This document describes a Special 510(k) Submission for the AMSure™ PVC Intermittent Catheter. This type of submission is for modifications to a previously cleared device, asserting substantial equivalence to its predicate device. As such, the focus of the submission is on demonstrating that the modifications do not raise new questions of safety or effectiveness.

Therefore, the provided text does not contain information about:

Acceptance criteria in the context of specific performance metrics for a novel device.
A "study that proves the device meets the acceptance criteria" in terms of clinical performance or diagnostic accuracy.
Sample sizes for test sets or training sets in the context of algorithm development.
Data provenance, expert ground truth establishment, or adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Instead, the document focuses on:

Non-Clinical Testing: "Performance and biocompatibility testing has demonstrated the safety and effectiveness of the AMSure™ PVC Intermittent Catheter for its intended use." This is very general and does not provide specific criteria or results.
Comparison to Predicate: "The AMSure™ PVC Intermittent Catheter is a configuration and label modification of the AMSure™ Urethral Catheterization Tray (K030712) and is intended for the same use." This implies that the device meets the same performance standards as the predicate device by virtue of being a minor modification.

Based on the provided text, the specific information requested in your prompt cannot be extracted because the submission is for a medical device (catheter), not an AI/software device, and thus the acceptance criteria and study designs are fundamentally different.

The document confirms that:

Device Name: AMSure™ PVC Intermittent Catheter
Intended Use: For use in the drainage of urine from the bladder.
Predicate Device: AMSure™ Urethral Catheterization Tray (K030712)
Changes: Configuration and label modification.
Testing: Performance and biocompatibility testing was performed to demonstrate safety and effectiveness. (No specific details provided).

Summary

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AMSINO

Special 510(k) Submission ----------------------------------------------------------------------------------------------------------------------------------------------------

K09/306

510(K) Summary of Safety and Effectiveness AMSelf™ PVC Intermittent Catheter

Company:	Amsino International, Inc.855 Towne Center DrivePomona,CA 91767(909)626-5888	AUG 21 2009
Contact:	Holiven JiManager of Regulatory Affairs
Date Prepared:	April 22, 2009
Classification Name:	Tray, Catheterization, Sterile Urethral, with or without Catheter(876.5130)
Common Name:	Urethral Catheter
Proprietary Name:	AMSure ™ PVC Intermittent Catheter
Product Code:	FCM
Medical Specialty:	Gastroenterology/Urology
Device Class:	Class II
Unmodified Device:	AMSure ™ Urethral Catheterization Tray (K030712)
Device Description:	The AMSure ™ PVC Intermittent Catheter is a sterile, single-use patient device, compromising a PVC tubing and funnel.
Intended Use:	The AMSure ™ PVC Intermittent Catheter is intended for use inthe drainage of urine from the bladder.
Comparison to Predicate:	The AMSure ™ PVC Intermittent Catheter is a configurationand label modification of the AMSure ™ UrethralCatheterization Tray (K030712) and is intended for the sameuse.
Non-Clinical Testing:	Performance and biocompatibility testing has demonstratedthe safety and effectiveness of the AMSure ™ PVCIntermittent Catheter for its intended use.

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Image /page/1/Picture/0 description: The image shows a logo and the word "DEPARTMENT". The logo is a stylized image of an eagle with three lines representing its wings. The word "DEPARTMENT" is in a bold, sans-serif font and is underlined. The image is in black and white.

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

AUG 2 1 2009

Mr. Holiven Ji Manager of International Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive POMONA CA 91767

Re: K091306

Trade/Device Name: AMSure" PVC Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 20, 2009 Received: July 28, 2009

Dear Mr, Ji:

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/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,

Lammy M. Mouck

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 Statement

510(k) Number:

K091/306

(if known)

510(k) Number --

Device Name: AMSure PVC Intermittent Catheter

Indications The AMSure PVC Intermittent Catheter is intended for use in for Use: the drainage of urine from the bladder.

Prescription Use √ AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices	K091306

Page - 4

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.