(211 days)
No reference devices were used in this submission.
No
The summary describes a physical guide wire and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device, a guide wire, is used to assist in the delivery or placement of other devices (like catheters) for diagnostic or interventional procedures. It does not actively treat a disease or condition itself.
No
The device is a guide wire used to direct a catheter, which is part of an interventional procedure. While the procedure itself might be diagnostic or interventional, the guide wire's role is to facilitate the delivery of another device (the catheter), not to diagnose a condition itself.
No
The device description clearly outlines physical components (Nitinol core wire, plastic jacket, hydrophilic coating) and performance testing related to material properties and physical characteristics, indicating it is a hardware device.
Based on the provided information, the ULTRASKIN™ Hydrophilic Guide Wire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure." This describes a device used within the body to facilitate a medical procedure, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details a physical wire with specific materials and features designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ULTRASKIN™ Hydrophilic Guide Wire is an interventional device used to guide other instruments within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral or coronary anatomical location
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)
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 (
§ 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/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 (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. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |