Three-way Disposable Silicone Foley Catheterization for bladder drainage and bladder irrigation for urological use only; the indwelling time is no more than 30 days.

Device Description

The Silicone Foley Catheter for single use is designed as an intermittent pathway for drainage and irrigation of the bladder. The device is made of silicone. The catheter is provided sterile in a variety of lengths and sizes.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Silicone Foley Catheter for single use). Such submissions are designed to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance against a detailed set of acceptance criteria in the manner requested for an AI/ML powered device.

Therefore, much of the requested information regarding acceptance criteria, specific study design for proving performance, and expert ground truth establishment for AI/ML devices is not applicable to this traditional medical device submission.

Here's an analysis based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like a Foley catheter, "acceptance criteria" are typically defined by recognized standards and benchmarks set by the predicate device, rather than a quantifiable performance metric for an AI system. The document focuses on demonstrating substantial equivalence to a predicate device.

The "performance" is implicitly demonstrated through adherence to relevant standards and direct comparison of specifications with the predicate.

Acceptance Criteria (Implied from Standards & Predicate)	Reported Device Performance (as demonstrated by testing and comparison)
Biocompatibility: (No unacceptable biological response)	Successfully passed tests per ISO 10993-1, including Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, and Implantation.
Material: (Silicone)	Confirmed to be made of silicone, identical to predicate.
Sterility: (Sterile via EO)	Designed for EO sterilization, demonstrating an identical method to predicate.
Radiopacity: (If applicable)	Evaluated to be radiopaque in accordance with ASTM F640-2012.
Physical Performance: (e.g., flow rate, balloon function, retention)	Evaluated according to ASTM F623-99 (2013) and EN 1616:1997. (Specific numerical performance not detailed, but assumed to meet standards).
Dimensions/Specifications: (e.g., size range, balloon size, tube length)	Matches the predicate device across numerous specifications including size range (6Fr-24Fr), tube length, balloon sizes, lumen types, etc. Minor difference in catheter size range (predicate 6Fr-26Fr vs. proposed 6Fr-24Fr, but "Identical" is stated in table for sizes that overlap).
Intended Use/Indications: (Same as predicate)	Identical indications for use as the predicate device (bladder drainage and irrigation, indwelling time no more than 30 days).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., how many catheters were tested for biocompatibility or physical performance). It only states that the tests were "conducted" and "evaluated." For a traditional device, testing is typically done on a representative sample to ensure consistency and compliance with standards.
Data Provenance: The tests are non-clinical (laboratory-based performance and biocompatibility). The manufacturer is CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY CO., LTD., located in China. The data would originate from their internal testing or third-party labs they commissioned. The studies are by nature prospective as they are specifically conducted to support market clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. For a traditional catheter, "ground truth" is established by adherence to engineering specifications, material science, and performance standards, not by expert human interpretation of medical images or data (as would be the case for an AI/ML device). The "experts" involved would be engineers, material scientists, and quality assurance personnel performing the tests according to established protocols.

4. Adjudication method for the test set

Not applicable in the context of a traditional device. Adjudication methods (like 2+1, 3+1 for consensus readings) are relevant for subjective human interpretations, particularly in medical image analysis for AI. For device testing, results are typically objective measurements or pass/fail criteria according to a standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device, not an AI/ML software. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This query refers to AI/ML algorithm performance. The device is a physical catheter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As mentioned in point 3, the concept of "ground truth" as applied to AI/ML or diagnostic studies is not directly transferable here. Instead, compliance with recognized industry standards (e.g., ASTM, EN, ISO for biocompatibility) and direct comparison to the predicate device's established specifications serve as the "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm. There is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set as this is not an AI/ML device.

Summary

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June 4, 2018

Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Qinglan Street Panyu District Guangzhou, 510006 CHINA

Re: K172807

Trade/Device Name: Silicone Foley Catheter for Single Use Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZL Dated: May 4, 2018 Received: May 4, 2018

Dear Mike Gu:

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

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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); 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Benjamin R. Fisher -S

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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Indications for Use

510(k) Number (if known)

K172807

Device Name Silicone Foley Catheter for single use

Indications for Use (Describe)

Two-way Disposable Silicone Foley Catheterization for bladder drainage and urological use only; the indwelling time is no more than 30 days.

Three-way Disposable Silicone Foley Catheterization for bladder drainage and bladder irrigation for urological use only; the indwelling time is no more than 30 days.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. SUBMITTER

CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY CO., LTD. No. 8, Jianerkang Road, Industrial Concentration Area, Zhixi Town, Jintan City, Jiangsu Province, China Tel: +86-0519-82446628 Fax: +86-0519-82446610

Primary Contact	Mike Gu
Person:	Regulatory Affairs Manager
	Guangzhou Osmunda Medical Device Technical Service
	Co., Ltd.
	Tel: (+86)-20-6231 6262
	Fax: (+86) -20-8633 0253
Secondary Contact	Ping Liu
Person:	Quality Assurance Manager
	CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION
	TECHNOLOGY CO., LTD.
	Tel: +86-0519-82446628
	Fax: +86-0519-82446610
Date prepared	May 3, 2018
2. DEVICE
Device Name:	Silicone Foley Catheter for single use

Common/Usual Name:	Silicone Foley Catheter for single use
Regulation number	21 CFR 876.5130
Regulation Name	Urological catheter and accessories
Regulation Class:	II
Product Code:	EZL
Classification Name	Catheter, Retention Type, Balloon

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3.

ന് PREDICATE DEVICES

Predicate device: K130908, Disposable Balloon-retention Catheter These predicates have not been subject to a design-related recall.

4. DEVICE DESCRIPTION

5. Indications for USE

Two-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage for urological use only; the indwelling time is no more than 30 days. Three-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwelling time is no more than 30 days.

Specification	Predicate Device	Proposed Device	Discussion ofDifferences
Device name	Disposable Balloon-retentionCatheter	Silicone Foley Catheter for singleuse	similar
K number	K130908	--
Indications foruse	Two-way Disposable SiliconeFoley Catheter: Urethralcatheterization for bladderdrainage and urological use only;the indwelling time is no morethan 30 days.Three-way Disposable SiliconeFoley Catheter: Urethralcatheterization for bladderdrainage and bladder irrigationfor urological use only; theindwelling time is no more than30 days.	Two-way Disposable SiliconeFoley Catheter: Urethralcatheterization for bladderdrainage and urological use only;the indwelling time is no morethan 30 days.Three-way Disposable SiliconeFoley Catheter: Urethralcatheterization for bladderdrainage and bladder irrigationfor urological use only; theindwelling time is no more than30 days.	Identical
Specification	Predicate Device	Proposed Device	Discussion ofDifferences
Intendedpopulation	Pediatric ,male and female	Pediatric ,male and female	Identical
AnatomicalSites	Urethra, bladder	Urethra, bladder	Identical
Lumen	Two way, three way	Two way, three way	Identical
Size range	6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr,18Fr, 20Fr, 22Fr, 24Fr, 26Fr	6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr,18Fr, 20Fr, 22Fr, 24Fr	Identical
Tube Length	6Fr, 8Fr ,10Fr: 310mm12Fr-26Fr: 400mm	6Fr, 8Fr ,10Fr: 310mm12Fr-24Fr: 400mm	Identical
Balloon	Yes	Yes	Identical
Balloon size	1.5ml, 3ml, 5ml, 10ml, 15ml,20ml, 30ml	3ml, 5ml, 10ml, 15ml, 30ml	Identical
Eyes in tip	Two-way: noThree-way: yes	Two-way: noThree-way: yes	Identical
Tip shape	circular	circular	Identical
Standard funnel	Yes	Yes	Identical
Steel wire inpediatric models	yes	yes	Identical
Material of mainshaft	silicone	silicone	Identical
Single use	Yes	Yes	Identical
Shelf life	3 years	3 years	Identical
Sterility	EO	EO	Identical

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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K172807

Silicone Foley Catheter for single use is substantially equivalent to the cleared predicate device, Disposable Balloon-retention Catheter (K130908) because it has same indications for use, is composed of the same materials, and has similar technological characteristics.

7. NON-CLINICAL DATA

The following non-clinical data were provided in support of the substantial equivalence determination.

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The device were evaluated according to ASTM F623-99 (2013) and EN 1616:1997. Also, the device was evaluated to be radiopaque in accordance with ASTM F640-2012.

Biocompatibility

According to the guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the following tests have been conducted. Sample preparation and reference materials were conducted based on ISO 10993-12:2012.

Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Subchronic Toxicity
Genotoxicity
Implantation

Sterility

The device is designed for EO sterilization.

Animal Study

The subject of this premarket submission, Silicone Foley Catheter for single use, does not require animal studies to support substantial equivalence.

8. CLINICAL DATA

The subject of this premarket submission, Silicone Foley Catheter for single use, did not require clinical studies to support substantial equivalence.

9. CONCLUSION

The differences between the Silicone Foley Catheter for single use and its predicate devices do not raise different questions of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Silicone Foley Catheter for single use should perform as intended in the specified use conditions.

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Image /page/8/Picture/0 description: The image shows a logo with a green leaf on the left and a blue wave on the right. The leaf and wave are connected, forming a circular shape. The logo is simple and modern, and it likely represents a company or organization that is focused on environmental sustainability or water resources.

From the results of non-clinical data including the performance testing and comparative performance testing described, CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY CO., LTD. concludes that the Silicone Foley Catheter for single use is as safe and as effective as the predicate devices.

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.