EsoFLIP® ES-310 Balloon Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. November 22, 2017 Crospon Ltd. % Paul E. Dryden Consultant Crospon Ltd., % ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 Re: K172128 Trade/Device Name: EsoFLIP® ES-310 balloon catheter Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIE Dated: October 4, 2017 Received: October 5, 2017 Dear Paul E. 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. {1}------------------------------------------------ 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, Joyce M. Whang -S 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172128 Device Name EsoFLIP® ES-310 balloon catheter Indications for Use (Describe) The EsoFLIP® ES-310 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-310 balloon catheter is to be used only with the EndoFLIP® system. Type of Use (Select one or both, as applicable) | <span style="font-size:100%;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |-------------------------------------------------------------------------------------| | <span style="font-size:100%;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 20-Nov-17 | | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Company | Crospon Ltd.<br>Galway Business Park<br>Dangan<br>Galway, Ireland | | | Tel – 011 [353] (91) 519882<br>Fax - 011 [353] (91) 519873 | | Official Contact: | John O'Dea, PhD - President | | Proprietary or Trade Name: | EsoFLIP® ES-310 Balloon Catheter | | Common/Usual Name: | Esophageal Dilator | | Classification Name: | Gastrointestinal Tube and Accessories<br>(21 CFR 876.5980) | | Regulatory Class: | Class 2 | | Product Code: | PIE | | Device: | EsoFLIP® ES-310 Balloon Catheter | | Predicate Device:<br>Reference Devices: | K142000 - Crospon ES series Catheters (ES-320)<br>K130906 – Crospon – BF-325N<br>K132337 – Crospon – EsoFLIP® ES-330 Catheter | #### Device Description: The EsoFLIP® ES-310 catheter is a balloon dilation catheter. It is used by surgeons or gastroenterologists to dilate esophageal strictures due to esophageal surgery, primary gastroesophageal reflux, and radiation therapy. This indication for use is identical to the predicate EsoFLIP® ES-series (ES-320) predicate, K142000. The EsoFLIP® catheter connects to the EndoFLIP® imaging system in the same fashion as the predicate EsoFLIP® catheter, to display an image of the cross-sectional-areas (CSAs) of the dilation balloon, and to allow the balloon to be inflated using the EndoFLIP® syringe driver. 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-310 catheter and the predicate EsoFLIP® ES-series (ES-320) catheter, cleared under K142000. - (1) Change of the balloon size for use in smaller strictures. - a. This of course affects the working specifications of the balloon - b. Measurement range, Reading Length, Working Length, Maximum Filling Volume - (2) Has diameter measurements (Sensors) at 8 points vs. the ES-320 (K142000) at 16 points - a. Other EndoFLIP® catheters have been cleared with 8 sensors (BF-325N -K130906) {4}------------------------------------------------ - Maximum Balloon Inflation Pressure 1.5 ATM (3) - a. The predicate ES-320 (K142000) has a Maximum Inflation Pressure of 2 ATM; however reference ES-330 (K132337) with similar indications has a maximum inflation pressure of 1.5 ATM. The EsoFLIP® ES-310 balloon dilation catheter is used exclusively with the EndoFLIP® system. The user interface is unchanged. #### Indications for Use: The EsoFLIP® ES-310 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-310 catheter is to be used only with the EndoFLIP® system. | 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 and dilation of strictures smaller than 6mm or greater than 10mm #### Predicate Device Comparison: Table 1 compares the EsoFLIP® ES-310 catheter to the predicate Crospon EsoFLIP® ES-series (ES-320) (K142000) and the references. The EsoFLIP® ES-310 dilation catheter is viewed as substantially equivalent to the predicate -Crospon EsoFLIP® ES -series (ES-320) cleared under K142000 because: #### Indications - The dilation indications for use are identical to the predicate K142000. Discussion - The indications for use for the proposed device does not change from the predicate Crospon EsoFLIP® ES-series, K142000. #### 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 Crospon EsoFLIP® ES-series, K142000. However, the diameter of strictures that the ES-310 dilation catheter is intended to be used with is smaller (6 to 10 mm). #### Environment of Use - The environments of use - hospital and surgery centers - are identical to the predicate. Discussion - The environments of use are identical to the predicate Crospon EsoFLIP® ESseries. K142000. {5}------------------------------------------------ ### Contraindications - The contraindication related to minimum and maximum diameters of strictures that the catheter may be used with has been updated to reflect the proposed ES-310's smaller balloon size. Discussion - The contraindications are identical with exception of the update of sizing to the predicate Crospon EsoFLIP® ES-series, K142000. #### Technology - The EsoFLIP® Des measurement technology, construction, and design are unchanged from the EsoFLIP® ES-series catheter, K142000, when used with the EndoFLIP® system as cleared under K160725. Discussion - The diameter measurement technology is unchanged from the predicate. The proposed EsoFLIP® ES-310 catheter measures diameter at 8 points, whereas the predicate K142000 measures at 16 points. However, Crospon has clearance for catheters which measure at 8 points, namely BF-325N, K130906. The dilation technology of the EsoFLIP® ES catheter: maximum diameter and balloon working length, is similar to the predicate Crospon ES-series (ES-320) K142000. The maximum inflation pressure of 1.5 ATM is identical to that of the reference Crospon EsoFLIP® ES-330 (K132337). While different from the predicate, which has a maximum inflation pressure of 2 ATM, Crospon has clearance for a catheter with a 1.5 ATM maximum inflation pressure that has a similar intended use. ### Non-clinical Comparative Performance and Specifications - #### Bench Testing - The Performance Testing included - - Balloon Fatigue testing - Balloon Compliance testing ● - Balloon Burst test - . Catheter Assembly test - Diameter measurement accuracy testing . Other testing was leveraged from the predicate. The testing demonstrated that the proposed EsoFLIP® ES-310 Balloon Dilation Catheter performed to its specifications (dilation and measurement) and thus is substantially equivalent to the predicate devices. #### Biocompatibility- The materials in contact with the patient are identical to the predicate, EsoFLIP® ES-series (K142000). Discussion - The materials are unchanged from the predicate. #### Discussion of Differences The differences between the proposed and predicate device relate to: - Size of balloon ● - This does not alter population or indications for use. It allows the clinician a o smaller size for use with their patients - Contraindication ● {6}------------------------------------------------ #### 510(k) Summary Page 4 of 6 20-Nov-17 - The change is only with the dimensions. Otherwise the contraindications are o identical - Maximum inflation pressure - Crospon has clearance for inflation at 1.5 ATM vs. the predicate at 2.0 ATM O - . Number of Sensors - o The subject device has 8 sensors. The K130906 BF-325N also has 8 sensors. All of the differences have been cleared under previous 510(k) except the balloon size, which is only being offered for the clinician who requires a smaller size. These changes do not alter the indications for use, patient population, environments of use, technological characteristics, contraindications, or performance specifications. The differences do not raise new concerns of safety or effectiveness. ### Substantial Equivalence Conclusion - The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device does not raise any new safety concerns compared to the predicates. {7}------------------------------------------------ ### 510(k) Summary Page 5 of 6 20-Nov-17 ## Table 1 - Comparison of Proposed Device vs. Predicate | | Proposed<br>EsoFLIP® ES-310 catheter | Predicate<br>Crospon EsoFLIP®<br>ES-series (ES-320)<br>K142000 | Reference<br>Crospon ES-330<br>K132337 | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The EsoFLIP® ES balloon catheter is indicated<br>for use to dilate esophageal strictures due to<br>esophageal surgery, primary gastro-esophageal<br>reflux, radiation therapy. | The EsoFLIP® ES balloon catheter is indicated<br>for use to dilate esophageal strictures due to<br>esophageal surgery, primary gastro-esophageal<br>reflux, radiation therapy. | The EsoFLIP® Balloon Catheter is used in<br>a clinical setting to dilate the Gastro-<br>Esophageal Junction for the purpose of<br>treating Achalasia. | | Environments of use | Hospital and surgery centers | Hospital and surgery centers | Hospital and surgery centers | | Patient Population | Patients needing to dilate esophageal strictures | Patients needing to dilate esophageal strictures | Patient with Achalasia | | Contraindications | In cases where endoscopy is contraindicated<br><br>Patients with actively bleeding varices<br><br>diameter measurements and dilation of strictures<br>smaller than 6mm or greater than 10mm | In cases where endoscopy is contraindicated<br><br>patients with actively bleeding varices<br><br>diameter measurements<br>smaller than 8 mm or greater than 20 mm | In cases where endoscopy is contraindicated<br><br>Patients with actively bleeding varices<br><br>diameter measurements smaller than<br>8mm or greater than 30 mm | | Inflation Pressure | 1.5 ATM | 2.0 ATM | 1.5 ATM | | Maximum Balloon<br>Diameter | 10 mm | 20 mm | 30 mm | | Maximum Fill<br>Volume | 16 ml | 42 ml | 75ml | | Balloon Length | 40 mm | 80 mm | 80 mm | | Catheter Tip | Guide-wire | Guide-wire | Guide-wire | | Number of Sensors | 8<br>Reference K130906 – BF-325N has 8 sensors | 16 | 16 | | Principle of Operation | Measurement: Provides an Estimated Diameter<br>(Dest) of the balloon at 8 points along its length<br>when inflated with saline solution. | Measurement: Provides an Estimated Diameter<br>(Dest) of the balloon at 16 points along its length<br>when inflated with saline solution. | Measurement: Provides an Estimated<br>Diameter (Dest) of the balloon at 14 points<br>along its length when inflated with saline<br>solution. | | Equipment<br>Compatibility | Only to be used with EndoFLIP® system | Only to be used with EndoFLIP® system | Only to be used with EndoFLIP® system | | | Proposed<br>EsoFLIP® ES-310 catheter | Predicate<br>Crospon EsoFLIP®<br>ES-series (ES-320)<br>K142000 | Reference<br>Crospon ES-330<br>K132337 | | Materials used /<br>Biocompatibility | Balloon - Nylon 12 | Balloon – Nylon 12 | Balloon – Pebax | | | Shaft - Pebax 7233 SA01<br>Tip - Pebax 2533 SA01 | Shaft - Pebax 7233 SA01<br>Tip - Pebax 2533 SA01 | Shaft - Pebax 7233 SA01<br>Tip - Pebax 2533 SA01 | | Biocompatibility | Surface Contacting<br>Mucosal membrane<br>Limited duration of use<br>(less than 24h) | Surface Contacting<br>Mucosal membrane<br>Limited duration of use<br>(less than 24h) | Surface Contacting<br>Mucosal membrane<br>Limited duration of use<br>(less than 24h) | | Sterility | Accessories are supplied non-sterile, and are<br>single patient use, disposable | Accessories are supplied non-sterile, and are<br>single patient use, disposable | Accessories are supplied non-sterile, and<br>are single patient use, disposable | | Performance | Range: 6 to 10 mm | Range: 8 to 20 mm | Range: 8 to 30 mm | | | Resolution: 0.1 mm | Resolution: 0.1 mm. | Resolution: 0.1 mm. | | | Accuracy: ± 1mm (at 95% confidence) rounded | Accuracy: ± 1mm (at 95% confidence) rounded | Accuracy: ± 1mm (at 95% confidence)<br>rounded to nearest integer | | | to nearest integer | to nearest integer | | {8}------------------------------------------------ # 510(k) Summary