SHOOCIN INTRODUCER KIT

• K Number: K123475
• Device Name: SHOOCIN INTRODUCER KIT
• Manufacturer: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
• Date Cleared: 2014-02-03 ( 447 days)
• Product Code: DYB
• Regulation Number: 870.1340

Intended 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.

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 introduction 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 and contains marking that are visible under fluoroscopy, which can determine in length of the guide wire within the vascular system. The sheath introducer 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 with tubing connected to 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. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

Predicate Devices

K111606

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and mechanical properties of the introducer kit, with no mention of AI or ML.

Therapeutic

No

Explanation: The device is an introducer kit designed to facilitate access to veins or arteries for other medical devices; it does not directly treat a disease or condition.

Diagnostic

No

The device is an introducer kit designed to facilitate the insertion of other medical devices into the vascular system. It does not perform any diagnostic function such as detecting, monitoring, or predicting diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components (puncture needle, guide wire, sheath introducer, dilator) and describes their physical properties and functions. The performance studies also focus on the physical characteristics and performance of these hardware components.

IVD (In Vitro Diagnostic)

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 used to facilitate the introduction of other medical devices into the body (vein or artery). IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
• Device Description: The description details components like needles, guide wires, sheaths, and dilators, all designed for accessing and navigating within the vascular system. These are typical components of interventional or access devices, not diagnostic tests performed on samples.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be performed in vitro to obtain diagnostic information.

Therefore, the ShoocinTM Introducer Kits are medical devices used for procedural access, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 (comma separated list FDA assigned to the subject device)

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 introduction 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 and contains marking that are visible under fluoroscopy, which can determine in length of the guide wire within the vascular system. The sheath introducer 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 with tubing connected to 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. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy

Anatomical Site

Vein or artery (vascular system)

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)

The ShoocinTM Introducer Kit successfully passed all of the following performance tests:
Sheath Introducer Performance Testing:

• Sheath Introducer should be free of defects
• Sheath Introducer ID
• Sheath Introducer Effective Length
• Radiodetectability
• Dilator accessibility
• Fracture Strength Test
• Leaking Performance Test
  Dilator Performance Testing:
• Dilator should be free of defects
• Dilator OD
• Dilator ID
• Dilator Effective Length
• Radiodetectability
• Guide wire accessibility
  Guide wire Performance Testing:
• Fracture Strength Test
• Surface free from impurity
• Guide wire length
• Guide wire OD
• Radiodetectability
• Corrosion Resistance
• Fracture Strength Test
• Flexing Resistance Test
• Associative Guide Wire Strength Test
  Puncture Needle Performance Testing:
• Surface free from defects
• Needle OD
• Needle ID
• Needle Effective Length
• Accessibility - Guide wire
• Corrosion Resistance
• Joint Strength - Needle to hub

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111606

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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K.123475
FEB - 3 2014

Section 5: 510k) Summary

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The Summary of Safety and Ifferintion on the Shocial" in the submitted hat or revience with the requirences in the requirences in the requirences in the regirents in the rece

| Applicant: | Lepu Medical Technology (Beijing) Co., Ltd.
No. 37 Chaoqian Road
Changping District, Beijing 102200
P.R. China |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Contact: | Shan Zhao |
| Date: | November 6, 2012 |
| Name: | ShoocinTM Introducer Kit |
| Classification Name: | Catheter Introducer, 870.1340 |
| Product Code: | DYB |
| Predicate: | Pinnacle Precision Access System, Terumo Corporation, K111606 with market
clearance dates of October 3, 2011. |
| 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 introduction 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 and
contains marking that are visible under fluoroscopy, which can determine in
length of the guide wire within the vascular system. The sheath introducer
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 with tubing connected to 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.
Both the sheath and dilator contain bismuth, making these devices visible
under fluoroscopy. |
| Intended 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. |

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Section 5: 510k) Summary

ﺰ

:

·

| Specification
Comparison: | | | The Shoocin™ Introducer Kit specifications are similar to the Pinnacle Access
System (K111606) and the differences do not raise any new issues of safety or
effectiveness. |
|------------------------------|---------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Pinnacle | Shoocin |
| | Sheath Diameter: | 4F through 11F | 4F through 11F |
| | Sheath Length: | 10cm - 25cm | 7cm - 23cm |
| | Guide Wire Length: | 45cm | 45cm and 80 cm |
| | Guide Wire OD: | .035" - .038" | .018" - .038" |
| | Introducer Needle: | 19 – 21G | 18 – 20G |
| | Dilator: | 15.5cm or 16.0cm | 7cm, 11cm, 16cm, 23cm |
| | | | |
| Materials
Comparison: | | | The Shoocin ™ Introducer Kit materials have been subjected to
biocompatibility tests and the differences between the Pinnacle Access System
(K111606) do not raise any new issues of safety or effectiveness. |
| | | Pinnacle | Shoocin |
| | Needle: | Stainless Steel | Stainless Steel |
| | Needle Luer: | Styrene-Butadiene | Polycarbonate |
| | Guide Wire: | Stainless Steel or Nitinol
w/Palladium distal coil | Stainless Steel |
| | Guide Wire
Collimator: | Polypropylene | Polycarbonate |
| | Dilator Tube: | Polypropylene w/Bismuth
subcarbonate | Polypropylene |
| | Dilator Luer: | Polypropylene | Acrylobutyistyrene |
| | Outer Sheath: | ETFE w15% BiO3, w/2%
TiO2 | Fluorinated Ethylene
Propylene |
| | Sheath base: | Styrene elastomer | Acrylobutyistyrene |
| | Side Port Tubing | Polybutadiene | Polyurethane |
| | Hemostasis Valve: | Silicone Rubber | Silicone |
| | 3-Way Stop Cock: | Polypropylene | Acrylobutyistyrene |
| | Cap: | Polypropylene | Polyethylene |
| | Valve: | Polypropylene | Polyethylene |
| Sterilization: | | | The method used is based on practices recommended by AAMI / ANSI / ISO
11135:2007 and provides a Sterility Assurance Level (SAL) of 106 |
| Shelf Life: | | | In accordance with ISO 11070 the real time aging of Shoocin ™ Introducer Kit
demonstrated that the performance of the specific components met the
standard requirements without any significant difference to product
performance requirements before aging. So the product is stable and reliable
within the two-year useful life |

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Section 5: 510k) Summary
Biocompatibility:	The ShoocinTM 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 ShoocinTM
Introducer Kit would be classified as an External Communicating Device in
contact with the Circulating Blood for a Limited Duration (In Vivo
Thromboresistance	ISO 10993-4	The test article and control
were thromboresistant and
comparable.
	Partial Thromboplastin
Time	ISO 10993-4	The test article would be
considered a minimal activator
and met the requirements of the
test.
Performance Testing:	The ShoocinTM Introducer Kit successfully passed all of the following
performance tests:
	ShoocinTM	Introducer Kit Performance Testing
	Sheath Introducer	Sheath Introducer should be free of defects
		Sheath Introducer ID
		Sheath Introducer Effective Length
		Radiodetectability
		Dilator accessibility
		Fracture Strength Test
		Leaking Performance Test
Section 5: 510k) Summary
Performance Testing:	The ShoocinTM Introducer Kit successfully passed all of the following performance tests:
		ShoocinTM Introducer Kit Performance Testing
	Dilator	Dilator should be free of defects
		Dilator OD
		Dilator ID
		Dilator Effective Length
		Radiodetectability
		Guide wire accessibility
	Guide wire	Fracture Strength Test
		Surface free from impurity
		Guide wire length
		Guide wire OD
		Radiodetectability
		Corrosion Resistance
		Fracture Strength Test
		Flexing Resistance Test
		Associative Guide Wire Strength Test
	Puncture Needle	Surface free from defects
		Needle OD
		Needle ID
		Needle Effective Length
		Accessibility - Guide wire
		Corrosion Resistance
		Joint Strength - Needle to hub
Substantial
Equivalency
Information:	The information provided in this submission, comparing intended use, principle of operation and performance, the ShoocinTM Introducer Kit device is substantially equivalent to existing legally marketed device.
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 ShoocinTM Introducer Kit supports a determination of substantially equivalent to existing legally marketed predicate device Pinnacle Precision Access System. Any technological differences between the ShoocinTM Introducer Kit and the predicate Pinnacle Precision Access System device do not raise new questions of safety or effectiveness.

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines underneath, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is printed in black and white.

11 February 3, 2014

Lepu Medical Technology (Beijing) Co., Ltd. c/o Arthur Goddard FDA Regulatory and Quality Systems Consultant 1531 Felton Road South Euclid, Ohio 44121-2722

Re: K123475

Trade Name: Shoocin™ Introducer Kit Dated: January 21, 2014 Received: January 27, 2014

Dear Mr. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

5

Page 2 - Mr. Goddard

" If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDeyices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. Zillberman

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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Section 4: Indication for Use Summary

510(k) Number (if known):	K123475
Device Name:	Shoocin TM Introducer Kit

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.

Prescription Use	X	OR	Over-The-Counter-Use
(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Z. Hillman

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