The 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.

Device Description

The PVC Hydrophilic Urethral Catheter is a single use urinary catheter designed for clean intermittent catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer with/without water sachet (pure water). The catheters are coated with a coating containing polyvinyl pyrrolidone (PVP) - a kind of hydrophilic polymer, which binds the water molecules to the catheter to reduce the risk of friction while inserting the catheter into the urethra. Coating is activated by the water by squeezing the water sachet or purified water. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PVC Hydrophilic Urethral Catheter is supplied in French size ranging from 8 to 18. It is available for male and female.

AI/ML Overview

This document describes a 510(k) premarket notification for a PVC Hydrophilic Urethral Catheter (K212567). However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical urological catheter, not an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of medical device described in the provided text.

The document primarily focuses on demonstrating "substantial equivalence" of the new PVC Hydrophilic Urethral Catheter to a legally marketed predicate device (K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter) based on non-clinical performance testing and biocompatibility testing.

Here's a breakdown of the information that is present, but tailored to a physical medical device, not an AI/ML one:

Acceptance Criteria and Device Performance (for a physical catheter)

The document states that the "PVC Hydrophilic Urethral Catheter meets all the pre-determined testing and acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria. It mentions the types of tests conducted:

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
General Performance:
- Flow rate	Met criteria
- Strength of the catheter	Met criteria
- Connector Security	Met criteria
- Coefficients of friction	Met criteria
Biocompatibility (ISO 10993-1:2009):
- Cytotoxicity (ISO 10993-5:2009)	Biocompatible
- Irritation (ISO 10993-10:2010)	Biocompatible
- Sensitization (ISO 10993-10:2010)	Biocompatible
- Subacute toxicity (ISO 10993-11:2017)	Biocompatible

Explanation of the Study and its intent:

The study conducted was a non-clinical performance testing and biocompatibility testing program. The purpose of these tests was to demonstrate that the new PVC Hydrophilic Urethral Catheter is substantially equivalent to a predicate device (K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter) in terms of safety and effectiveness, as required for a 510(k) submission.

Regarding the specific questions asked for AI/ML devices, here's why they are not applicable and thus not available in the provided text:

Sample sized used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML model. Testing was likely performed on
physical catheter samples in a laboratory setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI/ML sense is established by human experts for a physical catheter's performance. Performance is measured against engineering specifications and biocompatibility standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus for AI/ML model output, not physical device testing.
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 is for AI-assisted image interpretation or similar.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "truth" for this device's performance is derived from physical measurements (e.g., flow rate, strength, friction) and standardized biological responses from biocompatibility tests.
The sample size for the training set: Not applicable. No AI/ML model, so no training set.
How the ground truth for the training set was established: Not applicable. No AI/ML model, so no training set or ground truth establishment in that context.

Summary

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December 7, 2022

Chengdu Daxan Innovative Medical Tech. Co., Ltd Kevin Huang RA Manager Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District Chengdu. Sichuan 611135 China

Re: K212567

Trade/Device Name: PVC Hydrophilic Urethral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: November 17, 2022 Received: November 22, 2022

Dear Kevin Huang:

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.

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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 (OS) 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,

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) K212567

Device Name PVC Hydrophilic Urethral Catheter

Indications for Use (Describe)

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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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	2022/11/16
Submitter:	Chengdu Daxan Innovative Medical Tech. Co.,LtdUnit 6, Building 1, No.18, North Bayi Road, Wenjiang District,611135 Chengdu, Sichuan Province, China
Contact Person:	Kevin huangRegulatory Affairs ManagerChengdu Daxan Innovative Medical Tech. Co.,LtdEmail: kevin_huang1021@sina.comTel: +86-760-22819569Fax: +86-760-22819569
Trade or Proprietary Name:	PVC Hydrophilic Urethral Catheter
Common or Usual Name:	Catheter, Straight
Regulation Number:	21 CFR 876.5130
Classification Name:	Urological Catheters and Accessories
Product Code:	EZD
Device Classification:	Class II
Review Panel:	Gastroenterology-Urology
Predicate Device(s):	K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter

1. Intended Use

2. Device Description

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is immersed in water for 30 seconds, it becomes slippery and ready to use. The PVC Hydrophilic Urethral Catheter is supplied in French size ranging from 8 to 18. It is available for male and female.

3. Substantial Equivalence-Comparison to Predicate Devices

The PVC Hydrophilic Urethral Catheter is similar to the predicate Hi-Slip Plus Hydrophilic Urethral Catheter K06244. The similar indications for use and technological characteristics of the PVC Hydrophilic Urethral Catheter as compared to the predicate device support a determination of substantial equivalency.

Similarities Between Proposed and Predicate Device

The proposed PVC Hydrophilic Urethral Catheter and the predicate device, K062444 -Hi-Slip Plus Hydrophilic Urethral Catheter, have the similar intended use, principle of operation, performance characteristics and scientific technology.

Differences Between Proposed and Predicate Device

There is no difference between the proposed and the predicate devices.

Therefore, the proposed PVC Hydrophilic Urethral Catheter are substantially equivalent to the K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter. The proposed device has the same classification information, similar intended use and technological characteristics as compared to the predicate devices.

4. Summary of Non-Clinical Performance Testing

The following performance testing was conducted for the PVC Hydrophilic Urethral Catheter:

1) General performance testing including:

· Analysis of Flow rate
· Analysis of strength of the catheter
· Analysis of Connector Security
· Analysis of Coefficients of friction

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for use as a urethral catheter.

Testing data and results are included in this submission, and demonstrated that the PVC Hydrophilic Urethral Catheter meets all the pre-determined testing and acceptance criteria.

2) Bio-compatibility testing as per ISO 10993-1:2009 including:

· Cytotoxicity as per ISO 10993-5:2009

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Irritation as per ISO 10993-10:2010
· Sensitization as per ISO 10993-10:2010
· Subacute toxicity as per ISO 10993-11:2017

Bio-compatibility testing reports are included in this submission, and demonstrated that the device components that are in contact with the patient are bio-compatible.

Conclusions Drawn from the Non-Clinical Testing

The results of these tests demonstrate that the device is as safe, as effective, and performs as well as the identified predicates and support a determination of substantial equivalence.

5. Conclusion

The PVC Hydrophilic Urethral Catheter is substantially equivalent to predicate devices K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter. Based on the intended use, principle of operation, performance characteristics, and technological characteristics, the proposed PVC Hydrophilic Urethral Catheter is substantially equivalent to and as safe, as effective and performs as the legally marketed predicate devices.

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.