The Sublime™ Microcatheter is intended to access the peripheral vasculature in order to facilitate the placement and/or the exchange of guidewires. The Sublime Microcatheter is also intended to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

The Sublime Microcatheter is a sterile, single-use, disposable intravascular catheter with an atraumatic distal tip and a proximal hub with a luer fitting. The Sublime Microcatheter is a single lumen support catheter, compatible with 014", 018", and 035" guide wire platforms and a 4F guide catheter. It has a working length of up to 200 cm, and both straight and angled tip configurations. The catheter has a stainless-steel braid supported construction with hydrophilic coating. The distal end of the catheter includes a radiopaque markerband to facilitate visualization under fluoroscopy.

AI/ML Overview

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Sublime™ Microcatheter. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document pertains to a medical device (Microcatheter), not an AI/software device. Therefore, many of the typical questions for AI/software such as "Number of experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Training set sample size," and "How ground truth for training set was established" are not applicable in this context. The acceptance criteria and studies are for a physical medical device's performance characteristics.

Acceptance Criteria and Reported Device Performance

The document states that "All test results met documented acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed, implying that specific criteria were defined and met internally by the manufacturer.

Table 1: Acceptance Criteria and Reported Device Performance (as inferred from the text)

Performance Characteristic/Test	Acceptance Criteria (Not explicitly stated in document, but implied meeting criteria)	Reported Device Performance (Not explicitly quantified, but stated as "met documented acceptance criteria")
Flow Rate	Must meet intended flow rates for saline/contrast delivery	Met documented acceptance criteria
Dimensional Evaluations	Must conform to specified dimensions (e.g., ID, OD, length)	Met documented acceptance criteria
Radiopacity	Must be sufficiently visible under fluoroscopy	Met documented acceptance criteria
Tensile Strength	Must withstand specified tensile forces without failure	Met documented acceptance criteria
Freedom from Leakage	Must not leak under specified pressure/conditions	Met documented acceptance criteria
Hub/Luer connector compatibility	Must be compatible with standard luer fittings	Met documented acceptance criteria
Guidewire Movement	Must allow smooth guidewire placement and exchange	Met documented acceptance criteria
Burst Testing	Must withstand specified internal pressures without bursting	Met documented acceptance criteria
Flexibility and Kink Resistance	Must exhibit appropriate flexibility and resist kinking during insertion/maneuvering	Met documented acceptance criteria
Track Force	Must achieve specified trackability over a guidewire	Met documented acceptance criteria
Torque Strength	Must withstand specified torque forces without failure	Met documented acceptance criteria
Hydrophilic Coating	Must maintain lubricity and integrity as specified	Met documented acceptance criteria
Particulate Testing	Must demonstrate minimal particulate release	Met documented acceptance criteria
Atraumatic Surfaces	Must have smooth surfaces to prevent vessel damage	Met documented acceptance criteria
Simulated Use Testing	Must perform acceptably in simulated clinical scenarios	Met documented acceptance criteria
Biocompatibility
- Cytotoxicity	Non-cytotoxic	Met documented acceptance criteria
- Hemocompatibility	Hemocompatible	Met documented acceptance criteria
- Sensitization	Non-sensitizing	Met documented acceptance criteria
- Acute System Toxicity	Non-toxic acute system response	Met documented acceptance criteria
- Irritation/Reactivity	Non-irritating/non-reactive	Met documented acceptance criteria
- Pyrogenicity	Non-pyrogenic	Met documented acceptance criteria

Study Details

As this is a physical medical device, the "study" primarily consists of design verification testing rather than clinical performance studies typically seen with diagnostic or AI devices. The goal is to demonstrate "substantial equivalence" to a predicate device based on performance characteristics.

Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes used for each of the listed tests (e.g., number of catheters tested for flow rate, tensile strength, etc.).
- Data Provenance: This would typically be from laboratory bench testing and simulated use, conducted by the manufacturer (Surmodics Inc.). The country of origin is implied to be the USA, as the company is based in Eden Prairie, Minnesota, and submitting to the US FDA. The testing is prospective in nature, as it's part of the premarket notification process for a new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable for this type of medical device clearance. "Ground truth" in this context refers to engineering specifications and performance standards established by the manufacturer and recognized industry standards (e.g., ISO standards for medical devices). The expertise would be in materials science, mechanical engineering, and quality control, rather than medical interpretation by radiologists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for engineering bench testing. Adjudication methods are typically for human interpretation of medical images or clinical outcomes. Deviations from expected test results would be handled through a non-conformance process and investigation by engineers and quality personnel.
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:
- This is not applicable. This is a physical microcatheter, not an AI software. No human reader studies (MRMC) were conducted or required for this type of device clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or more appropriately, the reference standard) for these tests is based on defined engineering specifications, performance standards (e.g., ISO standards for catheters), and validation methods for each physical characteristic (e.g., a calibrated flow meter for flow rate, a universal testing machine for tensile strength, a pressure gauge for burst testing). Biocompatibility is assessed against established biological safety standards.
The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above.

Summary

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October 14, 2022

Surmodics Inc. Holly Ramirez Senior Staff Regulatory Affairs Specialist 7905 Golden Triangle Drive Suite 190 Eden Prairie, Minnesota 55344

Re: K221886

Trade/Device Name: Sublime Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: June 28, 2022 Received: June 29, 2022

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 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

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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 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 (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) K221886

Device Name Sublime™ Microcatheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K221886 510(K) Summary

Image /page/3/Picture/1 description: The image shows the word "SURMODICS" in a sans-serif font. The letters are dark gray, and there is a blue and green geometric shape to the left of the word. The shape appears to be made up of three triangular prisms.

Date Prepared: 10/3/2022

Submitters Name / Contact Person

510k Submitter Address

Surmodics, Inc. 7905 Golden Triangle Dr. Ste. 190 Eden Prairie MN 55344 Phone - (952) 500 - 7528 Fax - (763) 557-6674

Contact for Official/Routine Correspondence

Holly Ramirez Senior Principal Regulatory Specialist 7805 Golden Triangle Dr. Ste. 190 Eden Prairie, MN 55344 Phone - (952) 500 - 7545 Email - hramirez@surmodics.com

Table 1: General Information
Trade Name:	Sublime™ Microcatheter
Common / Usual Name:	Microcatheter
Classification:	Class II
Product Code:	DQY, KRA
Predicate Device:	K160884 CXI Support Catheter (cleared November 22, 2016)
Reference Devices:	K173560 Telemark Microcatheter (cleared January 12, 2018)K211044 Sublime 018 Radial Access Rx Dilatation Catheter(cleared June 16, 2021)

Device Description

The Sublime Microcatheter is a sterile, single-use, disposable intravascular catheter with an atraumatic distal tip and a proximal hub with a luer fitting.

The Sublime Microcatheter is a single lumen support catheter, compatible with 014", 018", and 035" guide wire platforms and a 4F guide catheter. It has a working length of up to 200 cm, and both straight and angled tip configurations. The catheter has a stainless-steel braid supported construction with hydrophilic coating. The distal end of the catheter includes a radiopaque markerband to facilitate visualization under fluoroscopy.

Intended Use / Indications

The Sublime Microcatheter is intended to access the peripheral vasculature in order to facilitate the placement and/or the exchange of guidewires. The Sublime Microcatheter is also intended to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

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Comparison of Technological Characteristics

The Sublime™ Microcatheter is substantially equivalent to the legally marketed predicate device in design, intended use, principles of use, materials, and sterility. The Sublime Microcatheter and the predicate device are intended as support catheters to assist in the placement and/or exchange of guidewires. Both devices have equivalent performance and safety profiles, as evidenced through design verification and comparative testing. The devices are made from similar materials, and both have a lubricious coating.

Table 2: Predicate Device Comparison
510(k) #	K221886	K160884
Intended Use /Indications	The Sublime Microcatheter is intended toaccess the peripheral vasculature in order tofacilitate the placement and/or the exchangeof guidewires. The Sublime Microcatheteris also intended to provide a conduit for thedelivery of saline solutions or diagnosticcontrast agents.	The CXI™ Support Catheter is intendedfor use in small vessel or super selectiveanatomy for diagnostic and interventionalprocedures, including peripheral use.
Principles of Use	The Sublime Microcatheter is presented toa sterile field through aseptic presentation.The device is inserted over a guidewire intothe vasculature and advanced, following thepath of the guidewire. The microcatheteracts a rigid support for the guidewire forsections of the vasculature that may bedifficult to cross due to excessive stenosis,or where lesions may be present. Once inthe intended location in the vasculature, themicrocatheter lumen may be used toexchange guidewires, or for injection ofsaline solutions and contrast media.	The Cook CXI Support Catheter ispresented to a sterile field through asepticpresentation. The device is inserted overa guidewire into the vasculature andadvanced, following the path of theguidewire. The microcatheter acts a rigidsupport for the guidewire for sections ofthe vasculature that may be difficult tocross due to excessive stenosis, or wherelesions may be present. Once in theintended location in the vasculature, themicrocatheter lumen may be used toexchange guidewires, or for injection ofsaline solutions and contrast media.
Dimensions	Distal ID (inches): 0.015, 0.019, 0.036Shaft OD: 2.4Fr, 2.6Fr, 4.0FrCatheter Effective Length (cm): 65-200	Distal ID (inches): 0.014, 0.018, 0.035Shaft OD: 2.3Fr, 2.6Fr, 4.0FrCatheter Effective Length (cm): 65-150
TipConfigurations	Straight and Angled Tip Profiles	Straight and Angled Tip Profiles
Materials	Dual layer Stainless Steel Braid withreflowed PEBAX Jacket	Stainless Steel Braid with reflowedPEBAX Jacket
Distal Coating	Hydrophilic Coating	Hydrophilic Coating
Ancillary Device	014", 018", and 035" guide wire	014", 018", and 035" guide wire
Compatibility	4F Guide Catheter	4F Guide Catheter
Sterilization	Ethylene Oxide	Ethylene Oxide
Single Use	Single Use	Single Use

Substantial Equivalence and Summary of Studies

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 Sublime Microcatheter is

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substantially equivalent to the predicate device based on intended use/indications for use and technological characteristics. The subject device has been evaluated through the following tests:

Flow Rate
. Dimensional Evaluations
Radiopacity .
Tensile Strength .
Freedom from Leakage
. Hub/Luer connector compatibility
. Guidewire Movement
Burst Testing ●
. Flexibility and Kink Resistance
. Track Force
Torque Strength ●
Hydrophilic Coating ●
Particulate Testing
Atraumatic Surfaces
Simulated Use Testing
Biocompatibility ●
- o Cytotoxicity
- o Hemocompatibility
- Sensitization o
- Acute System Toxicity O
- Irritation/Reactivity O
- Pyrogenicity o

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