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 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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Brilliant Introducer Kit." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a novel AI/software component within the device.

Therefore, many of the requested points regarding AI/algorithm performance studies cannot be answered from this document.

However, I can extract information related to the device's biocompatibility and performance testing, which are critical acceptance criteria for this type of medical device.

Here's the information that can be extracted and a clear indication of what cannot be derived from the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through biocompatibility testing and general performance testing. The text does not provide quantitative acceptance criteria targets in the way one might for a software algorithm's accuracy, but rather indicates that the device "met the requirements" or "successfully passed" various tests based on established standards.

Table 1: Acceptance Criteria (as implied by successful testing) and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance (Results)
Biocompatibility
Cytotoxicity	No cytotoxicity potential (as per ISO 10993-5)	Under the conditions of this study, the Mem test extracts would be considered no cytotoxicity potential. The negative controls, blank controls, and the positive controls performed as anticipated.
ISO Intracutaneous Study	Met requirements, with no significant difference between test extract and control overall mean scores (as per ISO 10993-10)	Under the conditions of this study, the test article met the requirements of the test since the difference between each test extract overall mean score and corresponding control overall mean score was 0.0 and 0.0 for the SC and CSO test extracts, respectively.
ISO Guinea Pig Maximum Sensitization	No evidence of causing delayed dermal contact sensitization (as per ISO 10993-10)	Under the conditions of this study, the test article extracts showed no evidence of causing delayed dermal contract sensitization in the Guinea pig. The test article was not considered a sensitizer in the Guinea pig maximization test.
ISO Systemic Toxicity	No mortality or evidence of systemic toxicity (as per ISO 10993-11)	Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study.
Complement Activation Assay	Not significantly different from negative control (P>0.05) (as per ISO 10993-4)	Under the conditions of this study, the Sc5b-9 concentration from the test article were not significantly different from that of negative control sample and Control article (P>0.05).
ASTM Hemolysis	Non-hemolytic (as per ISO 10993-4, ASTM F756)	Under the conditions of this study, the Hemolytic Index for the test article in direct contact with blood was 1.9% and that for the test article extract was 0.6%. Both the test article in direct contact with blood and test article were non-hemolytic.
USP Pyrogen Study	Non-pyrogenic (maximum rise of rabbit temperatures not showing a rise of 0.5 °C or more above baseline) (as per ISO 10993-11, USP <151>)	Under the conditions of this study, the maximum rise of each rabbit temperatures did not show a rise of 0.5 °C or more above its baseline temperature during 3 hour observation period. The test article was judged as nonpyrogenic.
Partial Thromboplastin Time	Mild thrombogenicity response considered acceptable (as per ISO 10993-4)	Under the conditions of this study, the % negative control is 72.32%, the test article would be considered mild thrombogenicity response.
In Vivo Thromboresistance	Thromboresistant (no thrombosis, similar to control) (as per ISO 10993-4)	Under the conditions of this study, the test article showed no thrombosis which was similar with the control article. The test article would be considered as thromboresistant.
Performance Testing	Successfully passed all listed performance tests. Specific quantitative acceptance criteria are not provided, but passing indicates meeting internal or standard specifications for these parameters.	The Brilliant™ Introducer Kit successfully passed all of the following performance tests: Radio-detectability (Sheath Introducer), Peak Tensile Force between Side Port Tubing and Hemostasis Valve, Dilator internal diameter, Radio-detectability (Dilator), Guidewire accessibility, Coating integrity, Coating efficacy, Particulate evaluation, Residual EO and ECH, Sterile, Bacterial endotoxin.
Sterilization	Sterility Assurance Level (SAL) of 10-6 (as per AAMI / ANSI / ISO 11135:2014)	The method used is based on practices recommended by AAMI / ANSI / ISO 11135:2014 and provides a Sterility Assurance Level (SAL) of 10-6.

Additional Information Requests:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document for the biocompatibility or performance tests.
- Data Provenance: The document does not specify the country of origin for the test data, nor whether the studies were retrospective or prospective. The applicant is Lepu Medical Technology (Beijing) Co., Ltd., which is located in P.R. China, implying the studies were likely conducted there or overseen by them.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to the type of device and testing described. The "ground truth" here is established by standardized laboratory testing procedures (e.g., ISO, ASTM, USP standards) for biocompatibility and engineering performance, not by expert interpretation of clinical images or data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, not for objective laboratory test results.
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 not an AI/software device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility: Ground truth is established by the specific endpoints and methodologies defined in the referenced international standards (e.g., cell viability for cytotoxicity, skin irritation scores for intracutaneous reactivity, sensitization response for maximization tests, mortality/organ effects for systemic toxicity, complement activation markers for complement assay, hemolytic index for hemolysis, temperature rise for pyrogenicity, clotting times for thromboplastin, and visual/histological assessment for in vivo thromboresistance).
- For performance testing: Ground truth is established by engineering specifications and measurements (e.g., tensile force measurements, diameter measurements, visual inspection for coating integrity, particulate counts, chemical residue analysis, microbial culture for sterility, endotoxin assays).
The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
How the ground truth for the training set was established
- Not applicable (no training set).

In summary, the provided document is a 510(k) premarket notification for a conventional introducer kit, primarily demonstrating substantial equivalence through adherence to existing medical device standards for biocompatibility and performance. It does not involve AI/machine learning components, and thus, metrics pertinent to AI/software validation are not present.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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:	+86-10-80123510
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 thisstudy, the Mem test extractswould be considered nocytotoxicity potential. Thenegative controls, blankcontrols, and the positivecontrols performed asanticipated.
ISOIntracutaneousstudy	ISO 10993-10	Under the conditions of thisstudy, the test article met therequirements of the test sincethe difference between eachtest extract overall meanscore and correspondingcontrol overall mean scorewas 0.0 and 0.0 for the SCand CSO test extracts,respectively.
ISO GuineaPig MaximumSensitization	ISO 10993-10	Under the conditions of thisstudy, the test article extractsshowed no evidence of causingdelayed dermal contractsensitization in the Guinea pig.The test article was notconsidered a sensitizer in theGuinea pig maximization test.
ISO SystemicToxicity	ISO 10993-11	Under the conditions of thisstudy, there was no mortality orevidence of systemic toxicityfrom the extracts injected intomice. Each test article extractmet the requirements of thestudy.
ComplementActivationAssay	ISO 10993-4	Under the conditions of thisstudy, the Sc5b-9 concentrationfrom the test article were notsignificantly different from thatof negative control sample andControl article (P>0.05).
ASTMHemolysis	ISO 10993-4ASTM F756	Under the conditions of thisstudy, the Hemolytic Index forthe test article in direct contactwith blood was 1.9% and thatfor the test article extract was0.6%. Both the test article indirect contact with blood andtest article were non-hemolytic.
USP PyrogenStudy	ISO 10993-11USP <151>	Under the conditions of thisstudy, the maximum rise of eachrabbit temperatures did not showa rise of 0.5 °C or more above itsbaseline temperature during 3hour observation period. The testarticle was judged asnonpyrogenic.
PartialThromboplastin Time	ISO 10993-4	Under the conditions of thisstudy, the % negative control is72.32%, the test article would beconsidered mild thrombogenicityresponse.
In VivoThromboresistance	ISO 10993-4	Under the conditions of thisstudy, the test article showed nothrombosis which was similarwith the control article. The testarticle would be considered asthromboresistant.

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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 betweenSide Port Tubing andHomeostasis 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).

Regulation Number and Section

§ 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).