Sterile Syringes for Single Use are sterile, single-use, disposal, without needle and manually operated syringes intended to use with a 6% conical fitting device for injection of drug into the body. The syringes are intended for use immediately after filling and are not intended to contain the fluid/medication for extended periods of time.

Device Description

KDL Sterile Syringes for Single Use are composed of barrel, plunger, and a moveable piston. The plunger does not contact any part of the fluid path, rather the plunger which attaches to the piston and the barrel are fluid path components. Materials of construction for the components have been shown to meet the applicable requirements of ISO 10993-1. Additionally, there is a small amount of lubricant for moving the plunger smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals. The Sterile Syringes for Single Use have different specifications, include 1ml, 3ml, 10ml, 20ml and 30ml.

AI/ML Overview

The provided text is a 510(k) summary for the "Sterile Syringes for Single Use". This document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes compliance with recognized international standards (ISO and ASTM) and specific tests conducted. The "Performance" column in the table below represents the device's conformance to these standards and the completion of the described tests.

Acceptance Criteria (as implied by standards and tests conducted)	Reported Device Performance (Conformance/Results)
Conformance to ISO 7886-1:2017 (Sterile hypodermic syringes for manual use)	Confirmed conformance to ISO 7886-1:2017
Conformance to ISO 80369-7:2016 (Small-bore connectors for intravascular/hypodermic applications)	Confirmed conformance to ISO 80369-7:2016
Biocompatibility (ISO 10993-1 and FDA Guidance)	Conformance demonstrated for:
- Cytotoxicity	Tested and conformed
- Sensitization	Tested and conformed
- Irritation	Tested and conformed
- Acute Systemic Toxicity	Tested and conformed
- Material-Mediated Pyrogenicity	Tested and conformed
- Hemolysis	Tested and conformed
Particulate Testing (USP <788>)	Tested and conformed
Sterilization (ISO 11135)	Evaluated for sterility using ISO 11135
Packaging Integrity (ASTM F88/F88M-15 & ASTM F1929-15)	Tested using ASTM F88/F88M-15 and ASTM F1929-15 (Seal Strength, Dye Penetration)
Simulated Shipping (ISTA 3A:2018)	Tested using ISTA 3A:2018
Shelf-life (5 years)	Validated using ASTM F1980-16 for 5 years

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the performance tests. It only states that the device was "tested" and "evaluated."

Regarding data provenance: The testing appears to be conducted by the manufacturer, Shanghai Kindly Enterprise Development Group Co., Ltd. within China, or by a testing facility on their behalf. The studies are prospective as they are conducted specifically to support this regulatory submission for the proposed device (non-clinical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this device and the type of studies conducted. The device is a sterile syringe, and the studies are primarily non-clinical performance and biocompatibility tests against established international standards. "Ground truth" in the context of expert consensus (like in AI/medical imaging studies) is not relevant here. The "ground truth" is defined by the technical specifications and performance requirements of the ISO and ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers interpreting results, especially in complex diagnostic scenarios or AI performance evaluation. The studies for this device are non-clinical, laboratory-based performance tests against standards.

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 is not applicable. The device is a disposable, manually operated syringe, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted or warranted.

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

This is not applicable. The device is a physical medical device (syringe), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests is based on established international standards and validated testing methodologies described within those standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series, USP <788>, ISO 11135, ASTM F88/F88M-15, ASTM F1929-15, ISTA 3A:2018, ASTM F1980-16). These standards define acceptable performance limits and test procedures.

8. The sample size for the training set

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or deep learning algorithms.

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

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

Summary

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February 9, 2023

Shanghai Kindly Enterprise Development Group Co., Ltd. Amv Li Technology Director No. 658 Gaochao Road Shanghai, Shanghai 201803 China

Re: K223678

Trade/Device Name: Sterile Syringes for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 05, 2022 Received: December 8, 2022

Dear Amy Li:

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.

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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 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.

Courtney	Digitally signed byCourtney Evans -S
Evans -S	Date: 2023.02.0911:34:59-05'00'

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

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Indications for Use

510(k) Number (if known) K223678

Device Name Sterile Syringes for Single Use

Indications for Use (Describe)

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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K223678- 510(K) Summary

1. Date of preparation: February 9, 2023
1. Sponsor Identification

Shanghai Kindly Enterprise Development Group Co., Ltd. 658 Gaochao Road, Shanghai, 201803, China

Contact Person: Hualong Liu Position: Technology Director Tel: +86 02169118232 Email: henry_liu@kdIchina.net

1. Designated submission correspondent
  Ms.Amy Lee(Primary Contact Person) Mind-Link Consulting Co., Ltd. Tel: +86 15721449974 Email: amy.li@mind-link.net
1. Identification of Proposed Device
  Trade Name: Sterile Syringes for Single use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General hospital
1. Indication for use
  Sterile Syringes for Single Use are sterile, single-use, disposal, without needle and manually operated syringes intended to use with a 6% conical fitting device for injection of drug into the body. The syringes are intended for use immediately after filling and are not intended to contain the fluid/medication for extended periods of time.
1. Device description

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The Sterile Syringes for Single Use have different specifications, include1ml, 3ml, 10ml, 20ml and 30ml.

1. Identification of predicate device
  510(k) Number: K103736 Product name: DMC Medical Single-use Polycarbonate Syringe

7.1 Technological Comparison Table with the predicate

Items	Proposed device	Predicate device	Comment
Indications for Use	Sterile Syringes for SingleUse are sterile, single-use,disposal, without needleand manually operatedsyringes intended to usewith a 6% conical fittingdevice for injection of druginto the body. Thesyringes are intended foruse immediately afterfilling and are not intendedto contain thefluid/medication forextended periods of time.	DMC Medical piston typesyringes are single usesyringes, intended forinjecting fluids into orwithdrawing fluids from thebody.K103736	SimilarPlease seeComment 1
Description of SubmittedDevice	Sterile syringes for singleuse are composed of barrel,plunger, and a moveablepiston. The plunger does	DMC Medical Sing-UsePolycarbonate Syringe isoffered in the sameconfigurations as the	Same

	not contact any part of thefluid path, rather the plungerwhich attaches to the pistonand the barrel are fluid pathcomponents. Individualcomponents are made fromproperly tested materialsincluded in this submission.Additionally, there is a smallamount of lubricant formoving the plungersmoothly along the insidesurface of barrel. Theconnector is a universal luerthreaded style connector.The device is used ingeneral medicine in clinical,hospital, or other settings ofhealthcare professionals.	predicate. It is made from acalibrated hollow barrel,and a moveable piston witha plunger tip at the end ofthe piston. The piston shaftdoes not contact any part ofthe fluid path, rather the tipwhich attaches to the shaftand the barrel are fluid pathcomponents. Individualcomponents are made fromproperly tested materialsincluded in this submission.Additionally, there is a smallamount of lubricant formoving the piston shaftsmoothly along the insidesurface of barrel. Theconnector is a universal luerthreaded style connector.The device is used ingeneral medicine in clinical,hospital, or other settings ofhealthcare professionals.
			510(k)
Component and Materials:			Same
Syringe Barrel	Polycarbonate	Polycarbonate
Plunger tip	Polyisoprene rubber	Polyisoprene
Silicone Oil	Medical Grade Oil(DC 360)	Medical Grade Oil
Calibrated Barrel Volume	YES	YES
Sterilization method	EtO	EtO
510(k) Approval	This submission	K103736
Principle of Operation	Sterile Syringes for SingleUse, the user connects thesyringe via the threadedluer, then manuallyadvancing or withdrawingthe plunger internal to thebarrel, is able to express orwithdraw fluids. Fluids aremeasured via the printedexternal scale of the barrel;measurements areindicated in ml(milliliters)	The user connects thesyringe via the threadedluer, then manuallyadvancing or withdrawingthe plunger internal to thebarrel, is able to express orwithdraw fluids. Fluids aremeasured via the printedexternal housing of thebarrel; measurements areindicated in ml(milliliters).operation is similar for most	Same
		all piston syringes whetherfitted with a threaded luer ora slip-fit only end.


Safety and Performances	Conforms to ISO7886-1:2017.SAL:10-6Complies with:ISO 10993-1: Evaluationand Testing;Part 4: Selection of tests forinteractions with blood;Part 5: Tests for in vitrocytotoxicity;Part 7: Ethylene oxidesterilization residuals;Part 10: Tests for irritationand delayed typehypersensitivity;Part 11: Tests for systemictoxicity, tests for Bacterialendotoxins, Tests forPyrogenicityAnd Conforms to USP<788>:Particulate Matter forinjectionNo re-use	DMC Medical syringesconform to therequirements of ISO7886-1, an FDA recognizedstandard. Additionally, theSterility Assurance Level,(SAL) has been establishedto meet the 10-6 level. Thesingle use syringes arepackaged in a way as toensure conformity with ISO10993-1, includingminimizing residual gasesas well as discouragere-use.	SimilarPlease seecomment 2.
Length (mm)	1ml: 86.6±0.53ml: 80.85±0.55ml: 83.5±0.510ml: 88.45±0.520ml: 96.4±0.530ml: 106.8±0.5	Not Clear.	DifferencePlease seecomment 3.
Diameter(mm)	1ml:OD:9.45±0.1ID: 4.7±0.13ml:OD:11.7±0.1ID: 9.13±0.15ml:OD: 15.5±0.1ID:12.83±0.110ml:OD: 19.45±0.1	Not Clear.	DifferencePlease seecomment 4.

	ID: 16.45±0.1
	20ml:
	OD: 22.9±0.1
	ID: 19.9±0.1
	30ml:
	OD: 26.2±0.1
	ID: 23.7±0.1
Size of Syringes(ml)	1, 3, 5, 10, 20, 30	Not Clear.	DifferencePlease seecomment 5.
Luer Lock	ISO 80369-7	ISO 594-2	DifferencePlease seecomment 6.
Prescription (Rx) orover the counter	Prescription	Prescription	Same

Table 3-1 Technological Comparison Table

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510(K)

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SE Comment 1: Indications for Use

The proposed device and the predicate device have same indication, that is, they are both intended for injecting fluid into body. But, the predicate device(K103736) has an additional indication, intended for withdrawing fluid from body The proposed device doesn't have this indication. However, the operation principle is same to achieve the indication. Therefore, the difference will not raise new questions on safety and effectiveness of the proposed device and substantially equivalence to the predicate.

SE Comment 2: Safety and Perform

The proposed device and the predicate device have the same test standard for ISO 7886-1 and ISO 10993-serious. But, the proposed device has different models and has added <USP 788> testing. However, all models are tested in accordance with ISO 7886-1 and USP <788> is required for the injection particles to ensure the safe clinical application. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate devices.

SE Comment 3: Length

The proposed device and the predicate device have similar components (Barrel, Plunger, Plunger Stopper) and all comply with ISO 7886-1. However, the differences in dimensions between the proposed device and the predicate are not known. However, dimensional differences do not raise new or different questions of safety and effectiveness. In addition, all barrel lengths and other dimensions have been shown to comply with ISO 7886-1.

SE Comment 4: Diameter

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SE Comment 5: Size of Syringes

SE Comment 6: Luer Lock

The proposed device and the predicate device have similar components (Barrel, Plunger, Plunger Stopper) and all comply with ISO 7886-1 However, the differences in test standard for Luer Lock between the proposed device and the predicate are different, the predicated device have finished 510(K) in 2010 and the Luer lock have been tested in accordance with ISO 594-2, but ISO 594-2 was replaced by ISO 80369-7. However, standard number difference does not raise new or different questions of safety and effectiveness.

1. Non-clinical test conclusion
  A. Performance testing was validated using the following Standard:
ISO 7886-1:2017 Sterile hypodermic syringes for single use Part 1: Syringes for manual use A
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -A Part 7 : Connectors for intravascular or hypodermic applications.

B. Biocompatibility

The device described in this summary the Sterile Syringe for Single Use were tested and demonstrated to be in conformance to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1 "Biological evaluation of Medical Devices -Part 1 : Evaluation and Testing within a risk management process". The proposed device is external communicating, blood path indirect, limited <24hr contact duration.

. Cytotoxicity
. Sensitization
Irritation
. Acute Systemic Toxicity
Material-Mediated Pyrogenicity .
Hemolysis ●

Particulate Testing using USP <788> Particulate Matter in Injection

C. Sterilization, Shipping, Shelf-life

The proposed device was evaluated for sterility using ISO 11135-Sterilization of healthcare products- Ethylene Oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices

Packaging Integrity Testing ASTM F88/F88M-15 and ASTM F1929-15
- o Seal Strength ASTM F00-09
- Dye Penetration- ASTM F1929
Simulated Shipping- ISTA 3A:2018

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Shelf-life of 5 years validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
1. Clinical test conclusion

No clinical study is included in this submission.

1. Conclusion
  The conclusion drawn from the nonclinical tests demonstrates that the subject device, Sterile Syringes for Single Use are as safe, as effective, and are therefore substantially equivalentto the legally marketed predicate device DMC Medical Single-use Polycarbonate Syringe(K103736).

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).