(478 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a hydrophilic coated catheter, with no mention of AI or ML technologies.
Yes
The device is used for clean intermittent catheterization to treat chronic urine retention, which falls under the definition of therapy.
No
Explanation: The device is a urinary catheter designed for "clean intermittent catheterization -CIC treatment" and "drainage of bladder". Its purpose is to physically empty the bladder, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical catheter made of PVC with a hydrophilic coating, and the performance studies focus on physical properties and biocompatibility. There is no mention of software components.
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." This is a therapeutic procedure for draining the bladder, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical catheter designed to be inserted into the urethra to drain urine. It does not involve the analysis of biological samples outside of the body.
- Performance Studies: The performance studies focus on the physical properties of the catheter (flow rate, strength, friction, biocompatibility) and its ability to perform its intended function of draining the bladder. There are no studies related to analyzing biological samples or providing diagnostic information.
- Anatomical Site: The anatomical sites are the urethra and bladder, which are the locations where the device is used for drainage, not where samples are collected for in vitro analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used to manage a condition by draining the bladder.
N/A
Intended Use / Indications for Use
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.
Product codes
EZD
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.
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
Not Found
Intended User / Care Setting
Not Found
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)
The following performance testing was conducted for the PVC Hydrophilic Urethral Catheter:
- 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.
- Bio-compatibility testing as per ISO 10993-1:2009 including:
- Cytotoxicity as per ISO 10993-5:2009
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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 (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
2
Indications for Use
510(k) Number (if known) K212567
Device Name PVC Hydrophilic Urethral Catheter
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.,Ltd |
| Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District, | |
| 611135 Chengdu, Sichuan Province, China | |
| Contact Person: | Kevin huang |
| Regulatory Affairs Manager | |
| Chengdu Daxan Innovative Medical Tech. Co.,Ltd | |
| Email: kevin_huang1021@sina.com | |
| Tel: +86-760-22819569 | |
| Fax: +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
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.
2. 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
4
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
5
- 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.