The Wuzhou Syringe, with/without needle for single use only, is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Device Description

The Wuzhou Syringe, with/without needle, is a standard piston syringe 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 syringe is designed for manual use. It is available in 1, 2, 3, 5, 10, 20, 30, 50, 60 and 100ml volumes, with luer slip, luer lock, centrally or eccentrically tip configurations. Syringe with 50 ml volume is irrigating syringe.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Wuzhou Syringe, with/without needle. This submission demonstrates substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through novel performance data.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of regulatory submission. The information provided focuses on conformance to established standards and comparison to a legally marketed predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of specific acceptance criteria for a novel performance study, the document asserts conformance to various international and national standards. These standards define the "acceptance criteria" for the device's design, materials, and functional properties. The reported device performance is implicitly "conforms to" these standards and is "substantially equivalent" to the predicate device.

Acceptance Criteria (Standards Conformed To)	Reported Device Performance
Mechanical/Physical Standards:
GB 15810-2001 (ISO 7886-1) - Sterile Hypodermic Syringe for Single Use, Part 1: Syringe for manual use	Complies (implicitly, as part of substantial equivalence claim)
GB 15811-2001 (ISO 7864) - Sterile Hypodermic needles for Single Use	Complies (implicitly, as part of substantial equivalence claim)
GB/T 1962.1-2001 (ISO 594-1:1986) - Conical Fittings with a 6% Taper, Part 1: General Requirements	Complies (implicitly, as part of substantial equivalence claim)
GB/T 1962.2-2001 (ISO 594-2:1998) - Conical Fittings with a 6% Taper, Part 2: Lock Fitting	Complies (implicitly, as part of substantial equivalence claim)
GB18457-2001 (ISO 9626) - Stainless Steel Needle Tubing for Manufacture of Medical Devices	Complies (implicitly, as part of substantial equivalence claim)
Sterilization Standards:
GB18279-2000 (ISO 11135) - Medical Devices - Validation and Routine Control for Ethylene Oxide Sterilization	Complies (implicitly, as part of substantial equivalence claim)
Biocompatibility Standards:
ISO 10993-1 - Biological Evaluation of Medical Devices: Evaluation and Testing	Complies (implicitly, as part of substantial equivalence claim)
ISO 10993-5 - Tests for Cytotoxicity	Complies (implicitly, as part of substantial equivalence claim)
ISO 10993-10 - Tests for Irritation and Sensitization	Complies (implicitly, as part of substantial equivalence claim)
ISO 10993-4 - Tests for Interactions with Blood	Complies (implicitly, as part of substantial equivalence claim)
ISO 10993-11 - Test for Systemic Toxicity	Complies (implicitly, as part of substantial equivalence claim)
Clean Room Standards:
JGJ71-1990 - Practice of constructing and verifying clean room	Complies (implicitly, as part of substantial equivalence claim)
GB/T 16292-1996 (FS/209E) - Test method for airborne particles in clean room (area) of the pharmaceutical industry	Complies (implicitly, as part of substantial equivalence claim)
General Guidance:
FDA guidance document, "Guidance on the Content of Premarket Notification [510(k)] Submission for Piston Syringes", dated April 1993	Followed for submission content
Substantial Equivalence to Predicate Device (K042500, DuoProSS Syringe)	"Substantially equivalent in intended use, labeling, design and materials, and specifications." "The DuoProSS Syringe (K042500) manufactured by DuoProSS Meditech Corporation."

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

Sample Size: Not specified. Performance data, if collected for compliance with the listed standards, would typically involve specific sample sizes as per the respective standard's requirements (e.g., for mechanical, sterility, and biocompatibility testing). However, specific test set sample sizes for a clinical performance study are not provided or required for this type of submission.
Data Provenance: The document implies that the device "complies with" various standards. This suggests that internal testing or third-party laboratory testing was conducted according to these standards. The manufacturing company is based in Wenzhou, China, so testing likely occurred in China or at accredited international labs. The data would be "prospective" in the sense that it was generated for the purpose of demonstrating compliance.

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

Not Applicable. This submission is based on conformance to engineering and biological standards, not on expert-adjudicated clinical ground truth for a diagnostic or prognostic performance claim.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

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. This device is a manual piston syringe, not an AI-assisted diagnostic or therapeutic device.

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

Not Applicable. This device is a manual piston syringe, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by the definitions and requirements within the referenced international and national standards (e.g., ISO, GB) and the characteristics of the legally marketed predicate device. For example, the "ground truth" for sterility would be a negative bacterial growth result when tested according to ISO 11135. The "ground truth" for material composition is the actual composition of the materials used in manufacturing.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device.

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

Not Applicable. See point 8.

Summary

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K060211

(f,2.4)

FEB 1 0 2006

510(k) Summary

Submitter Information:

Name and Address:

Wenzhou Wuzhou Group Co., Ltd. Rm. 606-608, Dongfang Bldg., Wenzhou, China

Contact Person:

George Su Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA

Tcl: 310-229-5748 Fax: 310-388-1067 Email: crosslinks2000@aol.com

Device Name:

Trade Name: Wuzhou Syringe, with/without needle Common Name: Sterile Piston Syringe, Hypodermic Single Lumen Needle Classification Name: Piston Syringe, Hypodermic Single Lumen Needle

FDA Classification (class I, II or III)

Piston Syringe 21 C.F.R. 880.5680, Product Code FMF, Class II Hypodermic Single Lumen Needle 21 C.F.R. 880.5570, Product Code FMI, Class II

Predicate Device:

The DuoProSS Syringe (K042500) manufactured by DuoProSS Meditech Corporation.

Intended Use:

The Wuzhou Syringe, with/without needle is intended to be used for medical purposes to inject fluids

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into or withdraw fluids from the body.

K464211 (P.22034)

Principle of Operation and Technology:

The Wuzhou Syringe, with/without needle is designed for manual use.

Design and Materials:

The Wuzhou Syringe, with/without needle, consists mainly of 3 parts or 4 pars: a barrel, a plunger, a gasket and a needle (for the needle type). The barrel and the plunger are made from medical polypropylene. The gasket is made from rubber (not include emulsion and natural rubber). The needle is made from stainless steel. The lubricant on barrel is the Polydimethylsiloxane oil.

Description of Device:

Declaration of the Conformance to Applicable Standards

The Wuzhou Syringe, with/without needle, complies with:

-- GB 15810-2001, which is equal to specific sections of ISO 7886-1 Guidance for Sterile Hypodermic Syringe for Single Use, Part 1: Syringe for manual use.

-- GB 15811-2001, which is equal to ISO 7864, Sterile Hypodermic needles for Single Use;

-- GB/T 1962.1-2001, equals to ISO 594-1:1986, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment, Part 1: General Requirements;

-- GB/T 1962.2-2001, equals to ISO 594-2:1998, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment, Part 2: Lock Fitting;

-- GB18279-2000, equals to ISO 11135, Medical Devices-Validation and Routine Control for Ethylene Oxide Stcrilization;

-- GB18457-2001, equals to ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices;

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-- JGJ71-1990, Practice of constructing and verifying clean room

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-- GB/T 16292-1996, equals to FS/209E (withdrawn from use in USA), Test method for airborne particles in clean room (area) of the pharmaceutical industry. And FS/209E is still in use in the pharmaceutical industry in USA, Japan, some European Countries and China.

-- ISO 10993, Biological Evaluation of Medical Devices;
ISO 10993-1: Evaluation and Testing,
ISO 10993-5 Tests for Cytotoxicity
ISO 10993-10 Tests for irritation and Sensitization,
ISO 10993-4 Tests for interactions with blood,
ISO 10993-11 Test for systemic toxicity.

-- FDA guidance document," Guidance on the Content of Premarket Notification [510(k)] Submission for Piston Syringes", dated April 1993.

Substantial Equivalence Comparison:

The Wuzhou Syringe, with/without needle, is substantially equivalent to the predicate DuoProSS Syringe as follows:

Intended Uses: Both The Wuzhou Syringe, with/without needle, and DouProSS Syringe are intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Labeling: Both of their labeling include the identity of the device (type, size, needle gauge and length), quantity and the required warnings and prescription statement according to 880.5860(b) (1).
Design and materials: The design of Wuzhou Syringe and DuoProSS Syringe are basically the same. Both devices are comprised of a barrel, plunger, gasket and needle. The materials of them are totally the same.
Specifications: The physical specifications of Wuzhou Syringe, with/without needle, and DuoProSS Syringe are basically the same. The difference between them is syringe sizes and needle length. Both of the Mechanical and Biological conform to the same international standard.

Substantial Equivalence Summary:

In summary, The Wuzhou Syringe, with/without needle, is substantially equivalent in intended use, labeling, design and materials, and specifications to the predicate DuoProSS Syringe (K042500) manufactured by DuoProSS Meditech Corporation. Any noted differences between the two devices do

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not raise new issues of the safety and effectiveness.

K464271 (P.4064)

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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Public Health Service

FEB 1 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wenzhou Wuzhou Group Company, Limited C/O Ms. Laura Danielson Responsible Third Party Official TÜV America, Incorporated 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

Re: K060211

Trade/Device Name: Wuzhou Syringe with/Without Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: Il Product Code: FMF Dated: January 26, 2006 Received: January 27, 2006

Dear Ms. Danielson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affectung vour 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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Page 2 - Ms. Danielson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Russo
to Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) .-

Wuzhou Syringe With/Without Needle Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Wuzhou Syringe, with/without needle for single use only, is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinta Vimo

K464211

Page 1 of _1

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).