Intermittent nelaton catheter for single use

K222677 · Hangzhou Jimushi Meditech Co., Ltd. · EZD · Apr 5, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K222677
• Device Name: Intermittent nelaton catheter for single use
• Applicant: Hangzhou Jimushi Meditech Co., Ltd.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Apr 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.

Device Story

Disposable, sterile, single-use intermittent nelaton catheter for urine drainage. Device consists of a PVC shaft with a gel lubricating coating (glycerin, polyacrylic acid, propylene glycol, sodium polyacrylate), a distal end with two eyelets (straight or coude tip), and a proximal color-coded funnel connector. Includes a contact-free grip device for touchless insertion. Used in clinical or home settings by patients or healthcare providers. Inserted through the urethra into the bladder to facilitate urine flow into a collection container. Benefits include efficient bladder drainage and reduced risk of contamination via touchless design.

Clinical Evidence

Bench testing only. Performance verified against ISO 20696:2018, ASTM F623-19, and EN 1616:1997. Tests included product length, ID/OD, eyelet dimensions, connector separation force, peak tensile force, flow rate, bending resistance, kink stability, lubricity, and gel appearance. Biocompatibility testing performed per ISO 10993-1, -5, -10, -23, and -7. Sterilization validated per ISO 11135:2014. All tests passed.

Technological Characteristics

Materials: PVC shaft, gel lubricant (glycerin, polyacrylic acid, propylene glycol, sodium polyacrylate). Design: Tubular shaft, straight or coude tip, two eyelets, color-coded funnel connector. Sterilization: Ethylene oxide (ISO 11135). Standards: ISO 20696:2018, ASTM F623-19, EN 1616:1997, ISO 10993 series. Dimensions: 8-18 Fr, lengths 155-405mm.

Indications for Use

Indicated for intermittent urinary catheterization in male, female, and pediatric patients (greater than 2 years of age) to pass urine from the bladder. Contraindicated in patients with acute urethritis, acute prostatitis, acute epididymitis, PVC or gel allergy, during menstruation, or with calcareous urolithiasis.

Regulatory Classification

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).

Predicate Devices

• Jimushi Sterile Urethral Catheter for single use-Hydrophilic coated model (K200134)

Submission Summary (Full Text)

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April 5, 2023

Hangzhou Jimushi Meditech Co., Ltd. % Wei Shan Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China

Re: K222677

> Trade/Device Name: Intermittent nelaton catheter for single use Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: March 2, 2023 Received: March 2, 2023

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.

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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jessica K. Nguyen -S

Jessica Nguyen 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) K222677

Device Name Intermittent nelaton 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) | |
|---------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b> × </b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

#### 1. Date Prepared

April 4th, 2023

#### 2. Submitter's Information

Name of Sponsor: Hangzhou Jimushi Meditech Co.,Ltd.

Address: Bldg. 1, No. 12 Longtan Rd., Canggian St., Yuhang Dist., Hangzhou,

Zhejiang Prov., P.R. China

Contact Name: Fenlong Wu

Telephone No.: [phone]

### 3. Trade Name, Common Name, Classification

Trade Name: Intermittent nelaton catheter for single use Common Name: Urethral Catheter Classification Name: Urological Catheter and Accessories Regulation Number: 21 CFR 876.5130 Product Code: EZD Device Class: Class II

## 4. Identification of Predicate Device(s)

K200134 Jimushi Sterile Urethral Catheter for single use-Hydrophilic coated model

This predicate has not been subject to a design-related recall.

## 5. Description of the Device

Intermittent nelaton 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. The catheter body is made of polyvinyl chloride (PVC) coated with gel lubricating substance. The distal end is either a smooth closed straight or coude tip and has two eyelets for efficient drainage. The funnel shaped

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color-coded connector at the proximal end can be connected to a urine collection container. There is a contact free device, which is for an easy grip, allowing for touchless insertion.

The product is packaged in sealed plastic bags and sterilized with ethylene oxide.

#### 6. Indication for Use

Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.

#### 7. Model Information

| Product<br>code | Specifications<br>(Fr) | Color of the<br>drainage<br>funnel | Total length<br>(L2) / mm | Tip | Population |
|-----------------|------------------------|------------------------------------|---------------------------|--------------|------------|
| NCG08M | 08 | Light blue | 405±10 | | Male |
| NCG10M | 10 | Black | 405±10 | | |
| NCG12M | 12 | White | 405±10 | Straight-tip | |
| NCG14M | 14 | Green | 405±10 | | |
| NCG16M | 16 | Orange | 405±10 | | |
| NCG18M | 18 | Red | 405±10 | | |
| NCG08MC | 08 | Light blue | 405±10 | | Male |
| NCG10MC | 10 | Black | 405±10 | | |
| NCG12MC | 12 | White | 405±10 | Coude-tip | |
| NCG14MC | 14 | Green | 405±10 | | |
| NCG16MC | 16 | Orange | 405±10 | | |
| NCG18MC | 18 | Red | 405±10 | | |
| NCG08F | 08 | Light blue | 155±10 | | Female |
| NCG10F | 10 | Black | 155±10 | | |
| NCG12F | 12 | White | 155±10 | Straight-tip | |
| NCG14F | 14 | Green | 155±10 | | |
| NCG16F | 16 | Orange | 155±10 | | |
| NCG18F | 18 | Red | 155±10 | | |
| NCG08P | 08 | Light blue | 255±10 | | Pediatric |
| NCG10P | 10 | Black | 255±10 | | |
| NCG12P | 12 | White | 255±10 | Straight-tip | |
| NCG14P | 14 | Green | 255±10 | | |
| NCG16P | 16 | Orange | 255±10 | | |
| NCG18P | 18 | Red | 255±10 | | |

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## 8. Similarities and Differences of the Proposed Devices to the Predicate Devices

The Intermittent nelaton catheter for single use is substantially equivalent to the predicate device, Jimushi Sterile Urethral Catheter for single use (K200134) in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. The differences between the subject device and predicate device do not affect the basic design principle and usage.

| | Subject Device | Predicate Device | Similarities<br>and<br>Differences |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Manufacturer | Hangzhou Jimushi<br>Meditech Co.,Ltd. | Hangzhou Jimushi<br>Meditech Co.,Ltd. | |
| Trade Name | Intermittent nelaton<br>catheter for single<br>use | Jimushi Sterile<br>Urethral Catheter for<br>single use-Hydrophilic<br>coated model | |
| 510(k) number | N/A | K200134 | - - |
| Device Class | Class II | Class II | Same |
| Product Code | EZD | GBM | FDA<br>procode<br>change |
| Device<br>classification<br>Name | Urological Catheter<br>and Accessories | Urological Catheter<br>and Accessories | Same |
| Regulation<br>number | 876.5130 | 876.5130 | Same |
| Indications for<br>Use | Intermittent urinary<br>catheterization by<br>inserting through the<br>urethra to pass urine<br>from the bladder. | Intermittent urinary<br>catheterization by<br>inserting through the<br>urethra to pass urine<br>from the bladder. | Same |
| Contraindications | -Acute urethritis<br>-Acute prostatitis<br>-Acute epididymitis<br>-Patients with PVC or<br>Gel allergy<br>-Patients are in<br>menstrual period<br>-Patients have<br>calcareous urolithiasis | -Acute urethritis<br>-Acute prostatitis<br>-Acute epididymitis<br>-Patients with PVC or<br>Gel allergy<br>-Patients are in<br>menstrual period<br>-Patients have<br>calcareous urolithiasis | Same |
| Population | Male, Female and<br>Pediatric | Male, Female and<br>Pediatric | Same |
| Size range | 8-18 Fr. | 8-18 Fr. | Same |
| Effective shaft<br>length | Fr Effective length (mm) | Fr Effective length (mm) | Different 1 |
| | 08 Male,Straight:343±10<br>10 Male, Coude: 337±10<br>Female:96±10<br>Pediatric: 196±10 | 08 Male,Straight:343±3<br>10 Male, Coude: 337±3<br>Female:141±3<br>Pediatric: 241±3 | |
| | 12 Male,Straight:<br>337±10<br>14 Male, Coude: 333±10<br>16 Female:92±10<br>18 Pediatric: 192±10 | 12 Male,Straight: 337±3<br>14 Male, Coude: 333±3<br>16 Female:137±3<br>18 Pediatric: 237±3 | |
| Shaft | Tubular | Tubular | Same |
| Shaft Material | PVC | PVC | Same |
| Coating | Gel (glycerin,<br>polyacrylic acid,<br>propylene glycol,<br>sodium polyacrylate) | Hydrophilic (PVP) | Different 2 |
| Tip | Straight and Coude | Straight and Coude | Same |
| Eyelets | Yes | Yes | Same |

A detailed comparison to the predicate is provided in Table 1.

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| Biocompatibility | ISO 10993-5<br>Cytotoxicity<br>ISO 10993-10<br>Sensitization<br>ISO 10993-23 Penile<br>irritation<br>ISO 10993-11:2017<br>Subchronic systemic<br>toxicity test | ISO10993-5<br>Cytotoxicity<br>ISO 10993-10<br>Sensitization<br>ISO 10993-10 Penile<br>irritation | Different 3 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------|
| Primary<br>Packaging | PE+PET film/ XPP-R<br>film | Dialysis paper and<br>plastic film | Different 4 |
| Single use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |

#### 9. Justification for the differences

- (1) Different effective shaft length
The subject device has shorter effective shaft length for female and pediatrics than predicate device. The effective shaft length of subject device fulfills the requirement of ISO 20696:2018. This difference does not affect the substantial equivalence of the device.

- (2) Different coating material
The coating material of subject device and predicate device is different. Biocompatibility tests were conducted to demonstrate substantial equivalence of the subject device.

- (3) Different ISO 10993 standard for irritation test and addition of subchronic systemic toxicity test
The penile irritation of the subject device complies to new standard ISO 10993-23:2021, which is specific for irritation testing instead of ISO 10993-10:2010. This difference does not affect the substantial equivalence of the device.

As this product is considered to be a device with prolonged contact-

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duration given the repeated use, subchronic systemic toxicity test was conducted to validate the biocompatibility.

- (4) Different packaging material
The packaging material of subject device and predicate device is different. Packaging integrity testing was conducted to demonstrate the substantial equivalence of the subject device.

#### Non-clinical Performance Data 10.

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 |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------|---------|
| Product length | ISO 20696:2018 | Pass |
| ID/OD | ASTM F623-19, EN 1616:1997 | Pass |
| Eyelets dimensions | N/A | Pass |
| Drainage Funnel<br>Connector separation<br>force | ISO 20696:2018 | Pass |
| Peak tensile force | ISO 20696:2018 | Pass |
| Flow Rate | ASTM F623- 19, EN 1616:1997,<br>ISO 20696:2018 | Pass |
| Bending resistance | YY-0325:2016 | Pass |
| Kink stability | ISO 20696:2018 | Pass |
| Lubricity of coating | N/A | Pass |
| Gel appearance | N/A | Pass |
| Biocompatibility Testing | ISO 10993-1:2009<br>ISO 10993-5:2009<br>ISO 10993-10:2021<br>ISO 10993-23:2021<br>ISO 10993-7:2008 | Pass |
| Sterilization | ISO 11135: 2014 | Pass |

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Overall, the results are comparable to the predicate and support a determination of substantial equivalence.

#### 11. Conclusion

The Intermittent nelaton catheter for single use has the same intended use and technological characteristics as the predicate. Both the subject and predicate devices are intended for same patient populations- male, female and pediatric. Both the subject and predicate devices are disposable, sterile, single patient use devices.

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. In conclusion, the Intermittent nelaton catheter for single use is substantially equivalent to the predicate device.