ESOFLIP ES

K142000 · Crospon, Ltd. · PIE · Sep 25, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K142000
• Device Name: ESOFLIP ES
• Applicant: Crospon, Ltd.
• Product Code: PIE · Gastroenterology, Urology
• Decision Date: Sep 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

EsoFLIP® ES is an esophageal balloon dilation catheter used exclusively with the EndoFLIP® system. It functions as an endoscopically placed device for dilating esophageal strictures. The device features a balloon that is inflated with saline; it incorporates electrode sensors to provide real-time diameter measurements at 16 points along the balloon length. Used in hospitals and surgery centers by physicians, the device provides clinicians with visual feedback on balloon diameter during the dilation procedure. This allows for controlled dilation of strictures. The device is a single-patient-use, disposable accessory. It utilizes a stiffer balloon material compared to its predecessor to support increased inflation pressures up to 2 ATM.

Clinical Evidence

Bench testing only. Testing included accuracy, bond strength, balloon fatigue, catheter torque, balloon burst, balloon compliance, assembly tests, and 2-year shelf life. Materials were tested for biocompatibility per ISO 10993-1.

Technological Characteristics

Balloon material: Nylon 12. Shaft/Tip material: Pebax 2533 SA01. Sensing: Electrode-based impedance measurement of balloon diameter at 16 points. Energy: Saline-inflated balloon (up to 2 ATM). Connectivity: Proprietary interface with EndoFLIP® system. Sterilization: Supplied non-sterile, single-patient use. Dimensions: 8-20 mm diameter range, 80 mm working length.

Indications for Use

Indicated for patients requiring dilation of esophageal strictures resulting from esophageal surgery, primary gastro-esophageal reflux, or radiation therapy. Contraindicated if endoscopy is contraindicated, in the presence of actively bleeding varices, or for diameter measurements <8 mm or >20 mm.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• B. Braun Impact Balloon Dilation Catheter (K983373)
• Crospon EsoFLIP® Catheter (K132337)

Reference Devices

• EndoFLIP® System (K120997)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) Summary<br>Page 1 of 5 | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 24-Sep-14 |
| Company | Crospon Ltd.<br>Galway Business Park<br>Dangan<br>Galway, Ireland<br>Tel - 011 [353] (91) 519882<br>Fax - 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 Catheter<br>K132337 - Crospon - EsoFLIP® Catheter |

## 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.

## 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 catheter<br>K132337 | B. Braun Impact Balloon Dilation<br>Catheter K983373 | Proposed<br>EsoFLIP® ES Catheter |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Indicated for use in a clinical setting for<br>dilating the gastro-esophageal junction of<br>a patient with Achalasia | Indicated for use in adult and adolescent<br>patients to dilate esophageal strictures due<br>to: esophageal surgery, primary<br>gastroespoh reflux and radiation therapy. | Indicated for use to dilate esophageal<br>strictures due to esophageal surgery, primary<br>gastro-esophageal reflux and radiation<br>therapy. |
| Environments of use | Hospital and surgery centers | Hospital and surgery centers<br>Inflation pressure of 2.0 ATM | Hospital and surgery centers |
| Patient Population | Patients with Achalasia | Patients needing to dilate esophageal<br>strictures | Patients needing to dilate esophageal<br>strictures |
| Contraindications | endoscopy is contraindicated,<br><br>with actively bleeding varices and<br><br>with perforation of the esophagus. | Not listed in labeling | endoscopy is contraindicated,<br><br>with actively bleeding varices and<br><br>not suitable for diameter measurements<br>smaller than 8mm or greater than 20mm. |
| Inflation Pressure | 1.5 atm | 2.0 atm | 2.0 atm |
| Principle of Operation | Measurement: Provides an Estimated<br>Diameter (Dest) of the balloon at 14<br>points along its length when inflated with<br>saline solution.<br><br>Dilation: Balloon inflates to 30mm<br>diameter along a working length of 80mm | Measurement: No measurements.<br><br>Dilation: Balloon inflation range from 16<br>to 25 mm | Measurement: Provides an Estimated<br>Diameter (Dest) of the balloon at 16 points<br>along its length when inflated with saline<br>solution.<br><br>Dilation: Balloon inflates to 20mm diameter<br>along a working length of 80mm |

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

| | EsoFLIP® ES-330 catheter<br>K132337 | B. Braun Impact Balloon Dilation<br>Catheter K983373 | Proposed<br>EsoFLIP® ES Catheter |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Materials used /<br>Biocompatibility | Balloon and shaft material Pebax 7233<br>SA01 | Not disclosed. | Balloon – Nylon 12 |
| | Tip - Pebax 2533 SA01<br>All materials have passed<br>biocompatibility tests in accordance with<br>ISO 10993-1 (K120997) | | Shaft and Tip - Pebax 2533 SA01<br>Identical material to predicate<br>Crospon EsoFLIP® catheter (K132337) |
| Biocompatibility | All materials have passed<br>biocompatibility tests in accordance with<br>ISO 10993-1 (K120997) | Not disclosed | Identical materials to predicate<br>Crospon EsoFLIP® catheter (K132337)<br>ISO 10993-1 testing for Nylon 12 |
| Compatibility With<br>The Environment And<br>Other Devices | Only operates with EndoFLIP® system | Not disclosed. | Only operates with EndoFLIP® system |
| Sterility | Accessories are supplied non-sterile, and<br>are single patient use, disposable | Accessories are supplied non-sterile,<br>and are single patient use, disposable | Accessories are supplied non-sterile, and are<br>single patient use, disposable |
| Performance | Range: 8 to 30 mm<br>Resolution: 0.1 mm | No measurement function | Range: 8 to 20 mm<br>Resolution: 0.1 mm.<br>(Identical to K132337) |
| | Accuracy: ± 1mm (at 95% confidence)<br>rounded to nearest integer | | Accuracy: ± 1mm (at 95% confidence)<br>rounded to nearest integer.<br>(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): | |
|--------------------------------------------------|--|
|--------------------------------------------------|--|

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)

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