(243 days)
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.
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.
Please find the requested information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, as extracted from the provided document.
Acceptance Criteria and Reported Device Performance
The provided document describes the "Brilliant™ Introducer Kit," which is a collection of medical devices, not a digital algorithm or AI. Therefore, the acceptance criteria and study details are related to the physical performance and biocompatibility of the medical device components rather than algorithmic or AI-assisted performance metrics (like sensitivity, specificity, or improvement in human reader performance with AI assistance).
The document states that the Brilliant™ Introducer Kit underwent various performance and biocompatibility tests to demonstrate substantial equivalence to its predicate device, the "Shoocin™ Introducer Kit."
1. Table of Acceptance Criteria and Reported Device Performance:
Since the document does not explicitly state numerical acceptance criteria for each specific test but rather states that the device "passed" or "met the requirements," I will present the tests performed and the reported outcome.
| Test Category | Specific Test / Criterion | Reported Device Performance / Outcome |
|---|---|---|
| Biocompatibility | Hemolysis (ISO 10993-4) | Both the test article in direct contact with blood and the test article extract were non-hemolytic. |
| 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 was not considered a sensitizer in the guinea pig maximization test. | |
| 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. | |
| USP Pyrogen Study (ISO 10993-11) | The test article was judged as nonpyrogenic. | |
| In Vivo Thromboresistance (ISO 10993-4) | Under conditions of the study of extreme exaggeration of clinical use, the test article was not thromboresistant and the control article was thromboresistant. | |
| 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 | Sterilization Method (AAMI / ANSI / 11135:2007) | Provides a Sterility Assurance Level (SAL) of 10-6. |
| Shelf Life | Real time aging (ISO 11070) | Performance of specific components met standard requirements without significant difference to product performance requirements before aging. Product is stable and reliable. |
| Performance Testing (General Statement) | Various performance tests for Sheath Introducer, Dilator, Guide wire, Puncture Needle (e.g., freedom of defects, ID/OD, length, radiodetectability, fracture strength, leaking performance, coating efficacy/integrity, corrosion resistance, flexing resistance, joint strength, accessibility). | The Brilliant™ Introducer Kit successfully passed all of the listed performance tests. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify explicit sample sizes for the performance or biocompatibility tests in terms of number of devices or data points used. However, testing was conducted on samples of the physical device.
- Data Provenance: The studies were conducted by Lepu Medical Technology (Beijing) Co., Ltd. Given the company's location and the context of a 510(k) submission to the FDA, these tests would be considered prospective studies specifically designed to evaluate the new device for regulatory clearance. The country of origin of the data would be China, where Lepu Medical Technology is based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to the provided document. The "ground truth" in this context refers to the direct measurement and observation of the physical properties and biological reactions of the device, typically performed through standardized laboratory and animal testing protocols, rather than expert consensus on diagnostic interpretations. No human experts in the sense of clinicians establishing a "ground truth" for a diagnostic outcome are mentioned or relevant here.
4. Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, which is not the nature of the biocompatibility and performance tests described for this medical device. The results of these tests are typically objective measurements or observations against defined standards.
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. The Brilliant™ Introducer Kit is a physical medical device (catheter introducer kit) and not an AI or imaging algorithm. Therefore, no studies involving human readers, AI assistance, or MRMC analysis were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance and safety is established through:
- Standardized Test Protocols: Adherence to international standards like ISO 10993 (for biocompatibility) and ISO 11070 (for shelf life) and AAMI/ANSI/11135 (for sterilization).
- Physical Measurements and Chemical Analysis: Direct measurement of device dimensions (ID/OD, length), material properties, fracture strength, corrosion resistance, and observation of defects.
- In Vitro and In Vivo Biological Assays: Laboratory tests (e.g., hemolysis, cytotoxicity, complement activation) and animal studies (e.g., sensitization, systemic toxicity, pyrogenicity, in vivo thromboresistance).
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical device.
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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 (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): _ _ 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
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, andIV). Type I and II consists of a sheath introducer, a dilator, a guide wire with aguide wire collimator, a puncture needle; Type III consists of a sheathintroducer, a dilator, a guide wire with a guide wire collimator; and Type IVconsists of a sheath introducer, a dilator, a guide wire with a guide wirecollimator, an intravascular catheter with introducer needle, a scalpel and asyringe. | ||
| The puncture needle or an intravascular catheter incorporates a lumen, whichprovides 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 guidingmechanism for the insertion of the introduction sheath into the vascularsystem. The guide wire contains a wire collimator, which assists in funnelingthe wire through the lumen of the puncture needle or the intravascular catheterand contains marking that are visible under fluoroscopy, which can determinethe length of the guide wire within the vascular system. The sheath introducerprovides a conduit for introducing other interventional devices, includingguide wires and interventional catheters, into the vasculature. The maincomponents of the sheath introducer assembly are a hydrophilic coated sheathintroducer, hemostasis valve housing, and a side port with tubing connected toa 3-way stopcock/valve. The hydrophilic coated dilator is used to providesupport and stability to the sheath introducer during deployment into thevascular system. The proximal end of the dilator includes a luer port and has atapered, 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 theintroduction of guide wires, catheters and other accessory medical devicesthrough the skin into a vein or artery and minimize blood loss associated withsuch introduction. |
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Section 5: 510k) Summary
| SpecificationComparison: | 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 |
| MaterialsComparison: | 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,orPolyurethane 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, "Biologicalmaterial: | The Brilliant " Introducer Kit produced by Lepu Medical Technology wasevaluation of medical devices. Part 1. Guidance on selection of tests." TheShoocin "10 Introducer Kit would be classified as an External CommunicatingDevice in contact with the Circulating Blood for a Limited Duration (<24hours). The following test would be required for any patient / user contacting | ||
| Test | Standard | Results | ||
| Hemolysis | ISO 10993-4 | Both the test article in directcontact with blood and the testarticle extract were non-hemolytic. | ||
| Cytotoxicity | ISO 10993-5 | The test article extract showedno evidence of causing celllysis or toxicity. | ||
| MaximumSensitization | ISO 10993-10 | The test article was notconsidered a sensitizer in theguinea pig maximization test. | ||
| IntracutaneousIrritation | ISO 10993-10 | The test article met therequirements for the SC and SOtest extracts. | ||
| Systemic Toxicity | ISO 10993-11 | There was no mortality orevidence of systemic toxicityfrom the extracts injected intomice. | ||
| USP Pyrogen Study | ISO 10993-11 | The test article was judged asnonpyrogenic. | ||
| In VivoThromboresistance | ISO 10993-4 | Under conditions of the studyof extreme exaggeration ofclinical use, the test article wasnot thromboresistant and thecontrol article wasthromboresistant. | ||
| Partial ThromboplastinTime | ISO 10993-4 | The test article would beconsidered a minimal activatorand met the requirements of thetest. | ||
| C3a ComplementActivation Assay | ISO 10993-4: | The test article was notconsidered to be a potentialactivator of the complementsystem. | ||
| SC5b-9 ComplementActivation Assay | ISO 10993-4: | The test article was notconsidered to be a potentialactivator of the complementsystem. |
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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 defectsSheath Introducer IDSheath Introducer Effective LengthRadiodetectabilityDilator accessibilityFracture Strength TestLeaking Performance TestCoating Efficacy TestCoating 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 defectsDilator ODDilator IDDilator Effective LengthRadiodetectabilityGuide wire accessibilityFracture Strength TestCoating Efficacy TestCoating IntegritySurface free from impurity Guide wire Guide wire lengthGuide wire ODRadiodetectabilityCorrosion ResistanceFracture Strength TestFlexing Resistance TestAssociative Guide Wire Strength TestCoating IntegritySurface free from defects Puncture Needle Needle ODNeedle IDNeedle Effective LengthAccessibility – Guide wireCorrosion ResistanceJoint Strength - Needle to hub |
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| Section 5: 510k) Summary | |
|---|---|
| SubstantialEquivalencyInformation: | The information provided in this submission, comparing intended use,principle of operation and performance, the BrilliantTM Introducer Kit device issubstantially equivalent to existing legally marketed device. |
| Conclusion: | The information provided in this submission and comparing intended use,principle of operation and overall technological characteristics (i.e. punctureneedle, guide wire, dilator, and sheath introducer to obtain access to thevascular system), the BrilliantTM Introducer Kit supports a determination ofsubstantially 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 newquestions of safety or effectiveness. |
§ 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).