(117 days)
No
The document describes a mechanical support catheter and does not mention any AI/ML components or functionalities.
No
The device is a support catheter used to facilitate the placement and exchange of guidewires and other interventional devices and for delivery of solutions, not to provide therapy itself.
No
The device is described as a support catheter intended to facilitate the placement of guidewires and other interventional devices and to provide a conduit for the delivery of diagnostic contrast. While it can deliver diagnostic contrast, its primary function is not to diagnose a condition itself, but rather to support other diagnostic or interventional procedures.
No
The device description clearly outlines a physical catheter with a body, luer end, and tip, and the performance studies focus on bench testing of physical properties like kink resistance and bond testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cora Catheters are described as devices used within the body (in the coronary and peripheral vasculature) to facilitate access, guidewire placement, and delivery of substances like saline or contrast. They are interventional devices used during procedures, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states accessing and facilitating procedures within the vasculature. While they can deliver diagnostic contrast, the primary function is not the analysis of a sample for diagnostic purposes.
Therefore, the Cora Catheters fall under the category of medical devices used for interventional procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.
Product codes
DQY
Device Description
The coraForce and coraFlex Support Catheters are devices intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary vasculature.
The device consists of a support catheter body with a luer end and a polymer tip (coraFlex) or metallic tip (coraForce). The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and 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)
A full bench testing package is provided with the following data:
- Simulated Use
- Kink Resistance
- Corrosion Resistance
- Component Integrity
- Bond Testing
- Torque Testing
- Flow Rate and Burst Testing
- Lubricity and Coating Integrity Testing
- Particulate Characterization
- Usability Verification
- Sterilization Adoption
- Biocompatibility Assessment
The coraForce and coraFlex Support Catheters met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the coraForce and coraFlex Support Catheters were found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
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.
October 26, 2020
Reflow Medical, Inc. Krystal Santiago Director RA/QA 208 Avenida Fabricante #100 San Clemente, California 92672
Re: K201811
Trade/Device Name: coraForce and coraFlex Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 30, 2020 Received: July 1, 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
1
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 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
2
Indications for Use
510(k) Number (if known) K201811
Device Name
coraForce and coraFlex Support Catheters
Indications for Use (Describe)
Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
SECTION 5 - 510(K) SUMMARY
| Submitter | Reflow Medical, Inc.
208 Avenida Fabricante
#100
San Clemente, CA 92672
Contact person: Krystal Santiago
Phone: (310) 707.5882 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | October 26, 2020 |
| Device | Name of the device: coraForce and coraFlex Support Catheters
Common of usual name: Percutaneous Catheter
Classification name: Percutaneous Catheter
Regulatory Class: 2
Product Code: DQY |
| Legally marketed device to
which your firm is claiming
equivalence | Predicate -
Spex 14/18 Support Catheters - K193012
Reference Devices -
Spex 35 – K173662
Spex LP 14/18 Support Catheters - K200094
Wingman 14C – K190393 |
| Description of the device | The coraForce and coraFlex Support Catheters are devices intended to provide
additional support to a steerable guidewire when accessing discrete regions of the
peripheral and coronary vasculature.
The device consists of a support catheter body with a luer end and a polymer tip
(coraFlex) or metallic tip (coraForce). The through-lumen of the device can serve
as a conduit for the delivery of diagnostic contrast. |
| Intended use of the device | Cora Catheters are intended to be used in conjunction with steerable guidewires
to access discrete regions of the coronary and peripheral vasculature. They may
be used to facilitate placement and exchange of guidewires and other
interventional devices and provide a conduit for delivery of saline solutions or
diagnostic contrast. |
| Summary of the technological characteristics of your device compared to the predicate device | |
| The technological characteristics of the subject coraForce and coraFlex Support Catheters are similar to the
technological characteristics of the Spex 14/18 Support Catheters previously cleared under K173662 (14/18
approval), K193012 (coronary indication), and K200094 (low profile models). | |
At a high level, the subject and predicate devices are based on the following same 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
- all use a specialized distal tip to facilitate crossing of the lesion ●
The following technological differences exist between the subject and predicate devices:
- Coiled catheter shaft to promote additional flexibility ●
- . Differentiated distal tip in a flexible polymer (coraFlex) or metallic (coraForce)
4
| | Cora Support Catheter | Spex 14/18 Support Catheter
(K193012) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Cora Catheters are intended to be used
in conjunction with steerable guidewires to
access discrete regions of the coronary and
peripheral vasculature. They may be used
to facilitate placement and exchange of
guidewires and other interventional
devices and provide a conduit for delivery
of saline solutions or diagnostic contrast. | 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
contrast. |
| Guidewire
Compatibility | 0.014" | 0.014"/0.018" |
| Sheath
Compatibility | Identical | 4F |
| Catheter
Length | 135cm/150cm | 90cm/135cm/150cm |
| Catheter Shaft
OD | Max 0.032" (nominal 0.029") | Spex 14 - Max 0.034"
Spex 18 - Max 0.038" |
| Tip | Rigid (coraForce)
Flexible (coraFlex) | Shapeable Hypotube |
| Component
Materials | Stainless Steel w/PTFE Coating
Stainless steel with gold
plating(coraForce)
Polymers | Stainless Steel
Stainless Steel w/gold plating
Polymers |
| Coating
Material | Identical | Identical |
| Coating Length | 60cm | 40cm |
| Packaging
Configuration | Identical (new backer card) | HDPE backer card and coil in a single
poly/Tyvek pouch |
| Sterilization
Method | Identical | Ethylene Oxide |
| A brief discussion of the nonclinical tests submitted | | |
| • | A full bench testing package is provided with the following data:
Simulated Use | • Flow Rate and Burst Testing |
| • | Kink Resistance | • Lubricity and Coating Integrity Testing |
| • | Corrosion Resistance | • Particulate Characterization |
| • | Component Integrity | • Usability Verification |
| • | Bond Testing | • Sterilization Adoption |
| • | Packaging Qualification | • Biocompatibility Assessment |
| • | Torque Testing | |
| The coraForce and coraFlex Support Catheters met all specified criteria and did not raise new safety or
performance questions. Based on the performance testing the coraForce and coraFlex Support Catheters were | | |
| found to have a safety and effectiveness profile that is similar to the predicate device. | | |
| A brief discussion of the clinical data submitted | | |
| No clinical data is submitted. | | |
| Conclusions | | |
The conclusions drawn from the nonclinical testing demonstrate that the device is substantially equivalent to the legally marketed devices identified.