(211 days)
The ULTRASKIN™ Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure.
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.
The provided text describes the ULTRASKIN™ Hydrophilic Guide Wire, a medical device, and its supporting data for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely derived from international standards and internal performance testing, demonstrating safety and effectiveness compared to a predicate device.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 (Guidance on selection of tests for External Communicating Device in contact with Circulating Blood for a Limited Duration (<24 hours)) | Device produced by Lepu Medical was assessed against this standard. |
| 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 | AAMI / ANSI / ISO 11135:2007 | Provides a Sterility Assurance Level (SAL) of 10-6. |
| Shelf Life | ISO 11070 (Real-time aging) | Demonstrated that the performance of specific components met standard requirements without significant difference to product performance requirements before aging. Product is stable. |
| 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. (ULTRASKIN™ Hydrophilic Guide Wire Performance Testing) | The ULTRASKIN™ Hydrophilic Guide Wire successfully passed all these performance tests. The materials comparison showed no new issues of safety or effectiveness compared to the predicate device, despite the addition of Wolfram Carbide in the plastic jacket. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample sizes used for each specific biocompatibility and performance test (e.g., number of animals for toxicity tests, number of guide wires for mechanical tests). It generally states that "The ULTRASKIN™ Hydrophilic Guide Wire successfully passed all of the following performance tests" and provides "Results" for each biocompatibility test.
- Data Provenance: The data is generated from testing conducted by Lepu Medical Technology (Beijing) Co., Ltd. The document does not specify the country of origin for the studies themselves (e.g., where the animal studies were conducted), but the manufacturer is based in Beijing, P.R. China. The studies are assumed to be prospective as they were conducted for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes technical and biological performance testing, not studies requiring expert interpretation of clinical data or images. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable here. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified ISO standards and validated internal engineering tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against predefined criteria in scientific standards, not subjective assessments requiring adjudication.
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
Not applicable. This is a medical device (guide wire), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance of systems, often involving human readers and AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the ULTRASKIN™ Hydrophilic Guide Wire is based on:
- International Standards: Primarily ISO 10993 series for biocompatibility and ISO 11070 for shelf life, which define the acceptable limits and methodologies.
- Engineering Specifications/Internal Standards: For performance tests like dimension verification, tensile strength, etc., the "ground truth" or acceptance criteria are derived from the device's design specifications and industry safety/performance expectations for guide wires.
- Predicate Device Comparison: The ultimate "ground truth" for FDA 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device (Radifocus® Glidewire® Advantage, K063372) by showing that any differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The device's performance is established through direct physical, chemical, and biological testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
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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
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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
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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)
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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 RoadChangping District, Beijing 102200P.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 marketclearance 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 tothe desired peripheral or coronary anatomical location during diagnostic orinterventional procedure. |
|---|---|
| --------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
COMPARISION OF TECHNOLOGICAL CHARACTERISTIC WITH PREDICATE VI. DEVICE
| SubstantialEquivalencyInformation: | The information provided in this submission, comparing intended use, principleof operation and performance, the ULTRASKIN™ Hydrophilic Guide Wiredevice is substantially equivalent to existing legally marketed device. |
|---|---|
| -------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Section 5: 510(k) Summary
VII. PERFORMACE DATA
| Biocompatibility: The ULTRASKIN™ Hydrophilic Guide Wire produced by Lepu Medical wasassessed against the International Standard ISO 10993-1, "Biological evaluation ofmedical devices. Part 1. Guidance on selection of tests." The ULTRASKIN™Hydrophilic Guide Wire would be classified as an External CommunicatingDevice 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 noevidence of causing cell lysis ortoxicity |
| MaximumSensitization | ISO 10993-10 | The test article extracts showed noevidence of causing delayed dermalcontact sensitization in the guinea pig. |
| IntracutaneousIrritation | ISO 10993-10 | The test article met the requirementsfor the SC and SO test extracts. |
| Systemic Toxicity | ISO 10993-11 | There was no mortality or evidence ofsystemic toxicity from the extractsinjected into mice. |
| Haemolysis | ISO 10993-4 | Both the test article in direct contactwith blood and the test article extractwere non-hemolytic. |
| USP Pyrogen Study | ISO 10993-11 | The test article was judged asnonpyrogenic. |
| In VivoThromboresistance | ISO 10993-4 | The test article and control werethromboresistant and comparable. |
| PartialThromboplastinTime | ISO 10993-4 | The test article would be considered aminimal activator and met therequirements of the test. |
| C3a ComplementActivation Assay | ISO 10993-4 | The test article was not considered tobe a potential activator of thecomplement system. |
| SC5b-9ComplementActivation Assay | ISO 10993-4 | The test article was not considered tobe a potential activator of thecomplement system. |
| Sterilization: | The method used is based on practices recommended by AAMI / ANSI / ISO11135:2007 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 specificcomponents met the standard requirements without any significant difference toproduct performance requirements before aging. So the product is stable and |
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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 |
| MaterialsComparison: | 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 | Hydrophiliccoating | Hydrophiliccoating |
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. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.