The UHP Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Surmodics™ Arise™ UHP Dilatation Catheter is a coaxial Over the Wire (OTW) 0.035' PTA Balloon Dilatation Catheter with a distal inflatable balloon intended to be used for the treatment of peripheral arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The UHP Dilatation Catheter obtains a low compliance at high pressure over a large working range. The proximal portion of the catheter has a bifurcated manifold which includes a balloon lumen marked "BAL" and a guidewire lumen. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The catheter is designed so that a specific balloon diameter can be reached depending on the balloon size and defined pressure.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the Arise™ UHP Dilatation Catheter. This document details the regulatory approval process for a new medical device and focuses on establishing "substantial equivalence" to a predicate device, rather than proving a device's performance against specific clinical acceptance criteria in the manner one might see for an AI/ML diagnostic or prognostic device.

Therefore, many of the requested criteria, such as those related to AI model performance, expert ground truth establishment, MRMC studies, and training/test set details, are not applicable to this type of device and submission.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document states that "All test results met documented acceptance criteria and/or included justification of values." However, it does not provide a table with specific quantitative acceptance criteria or the reported performance values for each test. Instead, it lists the types of tests performed:

Category	Tests Performed	Acceptance Criteria / Performance
Performance Bench Testing	- Rated Burst Pressure (RBP)- Balloon Diameter at Nominal Pressure- Inflation & Deflation Time- Balloon Length & Marker Band Position- Radiopacity- Ancillary Tool Compatibility (Guidewire)- Catheter Effective Length- Tip Profile (Geometry of the catheter most distal tip)- Simulated Use- Crossing Profile- Multiple Inflation/Fatigue & Leak Test- Tensile Strength (strength of the catheter shafts, bonds, and tip)- Flexibility & Kink	"All test results met documented acceptance criteria and/or included justification of values." (Specific values not provided in this document). Testing demonstrated that "technological differences identified do not raise new questions of safety or effectiveness."
Biocompatibility	- Cytotoxicity- Irritation / Intracutaneous Reactivity- Sensitization- Acute Systemic Toxicity- Pyrogenicity- Hemocompatibility (Hemolysis ASTM Method (Direct and Indirect), C3a Complement Activation Assay, O SC5b Complement Activation Assay, In Vivo Thrombogenicity)- Genotoxicity- Bacterial Reverse Mutation- Chemical Characterization	"All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." (Specific values not provided). Biocompatibility evaluated per ISO 10993-1 and FDA Guidance.
Sterilization	Product testing for Ethylene Oxide (EtO) sterilization	"Sterilization method... meets the requirements of ISO 11135, and that the sterility of the device will be maintained over the entirety of shelf life."

2. Sample sizes used for the test set and the data provenance

For the bench testing, the specific sample sizes for each test are not detailed in this summary. The data provenance is laboratory-based testing on the device components and the assembled device itself (e.g., testing the mechanical properties of the catheter, balloon, etc.). There is no patient data or clinical data utilized for testing in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device relying on expert-labeled ground truth from medical images or clinical data. The "ground truth" for this device's performance is established through engineering specifications, material science, and established test methodologies (e.g., ISO standards, ASTM methods).

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication involved in the bench testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

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

Not applicable. This is not an algorithm; it is a physical medical device (catheter). Standalone performance refers to the device's mechanical, material, and functional properties as tested in the lab.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's safety and effectiveness is primarily based on:

Engineering specifications and design requirements: Whether the device meets its intended physical and mechanical properties.
Established international standards (ISO, ASTM): Compliance with recognized standards for medical device performance, biocompatibility, and sterilization.
Comparison to a predicate device: Establishing substantial equivalence by demonstrating similar performance characteristics to a legally marketed device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML model for this type of device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

March 22, 2023

Creagh Medical Ltd Peter Bather Sr. Regulatory Affairs Associate IDA Business Park Ballinasloe, Galway H53 K8P4 Ireland

Re: K230191

Trade/Device Name: Arise™ UHP Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: January 23, 2023 Received: January 24, 2023

Dear Peter Bather:

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 W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2023.03.22

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) K230191

Device Name Arise™ UHP Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/2 description: The image shows the text "510(K) Summary" at the top, followed by the Surmodics logo. The Surmodics logo is a stylized blue and green shape, followed by the text "SURMODICS" in a sans-serif font. The logo is likely for a medical device company, given the 510(K) reference.

Date Prepared: January 23, 2023

Submitters Name / Contact Person

510k Submitter Address

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

Contact for Official/Routine Correspondence Peter Bather Sr. Regulatory Affairs Associate 7905 Golden Triangle Drive Suite 190 Eden Prairie, MN 55344 Phone: (952) 500-7548

Email: pbather@surmodics.com

General Information
Trade Name:	Arise™ UHP 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:	ELM High Pressure Balloon Dilatation Catheter510(k)#: K102645

Device Description

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Intended Use / Indications

Comparison of Technological Characteristics

The UHP Dilatation Catheter is equivalent to the legally marketed predicate device (ELM High Pressure Balloon Dilatation Catheter) in design, indications for use, materials, sizes, and sterility. The UHP Dilatation Catheter and the predicate device are indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Substantial Equivalence and Summary of Studies

The UHP Dilatation Catheter is substantially equivalent to the predicate devices based on the indications for use, technological characteristics, and principles of use. Results of successful design verification testing demonstrate that the technological differences identified do not raise new questions of safety or effectiveness for the UHP Dilation Catheter compared to the predicate device. All test results met documented acceptance criteria and/or included justification of values.

The subject device has been evaluated through the following categories of testing.

Performance Bench Testing .
Biocompatibility
Sterilization ●

Performance Bench Testing

The UHP Dilatation Catheter has been evaluated through the following tests:

Rated Burst Pressure (RBP) ●
Balloon Diameter at Nominal Pressure ●
Inflation & Deflation Time ●
Balloon Length & Marker Band Position
. Radiopacity
Ancillary Tool Compatibility (Guidewire) ●
Catheter Effective Length
Tip Profile (Geometry of the catheter most distal tip) ●
Simulated Use
Crossing Profile
Multiple Inflation/Fatigue & Leak Test ●
Tensile Strength (strength of the catheter shafts, bonds, and tip) ●
Flexibility & Kink ●

Biocompatibility

Biocompatibility of the Braided Balloon 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 10993-1 the Braided Balloon Catheter is

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classified as an externally communicating device in contact with circulating blood for limited exposure duration. Biocompatibility and chemical characterisation 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 and chemical characterization tests were performed in accordance with ISO 10993-1:

Cytotoxicity ●
Irritation / Intracutaneous Reactivity .
Sensitization .
Acute Systemic Toxicity ●
Pyrogenicity
Hemocompatibility ●
- Hemolysis ASTM Method (Direct and Indirect) o
- C3a Complement Activation Assay o
- O SC5b Complement Activation Assay
- In Vivo Thrombogenicity o
. Genotoxicity
Bacterial Reverse Mutation .
. Chemical Characterization

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

Sterilization

The results of the sterilization product testing have demonstrated that the Ethylene Oxide (EtO) sterilization method for the UHP Dilatation Catheter meets the requirements of ISO 11135, and that the sterility of the device will be maintained over the entirety of shelf life.

Animal Testing

No animal testing data is being submitted for the UHP Dilatation Catheter.

Clinical Data

No clinical data is being submitted for the UHP Dilatation Catheter.

Conclusions

Based upon the device description, indications for use, technological characteristics & performance data it can be concluded that the UHP Dilatation Catheter is substantially equivalent to the predicate device.

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).