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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device: the Wellead® Latex Foley Catheter. It is not an AI/ML device, therefore, the information requested in your prompt regarding AI/ML acceptance criteria and studies (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance) is not applicable.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K082815, also a Well Lead Latex Foley Catheter) through nonclinical testing.

Here's an analysis of the provided text in the context of your request, highlighting what is and isn't present:

Not Applicable for this document: The device in question is a physical medical device (Foley catheter), not an AI/ML software or a device that uses AI/ML. Therefore, criteria and studies related to AI/ML device performance (like the number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details, or effect size of AI assistance) are not found in this type of 510(k) submission.

Here's what can be extracted from the document regarding acceptance criteria and performance for this physical device:

1. Acceptance Criteria and Reported Device Performance

The document states that all pre-determined acceptance criteria were met for the nonclinical tests. While specific numerical acceptance criteria (e.g., "flow rate must be >X mL/min") are not explicitly listed in this summary, the types of tests conducted and their successful completion imply meeting such criteria.

Acceptance Criterion (Implied by Test)	Reported Device Performance
Biocompatibility (ISO 10993-1:2018)	Met (successfully completed)
EO Sterilization (ANSI/AAMI/ISO 11135:2014)	Validated (successfully completed)
Flow Rate through Drainage Lumen (ASTM F623-19 / BS EN 1616:1997)	Met (successfully completed)
Balloon Integrity (Resistance to Rupture) (ASTM F623-19)	Met (successfully completed)
Inflated Balloon Response to Traction (ASTM F623-19)	Met (successfully completed)
Balloon Volume Maintenance (ASTM F623-19)	Met (successfully completed)
Balloon Size and Shaft Size (ASTM F623-19)	Met (successfully completed)
Deflation Reliability (Failure to Deflate) (ASTM F623-19)	Met (successfully completed)
Performance for 6-10Fr. and 28-30 Fr. catheters (BS EN 1616:1997)	Met (successfully completed)

Note: The document only states that the acceptance criteria were "met" for all tests. It does not provide the specific numerical results or the exact numerical thresholds for each acceptance criterion. This is typical for a 510(k) summary, as detailed test reports are part of the full submission but not usually included in the public summary.

2. Sample Size Used for the Test Set and Data Provenance

The document describes nonclinical bench testing. It does not specify sample sizes for these tests, nor does it refer to "test sets" in the context of patient data for AI/ML validation.

Test Set Sample Size: Not specified. (The tests are done on physical catheter samples, not on a dataset of patient images/records.)
Data Provenance: Not applicable in the context of patient data for AI/ML. The "data" are measurements from bench testing of the physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Ground truth for a physical device's performance (e.g., flow rate, balloon integrity) is established through standardized engineering and laboratory testing protocols, not through expert human review of data.
Qualifications of Experts: Not applicable. The validation relies on the expertise of engineers and lab technicians performing tests according to recognized standards (ASTM, ISO, BS EN).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no human subjective assessment of "truth" that requires adjudication for these nonclinical performance tests.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This is a physical device, not an AI-assisted diagnostic tool for which MRMC studies would be relevant.

6. Standalone Performance

Standalone Performance: Yes, in a sense. The "standalone" performance here refers to the physical device's performance determined through bench testing (e.g., flow rate, balloon integrity) without human intervention in the device's function or the test outcome. It is not "standalone algorithm performance" as it would be for an AI device.

7. Type of Ground Truth Used

Ground Truth Type:
- Engineering/Physical Measurements: The ground truth for the device's performance characteristics (e.g., flow rate, balloon volume, resistance to rupture) is established by using calibrated instruments and standardized methods to measure these physical properties.
- Compliance with Standards: The "ground truth" for regulatory acceptance is that the device's performance measurements fall within the specified limits defined by international standards (e.g., ASTM F623-19, BS EN 1616:1997) and the manufacturer's own pre-determined acceptance criteria.
- Biocompatibility: Demonstrated through specific assays and tests as per ISO 10993-1.
- Sterilization: Validated against a standard (ANSI/AAMI/ISO 11135:2014) to confirm sterility.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable.

Summary

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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"

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(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

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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

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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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TRADITIONAL 510(K) SUMMARY

1. SUBMITTER INFORMATION

Applicant	Well Lead Medical (Hainan) Co., Ltd,No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park571157, Haikou, Hainan, China,
Official Correspondent	Ms. Jenny Zhu (RA Supervisor),E-mail: jenny_zhu@welllead.com.cnMiss. 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

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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 (SubjectCatheter)	K082815 (PredicateDevice)	K071423(Reference)
Device Name	Well Lead LatexFoley Catheter	Well Lead Latex FoleyCatheters	Medline Latex FoleyCatheter
Indication Foruse	Latex Foley Catheter isinserted into the bladderthrough urethra and areindicated for routineurine drainage or forroutine post-operativedrainage and bladderirrigation.	Two-Way Catheterurethral catheterization forbladder drainage forurological use only.Three-Way Catheterurethral catheterization forbladder drainage andbladder irrigation forUrological use only.	The Medline Latex FoleyCatheter is intended to beused as a urologicalcatheter inserted throughthe urethra for thepurpose of draining urineand other fluids from theurinary tract.
Device Type	2-Way and 3-wayFoley Catheter	2-Way and 3-way FoleyCatheter	2-Way and 3-wayFoley Catheter
Catheter tubeMaterial	Latex	Latex	Latex
Catheter FrenchSize (Fr.)	6-30Fr.	6-30Fr.	6-30Fr.
Catheter ShaftEffective 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
Useenvironment	Health care facilities	Health care facilities	Health care facilities
Surface Coating	Silicon Coating	Silicon Coating	Silicon Elastomer
Sterile andSingle 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.

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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.

Regulation Number and Section

§ 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.