The Gvrus ACMI Nephro - EZDilate Nephrostomy 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 the nephrostomy tract.

AI/ML Overview

The manufacturer, Gyrus ACMI, Inc., submitted a 510(k) premarket notification for their Nephro - EZDilate Nephrostomy Balloon Dilation Catheter. This application describes the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a medical device (a balloon dilation catheter), not an AI/ML powered device. Therefore, many of the requested fields (such as multi-reader multi-case studies, standalone performance, ground truth establishment, training set details) are not applicable to this submission.

Here's the information that could be extracted regarding the device's acceptance criteria and the supporting "study" (which in this context refers to performance testing rather than clinical trials or AI model validation):

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Material/Design	Compliant with relevant ISO and ANSI/AAMI standards, similar to predicate device for safety/effectiveness	Polycarbonate two-way hub, polyurethane strain relief, polyamide outer tube, Polyethylene Terephthalate balloon, non-patient contacting loaded polyamide inner catheter body.
Sterilization	Sterile, Ethylene Oxide sterilization method, single patient use	Ethylene Oxide sterilization, sterile.
Shelf Life	Not explicitly stated as acceptance criteria, but a shelf life of one year is reported.	One year
Intended Use	Dilation of the nephrostomy tract	Recommended for dilation of the nephrostomy tract. (Matches)
First Article Inspection	Not specified (assumed to meet design specifications)	Conducted
Balloon Burst Testing	Not specified (assumed to meet performance requirements)	Conducted
Balloon Kink Testing	Not specified (assumed to meet performance requirements)	Conducted
Durability Testing (cycle testing)	Not specified (assumed to meet performance requirements)	Conducted
Compliance Testing	Not specified (assumed to meet specified compliance standards)	Conducted
Balloon Shape Characteristics Testing	Not specified (assumed to meet design specifications)	Conducted
Balloon Insertion Force Testing	Not specified (assumed to meet performance requirements)	Conducted
Bond Strength	Not specified (assumed to meet design specifications)	Conducted
Fluoroscopy Testing	Not specified (assumed to demonstrate visibility)	Conducted
Amplatz Sheath Visibility and Compression Testing	Not specified (assumed to meet performance requirements)	Conducted
Substantial Equivalence	Same intended use, design, and scientific technology as the Predicate Boston Scientific NephroMax Balloon Dilation Catheter (K121614), with no new issues of safety or effectiveness.	Determined to be substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance
The document describes performance tests conducted on the device itself (e.g., balloon burst, kink, durability tests). These are engineering/device-centric tests, not clinical studies involving patient data. Therefore, the concept of "test set" and "data provenance" in the context of patient data is not applicable. The tests are performed on manufactured device units. No specific sample sizes for these tests are mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical device premarket notification for substantial equivalence, not an AI/ML device requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for device performance tests in this document.

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 is not an AI/ML powered medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered medical device.

7. The Type of Ground Truth Used
For the performance testing, the "ground truth" would be the engineering specifications and performance requirements established by the manufacturer and relevant industry standards (ISO, ANSI/AAMI). For the overall submission, the "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML powered medical device.

9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML powered medical device.

Summary

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510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc.

Gyrus ACMI Nephro - EZDilate Nephrostomy 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:

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Classification Name:

3003790304

Gyrus ACMI, Inc.

136 Turnpike Rd.

1646831

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

Southborough, MA 01772-2104

July 31, 2013

Catheter, Nephrostomy Unclassified LJE Gastroenterology/Urology

Balloon Dilation Catheter

Gyrus ACMI Nephro – EZDilate

Nephrostomy Balloon Dilation Catheter

Trade Name:

Generic/Common Name:

Predicate Devices

Boston Scientific NephroMax High Pressure Balloon Dilation Catheter

K121614

July 31, 2013

FEB - 4 2014

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Product Description

Technological Characteristics

The Gyrus ACMI Nephro - EZDilate Nephrostomy 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.

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 Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is recommended for dilation of the nephrostomy tract.

Compliance to Voluntary Standards

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

ISO 10993-5, 2009 ISO 10993-10, 2010 ISO 10993-11, 2006 ANSI/AAMI/ISO 11607-1, 2006 ANSI/AAMI/ISO 11135-1, 2007 ISO 14971, 2007

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Gyrus ACMI Nephro -EZDilate Nephrostomy Balloon Dilation Catheter Traditional 510(k) Notification Gyrus ACMI, Inc. July 31, 2013

Summary of Sterilization and Shelf Life Discussion

The Gyrus ACMI Nephro - EZDilate Nephrostomy 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 .
Bond Strength .
Fluoroscopy Testing .
Amplatz Sheath Visibility and Compression Testing .

Substantial Equivalence

The proposed Gyrus ACMI Nephro – EZDilate Nephrostomy Balloon Dilation Catheter has the same intended use, design, and scientific technology as the Predicate Boston Scientific NephroMax Balloon Dilation Catheter (K121614). 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 Nephro – EZDilate Nephrostomy 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, representing health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 4, 2014

Olympus Surgical Technologies America Gyrus ACMI, Inc. Neil Kelly Regulatory Affairs Specialist 136 Turnpike Road Southborough, MA 01772

K132383 Re:

Trade/Device Name: Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter Regulation Number: None

Regulation Name: None Regulatory Class: Unclassified Product Code: LJE Dated: January 2, 2014 Received: January 6, 2014

Dear Neil Kelly,

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.

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Page 2 - Neil Kelly

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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 (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 Beniamin 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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Gyrus ACMI Nephro -EZDilate Nephrostomy Balloon Dilation Catheter Gyrus ACMI, Inc.

Traditional 510(k) Notification July 31, 2013

Indications for Use

• • • • • • •

Device Name: Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter

510(k) Number: K132383

Indications for use:

The Gyrus ACMI Nephro - EZDilate Nephrostomy Balloon Dilation Catheter is . recommended for dilation of the nephrostomy tract.

Prescription Use: __ X __

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 F 7-05'00' 2014.02.04 0

Regulation Number and Section

N/A