(107 days)
No
The description focuses on the physical characteristics and performance of a microcatheter for accessing peripheral vasculature and delivering substances, with no mention of AI or ML capabilities.
No
The device is intended to facilitate access and delivery of other substances or devices, not to directly treat a medical condition.
No
The "Intended Use / Indications for Use" section states that the device is intended to "provide a conduit for the delivery of saline solutions or diagnostic contrast agents," which implies it assists in diagnosis but is not a diagnostic device itself. Its primary function is to access vasculature and facilitate guidewire placement.
No
The device description clearly describes a physical catheter with material properties, dimensions, and a luer fitting, indicating it is a hardware device, not software only.
Based on the provided information, the Sublime™ Microcatheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for accessing the peripheral vasculature to facilitate guidewire placement/exchange and deliver saline or contrast agents. This is an in vivo application, meaning it is used within the living body.
- Device Description: The description details a catheter designed for insertion into blood vessels. This aligns with an in vivo medical device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Sublime Microcatheter's function is entirely focused on facilitating procedures within the patient's circulatory system.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160884 CXI Support Catheter
Reference Device(s)
K173560 Telemark Microcatheter, K211044 Sublime 018 Radial Access Rx Dilatation Catheter
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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
2
Indications for Use
510(k) Number (if known) K221886
Device Name Sublime™ Microcatheter
Indications for Use (Describe)
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.
| 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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3
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.
4
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 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. | The CXI™ Support Catheter is intended | |
| for use in small vessel or super selective | ||
| anatomy for diagnostic and interventional | ||
| procedures, including peripheral use. | ||
| Principles of Use | The Sublime Microcatheter is presented to | |
| a sterile field through aseptic presentation. | ||
| The device is inserted over a guidewire into | ||
| the vasculature and advanced, following the | ||
| path of the guidewire. The microcatheter | ||
| acts a rigid support for the guidewire for | ||
| sections of the vasculature that may be | ||
| difficult to cross due to excessive stenosis, | ||
| or where lesions may be present. Once in | ||
| the intended location in the vasculature, the | ||
| microcatheter lumen may be used to | ||
| exchange guidewires, or for injection of | ||
| saline solutions and contrast media. | The Cook CXI Support Catheter is | |
| presented to a sterile field through aseptic | ||
| presentation. The device is inserted over | ||
| a guidewire into the vasculature and | ||
| advanced, following the path of the | ||
| guidewire. The microcatheter acts a rigid | ||
| support for the guidewire for sections of | ||
| the vasculature that may be difficult to | ||
| cross due to excessive stenosis, or where | ||
| lesions may be present. Once in the | ||
| intended location in the vasculature, the | ||
| microcatheter lumen may be used to | ||
| exchange guidewires, or for injection of | ||
| saline solutions and contrast media. | ||
| Dimensions | Distal ID (inches): 0.015, 0.019, 0.036 | |
| Shaft OD: 2.4Fr, 2.6Fr, 4.0Fr | ||
| Catheter Effective Length (cm): 65-200 | Distal ID (inches): 0.014, 0.018, 0.035 | |
| Shaft OD: 2.3Fr, 2.6Fr, 4.0Fr | ||
| Catheter Effective Length (cm): 65-150 | ||
| Tip | ||
| Configurations | Straight and Angled Tip Profiles | Straight and Angled Tip Profiles |
| Materials | Dual layer Stainless Steel Braid with | |
| reflowed PEBAX Jacket | Stainless Steel Braid with reflowed | |
| PEBAX 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
5
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.