(99 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML capabilities.
No.
The device is a guidewire intended to facilitate the placement and exchange of diagnostic and therapeutic devices, but it is not itself performing a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for the "placement and exchange of diagnostic and therapeutic devices," meaning it facilitates diagnostic procedures but is not diagnostic itself.
No
The device description clearly states it is a physical guidewire made of stainless steel with a spring coil and coating, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Cardio Flow Peripheral Guide Wire is a device intended for temporary placement within the peripheral vasculature to facilitate the placement and exchange of other devices during procedures. It is a tool used in vivo (within the living body).
- Intended Use: The intended use clearly states it's for "temporary placement in peripheral vasculature the placement and exchange of diagnostic and therapeutic devices during percutaneous intravascular procedures." This describes a procedural tool, not a diagnostic test performed on a sample.
The information provided about the device's description, performance studies (bench testing), and predicate devices further supports that it is a procedural device used within the body, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
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.
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
Bench evaluations were conducted to confirm compliance with performance requirements. Tests performed include: Corrosion Resistance, Dimensional Verification, Kink Resistance, Lubricity, Particulate Evaluation, Radiopacity, Silicone Coating Integrity, Simulated Use (Compatibility), Tensile Strength, Tip Flexibility, Tip Pull, Torque Strength, Torqueability (Torque Response), Flex Resistance, Fracture Resistance, Tip Load, Sterility, Sterile barrier integrity, Biocompatibility, and Shelf life two (2) years. All tests passed. Animal and Clinical data are not needed to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
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
1
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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3
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 Avenue
Mahtomedi, 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 II
Product Code: DQX |
| Predicate Device: | K103057, Asahi Astato XS 20 Guide Wire
Asahi 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 Guide | ||
| Wire | |||
| (Under Review) | Asahi Astato XS 20 Guide | ||
| Wire | |||
| (Predicate: K10357) | Equivalence | ||
| Comments | |||
| Product Code, | |||
| Classification | DQX, | ||
| 21 CFR 870.1330, Catheter Guide | |||
| Wire, Class II | DQX, | ||
| 21 CFR 870.1330, Catheter Guide | |||
| Wire, Class II | Identical to predicate. | ||
| Substantial Equivalence Technical Characteristics | |||
| Feature | Cardio Flow Peripheral Guide Wire | ||
| (Under Review) | Asahi Astato XS 40 Guide | ||
| Wire | |||
| (Predicate: K153443K) | Equivalence | ||
| Comments | |||
| Intended Use | Guidewire supporting guiding | ||
| diagnostic and interventional devices | |||
| through peripheral vasculature. | Guidewire supporting guiding | ||
| diagnostic and interventional devices | |||
| through peripheral vasculature. | Same | ||
| Indications for | |||
| Use | The Cardio Flow peripheral guidewire | ||
| 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. | The ASAHI Astato XS 20 Peripheral | ||
| Guide Wire is intended to facilitate | |||
| the placement and exchange of | |||
| diagnostic and therapeutic devices | |||
| during intravascular procedures. | |||
| This device is intended for peripheral | |||
| vascular use only. | Same | ||
| Prescription Use | |||
| Only | Yes | Yes | Same |
| Single use, | |||
| disposable | Yes | Yes | Same |
| Provided sterile | Yes | Yes | Same |
| Sterilization | |||
| method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterility | |||
| Assurance Level | $\leq$ 10-6 | $\leq$ 10-6 | Same |
| Sterile barrier | |||
| package | Tyvek Flexible Pouch | Tyvek Flexible Barrier | Similar |
| Blood | |||
| contacting | |||
| materials | Pt-Ni, 304V Stainless Steel | ||
| Au-Sn (Solder) | |||
| Silicone | Pt-Ni, 304 Stainless Steel | ||
| Au-Sn and Ag-Sn (Solder) | |||
| PTFE | |||
| Hydrophilic coating on coil tip | Similar | ||
| Biocompatibility | |||
| evaluations | Cytotoxicity ISO L929 MEM Elution, | ||
| Cytotoxicity Neutral Red Uptake, | |||
| ASTM Hemolysis Assay, | |||
| Complement Activation Assay SC5b-9, | |||
| Intracutaneous Reactivity, | |||
| Sensitization Test ISO Guinea Pig | |||
| Maximization, | |||
| Material Mediated-Pyrogenicity, | |||
| Acute Systemic Toxicity Test: Acute | |||
| Systemic Injection Assay, | |||
| Hemocompatibility: Heparinized | |||
| Platelet and Leukocyte Count Assay, | |||
| Standard In Vivo Thrombogenicity in | |||
| Canine | Cytotoxicity Study, | ||
| In Vitro Hemolysis Study, | |||
| C3a Complement Activation Study, | |||
| SC5b-9 Complement Activation | |||
| Study, | |||
| Intracutaneous Study, | |||
| Sensitization Study, | |||
| Pyrogen Study, | |||
| Systemic Toxicity Study, | |||
| Plasma Recalcification Time | |||
| Coagulation 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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5
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 accordance | |
| to ISO 11070:2014 Annex G criterion, between two cylindrical | ||
| mandrels with diameters equal to 20 times the guide wire diameter. | Pass | |
| Fracture Resistance | The guide wire shall not fracture or fail when tested in accordance | |
| to 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. | Pass | |
| Sterility | Sterilization of the subject device was validated according to | |
| ANSI/AAMI/ISO 11135:2014, Sterilization of healthcare products |
- Ethylene oxide - Requirements for development, validation and
routine control of a sterilization process for medical devices, with a
minimum sterility assumed level (SAL) of 10-6. | Pass |
| Sterile barrier integrity | The sterile barrier package is a flexible pouch. The methods applied
to evaluate the sterile barrier package integrity included post
terminal sterilization simulated distribution, seal peel and bubble
emission testing. | Pass |
| Biocompatibility | ISO 10993-4, -5, -10, -11 appliable standard applied for:
Cytotoxicity, Complement Activation, Intracutaneous Reactivity,
Sensitization, Material Mediated-Pyrogenicity, Acute Systemic
Toxicity, and Standard in Vivo Thrombogenicity in Canine. ASTM
F756 applied for Hemolysis. ASTM F2888 applied for Heparinized
Platelet and Leukocyte Count. | Pass |
| Shelf life two (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 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.