(86 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of the introducer kit, with no mention of AI or ML capabilities.
No
The device is described as an Introducer Kit, intended to facilitate the introduction of other medical devices into the body, not to treat a condition itself.
No
The device is an introducer kit used to facilitate the introduction of other medical devices into the vascular system. Its function is to provide access, not to diagnose a condition.
No
The device description clearly outlines multiple physical components (puncture needle, guide wire, sheath introducer, dilator) and performance studies focus on bench tests of these physical attributes, indicating it is a hardware-based medical device kit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the introduction of medical devices into the body (veins or arteries). This is an in vivo procedure, meaning it takes place within a living organism.
- Device Description: The description details components used for accessing blood vessels and introducing other devices. These are all tools for performing a medical procedure on a patient.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside the body to diagnose a condition. IVDs are designed for this type of analysis.
- Performance Studies: The performance studies focus on the physical properties and functionality of the device for its intended use in accessing blood vessels, not on the accuracy or reliability of a diagnostic test.
In summary, the ShoocinTM Introducer Kit is a medical device used for a procedural purpose within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The ShoocinTM Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
Product codes
DYB
Device Description
The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling the wire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: The Shoocin ™ Introducer Kit modifications and new models were subjected to the following test methods (bench test) to demonstrate that these devices comply with the performance data from the predicate device.
Test categories include:
Sheath Introducer (Appearance, Size designation, Radio-detectability, Freedom from leakage from sheath introducer, Freedom from leakage through haemostasis valve, Hub, Peak tensile force, Dilator accessibility)
3-way stopcock/valve (Hub)
Dilator (Appearance, Size designation, Hub, Strength of union between hub and dilator, Guidewire accessibility)
Puncture Needle (Appearance, Radio-detectability, Corrosion resistance, Size Designation, Needle point, Hub, Strength of union of needle tube and needle hub, Guidewire accessibility)
Guidewire (Appearance, Size designation, Fracture test, Flexing test, Peak tensile force of guidewire, Corrosion resistance, Radio-detectability)
Particulate evaluation
Chemical performance (Reduced substances, Heavy metal, pH variation value, Nonvolatile matter, Residual EO and ECH)
Biological (Sterile, Bacterial endotoxin)
Biocompatibility: The Shoocin™ Introducer Kit produced by Lepu Medical was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The Shoocin ™ Introducer Kit would be classified as an External Communicating Device in contact with the Circulating Blood for a Limited Duration (): Under the conditions of this study, the maximum rise of each rabbit temperatures did not show a rise of 0.5° C or more above its baseline temperature during 3 hour observation period. The test article was judged as nonpyrogenic.
Partial Thromboplastin Time (ISO 10993-4): Under the conditions of this study, the % negative control is 68.69%, the test article would be considered mild thrombogenicity response.
In Vivo Thromboresistance (ISO 10993-4): Under the conditions of this study, the test article showed no thrombosis which was similar with the control article. The test article would be considered as thromboresistant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ShoocinTM Introducer Kit, Lepu Medical Technology (Beijing) Co., Ltd., K123475
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to form a single, abstract figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2017
Lepu Medical Technology (Beijing) Co., Ltd. % Arthur Goddard President FDA Regulatory and Quality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445
Re: K172099
Trade/Device Name: Shoocin™ Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 4, 2017 Received: August 9, 2017
Dear Arthur Goddard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Kenneth J. Cavanaugh -S
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) K172099
Device Name ShoocinTM Introducer Kit
Indications for Use (Describe)
The ShoocinTM Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------- |
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3
The information on the Shoocial™ Introducer Kit is being submitted in accordences of 21 C.F. R. §807.92 and The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
| Applicant: | Lepu Medical Technology (Beijing) Co., Ltd.
No. 37 Chaoqian Road
Changping District, Beijing 102200
P.R. China |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | +86-10-80123510 |
| Contact: | Xiangdan Kim |
| Date: | June 30, 2017 |
| Name: | ShoocinTM Introducer Kit |
| Classification Name: | Catheter Introducer, 870.1340 |
| Product Code: | DYB |
| Predicate: | ShoocinTM Introducer Kit, Lepu Medical Technology (Beijing) Co.,
Ltd., K123475 with market clearance dates of February 3, 2014. |
| Modification to
Predicate K123475 | 1. Addition of two 7Fr models to the Radial Sheath Introducer
(RS070718 and RS071118).
2. Change of the radiocontrast agent in the Introducer Sheath from
Bismuth to Barium sulfate (BaSO4).
3. Removal of the radiocontrast agent Bismuth in the Dilator |
| Description: | The ShoocinTM Introducer Kit consists of a puncture needle, a guide
wire with a guide wire collimator, a sheath introducer, and a dilator.
The Puncture Needle incorporates a lumen, which provides a conduit
for the insertion of the Guide Wire into the vascular system. The
flexible stainless-steel guide wire is utilized as a guiding mechanism
for the insertion of the Introducer Sheath into the vascular system. The
Guide Wire contains a wire collimator, which assists in funneling the
wire through the lumen of the Puncture Needle. The Guide Wire is
radio-detective under fluoroscopy. The Sheath Introducer contains
Barium sulfate (BaSO4), making the device visible under fluoroscopy
and provides a conduit for introducing other interventional devices,
including guide wires and interventional catheters, into the vascular
system. The main components of this assembly are a non-hydrophilic
coated Sheath Introducer, hemostasis valve housing, and a side port
tubing with a 3-way stopcock/valve. The Dilator is used to provide
support and stability to the Sheath Introducer during deployment into
the vascular system. The proximal end of the Dilator includes a luer
port and has a tapered, atraumatic distal tip. There is no radiocontrast
agent on the dilator. |
| Indication For Use: | The ShoocinTM Introducer Kits are intended for use to facilitate the
introduction of guide wires, catheters and other accessory medical
devices through the skin into a vein or artery and minimize blood loss
associated with such introduction. |
4
| Predicate Device | Lepu Medical Technology (Beijing) Co., Ltd. added two models to the |
|---|---|
| Comparison: | Radial Sheath Introducer, the sheath introducer radiocontrast agent |
| was changed from Bismuth to Barium sulfate (BaSO4), and the | |
| removal of a radiocontrast agent on the dilator to the currently | |
| marketed ShoocinTM Introducer Kit. The subject device is | |
| substantially equivalent to the predicate device in terms of intended | |
| use, indication for use, operational characteristics, and fundamental | |
| design and technology characteristics. |
Biocompatibility: The Shoocin™ Introducer Kit produced by Lepu Medical was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The Shoocin ™ Introducer Kit would be classified as an External Communicating Device in contact with the Circulating Blood for a Limited Duration ( | Under the conditions of this study, the maximum rise of each rabbit temperatures did not show a rise of 0.5° C or more above its baseline temperature during 3 hour observation period. The test article was judged as nonpyrogenic. |
| | Partial Thromboplastin Time | ISO 10993-4 | Under the conditions of this study, the % negative control is 68.69%, the test article would be considered mild thrombogenicity response. |
| | In Vivo Thromboresistance | ISO 10993-4 | Under the conditions of this study, the test article showed no thrombosis which was similar with the control article. The test article would be considered as thromboresistant. |
5
6
Performance Testing: The Shoocin ™ Introducer Kit modifications and new models were subjected to the following test methods (bench test) to demonstrate that these devices comply with the performance data from the predicate device.
| ShoocinTM Introducer Kit Performance Testing | |
|---|---|
| Sheath | |
| Introducer | Appearance |
| Size designation | |
| Radio-detectability | |
| Freedom from leakage from sheath introducer | |
| Freedom from leakage through haemostasis valve | |
| Hub | |
| Peak tensile force | |
| Dilator accessibility | |
| 3-way | |
| stopcock/ | |
| valve | Hub |
| Dilator | Appearance |
| Size designation | |
| Hub | |
| Strength of union between hub and dilator | |
| Guidewire accessibility | |
| Puncture | |
| Needle | Appearance |
| Radio-detectability | |
| Corrosion resistance | |
| Size Designation | |
| Needle point | |
| Hub | |
| Strength of union of needle tube and needle hub | |
| Guidewire accessibility | |
| Guidewire | Appearance |
| Size designation | |
| Fracture test | |
| Flexing test | |
| Peak tensile force of guidewire | |
| Corrosion resistance | |
| Radio-detectability | |
| Particulate evaluation | |
| Reduced substances | |
| Chemical | |
| performance | Heavy metal |
| pH variation value | |
| Nonvolatile matter | |
| Residual EO and ECH | |
| Biological | Sterile |
| Bacterial endotoxin |
7
Sterilization: The method used is based on practices recommended by AAMI / ANSI / ISO 11135:2014 and provides a Sterility Assurance Level (SAL) of 10-6.
- Conclusion: The information provided in this submission and comparing intended use, principle of operation and overall technological characteristics (i.e. puncture needle, guide wire, dilator, and sheath introducer to obtain access to the vascular system), the Shoocin™ Introducer Kit supports a determination of substantially equivalent to existing legally marketed predicate device Shoocin™ Introducer Kit (K123475).