Who is the manufacturer of 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

Creagh Medical Ltd. Dba Surmodics, Inc. filed the 510(k) submission for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K242419).

What is the FDA product code for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

LIT. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

K242419 · Creagh Medical Ltd. Dba Surmodics, Inc. · LIT · Nov 15, 2024 · Cardiovascular

Device Facts

Record ID	K242419
Device Name	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Applicant	Creagh Medical Ltd. Dba Surmodics, Inc.
Product Code	LIT · Cardiovascular
Decision Date	Nov 15, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Coaxial, over-the-wire (OTW) PTA balloon dilatation catheter; semi-compliant balloon at distal tip; two radiopaque markers for placement; bifurcated manifold for 0.018" guidewire and inflation device attachment. Used by physicians in clinical settings; catheter positioned over guidewire under fluoroscopy; balloon inflated with contrast medium to dilate stenotic vessels/fistulae; deflated under vacuum and removed. Benefits include restoration of blood flow in peripheral arteries and dialysis access sites. Provided sterile via ethylene oxide; single-use.

Clinical Evidence

No clinical data; bench testing only. Verification testing included rated burst pressure, inflation/deflation time, balloon diameter, simulated use (pushability/trackability), coating integrity, fatigue/leak testing, and tensile strength. Additional performance data leveraged from the predicate device.

Technological Characteristics

Coaxial catheter; semi-compliant balloon; hydrophilic coating; radiopaque marker bands; ethylene oxide sterilization. Materials: biocompatible polymers. Dimensions: 5Fr sheath compatibility, 0.018" guidewire compatibility. Energy: manual hydraulic inflation via contrast medium.

Indications for Use

Indicated for Percutaneous Transluminal Angioplasty (PTA) of peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal arteries) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K180007)

Reference Devices

Sterling™ Over-the-Wire (OTW) PTA Balloon Dilatation Catheter (K132430)

Related Devices

K180007 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter · Creagh Medical, Ltd. · Apr 19, 2018
K171251 — 014 Hydrophilic Coated PTA Balloon Dilatation Catheter · Creagh Medical · Sep 8, 2017
K143561 — ELM PTA Balloon Dilatation Catheter · O'Connell Regulatory Consultants, Inc. · May 19, 2015
K053116 — STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX · Boston Scientific Corp · Dec 16, 2005
K141118 — NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER · Ev3, Inc. · Jul 18, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 15, 2024 Creagh Medical Ltd. dba Surmodics, Inc. Anne-Marie Keenan Senior Regulatory Affairs Specialist IDA Business Park, Ballinasloe Co. Galway Ballinasloe, H53 K8P4 Ireland Re: K242419 Trade/Device Name: Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: September 19, 2024 Received: September 19, 2024 Dear Anne-Marie Keenan: 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, | Ariel G. Ash- shakoor -S | Digitally signed by Ariel G. Ash-shakoor -S Date: 2024.11.15 19:09:54 -05'00' | |--------------------------------|-------------------------------------------------------------------------------------------| |--------------------------------|-------------------------------------------------------------------------------------------| For Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K242419 Device Name Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter Indications for Use (Describe) The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the word "SURMODICS" in all capital letters. To the left of the word is a blue and green graphic. The graphic is a stylized shape that looks like a ribbon or folded piece of paper. The word "SURMODICS" is in a sans-serif font and is black. ## 510k Summary ## Date Prepared: November 14, 2024 ## Submitters Name/Contact Person ## 510K Submitter and Contact for Routine Correspondence Anne-Marie Keenan Senior Regulatory Affairs Specialist Creagh Medical Ltd. (Surmodics Inc.) Ballinasloe Co. Galwav H53 K8P4 IRELAND Email: akeenan@surmodics.com # 510k Submitter Establishment Registration Number 3005994106 | General Information | | |----------------------------|-------------------------------------------------------------------------| | Trade Name: | Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter | | Common / Usual Name: | PTA Balloon Dilatation Catheter | | Classification Name | Catheter, Angioplasty, Peripheral, Transluminal | | Regulation/Product Code | 21 CFR 870.1250 | | Device Panel | Cardiovascular | | Regulatory Classification: | Class II | | Product Code: | LIT | | Predicate Device: | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K180007) | | Reference Device | Sterling™ Over-the-Wire (OTW) PTA Balloon Dilatation Catheter (K132430) | #### 1.1 Device Description The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Anqioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only. Surmodics, Inc. 9924 West 74th Street Eden Prairie, MN 55344 USA Phone 952-500-7001 www.surmodics.com Creagh Medical Ltd. & Vetex Medical Ltd are now part of Surmodics, Inc. IDA Business Park Ballinasloe, Co. Galway Ireland Phone +353 90 9646300 {5}------------------------------------------------ ### 1.2 Indications for Use The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. ### 1.3 Comparison of Technological Characteristics The subject Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is substantially equivalent to the predicate 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K180007) in design, intended use, principles of use, biocompatibility, sterility, and labeling. Changes to the predicate device that have led to the submission of this new 510(k), are the expansion of the matrix of dilatation balloons available for peripheral balloon angioplasty. All characteristics that were not identical to the predicate device were verified through performance bench testing and determined to be substantially equivalent. | Characteristic | Subject Device: K242419 Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter | Predicate Device: K180007 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Comparison | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Indications for Use | The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infra- popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. | The 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infra- popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. | Identical | | Principles of Operation | Inflation of semi-compliant balloon for dilatation | | Identical | | Guidewire Compatibility | 018" | | Identical | | Catheter Shaft Length (cm) | 40, 90, 120, 135 | 40, 90, 120, 135, 150 | Identical (40, 90, 120, 135cm) | | Sheath Compatibility | 5Fr | 4Fr, 5Fr | Identical (5Fr) | | Catheter Shaft Outer Diameter (mm) | 5Fr: ≤1.667 | 4Fr: ≤1.333 5Fr: ≤1.667 | Identical (5Fr) | | Balloon Length (mm) | 220 | 15, 20, 40, 60, 80, 100, 120, 150, 220 | Identical (220mm) | | Balloon Diameters (mm) | 5.0, 6.0 & 7.0 | 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 | Identical (5.0, 6.0 & 7.0mm) | | Nominal Pressure | 8 ATM | 8 ATM | Identical | | Rated Burst Pressure | 14 & 16 ATM | 10, 12, 14, 16 ATM | Identical (14 & 16 ATM) | | Balloon Material | Semi-Compliant | | Identical | | Catheter Shaft Materials | Polymers, all materials are biocompatible | | Substantially Equivalent | {6}------------------------------------------------ | Characteristic | Subject Device: K242419 Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter | Predicate Device: K180007 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Comparison | |----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------| | Radiopaque Marker Bands | Two radiopaque marker bands | | Identical | | Coating Material | Hydrophilic Coating | | Identical | | Packaging Configuration | Same function and design | | Identical | | Sterilization Method | Ethylene Oxide | | Identical | | Biocompatibility | Externally communicating device in contact with circulating blood for limited exposure duration. | | Substantially Equivalent | | Single Use/ Reprocess | Single use only | | Identical | ### 1.4 Performance Bench Testing Results of design verification testing demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The device has been evaluated through the following tests: - Rated burst pressure (RBP) - - Inflation & deflation time - - -Balloon diameters at nominal pressure to RBP - -Simulated use - Pushability & Trackability & Sheath Compatibility - -Coating integrity (b) - Multiple inflation/fatique & leak test - - Tensile strength Balloon to Shaft (proximal bond) - - -Particulate Performance Bench Tests have been leveraged from predicate device for the following: - Balloon Length & Marker Band Position - - -Radiopacity - -Ancillary Tool Compatibility (Guidewire) - Catheter Effective Length - - Tensile Strength Manifold to Shaft (Manifold Bond) - - -Tensile Strength (Distal / Tip Bond) - Tip Profile (Geometry of the catheter most distal tip) - - -Simulated Use, Push & Track - -Flexibility & Kink - Coating Lubricity - - -Coating Integrity (a) - -Torque Strength ### 1.5 Clinical Studies and Testing No clinical studies were required for the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter. ### 1.6 Conclusion Based on the device description, materials, technological characteristics, and accompanying performance data, it can be concluded that the device modifications made to the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter are substantially equivalent to the predicate device.