(243 days)
No
The device description and performance studies focus on the physical components and mechanical properties of the introducer kit, with no mention of AI or ML capabilities.
No.
The device facilitates the introduction of other medical devices into the body and minimizes blood loss, but it does not directly treat a disease or condition.
No
The device is an introducer kit designed to facilitate the insertion of other medical devices into a vein or artery. Its function is to provide a conduit for access, not to diagnose a condition or disease.
No
The device description clearly outlines multiple physical components (sheath introducer, dilator, guide wire, puncture needle, etc.) and performance testing related to these hardware components. There is no mention of software as a component or its function.
Based on the provided information, the Brilliant™ Introducer Kits are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the introduction of medical devices through the skin into a vein or artery. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description details components like sheath introducers, dilators, guide wires, and needles, all designed for accessing and navigating within the vascular system. These are tools for direct intervention within the body.
- Anatomical Site: The specified anatomical site is "Vein or artery," which are internal structures within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. The Brilliant™ Introducer Kits are designed for direct access and manipulation within the vascular system, making them an in vivo medical device.
N/A
Intended Use / 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.
Product codes
DYB
Device Description
The BrilliantTM Introducer Kit classifies into four types (Type I, II, III, and IV). Type I and II consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, a puncture needle; Type III consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator; and Type IV consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, an intravascular catheter with introducer needle, a scalpel 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 and contains marking that are visible under fluoroscopy, which can determine the length of the guide wire within the vascular system. 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 with tubing connected to 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. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery / vascular system / vasculature
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)
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. Based on the International Standard ISO 10993-1, the BrilliantTM Introducer Kit was evaluated as an External Communicating Device in contact with the Circulating Blood for a Limited Duration (
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
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
1
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 (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): _ _ 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)
3
510(k) Summary: K140768
The Summary of Saley and Effectiven on the Filliant" " Introducer Kit is ocordane with be evit he reguirenents of 2
C.F.R. $807.92 and reflects data wallable in the cubmissio
| Applicant: | Lepu Medical Technology (Beijing) Co., Ltd. | ||
|---|---|---|---|
| No. 37 Chaoqian Road | |||
| Changping District, Beijing 102200 | |||
| P.R. China | |||
| Telephone: | +86-10-80120641 | ||
| 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 | ||
| IV). Type I and II consists of a sheath introducer, a dilator, a guide wire with a | |||
| guide wire collimator, a puncture needle; Type III consists of a sheath | |||
| introducer, a dilator, a guide wire with a guide wire collimator; and Type IV | |||
| consists of a sheath introducer, a dilator, a guide wire with a guide wire | |||
| collimator, an intravascular catheter with introducer needle, a scalpel 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 | |||
| and contains marking that are visible under fluoroscopy, which can determine | |||
| the length of the guide wire within the vascular system. 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 with tubing connected to | |||
| 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. Both the sheath and dilator contain bismuth, | |||
| making these devices visible under fluoroscopy. | |||
| Intended Use: | The BrilliantTM 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. |
4
Section 5: 510k) Summary
| Specification
| 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 | ||
| 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, | |
| Stainless Steel w/nitinol core, | ||
| or | ||
| 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 | |||
| material: | The Brilliant " Introducer Kit produced by Lepu Medical Technology was | |||
| evaluation of medical devices. Part 1. Guidance on selection of tests." The | ||||
| Shoocin "10 Introducer Kit would be classified as an External Communicating | ||||
| Device in contact with the Circulating Blood for a Limited Duration ( |