The Sublime™ Radial Access 014 RX PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The 014 RX PTA 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 0.014" 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 014 RX PTA Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Surmodics™ Sublime™ Radial Access 014 RX PTA Dilatation Catheter. This document asserts substantial equivalence to a predicate device, meaning it's claimed to be as safe and effective as a legally marketed device, and therefore does not typically involve the extensive clinical trials and efficacy studies seen with novel devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formalized table of acceptance criteria with quantified performance targets and corresponding results. Instead, it states that "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." for the biocompatibility tests and that performance bench testing results "demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device."

Here's a summary of the types of tests performed and the implicit "acceptance criteria" met:

Acceptance Criteria Category	Reported Device Performance	Implicit Acceptance Criteria
Performance Bench Testing
Rated burst pressure (RBP)	Met criteria	RBP is sufficient for intended use and comparable to predicate.
Inflation & deflation time	Met criteria	Inflation/deflation times are within acceptable ranges for clinical use.
Balloon diameters at nominal pressure	Met criteria	Balloon diameters at nominal pressure are within specifications.
Simulated use pushability & trackability	Met criteria	Device can be successfully maneuvered and positioned in simulated vessels.
Coating lubricity	Met criteria	Coating reduces friction sufficiently.
Coating durability	Met criteria	Coating integrity is maintained during use.
Coating length	Met criteria	Coating covers the specified length of the device.
Ancillary tool compatibility (guidewire)	Met criteria	Device is compatible with specified guidewires.
Tip profile	Met criteria	Tip profile is within dimensions for safe navigation.
Multiple inflation/fatigue & leak test	Met criteria	Balloon can withstand multiple inflations and does not leak.
Tensile strength	Met criteria	Catheter components have sufficient tensile strength.
Flexibility & kink	Met criteria	Device is flexible enough for navigation and resists kinking.
Particulate	Met criteria	Particulate matter is within acceptable limits.
Torque strength	Met criteria	Device can be torqued without structural failure.
Biocompatibility Testing
MEM Elution Cytotoxicity	Met documented acceptance criteria	No cytotoxic effects observed.
Kligman Maximization Sensitization	Met documented acceptance criteria	No significant sensitization response observed.
Irritation by Intracutaneous Injection	Met documented acceptance criteria	No significant irritation observed.
Acute Systemic Toxicity by Systemic Injection	Met documented acceptance criteria	No acute systemic toxic effects observed.
Rabbit Pyrogen Test (Material Mediated)	Met documented acceptance criteria	No pyrogenic response observed.
Hemolysis ASTM Method	Met documented acceptance criteria	No significant hemolysis observed.
SC5b Complement Activation Assay	Met documented acceptance criteria	No significant complement activation observed.
Thrombogenicity Testing	Met documented acceptance criteria	No significant thrombogenic potential observed.
Sterilization Testing
Sterilization Product Testing	Demonstrated suitability	Sterilization cycle effectively sterilizes the device.
Product Bioburden	Demonstrated suitability	Bioburden level is acceptable for sterilization.
LAL/Endotoxin Testing	Demonstrated suitability	Endotoxin levels are below acceptable limits.
Residual Degas Assessment	Demonstrated suitability	EO residuals are within acceptable limits after degassing.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes for the performance bench tests, biocompatibility tests, or sterilization tests. It only lists the types of tests performed.

Regarding data provenance:

The tests were conducted by the manufacturer, Creagh Medical, Ltd., dba Surmodics, Inc.
The sterilization site is Synergy Health Ireland.
The device is intended for the U.S. market, regulated by the FDA.
The data would be considered retrospective in the sense that these are studies conducted on manufactured devices as part of the development and regulatory submission process, not ongoing clinical data collection.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the document. The type of device (dilatation catheter) and the studies performed (bench, biocompatibility, sterilization) do not inherently require "ground truth" to be established by experts in the same way an AI diagnostic device would. For these types of tests, ground truth is typically established by physical measurement against engineering specifications and industry standards.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert panel reviews for diagnostic devices to resolve discrepancies in interpretations of medical images or patient data. The current document describes bench, biocompatibility, and sterilization testing, which rely on standardized laboratory procedures and measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical instrument (a dilatation catheter), not an AI algorithm assisting human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this device.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument and does not involve any artificial intelligence algorithms.

7. The Type of Ground Truth Used:

For the performance bench testing, the "ground truth" would be the engineering specifications, industry standards (e.g., ISO), and design requirements for a PTA balloon catheter.
For biocompatibility, the ground truth is established by internationally recognized standards and guidelines (ISO 10993-1), with testing against biological responses (e.g., cytotoxicity, irritation, hemolysis).
For sterilization, the ground truth is established by sterilization standards (ISO 11135) and validated procedures to ensure sterility assurance levels.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. "Training set" refers to data used to train machine learning models. This device is a physical catheter, not an AI algorithm.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as above (not an AI device).

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 14, 2020

Creagh Medical Ltd. Amy Yanta Regulatory Affairs 9924 W 74th St Eden Prairie, MN 55344

Re: K200700

Trade/Device Name: Surmodics™ Sublime™ Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: March 16, 2020 Received: March 17, 2020

Dear Ms. Yanta:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 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-regulatoryassistance/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,

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 (if known) K200700

Device Name

Surmodics™ Sublime™ Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter

Indications for Use (Describe)

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

Image /page/3/Picture/2 description: The image shows the logo for "SURMODICS". The logo consists of a stylized graphic to the left of the company name. The graphic is a gray, folded or layered shape, possibly representing a ribbon or a stylized "S". The text "SURMODICS" is in a bold, sans-serif font, with each letter clearly legible.

Date Prepared: March 16, 2020

Submitters Name / Contact Person 510k Submitter Address

Creagh Medical, Ltd., dba Surmodics, Inc. IDA Business Park, Ballinasloe, Co. Galway, H53 K8P4 Ireland

Contact for Official/Routine Correspondence

Amy Yanta Regulatory Affairs 9924 W 74th St Eden Prairie, MN 55344 Phone: (952) 500-7562 Email: ayanta@surmodics.com

510k Submitter Establishment

Registration Number

3005994106

General Information
Trade Name:	SurmodicsTM SublimeTM Radial Access 014 RX PTA (PercutaneousTransluminal Angioplasty) Dilatation Catheter
Common / Usual Name:	014 RX PTA 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:	014 Hydrophilic Coated PTA Balloon Dilatation Catheter510(k)#: K171251

Device Description

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Indications for Use

The Sublime™ Radial Access 014 RX PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Comparison of Technological Characteristics

The 014 RX PTA Dilatation Catheter incorporates substantially equivalent device design, materials, packaging, manufacturing processes & sterilization method as the predicate 014 Hydrophilic Coated PTA Balloon Dilatation Catheter. The 014 RX PTA Dilatation Catheter incorporates substantially equivalent device design, materials, and hydrophilic coating as the predicate 014 Hydrophilic Coated PTA Balloon Dilatation Catheter. The 014 RX PTA Dilatation Catheter has the same indications for use and classification as the predicate device. Where substantial equivalence is not directly demonstrated from the perspective of technology and performance, design verification testing provides evidence of the substantial equivalence of the 014 RX PTA Dilatation Catheter with the 014 Hydrophilic Coated PTA Balloon Dilatation Catheter.

Substantial Equivalence and Summary of Studies

The following non-clinical testing was performed:

Performance Bench Testing
Biocompatibility
Sterilization

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 Dilatation 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 -
-Particulate
-Torque strength

Biocompatibility

Biocompatibility of the 014 RX PTA Dilatation Catheter has been evaluated in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, Guidance for Industry and Food and Drug Administration Staff". Per the requirements of ISO 10993

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1 the 014 RX PTA Dilatation Catheter is classified as an externally communicating device in contact with circulating blood for limited exposure duration. Biocompatibility tests appropriate for the device classification were selected, and testing was completed in accordance with FDA Good Laboratory Practice (GLP) regulations (21 CFR, Part 58). The following biocompatibility tests were performed:

-MEM Elution Cytotoxicity Testing
Kligman Maximization Sensitization Test -
-Irritation by Intracutaneous Injection
Acute Systemic Toxicity by Systemic Injection -
Rabbit Pyrogen Test (Material Mediated) -
-Hemolysis ASTM Method
-SC5b Complement Activation Assay
-Thrombogenicity Testing

All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness.

Sterilization

The Ethylene Oxide (EtO) sterilization cycle used for the predicate 014 Hydrophilic Coated PTA Balloon Dilatation Catheter device will be adapted to include the 014 RX PTA Dilatation Catheter. To confirm the suitability of the sterilization cycle for the device the following sterilization product testing has been completed:

Sterilization Product Testing at the sub-lethal cycle and full cycle of the validated sterilization cycle.
Product Bioburden (Bioburden Validation)
LAL/Endotoxin Testing (LAL Validation)
Residual Degas Assessment ●

The results of the sterilization product testing have demonstrated that the Ethylene Oxide (EtO) sterilization method for the 014 RX PTA Dilatation Catheter meets the requirements of ISO 11135, and that the sterility of the device will be maintained.

Creagh Medical utilized the following sterilization site:

Synergy Health Ireland, Sragh Industrial Estate, Tullamore. Co. Offaly, Ireland.

Clinical Data

No clinical data is being submitted for the 014 Rx PTA Balloon Catheter.

Conclusions

Based upon the device description, indications for use, technological characteristics & performance data it can be concluded that the 014 RX PTA Dilatation Catheter is substantially equivalent to the predicate devices and is appropriate for the intended use.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).