(99 days)
The Cardio Flow Peripheral Guide Wire is intended for temporary placement in peripheral vasculature the placement and exchange of diagnostic and therapeutic devices during percutaneous intravascular procedures. This guidewire device is intended for peripheral vascular use only.
The Cardio Flow Peripheral Guide Wire (Guidewire), Model GW1001 is a 304V stainless steel mandrel guidewire with a fixed distal spring coil. The distal coil is radiopaque to fluoroscopy. The coil is medium-stiffness in load-force and the distal end is coated in hydrophobic silicone to facilitate tracking. The Guidewire has a maximum outer diameter of 0.36 mm (0.014-inch). The GW1001 Guidewire has overall nominal length of 325 cm.
The Cardio Flow Peripheral Guide Wire (Model GW1001) underwent several non-clinical performance tests to demonstrate substantial equivalence to its predicate device, the Asahi Astato XS 20 Guide Wire (K103057).
Here's the breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (based on implied compliance with standards/guidance) | Reported Device Performance |
|---|---|---|
| Corrosion Resistance | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Dimensional Verification | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Kink Resistance | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Lubricity | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Particulate Evaluation | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Radiopacity | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Silicone Coating Integrity | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Simulated Use (Compatibility) | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Tensile Strength | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Tip Flexibility | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Tip Pull | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Torque Strength | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Torqueability (Torque Response) | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Flex Resistance | Resistant to damage by flexing in accordance with ISO 11070:2014 Annex G criterion, between two cylindrical mandrels with diameters equal to 20 times the guidewire diameter. | Pass |
| Fracture Resistance | Shall not fracture or fail when tested in accordance with ISO 11070:2014 Annex F criterion, test article wrapped around a mandrel with a diameter 10 times larger than the guidewire outside diameter. | Pass |
| Tip Load | Guidewire tip load buckling force inducing buckling deformation with a 20 mm gauge length from the distal tip is documented. (Implied acceptance is demonstration of acceptable force for intended use) | Pass |
| Sterility | Sterilization validated according to ANSI/AAMI/ISO 11135:2014 with a minimum sterility assurance level (SAL) of 10-6. | Pass |
| Sterile barrier integrity | Post terminal sterilization simulated distribution, seal peel (per ASTM F88), and bubble emission testing (per ASTM F2096) results demonstrate integrity. | Pass |
| Biocompatibility | Compliance with ISO 10993-4, -5, -10, -11 (for Cytotoxicity, Complement Activation, Intracutaneous Reactivity, Sensitization, Material Mediated-Pyrogenicity, Acute Systemic Toxicity, and Standard in Vivo Thrombogenicity in Canine), ASTM F756 (for Hemolysis), and ASTM F2888 (for Heparinized Platelet and Leukocyte Count). | Pass |
| Shelf life (2 years) | Confirmation of device functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench evaluations and non-clinical performance tests. This implies that physical samples of the Cardio Flow Peripheral Guide Wire were tested in a laboratory setting.
- Sample Size: Not explicitly stated for each individual test. However, it is standard practice for such tests to use a statistically significant number of samples to ensure robust results.
- Data Provenance: The tests were conducted internally by or on behalf of Cardio Flow, Inc., likely at their facilities or a contracted testing lab, following established international and FDA-recognized standards. There is no mention of country of origin for test data, but the company is based in Mahtomedi, MN, USA. The data is prospective for the device under review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a physical device performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" for these tests is defined by the objective performance criteria specified in the referenced standards (e.g., ISO, ASTM, FDA guidance).
4. Adjudication Method for the Test Set
Not applicable, as this was a physical device performance study, not a clinical study involving human judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a medical guidewire, not a diagnostic AI system that evaluates medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical guidewire, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this type of device performance testing is established by objective engineering and performance specifications defined in recognized national and international standards (e.g., ISO, ASTM) and FDA guidance documents. These standards dictate acceptable ranges, thresholds, or qualitative outcomes (e.g., "Pass/Fail") for various physical and material properties.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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March 18, 2022
Cardio Flow, Inc. Michael Kallok Chief Executive Officer Quality & Regulatory Associates, LLC 888 East Evenuse, Mahtomedi, MN 55115 USA
Re: K213834
Trade/Device Name: Cardio Flow Peripheral Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: February 15, 2022 Received: February 17, 2022
Dear Michael Kallok:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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 medical devices and radiation-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 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) K213834
Device Name Cardio Flow Peripheral Guidewire
Indications for Use (Describe)
The Cardio Flow Peripheral Guide Wire is intended for temporary placement in peripheral vasculature the placement and exchange of diagnostic and therapeutic devices during percutaneous intravascular procedures. This guidewire device is intended for peripheral vascular use only.
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
This 510(k) summary was prepared to provide an understanding of the basis for the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.
| Submitters Name: | Cardio Flow, Inc.888 East AvenueMahtomedi, MN 55115 |
|---|---|
| Contact Person: | Michael J. Kallok, Ph.D., FACC, FAHA; Chief Executive Officer,Director, Cardio Flow, Inc. |
| Contact Phone: | (800) 294-5517 |
| Date Summary Prepared: | December 8, 2021 |
| Device Trade Name: | Cardio Flow Peripheral Guide Wire |
| Common Name: | Peripheral Guide Wire |
| Classification Name: | 21 CFR 870.1330, Catheter Guide Wire, Class IIProduct Code: DQX |
| Predicate Device: | K103057, Asahi Astato XS 20 Guide WireAsahi Intecc, Co. Ltd |
Device Description
The Cardio Flow Peripheral Guide Wire (Guidewire), Model GW1001 is a 304V stainless steel mandrel guidewire with a fixed distal spring coil. The distal coil is radiopaque to fluoroscopy. The coil is medium-stiffness in load-force and the distal end is coated in hydrophobic silicone to facilitate tracking. The Guidewire has a maximum outer diameter of 0.36 mm (0.014-inch). The GW1001 Guidewire has overall nominal length of 325 cm.
Intended Use of the Device
The Cardio Flow Peripheral Guide Wire is intended for temporary placement in peripheral vasculature to facilitate the placement and exchange of diagnostic and therapeutic devices during percutaneous intravascular procedures. This guidewire device is intended for peripheral vascular use only.
Summary of Technological Characteristics
The following table provides a side-by-side comparison of the Guidewire to the predicate device applied to support this pre-market notification.
| Substantial Equivalence Technical Characteristics | |||
|---|---|---|---|
| Feature | Cardio Flow Peripheral GuideWire(Under Review) | Asahi Astato XS 20 GuideWire(Predicate: K10357) | EquivalenceComments |
| Product Code,Classification | DQX,21 CFR 870.1330, Catheter GuideWire, Class II | DQX,21 CFR 870.1330, Catheter GuideWire, Class II | Identical to predicate. |
| Substantial Equivalence Technical Characteristics | |||
| Feature | Cardio Flow Peripheral Guide Wire(Under Review) | Asahi Astato XS 40 GuideWire(Predicate: K153443K) | EquivalenceComments |
| Intended Use | Guidewire supporting guidingdiagnostic and interventional devicesthrough peripheral vasculature. | Guidewire supporting guidingdiagnostic and interventional devicesthrough peripheral vasculature. | Same |
| Indications forUse | The Cardio Flow peripheral guidewireis intended for temporary placement inperipheral vasculature to facilitate theplacement and exchange of diagnosticand therapeutic devices duringpercutaneous intravascular procedures.This guidewire device is intended forperipheral vascular use only. | The ASAHI Astato XS 20 PeripheralGuide Wire is intended to facilitatethe placement and exchange ofdiagnostic and therapeutic devicesduring intravascular procedures.This device is intended for peripheralvascular use only. | Same |
| Prescription UseOnly | Yes | Yes | Same |
| Single use,disposable | Yes | Yes | Same |
| Provided sterile | Yes | Yes | Same |
| Sterilizationmethod | Ethylene Oxide | Ethylene Oxide | Same |
| SterilityAssurance Level | $\leq$ 10-6 | $\leq$ 10-6 | Same |
| Sterile barrierpackage | Tyvek Flexible Pouch | Tyvek Flexible Barrier | Similar |
| Bloodcontactingmaterials | Pt-Ni, 304V Stainless SteelAu-Sn (Solder)Silicone | Pt-Ni, 304 Stainless SteelAu-Sn and Ag-Sn (Solder)PTFEHydrophilic coating on coil tip | Similar |
| Biocompatibilityevaluations | Cytotoxicity ISO L929 MEM Elution,Cytotoxicity Neutral Red Uptake,ASTM Hemolysis Assay,Complement Activation Assay SC5b-9,Intracutaneous Reactivity,Sensitization Test ISO Guinea PigMaximization,Material Mediated-Pyrogenicity,Acute Systemic Toxicity Test: AcuteSystemic Injection Assay,Hemocompatibility: HeparinizedPlatelet and Leukocyte Count Assay,Standard In Vivo Thrombogenicity inCanine | Cytotoxicity Study,In Vitro Hemolysis Study,C3a Complement Activation Study,SC5b-9 Complement ActivationStudy,Intracutaneous Study,Sensitization Study,Pyrogen Study,Systemic Toxicity Study,Plasma Recalcification TimeCoagulation Study,In Vivo Thromboresistance Study | Similar |
| Outer Diameter | 0.36 mm (0.014 inches)Maximum Outer Diameter | 0.36 mm (0.014 inches)Maximum Outer Diameter | Similar |
| Overall Length | 325 cm | 180 to 300 cm | Similar |
| Tip Length | 35 mm | 17 cm | Similar |
| Tip Flexibility(Tip Load) | 10 to 25 gf(13 gf average) | 20 gf | Similar |
| Shelf life | 2 Years | 3 Years | Similar |
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Non-clinical Performance Tests to Demonstrate Substantial Equivalency
To establish the technical equivalency of the Guidewire, bench evaluations were conducted to confirm compliance with performance requirements.
| Test | Test Method Summary | Result |
|---|---|---|
| Corrosion Resistance | FDA Guidance: Coronary, Peripheral, and Neurovascular | Pass |
| Dimensional Verification | Guidewires - Performance Tests and Recommended Labeling,(October 10, 2019) | Pass |
| Kink Resistance | Pass | |
| Lubricity | Pass | |
| Particulate Evaluation | Pass | |
| Radiopacity | Pass | |
| Silicone Coating Integrity | Pass | |
| Simulated Use (Compatibility) | Pass | |
| Tensile Strength | Pass | |
| Tip Flexibility | Pass | |
| Tip Pull | Pass | |
| Torque Strength | Pass | |
| Torqueability (Torque Response) | Pass | |
| Flex Resistance | The guidewire will be resistant to damage by flexing in accordanceto ISO 11070:2014 Annex G criterion, between two cylindricalmandrels with diameters equal to 20 times the guide wire diameter. | Pass |
| Fracture Resistance | The guide wire shall not fracture or fail when tested in accordanceto ISO 11070:2014 Annex F criterion, test article wrapped around amandrel with a diameter 10 times larger than the guidewire outsidediameter. | Pass |
| Tip Load | Guidewire tip load buckling force inducing buckling deformationwith a 20 mm gauge length from the distal tip is documented. | Pass |
| Sterility | Sterilization of the subject device was validated according toANSI/AAMI/ISO 11135:2014, Sterilization of healthcare products- Ethylene oxide - Requirements for development, validation androutine control of a sterilization process for medical devices, with aminimum sterility assumed level (SAL) of 10-6. | Pass |
| Sterile barrier integrity | The sterile barrier package is a flexible pouch. The methods appliedto evaluate the sterile barrier package integrity included postterminal sterilization simulated distribution, seal peel and bubbleemission testing. | Pass |
| Biocompatibility | ISO 10993-4, -5, -10, -11 appliable standard applied for:Cytotoxicity, Complement Activation, Intracutaneous Reactivity,Sensitization, Material Mediated-Pyrogenicity, Acute SystemicToxicity, and Standard in Vivo Thrombogenicity in Canine. ASTMF756 applied for Hemolysis. ASTM F2888 applied for HeparinizedPlatelet and Leukocyte Count. | Pass |
| Shelf life two (2) years | Confirmation of device functional performance and sterile barrierpouch integrity (seal peel per ASTM F88 and bubble leak perASTM F2096) with accelerated aging and simulated distributionper ASTM 4169-16 and bubble leak (ASTM F2096). | Pass |
Animal and Clinical data are not needed to support substantial equivalence.
Conclusion
The Guidewire meets performance requirements equivalent to the predicate device. The intended use and technology of the Guidewire is the same as the predicate device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.