An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

Device Description

The Cure Pediatric Catheter device is an intermittent urinary catheter intended to be used by pediatric males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to open, sterile, single-use packages.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Cure Pediatric Catheter." This document is a regulatory submission, not a study report. Therefore, it does not contain the detailed information necessary to fully address all parts of your request which are typical for studies proving device performance against acceptance criteria.

However, I can extract the available information and highlight what is not present in this type of document.

Understanding the Document's Nature:

This is a 510(k) Summary, which aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than directly proving performance against pre-defined acceptance criteria in the sense of a clinical or analytical study with statistical endpoints. Substantial equivalence is established primarily through comparisons of technological characteristics, materials, and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not provided in a 510(k) Summary for a device like a urinary catheter. Acceptance criteria typically involve specific quantitative benchmarks (e.g., flow rate, force to insert, material strength, biocompatibility limits) that would be evaluated in a detailed test protocol.

Instead, the document states:

"The Cure Pediatric Catheter is substantially equivalent to the predicate devices."
"The catheter design is identical to both predicates K072539 and K080881 (except in length) and materials are identical to the predicate K080881."
"Standard biocompatibility tests were performed on the Cure Catheter to establish device safety. All tests were performed in accordance with ISO10993-1... The studies indicated that the Cure Pediatric Catheter is biocompatible and safe for its intended use."

These statements serve as the "reported device performance" in the context of a 510(k) as they indicate compliance with established standards and similarity to devices already on the market, which inherently implies acceptable performance. Specific numerical "acceptance criteria" and "reported performance" values are not listed here.

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

Sample Size: Not explicitly stated. Biocompatibility testing for medical devices involves a variety of tests on material samples, not a "test set" of patients or images as might be seen for AI/diagnostic devices. The number of samples for ISO 10993 testing is determined by the specific methods employed (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity).
Data Provenance: Not explicitly stated. Biocompatibility tests are typically performed in a laboratory setting, either internally by the manufacturer or by a contract research organization. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of biocompatibility testing, it is always prospective for the device being evaluated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable to this type of device and submission. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret data (like images). For a simple Class II urinary catheter, performance and safety are assessed through engineering specifications, material testing, and biocompatibility studies, not by expert interpretation of clinical cases to establish a "ground truth."

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert opinions when establishing ground truth for diagnostic studies. This is not pertinent to the evaluation of a urinary catheter's physical and biological properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is primarily for diagnostic imaging devices or algorithms where human readers interpret cases, and the AI's impact on their performance is evaluated. A urinary catheter is a therapeutic/drainage device, not an interpretive diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study in the context of an algorithm was not done. There is no AI algorithm in this device. The device itself is a physical medical instrument. Its "standalone performance" refers to its physical and material properties (e.g., sterility, biocompatibility, dimensions, material integrity) as confirmed by standard engineering and biological tests, not an algorithm's output.

7. The Type of Ground Truth Used

This question is not applicable in the conventional sense of expert consensus, pathology, or outcomes data for diagnosing a condition. For this device, the "ground truth" for demonstrating safety and effectiveness relies on:

Compliance with recognized standards: Such as ISO 10993-1 for biocompatibility.
Material specifications: Ensuring materials meet medical-grade requirements and match predicate devices.
Design specifications: Confirming physical dimensions and features are appropriate and identical to predicates (except length).
Performance specifications: While not detailed in the summary, underlying testing would verify catheter integrity, burst pressure, surface friction, etc., against defined engineering standards.

So, the "ground truth" is essentially adherence to established engineering, material science, and biological safety standards, as well as a demonstration of substantial equivalence to already approved devices.

8. The Sample Size for the Training Set

This question is not applicable as there is no AI algorithm or "training set" for a urinary catheter.

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

This question is not applicable as there is no AI algorithm or "training set" for a urinary catheter.

Summary

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K1106.53
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AUG - 1 2011

5. 510(k) Summary

SUMMARY

Cure Medical, LLC

Submitter's name:

Address:

2113 Seville Avenue Newport Beach, CA 92661

Phone: Fax number: 949-673-5117 949 723-4818

Name of contact person:

Robyn Scopis Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821

Date the summary was prepared: July 28, 2011

Name of the device: Trade or proprietary name: Common or usual name: Classification name: Classification Product Code

Cure Pediatric Catheter Cure Pediatric Catheter Intermittent Urinary Catheter Catheter, Straight 2 EZD

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

510(k)Number	Trade or Proprietary or Model Name	Manufacturer
K072539	Cure Catheter	Cure Medical
K080881	Cure Catheter Closed System	Cure Medical

Description of the device:

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K110 653
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Indications:

Summary of the technological characteristics of our device compared to the predicate device:

The Cure Pediatric Catheter is substantially equivalent to the predicate devices. The catheter design is identical to both predicates K072539 and K080881 (except in length) and materials are identical to the predicate K080881.

Summary of Nonclinical Testing:

Standard biocompatibility tests were performed on the Cure Catheter to establish device safety. All tests were performed in accordance with ISO10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices). The studies indicated that the Cure Pediatric Catheter is biocompatible and safe for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

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

Cure Medical. LLC % Ms. Robyn Scopis Regulatory Specialist Regulatory Specialist, Inc. 3722 Ave. Sausalito IRVINE CA 92606

AUG - 1 2011

Re: K110653

Trade/Device Name: Cure Pediatric Catheter by Cure Medical, LLC Regulation Number: 21 CFR$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 25, 2011 Received: July26, 2011

Dear Ms. Scopis:

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

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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/ucm11.5809.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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

v.tua.gov/medicaldevices/recallssection.cfm/industry/declaration.htm

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

Indications for Use

510(k) Number (if known): K110653

Device Name: Cure Pediatric Catheter by Cure Medical, LLC

Indications for Use:

× AND/OR 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 ANOTHER PAGE OF NEEDED)

해양도출장샵ロューヨン

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

icion Sion-Of of Reproductive, Gastro-Renal, and

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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.