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 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.

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

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (ThinkMed Intermittent Catheter with/without Hydrophilic Coating). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria cannot be found in this document. This submission is about showing that the new device is as safe and effective as a previously approved device, not about proving groundbreaking performance through a new clinical trial.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria or reported device performance metrics in the way one would see for a new clinical study. Instead, it relies on demonstrating equivalence to existing standards and a predicate device.

Acceptance Criteria (Inferred)	Reported Device Performance	Source/Method
Intended Use (Same as predicate)	Indicated for intermittent catheterization of the urethra for individuals unable to promote natural urine flow or with significant residual urine.	Comparison Table
Condition of Use (Same as predicate)	Single Use	Comparison Table
Principle of Operation (Same as predicate)	Intermittent catheterization	Comparison Table
Biocompatibility (Conform to ISO10993)	Conforms to ISO10993; Cytotoxicity and Sensitization tests passed.	Comparison Table, Biocompatibility Test section
Labeling (Meet 21 CFR Part 801)	Meets the requirements of 21 CFR Part 801	Comparison Table
Material Composition (Similar to predicate)	Conventional medical grade, latex-free, biocompatible materials (e.g., polyvinylpyrollid for hydrophilic coating).	Device Description, Comparison Table
Design Characteristics (Similar to predicate)	Nelaton & Tiemann tip designs, drainage funnel, various sizes (6Fr-22Fr).	Device Description, Comparison Table
Sterilization Method (Similar to predicate)	EtO Gas	Comparison Table
Dimensional, Design, Material, Sterility, Packaging (Conform to ASTM F 623)	Conformed with ASTM F 623.	Non-Clinical Test Conclusion

Missing Information:

Specific quantitative acceptance criteria (e.g., "flexibility must be X N/mm," "flow rate must be Y mL/sec").
Quantitative device performance data against such criteria. The document only states that it conforms or meets standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for any performance testing. The ASTM F 623 and ISO 10993 tests would have involved samples, but the number is not provided.
Data Provenance: The document does not describe the origin of data in terms of country or retrospective/prospective for clinical outcomes. It refers to non-clinical tests conducted to verify compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. The "tests" mentioned are non-clinical, laboratory-based tests (e.g., biocompatibility) against established standards rather than clinical studies requiring expert ground truth or assessment of outcomes.

4. Adjudication Method for the Test Set

Not applicable and not provided. There was no clinical study described that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This type of study is typically for evaluating diagnostic accuracy of imaging or AI systems with human readers, which is not relevant to an intermittent catheter.
Therefore, an effect size for human readers improving with/without AI assistance is not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is an intermittent catheter, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is primarily compliance with established international standards (ISO 10993 for biocompatibility) and national standards (ASTM F 623 for performance specification for foley catheter), along with demonstrating substantial equivalence to a predicate device.
There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as it's a 510(k) focused on equivalence and non-clinical testing.

8. Sample Size for the Training Set

Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three human profiles facing to the right, resembling a bird-like shape.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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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, CHINANo 20 South Renhe Road Tianchang city, CHINA
Contactor Name:	Garfield Wang
TEL:	+86-13564751751
E-mail:	Garfield.wang@thinkmed.cn
Web:	www.thinkmed.cn
Fax:	+86-0512-57475588

US Agent:

Name:	CARELIFE (USA) INC.
Address:	1580 Boggs Rd, Suite 500/600 Duluth GA 30096
TEL:	404 6612228
	Contact person : Ms. LI QIAN liqian@shanghaicarelife.com

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:

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.

5. Intended Use:

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 IntermittentCatheter with/withoutHydrophilic Coating is indicatedfor intermittent catheterization ofthe urethra for those individualswho are unable to promote anatural urine flow or for thoseindividuals who have asignificant volume of residualurine following a natural bladder- voiding episode. The catheteris inserted into urethra to reachthe bladder allowing urine todrain.	The BEVER IntermittentCatheter is indicated forintermittent catheterization ofthe urethra for those individualswho are unable to promote anatural urine flow or for thoseindividuals who have asignificant volume of residualurine following a naturalbladder - voiding episode. Thecatheter is inserted into urethrato reach the bladder allowingurine 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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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 CFRPart 801	Meet the requirements of 21CFR 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

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.