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

Device Description

The EZDilate 3-Stage Balloon Dilatation Catheter consists 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. 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. 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).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the EZDilate 3-Stage Balloon Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or developing new acceptance criteria through extensive clinical studies. Therefore, much of the information requested in your prompt (e.g., sample size for test/training sets, number/qualifications of experts for ground truth, MRMC studies, standalone performance, adjudication methods) is not typically part of a 510(k) submission for this type of device and is not present in the provided document.

The "acceptance criteria" for a 510(k) are primarily demonstrating that the new device performs as intended and is as safe and effective as its predicate. The "study that proves the device meets the acceptance criteria" refers to the engineering and bench testing performed to show the device's functional integrity and similarity to the predicate.

Here's an attempt to answer your questions based on the available information, with explanations where information is not applicable or provided:

1. A table of acceptance criteria and the reported device performance

For a 510(k) relating to a balloon dilatation catheter, "acceptance criteria" are essentially the performance specifications derived from the device's design and intended use, and often benchmarked against its predicate. "Reported device performance" comes from bench testing. The document lists the types of tests performed.

Acceptance Criteria (Implied from tests and predicate comparison)	Reported Device Performance (Summary from "Summary of Performance Testing")
Mechanical Integrity/Dimensions:	Passed:
- Correct dimensions	- First Article Inspection (Dimensional Measurements)
- Resistance to tensile forces	- Tensile Testing
- Ability to withstand repeated stress	- Fatigue Testing
- Proper Luer connection	- Luer Gauging Test
- Balloon working length as specified	- Balloon Working Length
- Appropriate tip stiffness	- Tip Stiffness Testing
Balloon Functionality:	Passed:
- Consistent expansion across 3 stages	- Compliance Testing
- Resistance to rupture at specified pressures	- Balloon Burst Testing
- Ease of insertion	- Balloon Insertion Force Testing
- Low friction for movement within scope	- Balloon Friction Testing
- Effective deflation	- Balloon Deflation Testing
- Compatibility with endoscopes	- Balloon Endoscope Compatibility Testing
Biocompatibility:	Passed:
- Non-toxic, non-irritating, non-sensitizing	- ISO 10993-1, 10993-5, 10993-7, 10993-10 (Compliance to standards)
Sterility/Shelf Life:	Passed:
- Sterile upon delivery (EO sterilization)	- Sterilization validated (Ethylene oxide)
- Maintains integrity over time	- Six month shelf life data submitted (product launched with 3-year shelf life post-submission)
Packaging Integrity:	Passed:
- Maintain sterility and product integrity	- ISTA P2A, ASTM D4169-09, ASTM F2096-11, ASTM F88/F88M:2009,ASTM F1886/F1886M:2009, ASTM F1980-07 (Compliance to standards)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the document. For bench testing of physical devices, sample sizes are typically determined by statistical methods for specific tests but are not explicitly reported in this summary.
Data Provenance: The study described is entirely in-vitro bench testing of the device's physical and functional properties, performed by the manufacturer/contract manufacturer. There is no patient data involved (retrospective or prospective). The location of the testing laboratories is not specified beyond the manufacturer's location in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of device performance in a 510(k) for this type of device is established through engineering specifications, material properties, and comparison to the predicate device's known performance characteristics. Expert panels for diagnostic accuracy or clinical outcomes are not part of this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among human readers or experts. This submission is based on bench testing.

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. MRMC studies are typically for diagnostic AI-powered devices to assess how the AI impacts human reader performance. The EZDilate is a physical medical device (catheter) and does not involve AI assistance or human readers in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. "Standalone performance" refers to the performance of a diagnostic algorithm without human intervention, which is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for the bench testing is defined by engineering specifications, material standards (e.g., ISO, ASTM), and the performance characteristics of the legally marketed predicate device (Boston Scientific CRE Dilatation Balloon K112994). The tests confirm that the EZDilate catheter meets these predefined physical and functional benchmarks.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical medical device submissions like this. Training sets are relevant for machine learning algorithms.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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

March 27, 2015

Olympus Surgical Technologies America Gyrus ACMI, Inc. Mary Anne Patella Senior Specialist, Regulatory Affairs 136 Turnpike Road Southborough, MA 01772-2104

Re: K143609

Trade/Device Name: EZDilate 3-Stage Balloon Dilatation Catheters Regulation Number: 21 CFR§ 876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNO, FGE Dated: January 16, 2015 Received: January 20, 2015

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, 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.

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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 (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 contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

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) K143609

Device Name EZDilate 3-Stage Balloon Dilatation Catheters

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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510(k) Summary Gyrus ACMI, Inc. 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:	Gyrus 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:	December 16, 2014
Device Description
Classification Name:CFR citationProcodeClassificationClassification Panel	Catheter, Biliary, DiagnosticDilator, Esophageal21 CFR 876.5010, 876.5365FGE, KNQClass IIGastroenterology/Urology
Trade Name:	EZDilate 3-Stage Balloon DilatationCatheter
Generic/Common Name:	Balloon Dilation Catheter
Predicate Devices

Boston Scientific CRE Dilatation Balloon

K112994

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Product Description

Technological Characteristics

The 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.

Material

The EZDilate - Wire Guided 3-stage balloon dilatation catheter is a dual lumen catheter with a distal end comprising a nylon balloon and a proximal end comprising an inflation port and guidewire port. . The balloon tube, guidewire tube, and bifurcation hub are all constructed of Pebax. A silicone coating is applied to the balloon. A PTFE coated guidewire is pre-loaded into the guidewire lumen.

Intended Uses

The EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult 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.

Compliance to Voluntary Standards

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

ISO 594-1:1986 ISO 594-2: 1998 ISO 10993-1, 2009 ISO 10993-5, 2009

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Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter Gyrus ACMI, Inc.

ISO 10993-7:2008(R)2012 ISO 10993-10, 2010 ANSI/AAMI/ISO 11135-1, 2007 ISO 1138-2:2006 ISO 14971, 2012 ISTA P2A, 2011 ASTM D4169-09 ASTM F2096-11 ASTM F88/F88M:2009 ASTM F1886/F1886M:2009 ASTM F1980-07 (2011)

Summary of Sterilization and Shelf Life Discussion

The EZDilate 3-Stage Balloon Dilatation Catheter is delivered in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide. Six month shelf life data will be submitted to support the 510(k) submission; the product will be launched with a shelf life of three (3) years.

Summary of Performance Testing

During design verification, the output of the design process was evaluated against the physical and performance specifications. In general, the evaluation compared the function of the EZDilate 3-Stage Balloon Dilatation Catheter against these specified requirements.

First Article 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 Friction Testing ●
Balloon Deflation Testing
Balloon Endoscope Compatibility Testing ●

Substantial Equivalence

The proposed EZDilate 3-Stage Balloon Dilatation Catheter has the same intended use, design, and scientific technology as the Predicate Boston Scientific CRE

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Dilatation Balloon (K112994). Both devices are of similar design and there were no new issues of safety or effectiveness with the proposed device.

Conclusion:

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

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.