Type I, Type II, Type III, Type IV

K172331 · Lepu Medical Technology (Beijing) Co., Ltd. · DYB · Mar 2, 2018 · Cardiovascular

Device Facts

• Record ID: K172331
• Device Name: Type I, Type II, Type III, Type IV
• Applicant: Lepu Medical Technology (Beijing) Co., Ltd.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 2, 2018
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Brilliant Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

Device Story

Brilliant Introducer Kit facilitates vascular access; provides conduit for guide wires, catheters, and interventional devices. Kit components include hydrophilic-coated sheath introducer, dilator, guide wire with collimator, puncture needle, and syringe (model dependent). Sheath features hemostasis valve and side port with 3-way stopcock to minimize blood loss. Dilator provides support/stability during deployment; includes luer port and tapered tip. Device used by clinicians in clinical settings. Sheath contains Barium sulfate for fluoroscopic visibility. Operation involves percutaneous insertion into vein or artery; guide wire acts as tracking mechanism for sheath placement. Output is established vascular access conduit. Benefits include simplified device delivery and reduced blood loss during interventional procedures.

Clinical Evidence

Bench testing only. No clinical data. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, thrombogenicity). Mechanical performance testing included radio-detectability, tensile force, dimensional verification, coating integrity/efficacy, and particulate evaluation. Sterilization validated per ISO 11135:2014.

Technological Characteristics

Components: hydrophilic-coated sheath introducer, dilator, guide wire, puncture needle. Materials: Barium sulfate (BaSO4) used as radiocontrast agent. Sterilization: Ethylene Oxide (EO) per AAMI/ANSI/ISO 11135:2014 (SAL 10^-6). Biocompatibility: ISO 10993-1. Mechanical specs: ASTM F756 (hemolysis). Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring vascular access for the introduction of guide wires, catheters, and other accessory medical devices into a vein or artery.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Brilliant™ Introducer Kit (K140768)

Submission Summary (Full Text)

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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 2, 2018

Lepu Medical Technology (Beijing) Co., Ltd. % Arthur Goddard President FDA Regulatory and Quality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445

### Re: K172331

Trade/Device Name: Brilliant Introducer Kits Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: January 26, 2018 Received: January 30, 2018

### Dear Arthur 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration. Iisting 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

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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.

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 ([e-mail]) or phone [phone] 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) K172331

Device Name Brilliant Introducer Kit

Indications for Use (Describe)

The Brilliant Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

| 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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# K172331

| Applicant: | Lepu Medical Technology (Beijing) Co., Ltd. |
|----------------------|-----------------------------------------------------------------------------|
| | No. 37 Chaoqian Road Changping District, Beijing 102200 P.R. China |
| Telephone: | [phone] |
| Contact: | Xiangdan Kim |
| Date: | July, 31, 2017 |
| Name: | Brilliant™ Introducer Kit |
| Classification Name: | Catheter Introducer, 870.1340 |
| Product Code: | DYB |
| Predicate: | Brilliant™ Introducer Kit, Lepu Medical Technology, Ltd., K140768 with |
| | market clearance date of November 25, 2014. |
| Modification to | 1. Addition of six models to Type III (ACS061135, ACS062435, |
| Predicate K140768 | ACS070735, ACS071135, ACS071635 and ACS072435); |
| | 2. Change of the radiocontrast agent in the Sheath Introducer from |
| | Bismuth to Barium sulfate (BaSO4), and |
| | 3. Removal of the radiocontrast agent Bismuth in the Dilator; |
| | 4. Change of the coating location on the surface of Sheath Introducer, |
| | Dilator and guidewire; |
| | 5. Removal of guidewire with guidewire collimator and puncture needle |
| | in Type I, removal scalpel in Type IV. |
| Description: | The Brilliant™ Introducer Kit classifies into four types (Type I, II, III, |
| | and IV). Type I consists of a sheath introducer and a dilator. Type II |
| | consists of a sheath introducer, a dilator, a guide wire with a guide wire |
| | collimator and a puncture needle. Type III consists of a sheath introducer, |
| | a dilator, a guide wire with a guide wire collimator. Type IV consists of a |
| | sheath introducer, a dilator, a guide wire with a guide wire collimator, an |
| | Intravascular catheter (with needle) and a syringe. |
| | The puncture needle or an intravascular catheter incorporates a lumen, |
| | which provides a conduit for the insertion of the guide wire into the |
| | vascular system. The various types of guide wires, model dependent, are |
| | utilized as a guiding mechanism for the insertion of the introduction |
| | sheath into the vascular system. The guide wire contains a wire |
| | collimator, which assists in funneling the wire through the lumen of the |
| | puncture needle or the intravascular catheter. The guide wire is radio- |
| | detective under fluoroscopy. The sheath introducer provides a conduit for |
| | introducing other interventional devices, including guide wires and |
| | interventional catheters, into the vasculature. The main components of |
| | the sheath introducer assembly are a hydrophilic coated sheath introducer, |
| | hemostasis valve housing, and a side port tubing with a 3-way |
| | stopcock/valve. The hydrophilic coated dilator is used to provide support |
| | and stability to the sheath introducer during deployment into the vascular |
| | system. The proximal end of the dilator includes a luer port and has a |
| | tapered, atraumatic distal tip. The sheath introducer contains Barium |
| | sulfate (BaSO4), making the device visible under fluoroscopy. There is no |
| | radiocontrast agent in the dilator. |

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- The Brilliant™ Introducer Kits are intended for use to facilitate the Intended Use: introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
Predicate Device Lepu Medical Technology (Beijing) Co., Ltd. added six models to Type Comparison: III; the sheath introducer radiocontrast agent was changed from Bismuth to Barium sulfate (BaSO4); radiocontrast agent in dilator is removed; coating location on the surface of Sheath Introducer, Dilator and guidewire is changed; guidewire with guidewire collimator and puncture needle are removed in Type I, scalpel in Type IV is remove. Compared with currently marketed Brilliant™ Introducer Kit, the subject device is substantially equivalent to the predicate device in terms of intended use, indication for use, operational characteristics, and fundamental design and technology characteristics.

The Brilliant™ Introducer Kit produced by Lepu Medical Technology Biocompatibility: was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The Brilliant "10 Introducer Kit 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 | Under the conditions of this<br>study, the Mem test extracts<br>would be considered no<br>cytotoxicity potential. The<br>negative controls, blank<br>controls, and the positive<br>controls performed as<br>anticipated. |
| ISO<br>Intracutaneous<br>study | ISO 10993-10 | Under the conditions of this<br>study, the test article met the<br>requirements of the test since<br>the difference between each<br>test extract overall mean<br>score and corresponding<br>control overall mean score<br>was 0.0 and 0.0 for the SC<br>and CSO test extracts,<br>respectively. |
| ISO Guinea<br>Pig Maximum<br>Sensitization | ISO 10993-10 | Under the conditions of this<br>study, the test article extracts<br>showed no evidence of causing<br>delayed dermal contract<br>sensitization in the Guinea pig.<br>The test article was not<br>considered a sensitizer in the<br>Guinea pig maximization test. |
| ISO Systemic<br>Toxicity | ISO 10993-11 | Under the conditions of this<br>study, there was no mortality or<br>evidence of systemic toxicity<br>from the extracts injected into<br>mice. Each test article extract<br>met the requirements of the<br>study. |
| Complement<br>Activation<br>Assay | ISO 10993-4 | Under the conditions of this<br>study, the Sc5b-9 concentration<br>from the test article were not<br>significantly different from that<br>of negative control sample and<br>Control article (P>0.05). |
| ASTM<br>Hemolysis | ISO 10993-4<br>ASTM F756 | Under the conditions of this<br>study, the Hemolytic Index for<br>the test article in direct contact<br>with blood was 1.9% and that<br>for the test article extract was<br>0.6%. Both the test article in<br>direct contact with blood and<br>test article were non-hemolytic. |
| USP Pyrogen<br>Study | ISO 10993-11<br>USP <151> | Under the conditions of this<br>study, the maximum rise of each<br>rabbit temperatures did not show<br>a rise of 0.5 °C or more above its<br>baseline temperature during 3<br>hour observation period. The test<br>article was judged as<br>nonpyrogenic. |
| Partial<br>Thromboplast<br>in Time | ISO 10993-4 | Under the conditions of this<br>study, the % negative control is<br>72.32%, the test article would be<br>considered mild thrombogenicity<br>response. |
| In Vivo<br>Thromboresist<br>ance | ISO 10993-4 | Under the conditions of this<br>study, the test article showed no<br>thrombosis which was similar<br>with the control article. The test<br>article would be considered as<br>thromboresistant. |

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| Performance The Brilliant™ Introducer Kit successfully passed all of the following |
|---------------------------------------------------------------------------------------|
| Testing: performance tests: |

| | Test items |
|------------------------|-------------------------------------------------------------------------|
| Sheath Introducer | Radio-detectability |
| | Peak Tensile Force between<br>Side Port Tubing and<br>Homeostasis Valve |
| Dilator | Dilator internal diameter |
| | Radio-detectability |
| | Guidewire accessibility |
| Coating performance | Coating integrity |
| | Coating efficacy |
| Particulate evaluation | |
| Residual EO and ECH | |
| Sterile | |
| Bacterial endotoxin | |

Sterilization: The method used is based on practices recommended by AAMI / ANSI / ISO 11135:2014 and provides a Sterility Assurance Level (SAL) of 10-6.

- The information provided in this submission and comparing intended Conclusion: use, principle of operation and overall technological characteristics (i.e. puncture needle, guide wire, dilator, and sheath introducer to obtain access to the vascular system), the Brilliant™ Introducer Kit supports a determination of substantial equivalence to existing legally marketed predicate device Brilliant ™ Introducer Kit (K140768).