O Flow Rate through Drainage Lumen
- Balloon Integrity (Resistance to Rupture) O
- Inflated Balloon Response to Traction O
- Balloon Volume Maintenance o
- Balloon Size and Shaft Size O
- Deflation Reliability (Failure to Deflate) O
-
· For 6-10Fr. and 28-30 Fr. catheters, the bench performance testing was conducted per BS EN 1616:1997 as theses French sizes are outside of the scope of ASTM F623-19.
All pre-determined acceptance criteria were met.
8. CONCLUSIONS
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate device.