(113 days)
Not Found
No
The document describes a physical medical device (a catheter) and its intended use and performance testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML technologies in medical devices.
No
The device facilitates the delivery of therapeutic agents and other devices, but it does not perform a therapeutic action itself.
No
The device is described as a "Support Catheter" used to facilitate placement and exchange of guidewires and other interventional devices, and for delivery of agents. While it can deliver "diagnostic agents," it doesn't perform diagnostic functions itself.
No
The device description clearly states it is a "support catheter body with a luer end," indicating a physical, hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The speX 14/18 Support Catheter is an interventional device used inside the body (in vivo) to assist with procedures in the peripheral and coronary vasculature. It helps with guidewire placement, device exchange, and delivery of substances directly into the body.
The intended use and device description clearly indicate that this is a device used for direct intervention within the patient's circulatory system, not for testing samples taken from the patient.
N/A
Intended Use / Indications for Use
The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic therapeutic agents
Product codes
DQY
Device Description
The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature.
The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral and coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence.
- Simulated Use Testing ●
- . Particulate Testing
The speX Support Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the speX Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
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).
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February 19, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
ReFlow Medical Krystal Santiago Director RA/QA 208 Avenida Fabricante #100 San Clemente, California 92672
Re: K193012
Trade/Device Name: speX Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 13, 2020 Received: January 14, 2020
Dear Krystal Santiago:
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-regulatory-assistance/contact-usdivision-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.
for Lydia Glaw, Ph.D. 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)
Device Name speX 14/18 Support Catheter
Indications for Use (Describe)
The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic therapeutic agents
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 K193012
I. SUBMITTER
ReFlow Medical, Inc. 208 Avenida Fabricante #100 San Clemente, CA 92672
Contact person: Krystal Santiago Phone: (310) 707.5882 Date prepared: October 28, 2019
II. DEVICE
Name of the device: speX Support Catheter Common of usual name: Support Catheter Classification name: Percutaneous Catheter Regulatory Class: 2 Product Code: DQY
- III. PREDICATE DEVICE speX Support Catheter (K173662) This predicate has not been subject to a design-related recall
- IV. DEVICE DESCRIPTION The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature.
The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
V. INDICATIONS FOR USE
The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE
There are no design or material changes to the speX Support Catheter previously cleared (K173662) version of the device.
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The subject and predicate devices are based on the following identical technological elements:
- all delivered to the target site using an over-the-wire percutaneous . technique
- all have a through lumen to allow passage and exchange of guidewires ●
- all have a smooth inner lumen to provide reduced friction for ● guidewire movement
- all have a polymer catheter shaft with specific geometry to control the ● torque and push movements associated with lesion crossing
The following technological differences exist between the subject and predicate devices:
- Addition of the coronary indication .
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence.
- Simulated Use Testing ●
- . Particulate Testing
The speX Support Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the speX Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. CONCLUSIONS
The design testing performed for the speX Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices.