SHOOCIN INTRODUCER KIT by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

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.

AI/ML Overview

The provided text describes a medical device, the Shoocin™ Introducer Kit, and its substantial equivalence to a predicate device (Pinnacle Precision Access System). The acceptance criteria and the study proving the device meets them are primarily focused on biocompatibility and performance testing, rather than an AI/ML-based diagnostic or prognostic device study.

Here's an analysis of the provided information, structured according to your request, with an emphasis on what is and is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be meeting the standards of the predicate device and relevant ISO standards. The document explicitly lists performance tests and biocompatibility tests from ISO standards as criteria. The reported performance is that the device "successfully passed all" these tests.

Acceptance Criteria (Test/Standard)	Reported Device Performance (Shoocin™ Introducer Kit)
Biocompatibility (ISO 10993-1, External Communicating Device, Limited Duration <24 hours)
Haemolysis (ISO 10993-4)	Both the test article in direct contact with blood and the test article extract were non-hemolytic.
Cytotoxicity (ISO 10993-5)	The test article extract showed no evidence of causing cell lysis or toxicity.
Maximum Sensitization (ISO 10993-10)	The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
Intracutaneous Irritation (ISO 10993-10)	The test article met the requirements for the SC and SO test extracts.
Systemic Toxicity (ISO 10993-11)	There was no mortality or evidence of systemic toxicity from the extracts injected into mice.
USP Pyrogen Study (ISO 10993-11)	The test article was judged as nonpyrogenic.
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
Sheath Introducer: Free of defects	Successfully passed
Sheath Introducer ID	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Sheath Introducer Effective Length	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Radiodetectability (Sheath Introducer)	Successfully passed
Dilator accessibility (Sheath Introducer)	Successfully passed
Fracture Strength Test (Sheath Introducer)	Successfully passed
Leaking Performance Test (Sheath Introducer)	Successfully passed
Dilator: Free of defects	Successfully passed
Dilator OD	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Dilator ID	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Dilator Effective Length	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Radiodetectability (Dilator)	Successfully passed
Guide wire accessibility (Dilator)	Successfully passed
Guide wire: Surface free from impurity	Successfully passed
Guide wire length	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Guide wire OD	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Radiodetectability (Guide wire)	Successfully passed
Corrosion Resistance (Guide wire)	Successfully passed
Fracture Strength Test (Guide wire)	Successfully passed
Flexing Resistance Test (Guide wire)	Successfully passed
Associative Guide Wire Strength Test	Successfully passed
Puncture Needle: Surface free from defects	Successfully passed
Needle OD	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Needle ID	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Needle Effective Length	Successfully passed (Implied to meet specified dimensions or be comparable to predicate)
Accessibility - Guide wire (Puncture Needle)	Successfully passed
Corrosion Resistance (Puncture Needle)	Successfully passed
Joint Strength - Needle to hub	Successfully passed
Sterility Assurance Level (SAL)	10^-6 (achieved via AAMI/ANSI/ISO 11135:2007) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Shelf Life	Stable and reliable within two-year useful life (demonstrated by real-time aging per ISO 11070 with no significant difference to product performance requirements before aging). ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for each performance or biocompatibility test. The document indicates that the tests were conducted, and results are reported as "non-hemolytic," "no evidence of causing cell lysis or toxicity," "met the requirements," etc. This suggests that the sample sizes were sufficient for the specific tests based on their respective ISO standards.
Data Provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. The tests appear to be laboratory-based evaluations of the device's physical and biological properties.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This question is not directly applicable to the type of device and study described. The "ground truth" for a medical introducer kit is established by objective measurements against engineering specifications and biological standards (e.g., ISO 10993 for biocompatibility), not by human expert opinion like in an AI/ML diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. As this is a physical medical device being evaluated against engineering and biological standards, there isn't a need for expert adjudication in the way it would be applied to, for example, medical image interpretation. The testing results are objective measurements.

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

Not applicable. The Shoocin™ Introducer Kit is a physical medical device, not an AI/ML-based diagnostic or prognostic tool involving human readers and AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

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 evaluation is primarily established by:

Adherence to relevant international standards: ISO 10993 for biocompatibility and ISO 11070 for shelf life.
Meeting engineering specifications: Implied for dimensions (Sheath ID/OD, Lengths, Guide Wire OD, Needle OD/ID) and mechanical properties (Fracture Strength, Flexibility, Joint Strength).
Absence of manufacturing defects: (e.g., "Sheath Introducer should be free of defects," "Surface free from impurity").
Comparison to a predicate device: The overall claim is substantial equivalence to the Pinnacle Precision Access System (K111606).

8. The Sample Size for the Training Set

Not applicable. This document describes the evaluation of a physical medical device, not the development or training of an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

K.123475
FEB - 3 2014

Section 5: 510k) Summary

ﻪ ﺍ

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 RoadChangping District, Beijing 102200P.R. China
Telephone:	+86-10-80120641
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 marketclearance dates of October 3, 2011.
Description:	The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire witha guide wire collimator, a sheath introducer, and a dilator. The punctureneedle incorporates a lumen, which provides a conduit for the insertion of theguide wire into the vascular system. The flexible stainless steel guide wire isutilized as a guiding mechanism for the insertion of the introduction sheathinto the vascular system. The guide wire contains a wire collimator, whichassists in funneling the wire through the lumen of the puncture needle andcontains marking that are visible under fluoroscopy, which can determine inlength of the guide wire within the vascular system. The sheath introducerprovides a conduit for introducing other interventional devices, includingguide wires and interventional catheters, into the vascular system. The maincomponents of this assembly are a non-hydrophilic coated sheath introducer,hemostasis valve housing, and a side port with tubing connected to a 3-waystopcock/valve. The dilator is used to provide support and stability to thesheath introducer during deployment into the vascular system. The proximalend of the dilator includes a luer port and has a tapered, atraumatic distal tip.Both the sheath and dilator contain bismuth, making these devices visibleunder fluoroscopy.
Intended Use:	The ShoocinTM Introducer Kits are intended for use to facilitate theintroduction of guide wires, catheters and other accessory medical devicesthrough the skin into a vein or artery and minimize blood loss associated withsuch introduction.

{1}------------------------------------------------

Section 5: 510k) Summary

ﺰ

SpecificationComparison:			The Shoocin™ Introducer Kit specifications are similar to the Pinnacle AccessSystem (K111606) and the differences do not raise any new issues of safety oreffectiveness.
		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

MaterialsComparison:			The Shoocin ™ Introducer Kit materials have been subjected tobiocompatibility 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 Nitinolw/Palladium distal coil	Stainless Steel
	Guide WireCollimator:	Polypropylene	Polycarbonate
	Dilator Tube:	Polypropylene w/Bismuthsubcarbonate	Polypropylene
	Dilator Luer:	Polypropylene	Acrylobutyistyrene
	Outer Sheath:	ETFE w15% BiO3, w/2%TiO2	Fluorinated EthylenePropylene
	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 / ISO11135:2007 and provides a Sterility Assurance Level (SAL) of 106
Shelf Life:			In accordance with ISO 11070 the real time aging of Shoocin ™ Introducer Kitdemonstrated that the performance of the specific components met thestandard requirements without any significant difference to productperformance requirements before aging. So the product is stable and reliablewithin the two-year useful life

…… ち "

, . .. !

· 《中语·

. '.

ﺒﻴ

. '

{2}------------------------------------------------

Section 5: 510k) Summary
Biocompatibility:	The ShoocinTM Introducer Kit produced by Lepu Medical was assessedagainst the International Standard ISO 10993-1, "Biological evaluation ofmedical devices. Part 1. Guidance on selection of tests." The ShoocinTMIntroducer Kit would be classified as an External Communicating Device incontact with the Circulating Blood for a Limited Duration (<24 hours). Thefollowing test would be required for any patient / user contacting material:
	Test	Standard	Results
	Haemolytsis	ISO 10993-4	Both the test article in directcontact with blood and the testarticle extract were non-hemolytic.
	Cytotoxicity	ISO 10993-5	The test article extract showedno evidence of causing celllysis or toxicity
	MaximumSensitization	ISO 10993-10	The test article extracts showedno evidence of causing delayeddermal contact sensitization inthe guinea pig.
	IntracutaneousIrritation	ISO 10993-10	The test article met therequirements for the SC and SOtest extracts.
	Systemic Toxicity	ISO 10993-11	There was no mortality orevidence of systemic toxicityfrom the extracts injected intomice.
	USP Pyrogen Study	ISO 10993-11	The test article was judged asnonpyrogenic.
	In VivoThromboresistance	ISO 10993-4	The test article and controlwere thromboresistant andcomparable.
	Partial ThromboplastinTime	ISO 10993-4	The test article would beconsidered a minimal activatorand met the requirements of thetest.
Performance Testing:	The ShoocinTM Introducer Kit successfully passed all of the followingperformance 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
SubstantialEquivalencyInformation:	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.

{3}------------------------------------------------

{4}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{6}------------------------------------------------

Section 4: Indication for Use Summary

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

Indications For Use:

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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).