K Number

Device Name

1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle

Manufacturer

Jiangsu Caina Medical Co., Ltd.

Date Cleared

2020-08-10

(328 days)

Product Code

MEG FMF FMI

Regulation Number

880.5860

Intended Use

1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

Device Description

The proposed Syringes include 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle. Each of the 1ml Luer Slip or Luer Lock Syringe, Safety Syringe with permanently attached needle. have one kind of product configuration, and the Syringe with permanently attached needle has two kinds of product configurations (Type A and Type B). The proposed syringes are available in different combination of syringe volumes and/or needle sizes (refer to Table 1). The proposed Syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K170651, K132681

Reference Devices

K150758

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for standard syringes and safety syringes, which are mechanical devices and do not involve AI or ML. The performance studies focus on physical and material properties and compliance with relevant standards for syringes.

Therapeutic

Yes
The device is described as a syringe intended for general purpose aspiration of fluid and liquid injection below the surface of the skin, which constitutes a medical intervention.

Diagnostic

No
The primary intended use of the device is for aspiration of fluid and liquid injection, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components such as syringes, needles, and safety sheaths, and the testing performed relates to the physical properties and sterility of these hardware components. There is no mention of software as part of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states the device is for "general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin." This describes a device used for administering substances into or withdrawing substances from the body, which is an in vivo application.
Device Description: The description details syringes and needles, which are instruments for in vivo procedures.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes.

IVDs are devices used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor medical conditions. This device is for direct use on a patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

Product codes

FMF, MEG

Device Description

The proposed Syringes include 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle.

Each of the 1ml Luer Slip or Luer Lock Syringe, Safety Syringe with permanently attached needle. have one kind of product configuration, and the Syringe with permanently attached needle has two kinds of product configurations (Type A and Type B).

The proposed syringes are available in different combination of syringe volumes and/or needle sizes (refer to Table 1).

The proposed Syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 ° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care professionals

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)

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 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications.
A ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods.
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices.
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
USP 41-NF36:2018 Bacterial Endotoxin Limit
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ISO 23908: 2011 Sharps injury protection - Requirements and test methods -Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff

Biocompatibility testing:
The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (

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).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 10, 2020

Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn

Re: K192551

Trade/Device Name: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF. MEG Dated: June 24, 2020 Received: July 13, 2020

Dear Diana 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K192551

Device Name

1ml Luer Slip or Luer Lock Syringe Syringe with permanently attached needle Safety Syringe with permanently attached needle

Indications for Use (Describe)

1ml Luer Slip or Luer Lock Syringe

Syringe with permanently attached needle

The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

Safety Syringe with permanently attached needle

as annlicahle)

The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Exhibit #3 510(k) Summary

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

The assigned 510(k) Number:____K192551

1. Date of Preparation: 08/06/2020
1. Sponsor Identification

Jiangsu Caina Medical Co., Ltd.

No.23, Huanxi Road, Zhutang Town, Jiangyin City, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

Contact Person: Jianwei Pan Position: Management Representative Tel: +86-0510-8686 6666-8027 Fax: +86-0510-8686 6666-8009 Email: jianwei.pan@cainamed.com

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

Identification of Proposed Device 4.

Trade Name: 1ml Luer Slip or Luer Lock Syringe Syringe with permanently attached needle Safety Syringe with permanently attached needle Common Name: Piston Syringe and antistick syringe

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

Indications for Use:

1ml Luer Slip or Luer Lock Syringe

Syringe with permanently attached needle

Safety Syringe with permanently attached needle

The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

Device Description

The proposed Syringes include 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle.

The proposed syringes are available in different combination of syringe volumes and/or needle sizes

(refer to Table 1).

Model	Needle length (mm)	Needle gauge	Needle wall type	Needle bevel	Syringe size/volume
1ml Luer Slip or Luer Lock Syring	NA	NA	NA	NA	1ml
Syringe with permanently attached needle-type B	20, 25	21G	RW, TW	11°±2°, 15°±2°	1ml
	20, 25	23G	RW, TW	11°±2°, 15°±2°
Syringe with permanently attached needle-type A	8,10,13,16	29G	RW, TW	11°±2°, 15°±2°	0.3ml
	8,10,13,16	30G	RW, TW	11°±2°, 15°±2°
	8,10,13,16	31G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	25G	RW, TW	11°±2°, 15°±2°	0.5ml
	10, 13, 16	26G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	27G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	28G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	29G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	30G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	31G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	25G	RW, TW	11°±2°, 15°±2°	1ml
	10, 13, 16	26G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	27G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	28G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	29G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	30G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	31G	RW, TW	11°±2°, 15°±2°
Safety Syringe with permanently attached needle	8,10,13,16	29G	RW, TW	11°±2°, 15°±2°	0.3ml
	8,10,13,16	30G	RW, TW	11°±2°, 15°±2°
	8,10,13,16	31G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	25G	RW, TW	11°±2°, 15°±2°	0.5ml
	10, 13, 16	26G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	27G	RW, TW	11°±2°, 15°±2°
	10, 13, 16	28G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	29G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	30G	RW, TW	11°±2°, 15°±2°
	8, 10, 13, 16	31G	RW, TW	11°±2°, 15°±2°
10, 13, 16	25G	RW, TW	11°±2°, 15°±2°	1ml
10, 13, 16	26G	RW, TW	11°±2°, 15°±2°
10, 13, 16	27G	RW, TW	11°±2°, 15°±2°
10, 13, 16	28G	RW, TW	11°±2°, 15°±2°
8, 10, 13, 16	29G	RW, TW	11°±2°, 15°±2°
8, 10, 13, 16	30G	RW, TW	11°±2°, 15°±2°
8, 10, 13, 16	31G	RW, TW	11°±2°, 15°±2°

Table 1 specification of proposed device

ડ. Identification of Predicate Devices

5.1 Predicate device 1
510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe with Needle Sterile Disposable Syringe (used as predicate device) Sterile Disposable Safety Needle Sterile Disposable Needle Manufacturer: Yangzhou Medline Industry Co., Ltd.
5.2 Predicate device 2
510(k) Number: K132681 Product Name: Sol-Guard Insulin Safety Syringe and Tuberculin Safety Syringe Manufacturer: Sol-Millennium Medical, Inc.

Identification of Reference Devices 6.

510(k) Number: K150758 Product Name: Safelock Disposable Insulin Syringe Manufacturer: Jiangsu Caina Medical Co., Ltd.

Indication for Use:

Safelock disposable insulin syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.

The safety shield of the proposed syringes is the same as that of the legally marketed device, Safety Insulin Syringe (Safelock Disposable Insulin Syringe), as cleared in K150758, which is also

manufactured by Jiangsu Caina Medical Co., Ltd

7. Non-Clinical Test Conclusion

A ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications.
A ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods.
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices.
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
USP 41-NF36:2018 Bacterial Endotoxin Limit
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ISO 23908: 2011 Sharps injury protection - Requirements and test methods -Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff

Biocompatibility testing

The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (