TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT

K140768 · Lepu Medical Technology (Bejing) Co., Ltd. · DYB · Nov 25, 2014 · Cardiovascular

Device Facts

• Record ID: K140768
• Device Name: TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
• Applicant: Lepu Medical Technology (Bejing) Co., Ltd.
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 25, 2014
• Decision: SESE
• 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

Introducer kit facilitates vascular access; components include sheath introducer, dilator, guide wire, puncture needle, and accessories (scalpel, syringe). Puncture needle/catheter creates initial access; guide wire inserted through lumen to guide sheath placement. Sheath provides conduit for interventional devices; hemostasis valve minimizes blood loss. Dilator supports sheath during deployment. Components contain bismuth for fluoroscopic visibility. Used in clinical settings by healthcare professionals. Benefits include stable vascular access and reduced blood loss during interventional procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (hemolysis, cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, thromboresistance, PTT, complement activation). Performance testing verified sheath/dilator/guide wire/needle dimensions, radiodetectability, fracture strength, leakage, coating integrity, and corrosion resistance.

Technological Characteristics

Components: stainless steel, polycarbonate, polyurethane, fluorinated ethylene propylene, silicone, polyethylene, acrylobutyistyrene. Features: hydrophilic coatings, bismuth-loaded radiopaque sheath/dilator. Sterilization: AAMI/ANSI/ISO 11135:2007 (SAL 10^-6). Compliance: ISO 11070 for shelf life/performance. No software or electronic components.

Indications for Use

Indicated for facilitating the introduction of guide wires, catheters, and other accessory medical devices through the skin into a vein or artery while minimizing blood loss.

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

• Shoocin™ Introducer Kit (K123475)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized representation of a human figure. The figure is composed of three profiles facing right, suggesting a sense of community and support. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2014

Lepu Medical Technology (Beijing) Co., Ltd. % Arthur Goddard President 1531 Felton Road South Euclid, Ohio 44121

Re: K140768

> Trade/Device Name: Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type IIi Brilliant Introducer Kit, Type IV Brilliant Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 3. 2014 Received: October 8, 2014

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. 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 device

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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.

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 [phone] or [phone] 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 [phone] or [phone] 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): _ _ K140768 Device Name: _ _ _ _ Brilliant™ Introducer Kit

## Indications For 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.

Prescription Use X (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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## 510(k) Summary: K140768

The Summary of Saley and Effectiven on the Filliant" " Introducer Kit is ocordane with be evit he reguirenents of 2
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| Applicant: | Lepu Medical Technology (Beijing) Co., Ltd. | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | No. 37 Chaoqian Road | | |
| | Changping District, Beijing 102200 | | |
| | P.R. China | | |
| Telephone: | [phone] | | |
| Contact: | Kim Xiangdan | | |
| Date: | March 24, 2014 | | |
| Name: | BrilliantTM Introducer Kit | | |
| Classification Name: | Catheter Introducer, 870.1340 | | |
| Product Code: | DYB | | |
| Predicate: | ShoocinTM Introducer Kit, Lepu Medical Technology, Ltd., K123475 with | | |
| | market clearance date of February 3, 2013. | | |
| Description: | The BrilliantTM Introducer Kit classifies into four types (Type I, II, III, and<br>IV). Type I and II consists of a sheath introducer, a dilator, a guide wire with a<br>guide wire collimator, a puncture needle; Type III consists of a sheath<br>introducer, a dilator, a guide wire with a guide wire collimator; and Type IV<br>consists of a sheath introducer, a dilator, a guide wire with a guide wire<br>collimator, an intravascular catheter with introducer needle, a scalpel and a<br>syringe. | | |
| | The puncture needle or an intravascular catheter incorporates a lumen, which<br>provides a conduit for the insertion of the guide wire into the vascular system.<br>The various types of guide wires, model dependent, are utilized as a guiding<br>mechanism for the insertion of the introduction sheath into the vascular<br>system. The guide wire contains a wire collimator, which assists in funneling<br>the wire through the lumen of the puncture needle or the intravascular catheter<br>and contains marking that are visible under fluoroscopy, which can determine<br>the length of the guide wire within the vascular system. The sheath introducer<br>provides a conduit for introducing other interventional devices, including<br>guide wires and interventional catheters, into the vasculature. The main<br>components of the sheath introducer assembly are a hydrophilic coated sheath<br>introducer, hemostasis valve housing, and a side port with tubing connected to<br>a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide<br>support and stability to the sheath introducer during deployment into the<br>vascular system. The proximal end of the dilator includes a luer port and has a<br>tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth,<br>making these devices visible under fluoroscopy. | | |
| Intended Use: | The BrilliantTM Introducer Kits are intended for use to facilitate the<br>introduction of guide wires, catheters and other accessory medical devices<br>through the skin into a vein or artery and minimize blood loss associated with<br>such introduction. | | |

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## Section 5: 510k) Summary

| Specification<br>Comparison: | The BrilliantTM Introducer Kit specifications are similar to the ShoocinTM Introducer Kit (K123475) and the differences do not raise any new issues of safety or effectiveness. | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | BrilliantTM | ShoocinTM |
| Sheath Diameter: | 4F through 7F | 4F through 11F |
| Sheath Length: | 7cm – 24cm | 7cm – 23cm |
| Guide Wire Length: | 45cm and 70cm | 45cm and 80 cm |
| Guide Wire OD: | .018" – .035" | .018" – .038" |
| Introducer Needle: | 20G and 22G | 18 – 20G |
| Dilator: | 12.5cm – 29.5cm | 7cm – 23cm |
| Materials<br>Comparison: | The BrilliantTM Introducer Kit materials have been subjected to biocompatibility tests and the differences between the ShoocinTM Introducer Kit (K123475 do not raise any new issues of safety or effectiveness. | |
| | BrilliantTM | ShoocinTM |
| Needle: | Stainless Steel | Stainless Steel |
| Needle Luer: | Polycarbonate | Polycarbonate |
| Guide Wire: | Stainless Steel,<br>Stainless Steel w/nitinol core,<br>or<br>Polyurethane jacket w/nitinol coil | Stainless Steel |
| Guide Wire Collimator: | Polycarbonate | Polycarbonate |
| Dilator Tube: | Polycarbonate | Polypropylene |
| Dilator Luer: | Acrylobutyistyrene | Acrylobutyistyrene |
| Outer Sheath: | Fluorinated Ethylene Propylene | Fluorinated Ethylene Propylene |
| Sheath base: | Acrylobutyistyrene | Acrylobutyistyrene |
| Side Port Tubing | Polyurethane | Polyurethane |
| Hemostasis Valve: | Silicone | Silicone |
| 3-Way Stop Cock: | Acrylobutyistyrene | Acrylobutyistyrene |
| Cap: | Polyethylene | Polyethylene |
| Valve: | Polyethylene | Polyethylene |
| Sterilization: | The method used is based on practices recommended by AAMI / ANSI / 11135:2007 and provides a Sterility Assurance Level (SAL) of 10-6 | |
| Shelf Life: | In accordance with ISO 11070 the real time aging of BrilliantTM Introducer Kit 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 reliable. | |

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| Section 5: 510k) Summary | | | | |
|--------------------------|-----------------------------------------------------------------------------------|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Biocompatibility: | assessed against the International Standard ISO 10993-1, "Biological<br>material: | | The Brilliant " Introducer Kit produced by Lepu Medical Technology was<br>evaluation of medical devices. Part 1. Guidance on selection of tests." The<br>Shoocin "10 Introducer Kit would be classified as an External Communicating<br>Device in contact with the Circulating Blood for a Limited Duration (<24<br>hours). The following test would be required for any patient / user contacting | |
| | Test | Standard | Results | |
| | Hemolysis | ISO 10993-4 | Both the test article in direct<br>contact with blood and the test<br>article extract were non-<br>hemolytic. | |
| | Cytotoxicity | ISO 10993-5 | The test article extract showed<br>no evidence of causing cell<br>lysis or toxicity. | |
| | Maximum<br>Sensitization | ISO 10993-10 | The test article was not<br>considered a sensitizer in the<br>guinea pig maximization test. | |
| | Intracutaneous<br>Irritation | ISO 10993-10 | The test article met the<br>requirements for the SC and SO<br>test extracts. | |
| | Systemic Toxicity | ISO 10993-11 | There was no mortality or<br>evidence of systemic toxicity<br>from the extracts injected into<br>mice. | |
| | USP Pyrogen Study | ISO 10993-11 | The test article was judged as<br>nonpyrogenic. | |
| | In Vivo<br>Thromboresistance | ISO 10993-4 | Under conditions of the study<br>of extreme exaggeration of<br>clinical use, the test article was<br>not thromboresistant and the<br>control article was<br>thromboresistant. | |
| | Partial Thromboplastin<br>Time | ISO 10993-4 | The test article would be<br>considered a minimal activator<br>and met the requirements of the<br>test. | |
| | C3a Complement<br>Activation Assay | ISO 10993-4: | The test article was not<br>considered to be a potential<br>activator of the complement<br>system. | |
| | SC5b-9 Complement<br>Activation Assay | ISO 10993-4: | The test article was not<br>considered to be a potential<br>activator of the complement<br>system. | |

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| Section 5: 510k) Summary | | | | | | | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| Performance Testing: | The BrilliantTM Introducer Kit successfully passed all of the following performance tests: | | | | | | | | |
| | BrilliantTM Introducer Kit Performance Testing Sheath Introducer Sheath Introducer should be free of defects<br>Sheath Introducer ID<br>Sheath Introducer Effective Length<br>Radiodetectability<br>Dilator accessibility<br>Fracture Strength Test<br>Leaking Performance Test<br>Coating Efficacy Test<br>Coating Integrity Test | | | | | | | | |
| Performance Testing: | The BrilliantTM Introducer Kit successfully passed all of the following performance tests: | | | | | | | | |
| | BrilliantTM Introducer Kit Performance Testing Dilator Dilator should be free of defects<br>Dilator OD<br>Dilator ID<br>Dilator Effective Length<br>Radiodetectability<br>Guide wire accessibility<br>Fracture Strength Test<br>Coating Efficacy Test<br>Coating Integrity<br>Surface free from impurity Guide wire Guide wire length<br>Guide wire OD<br>Radiodetectability<br>Corrosion Resistance<br>Fracture Strength Test<br>Flexing Resistance Test<br>Associative Guide Wire Strength Test<br>Coating Integrity<br>Surface free from defects Puncture Needle Needle OD<br>Needle ID<br>Needle Effective Length<br>Accessibility – Guide wire<br>Corrosion Resistance<br>Joint Strength - Needle to hub | | | | | | | | |

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| Section 5: 510k) Summary | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalency<br>Information: | The information provided in this submission, comparing intended use,<br>principle of operation and performance, the BrilliantTM Introducer Kit device is<br>substantially equivalent to existing legally marketed device. |
| Conclusion: | The information provided in this submission and comparing intended use,<br>principle of operation and overall technological characteristics (i.e. puncture<br>needle, guide wire, dilator, and sheath introducer to obtain access to the<br>vascular system), the BrilliantTM Introducer Kit supports a determination of<br>substantially equivalent to existing legally marketed predicate device ShoocinTM Introducer Kit. Any technological differences between the BrilliantTM Introducer Kit and the predicate ShoocinTM Introducer Kit do not raise new<br>questions of safety or effectiveness. |