Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body. Needles are intended to be used with a legally marketed syringe intended to inject fluids into or withdraw fluids from the body.

Device Description

The proposed devices contain syringes and needles with various models. All the models for syringes and needles follow same design principle respectively; the differences are the size of the devices. The proposed devices are intended to inject fluids into or withdraw fluids from the body. The proposed devices would be available in two different configurations: Syringe with needle and Syringe without needle. Proposed devices are provided radiation (Co60) sterilized with a hard pack package which could maintain the sterility of the devices for five years. They are for single use only.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device (syringes and needles). The purpose of this type of submission is to demonstrate that the new device is "substantially equivalent" to a predicate device already on the market. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating substantial equivalence, primarily by conforming to recognized standards and showing comparable performance to the predicate device.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are the international standards the device aims to comply with, and the reported performance is the confirmation that the device does comply with these standards.

Acceptance Criteria (Standard)	Reported Device Performance
ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use	Complied with standard
ISO 7864:1993 Sterile hypodermic needles for single use	Complied with standard
ISO 9626:1991, AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices	Complied with standard
ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements	Complied with standard
ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings	Complied with standard
ISO 11137-2:2012, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose	Complied with standard (for radiation sterilization)
ISO 10993:5 Standard (Biocompatibility - Cytotoxicity)	Complied with standard
ISO 10993:10 Standard (Biocompatibility - Irritation and Sensitization)	Complied with standard

Note: The document only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device, [and] The test results demonstrated that the proposed device complies with the following standards." It does not provide specific numerical performance metrics for the device against each standard's criteria, but rather a blanket statement of compliance.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "non clinical tests" but does not detail the number of units tested for each standard.
Data Provenance: The manufacturing company is Jiangyin Caina Technology Co., Ltd. in Jiangsu, China, and the submission correspondent is also based in Shanghai, China. The testing was conducted by the manufacturer, or a facility contracted by them. The data is retrospective in the sense that the tests were performed on finished products.

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

This section is not applicable to this type of device and submission. This document pertains to the regulatory clearance of basic medical devices (syringes and needles) based on engineering performance and biocompatibility standards, not on expert interpretation of complex diagnostic data. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this product.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data (e.g., medical images) and their decisions need to be reconciled to establish a ground truth. For this submission, the "ground truth" is defined by compliance with established international performance and safety standards, as measured by objective tests.

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

This section is not applicable. This submission is for a physical medical product (syringes and needles), not an AI-powered diagnostic device or software. Therefore, there are no human readers or AI assistance involved in its intended use or evaluation.

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

This section is not applicable. As mentioned above, this is not an AI algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is compliance with established performance and safety standards (ISO standards) for sterile hypodermic syringes, needles, and their components, as well as biocompatibility standards. The standards themselves define the acceptable parameters for mechanical performance, material properties, sterility, and safety.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of a physical medical device like a syringe and needle. Training sets are relevant for machine learning algorithms.

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

This section is not applicable for the same reason as point 8.

Summary

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Premarket Notification 510(k) Submission

JUL 2 5 2014

Exhibit #3 510(k) Summary

This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

K141359 The assigned 510(k) Number:

Date the summary was prepared: April 5, 2014

Sponsor Identification 2.

Jiangyin Caina Technology Co., Ltd. No.2, Taifu Road. Huashi Town, Jiangyin. Jiangsu, 214421. China

Establishment Registration Number: 3005670221

Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamedical.com

3. Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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Proposed Device Identification 4.

Proposed Device Name: Hard pack syringe Proposed Device Common Name: Syringe with or without needle

Regulatory Information: Classification Name: Piston Syringe; Classification: II; Product Code: FMF; Additional Product Code: FMI; Regulation Number: 21CFR 880.5860 Review Panel: General Hospital:

Indications for Use:

Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.

Needles are intended to be used with a legally marketed syringe intended to inject fluids into or withdraw fluids from the body.

1. Predicate Device Identification
  510(k) Number: K113091 Product Name: Syringes with or without needles: Needles Manufacturer: Jiangyin Caina Technology Co., Ltd.
Device Description 6.
The proposed devices contain syringes and needles with various models. All the models for syringes and needles follow same design principle respectively; the differences are the size of the devices. The proposed devices are intended to inject fluids into or withdraw fluids from the body.

The proposed devices would be available in two different configurations: Syringe with needle and Syringe without needle.

Proposed devices are provided radiation (Co60) sterilized with a hard pack package which could maintain the sterility of the devices for five years. They are for single use only.

1. Non-Clinical Test Conclusion
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Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, The test results demonstrated that the proposed device complies with the following standards:

A ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use;
A ISO 7864:1993 Sterile hypodermic needles for single use.
产 ISO 9626:1991, AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices.
/A ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements;
A ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.
A ISO11137-2:2012, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
1. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Devices	Predicate Devices
		K113091
Product Code	FMF& FMI;	FMF& FMI;
Regulation Number	21CFR 880.5860 & 21 CFR 880.5570	21CFR 880.5860 & 21 CFR 880.5570
Intended Use	Syringes with or without needle areintended to inject fluids into or withdrawfluids from the body.Needles are intended to be used with alegally marketed syringe intended toinject fluids into or withdraw fluids fromthe body.	Syringes with or without needle areintended to inject fluids into orwithdraw fluids from the body.Needles are intended to be used with alegally marketed syringe intended toinject fluids into or withdraw fluidsfrom the body.
Component	Syringes and Needles	Same
Sterile	Yes	Same
Single Use	Yes	Same
Shelf Life	Five year	Same
Biocompatibility	ISO 10993:5 StandardISO 10993:10 Standard	Same

Table 3-1 Comparison of Technology Characteristics

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Performance	ISO 7864 StandardISO 7886 StandardISO 9626 StandardISO 594-1 StandardSIO 594-2 Standard	Same
Immediate Package	Hard pack package	Soft package

The proposed devices, Hard pack syringe, are determined to be Substantially Equivalent (SE) to the predicate devices. Syringes and needles (K113091). in respect of safety and effectiveness.

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Image /page/4/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name around the perimeter, reading "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". In the center is a stylized emblem of an eagle with three lines representing its body and wings.

Public Health Service

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

July 25. 2014

Jiangyin Caina Technology Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited Post Office Box 120-119 Shanghai CHINA 200120

Re: K141359

Trade/Device Name: Hard pack syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 23, 2014 Received: June 30, 2014

Dear Ms. Hong:

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 docs 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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Page 2 - Ms. Hong

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 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/ResourcesforYou/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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin I. Keith, M.S. 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141359

Device Name Hard pack svringe

Indications for Use (Describe)

Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.

Necdles are intended to be used with a legally marketed syrings intended to injoct fluids into or withdraw fluids from the body.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed byRichard C. Chapman -S
Date: 2014.07.25
08:45:03 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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).