(12 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of the introducer set, with no mention of AI or ML capabilities.
No.
The device is intended to facilitate the introduction of other medical devices into the body, acting as a conduit rather than providing therapeutic treatment itself. The description explicitly states it is "designed specifically to introduce therapeutic or diagnostic devices into the vasculature."
No
The device is an introducer set, which is designed to provide access and facilitate the introduction of other medical devices (therapeutic or diagnostic) into the vasculature, rather than performing diagnostic functions itself.
No
The device description clearly outlines physical components (sheath, dilator, guidewire, access needle) made of materials like Fluorinated ethylene propylene and polypropylene, indicating it is a hardware medical device.
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 femoral or radial artery. It is a tool for accessing the vascular system for interventional procedures.
- Device Description: The description details the physical components of the introducer set (sheath, dilator, guidewire, needle) and how they are used to gain access to the vasculature. It describes a mechanical process for introducing other devices.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's health.
- Focus on Access and Introduction: The entire description revolves around the function of providing a conduit for other devices to enter the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This introducer set does not perform any such tests. It is a procedural device used to facilitate other medical interventions.
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 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.
Product codes
DYB
Device Description
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.
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
Adult
Intended User / Care Setting
Prescription Use
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
Not Found
Summary of Performance Studies
Non-clinical, bench testing were conducted according to ISO 11070: 2014, ISO 80369-7:2016 and ISO 9626:2016, covering testing items such as Appearance, O.D and I.D, Effective length, Sheath hub, Sheath introducer leakage, Hemostasis valve leakage, Peak tensile force for Sheath introducer; Appearance, O.D and I.D, Effective length, Dilator hub, Strength of union for Dilator; Appearance, O.D., Effective length, Corrosion resistance, Fracture test, Flexing test, Peak tensile force, Torque strength, Torqability, Tip flexibility for Guidewire; Appearance, O.D and I.D., Effective length, Corrosion resistance, Luer connector, Strength union, Needle point, Patency, Stiffness, Breakage resistance, Compatibility test for Introducer needle; and Radio-detectability, Particulate, EO residual, limits for acidity and alkalinity(PH), Sterility, Bacterial Endotoxin (LAL test) for the INT introducer set.
Sterilization and Shelf-Life Testing were performed for EO residue (ISO 10993-7:2008), Bacteria Endotoxin Limit (USP), Visual Inspection test (ASTM F1886-2016), Seal Strength test (ASTM F 88/F88M-2015), Dye penetration test (ASTM F 1929), and Shelf-Life Evaluation (Physical, Mechanical, Chemical, Package Tests on aging samples).
Biocompatibility testing complied with ISO 10993-1 for external communicating devices with limited exposure (
§ 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 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
1
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.
4
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
5
| 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 to | ||
| provide access and facilitate the | |||
| introduction of guide wire and catheters | |||
| through the skin into femoral or radial | |||
| artery while minimize blood loss during | |||
| interventional procedures. | 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 while minimize blood loss | |||
| during interventional procedures. | Similar, | ||
| The intended | |||
| use of predicate | |||
| device cover | |||
| that of | |||
| proposed | |||
| device. | |||
| Principle of | |||
| Operation | By manually operated | By manually operated | Identical |
| Anatomical | |||
| location | Femoral artery and Radial artery | Femoral artery and Radial artery | Identical |
| Intended patient | |||
| population | Adult | Adult | Identical |
| Hydrophilic | |||
| coating | No Hydrophilic coating | Only for Radial Sheath and Guidewire within | |
| type radial artery. | Analysis 1 | ||
| Radio-opaque | |||
| materials | Barium sulfate | Barium sulfate | Identical |
| Function of the | |||
| side tube with | |||
| three ways stop | |||
| cock | Injection of saline and heparin | Injection and injection contrast medium | Analysis 2 |
| Components | A Sheath Introducer, a dilator, a introducer | ||
| Needle, a Guidewire. | A Sheath Introducer, a dilator, a Needle, a | ||
| Needle, a I.V. Needle, a Guidewire with straightener. | Similar, | ||
| Analysis 8 | |||
| Sheath | |||
| hemostasis | |||
| control | Hemostasis seal | Hemostasis seal | Identical |
| Product specification | |||
| Sheath length | 50mm, 70mm, 110mm | 110mm, 160mm | Analysis 3 |
| Size | 5F~8F | 5F~8F | Identical |
| Guidewire | |||
| Diameter | 0.018", 0.021" | 0.038", 0.021",0.025" | Analysis 4 |
| Guidewire | |||
| length | 45cm | 45cm | Identical |
| Needle | 21G | 18G, 21G, 20G | Analysis 5 |
| Dilator length | 110mm, 130mm, 170mm | 168mm, 218mm | Analysis 6 |
| Package | |||
| Content | 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 Port | |||
| Tubing | Polyvinylchloride(PVC) | ||
| Polyurethane (PU) | Polyvinylchloride(PVC) | ||
| Polyurethane (PU) | Identical | ||
| Hemostasis | |||
| Valve | Silicon | Silicon | Identical |
| 3-Way | |||
| Stopcock Body | Polycarbonate (PC) | Polyethylene (PE) | Analysis 7 |
| Stopcock Cap | High Density Polyethylene (HDPE) | Polycarbonate (PC) | Analysis 7 |
| Stopcock Valve | |||
| core | 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 |
| Sterilized | |||
| Method | EO | EO | Identical |
| Sterility level | SAL 10-6 | SAL 10-6 | Identical |
6
7
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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 | Sheath | |
| introducer | 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 | Introducer | |
| needle | Appearance | |
| 26 | O.D and I.D. |
9
| 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 | INT | |
| introducer | ||
| set | 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 |
| 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 performed |
| on 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 (