(231 days)
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.
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.
The provided document is a 510(k) premarket notification summary for a medical device (KDL Introducer Set). It outlines the device's technical specifications, intended use, and comparison to a predicate device. However, this document describes a Class II medical device (a catheter introducer) and not an AI/ML-driven device. Therefore, the information typically requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, training set details, etc.) is not applicable to this type of traditional medical device.
Instead, the document details non-clinical performance testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the relevant information provided in the document concerning how the device meets acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a single table with "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic output (e.g., sensitivity, specificity thresholds). Instead, it lists various "Testing item" and "Reference Standard/Guidance" for different components of the Introducer Set. The document then states:
"All sample tested met the standard applicable to each test." and "Base 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."
Here's a re-composition of this information into a table format based on the supplied text:
| Component | Testing Item | Reference Standard/Guidance | Reported Device Performance |
|---|---|---|---|
| Sheath Introducer | Appearance | Section 4.3 of ISO 11070:2014 | Met standard |
| O.D and I.D. | Section 7.2 a) of ISO 11070:2014 | Met standard | |
| Effective Length | Section 7.2 b) of ISO 11070:2014 (detail size see section V in this submission) | Met standard | |
| Luer connector | ISO 594-2 | Met standard | |
| Sheath introducer leakage | Section 7.3 of ISO 11070:2014 | Met standard | |
| Haemostasis valve leakage | Section 7.4 of ISO 11070 | Met standard | |
| Peak tensile force | Section 7.6 of ISO 11070 | Met standard | |
| Coating Integrity (if applicable) | In-house standard | Met standard | |
| Coating Friction force (if applicable) | In-house standard | Met standard | |
| Radio-detectability | ASTM F640-12 | Met standard | |
| Dilator | Appearance | Section 4.3 of ISO 11070:2014 | Met standard |
| O.D. and I.D. | Section 9.2 a), b) of ISO 11070:2014 | Met standard | |
| Effective Length | Section 9.2 c) of ISO 11070:2014 | Met standard | |
| Luer connector | ISO 594-2 | Met standard | |
| Strength of union | Section 9.3.3 of ISO 11070:2014 | Met standard | |
| Coating Friction force (if applicable) | In-house standard TBD (specific to radial artery and guidewire) | Met standard | |
| Coating Integrity (if applicable) | In-house standard TBD (specific to radial artery and guidewire) | Met standard | |
| Radio-detectability | ASTM F640-12 | Met standard | |
| Introducer Needle | Appearance | Section 4.3 of ISO 11070:2014 | Met standard |
| O.D and I.D. | Table 1 of ISO 9626 | Met standard | |
| Effective Length | Section 5.2 of ISO 11070:2014 | Met standard | |
| Luer connector | ISO 594-1:1986 | Met standard | |
| Strength union | Section 5.4.2 of ISO 11070:2014 | Met standard | |
| Corrosion resistance | Section 4.4 ISO 11070:2014 | Met standard | |
| Needle point | Section 5.3 of ISO 11070 | Met standard | |
| Patency | Section 13.2 ISO 7864 | Met standard | |
| Stiffness | Section 5.8 of ISO 9626 | Met standard | |
| Breakage resistance | Section 5.9 of ISO 9626 | Met standard | |
| Limits for acidity and alkalinity | Section 5.4 of ISO 9626 | Met standard | |
| Guidewire | Appearance | Section 4.3 of ISO 11070:2014 | Met standard |
| O.D. | Section 8.2 a) of ISO 11070:2014 | Met standard | |
| Length | Section 8.2 b) of ISO 11070:2014 | Met standard | |
| Corrosion resistance | Section 4.4 ISO 11070:2014 | Met standard | |
| Fracture test | Section 8.4 of ISO 11070:2014 | Met standard | |
| Flexing test | Section 8.5 of ISO 11070:2014 | Met standard | |
| Peak tensile force | Section 8.6 of ISO 11070:2014 | Met standard | |
| Torque strength | 3b of FDA Guidance for Coronary and Cervicovascular Guidewire Guidance 1995 | Met standard | |
| Torqueability | 3c of FDA Guidance for Coronary and Cervicovascular Guidewire Guidance 1995 | Met standard | |
| Tip flexibility | 3d of FDA Guidance for Coronary and Cervicovascular Guidewire Guidance 1995 | Met standard | |
| Coating Integrity (if applicable) | In-house standard TBD (specific to radial artery and guidewire) | Met standard | |
| Coating Friction force (if applicable) | In-house standard TBD (specific to radial artery and guidewire) | Met standard | |
| Radio-detectability | ASTM F640-12 | Met standard | |
| Biocompatibility | In Vitro Hemolytic | ASTM F756-13 Standard Practice for assessments of hemolytic properties of material | Met standard |
| In Vitro Cytotoxicity | ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - Part 5: Tests for In Vitro Cytotoxicity | Met standard | |
| Intracutaneous Reactivity | ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Skin Sensitization | Met standard | |
| Skin Sensitization | ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Skin Sensitization | Met standard | |
| Acute Systemic Toxicity | ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity | Met standard | |
| Pyrogen | ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity | Met standard | |
| In Vivo Thrombogenicity | ISO 10993-4:2002/Amd1:2006, Biocompatibility Evaluation of Medical Device - Part 4: Selection of tests for interactions with blood | Met standard |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each test. It states "The performance tests were performed on the non-aged and ages to 3 years sample." This implies that samples were tested for immediate performance and also after accelerated aging simulating 3 years of shelf life. Specific lot sizes or number of units tested per parameter are not disclosed in this summary.
- Data Provenance: Not explicitly stated, however, the manufacturer is Shanghai Kindly Medical Instruments Co., Ltd. in Shanghai, China. The testing would have been conducted by or for them, likely in China. The study is a non-clinical performance testing and biocompatibility assessment, rather than a clinical study with patient data.
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 as this is a traditional medical device undergoing physical and biological performance testing, not an AI/ML device relying on interpretation of medical images or data by experts to establish ground truth. The "ground truth" here is defined by the technical specifications and standards (e.g., ISO, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable for the same reason as point 3. Testing involves objective measurements against established engineering and biocompatibility 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:
- This question is not applicable as the device is not an AI-driven product nor does it involve human readers interpreting medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on engineering specifications, established international standards (ISO, ASTM), and FDA guidance documents for medical devices (specifically catheter introducers and guidewires). For biocompatibility, it's based on standard biological test methods outlined in ISO 10993 and ASTM F756.
8. The sample size for the training set:
- This question is not applicable as this is a manufactured medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
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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
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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
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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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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
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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 |
|---|---|---|
| Sheathintroducer | 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 thissubmission ) | |
| 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 ISO11070:2014 | |
| 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 | |
| Introducerneedle | 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 andalkalinity | 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 Coronaryand Cerebrovascular GuidewireGuidance 1995 |
| Torqueability | 3c of FDA Guidance for Coronaryand Cerebrovascular GuidewireGuidance 1995 | |
| Tip flexibility | 3d of FDA Guidance for Coronaryand Cerebrovascular GuidewireGuidance 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
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| Test Item | Reference Standards |
|---|---|
| In VitroHemolytic | ASTM F756-13 Standard Practice for assessments of hemolyticproperties of material |
| In VitroCytotoxicity | ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device -Part 5: Tests for In Vitro Cytotoxicity |
| IntracutaneousReactivity | ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device -Part 10: Tests for Irritation and Shin Sensitization |
| SkinSensitization | ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device -Part 10: Tests for Irritation and Shin Sensitization |
| Acute SystemicToxicity | 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 VivoThrombogenicity | ISO 10993-4:2002/Amd1:2006, Biocompatibility Evaluation ofMedical 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 areintended to provide accessand facilitate theintroduction of guide wire,catheters and otheraccessory medical devicesthrough the skin into femoraland/or radial artery andminimize blood loss duringinterventional procedures. | The Brilliant™ IntroducerKit are intended for use tofacilitate the introduction ofguide wires, catheters andother accessory medicaldevices through the skin intoa vein or artery andminimize blood lossassociated with suchintroduction. | Identical |
| Principle ofOperation | By manually operated | By manually operated | Identical |
| Components | A Sheath Introducer, adilator, a Needle, a I.V.Needle,a Guidewire withstraightener. | A sheath introducer, adilator, a guide wire with aguide wire collimator, apuncture needle;anintravascular catheter withintroducer needle, a scalpeland a syringe | Identical |
| AnatomicalLocations | Femoral artery and Radialartery | Peripheral Vasculature | Identical |
| Hydrophilic coating | Only for Radial Sheath andGuidewire within type radialartery. | Sheath, dilator, guidewire | Analysis 2 |
| Sheath hemostasiscontrol | Hemostasis seal | Hemostasis seal | Identical |
| Product Specification | |||
| Sheath length | 110mm, 160mm | 70mm~240mm | Analysis 3 |
| Sheath French Size | 5F~8F | 4F~7F | Analysis 4 |
| Guidewire Diameter | 0.038", 0.021",0.025" | 0.018"~0.035" | Analysis 5 |
| Guidewire length | 45cm | 45cm and 70cm | Analysis 6 |
| Needle | 18G, 21G, 20G | 20G and 22G | Analysis 7 |
| Dilator | 168mm, 218mm | 125mm~295mm | Analysis 8 |
| Package Content | Sheath Introducer, Dilator,Guidewire, Needle orI.V.Cannula | Sheath Introducer, a dilator,a guidewire, a punctureneedle, intravascular catheterwith introducer needle, a | Identical |
| scalpel, a syringe. | |||
| Material | |||
| Outer Sheath | Fluorinated EthylenePropylene (FEP) | Fluorinated EthylenePropylene | Identical |
| Sheath Hub | Copolyester | Acrylobutyistyrene | Analysis 9 |
| Side Port Tubing | Polyvinylchloride(PVC)Polyurethane (PU) | Polyurethane | Analysis 10 |
| Hemostasis Valve | Silicon | Silicon | Identical |
| 3-Way StopcockBody | 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, NickelTitanium Alloy,ThermoplasticPolyurethanes (TPU) | Stainless Steel, StainlessSteel w/nitinol core, orPolyurethane jacketw/nitinol coil | Identical |
| GuidewireJ-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
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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.
§ 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).