The EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.

Device Description

The EsoFLIP® balloon dilation catheter is a modification of the predicate Crospon EndoFLIP® catheters. The EsoFLIP® is a small catheter with an inflatable balloon which is inserted into the gastro-esophageal junction of a patient with Achalasia. It is connected to the EndoFLIP® controller system (K I20997) and the catherer is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The EsoFLIP® catheter is inserted by the clinician. The proposed balloon dilation catheter, EsoFLIP®, can also make diameter measurements electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system. K 120997.

AI/ML Overview

This document is a 510(k) Premarket Notification for the EsoFLIP® Balloon Dilation Catheter. It outlines the device's description, indications for use, comparison to predicate devices, and a summary of non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for each performance metric with specific thresholds. Instead, it states that "The results demonstrate that the EsoFLIP® has met the performance specifications." and that the device is "substantially equivalent" to predicate devices. The performance data provided is primarily a comparison to the predicate device's specifications.

Performance Metric	Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance
Indications for Use	Identical to Cook Endoscopy Achalasia Balloon K 900924 (dilation of esophageal strictures, specifically for Achalasia patients).	The EsoFLIP® catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia. (Identical to K900924)
Technology (Dilation)	Maximum diameter 30 mm, working length 80 mm, use with guidewire (similar to K900924).	Balloon inflates to 30mm diameter, along a working length of 80mm. Features a guidewire tip. (Identical to K900924)
Technology (Measurement)	Similar measurement technique to EndoFLIP® K120997, with minor modifications (reduction in measurement points).	Provides an Estimated Diameter (Dest) of the balloon at 14 points along its length when inflated with saline solution.
Environment of Use	Hospital and surgery centers (identical to predicates).	Hospital and surgery centers (identical to predicates).
Patient Population	Patients with Achalasia (identical to K900924).	Patients with Achalasia (Identical to K900924).
Materials	Identical to predicate EndoFLIP® catheters, K 120997. Biocompatibility based on G95-1 and ISO 10993-1.	Patient contacting materials are identical to predicate EndoFLIP® catheters, K 120997. Considered surface contacting, mucosal membrane, limited duration (<24h).
Performance (Measurement Range)	Similar to EndoFLIP® K120997 (5 to 25 mm) and Cook Endoscopy Achalasia Balloon K900924 (30 mm for product G24893).	Range: 8 to 30 mm.
Performance (Measurement Resolution)	Similar to EndoFLIP® K120997 (0.1 mm).	Resolution: 0.1 mm. (Identical to K120997)
Performance (Measurement Accuracy)	Similar to EndoFLIP® K120997 (± 1mm at 95% confidence).	Accuracy: ± 1mm (at 95% confidence) rounded to nearest integer. (Identical to K120997)

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

The document lists "Bench Testing" reports (e.g., DHF_1343, DHF_1290, DHF_1296, etc.) which indicate non-clinical lab-based testing. However, the specific sample sizes used for these tests are not provided within this document. The provenance of this data is from the manufacturer, Crospon Ltd. in Ireland, as indicated by the company's address. The testing is non-clinical, so "retrospective or prospective" does not directly apply in the same way it would for clinical data, though it represents new testing performed for this submission.

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)

This document details bench testing (non-clinical), not clinical trials involving human subjects or expert assessment of medical images for ground truth. Therefore, information about the number of experts or their qualifications for establishing ground truth is not applicable and not provided in this submission.

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

As this document describes bench testing, there is no adjudication method for a test set involving human interpretation of results. The "ground truth" for the bench tests would have been established by the test protocols and measurement instruments.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. This submission is for a medical device (catheter) and focuses on its physical and functional equivalence to predicate devices through non-clinical testing.

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

This document describes a physical medical device (catheter) with a measurement function described as "electrically using the same impedance planimetry measuring technique as that deployed in the predicate EndoFLIP® system." While there is a "measurement" aspect, it's not an AI algorithm in the typical sense that would have a standalone performance evaluated for "algorithm only" against human-in-the-loop. The performance listed (range, resolution, accuracy) refers to the device's ability to measure diameter, which is a standalone function of the device and its associated controller.

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

For the non-clinical bench testing, the "ground truth" would be established by controlled experimental conditions, metrology standards, and validated measurement equipment. For example, in "Balloon Compliance Tests," the ground truth for displacement or pressure would come from calibrated sensors and known physical properties. There is no expert consensus, pathology, or outcomes data relevant to these non-clinical tests.

8. The sample size for the training set

This document describes a medical device, not an AI algorithm that requires a "training set." Therefore, this information is not applicable and not provided.

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

As there is no training set for an AI algorithm, this information is not applicable and not provided.

Summary

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

October 9, 2014

Crospon, Ltd. % Paul E. Dryden President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K132337

Trade/Device Name: EsoFLIP® Balloon Dilation Catheter Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PID, PIE Dated (Date on orig SE ltr): August 8, 2013 Received (Date on orig SE Itr): August 9, 2013

Dear Paul E. Dryden,

This letter corrects our substantially equivalent letter of October 7, 2013.

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.

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Page 2 - Paul E. Dryden

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Image /page/1/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The letters are uniformly sized and spaced, creating a clear and legible presentation of the name.

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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. Indications for Use Statement

Page I of I

510(k) Number: K132337

Device Name:

EsoFLIP® Balloon Dilation Catheter

Indications for Use:

The EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(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. 2013.10.07 16:43:01 --04'00'

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Premarket Notification 510(k) Section 5 - 510(k) Summary

EsoFLIP®

510(k) SummaryPage 1 of 6
Date Prepared	25-Jul-13
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® Balloon Dilation CatheterES-330
Common/Usual Name:	Esophageal Dilator
Classification / CFR:	KNQ / CFR 876.5365 / Class 2
Device:	EsoFLIP® Balloon Dilation Catheter
Predicate Devices:	K900924 - Cook Endoscopy Achalasia BalloonK120997 - Crospon - EndoFLIP® Catheter

Device Description:

Modifications of these devices vs. Predicates:

The following is a summary of the differences between the proposed EsoFLIP® and the predicate Crospon EndoFLIP® catheters.

(1) Change in indications for use
(2) Change of the balloon material to a stiffer material, a material which is used in the predicate
(3) Increase the overall diameter of the balloon from 25 mm to 30 mm
(4) Reduce the number of Dest measurements points from 16 to 14
(5) Change of the tip to be a guidewire tip made from the same material in the predicate EndoFLIP®

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Prémarket Notification 510(k) Section 5 - 510(k) Summary

EsoFLIP®

510(k) Summary Page 2 of 6 25-Jul-13

Indications for Use:

The EsoFLIP® catherer is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.

Patient Population: Patient population is patients with Achalasia.

Environment of Use: ・ Hospitals and Surgery Centers

Contraindications:

The EsoFLIP® System is contraindicated where endoscopy is contraindicated. .
Do not use the EsoFLIP® System on patients with actively-bleeding varices in the ● esophagus or with esophageal perforation.
The EsoFLIP® catheter is not suitable for diameter measurements smaller than 8mm or ● greater than 30mm.

Predicate Device Comparison:

Table 1 compares the EsoFLIP® Balloon Dilation catheter to the predicate Cook Endoscopy Achalasia Balloon K 900924.

The EsoFLIP® dilation cather is viewed as substantially equivalent to the predicates Cook Endoscopy Achalasia Balloon K900924 and the EndoFLIP® system with catheter K 120997 because:

Indications ~

The dilation indications for use are identical to the Cook Endoscopy Achalasia Balloon K 900924. This device is used to dilate strictures of the esophagus. [Specifically indicated for patients with Achalasia.]

Discussion - The indications for use are identical to the dilation predicate. Cook Endoscopy Achalasia Balloon, K900924.

Technology -

The EsoFLIP® Dest measurement technology, construction, and design is unchanged from the EndoFLIP® K120997 apart from a reduction in the measurement points from 16 to 14 and the increase in the balloon maximum diameter from 25 to 30mm.

The 30 mm maximum diameter and 80 mm dilation working length is identical to the Cook Endoscopy Achalasia Balloon, K900924.

The EsoFLIP® catheter features a guidewire tip (guidewire not supplied) while the Cook Endoscopy Achalasia Balloon K900924 is also used with a guidewire not supplied; per the Cook IFU P/N 18931/0411).

PDF Page 42 of 216

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K132337 Page 3 of 6

Premarket Notification 510(k) Section 5 - 510(k) Summary

EsoFLIP®

510(k) Summary Page 3 of 6 25-Jul-13

Discussion - The technology is unchanged from the Dest measurement predicate, EndoFLIP® -K 120997.

The dilation technology of the EsoFLIP® catheter: maximum diameter and balloon working length, together with its use with a guidewire, is identical to the dilation predicate Cook Endoscopy Achalasia Balloon, K900924.

Environment of Use -

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

Discussion - The environments of use are unchanged and identical to the predicates, Crospon EndoFLIP® (K 120997) and Cook Endoscopy Achalasia Balloon (K 900924).

Patient Population -

The patient populations are identical, specifically indicated for patients with Achalasia.

Discussion - The patient population is unchanged and identical to the predicate Cook Endoscopy Achalasia Balloon (K900924).

Non-clinical Testing Summary -

. Bench Testing -

We performed testing which included -

DHF_1343 EsoFLIP Dilation Catheter DV Summary Test Report .
DHF 1290 EsoFLIP Balloon Manufacturer Cert of Conformance .
DHF 1296 EsoFLIP Dilation Catheter Bonds Test Report .
DHF_1300 EsoFLIP Balloon Fatigue Test Report .
DHF 1307 EsoFLIP Dest Performance Test Report es
DHF 1338 EsoFLIP Catheter Torque Tests Test Report .
DHF 1340 EsoFLIP Balloon Compliance Tests Test Report ●
DHF_1342 EsoFLIP Catheter Assembly Tests Test Report

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

Materials -

The patient contacting materials in the EsoFLIP® catheter are identical to the predicate EndoFLIP® catheters, K 120997.

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 identical to the predicate EndoFL.IPO catheters, K 120997.

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EsoFLIP®

510(k) Summary

' 25-Jul-13 Table 1 - Comparison of Proposed Device vs. Predicate

	EndoFLIP® system with catheterK120997	Cook Endoscopy AchalasiaBalloon K900924	ProposedEsoFLIP® Catheter
Indications for Use	The EndoFLIP® system is indicated foruse in a clinical setting as a pressure anddimension measurement device and as anadjunct to other methods in thecomprehensive evaluation of patients withsymptoms consistent with esophagealsensory hypersensitivity.Note: EndoFLIP® is a measurementsystem. It is not intended to perform adiagnostic test.	This device is used to dilate stricturesof the esophagus. [Specificallyindicated for patients with Achalasia.]	The EsoFLIP® catheter is indicated for usein a clinical setting for dilating the gastro-esophageal junction of a patient withAchalasia.
Environments of use	Hospital and surgery centers	Hospital and surgery centers	Hospital and surgery centers
Patient Population	Patients with esophageal disorders	Patients with Achalasia	Patients with Achalasia(Identical to K900924)
Contraindications	The EndoFLIP® System iscontraindicated where endoscopy iscontraindicated.	Those specific to Upper GlEndoscopy.Those specific to dilation include butare not limited to: uncooperativepatient, asymptomatic rings orstrictures. inability to advance theballoon through the strictured area.	The EsoFLIP® catheter is contraindicatedwhere endoscopy is contraindicated.Do not use the EsoFLIP® System on patientswith actively bleeding varices in theesophagus or with esophageal perforation.
		coagulopathy, known or suspectperforation, severe inflammation orscarring near the dilation site.	The EsoFLIP® catheter is not suitable fordiameter measurements smaller than 8mm orgreater than 30mm.

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EsoFLIP®

510(k) Summury

25-Jul-13

・

	EndoFLIP® system with catheterK120997	Cook Endoscopy AchalasiaBalloon K900924	ProposedEsoFLIP® Catheter
Prescription/OTC	Prescription use	Prescription use	Prescription use
Principle of Operation	Measurement: Provides an EstimatedDiameter (Dest) of the balloon at 16points along its length when inflated withsaline solution.	Measurement: No measurements.	Measurement: Provides an EstimatedDiameter (Dest) of the balloon at 14 pointsalong its length when inflated with salinesolution.
	Dilation: Not indicated for dilation.	Dilation: Balloon inflates to 30mmdiameter along a working length of80mm.	Dilation: Balloon inflates to 30mm diameteralong a working length of 80mm(Identical to K900924).
Biocompatibility	All materials have passedbiocompatibility tests in accordance withISO 10993-1 (K120997)	Not disclosed	Identical materials to predicateCrospon EndoFLIP® catheter (K120997)
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: 5 to 25 mm	Product Number G24893 = 30 mm	Range: 8 to 30 mm
	Resolution: 0.1 mm		Resolution: 0.1 mm.(Identical to K120997)
	Accuracy: ± Imm (at 95% confidence)rounded to nearest integer	Accuracy: Not disclosed	Accuracy: ± 1mm (at 95% confidence)rounded to nearest integer.(Identical to K120997)

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K132337 Page 6 of 6

Premarket Notification 510(k) Section 5 - 510(k) Summary

EsoFLIP®

510(k) Summary Page 6 of 6 25-Jul-13

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance lesting, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

PDF Page 46 of 216

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.