The AMSURE Hydrophilic Latex Foley Catheter is a retention type urological catheter made of silicone coated natural Latex material modified with the addition of a lubricious/hydrophilic coating to facilitate the insertion of the catheter. It consists of a double lumen drainage tube with 2 opposing drainage eyes at the distal end. One lumen drains fluid to and from the urinary tract, while the second lumen is for inflation and deflation of the balloon. On the opposing end of the shaft are a connecting funnel and a luer activated valve. This product is available in a combination of French sizes, balloon capacities and lengths to accommodate pediatric and adult male and female applications. The device will be offered in French sizes from 12Fr to 28Fr, balloon size of 5 cc and 16-28 Fr in balloon size of 30cc. The device is disposable, sterile (Ethylene Oxide sterilization) and for single use only. The coating has been tested for its safety and efficacy.

AI/ML Overview

The provided text is a 510(k) summary for the AMSURE® HYDROPHILIC LATEX FOLEY CATHETER, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial or detailed performance study against specific acceptance criteria. Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a standalone or MRMC study as would be present for software or AI-based devices.

However, based on the information provided, we can infer some aspects relevant to performance.

Acceptance Criteria and Device Performance

The core "acceptance criterion" for a 510(k) submission, especially a Special 510(k), is demonstrating that the device meets predetermined criteria through verification and validation activities and is substantially equivalent to predicate devices. This implies that the device's performance characteristics align with the established safety and effectiveness of the predicates.

Acceptance Criteria (Inferred from Substantial Equivalence and Device Description)	Reported Device Performance (from K091699)
Material: Must be medically acceptable and suitable for intended use.	Latex: Device is made of silicone-coated natural Latex. This material is also used in at least one predicate (K030120, K040658).
Lumen Configuration: Must facilitate drainage and balloon inflation/deflation.	Dual Lumen: Device has a double lumen, similar to all listed predicate devices. One lumen for drainage, one for balloon.
Lubrication/Ease of Insertion: Must facilitate safe and comfortable insertion.	Lubricious/Hydrophilic Coating: "modified with the addition of a lubricious/hydrophilic coating to facilitate the insertion of the catheter." This is a key feature and a main difference from predicate K030120, but similar to K040658, K070508, and K984084. "The coating has been tested for its safety and efficacy."
Sterility: Must be sterile for single use.	Sterile (Ethylene Oxide sterilization): Device is sterile. This method differs from one predicate (Gamma for K030120) but is common for others.
Biocompatibility: Must be biocompatible with the human body.	Meet Requirements: "Biocompa-tibility Meet Requirements" for both the device on submission and all predicate devices. This implies standard biocompatibility testing was performed and passed.
Intended Use: Must align with the specified medical purpose.	Drainage of fluids from, and to the urinary tract/bladder: The intended use is identical to predicate K030120, K070508, and K984084.
Sizes and Capacities: Must accommodate intended patient population.	French sizes 12Fr to 28Fr, balloon size of 5 cc and 16-28 Fr in balloon size of 30cc: Available in a range to accommodate pediatric and adult male and female applications. This range is typical for Foley catheters and implicitly considered acceptable as part of substantial equivalence.
Performance (general): Must perform similarly to predicate devices.	Similar technological features and performance as the predicate device(s). "The device under submission having the same material, manufactured in the same manner and having a lubricious coat function have the same intended use as currently marketed devices raise no new issues of safety and effectiveness and are substantially equivalent." This is the overarching statement of performance demonstration for a 510(k), particularly a Special 510(k), where changes are being made to a previously cleared device. The "Declaration of Conformity" states that "all verification and validation activities were performed... and the results demonstrate that the predetermined criteria were met." This confirms internal testing validated the design.

Detailed breakdown of study information:

A table of acceptance criteria and the reported device performance
- Please refer to the table above. The "acceptance criteria" for this type of submission are primarily implied by the demonstration of substantial equivalence to legally marketed devices and adherence to relevant standards for urological catheters, rather than specific numerical thresholds from a clinical trial. The "reported device performance" is the description of the device's characteristics and functions, and the claim that "all verification and validation activities were performed... and the results demonstrate that the predetermined criteria were met."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify a clinical test set sample size or data provenance (country of origin, retrospective/prospective). This is a 510(k) submission for a Class II medical device, and it relies on bench testing and comparison to predicates for substantial equivalence, rather than a clinical trial with human subjects that often requires defined sample sizes and data provenance. The declaration states "all verification and validation activities were performed," implying laboratory/bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided and is not typically part of a 510(k) submission for this type of device. The "ground truth" for a physical device like a catheter is established through engineering specifications, material testing, biocompatibility studies, and performance testing against industry standards, not by expert consensus in the same way it would be for an AI diagnostic device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or review processes where multiple experts evaluate ambiguous cases, often in diagnostic imaging or clinical outcomes. For a physical medical device, performance is typically measured through objective testing (e.g., tensile strength, flow rate, biocompatibility testing), not subjective adjudication.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which is not the case for this urological catheter.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This concept is specific to software algorithms, particularly in diagnostics. The device is a physical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be established through:
  - Material specifications: Conformance to material standards (e.g., latex specifications).
  - Biocompatibility testing: In-vitro and/or in-vivo tests showing non-toxicity and non-irritancy, following ISO 10993 series.
  - Physical performance testing: Bench tests measuring parameters like balloon integrity, inflation/deflation time, flow rate, coating durability, tensile strength, and lubricity.
  - Sterility assurance: Validation of the Ethylene Oxide sterilization process.
- These are technical and laboratory-based "ground truths" rather than clinical "ground truths" like pathology or outcomes data from human subjects in a trial for this type of submission.
The sample size for the training set
- This information is not provided and not applicable. Training sets are used for machine learning algorithms. This device is a physical medical instrument, not an AI product.
How the ground truth for the training set was established
- This information is not provided and not applicable, as there is no training set for a machine learning algorithm.

Summary

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510k SUMMARY

K091699

Page 1 of 4

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Submitter and Contact Person:

AMSINO International, Inc AUG 1 0 2009 855 Towne Center Drive Pomona, CA 91767 Jesus T. Farinas Manager, Quality Assurance & Regulatory Affairs

Establishment Number

2085175

Name of the Device: Classification Name:

Proprietary Name:

Urological Catheter/Catheter, Retention Type, Balloon AMSURE® HYDROPHILIC LATEX FOLEY CATHETER

510k Number Regulation Number: 876.5130 Class: ll Classification Product Code: 78 EZL

Predicate Devices: AMSURE FOLEY CATHETER (K030120) BARDEX I.C. Latex Foley Catheter (K040658) BARDEX LUBRI-Sil All Silicon Lubricious Coated Foley Catheters (K070508) BARDEX LUBRI-Sil Foley Catheters (K984084)

Intended use of the Device:

The AMSURE "HYDROPHILIC LATEX FOLEY CATHETER, is intended for use in the drainage of fluids from, and to the urinary tract/bladder.

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Device Description:

Fundamental Scientific Technology:

The catheter described in this premarket notification have similar technological features and performance as the predicate device(s). The catheters are manufactured from silicone coated natural latex material and have lubricious, hydrophilic coating that facilitates insertion of the catheter. The device under submission having the same material, manufactured in the same manner and having a lubricious coat function have the same intended use as currently marketed devices raise no new issues of safety and effectiveness and are substantially equivalent.

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K091699
Pg. 3 of 4

comparison table of the features of the Subject device to the PREDICATE DEVICE(S)

	Device onsubmission	Predicate deviceK030120	BardexK040658	BardexK070508	BardexK984084
Material	Latex	Latex	Latex	Silicon	Silicon
Lumen	Dual	Dual	Dual	Dual	Dual
Lubriciouscoated	Yes	No	Yes	Yes	Yes
Sterile	Yes-EtO	Yes Gamma	Yes EtO	Yes EtO	Yes EtO
Biocompatibility	MeetRequirements	MeetRequirements	MeetRequirements	MeetRequirements	MeetRequirements
IntendedUse	Drainage of fluidsto/from urinarytract/bladder	Drainage offluids to/fromurinary tract	Drainageand/orcollectionand/ormeasurementof urine.	Drainage offluids to/fromurinary tract	Drainage offluids to/fromurinary tract

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K091699
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DECLARATION OF CONFORMITY

(Special 510k: AMSURE® Hydrophilic Latex Foley Catheter)

I certify as the Vice President for Quality Assurance and Regulatory Affairs of Amsino International, that as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrate that the predetermined criteria were met. In addition, we certify that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

Gang Chen, VP Quality Assurance and Regulatory Affairs

(Signature) the text in the image is

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Jesus Farinas Quality Assurance and Regulatory Affairs Manager Amsino International, Inc. 855 Towne Center Drive POMONA CA 91767

AUG 1 0 2009

Re: K091699

Trade/Device Name: AMSURE® HYDROPHILIC LATEX FOLEY CATHETER Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: July 20, 2009 Received: July 28, 2009

Dear Mr. Farinas:

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.

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Judy M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K091699

RD51033

DEVICE NAME:

INDICATIONS FOR USE:

The AMSURE® HYDROPHILIC LATEX FOLEY CATHETER, is intended for use in the drainage of fluids from, and to the urinary tract/bladder.

Prescription Use X (Part 21 CFR801 Subpart D) AND/OR

Over-the Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

Division Sign-Off Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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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.