ThinkMed Intermittent Catheter with/without Hydrophilic Coating

K142767 · Thinkmed Medical Technology Co., Ltd. · GBM · Feb 3, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K142767
• Device Name: ThinkMed Intermittent Catheter with/without Hydrophilic Coating
• Applicant: Thinkmed Medical Technology Co., Ltd.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Feb 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ThinkMed Intermittent Catheter with/without Hydrophilic Coating is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder - voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

Device Story

Sterile, single-use intermittent urethral catheter; available in uncoated or hydrophilic-coated variants; features Nelaton (straight/rounded) or Tiemann (curved/tapered) tip configurations; includes drainage funnel and two polished eyelets. Used for bladder drainage in patients unable to void naturally or with residual urine. Inserted into urethra to reach bladder; urine drains through catheter shaft. Hydrophilic coating activated by sterile water to reduce friction against urethral mucosa. Available in sizes 6Fr-22Fr (Nelaton) and 8Fr-22Fr (Tiemann).

Clinical Evidence

Bench testing only. Device performance verified against ASTM F623 standards for foley catheters. Biocompatibility testing (cytotoxicity, sensitization) performed per ISO 10993 requirements for mucosal contact devices with short indwell times (1-3 minutes).

Technological Characteristics

Latex-free, biocompatible medical-grade materials. Hydrophilic coating: polyvinylpyrrolidone. Sterilization: EtO gas. Sizes: 6Fr-22Fr. Configurations: Nelaton and Tiemann tips. Standards: ASTM F623, ISO 10993.

Indications for Use

Indicated for individuals unable to promote natural urine flow or those with significant residual urine volume following bladder voiding; for intermittent urethral catheterization.

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

• BEVER Intermittent Catheter (K111405)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2015

Thinkmed Medical Technology Co., Ltd. Garfield Wang General Manager No.4 Building, 322 Hongyang Road Qiandeng Town, Kunshan City 215341 China

Re: K142767

Trade/Device Name: Thinkmed Intermittent Catheter with/without Hydrophilic Coating Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: January 4, 2015 Received: January 7, 2015

Dear Garfield Wang,

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. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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[ThinkMed Intermittent Catheter with/without Hydrophilic Coating]

Rev 0.00 23/09/14

# Section 004 Indications for Use

510(k) Number (if known): _ K142767

Device Name: ThinkMed Intermittent Catheter with/without Hydrophilic Coating

Indications for Use

The ThinkMed Intermittent Catheter with/without Hydrophilic Coating is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder - voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

AND/OR Over-The-Counter Use Prescription Use V (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the word "ThinkMed" in a sans-serif font. The letters are a gradient of blue, with the left side of the word being a darker blue and the right side being a lighter blue. The letters also have a slight 3D effect, with a dark blue outline around each letter.

15/01/15

Rev 0.02

[ThinkMed Intermittent Catheter with/without Hydrophilic Coating]

Section_005 510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

Date Prepared: 15. 01.2015

## 1. Submitter Name and Address:

| Owner Name: | ThinkMed Medical Technology Co., Ltd. |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Address: | No.4 Building, 322 Hongyang Road, Qiandeng Town,Kunshan City, CHINA<br>No 20 South Renhe Road Tianchang city, CHINA |
| Contactor Name: | Garfield Wang |
| TEL: | [phone] |
| E-mail: | [e-mail] |
| Web: | www.thinkmed.cn |
| Fax: | [phone] |

#### US Agent:

| Name: | CARELIFE (USA) INC. |
|----------|---------------------------------------------------------------|
| Address: | 1580 Boggs Rd, Suite 500/600 Duluth GA 30096 |
| TEL: | 404 6612228 |
| | Contact person : Ms. LI QIAN [e-mail] |

## 2. Submission Devices Information:

Trade/Proprietary Name: ThinkMed Intermittent Catheter with/without Hydrophilic Coating Common Name: Intermittent Urethral Catheter Classification name: Urological catheter and accessories Class: 2. Product codes: GBM Submission Type: 510(k) Regulation Number: 876.51306

## 3. Predicate Devices Information:

Trade Name: BEVER Intermittent Catheter 510(K) Number: K111405 Submitter: Hangzhou Bever Medical Devices Co., Ltd

## 4. Devices Description:

ThinkMed Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for male and female, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types.

The uncoated catheter is manufactured with conventional medical grade, latex-free, biocompatible materials. it is consists of a tubular catheter shaft with attached a drainage funnel.

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[ThinkMed Intermittent Catheter with/without Hydrophilic Coating]

The catheter is available in sizes 6Fr to 22Fr for Nelaton-tip and sizes 8Fr to 22Fr for Tiemanntip.

The coated catheter is manufactured with conventional medical grade, latex-free, biocompatible materials. Coated with a hydrophilic low-friction coating, with attached a drainage funnel. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water, it becomes slippery and thus reduces friction against the urethra. This allows the coated catheter to slide in and out of the urethra in the most comfortable way. The coated catheter is available in sizes 6Fr to 22Fr for Nelaton-tip and sizes 8Fr to 22Fr for Tiemann-tip.

# 5. Intended Use:

The ThinkMed Intermittent Catheter with/without Hydrophilic Coating is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder - voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

## 6. Technological Characteristics:

Through comparisons between the submitted devices with the predicate devices as follows tables. We believe the applicant devices are substantially equivalent with the predicate devices.

| Element of Comparison | Submission Device | Predicate Device |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ThinkMed Intermittent<br>Catheter with/without<br>Hydrophilic Coating is indicated<br>for intermittent catheterization of<br>the urethra for those individuals<br>who are unable to promote a<br>natural urine flow or for those<br>individuals who have a<br>significant volume of residual<br>urine following a natural bladder<br>- voiding episode. The catheter<br>is inserted into urethra to reach<br>the bladder allowing urine to<br>drain. | The BEVER Intermittent<br>Catheter is indicated for<br>intermittent catheterization of<br>the urethra for those individuals<br>who are unable to promote a<br>natural urine flow or for those<br>individuals who have a<br>significant volume of residual<br>urine following a natural<br>bladder - voiding episode. The<br>catheter is inserted into urethra<br>to reach the bladder allowing<br>urine to drain. |
| Condition of Use | Single Use | Single Use |
| Principle of Operation | intermittent catheterization | intermittent catheterization |
| Prelubricated | NO | Yes-by sterile water |
| End Design | Funnel | Funnel |
| Tip Design | Nelaton & Tiemann | Nelaton & Tiemann |
| Hydrophilic Coating | polyvinylpyrollid | polyvinylpyrollid |
| Sterilization | EtO Gas | Eto Gas |

## Comparison Table

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Image /page/5/Picture/0 description: The image shows the word "ThinkMed" in a stylized font. The word is written in a gradient of blue, with the left side of the word being a darker shade of blue and the right side being a lighter shade of blue. The letters have a slight 3D effect, with a subtle shadow around them. The background is plain white.

Rev 0.02

15/01/15

| | | [ThinkMed Intermittent Catheter with/without Hydrophilic Coating] | | |
|--|--|-------------------------------------------------------------------|--|--|
| | | | | |
| | | | | |

| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
|------------------|---------------------------------------------|---------------------------------------------|
| Labeling | Meet the requirements of 21 CFR<br>Part 801 | Meet the requirements of 21<br>CFR Part 801 |

#### 7. Non-Clinical Test Conclusion:

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM F 623 Standard performance specification for foley catheter.

The ThinkMed Intermittent Catheter with/without Hydrophilic Coating maintains the same intended use as the predicate devices. It is a device that is inserted through the urethra and used to drain urine from the bladder.

The ThinkMed Intermittent Catheter with/without Hydrophilic Coating is composed essentially of the same materials as the predicate devices.

The ThinkMed Intermittent Catheter with/without Hydrophilic Coating has the same design and performance characteristic as the predicate devices.

The dimension, design, material, sterility, packaging and labeling of ThinkMed Intermittent Catheter with/without Hydrophilic Coating are conformed with ASTM F 623.

#### 8. Biocompatibility Test:

Biocompatibility testing was performed based on ISO 10993 requirements. The indwell time of ThinkMed Intermittent Catheter with/without Hydrophilic Coating is about 1-3 minutes. And it contact mucosal membrane. The Cytotoxicity, Sensitization biocompatibility tests were performed on ThinkMed Intermittent Catheter with Hydrophilic Coating. The tests indicated that the ThinkMed Intermittent Catheter is biocompatible and safe for its intended use.

#### 9. Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent.

END