Sterile Piston Hypodermic Syringes (With/Without Needed for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the fennector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from the body.

The hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe.

Device Description

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber.

The Hypodermic Needle is a single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection. The needle is sterilized by EtO gas. and it is a Non-Pyrogenic and single use device. The mainly raw materials are PP and stainless steel.

AI/ML Overview

The provided text is a 510(k) summary for WUXI YUSHOU MEDICAL APPLICANCES CO., LTD's "Iston Syringe With/Without Needle." This document outlines the substantial equivalence of the new device to existing predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria through clinical or performance data.

The FDA 510(k) pathway is for devices that are "substantially equivalent" to predicate devices already on the market. It does not typically involve the kind of detailed clinical study data, ground truth establishment, or multi-reader multi-case (MRMC) studies that would be necessary to demonstrate performance against acceptance criteria in the way you've described for an AI/CADe device.

Therefore, many of the requested fields cannot be filled from the provided document. The acceptance criteria in this context are implicitly that the device performs equivalently to the predicate devices and meets relevant recognized standards (like ISO).

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

For a traditional medical device like a syringe or needle, "acceptance criteria" are typically defined by recognized standards (e.g., ISO for sterility, performance, biocompatibility) and comparisons to predicate devices. The document states that the device conforms to these standards, implying it meets the criteria.

Acceptance Criteria (Standard/Attribute)	Reported Device Performance (Claimed Conformance)
Conformance to ISO7886-1 (Syringes)	Conforms to ISO7886-1
Conformance to ISO7864 (Needles)	Conforms to ISO7864
Conformance to ISO10993 (Biocompatibility)	Conforms to ISO10993
Labeling Requirements (21 CFR Part 801)	Meets the requirements of 21 CFR Part 801
Intended Use	Same as predicate devices
Principle of Operation	Normal (Same as predicate devices)
Syringe Capacity/Needle Gauge & Length	Various Sizes
Lubricant	Silicone Oil
Materials (Barrel, Plunger, Piston, etc.)	PP, PE, Rubber, Stainless Steel (Same as predicate)

2. Sample size used for the test set and the data provenance

Sample size: Not explicitly mentioned in terms of a "test set" for clinical performance. The document refers to conformance to standards, which would involve testing multiple units, but the specific sample size for these tests is not provided in this summary.
Data provenance: Not explicitly mentioned. Testing would likely have been conducted by the manufacturer or a contracted lab in China to demonstrate conformance to ISO standards. The submission is from China.
Retrospective or prospective: Not applicable in this context; these terms are used for clinical studies with patient data, which is not described here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable. Ground truth, in the context of AI/CADe, refers to a definitive diagnosis or finding. For a syringe/needle, "ground truth" relates to its physical performance and material properties. Compliance with standards is typically assessed through engineering tests and material analysis by qualified technicians/engineers, not medical experts establishing a "ground truth" for a diagnostic outcome.
Qualifications of experts: Not applicable for establishing diagnostic ground truth.

4. Adjudication method for the test set

Adjudication method: Not applicable. Adjudication is used to resolve discrepancies in expert interpretations in diagnostic studies. For device performance, adherence to standards is demonstrated through validated test methods.

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

MRMC study: No. This is not applicable to a hypodermic syringe or needle. MRMC studies are for diagnostic devices, especially those involving human interpretation of medical images with or without AI assistance.

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

Standalone performance: No. This is not applicable to an entirely mechanical medical device like a syringe/needle.

7. The type of ground truth used

Type of ground truth: The "ground truth" here is the adherence to established international standards (ISO7886-1 for syringes, ISO7864 for needles, ISO10993 for biocompatibility) and regulatory requirements (21 CFR Part 801 for labeling). This is affirmed through technical testing and documentation, rather than clinical outcomes or expert consensus on a diagnostic finding.

8. The sample size for the training set

Training set sample size: Not applicable. This device is not an AI/ML product and does not have a "training set."

9. How the ground truth for the training set was established

Ground truth establishment for training set: Not applicable.

Summary

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[WUXI YUSHOU MEDICAL APPLICANCES CO., LTD] (WUXI CITY, JIANGSU, CHINA] Iston Syringe With/Without Needle]

510(k) Submission [PMN2012001] Rev 1.00 17/10/13

HACHASZET 002

510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

Date Prepared: Oct. 17.2013

1. Submitter Name and Address:

Name:	WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
Address:	215NO. XIGANG ROAD, DONGBEITANG WUXI CITY,JIANGSU, JIANGSU, 214191, CHINA
Contactor Name:	Garfield Wang
TEL:	+86-510-83777555
E-mail:	Wangxuebo_11@hotmail.com
US Agent:
Contact Name:	QIAN SHEN
Business Name:	P&L SCIENTIFIC INC.
Address:STATES	6840 SW 45TH LN, UNIT 5 Miami, Florida, 33155, UNITED
Phone:	305-6094701
Fax:	305 -3970289
E-mail Address:	info@plscientificinc.com

2. Submission Devices Information:

NOV 20 2013

Trade/Proprietary Name:

1. Sterile Piston Hypodermic Syringes (With/Without Needle).
1. Hypodermic Needles.

Common Name:

1. Piston Syringe
1. Hypodermic Needle.

Classification name:

1. Piston Syringe.
1. Hypodermic Single Lumen Needle.

Class:

1. II.
1. II.

Panel:

[PMN-510(K) SUBMISSION]

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510(k) Submission [PMN2012001] 17/10/13

Procodes:

1. FMF Piston Syringe and FMI Hypodermic Single Lumen Needle
1. FMI Hypodermic Single Lumen Needle

3. Predicate Devices Information:

1. Piston Syringe: Trade Name: BD Single Use, Hypodermic Syringe 510(K) Number: K110771 2. Hypodermic Needle: BD Hypoint™ Trade Name: 510(K) Number: K070440

4. Devices Description:

4.1 Sterile Piston Hypodermic Syringes (With/Without Needle).

RefNumber	ModelNumber	Description	Size
YSPS001	YSPS	Piston syringewith/without needles	0.5cc/ml≤Capacity of Syringe<2cc/ml
YSPS002	YSPS	Piston syringewith/without needles	2cc/ml≤Capacity of Syringe<5cc/ml
YSPS003	YSPS	Piston syringewith/without needles	5cc/ml≤Capacity of Syringe<10cc/ml
YSPS004	YSPS	Piston syringewith/without needles	10cc/ml≤Capacity of Syringe<20cc/ml
YSPS005	YSPS	Piston syringewith/without needles	20cc/ml≤Capacity of Syringe<30cc/ml
YSPS006	YSPS	Piston syringewith/without needles	30cc/ml≤Capacity of Syringe<50cc/ml
YSPS007	YSPS	Piston syringewith/without needles	50cc/ml≤Capacity of Syringe

4.2 Hypodermic Needles.

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[PMN-510(K) SUBMISSION]

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510(k) Submission (PMN2012001) Rav 1.00 17/10/13

Number	Number
YSHN001	YSHN	Hypodermic Needle Normal-walled	1/2 to 1"	30G
YSHN002	YSHN	Hypodermic Needle Normal-walled	1/2 to 1"	29G
YSHN003	YSHN	Hypodermic Needle Normal-walled	1/2 to 1"	28G
YSHN004	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	27G
YSHN005	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	26G
YSHN006	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	25G
YSHN007	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	24G
YSHN008	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	23G
YSHN009	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	22G
YSHN010	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	21G
YSHN011	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	20G
YSHN012	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	19G
YSHN013	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	18G
YSHN014	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	17G
YSHN015	YSHN	Hypodermic Needle Normal-walled	1 to 1 1/2"	16G

5. Intended Use:

5.1 Sterile Piston Hypodermic Syringes (With/Without Needle).

Sterile Piston Hypodermic Syringes (With/Without Needle) is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

5.2 Hypodermic Needles.

6. Technological Characteristics:

Through comparisons between the applicant devices with the predicate devices as follows tables. We believe the applicant devices are substantially equivalent with the predicate devices.

6.1 Sterile Piston Hypodermic Syringes (With/Without Needle) Comparison Table

Element of Comparison	Submission Device	Predicate DeviceK110771
Intended Use	Sterile Piston HypodermicSyringes (With/Without Needle) isa device intended for medicalpurposes that consists of acalibrated hollow barrel and a	The BD Single Use,Hypodermic Syringe is intendedfor use by health careprofessionals for generalpurpose fluid aspiration/

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.. . . . . . .

	movable plunger. At one end of thebarrel there is a male connector(nozzle) for fitting the femaleconnector (hub) of a hypodermicsingle lumen needle. The device isused to inject fluids into, orwithdraw fluids from, the body.	injection.
Principle of Operation	Normal	Normal
Syringe Capacity	Various Sizes	Various Sizes
Nozzle Type	Luer	Luer
Lubricant for Barrel	Silicone Oil	Silicone Oil
Barrel Transparency	Transparent and Clear	Transparent and Clear
Gradations Legibility	Legible	Legible
Needle Gauge and Length	Various Sizes	Various Sizes
Lubricant for Needle	Silicone Oil	Silicone Oil
Materials
Barrel	PP	PP
Plunger	PE	PE
Piston	Rubber	Rubber
Nozzle Cap	PE	PE
Needle Hub	PP	PP
Needle	Stainless Steel	Stainless Steel
Performances	Conforms to ISO7886-1	Conforms to ISO7886-1
Biocompatibility	Conforms to ISO10993	Conforms to ISO10993
Labeling	Meet the requirements of 21 CFRPart 801	Meet the requirements of 21CFR Part 801

··············································································································································································

6.2 Hypodermic Needles Comparison Table

Element of Comparison	Submission Device	Predicate DeviceK070440
Intended Use	The hypodermic needle is a deviceintended to inject fluids into, orwithdraw fluids from, parts of thebody below the surface of the skin.The device consists of a metaltube that is sharpened at one endand at the other end joined to afemale connector (hub) designedto mate with a male connector(nozzle) of a piston syringe.	The BD Hypoint™ HypodermicNeedle is intended for use withSyringes and injection devicesfor general purpose fluidaspiration/ injection.
Principle of Operation	Normal	Normal
Needle Gauge and Length	Various Sizes	Various Sizes
Lubricant for Needle	Silicone Oil	Silicone Oil
Materials
Needle Hub	PP	PP
Needle	Stainless Steel	Stainless Steel
Needle Sheath	PE	PE
Performances	Conforms to ISO7864	Conforms to ISO7864
Biocompatibility	Conforms to ISO10993	Conforms to ISO10993
Labeling	Meet the requirements of 21 CFRPart 801	Meet the requirements of 21CFR Part 801

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510(k) SubmIsslon [PMN2012001] Rev 1.00 17/10/13

.. ...

7. Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent. Our device and the predicate device are same in intended use, Essential Component, Material, Sterile, Function etc.

END

02 Page 5 of 5

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Public Health Service

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

November 20, 2013

Wuxi Yushou Medical Appliances Company, Limited C/O Garfield Wang Regulatory Associate 215 No. Xigang Road, Dongbeitang Wuxi City Jiangsu, China 21491

Re: K130230

Trade/Device Name: Sterile Piston Hypodermic Syringes (With/Without Needle) and Hypodermic Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF/FMI Dated: October 18, 2013 Received: October 21, 2013

Dear Mr. Wang:

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.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kwame
Ulmer

for

Erin Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K130230

Device Name

Sterile Piston Hypodermic Syringes (With/Without Needle)

Indications for Use (Describe)

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)

PSC Institutios services ( 411) 44 1 1.71.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Contract Contract Concerner Concerner Concerner Concerner Comments of the Super Market Concern Comments of Concern Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/7/Picture/12 description: The image shows the FDA logo. The letters "FDA" are stylized with a triple-line effect, giving them a bold and somewhat retro appearance. The logo is simple and monochromatic.

Digitally signed by Richard C. Chapman Date: 2013.11.19 13:00:19 -05'00'

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).