The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned inside the balloon that define the working length. The balloon catheter can be used to dilate strictures of the urinary tract.

AI/ML Overview

The provided text describes a traditional 510(k) Notification for a medical device, the Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data or performance metrics against specific acceptance criteria for AI/algorithm-based devices.

Therefore, many of the requested details, particularly those related to AI/algorithm performance, ground truth establishment, expert adjudication, and comparative effectiveness studies, are not applicable to this document. The submission relies on engineering and sterility testing, as well as the similarity to an existing device, to establish safety and effectiveness.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission like this are primarily met through demonstrating substantial equivalence to a predicate device and compliance with relevant voluntary standards and performance testing. There are no specific quantifiable acceptance criteria presented in the document in the format of AI performance metrics (e.g., sensitivity, specificity, AUC).

The reported "device performance" is described through a summary of various engineering and material tests, rather than clinical outcomes or diagnostic accuracy.

Acceptance Criterion (Implicit in 510(k) process)	Reported Device Performance (Summary of Testing)
Substantial Equivalence to Predicate Device (Boston Scientific UroMax Ultra K130804)	"The proposed Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter has the same intended use, design, and scientific technology as the Predicate Boston Scientific UroMax Ultra Balloon Dilation Catheter (K130804). Both devices are of similar design and there were no new issues of safety or effectiveness with the proposed device."
Biocompatibility	Complies with ISO 10993-5 (Cytotoxicity, 2009) and ISO 10993-10 (Irritation & Skin Sensitization, 2010)
Sterilization & Shelf Life	Ethylene oxide sterilization, 1-year shelf life, intended for single patient use.
Packaging & Sterility Maintenance	Complies with ANSI/AAMI/ISO 11607-1 (Packaging for terminally sterilized medical devices, 2006)
Sterilization Process	Complies with ANSI/AAMI/ISO 11135-1 (Sterilization of health care products - Ethylene oxide, 2007)
Risk Management	Complies with ISO 14971 (Medical devices - Application of risk management, 2007)
Physical and Mechanical Performance (Device Integrity)	- First Article Inspection- Balloon Burst Testing- Balloon Kink Testing- Durability Testing (cycle testing)- Compliance Testing- Balloon Shape Characteristics Testing- Balloon Insertion Force Testing- Balloon Cystoscope Compatibility Testing- Balloon Deflation Testing

Details Not Applicable or Not Provided in the Document:

Sample size used for the test set and the data provenance: This is not an AI/algorithm device that uses test sets of data for performance evaluation in the typical sense. The "testing" refers to bench testing and material compatibility.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI performance (e.g., diagnostic labels) is not part of this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's safety and effectiveness is primarily established through compliance with standards, material properties, and comparison to the predicate device's established safety record.
The sample size for the training set: Not applicable. This device does not involve machine learning or training sets.
How the ground truth for the training set was established: Not applicable.

Summary

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Gyrus ACMI Uro-EZDilate Ureteral Balloon Dilation Catheter Gyrus ACMI, Inc.

Traditional 510(k) Notification July 12, 2013

510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter

General Information

Contract Manufacturer:

Future Matrix Interventional, Inc. 1605 Enterprise Street Athens, TX 75751 Phone: 903-677-9166

Establishment Registration Number:

510(k) Submitter:

Contact Person:

Date Prepared:

Device Description

Classification Name:

Gyrus ACMI, Inc.

OCT 2 1 2013

136 Turnpike Rd. Southborough, MA 01772-2104

3003790304

1646831

Neil Kelly Regulatory Affairs Specialist 508-804-2690 Neil.kelly@olympus-osta.com

July 12, 2013

Dilator, Urethral Dilator, Catheter, Ureteral 21 CFR 876.5470, 876.5520 EZN. KOE Class II Gastroenterology/Urology

Gyrus ACMI Uro – EZDilate Ureteral Balloon Dilation Catheter

Balloon Dilation Catheter

Predicate Devices

Generic/Common Name:

Trade Name:

Boston Scientific UroMax Ultra

K130804

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Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter Gyrus ACMI, Inc.

Traditional 510(k) Notification July 12, 2013

Product Description

Technological Characteristics

The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. Upon inflation, a radial force is delivered over the length of the balloon. A hydrophilic coating applied to the balloon increases ease of insertion, positioning of the balloon within the ureter, and device removal.

The dilation catheter(s) is sold separately, or as part of a kit containing an inflation device. The inflation device is also available for individual sale.

Material

A polycarbonate two-way hub at the proximal end leads into a polyurethane strain relief and into polyamide outer tube. The Polyethylene Terephthalate balloon joins the . outer catheter body and sits over a non-patient contacting loaded polyamide inner catheter body. A guidewire is positioned within the patient and the proposed device is then fed over the guidewire and into position.

Intended Uses

The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is recommended for dilation of the urinary tract.

Compliance to Voluntary Standards

The design of the proposed device complies with the following standards:

ISO 10993-5. 2009 ISO 10993-10, 2010 ANSI/AAMI/ISO 11607-1, 2006 ANSI/AAMI/ISO 11135-1, 2007 ISO 14971, 2007

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Gyrus ACMI Uro-EZDilate Ureteral Balloon Dilation Catheter Gyrus ACMI, Inc.

Traditional 510(k) Notification July 12, 2013

Summary of Sterilization and Shelf Life Discussion

The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is delivered in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide and has a shelf.life of one(1) year.

Summary of Performance Testing

The following performance tests were conducted:

First Article Inspection .
. Balloon Burst Testing
Balloon Kink Testing .
Durability Testing (cycle testing) .
Compliance Testing .
Balloon Shape Characteristics Testing .
. Balloon Insertion Force Testing
Balloon Cystoscope Compatibility Testing D
Balloon Deflation Testing .

Substantial Equivalence

The proposed Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter has the same intended use, design, and scientific technology as the Predicate Boston Scientific UroMax Ultra Balloon Dilation Catheter (K130804). Both devices are of similar design and there were no new issues of safety or effectiveness with the proposed device.

Conclusion:

In summary, the Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

October 21, 2013

Olympus Surgical Technologics America Gyrus ACMI % Neil Kelly Regulatory Affairs Specialist 136 Turnpike Road Southborough, MA 01772

Re: K132181

Trade/Device Name: Gyrus ACM1 Uro – EZDilate Ureteral Balloon Dilation Catheter Regulation Number: 21 CFR§ 876.5470 Regulation Name: Ureteral dilator Regulatory Class: II Product Code: EZN, KOE Dated: September 25, 2013 Received: September 26, 2013

Dear Neil Kelly,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deternined 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 rou may the organisions of the Act include requirements for annual registration, listing of general controls providering 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Neil Kelly

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 (reporting of medical 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/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/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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Gyros ACMI URO - Ureteral EZDitate Ureteral Balloon Dilation Catheter Gyrus ACMI, Inc.

Traditional 510(k) Notification July 12, 2013

Indications for Use

Device Name: Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter

510(k) Number: TBD K132181

Indications for use:

The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is recommended for dilation of the urinary tract.

Prescription Use: ____________________________________________________________________________________________________________________________________________________________

OR Over-the-Counter Use: _

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2013.10.21 15:40:37 -04'00'

Regulation Number and Section

§ 876.5470 Ureteral dilator.

(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).