The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.

Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.

Device Description

The EndoFLIP® system is an endoscopically placed device that utilizes a catheter for various indications. Crospon submitted and received 510(k) clearances for the EndoFLIP® System with a number of different catheters with different indications for use. This submission is seeking to expand the indication for use for the proposed EsoFLIP® ES catheter to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.

In all cases the catheters are to only be used with the EndoFLIP® system.

AI/ML Overview

Here's an analysis of the provided text regarding the EsoFLIP® ES Balloon Dilation Catheter, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new, specific acceptance criteria for performance metrics like sensitivity, specificity, or image quality, which are more common for diagnostic AI/imaging devices. Instead, the acceptance criteria revolve around engineering specifications and material compatibility.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Mechanical Performance	Accuracy Test (EsoFLIP® Accuracy Test)	Met performance specifications
	Dilation Catheter Bonds Test (EsoFLIP® Dilation Catheter Bonds Test)	Met performance specifications
	Balloon Fatigue Test (EsoFLIP® Balloon Fatigue Test)	Met performance specifications
	Catheter Torque Tests (EsoFLIP® Catheter Torque Tests)	Met performance specifications
	Balloon Burst Test (EsoFLIP® Balloon Burst Test)	Met performance specifications
	Catheter Balloon Compliance (EsoFLIP® Catheter Balloon Compliance)	Met performance specifications
	Catheter Assembly Tests (EsoFLIP® Catheter Assembly Tests)	Met performance specifications
	Inflation Pressure	2.0 atm (Matches predicate K983373, higher than K132337)
	Measurement Range	8 to 20 mm (Matches predicate K132337 for minimum, lower maximum than K132337)
	Measurement Resolution	0.1 mm (Identical to K132337)
	Measurement Accuracy	± 1mm (at 95% confidence) rounded to nearest integer (Identical to K132337)
Material Compatibility / Biocompatibility	ISO 10993-1 Biocompatibility Testing	All materials have passed biocompatibility tests in accordance with ISO 10993-1 (for all relevant materials, including Nylon 12 for the balloon and existing materials for shaft/tip).
Shelf Life	2 Year Shelf Life Test (EsoFLIP® 2 Year Shelf Life Test)	Met performance specifications

2. Sample Size Used for the Test Set and Data Provenance:

This submission describes non-clinical bench testing rather than human clinical trials or studies with patient data. Therefore, the concept of a "test set" in the context of collected patient data (e.g., images for an AI algorithm) is not applicable here.

Sample Size: Not specified in terms of patient data. For bench tests, the number of catheter units tested would be the "sample size," but this is not explicitly stated.
Data Provenance: Not applicable as it's mechanical/material bench testing, not derived from a patient population or geographical region.
Retrospective/Prospective: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided and is not applicable to the type of testing described. Ground truth for these engineering tests would be established by validated measurement equipment and adherence to engineering specifications and international standards (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable. Adjudication methods are typically used for expert review of human data, particularly in clinical studies or AI algorithm validation to resolve discrepancies in diagnoses or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for evaluating diagnostic aids where human readers' performance with and without the device is compared. The EsoFLIP® ES is a therapeutic device (dilation catheter) with measurement capabilities, not a diagnostic imaging aid.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Yes, in a sense, a standalone study (bench testing) was performed. The "Non-clinical Testing Summary - Bench Testing" section lists various tests (e.g., Accuracy Test, Balloon Burst Test, Fatigue Test) that evaluate the device's inherent mechanical performance and capabilities (e.g., measurement range and accuracy) without direct human intervention in the performance measurement itself, beyond setup and data collection. The device itself performs the "measurement" function to provide an estimated diameter (Dest).

7. Type of Ground Truth Used:

The ground truth for the bench testing would be established by:

Engineering Specifications: Pre-defined design limits and performance expectations for the device components.
Reference Standards: Calibrated measurement equipment and established testing methodologies (e.g., for accuracy, burst pressure, fatigue).
International Standards: Compliance with standards like ISO 10993-1 for biocompatibility.

8. Sample Size for the Training Set:

This information is not applicable. The EsoFLIP® ES is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol features a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare.

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

September 25, 2014

CROSPON, LTD. % Paul Dryden Consultant ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K142000

Trade/Device Name: ESOFLIP ES Regulation Number: 21 CFR 876.5980 Regulation Name: Esophageal Dilator With Balloon And Electrode Sensors Regulatory Class: Class II Product Code: PIE Dated: July 22, 2014 Received: July 23, 2014

Dear Paul Dryden,

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. 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

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) SummaryPage 1 of 5
Date Prepared	24-Sep-14
Company	Crospon Ltd.Galway Business ParkDanganGalway, IrelandTel - 011 [353] (91) 519882Fax - 011 [353] (91) 519873
Official Contact:	John O'Dea PhD
Proprietary or Trade Name:	EsoFLIP® ES Balloon Dilation Catheter
Common/Usual Name:	Esophageal Dilator
Classification / CFR:	PIE / CFR 876.5980 / Class 2
Device:	EsoFLIP® ES Balloon Dilation Catheter
Predicate Devices:	K983373 – B. Braun Impact Balloon Dilation CatheterK132337 - Crospon - EsoFLIP® Catheter

Device Description:

In all cases the catheters are to only be used with the EndoFLIP® system.

Modifications of these devices vs. Predicates:

The following is a summary of the differences between the proposed EsoFLIP® ES and the predicate Crospon EsoFLIP® ES-330 catheter, cleared under K132337.

(1) Expanded indications for use
(2) Change of the balloon material to a stiffer material for the increased inflation pressure to 2 ATM.
(3) Has diameter measurements at 16 points vs. the ES-330 (K132337) at 14 points

Indications for Use:

The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy.

Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.

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510(k) Summary

Page 2 of 5 24-Sep-14

Patient Population:	Patient population is patients with strictures.
Environment of Use:	Hospitals and Surgery Centers

Contraindications:

The EsoFLIP® ES dilation catheter is contraindicated where:

(1) endoscopy is contraindicated,
(2) with actively bleeding varices and
(3) for diameter measurements smaller than 8 mm or greater than 20 mm

Predicate Device Comparison:

Table 1 compares the EsoFLIP® ES Balloon Dilation catheter to the predicate Crospon EsoFLIP® ES-330 (K132337) and the B. Braun Impact Balloon Dilation Catheter (K983373).

The EsoFLIP® ES dilation catheter is viewed as substantially equivalent to the predicates B. Braun Impact Balloon Dilation Catheter (K983373) and the EsoFLIP® ES-330 catheter K132337 because:

Indications – The dilation indications for use are identical to the B/ Braun Impact Balloon Dilation catheter (K983373).

Discussion - The indications for use are identical to the dilation predicate. B. Braun Impact Balloon Dilation Catheter (K983373).

Technology - The EsoFLIP® Dest measurement technology, construction, and design are unchanged from the EsoFLIP® ES-330 catheter, K132337, when used with the EndoFLIP® system, K120997.

Discussion - The technology is unchanged from the Degr measurement predicate, EndoFLIP® -K120997. The proposed EsoFLIP® ES catheter measures diameter at 16 points, like the predicate K130906, which is 2 more than the predicate ES-330 (K132337) which has 14 points.

The dilation technology of the EsoFLIP® ES catheter: maximum diameter and balloon working length, together with its use with a guidewire, is identical to the dilation predicate B. Braun Impact Balloon Dilation Catheter (K983373).

Environment of Use - The environments of use - hospital and surgery centers - are identical to the predicates.

Discussion - The environments of use are identical to the predicate B. Braun Impact Balloon Dilation Catheter (K983373) and the EsoFLIP® ES-330 (K132337).

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510(k) Summary Page 3 of 5 24-Sep-14

Patient Population - The patient populations are identical, specifically indicated for patients requiring dilation of esophageal strictures.

Discussion - The patient population is unchanged and identical to the predicate B. Braun Impact Balloon Dilation Catheter (K983373).

Non-clinical Testing Summary -

Bench Testing - We performed bench testing to demonstrate that the EsoFLIP® ES balloon dilation catheter will perform within specification.

DHF 1473 EsoFLIP® Accuracy Test ●
DHF 1296 EsoFLIP® Dilation Catheter Bonds Test ●
DHF 1475 EsoFLIP® Balloon Fatigue Test ●
DHF 1338 EsoFLIP® Catheter Torque Tests
DHF 1454 EsoFLIP® Balloon Burst Test
DHF 1471 EsoFLIP® Catheter Balloon Compliance ●
DHF 1469 EsoFLIP® Catheter Assembly Tests
DHF 1514 EsoFLIP® 2 Year Shelf Life Test

The results demonstrate that the EsoFLIP® ES has met the performance specifications.

Materials -

The materials in contact with the patient are identical to the predicates, EsoFLIP® ES-330 (K132337) and balloon materials has been tested per ISO 10993-1.

In accordance with G95-1 and ISO 10993-1 the catheters are considered as

. Surface Contacting
Mucosal membrane
Limited duration (<24h) ●

They are single patient use, disposables. The materials are either identical to the Crospon the predicate EndoFLIP® catheters, K120997 or have been tested per ISO 10993-1.

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510(k) Summary

Page 4 of 5
24 Sep 14

Table 1 – Comparison of Proposed Device vs. Predicate

	EsoFLIP® ES-330 catheterK132337	B. Braun Impact Balloon DilationCatheter K983373	ProposedEsoFLIP® ES Catheter
Indications for Use	Indicated for use in a clinical setting fordilating the gastro-esophageal junction ofa patient with Achalasia	Indicated for use in adult and adolescentpatients to dilate esophageal strictures dueto: esophageal surgery, primarygastroespoh reflux and radiation therapy.	Indicated for use to dilate esophagealstrictures due to esophageal surgery, primarygastro-esophageal reflux and radiationtherapy.
Environments of use	Hospital and surgery centers	Hospital and surgery centersInflation pressure of 2.0 ATM	Hospital and surgery centers
Patient Population	Patients with Achalasia	Patients needing to dilate esophagealstrictures	Patients needing to dilate esophagealstrictures
Contraindications	endoscopy is contraindicated,with actively bleeding varices andwith perforation of the esophagus.	Not listed in labeling	endoscopy is contraindicated,with actively bleeding varices andnot suitable for diameter measurementssmaller than 8mm or greater than 20mm.
Inflation Pressure	1.5 atm	2.0 atm	2.0 atm
Principle of Operation	Measurement: Provides an EstimatedDiameter (Dest) of the balloon at 14points along its length when inflated withsaline solution.Dilation: Balloon inflates to 30mmdiameter along a working length of 80mm	Measurement: No measurements.Dilation: Balloon inflation range from 16to 25 mm	Measurement: Provides an EstimatedDiameter (Dest) of the balloon at 16 pointsalong its length when inflated with salinesolution.Dilation: Balloon inflates to 20mm diameteralong a working length of 80mm

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510(k) Summary Page 5 of 5 24-Sep-14

	EsoFLIP® ES-330 catheterK132337	B. Braun Impact Balloon DilationCatheter K983373	ProposedEsoFLIP® ES Catheter
Materials used /Biocompatibility	Balloon and shaft material Pebax 7233SA01	Not disclosed.	Balloon – Nylon 12
	Tip - Pebax 2533 SA01All materials have passedbiocompatibility tests in accordance withISO 10993-1 (K120997)		Shaft and Tip - Pebax 2533 SA01Identical material to predicateCrospon EsoFLIP® catheter (K132337)
Biocompatibility	All materials have passedbiocompatibility tests in accordance withISO 10993-1 (K120997)	Not disclosed	Identical materials to predicateCrospon EsoFLIP® catheter (K132337)ISO 10993-1 testing for Nylon 12
Compatibility WithThe Environment AndOther Devices	Only operates with EndoFLIP® system	Not disclosed.	Only operates with EndoFLIP® system
Sterility	Accessories are supplied non-sterile, andare single patient use, disposable	Accessories are supplied non-sterile,and are single patient use, disposable	Accessories are supplied non-sterile, and aresingle patient use, disposable
Performance	Range: 8 to 30 mmResolution: 0.1 mm	No measurement function	Range: 8 to 20 mmResolution: 0.1 mm.(Identical to K132337)
	Accuracy: ± 1mm (at 95% confidence)rounded to nearest integer		Accuracy: ± 1mm (at 95% confidence)rounded to nearest integer.(Identical to K132337)

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device does not raise any new safety concerns compared to the predicates.

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Indications for Use

510(k) Number (if known)

Device Name

EsoFLIP® ES catheter Indications for Use (Describe)

The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux, radiation therapy.

Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.

Type of Use (Select one or both, as applicable):
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XX Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

Page 1 of 1

EF PSC Publishing Services (301) 443-6740

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.