(265 days)
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.
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.
The provided text describes a 510(k) summary for the Inno-Hydrowire, a catheter guide wire. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically relies on non-clinical performance testing and biocompatibility testing, rather than studies involving expert readers, AI assistance, or complex ground truth establishment as seen in diagnostic AI devices.
Therefore, many of the requested categories are not applicable to this type of device submission.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a directly comparable format for each test. Instead, it lists the performance tests conducted and then states that "The results of the following performance tests have demonstrated substantial equivalence to the predicate device" and that "Test results for all biocompatibility testing met the applicable test requirements."
Inferred Acceptance Criteria (Based on tested parameters): The acceptance criteria are implicitly defined by compliance with established medical device standards and the substantial equivalence to the predicate device for each performance characteristic.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Tensile Strength (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Torque Strength (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Tip Flexibility (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Surface Lubricity (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Corrosion (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Kink Resistance (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Torqueability (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Particulate (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Coating Adherence/Integrity (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Dimensional Verification (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Radiodetectability (compliance with ISO 11070:2014 & substantial equivalence to predicate) | Demonstrated substantial equivalence |
| Cytotoxicity (compliance with ISO 10993-5) | Met applicable test requirements |
| Sensitization (Kligman Maximization) (compliance with ISO 10993-10) | Met applicable test requirements |
| Intracutaneous Injection (compliance with ISO 10993-10) | Met applicable test requirements |
| Acute Systemic Toxicity (compliance with ISO 10993-11) | Met applicable test requirements |
| Rabbit Pyrogen (compliance with ISO 10993-11) | Met applicable test requirements (did not elicit a material mediated pyrogenic response) |
| Hemolysis (compliance with ASTM F756-08 / ISO 10993-4) | Met applicable test requirements |
| In Vitro Hemocompatibility (compliance with ISO 10993-4) | Met applicable test requirements |
| Lee & White Clotting Time (compliance with ISO 10993-4) | Met applicable test requirements |
| Dog Thrombogenicity (compliance with ISO 10993-4) | Met applicable test requirements |
| Complement Activation Assay (C3a) (compliance with ISO 10993-4) | Met applicable test requirements |
| Complement Activation Assay (Sc5b-9) (compliance with ISO 10993-4) | Met applicable test requirements |
| Sterility Assurance Level (SAL) (compliance with ISO 11135) | Achieved 10^-6 SAL |
| Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals (compliance with ISO 10993-7) | Met requirements for limited exposure devices |
2. Sample size used for the test set and the data provenance
The document describes non-clinical performance testing and biocompatibility testing. These tests are typically conducted on a specific number of device samples or using specific biological models (e.g., rabbits for pyrogenicity, dogs for thrombogenicity). The document does not specify the exact sample sizes for each individual test, nor does it refer to a "test set" in the context of human data or image data. Data provenance (country of origin, retrospective/prospective) is not relevant for these types of non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The device is a physical guidewire; there is no "ground truth" established by human experts in the context of diagnostic performance or image interpretation. The "ground truth" for its performance is instead defined by objective physical and chemical properties measured according to international standards (e.g., tensile strength, biocompatibility profiles).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, often in diagnostic contexts. The tests performed for this guidewire are objective and standardized, not requiring human adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document describes the substantial equivalence evaluation for a medical device (a guidewire), not an AI-powered diagnostic tool. Therefore, MRMC studies, human reader improvement with AI, or effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The Inno-Hydrowire is a manually operated physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for evaluating the Inno-Hydrowire is defined by:
- International Standards: Compliance with ISO 11070:2014 for physical performance and ISO 10993 series for biocompatibility, and ISO 11135 for sterilization.
- Predicate Device Performance: The primary method of demonstrating safety and effectiveness for a 510(k) device is by showing substantial equivalence to a legally marketed predicate device (Terumo Radifocus® Guidewire, K863138). This means the Inno-Hydrowire's performance characteristics must fall within acceptable ranges similar to the predicate under the specified test conditions.
8. The sample size for the training set
This is not applicable. The Inno-Hydrowire is a physical medical device, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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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.
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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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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 GarnerRegulatory Affairs Consultant979/864-9232darlene.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
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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:
| ComparisonFeature | Inno-HydrowireGuidewire | Radifocus® Guidewire |
|---|---|---|
| Principle ofOperation | Manual | Manual |
| Indications foruse | 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 |
| RadiopaqueMaterial | Barium Sulfate (BaSO4) | Tungsten |
| Comparison of the Inno-Hydrowire and Predicate Device | |||
|---|---|---|---|
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| ComparisonFeature | Inno-HydrowireGuidewire | Radifocus® Guidewire |
|---|---|---|
| HydrophilicCoating | Polyvinyl Pyrrolidon (PVP) | Half-ester methyl vinylether-maleic anhydride copolymer |
| Adhesive(Core/Jacket) | Extrusion | Extrusion |
| Distal TipConfigurations | 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 .
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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 (<24h).
The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Inno-Hydrowire:
| • | Cytotoxicity | ISO 10993-5 |
|---|---|---|
| • | Sensitization (Kligman Maximization) | ISO 10993-10 |
| • | Intracutaneous Injection | ISO 10993-10 |
| • | Acute Systemic Toxicity | SO 10993-11 |
| • | Rabbit Pyrogen | SO 10993-11 |
| • | Hemolysis | ASTM F756-08 /ISO 10993-4 |
| • | In Vitro Hemocompatibility | ISO 10993-4 |
| • | Lee & White Clotting Time | ISO 10993-4 |
| • | Dog Thrombogenicity | ISO 10993-4 |
| • | Complement Activation Assay(C3a) | ISO 10993-4 |
| • | Complement Activation Assay(Sc5b-9) | ISO 10993-4 |
Test results for all biocompatibility testing met the applicable test requirements.
Sterilization
Sterilization conditions have been validated in accordance with ISO 11135, Sterilization of health - care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. The device is sterilized to a Sterility Assurance Level (SAL) of 10th. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) will meet requirements for limited exposure devices (contact up to 24 hours) prior to use based on ISO 10993-7, Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals.
Pyrogenicity
The Inno-Hydrowire has been evaluated for non-endotoxin related factors. The rabbit pyrogen test as described in ANSI/AAMI/ISO 10993-11. The results concluded that the Inno-Hydrowire does not elicit a material mediated pyrogenic response.
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Conclusion
The Inno-Hydrowire was found to be substantially equivalent in its design, intended use, technology, principal of operation, and performance to the predicate device. There are no significant differences between the Inno-Hydrowire and the predicate device.
Suzhou Innomed has demonstrated that the proposed Inno-Hydrowire Guidewire is substantially equivalent to the predicate device (Terumo Radifocus Guidewire).
§ 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.