The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Device Description

Both the predicate and proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters consist of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device.

Like the predicate, the EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. The guidewire is manufactured by Lake Region Medical; and, is cleared under K935198, Gastroenterology and Urology Guidewire Modifications. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm.

The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).

The Gyrus ACMI EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.

AI/ML Overview

The provided document K180086 describes the Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter and its substantial equivalence to predicate devices, rather than a clinical study establishing specific performance criteria against predefined metrics.

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance with numerical values, as these are not part of the substantial equivalence claim.
Sample size used for the test set or data provenance, as this was not a clinical effectiveness study.
Number of experts, their qualifications, or adjudication methods for ground truth, as ground truth establishment for a diagnostic output is not relevant here.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance, as AI is not concerned in this submission.
Information on a standalone algorithm performance, as AI is not concerned in this submission.
Type of ground truth used (pathology, outcomes data, etc.), as this is a device clearance based on equivalence, not a diagnostic accuracy study.
Sample size for the training set or how ground truth was established for it, as this is irrelevant for this type of device submission.

However, based on the provided text, I can infer the "acceptance criteria" and how the device (Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter) was shown to "meet" these criteria in the context of a 510(k) submission:

1. Acceptance Criteria (Implied for 510(k) Substantial Equivalence):

For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device:

Has the same intended use as the predicate device.
Has the same technological characteristics as the predicate device, or that differences do not raise new questions of safety or effectiveness.

In this specific case, for the "minor process changes" that resulted in "rounders to the balloon; enhancing balloon visualization," the acceptance criteria for these particular changes would have been that the repeated performance tests demonstrated the device still met or exceeded the established specifications and safety profiles.

Reported Device Performance (against equivalence, not quantitative clinical metrics):

The submission asserts that the proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter is "substantially equivalent" to the predicate devices and "presents no new questions of safety or effectiveness."

This is supported by:

Identical intended use to a predicate Boston Scientific device (K112994).
Identical design and scientific technology to its own predicate (K143609).
No material changes from the predicate (K143609).
Successful completion of a battery of performance tests following minor process changes.

2. Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is the Traditional 510(k) Notification (K180086) document itself, which compares the new device to predicate devices and provides results from non-clinical performance testing.

Relevant information from the document:

Sample size used for the test set and the data provenance: Not explicitly stated as this is a technical verification, not a clinical study. The performance tests would have been conducted on a sufficient number of device samples to ensure design verification and validation, according to internal company procedures and relevant standards.
Number of experts and qualifications, and adjudication method: Not applicable as this is a device clearance based on engineering and design comparison, not subjective expert assessment of diagnostic output.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, etc.: No, this is not an AI/diagnostic imaging device, and such a study was not performed or required for this type of 510(k) submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For the performance tests, the "ground truth" would be the established engineering specifications and safety limits for the device. For example, for "Balloon Burst Testing," the ground truth is a specific pressure at which the balloon must not burst, or a specific range. For "Dimensional Measurements," the ground truth is the specified dimensions.
The sample size for the training set: Not applicable as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Specific Performance Tests Conducted (following minor process changes leading to improved balloon visualization):

The manufacturer conducted the following performance tests to demonstrate continued safety and effectiveness after minor process changes:

Visual Inspection
Dimensional Measurements
Tensile Testing
Fatigue Testing
Luer Gauging Test
Balloon Working Length
Tip Stiffness Testing
Compliance Testing
Balloon Burst Testing
Balloon Insertion Force Testing
Balloon Retrieval Force Testing
Balloon Friction Testing
Balloon Deflation Testing
Balloon Endoscope Compatibility Testing

The successful completion of these tests, along with the detailed comparison tables showing similarities in design features, intended use, and technological characteristics to the predicate devices, collectively serve as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence to its predicates.

Summary

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March 8, 2018

Gyrus ACMI, Inc. Mary Anne Patella Senior Specialist Regulatory Affairs 136 Turnpike Road Southborough, MA 01772

Re: K180086

Trade/Device Name: Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, KNO Dated: January 11, 2018 Received: January 12, 2018

Dear Mary Anne Patella:

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. Iisting 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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Benjamin R. Fisher -S

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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Indications for Use

510(k) Number (if known) K180086

Device Name

Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Notification January 11, 2018

510(k) Summary Gyrus ACMI, Inc. Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter

General Information

Contract Manufacturer:	Vention Medical, Inc.261 Cedar Hill DriveMarlborough, MA 01752Phone: 508-481-6233
Establishment Registration Number:	3004734318
510(k) Submitter:	Olympus Surgical Technologies AmericaGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104
Establishment Registration Number:	3003790304
Contact Person:	Mary Anne PatellaSenior Specialist Regulatory Affairs508-804-2771Maryanne.patella@olympus-osta.com
Date Prepared:	January 11, 2018
Device Description
Classification Name:CFR citationProcodeClassificationClassification Panel	Biliary catheter and accessoriesEsophageal dilator21 CFR 876.5010, 876.5365FGE, KNQClass IIGastroenterology/Urology
Trade Name:	Gyrus ACMI – EZDilate 3-Stage BalloonDilatation Catheter
Generic/Common Name:	Balloon Dilation Catheter
Predicate Devices

Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter	K143609
Boston Scientific CRE Dilatation Balloon	K112994

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K180086 Page 2 of 4

Product Description

The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).

Technological Characteristics

The proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter has the same intended use, design, and scientific technology as the predicate EZDilate 3-Stage Balloon Dilatation Catheter (K143609). Both devices are the same design and there were no new issues of safety or effectiveness with the proposed device.

Material

No material changes were made to the predicate EZDilate 3-Stage Balloon Dilatation Catheter cleared under K143609.

Intended Uses

The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

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Summary of Sterilization and Shelf Life Discussion

Like the predicate EZDilate 3-Stage Balloon Dilatation Catheter (K143609), the proposed EZDilate 3-Stage Balloon Dilatation Catheter will be distributed 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 three (3) years.

Summary of Performance Testing

The predicate EZDilate 3-Stage Balloon Dilatation Catheter (K143609) and the proposed EZDilate 3-Stage Balloon Dilatation Catheter are identical in every respect. Minor process changes to the predicate EZDilate - Wire Guided 18-19-20 balloon catheter resulted in rounders to the balloon; enhancing balloon visualization. As a result of the process changes, the following performance tests were repeated.

Visual Inspection ●
Dimensional Measurements ●
Tensile Testing
Fatigue Testing
Luer Gauging Test ●
Balloon Working Length
Tip Stiffness Testing
Compliance Testing
Balloon Burst Testing ●
Balloon Insertion Force Testing
Balloon Retrieval Force Testing
Balloon Friction Testing ●
Balloon Deflation Testing ●
Balloon Endoscope Compatibility Testing

Substantial Equivalence

The proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter has the same design, and scientific technology as the Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter; and the same intended use population as the Predicate Boston Scientific CRE Dilatation Balloon (K112994). Both devices are of similar design and there were no new issues of safety or effectiveness with the proposed device. Please see the following Substantial Equivalence Comparison Table:

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Traditional 510(k) Notification
January 11, 2018

Design Feature	Proposed Gyrus ACMIEZDilate 3-StageBalloon DilatationCatheter - Wire Guided	Predicate Gyrus ACMIEZDilate 3-StageBalloon DilatationCatheter - Wire Guided(K143609)	Predicate BostonScientific CRE™Dilatation Balloon(K112994)	Comments
Indication forUse	The EZDilate 3-StageBalloon DilatationCatheters are indicatedfor use in adult andadolescent populations toendoscopically dilatestrictures of thealimentary tract. It is alsoindicated in adults forendoscopic dilatation ofthe Sphincter of Oddiwith or without priorsphincterotomy.	The EZDilate 3-StageBalloon DilatationCatheters are indicatedfor use in adultpopulations toendoscopically dilatestrictures of thealimentary tract. It is alsoindicated in adults forendoscopic dilatation ofthe Sphincter of Oddiwith or without priorsphincterotomy.	The CRE™ WireguidedBalloon DilatationCatheter is indicated foruse in adult andadolescent populations toendoscopically dilatestrictures of thealimentary tract. It is alsoindicated in adults forendoscopic dilatation ofthe Sphincter of Oddiwith or without priorsphincterotomy.	Identical to thepredicate BostonScientific CRETMDilatation Balloon(K112994)
Balloon Length	5.5cm, 6.5cm	5.5cm, 6.5cm	5.5cm	Similar (The 6-7-8 and8.5-9.5-10.5 balloonsare 6.5cm)
Inflated OuterDiameter(OD)/InflationPressure (ATM)	InflatedOD6-7-88.5-9.5-10.511-12-1313.5-14.5-15.516-17-1818-19-20	PressureATM2.0-5.5-9.52.0-5.5-9.52.0-3.5-5.52.5-4.0-6.02.5-4.0-5.52.5-3.5-5.0	InflatedOD6-7-88.5-9.5-10.511-12-1313.5-14.5-15.516-17-1818-19-20	PressureATM2.0-5.5-9.52.0-5.5-9.52.0-3.5-5.52.5-4.0-6.02.5-4.0-5.52.5-3.5-5.0	InflatedOD6-7-88-9-1010-11-1212-13.5-1515-16.5-1818-19-20	PressureATM3-6-103.5-5-93-5-83-4.5-83-4.5-73-4.5-6	Similar (Identicalmaximum/minimuminflated outerdiameters.Intermediate sizes mayvary.)
DeviceWorkingLength	240 cm	240 cm	240 cm (Esophageal,Pyloric, Colonic &Biliary)180 cm (Esophageal,Pyloric & Biliary)	Similar (BostonScientific offers anadditional length.)
CompatibleGuidewire	0.035"	0.035"	0.035"	Identical
Semi-CompliantBalloon	Yes	Yes	Yes	Identical
RadiopaqueMarker	Yes	Yes	Yes	Similar (Markerlocation may vary.)
Roundedballoon taper	Yes	Yes	Yes	Similar (Facilitatesendoscopicvisualization of thestricture through theballoon.)

		Substantial Equivalence Comparison Table
--	--	------------------------------------------	--	--

Conclusion:

In summary, the Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter is substantially equivalent to the predicate devices and presents no new questions of safety or effectiveness.

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.