(117 days)
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 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.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as it relates to performance metrics like sensitivity, specificity, or F1-score which are typically found in AI/ML device studies. The document describes a medical device called "coraForce and coraFlex Support Catheters" and its substantial equivalence to predicate devices, focusing on technological characteristics and bench testing.
Therefore, I cannot provide the requested table or details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies.
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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
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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
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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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SECTION 5 - 510(K) SUMMARY
| Submitter | Reflow Medical, Inc.208 Avenida Fabricante#100San Clemente, CA 92672Contact person: Krystal SantiagoPhone: (310) 707.5882 |
|---|---|
| Date Prepared | October 26, 2020 |
| Device | Name of the device: coraForce and coraFlex Support CathetersCommon of usual name: Percutaneous CatheterClassification name: Percutaneous CatheterRegulatory Class: 2Product Code: DQY |
| Legally marketed device towhich your firm is claimingequivalence | Predicate -Spex 14/18 Support Catheters - K193012Reference Devices -Spex 35 – K173662Spex LP 14/18 Support Catheters - K200094Wingman 14C – K190393 |
| Description of the device | The coraForce and coraFlex Support Catheters are devices intended to provideadditional support to a steerable guidewire when accessing discrete regions of theperipheral 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 serveas a conduit for the delivery of diagnostic contrast. |
| Intended use of the device | Cora Catheters are intended to be used in conjunction with steerable guidewiresto access discrete regions of the coronary and peripheral vasculature. They maybe used to facilitate placement and exchange of guidewires and otherinterventional devices and provide a conduit for delivery of saline solutions ordiagnostic 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 thetechnological characteristics of the Spex 14/18 Support Catheters previously cleared under K173662 (14/18approval), 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)
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| Cora Support Catheter | Spex 14/18 Support Catheter(K193012) | |
|---|---|---|
| Indications forUse | The Cora Catheters are intended to be usedin conjunction with steerable guidewires toaccess discrete regions of the coronary andperipheral vasculature. They may be usedto facilitate placement and exchange ofguidewires and other interventionaldevices and provide a conduit for deliveryof saline solutions or diagnostic contrast. | The Spex 14/18 Support Catheter is intendedto be used in conjunction with steerableguidewires to access discreet regions of theperipheral and coronary vasculature. It maybe used to facilitate placement and exchangeof guidewires and other interventionaldevices and provide a conduit for thedelivery of saline solutions or diagnosticcontrast. |
| GuidewireCompatibility | 0.014" | 0.014"/0.018" |
| SheathCompatibility | Identical | 4F |
| CatheterLength | 135cm/150cm | 90cm/135cm/150cm |
| Catheter ShaftOD | Max 0.032" (nominal 0.029") | Spex 14 - Max 0.034"Spex 18 - Max 0.038" |
| Tip | Rigid (coraForce)Flexible (coraFlex) | Shapeable Hypotube |
| ComponentMaterials | Stainless Steel w/PTFE CoatingStainless steel with goldplating(coraForce)Polymers | Stainless SteelStainless Steel w/gold platingPolymers |
| CoatingMaterial | Identical | Identical |
| Coating Length | 60cm | 40cm |
| PackagingConfiguration | Identical (new backer card) | HDPE backer card and coil in a singlepoly/Tyvek pouch |
| SterilizationMethod | 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 orperformance 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.
§ 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).