(12 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 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 wres, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.
The Introducer Set is supplied with an introducer sheath, a dilator, a guidewire and an access needle. These devices will be manufactured in 5.0, 6.0, 7.0, and 8.0 French and in lengths of 5, 7 and 11 centimeters. The sets are compatible with the supplied 0.018", 0.021" guidewire and 21G needle in length of 7cm. The sets are supplied sterile and intended for single use.
The sheath shaft and hub are manufactured of Fluorinated ethylene propylene and copolyester; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling.
The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.
Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.
The provided text describes a 510(k) submission for the INT Introducer Set. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving performance against specific acceptance criteria for AI or diagnostic accuracy, which is what your request implies.
Therefore, many of the requested categories related to AI performance, expert ground truth, multi-reader studies, and training sets are not applicable to this type of device and document.
Below is a breakdown of the available information based on your request, with an explanation of why certain categories are not applicable.
Acceptance Criteria and Study Details for INT Introducer Set
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like an introducer set, "acceptance criteria" are typically defined by engineering specifications and relevant ISO/ASTM standards, rather than diagnostic performance metrics. The "reported device performance" is the result of testing against these engineering criteria.
| Test Category | Specific Test Item | Acceptance Criteria (Implicit from Standards/Good Engineering Practice) | Reported Device Performance (Implied as "passed") |
|---|---|---|---|
| Bench Testing (ISO 11070:2014, ISO 80369-7:2016, ISO 9626:2016) | |||
| Sheath Introducer | Appearance | Meets visual inspection standards | Met |
| O.D and I.D | Within specified dimensions | Met | |
| Effective Length | Within specified dimensions | Met | |
| Sheath Hub | Meets functional and dimensional standards | Met | |
| Sheath Introducer Leakage | No leakage beyond specified limits | Met | |
| Hemostasis Valve Leakage | No leakage beyond specified limits | Met | |
| Peak Tensile Force | Meets specified strength requirements | Met | |
| Dilator | Appearance | Meets visual inspection standards | Met |
| O.D and I.D | Within specified dimensions | Met | |
| Effective Length | Within specified dimensions | Met | |
| Dilator Hub | Meets functional and dimensional standards | Met | |
| Strength of Union | Meets specified strength requirements | Met | |
| Guidewire | Appearance | Meets visual inspection standards | Met |
| O.D. | Within specified dimensions | Met | |
| Effective Length | Within specified dimensions | Met | |
| Corrosion Resistance | No significant corrosion | Met | |
| Fracture Test | No fracture under specified conditions | Met | |
| Flexing Test | No failure after specified cycles | Met | |
| Peak Tensile Force | Meets specified strength requirements | Met | |
| Torque Strength | Meets specified torque resistance | Met | |
| Torqability | Meets specified rotational performance | Met | |
| Tip Flexibility | Meets specified flexibility range | Met | |
| Introducer Needle | Appearance | Meets visual inspection standards | Met |
| O.D and I.D. | Within specified dimensions | Met | |
| Effective Length | Within specified dimensions | Met | |
| Corrosion Resistance | No significant corrosion | Met | |
| Luer Connector | Meets ISO 80369-7 standards for connectors | Met | |
| Strength Union | Meets specified strength requirements | Met | |
| Needle Point | Meets sharpness and integrity standards | Met | |
| Patency | Demonstrates adequate fluid flow | Met | |
| Stiffness | Meets specified stiffness range | Met | |
| Breakage Resistance | No breakage under specified conditions | Met | |
| Compatibility Test | Compatible with related devices/substances | Met | |
| INT Introducer Set | Radio-detectability | Visually detectable under fluoroscopy | Met |
| Particulate | Within specified particulate limits | Met | |
| EO Residual | Within specified limits according to ISO 10993-7 | Met | |
| Acidity and Alkalinity (PH) | Within specified limits | Met | |
| Sterility | Sterile to SAL 10⁻⁶ | Met | |
| Bacterial Endotoxin (LAL test) | Within specified limits according to USP<85> | Met | |
| Sterilization and Shelf Life Testing | |||
| EO Residue | EO residual | Within specified limits (ISO 10993-7:2008) | Met |
| Bacteria Endotoxin Limit | Bacteria Endotoxin | Within specified limits (USP<85>) | Met |
| Visual Inspection Test | Package integrity | Meets visual inspection standards (ASTM F1886-2016) | Met |
| Seal Strength Test | Seal strength | Meets specified strength requirements (ASTM F 88/F88M-2015) | Met |
| Dye Penetration Test | Package integrity | No dye penetration (ASTM F 1929) | Met |
| Shelf-Life Evaluation | Physical, Mechanical, Chemical, Package Tests | Maintain integrity and function after aging | Met |
| Biocompatibility Testing (ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11) | |||
| In Vitro Hemolytic | Hemolytic properties | No influence on hemolytic properties (ASTM F756-17) | Met |
| Acute System Toxicity | Systemic toxicity | No evidence of systemic toxicity (ISO 10993-11:2017) | Met |
| In Vitro Cytotoxicity | Cytotoxicity | No potential toxicity to L-929 cells (ISO 10993-5:2009) | Met |
| Skin Sensitization | Sensitization | No evidence of causing skin sensitization (ISO 10993-10:2010) | Met |
| Intracutaneous Reactivity | Intracutaneous reactivity | No intracutaneous reactivity in rabbit (ISO 10993-10:2010) | Met |
| Pyrogenicity | Pyrogenic response | No individual rise in temperature of 0.5 °C or more (ISO 10993-11:2017) | Met |
| In Vivo Thrombogenicity | Thrombogenicity | Meets requirements of in vivo thrombogenicity test (ISO 10993-4:2017) | Met |
| Complement Activation | Complement activity | No influence on complement activity (ISO 10993-4:2017) | Met |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of devices) used for each individual bench or biocompatibility test. It lists the tests performed, implying that appropriate sample sizes were used according to the referenced standards.
Data provenance is for the device being submitted (INT Introducer Set), manufactured by Shanghai Kindly Medical Instruments Co., Ltd. The studies are non-clinical (bench and lab-based biocompatibility studies).
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. The device is a physical medical instrument (introducer set), not an AI/diagnostic software. "Ground truth" in this context refers to objective measurements and adherence to engineering and biocompatibility standards, not expert consensus on diagnostic interpretations.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or AI output review. This document describes bench and biocompatibility testing of a physical device.
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. This is a physical medical device, not an AI or imaging diagnostic software that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) for physical and material properties, sterility, and biocompatibility. The tests performed are designed to objectively measure these properties against predefined specifications from these standards.
8. The sample size for the training set
This question is not applicable. There is no AI component or algorithms that require a training set for this device.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
September 13, 2022
Shanghai Kindly Medical Instruments Co., Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K222647
Trade/Device Name: INT Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: August 31, 2022 Received: September 1, 2022
Dear Prithul Bom:
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 aware 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222647
Device Name INT 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 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 wres, 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
This 510(k) Summary is being submitted in accordance with the requirements of the guidance The 510(k) Program and 21 CFR 807.92.
510(k) Number: K222647
- Date of Submission: Aug, 25, 2022 1.
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.:+86-21-59140056 Fax: +86-21-59140056 Email: xujianhai(@kdl-int.com
Proposed Device 3.
Trade Name: INT Introducer set Common Name: Introducer set Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1340 Classification name: INTRODUCER, CATHETER Regulation Class: Class II Product Code: DYB
4. Predicate device
510(k) Number: K180178 Trade Name: KDL Introducer Set Product Code: DYB Device Class: II Classification Name: INTRODUCER, CATHETER Regulation Number: 21 CFR 870.1340 Manufacturer: Shanghai Kindly Medical Instruments Co., Ltd.
Device description న్.
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The Introducer Set is supplied with an introducer sheath, a dilator, a guidewire and an access needle. These devices will be manufactured in 5.0, 6.0, 7.0, and 8.0 French and in lengths of 5, 7 and 11 centimeters. The sets are compatible with the supplied 0.018", 0.021" guidewire and 21G needle in length of 7cm. The sets are supplied sterile and intended for single use.
The sheath shaft and hub are manufactured of Fluorinated ethylene propylene and copolyester; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling.
The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.
Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.
6. Indications for Use Statement
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. Substantial Equivalence comparison
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| Item | Proposed Device | Predicate Device (K180178) | Remark |
|---|---|---|---|
| Trade Name | INT Introducer set | KDL Introducer set | / |
| 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 INT Introducer set is intended toprovide access and facilitate theintroduction of guide wire and cathetersthrough the skin into femoral or radialartery while minimize blood loss duringinterventional procedures. | The Introducer set are intended to provideaccess and facilitate the introduction of guidewire, catheters and other accessory medicaldevices through the skin into femoral and/orradial artery while minimize blood lossduring interventional procedures. | Similar,The intendeduse of predicatedevice coverthat ofproposeddevice. |
| Principle ofOperation | By manually operated | By manually operated | Identical |
| Anatomicallocation | Femoral artery and Radial artery | Femoral artery and Radial artery | Identical |
| Intended patientpopulation | Adult | Adult | Identical |
| Hydrophiliccoating | No Hydrophilic coating | Only for Radial Sheath and Guidewire withintype radial artery. | Analysis 1 |
| Radio-opaquematerials | Barium sulfate | Barium sulfate | Identical |
| Function of theside tube withthree ways stopcock | Injection of saline and heparin | Injection and injection contrast medium | Analysis 2 |
| Components | A Sheath Introducer, a dilator, a introducerNeedle, a Guidewire. | A Sheath Introducer, a dilator, a Needle, aNeedle, a I.V. Needle, a Guidewire with straightener. | Similar,Analysis 8 |
| Sheathhemostasiscontrol | Hemostasis seal | Hemostasis seal | Identical |
| Product specification | |||
| Sheath length | 50mm, 70mm, 110mm | 110mm, 160mm | Analysis 3 |
| Size | 5F~8F | 5F~8F | Identical |
| GuidewireDiameter | 0.018", 0.021" | 0.038", 0.021",0.025" | Analysis 4 |
| Guidewirelength | 45cm | 45cm | Identical |
| Needle | 21G | 18G, 21G, 20G | Analysis 5 |
| Dilator length | 110mm, 130mm, 170mm | 168mm, 218mm | Analysis 6 |
| PackageContent | Sheath Introducer, Dilator, Guidewire,Introducer Needle | Sheath Introducer, Dilator, Guidewire,Needle or I.V.Cannula | Identical |
| Material | |||
| Sheath tube | Fluorinated Ethylene Propylene (FEP) | Fluorinated Ethylene Propylene (FEP) | Identical |
| Sheath Hub | Copolyester | Copolyester | Identical |
| Side PortTubing | Polyvinylchloride(PVC)Polyurethane (PU) | Polyvinylchloride(PVC)Polyurethane (PU) | Identical |
| HemostasisValve | Silicon | Silicon | Identical |
| 3-WayStopcock Body | Polycarbonate (PC) | Polyethylene (PE) | Analysis 7 |
| Stopcock Cap | High Density Polyethylene (HDPE) | Polycarbonate (PC) | Analysis 7 |
| Stopcock Valvecore | High Density Polyethylene (HDPE) | Polyethylene (PE) | Analysis 7 |
| Dilator Tube | Polypropylene (PP) | Polypropylene (PP) | Identical |
| Dilator Hub | Acrylonitrile-butadiene-styrene (ABS) | Acrylonitrile-butadiene-styrene (ABS) | Identical |
| Guidewire | NiTi, Stainless Steel | Stainless Steel, Nickel Titanium Alloy | Identical |
| Needle hub | Glue Q | Acrylonitrile-butadiene-styrene (ABS), PC | Analysis 7 |
| Needle Tube | Stainless Steel | Stainless Steel | Identical |
| Protect Cover | Polypropylene (PP) | PP, PE | Analysis 7 |
| SterilizedMethod | EO | EO | Identical |
| Sterility level | SAL 10-6 | SAL 10-6 | Identical |
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INT Introducer set is substantially equivalent in design, raw material, indication for use, package, sterilization method to the predicate devices, KDL introducer set. The differences were addressed using appropriate testing as follows.
8. Performance data
All necessary bench and non-clinical testing was conducted on introducer set to support a determination of substantial equivalence to the predicate device.
The non-clinical, bench testing were conducted according to ISO 11070: 2014, ISO 80369-7:2016 and ISO 9626:2016:
| No. | Testing item | |
|---|---|---|
| 1 | Sheathintroducer | Appearance |
| 2 | O.D and I.D | |
| 3 | Effective length | |
| 4 | Sheath hub | |
| 5 | Sheath introducer leakage | |
| 6 | Hemostasis valve leakage | |
| 7 | Peak tensile force | |
| 9 | Dilator | Appearance |
| 10 | O.D and I.D | |
| 11 | Effective length | |
| 12 | Dilator hub | |
| 13 | Strength of union | |
| 15 | Guidewire | Appearance |
| 16 | O.D. | |
| 17 | Effective length | |
| 18 | Corrosion resistance | |
| 19 | Fracture test | |
| 20 | Flexing test | |
| 21 | Peak tensile force | |
| 22 | Torque strength | |
| 23 | Torqability | |
| 24 | Tip flexibility | |
| 25 | Introducerneedle | Appearance |
| 26 | O.D and I.D. |
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| 27 | Effective length | |
|---|---|---|
| 28 | Corrosion resistance | |
| 29 | Luer connector | |
| 30 | Strength union | |
| 31 | Needle point | |
| 32 | Patency | |
| 33 | Stiffness | |
| 34 | Breakage resistance | |
| 35 | Compatibility test | |
| 36 | INTintroducerset | Radio-detectability |
| 37 | Particulate | |
| 38 | EO residual | |
| 39 | limits for acidity and alkalinity(PH) | |
| 40 | Sterility | |
| 41 | Bacterial Endotoxin (LAL test) |
Sterilization and Shelf Life 9.
Sterilization and Shelf-Life Testing were performed on the proposed device:
| EO residue | ISO 10993-7:2008 |
|---|---|
| Bacteria Endotoxin Limit | USP<85> |
| Visual Inspection test | ASTM F1886-2016 |
| Seal Strength test | ASTM F 88/F88M-2015 |
| Dye penetration test | ASTM F 1929 |
| Shelf-Life Evaluation | Physical, Mechanical, Chemical, Package Tests were performedon aging samples to verify the claimed shelf life of the device. |
10. Clinical Test
No clinical study is included in this submission
11. Biocompatibility Testing Summary
Biocompatibility testing was conducted in compliance with ISO 10993-1, for externally communicating devices with limited exposure (<24 hours) to circulating blood and included below test items.
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| Items | Standards | Conclusion |
|---|---|---|
| In Vitro hemolytic | ASTM F756-17 | The test result showed the device had no influence on hemolytic properties. |
| Acute System Toxicity | ISO 10993-11:2017 | Under the conditions of this study, there was no evidence of systemic toxicity from the extract, the test article extract met the requirements of this study. |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of this study, the test article Micro catheter extract did not show potential toxicity to L-929 cells. |
| Skin Sensitization | ISO 10993-10:2010 | No evidence of causing skin sensitization |
| Intracutaneous reactivity | ISO 10993-10:2010 | The test results showed that the polar and non-polar test article extracts did not induce intracutaneous reactivity in rabbit under the test condition. |
| Pyrogenicity | ISO 10993-11:2017 | No rabbit an individual rise in temperature of 0.5 °C or more. |
| In vivo thrombogenicity | ISO 10993-4:2017 | Meet the requirement of in vivo thrombogenicity test. |
| Complement activation | ISO 10993-4:2017 | No influence on complement activity. |
Table 12-1 Biocompatibility tests
The subject device, INT introducer set is subject to biocompatibility test in accordance with ISO 10993-1, the test results demonstrate that INT Introducer set is substantially equivalent to the predicate.
12. Conclusion
The nonclinical tests demonstrated that the device was substantially equivalent to the predicate device.
§ 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).