The Inno-Pathwire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Device Description

The Inno-Pathwire is a steerable guidewire available in a diameter of 0.014" (0.36 mm) and an effective length of 190 cm. The distal tip is shapeable. Before use, the tip can be shaped "J". The wire construction includes a stainless steel proximal shaft and a distal super-elastic nitinol shaft for flexibility and performance. The two shafts are connected by a super-elastic nitinol hypotube. The distal shaft is soldered with the tip coil or the tip coil and proximal coil both. For IW-14-190-EXS model, the distal shaft is soldered to the tip coil only but for IW-14-190-STS and IW-14-190-MDS, their distal shafts are soldered to the tip coil and proximal coil both. The tip coil is visible under Xray to assist the physician with the movement of the guidewire. The distal segment of the guidewire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guidewire movement within the catheter and arteries. The proximal end of the guidewire is coated with PTFE coating which reduces friction of the wire within a catheter.

The guidewire 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 for twisting and controlling the guidewire. The guidewires are packaged within a cardboard box which contains five individual guidewires.

AI/ML Overview

The provided text describes the acceptance criteria and study for the Inno-Pathwire, a medical device, in its 510(k) summary. However, this is a medical device submission for a guidewire, not a software or AI-based device. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable (N/A) for this type of submission.

Here is the information that can be extracted from the provided text, modified to acknowledge the product type:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Test)	Reported Device Performance (Demonstrated)
Dimensional Verification	Achieved
Visual Inspection	Achieved
Torque Strength	Achieved
Coating Adherence/Integrity	Achieved
Lubricity	Achieved
Kink Resistance	Achieved
Radiopacity	Achieved
Tensile Strength/Tip Pull	Achieved
Torqueability	Achieved
Particulate Evaluation	Achieved
Resistance to corrosion	Achieved
Tip Flexibility	Achieved
Biocompatibility:
Cytotoxicity	Acceptable (No safety risks)
Irritation and Skin Sensitization	Acceptable (No safety risks)
Acute Systemic Toxicity	Acceptable (No safety risks)
Pyrogenicity (Rabbit Pyrogen Test)	Acceptable (No pyrogenic response)
SC5b-9 Complement Activation	Acceptable (No safety risks)
Unactivated Partial Thromboplastin Time	Acceptable (No safety risks)
Rabbit Blood Hemolysis	Acceptable (No safety risks)
Hemocompatibility	Acceptable (No safety risks)
Thrombogenicity	Acceptable (No safety risks)
Sterilization:
Sterility Assurance Level (SAL)	10⁻⁶ (Validated to ISO 11135)
EO and ECH Residuals	Met requirements for limited exposure devices (ISO 10993-7)
Pyrogenicity (Bacterial Endotoxin Test)	Consistent with product release requirements

The following fields are N/A because the Inno-Pathwire is a physical medical device (guidewire), not an AI or software device. The studies described are bench tests and biocompatibility tests, not evaluations of algorithmic performance.

2. Sample size used for the test set and the data provenance: N/A (Not an AI/software device; testing involved physical device samples and materials)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is based on engineering specifications, material science, and biological testing standards)
4. Adjudication method for the test set: N/A (Not an AI/software device evaluation)
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: N/A (Not an AI/software device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/software device)
7. The type of ground truth used: For physical performance tests, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO, ASTM) and the expected physical and chemical properties of the materials. For biocompatibility, it's the biological response measured against toxicity, irritation, and other harmful effects as defined by ISO 10993 standards.
8. The sample size for the training set: N/A (Not an AI/software device; no "training set" in the AI sense)
9. How the ground truth for the training set was established: N/A (Not an AI/software device)

Summary

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March 11, 2019

Suzhou Innomed Medical Device Co.,Ltd % Darlene Garner Regulatory Consultant Darlene Garner 113 Garner Cove Georgetown, Texas 78633

Re: K182553

Trade/Device Name: Inno-Pathwire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: February 6, 2019 Received: February 7, 2019

Dear Darlene Garner:

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

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requirements, including, but not limited to: registration and listing (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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lydia S. Glaw. The signature was created on March 11, 2019 at 16:04:52 -04'00'.

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) K182553

Device Name Inno-Pathwire

Indications for Use (Describe)

The Inno-Pathwire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

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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Image /page/3/Picture/1 description: The image shows the word "INNOMED" in blue letters. The "O" in the middle of the word is a circle with a pink and white design inside. The word is written in a bold, sans-serif font and is centered in the image. The overall design is simple and modern.

510(k) SUMMARY

This 510(k) summary is provided per the requirements of 21CFR Part 807.92.

Applicant:	Suzhou Innomed Medical Device Co., LTD
	218 Xinghu St., Biobay B1-404, Suzhou, Jiangsu province, 215123, 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:	March 7, 2019
Trade Name:	Inno-Pathwire
Common Name:	Guidewire
Classification Name:	Device - 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:	HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire with HydrocoatHydrophilic Coating (K152709)

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Device Description

Intended Use

The Inno-Pathwire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Principle of Operation

The Inno-Pathwire is operated manually or by a manual process.

Substantial Equivalence

The Inno-Pathwire was found to be substantially equivalent to the HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wires, Premarket Notification K152709. A comparison of the technological characteristics is summarized on the table below:

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DeviceCharacteristic	New Device: Inno-Pathwire	Predicate: HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire
Principle ofOperation	Manual	Manual
Indication forUse	To facilitate the placement of balloondilatation catheters during percutaneoustransluminal coronary angioplasty(PTCA) and percutaneous transluminalangioplasty (PTA).	To facilitate the placement of balloondilatation catheters during percutaneoustransluminal coronary angioplasty(PTCA) and percutaneous transluminalangioplasty (PTA).
Materials	Proximal Shaft, Ribbon, Proximal coil:◇ 304 stainless steel Distal shaft, Hypotube:◇ Nickel-Titanium alloy Tip coil:◇ Platinum - Tungsten alloy Proximal of the guidewire coating:◇ PTFE Distal of the guidewire coating:◇ Hydromer® Hydrophilic coating	Proximal Shaft, Ribbon, Proximal coil:◇ 304 stainless steel Distal shaft, Hypo tube:◇ Nickel-Titanium alloy Tip coil:◇ Platinum-Nickel alloy Proximal of the guidewire coating:◇ PTFE Distal of the guidewire coating:◇ Pellathane hydrophilic coating
Diameter	0.014"	0.014"
Length	190cm	190cm
Sterility	Ethylene Oxide	Irradiation
Shelf - life	Two Years	Two Years

Comparison of the Inno-Pathwire and Predicate Device

The Inno-Pathwire is substantially equivalent to the HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire in technology / principal of operation is similar in the material and design. The main differences between the Inno-Pathwire device and the predicate device are the tip coil material and the hydrophilic coating material. These differences do not affect the intended use, safety or effectiveness of the Inno-Pathwire. Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices.

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Non-Clinical Performance Testing

Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995; Coronary, Peripheral, and Neurovascular Guidewire-Performance Tests and Recommended Labeling, Draft Guidance for Industry and Food and Drug Administration Staff, June 15, 2018; ISO 11070:2014, Sterile Single-use Intravascular Introducers, Dilators And Guidewires. The results of the following performance tests have demonstrated substantial equivalence to the predicate device.

Dimensional Verification and Visual Inspection ●
Torque Strength ●
Coating Adherence/Integrity ●
Lubricity ●
Kink Resistance ●
Radiopacity ●

Biocompatibility Testing

Tensile Strength/Tip Pull ●
Torqueability ●
Particulate Evaluation ●
Resistance to corrosion ●
Tip Flexibility ●

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-Pathwire 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-Pathwire:

• Cytotoxicity	ISO 10993-5
• Irritation and Skin Sensitization	ISO 10993-10
• Acute Systemic Toxicity	ISO 10993-11
• Pyrogenicity	ISO 10993-11
• SC5b-9 Complement Activation	ISO 10993-4
• Unactivated Partial Thromboplastin Time	ISO 10993-4
• Rabbit Blood Hemolysis	ASTM F756 /ISO 10993-4
• Hemocompatibility	ISO 10993-4
• Thrombogenicity	ISO 10993-4

The results obtained from the biological evaluation indicate that the products do not pose any safety risks associated with its introduction into the body and that materials selected for manufacture of these products are appropriate for the intended use.

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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 sterility Assurance Level (SAL) of 10 °. 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-Pathwire has been evaluated for non-endotoxin related factors. The rabbit pyrogen test was performed as described in ANSI/AAMI/ISO 10993-11. The results concluded that the Inno-Pathwire does not elicit a material mediated pyrogenic response. As a requirement for product release, finished product pyrogen testing is conducted on each manufacturing lot for commercial distribution as a requirement for product release. The test method used is the gel clot method for Bacterial Endotoxin Testing.

Conclusion

The Inno-Pathwire 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-Pathwire and the predicate device that raise new issues of safety and effectiveness.

Regulation Number and Section

§ 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.