(132 days)
No
The device description and performance studies focus on the physical properties and functionality of a conventional urinary catheter, with no mention of AI or ML.
Yes.
The device is a urethral catheter used to drain urine from the bladder, which is a therapeutic intervention to manage a physiological function.
No
The device is described as a sterile urethral catheter intended for intermittent urinary catheterization to drain urine from the bladder, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states the device is a physical catheter made of PVC, with different forms and coatings, intended for insertion into the body. It also details physical bench testing and sterilization methods, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Function: The Jimushi Sterile Urethral Catheter is a device that is inserted into the body (through the urethra) to drain urine. It is a medical device used for a therapeutic or diagnostic procedure performed on the patient, not for analyzing a sample from the patient.
- Intended Use: The intended use clearly states "Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder." This describes a procedure performed on the patient, not an in vitro test.
- Device Description: The description details the physical characteristics and function of a catheter for urine drainage, not a device for analyzing biological samples.
Therefore, based on the provided information, the Jimushi Sterile Urethral Catheter is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
Product codes
GBM
Device Description
Jimushi Sterile Urethral Catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men.
This product is supplied in three slightly different forms:
-
- Common model (conventional uncoated type)
-
- Hydrophilic coated model
-
- Hydrophilic coated with water pocket model
The catheter body is made of polyvinyl chloride (PVC) with or without hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel shaped connector at the proximal end can be connected to a urine collection container.
The catheter body is sterilized by EO, where the water pocket in some models is pre-sterilized by radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra to the bladder
Indicated Patient Age Range
children (greater than 2 years of age), women and men
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
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: Visual Inspection, Flow Rate, Product length, ID/OD, Eyelets dimensions, Angle of the coude tip, Strength, Peak tensile force, Bending resistance, Kink stability, Connector security, Coating appearance and length, Adhesion of coating, Lubricity of coating, Water volume, pressure performance of water pocket, Water quality of the water pocket, Biocompatibility Testing, and Sterilization.
The subject device was tested to the requirements of EN 1616:1997, ISO 20969:2018 and ASTM F623:2013.
Cytotoxicity, Sensitization and Irritation were performed to demonstrate biocompatibility of the patient contacting materials.
The subject device is sterilized using Ethylene Oxide method and the water pocket is sterilized using Gamma Irradiation method in advance. The respective sterilization validations performed are ETO overkill method and the dose audit study.
Overall, the results are comparable to the predicate and support a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 1, 2020
Hangzhou Jimushi Meditech Co., Ltd. % Wei-Shan Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong China
Re: K200134
Trade/Device Name: Jimushi Sterile Urethral Catheter for single use Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: April 24, 2020 Received: April 24, 2020
Dear Wei-Shan Hsu:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 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 medical devices and radiation-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.
for Purva Pandya Acting 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200134
Device Name
Jimushi Sterile Urethral Catheter for single use
Indications for Use (Describe) Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K200134
510(k) Summary
1. Date Prepared
May 27th, 2020
2. Submitter's Information
Name of Sponsor: Hangzhou Jimushi Meditech Co.,Ltd. Address: 5F, Building 2, No.12 Longtan Road, Canggian Street, Yuhang District, Hangzhou, Zhejiang, China Contact Name: Fenlong Wu Telephone No.: +86-571-85857559
3. Trade Name, Common Name, Classification
Trade Name: Jimushi Sterile Urethral Catheter for single use Common Name: Catheter, Urethral Regulation classification name: Urological catheter and accessories Regulation number: 21 CFR 876.5130 Product code: GBM Device Class: Class II
4. Identification of Predicate Device(s)
K183461 Teleflex Medical Rusch FloCath Quick Urological Catheter
5. Description of the Device
Jimushi Sterile Urethral Catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men.
This product is supplied in three slightly different forms:
-
- Common model (conventional uncoated type)
-
- Hydrophilic coated model
-
- Hydrophilic coated with water pocket model
4
The catheter body is made of polyvinyl chloride (PVC) with or without hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel shaped connector at the proximal end can be connected to a urine collection container.
The catheter body is sterilized by EO, where the water pocket in some models is pre-sterilized by radiation.
6. Indication for Use
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
7. Similarities and Differences of the Proposed Devices to the Predicate Devices
The subject device Jimushi Sterile Urethral Catheter for single use is substantially equivalent to the predicate device with respect to the intended use, technology and construction. The differences between the predicate and the subject device are minor and any risks have been mitigated through testing. The below table summarizes the differences between the subject and predicate device.
The subject device is substantially equivalent to the predicate device:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Manufacturer | Hangzhou | ||
| Jimushi Meditech | |||
| Co.,Ltd. | Teleflex Medical, | ||
| Inc. | Similarities and | ||
| Differences | |||
| Trade Name | Jimushi Sterile | ||
| Urethral Catheter | |||
| for single use | Rusch FloCath | ||
| QuickUrological | |||
| Catheter | |||
| 510(k) number | N/A | K183461 | -- |
| Device Class | Class II | Class II | Same |
5
K200134
Page 3 of 6
| Product Code | GBM | GBM | Same |
|---|---|---|---|
| Device | |||
| classification | |||
| Name | Urological | ||
| Catheter and | |||
| Accessories | Urological Catheter | ||
| and Accessories | Same | ||
| Regulation | |||
| number | 876.5130 | 876.5130 | Same |
| Indications for Use | Intermittent | ||
| urinary | |||
| catheterization by | |||
| inserting through | |||
| the urethra to | |||
| pass urine from | |||
| the bladder. | Rusch FloCath | ||
| Quick Urological | |||
| Catheter is a | |||
| tubular device that | |||
| is inserted through | |||
| the urethra to pass | |||
| urine from the | |||
| bladder. | Same | ||
| Contraindications | -Acute urethritis | ||
| -Acute prostatitis | |||
| -Acute | |||
| epididymitis | |||
| -Patients with PVC | |||
| or Gel allergy | |||
| -Patients are in | |||
| menstrual period | |||
| -Patients have | |||
| calcareous | |||
| urolithiasis | -Insurmountable | ||
| Urethral | |||
| obstructions | |||
| -Urethral injuries | |||
| -Urethral | |||
| inflammation | Similar | ||
| Population | Male, Female and | ||
| Pediatric | Adult and | ||
| Pediatric, Male and | |||
| Female | Same | ||
| Size range | 8-18 Fr. | 6-20 Fr. | Similar |
| The size of the | |||
| subject device | |||
| ranges within | |||
| that of the | |||
| predicate | |||
| device. |
6
| Overall length | Male: 40cm
Female: 20cm
Pediatric: 30cm | 40 cm | Similar |
|--------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shaft | Tubular | Tubular | Same |
| Shaft Material | PVC | PVC | Same |
| Coating | Hydrophilic (PVP) | Hydrophilic (PVP) | Same |
| Tip | Straight and
Coude | Nelaton, Olive, or
Tiemann tip | Similar |
| Eyelets | Yes | Yes | Same |
| Liquid for wetting | Purified water | 0.9% Sterile saline
solution | Different
Both purified
water and 0.9%
saline are
effective for
activating
hydrophilic
coating for a
safe, smooth and
comfortable
catheterization. |
| Biocompatibility | ISO10993-5
Cytotoxicity
ISO 10993-10
Sensitization
ISO 10993-10 Skin
Irritation | ISO10993-5
Cytotoxicity
ISO 10993-10
Sensitization
ISO 10993-10 Skin
Irritation | Same |
| Primary Packaging | Paper and film
peel back | Paper and film peel
back | Same |
| Single use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization | Ethylene Oxide
- Water pocket is
sterilized by
gamma radiation
in advance | Ethylene Oxide | Both are
sterilized to SAL
10-6 level. |
7
The basic technological and operating principles are the same for both devices. Both the predicate and subject devices have the same intended use. Both the subject and predicate devices are intended for similar patient populations- male, female and pediatric. Both the subject and predicate devices are disposable, sterile, single patient use devices. As evidenced by comparison Table above, the subject Jimushi Sterile Urethral Catheter for single use is substantially equivalent to the predicate device.
It is reasonable that there are some differences between the subject device and its predicate. The differences between the subject device and its predicate do not affect the safety and effectiveness.
8. Non-clinical Performance Data
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
| Testing Performed | Reference to Standard | Results |
|---|---|---|
| Visual Inspection | NA | Pass |
| Flow Rate | ASTM F623- 99 (Reapproved 2013), | |
| EN 1616:1997, ISO 20969:2018 | Pass | |
| Product length | ISO 20969:2018 | Pass |
| ID/OD | ASTM F623- 99 (Reapproved 2013), | |
| EN 1616:1997 | Pass | |
| Eyelets dimensions | NA | Pass |
| Angle of the coude tip | NA | Pass |
| Strength | ISO 20969:2018 | Pass |
| Peak tensile force | ISO 20969:2018 | Pass |
| Bending resistance | YY-0325:2016 | Pass |
| Kink stability | ISO 20969:2018 | Pass |
| Connector security | ISO 20969:2018 | Pass |
8
| Coating appearance and
| length | NA | Pass |
|---|---|---|
| Adhesion of coating | ISO11070:1998 | Pass |
| Lubricity of coating | NA | Pass |
| Water volume, pressure | ||
| performance of water | ||
| NA | Pass | |
| Water quality of the | ||
| water pocket | USP23 | Pass |
| Biocompatibility Testing | ISO 10993-1:2009 | |
| ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | Pass | |
| Sterilization | ISO 11135: 2014 | |
| ISO 11137-1: 2006 | Pass |
The subject device was tested to the requirements of EN 1616:1997, ISO 20969:2018 and ASTM F623:2013.
Cytotoxicity, Sensitization and Irritation were performed to demonstrate biocompatibility of the patient contacting materials.
The subject device is sterilized using Ethylene Oxide method and the water pocket is sterilized using Gamma Irradiation method in advance. The respective sterilization validations performed are ETO overkill method and the dose audit study.
Overall, the results are comparable to the predicate and support a determination of substantial equivalence.
9. Conclusion
The Jimushi Sterile Urethral Catheter for single use has the same intended use and technological characteristics as the predicate. Test results demonstrate that the subject devices meet their intended use and performs as well as the legally marketed predicate device. It is for these reasons that the subject device can be found substantially equivalent.