Sublime Radial Access 018 RX Dilatation Catheter

K211044 · Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, · LIT · Jun 16, 2021 · Cardiovascular

Device Facts

• Record ID: K211044
• Device Name: Sublime Radial Access 018 RX Dilatation Catheter
• Applicant: Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,
• Product Code: LIT · Cardiovascular
• Decision Date: Jun 16, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 018 Radial Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Co-axial rapid exchange (RX) balloon dilatation catheter; designed for 0.018" guidewire compatibility. Used in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal arteries) and arteriovenous dialysis fistulae. Operated by physicians in clinical settings. Procedure: catheter positioned over guidewire under fluoroscopic guidance; balloon inflated with contrast medium via external inflation device to dilate stenosis; deflated under vacuum; removed. Radiopaque markers facilitate placement. Hydrophilic coating enhances trackability. Single-use; sterile (ethylene oxide).

Clinical Evidence

No clinical studies were required. Substantial equivalence is supported by bench testing, including rated burst pressure, inflation/deflation time, balloon diameter, simulated use (pushability/trackability), coating lubricity/durability, tip profile, fatigue/leak testing, tensile strength, flexibility/kink, particulates, and torque strength.

Technological Characteristics

Co-axial RX catheter system; semi-compliant balloon; 0.018" guidewire compatible. Materials include hydrophilic coating. Single luer hub for inflation. Sterilized via ethylene oxide. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring PTA dilation of peripheral vasculature stenosis in iliac, femoral, popliteal, infra-popliteal, and 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

• Sublime™ Radial Access 014 RX PTA Dilatation Catheter (K200700)

Reference Devices

• 018 Hydrophilic Coated Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K180007)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 16, 2021

Creagh Medical Ltd. (a wholly owned subsidiary of Surmodics, Inc.) Holly Ramirez Senior Principal Regulatory Affairs Specialist IDA Business Park Ballinasloe, Galway H53 HY09 Ireland

Re: K211044

Trade/Device Name: Sublime Radial Access 018 RX Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: May 14, 2021 Received: May 17, 2021

Dear Holly Ramirez:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number: K211044

Device Name

SublimeTM Radial Access 018 RX Dilatation Catheter

#### Indications for Use (Describe)

The 018 Radial Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, poplited, infra-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) |
|-------------------------------------------------|
|-------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

Date Prepared: 07 April 2021

# 510K Submitter and Contact for Routine Correspondence

Holly Ramirez Senior Principal Regulatory Affairs Specialist 9924 W 74th St Eden Prairie, MN 88344 Phone (952) -500-7545 Email: [e-mail]

### 510k Submitter Establishment Registration Number

3005994106

| General Information | |
|----------------------------|--------------------------------------------------------------------------------------------------|
| Trade Name: | Sublime™ Radial Access 018 Rx 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: | Sublime™ Radial Access 014 RX PTA Dilatation Catheter (K200700) |
| Reference Device | 018 Hydrophilic Coated Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K180007) |

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#### Device Description

The 018 Radial Access Rx Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.018" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. 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 inflated with 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 018 Radial Access Rx Dilatation Catheter is provided sterile via ethylene oxide and is intended for single use only.

#### Indication for Use

The 018 Radial Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

#### Comparison of Technological Characteristics

The Surmodics Sublime Radial Access 018 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter device is substantially equivalent to the 014 Radial Access Rx Dilatation Catheter (K200700) 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 geometric and material in nature. All characteristics that were not identical to the predicate device were verified through performance bench testing and determined to be substantially equivalent.

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## 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 014 Rx PTA Balloon Catheter has been evaluated through the following tests:

- -Rated burst pressure (RBP)
- -Inflation & deflation time
- Balloon diameters at nominal pressure -
- -Simulated use - pushability & trackability
- Coating lubricity -
- Coating durability -
- Coating length -
- Ancillary tool compatibility (guidewire) -
- -Tip profile
- Multiple inflation/fatigue & leak test -
- -Tensile strength
- Flexibility & kink -
- Particulates -
- Torque Strength -

## Clinical Studies and Testing

No clinical studies were required for the 018 Radial Access Rx Dilatation Catheter.

### Conclusion

Based on the device description, materials, technological characteristics, and accompanying performance data it can be concluded that the device modifications made to the 018 Radial Access Rx Dilatation catheter are substantially equivalent to the predicate device and the device will continue to function per its intended use.