(86 days)
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.
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.
The document provided is a 510(k) premarket notification for a medical device called the "Shoocin™ Introducer Kit." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets acceptance criteria related to AI/ML or diagnostic performance studies.
Therefore, the information required to answer the prompt regarding AI/ML acceptance criteria and a study proving device performance (specifically, a diagnostic performance study for an AI/ML device) is not present in this document.
The document primarily focuses on:
- Substantial Equivalence: Comparing the modified device (Shoocin™ Introducer Kit) to its predicate (also Shoocin™ Introducer Kit, K123475) to demonstrate that changes (e.g., adding models, changing radiocontrast agent) do not alter its fundamental nature, intended use, or safety and effectiveness.
- Biocompatibility Testing: Results from tests performed according to ISO 10993 standards (e.g., cytotoxicity, intracutaneous study, sensitization, systemic toxicity, complement activation, hemolysis, pyrogen study, partial thromboplastin time, in vivo thromboresistance). These are biological safety tests.
- Performance Testing (Bench Tests): A list of physical and chemical bench tests performed on components of the introducer kit (sheath introducer, 3-way stopcock/valve, dilator, puncture needle, guidewire, particulate evaluation, chemical performance, biological sterility, bacterial endotoxin). These are engineering/material performance tests.
- Sterilization: The method used and the Sterility Assurance Level.
This document does not describe an AI/ML-based device, a study involving human readers, ground truth establishment for diagnostic images, or any of the other criteria relevant to the prompt's request for AI/ML device performance and acceptance criteria.
To directly answer your numbered points based on the provided document, I must state that the information is absent:
- A table of acceptance criteria and the reported device performance: Not applicable. The document lists performance tests for physical properties and biocompatibility, not diagnostic or AI performance.
- Sample sizes used for the test set and the data provenance: Not applicable. The tests are bench tests and biocompatibility studies, not diagnostic studies with test sets of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is established.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is an introducer kit, not a diagnostic AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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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
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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
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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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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 RoadChangping District, Beijing 102200P.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 toPredicate 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 fromBismuth 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 guidewire with a guide wire collimator, a sheath introducer, and a dilator.The Puncture Needle incorporates a lumen, which provides a conduitfor the insertion of the Guide Wire into the vascular system. Theflexible stainless-steel guide wire is utilized as a guiding mechanismfor the insertion of the Introducer Sheath into the vascular system. TheGuide Wire contains a wire collimator, which assists in funneling thewire through the lumen of the Puncture Needle. The Guide Wire isradio-detective under fluoroscopy. The Sheath Introducer containsBarium sulfate (BaSO4), making the device visible under fluoroscopyand provides a conduit for introducing other interventional devices,including guide wires and interventional catheters, into the vascularsystem. The main components of this assembly are a non-hydrophiliccoated Sheath Introducer, hemostasis valve housing, and a side porttubing with a 3-way stopcock/valve. The Dilator is used to providesupport and stability to the Sheath Introducer during deployment intothe vascular system. The proximal end of the Dilator includes a luerport and has a tapered, atraumatic distal tip. There is no radiocontrastagent on the dilator. |
| Indication For Use: | The ShoocinTM Introducer Kits are intended for use to facilitate theintroduction of guide wires, catheters and other accessory medicaldevices through the skin into a vein or artery and minimize blood lossassociated with such introduction. |
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| Predicate Device | Lepu Medical Technology (Beijing) Co., Ltd. added two models to the |
|---|---|
| Comparison: | Radial Sheath Introducer, the sheath introducer radiocontrast agentwas changed from Bismuth to Barium sulfate (BaSO4), and theremoval of a radiocontrast agent on the dilator to the currentlymarketed ShoocinTM Introducer Kit. The subject device issubstantially equivalent to the predicate device in terms of intendeduse, indication for use, operational characteristics, and fundamentaldesign 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 (<24 hours). The following test per ISO 10993 and results are:
| Test | Standard | Results | |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | Under the conditions of this study, the MEM test extracts would be considered no cytotoxicity potential. The negative controls, blank controls, and the positive controls performed as anticipated. | |
| ISO Intracutaneous study | ISO 10993-10 | Under the conditions of this study, the test article met the requirements of the test since the difference between each test extract overall mean score and corresponding control overall mean score was 0.0 and 0.0 for the SC and CSO test extracts, respectively. | |
| ISO Guinea Pig Maximum Sensitization | ISO 10993-10 | Under the conditions of this study, the test article extracts showed no evidence of causing delayed dermal contract sensitization in the Guinea pig. The test article was not considered a sensitizer in the Guinea pig maximization test. | |
| Biocompatibility continue: | Test | Standard | Results |
| ISO Systemic Toxicity | ISO 10993-11 | Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. | |
| Complement Activation Assay | ISO 10993-4 | Under the test condition, reading of C3a or Sc5b-9 of test article were significantly different (P<0.05) than those of negative control article. | |
| ASTM Hemolysis | ISO 10993-4ASTM F756 | Under the conditions of this study, the Hemolytic Index for the test article in direct contact with blood was 0.9% and that for the test article extract was 0.4%. Both the test article in direct contact with blood and test article were non-hemolytic. | |
| USP Pyrogen Study | ISO 10993-11USP <151> | 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. |
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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 | |
|---|---|
| SheathIntroducer | Appearance |
| Size designation | |
| Radio-detectability | |
| Freedom from leakage from sheath introducer | |
| Freedom from leakage through haemostasis valve | |
| Hub | |
| Peak tensile force | |
| Dilator accessibility | |
| 3-waystopcock/valve | Hub |
| Dilator | Appearance |
| Size designation | |
| Hub | |
| Strength of union between hub and dilator | |
| Guidewire accessibility | |
| PunctureNeedle | 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 | |
| Chemicalperformance | Heavy metal |
| pH variation value | |
| Nonvolatile matter | |
| Residual EO and ECH | |
| Biological | Sterile |
| Bacterial endotoxin |
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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).
§ 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).