(231 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of an introducer set, with no mention of AI/ML capabilities or data processing. The sections related to AI/ML training/test sets and key metrics are explicitly marked as "Not Applicable (Non-AI/ML device)".
No.
The device components like guidewires and sheaths facilitate the introduction of other devices but do not directly treat a disease or condition. Its primary function is access and introduction, not therapy.
No
The device is described as an introducer set intended to "provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices" for interventional procedures, not for diagnostic purposes. While it includes a side port for injecting contrast medium, which can be part of diagnostic procedures, the primary function of the introducer set itself is access and delivery, not diagnosis.
No
The device description explicitly lists physical components such as a sheath introducer, dilator, needle, and guidewire, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing access and facilitating the introduction of other medical devices through the artery. This is a procedural device used in vivo (within the body) for interventional procedures.
- Device Description: The description details components like sheaths, dilators, needles, and guidewires, all designed for accessing and navigating within the vascular system.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo to facilitate medical procedures.
N/A
Intended Use / Indications for Use
Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through artery while minimizing blood loss during interventional procedures.
Radial Artery Introducer Set. The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
This set classifies two types: Femoral Artery and Radial Artery. The Femoral Artery introducer set consist of a sheath introdcuer, dilator, needle, Guidewire. The Radial Artery introducer set consist of a sheath introdcuer lubricated with/without hydrophilic coating, dilator, I.V. cannula /Introducer needle,Guidewire (with/without hydrophilic coating).
The Introducer Set consists of sheath introducer, each packaged in a set to together with a dilator, introdcuer needle, and guidewire. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with tubing connected to a 3-way stopcocks is used for injection contrast medium. The dilator is provided to aid in the introduction of sheath to the target vessel. The Introducer needle/I.V. Cannula is provided a conduit for insertion of the guidewire into the vascular system. The guidewire is utilized as a guiding mechanism for the introducer sheath into the vascular system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral artery and Radial artery
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
Testing were conducted to ensure the performance of the proposed device throughout the labeled shelf life, verify conformity to the applicable parts of standards and demonstrate substantial equivalence to the predicate device. The performance tests were performed on the non-aged and ages to 3 years sample. All sample tested met the standard applicable to each test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Conclusion:
Testing were conducted to ensure the performance of the proposed device throughout the labeled shelf life, verify conformity to the applicable parts of standards and demonstrate substantial equivalence to the predicate device. The performance tests were performed on the non-aged and ages to 3 years sample. All sample tested met the standard applicable to each test.
The performance tests have completed per the following ISO standards:
Sheath introducer: Appearance, O.D and I.D., Effective Length, Luer connector, Sheath introducer leakage, Haemostasis valve leakage, Peak tensile force, Coating Integrity, Coating Friction force, Radio-dectectability (ASTM F640-12).
Dilator: Appearance, O.D. and I.D., Effective Length, Luer connector, Strength of union, Coating Friction force, Coating Integrity, Radio-dectectability (ASTM F640-12).
Introducer needle: Appearance, O.D and I.D., Effective Length, Luer connector, Strength union, Corrosion resistance, Needle point, Patency, Stiffness, Breakage resistance, Limits for acidity and alkalinity.
Guidewire: Appearance, O.D., Length, Corrosion resistance, Fracture test, Flexing test, Peak tensile force, Toque strength (3b of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995), Torqueability (3c of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995), Tip flexibility (3d of FDA Guidance for Coronary and Cerebrovascular Guidewire Guidance 1995), Coating Integrity, Coating Friction force, Radio-dectectability (ASTM F640-12).
The biocompatibility tests have completed as follows:
In Vitro Hemolytic (ASTM F756-13 Standard Practice for assessments of hemolytic properties of material).
In Vitro Cytotoxicity (ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - Part 5: Tests for In Vitro Cytotoxicity).
Intracutaneous Reactivity (ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Shin Sensitization).
Skin Sensitization (ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Shin Sensitization).
Acute Systemic Toxicity (ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity).
Pyrogen (ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity).
In Vivo Thrombogenicity (ISO 10993-4:2002/Amd1:2006, Biocompatibility Evaluation of Medical Device - Part 4: Selection of tests for interactions with blood).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 10, 2018
Shanghai Kindly Medical Instruments Co., Ltd. Su Jianhai Regulatory Affairs Supervisor No. 925, Jinyuan yi Road, 201803, Shanghai, China
Re: K180178 Trade/Device Name: KDL Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: June 4, 2018 Received: August 13, 2018
Dear Jeffery Hui:
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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good
1
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Image /page/1/Picture/6 description: The image shows the name "Finn E. Donaldson -S" in a large font. To the right of the name is the text "Digitally signed by Finn E. Donaldson -S". Below that is the text "DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000979673, cn=Finn E. Donaldson -S Date: 2018.09.10 11:34:58 -04'00'".
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180178
Device Name KDL Introducer set
Indications for Use (Describe)
Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through artery while minimizing blood loss during interventional procedures.
Radial Artery Introducer Set. The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.
| 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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3
510(k) Summary
510(k) Number: K180178
1. Date Prepared: August 31, 2018
2. Submitter
Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan yi Road, Shanghai, 201803, China Establishment Registration Number: 3009605245 Contact Person: Xu Jianhai Position: RA Supervisor Tel.:+086-021-59140056 Fax: +086-021-59140056 Email: xujianhai@kdlchina.com
3. Proposed Device
Trade Name: KDL Introducer Set Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1340 Regulation name: Catheter introducer Regulation Class: Class II Product Code: DYB.
4. Predicate device
510(k) Number: K140768 Product Name: Brilliant™ Introducer Kit Manufacturer: Lepu Medical Tchnology (Beijing) Co., Ltd.
5. Device description
This set classifies two types: Femoral Artery and Radial Artery. The Femoral Artery introducer set consist of a sheath introdcuer, dilator, needle, Guidewire. The Radial Artery introducer set consist of a sheath introdcuer lubricated with/without hydrophilic coating, dilator, I.V. cannula /Introducer needle,Guidewire (with/without hydrophilic coating).
The Introducer Set consists of sheath introducer, each packaged in a set to together with a dilator, introdcuer needle, and guidewire. The introducer sheath is fitted with a hemostasis valve to
4
minimize blood loss during catheter introduction and/or exchange. A side port with tubing connected to a 3-way stopcocks is used for injection contrast medium. The dilator is provided to aid in the introduction of sheath to the target vessel. The Introducer needle/I.V. Cannula is provided a conduit for insertion of the guidewire into the vascular system. The guidewire is utilized as a guiding mechanism for the introducer sheath into the vascular system.
Indications for Use Statement: 6.
Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the femoral artery while minimizing blood loss during interventional procedures.
Radial Artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.
7. Non-clinical Test Conclusion
Testing were conducted to ensure the performance of the proposed device throughout the labeled shelf life, verify conformity to the applicable parts of standards and demonstrate substantial equivalence to the predicate device. The performance tests were performed on the non-aged and ages to 3 years sample. All sample tested met the standard applicable to each test.
| Component | Testing item | Reference Standard/Guidance |
|---|---|---|
| Sheath | ||
| introducer | Appearance | Section 4.3 of ISO 11070:2014 |
| O.D and I.D. | Section 7.2 a) of ISO 11070:2014 | |
| Effective Length | Section 7.2 b) of ISO 11070:2014 | |
| (detail size see section V in this | ||
| submission ) | ||
| Luer connector | ISO 594-2 | |
| Sheath introducer leakage | Section 7.3 of ISO 11070:2014 | |
| Haemostasis valve leakage | Section 7.4 of ISO 11070 | |
| Peak tensile force | Section 7.6 of ISO 11070 | |
| Coating Integrity | In-house standard | |
| Coating Friction force | In-house standard | |
| Radio-dectectability | ASTM F640-12 | |
| Dilator | Appearance | Section 4.3 of ISO 11070:2014 |
| O.D. and I.D. | Section 9.2 a), b) of ISO | |
| 11070:2014 | ||
| Effective Length | Section 9.2 c) of ISO 11070:2014 | |
| Luer connector | ISO 594-2 | |
| Strength of union | Section 9.3.3 of ISO 11070:2014 | |
| Coating Friction force | In-house standard | |
| Coating Integrity | In-house standard | |
| Radio-dectectability | ASTM F640-12 | |
| Appearance | Section 4.3 of ISO 11070:2014 | |
| O.D and I.D. | Table 1 of ISO 9626 | |
| Effective Length | Section 5.2 of ISO 11070:2014 | |
| Luer connector | ISO 594-1:1986 | |
| Strength union | Section 5.4.2 of ISO 11070:2014 | |
| Introducer | ||
| needle | Corrosion resistance | Section 4.4 ISO 11070:2014 |
| Needle point | Section 5.3 of ISO 11070 | |
| Patency | Section 13.2 ISO 7864 | |
| Stiffness | Section 5.8 of ISO 9626 | |
| Breakage resistance | Section 5.9 of ISO 9626 | |
| Limits for acidity and | ||
| alkalinity | Section 5.4 of ISO 9626 | |
| Appearance | Section 4.3 of ISO 11070:2014 | |
| O.D. | Section 8.2 a) of ISO 11070:2014 | |
| Length | Section 8.2 b) of ISO 11070:2014 | |
| Corrosion resistance | Section 4.4 ISO 11070:2014 | |
| Fracture test | Section 8.4 of ISO 11070:2014 | |
| Flexing test | Section 8.5 of ISO 11070:2014 | |
| Peak tensile force | Section 8.6 of ISO 11070:2014 | |
| Guidewire | Toque strength | 3b of FDA Guidance for Coronary |
| and Cerebrovascular Guidewire | ||
| Guidance 1995 | ||
| Torqueability | 3c of FDA Guidance for Coronary | |
| and Cerebrovascular Guidewire | ||
| Guidance 1995 | ||
| Tip flexibility | 3d of FDA Guidance for Coronary | |
| and Cerebrovascular Guidewire | ||
| Guidance 1995 | ||
| Coating Integrity | In-house standard | |
| Coating Friction force | In-house standard | |
| Radio-dectectability | ASTM F640-12 |
The performance tests have completed per the following ISO standards:
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K180178
Page 3 of 6
6
| Test Item | Reference Standards |
|---|---|
| In Vitro | |
| Hemolytic | ASTM F756-13 Standard Practice for assessments of hemolytic |
| properties of material | |
| In Vitro | |
| Cytotoxicity | ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - |
| Part 5: Tests for In Vitro Cytotoxicity | |
| Intracutaneous | |
| Reactivity | ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - |
| Part 10: Tests for Irritation and Shin Sensitization | |
| Skin | |
| Sensitization | ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - |
| Part 10: Tests for Irritation and Shin Sensitization | |
| Acute Systemic | |
| Toxicity | ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - |
| Part 11: Tests for systemic toxicity | |
| Pyrogen | ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - |
| Part 11: Tests for systemic toxicity | |
| In Vivo | |
| Thrombogenicity | ISO 10993-4:2002/Amd1:2006, Biocompatibility Evaluation of |
| Medical Device - Part 4: Selection of tests for interactions with blood |
The biocompatibility tests have completed as follows
Clinical Test 8.
It is not applicable.
Summary Comparing the Technological Characteristics 9.
The subject device has the same intended use, principle of operation, design and technological characteristics as the predicate device. Size, material of components, sheath hub, side port tubing, 3-Way Stopcock Body and cap, dilator tube, dilator hub and Guidewire J-Straightener are different from the predicate device. The finished product has been evaluated the biocompatibility testing and tested on safety and performance testing, and the result were complied with the test requirements and standards. Any the difference of subject device and predicate device did not raise any issues.
| Item | Proposed Device | Predicate Device
(K140768) | Remark |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Product Name | Introducer set | BrilliantTM Introducer Kit | / |
| Product Code | DYB | DYB | Identical |
| Regulation No. | 21 CFR 870.1340 | 21 CFR 870.1340 | Identical |
| Classification | Class II | Class II | Identical |
| Intended Use | The Introducer set are
intended to provide access
and facilitate the
introduction of guide wire,
catheters and other
accessory medical devices
through the skin into femoral
and/or radial artery and
minimize blood loss during
interventional procedures. | The Brilliant™ Introducer
Kit 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. | Identical |
| Principle of
Operation | By manually operated | By manually operated | Identical |
| Components | A Sheath Introducer, a
dilator, a Needle, a I.V.
Needle,a Guidewire with
straightener. | A sheath introducer, a
dilator, a guide wire with a
guide wire collimator, a
puncture needle;an
intravascular catheter with
introducer needle, a scalpel
and a syringe | Identical |
| Anatomical
Locations | Femoral artery and Radial
artery | Peripheral Vasculature | Identical |
| Hydrophilic coating | Only for Radial Sheath and
Guidewire within type radial
artery. | Sheath, dilator, guidewire | Analysis 2 |
| Sheath hemostasis
control | Hemostasis seal | Hemostasis seal | Identical |
| Product Specification | | | |
| Sheath length | 110mm, 160mm | 70mm240mm | Analysis 3 |8F | 4F~7F | Analysis 4 |
| Sheath French Size | 5F
| Guidewire Diameter | 0.038", 0.021",0.025" | 0.018"0.035" | Analysis 5 |295mm | Analysis 8 |
| Guidewire length | 45cm | 45cm and 70cm | Analysis 6 |
| Needle | 18G, 21G, 20G | 20G and 22G | Analysis 7 |
| Dilator | 168mm, 218mm | 125mm
| Package Content | Sheath Introducer, Dilator,
Guidewire, Needle or
I.V.Cannula | Sheath Introducer, a dilator,
a guidewire, a puncture
needle, intravascular catheter
with introducer needle, a | Identical |
| | | scalpel, a syringe. | |
| | | | |
| Material | | | |
| Outer Sheath | Fluorinated Ethylene
Propylene (FEP) | Fluorinated Ethylene
Propylene | Identical |
| Sheath Hub | Copolyester | Acrylobutyistyrene | Analysis 9 |
| Side Port Tubing | Polyvinylchloride(PVC)
Polyurethane (PU) | Polyurethane | Analysis 10 |
| Hemostasis Valve | Silicon | Silicon | Identical |
| 3-Way Stopcock
Body | Polyethylene (PE) | Acrylobutyistyrene | Analysis 11 |
| Cap | Polycarbonate (PC) | Polyethylene | Analysis 12 |
| Valve | Polyethylene (PE) | Polyethylene | Identical |
| Dilator Tube | Polypropylene (PP) | Polycarbonate | Analysis 13 |
| Dilator Hub | Acrylobutyistyrene (ABS) | Acrylobutyistyrene | Analysis 14 |
| Guidewire | Stainless Steel, Nickel
Titanium Alloy,
Thermoplastic
Polyurethanes (TPU) | Stainless Steel, Stainless
Steel w/nitinol core, or
Polyurethane jacket
w/nitinol coil | Identical |
| Guidewire
J-Straightener | (High Density Polyethylene)
HDPE | Polycarbonate | Analysis 15 |
| Needle hub | Acrylobutyistyrene
(ABS)/PC | Polycarbonate | Identical |
| Needle Tube | Stainless Steel | Stainless Steel | Identical |
| Protect Cover | PP/PE | Unknown | / |
| Sterilization Method | EO | EO | Identical |
| Sterility Level | SAL 10-6 | SAL 10-6 | Identical |
Table 3-1 Technological Characteristics Comparison List
7
K180178
8
K180178 Page 6 of 6
10. Conclusion
Based on the result of the performance and biocompatibility testing, the proposed device, Introducer Set, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols. Therefore, the subject device is substantially equivalent to the legally market predicated device (K140768) in terms of intended use, principle of operation, design and technological characteristics.