(62 days)
Not Found
No
The summary describes a mechanical support catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a support catheter to access the peripheral or coronary vasculature and facilitate the placement and exchange of guidewires and other interventional devices. While it can deliver diagnostic/therapeutic agents, it is not a therapeutic device itself.
No
The device facilitates placement of other devices and delivery of agents, but it does not perform diagnostic functions itself. It can deliver diagnostic agents, but that does not make the catheter a diagnostic device.
No
The device description clearly states it is a "support catheter body with a luer end" and describes its physical function in the vasculature, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (peripheral and coronary vasculature) to facilitate the placement of other devices and deliver substances. This is an in vivo application.
- Device Description: The description reinforces the in vivo nature, mentioning a support catheter body and a lumen for delivery of agents.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (blood, urine, tissue, etc.) to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
Therefore, the speX LP Support Catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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 LP 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
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
Simulated Use Testing.
The speX LP Support Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the speX LP Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics
Not Found
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2020
Reflow Medical Krystal Santiago Director RA/QA 208 Avenida Fabricante #100 San Clemente, California 92672
Re: K200094
Trade/Device Name: speX LP Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 26, 2020 Received: February 27, 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-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,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional 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 LP Support Catheter
Indications for Use (Describe)
The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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
| Contact | ReFlow Medical, Inc.
208 Avenida Fabricante
#100
San Clemente, CA 92672
Contact person: Krystal Santiago
Phone: (949) 481-0399 |
|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | January 15, 2020 |
| Device | Name of the device: speX LP Support Catheter
Common of usual name: Support Catheter
Classification name: Percutaneous Catheter
Regulatory Class: 2
Product Code: DQY |
| Legally marketed device
to which your firm is
claiming equivalence | speX Support Catheter (K173662)
This predicate has not been subject to a design-related recall |
| Description of the device | The speX LP 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 |
| Intended use of the
device | The speX LP Support Catheter is intended to be used in conjunction with
steerable guidewires to access discreet regions of the peripheral
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. |
| Summary of the technological characteristics of your device compared to the predicate device | |
| The speX LP Support Catheter is nearly identical to the speX Support Catheter previously cleared
(K173662) version of the device. | |
| 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:
- The distal tip of the speX LP support catheter has been modified to replace the one (1) ● radiopaque marker with three (3) lower profile markers.
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A brief discussion of the nonclinical tests submitted
The following performance data were provided in support of the substantial equivalence.
- Simulated Use Testing .
The speX LP Support Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the speX LP Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions
The design testing performed for the speX LP Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices.