Who is the manufacturer of ULTRASKIN HYDROPHILIC GUIDE WIRE?

Lepu Medical Technology (Beijing) Co., Ltd. filed the 510(k) submission for ULTRASKIN HYDROPHILIC GUIDE WIRE (K141707).

What is the FDA product code for ULTRASKIN HYDROPHILIC GUIDE WIRE?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ULTRASKIN HYDROPHILIC GUIDE WIRE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ULTRASKIN HYDROPHILIC GUIDE WIRE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ULTRASKIN HYDROPHILIC GUIDE WIRE

K141707 · Lepu Medical Technology (Beijing) Co., Ltd. · DQX · Jan 21, 2015 · Cardiovascular

Device Facts

Record ID	K141707
Device Name	ULTRASKIN HYDROPHILIC GUIDE WIRE
Applicant	Lepu Medical Technology (Beijing) Co., Ltd.
Product Code	DQX · Cardiovascular
Decision Date	Jan 21, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

The ULTRASKIN™ Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure.

Device Story

The ULTRASKIN™ Hydrophilic Guide Wire is a medical device used to facilitate the placement of catheters within the peripheral or coronary vasculature. It consists of a Nitinol core wire encased in a plastic jacket with a hydrophilic coating, which reduces friction during navigation. The device is radiopaque, allowing for visualization under fluoroscopy. It is intended for use by clinicians in clinical settings during diagnostic or interventional procedures. By providing a steerable, low-friction path, the guide wire enables precise catheter positioning, which is essential for successful minimally invasive vascular interventions. The device is provided sterile and is designed for single use.

Clinical Evidence

Bench testing only. Performance testing included dimension verification, corrosion resistance, fracture, flexing, tensile strength, torque strength, torqueability, tip flexibility, coating integrity, particulate evaluation, and radiodetectability. Biocompatibility testing was conducted per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, and thromboresistance. All tests met established requirements.

Technological Characteristics

Nitinol core wire; polyurethane and Wolfram Carbide jacket; hydrophilic coating. Radiopaque. Dimensions vary by distal curve shape (straight, J, angled). Sterilized via method compliant with AAMI/ANSI/ISO 11135:2007 (SAL 10^-6).

Indications for Use

Indicated for patients undergoing diagnostic or interventional procedures requiring catheter navigation to peripheral or coronary anatomical locations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Radifocus® Glidewire® Advantage (K063372)

Related Devices

K193653 — Hydrophilic Coating Guide Wire · Suzhou Hengrui Disheng Medical Co., Ltd. · Aug 26, 2020
K954642 — HYDRO-SELECT GUIDEWIRE · Microvena Corp. · Dec 17, 1996
K170915 — TXM Hydrophilic Guidewire · Texasmedical Technologies, Inc. · Nov 21, 2017
K993257 — .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI · Micro Therapeutics, Inc. · Oct 21, 1999
K152740 — Radifocus Glidewire · Ashitaka Factory of Terumo Corp. · Nov 16, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 21, 2015 Lepu Medical Technology (Beijing) Co., Ltd. C/O Arthur Goddard Regulatory and Quality Systems Consultant 1531 Felton Road South Euclid, Ohio 44121 Re: K141707 > Trade/Device Name: ULTRASKIN™ Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 18, 2014 Received: December 23, 2014 Dear Mr. Goddard, 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Melissa A. Torres -S For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Section 4: Indication for Use Summary 510(k) Number (if known): _ _ Device Name: _ _ _ ULTRASKIN™ Hydrophilic Guide Wire Indications For Use: The ULTRASKIN™ Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ ## Section 5: 510(k) Summary The Summary of Safety and Effectiveness information on the ULTRASKIN™ Hydrophilic Guide Wire being with the requirements of 21 C.F.R. §807.92 and reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations or recommendations set forth. ### I. SUBMITTER | Applicant: | Lepu Medical Technology (Beijing) Co., Ltd. No. 37 Chaoqian Road Changping District, Beijing 102200 P.R. China | |------------|-------------------------------------------------------------------------------------------------------------------------| | Telephone: | +86-10-80123515 | | Contact: | Xiangdan Jin | | Date: | June 20, 2014 | ### II. DEVICE | Name: | ULTRASKIN™ Hydrophilic Guide Wire | |----------------------|-----------------------------------| | Classification Name: | Catheter guide wire 870.1330 | | Regulatory Class: | Class II | | Product Code: | DQX | ### III. PREDICATE DEVICE | Predicate: | Radifocus® Glidewire® Advantage, Terumo Corporation, K063372 with market clearance dates of Jan.19, 2007. | |------------|--------------------------------------------------------------------------------------------------------------| | | No reference devices were used in this submission. | ### IV. DEVICE DESCRIPTION | Description: The ULTRASKIN™ Hydrophilic Guide Wire consists of a Nitinol core wire, a | |-----------------------------------------------------------------------------------------| | plastic jacket with hydrophilic coating. The wire distal curve comes in different | | shapes such as straight, J angled and angled. The guide wire is radiopactitive | | under fluoroscopy. | | | ### INDICATION FOR USE V. | Intended Use: | The ULTRASKINTM Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure. | |---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ### COMPARISION OF TECHNOLOGICAL CHARACTERISTIC WITH PREDICATE VI. DEVICE | Substantial Equivalency Information: | The information provided in this submission, comparing intended use, principle of operation and performance, the ULTRASKIN™ Hydrophilic Guide Wire device is substantially equivalent to existing legally marketed device. | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ # Section 5: 510(k) Summary ### VII. PERFORMACE DATA | Biocompatibility: The ULTRASKIN™ Hydrophilic Guide Wire produced by Lepu Medical was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The ULTRASKIN™ Hydrophilic Guide Wire would be classified as an External Communicating Device in contact with the Circulating Blood for a Limited Duration (<24 hours). The following test would be required for any patient / user contacting material: | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Test | Standard | Results | | Cytotoxicity | ISO 10993-5 | The test article extract showed no evidence of causing cell lysis or toxicity | | Maximum Sensitization | ISO 10993-10 | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | | Intracutaneous Irritation | ISO 10993-10 | The test article met the requirements for the SC and SO test extracts. | | Systemic Toxicity | ISO 10993-11 | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. | | Haemolysis | ISO 10993-4 | Both the test article in direct contact with blood and the test article extract were non-hemolytic. | | USP Pyrogen Study | ISO 10993-11 | The test article was judged as nonpyrogenic. | | In Vivo Thromboresistance | ISO 10993-4 | The test article and control were thromboresistant and comparable. | | Partial Thromboplastin Time | ISO 10993-4 | The test article would be considered a minimal activator and met the requirements of the test. | | C3a Complement Activation Assay | ISO 10993-4 | The test article was not considered to be a potential activator of the complement system. | | SC5b-9 Complement Activation Assay | ISO 10993-4 | The test article was not considered to be a potential activator of the complement system. | | Sterilization: | The method used is based on practices recommended by AAMI / ANSI / ISO 11135:2007 and provides a Sterility Assurance Level (SAL) of 10-6 | | | Shelf Life: | In accordance with ISO 11070 the real time aging of ULTRASKIN™ Hydrophilic Guide Wire demonstrated that the performance of the specific components met the standard requirements without any significant difference to product performance requirements before aging. So the product is stable and | | {5}------------------------------------------------ # Section 5: 510(k) Summary ## VII. PERFORMACE DATA, continue | Performance Testing: | The ULTRASKIN™ Hydrophilic Guide Wire successfully passed all of the following performance tests: | |----------------------|---------------------------------------------------------------------------------------------------| | | ULTRASKIN™ Hydrophilic Guide Wire Performance Testing | | | Dimension Verification | | | Corrosion resistance | | | Fracture | | | Flexing test | | | Tensile strength | | | Torque strength | | | Torqueability | | | Tip flexibility | | | Coating integrity and particulate evaluation | | | Appearance | | | Chemical performance | | | Radiodetectability | | Materials | The ULTRASKIN™ Hydrophilic Guide Wire materials have been subjected to | | Materials Comparison: | The ULTRASKIN Hydrophilic Guide Wire materials have been subjected to biocompatibility tests and the differences between the Radifocus® Glidewire® Advantage (K063372), do not raise any new issues of safety or effectiveness. | | | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|----------------------------------| | | Components | Radifocus® Glidewire® Advantage | ULTRASKINTM | | | Core Wire | Nitinol | Nitinol | | | Plastic Jacket | Polyurethane | Polyurethane, Wolfram Carbide | | | Coating | Hydrophilic coating | Hydrophilic coating | ## VIII. CONCLUSION | Conclusion: | The information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the ULTRASKIN™ Hydrophilic Guide Wire supports a determination of substantially equivalent to existing legally marketed predicate device Radifocus® Glidewire® Advantage (K063372). Any technological differences between the ULTRASKIN™ Hydrophilic Guide Wire and the predicate device Radifocus® Glidewire® Advantage (K063372) do not raise new questions of safety or effectiveness. | |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|