The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The sterile insulin syringe for single use with needle, with the calibration unit of U-40, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Description

The proposed devices are Sterile Hypodermic Syringe for single use with/without Needle, Sterile Insulin Syringe for single use with Needle, and Sterile Hypodermic Needle for single use. The hypodermic syringes are available in Luer slip and Luer lock nozzles with volumes from 1ml to 50ml, made of PP, and can be with or without a needle. The insulin syringes have a fixed needle, are available in 0.3ml, 0.5ml, and 1ml volumes, made of PP, and come with a fixed needle. The hypodermic needles are available in Luer slip and Luer lock nozzles with gauges from 18G to 30G, made of Stainless Steel.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the medical devices, based on the provided text:

Important Note: The provided text is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed, standalone clinical study with strict acceptance criteria for a novel AI device. Therefore, the information related to AI-specific elements (like MRMC studies, human reader improvement with AI, standalone algorithm performance, training set details) is not present in this document. The "device" in this context refers to physical medical devices (syringes and needles), not an AI algorithm.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are defined by compliance with established international standards. The study demonstrates that the proposed devices comply with these standards, thereby meeting the acceptance criteria.

Device Category	Acceptance Criteria (Relevant Standards)	Reported Device Performance
Sterile Hypodermic Syringe for single use (with/without needle)	- ISO 7886-1:1993 (Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use) - ISO 594:1986 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements) - ISO 594:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings)	Device complies with these standards, demonstrating it meets design specifications and is substantially equivalent to predicate devices.
Sterile Insulin Syringe for single use (with needle)	- ISO 8537:2007 (Sterile single-use syringes, with or without needle, for insulin) - ISO 594:1986 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements) - ISO 594:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings)	Device complies with these standards, demonstrating it meets design specifications and is substantially equivalent to predicate devices.
Sterile Hypodermic Needle for single use	- ISO 7864:1993 (Sterile hypodermic needles for single use) - ISO 9626:1991 / Amendment: 2001 (Stainless steel needle tubing for the manufacture of medical devices) - ISO 594:1986 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements) - ISO 594:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings)	Device complies with these standards, demonstrating it meets design specifications and is substantially equivalent to predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- The document states that "Bench tests were conducted." It does not specify the sample size for these bench tests.
- Data Provenance: Not explicitly stated, but the manufacturer is based in Shanghai, China, and the standards are international (ISO), suggesting tests were conducted to meet these international standards. The nature of bench tests implies controlled laboratory conditions rather than patient data from a specific country. The study is non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a non-clinical bench testing for physical medical devices against engineering standards, not a study requiring expert clinical ground truth for an AI algorithm.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for non-clinical bench testing against engineering standards. Compliance is typically determined by measurement against the specified limits within the standard.
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:
- No. This is a 510(k) submission for physical medical devices (syringes and needles), not an AI-powered device. Therefore, no MRMC study or AI assistance evaluation was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm. The device is a physical medical instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is defined by the technical specifications and performance requirements outlined in the referenced ISO standards (e.g., specific force required to activate a plunger, leakage rates, needle sharpness, etc.).
The sample size for the training set:
- Not applicable. This is a physical non-AI device.
How the ground truth for the training set was established:
- Not applicable. This is a physical non-AI device.

Summary

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DEC 1 4 2011

Premarket Notification 510(k) Submission

Exhibit #2 510(k) Summary

Project #:M0102011Ab

Exhibit #2510(k) Summary

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

The assigned 510(k) Number: K112057

】. Date of Preparation: 18 NOV 2011
1. Sponsor

Shanghai Kindly Enterprise Development Group Co., Ltd. No. 18 Lanc 668 Huajiang Road, Jiading Shanghai, 201803. China Establishment Registration Number: 3005405146 Contact Person: Cailiang Wang Position: General Manager Tel: +86-21-59140045 Fax: +86-21-59118500-78 Email: wangcl@kdIchina.net

Submission Correspondent 3. Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
Proposed Device Identification 4.
- Proposed Device Name: Sterile Hypodermic Syringe for single use, with/without needle a. Proposed Device Model: Lucr slip (1, 2, 3, 5, 10, 20, 30, 35, 50 (ml)) and Luer lock (1, 2, 3, 5, 10. 20. 30. 35, 50 (ml)) Classification: II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital Intended Use Statement: The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

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b. Proposed Device Name: Sterile Insulin Syringe for single use, with needle Proposed Device Model: Fixed needle (0.3, 0.5, 1 (ml)) Classification: II
Product Code: FMF

Regulation Number: 21 CFR 880.5860

Review Panel: General Hospital
Intended Use Statement:

Proposed Device Name: Sterile Hypodermic Needle for single use ن
Proposed Device Model: Luer slip and Luer lock (18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G) Classification: 11 Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital Intended Use Statement: The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration
Predicate Device Identification 5.
- 510(k) Number: K070936 a. Product Name: Welmed Hypodermic Syringe (various sizes) Manufacturer: Welmed Inc.
- b. 510(k) Number: K072739. Product Name: Sterile Hypodermic Syringe for Single Use, without Needle Manufacturer: Shandong Weigao Group Medical Polymer Products Co., Ltd.
- 510(k) Number: K110421 C. Product Name: Disposable Insulin Syringe Manufacturer: Wenzhou Wuzhou Import & Export Co., Ltd.
- 510(k) Number: K070440 d. Product Name: BD Hypoint Manufacturer: BD Medical-Pharmaceutical Systems

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Exhibit #2 510(k) Summary

Premarket Notification 510(k) Submission

Project #:M0102011Ab

6. Device Description

Device Name	Device DescriptionIntended Use	Nozzle	Volume	Material	Remark
Sterile HypodermicSyringe for singleuse with/withoutNeedle	The Sterile Hypodermic Syringe for SingleUse with/without Needle is intended to beused for medical purposes to inject fluid intoor withdraw fluid from body.	Luer SlipLuer Lock	1,2,3,5,10,20,30,35,50(ml)	PP	With or Without Needle
Sterile InsulinSyringe for singleuse with Needle	The sterile Insulin Syringe for single use withneedle is a device intended for medicalpurposes for the manual aspiration of insulin,and for the injection of insulin into parts ofthe body below the surface skin.	Fixed Needle	0.3,0.5,1(ml)	PP	With Fixed Needle
Sterile HypodermicNeedle for single use	The Sterile Hypodermic Needle for single useis intended for use with syringes andinjection devices for general purpose fluidinjection/aspiration	Luer SlipLuer Lock	18G, 19G, 20G, 21G, 22G, 23G,24G, 25G, 26G, 27G, 28G, 29G, 30G	Stainless Steel	....

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・

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1. Summary Comparing the Technological Characteristics
  The proposed devices and predicate devices have the same classification information, intended use, principle of operation, performance, biocompatibility, materials, and sterilizations. Both the proposed devices and predicate devices meet the reguirements of ISO 10993, ISO 7886-1, ISO 8537, ISO 7864 and ISO 9626. Although there is some difference in syringe volumes and syringe nozzle, such difference will not affect the safety and effectiveness of the proposed devices. So the proposed devices are substantially equivalent to the predicate devices through the comparisons between the proposed devices and predicate devices.
1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed devices met all design specifications as were Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed devices comply with the following standards:
For Sterile Hypodermic Syringe for single use, with/without needle a.
ISO 7886-1:1993 Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use; ISO 594:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements

ISO 594:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings

For Sterile Insulin Syringe for single use, with needle b.
ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin; ISO 594:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements ISO 594:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings
For Sterile Hypodermic Needle for single use C.
ISO 7864:1993 Sterile hypodermic needles for single use;

ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices/Amendment: 2001

ISO 594:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements

ISO 594:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings

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9. Substantially Equivalent Conclusion

The proposed device. Sterile Hypodermic Syringe for single use, with needle, is determined to be Substantially Equivalent (SE) to the predicate device, Welmed Hypodermic Syringe (various sizes), K070936, in respect of safety and effectiveness.

The proposed device, Sterile Hypodermic Syringe for single use, without needle, is determined to be Substantially Equivalent (SE) to the predicate device, Sterile Hypodermic Syringe for Single Use, without Needle, K072739, in respect of safety and effectiveness.

The proposed device, Sterile Insulin Syringe for single use with needle, is determined to be Substantially Equivalent (SE) to the predicate device, Disposable Insulin Syringe, K110421, in respect of safety and effectiveness.

The proposed device, Sterile Hypodermic Needle for single use, is determined to be Substantially Equivalent (SE) to the predicate device. BD Hypoint, K070040, in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters. The text is arranged to follow the curve of the circle.

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

Shanghai Kindly Enterprise Division Group Company C/O Ms. Diane Hong MID-Link Consulting Company Limited P.O. Box 237-023 Shanghai China 200237

DEC 1 4 2011

Re: K112057

Trade/Device Name: Sterile Hypodermic Syringe for Single use with/ without Needle, Sterile Hypodermic Needle for Single use, Sterile Insulin Syringe for Single use with Needle (U-40), Sterile Insulin Syringe for Use with Needle (U-100) Regulation Number: 12 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: November 18, 2011 Received: November 29, 2011

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 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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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 clectronic 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/CDRH/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 vours.

Anthony V. Nun

Anthony D. Watson, B.S., M.S., M.B.A. Division 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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Exhibit #1 Indications for Use Statement

510(k) Number: K112057

Device Name: Sterile Hypodermic Syringe for Single Use with/without Needle

Indications for Use:

The sterile hypodermic syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

OPRESCRIPTION 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 ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of 4

Rill C. Ch 12/09/11

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112057

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Indications for Use Statement

510(k) Number: K112057

Device Name: Sterile Insulin Syringe for Single Use with Needle (U-100)

Indications for Use:

□PRESCRIPTION USE (Part 21 CFR 801 Subpart D) ZOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 4

Al C. Ch (2/14/11

ivision Sign-Off) islon of Anesthesiology, General Hospital ection Control, Dental Devices

510(k) Number: K112057

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Indications for Use Statement

510(k) Number: Ki112057 Device Name: Sterile Insulin Syringe for Single Use with Needle (U-40)

Indications for Use:

The sterile insulin syringe for single use with needle, with the callbration unit of U-40, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

[ PRESCRIPTION USE (Part 21 CFR 801 Subpart D) ZOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER I'AGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 4

Riff C. Chaym 12/14/11
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

112057

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Indications for Use Statement

510(k) Number: K112057 Device Name: Sterile Hypodermic Needle for Single Use

Indications for Use:

The sterile hypodermic needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

図PRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) '

Page 3 of 4

Rill C. Chape 12/14/11

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112057

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).