(265 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a guidewire, with no mention of AI or ML capabilities.
No.
The device's stated intended use is to direct a catheter, which is a diagnostic or interventional procedure aid, not a therapeutic action itself.
No
The device is described as a guidewire intended to direct a catheter during diagnostic or interventional procedures, but it does not perform any diagnostic function itself. It's a tool used in procedures, not a diagnostic device.
No
The device description clearly outlines physical components including a core wire, polymer coating, hydrophilic coating, plastic dispenser, and a Torquer. The performance studies also focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures." This describes a device used within the body to facilitate a procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details the physical components of a guidewire used for navigation within blood vessels. This aligns with the intended use and not with the components of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the Inno-Hydrowire is a medical device used for guiding catheters within the vascular system, which is an in vivo (within the living body) application, not an in vitro (in glass/outside the living body) diagnostic application.
N/A
Intended Use / Indications for Use
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.
Product codes
DOX
Device Description
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. It consists of a Nickel-Titanium alloy core wire; a polymer coating (Pebax containing BaSO4 for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The Inno-Hydrowire includes a 3cm flexible tip. The Inno-Hydrowire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire utilized for rotating and controlling the guidewire. The Hydrowires are packaged within a cardboard box which contains five individual guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculatory system
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)
Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995, ISO 11070:2014, Sterile single-use intravascular catheter introducers. The results of the following performance tests have demonstrated substantial equivalence to the predicate device.
- Tensile Strength
- Torque Strength
- Tip Flexibility
- Surface Lubricity
- Corrosion
- Kink Resistance
- Torqueability
- Particulate
- Coating Adherence/Integrity
- Dimensional Verification
- Radiodetectability
Biocompatibility testing was performed to ensure the material safety in accordance with the tests recommended in the International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part-I: Evaluation and testing within a risk management process."
The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Inno-Hydrowire:
- Cytotoxicity
- Sensitization (Kligman Maximization)
- Intracutaneous Injection
- Acute Systemic Toxicity
- Rabbit Pyrogen
- Hemolysis
- In Vitro Hemocompatibility
- Lee & White Clotting Time
- Dog Thrombogenicity
- Complement Activation Assay (C3a)
- Complement Activation Assay (Sc5b-9)
Test results for all biocompatibility testing met the applicable test requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
April 11,2018
Suzhou Innomed Medical Device Co., Ltd c/o Ms. Darlene Garner Regulatory Affairs Consultant 113 Garner Cove Georgetown, Texas 78633
Re: K172187
Trade/Device Name: Inno-Hydrowire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: March 13, 2018 Received: March 14, 2018
Dear Ms. Garner:
We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172187
Device Name Inno-Hydrowire
Indications for Use (Describe)
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.
| 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 is provided per the requirements of 21 CFR Part 807.92.
| Applicant: | Suzhou Innomed Medical Device Co., LTD |
|---|---|
| 218 Xinghu St.,#B1-404,Suzhou, Jiangsu, 215123, P.R. China | |
| Phone: +86 87897188-800 | |
| Fax: +86 87897188-801 | |
| Applicant Contact: | Darlene Garner |
| Regulatory Affairs Consultant | |
| 979/864-9232 | |
| darlene.garner50@yahoo.com | |
| Date Prepared: | April 5, 2018 |
| Trade Name: | Inno-Hydrowire |
| Common Name: | Guidewire |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Name: | Catheter guide wire |
| Regulation Number: | 21CFR Part 870.1330 |
| Product Code: | DQX |
| Classification: | Class II |
| Classification Panel: | Division of Cardiovascular Devices |
| Predicate device: | Terumo Radifocus® Guidewire (K863138) |
Device Description
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. It consists of a Nickel-Titanium alloy core wire; a polymer
4
coating (Pebax containing BaSO4 for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The Inno-Hydrowire includes a 3cm flexible tip. The Inno-Hydrowire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire utilized for rotating and controlling the guidewire. The Hydrowires are packaged within a cardboard box which contains five individual guidewires.
Intended Use
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.
Principle of Operation
The Inno-Hydrowire is operated manually or by a manual process.
Substantial Equivalence
The Inno-Hydrowire was found to be substantially equivalent to the Terumo Radifocus® Guidewire, Premarket Notification K863138. A comparison of the technological characteristics is summarized in the table below:
| Comparison
Feature | Inno-Hydrowire
Guidewire | Radifocus® Guidewire |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation | Manual | Manual |
| Indications for
use | Intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular. | Intended to direct a catheter to the desired anatomical location during diagnostic or interventional procedures. |
| Core Wire | Nickel Titanium | Nickel Titanium |
| Jacket | Pebax | Polyurethane |
| Radiopaque
Material | Barium Sulfate (BaSO4) | Tungsten |
| Comparison of the Inno-Hydrowire and Predicate Device | |||
|---|---|---|---|
5
| Comparison
Feature | Inno-Hydrowire
Guidewire | Radifocus® Guidewire |
|------------------------------|--------------------------------------------------|--------------------------------------------------------------|
| Hydrophilic
Coating | Polyvinyl Pyrrolidon (PVP) | Half-ester methyl vinyl
ether-maleic anhydride copolymer |
| Adhesive
(Core/Jacket) | Extrusion | Extrusion |
| Distal Tip
Configurations | Straight, Angle, | Straight, Angle, and J shape |
| Lengths | 80cm, 150cm, 180cm and 260cm | 120cm, 150cm, 180cm, 220cm,
260cm, 300cm, 400cm and 450cm |
| Diameters | 0.014",0.018",0.025",0.032"
0.035" and 0.038" | 0.018",0.025",0.032",
0.035" and 0.038" |
| Sterility | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | Two Years | Two Years |
The Inno-Hydrowire does not have the exact intended use as the predicate Radifocus Guidewire in that the Inno-Hydrowire is specific to the vasculatory system.
The Inno-Hydrowire is substantially equivalent to the Radifocus Guidewire in technology / principal of operation, and is similar in the material and design. The main differences between the Inno-Hydrowire device and the predicate device are the sizes and the material. These differences do not affect the intended use or performance of the Inno-Hydrowire. Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended.
Non-Clinical Performance Testing
Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995, ISO 11070:2014, Sterile single-use intravascular catheter introducers. The results of the following performance tests have demonstrated substantial equivalence to the predicate device.
- Tensile Strength ●
- Torque Strength ●
- Tip Flexibility ●
- Surface Lubricity ●
- Corrosion ●
- Kink Resistance ●
- Torqueability ●
- Particulate .
- Coating Adherence/Integrity ●
- Dimensional Verification ●
- Radiodetectability .
6
Biocompatibility Testing
Biocompatibility testing was performed to ensure the material safety in accordance with the tests recommended in the International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part-I: Evaluation and testing within a risk management process." The Inno-Hydrowire is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (