Sterile Syringes for Single Use

• K Number: K223678
• Device Name: Sterile Syringes for Single Use
• Manufacturer: Shanghai Kindly Enterprise Development Group Co., Ltd.
• Date Cleared: 2023-02-09 ( 63 days)
• Product Code: FMF
• Regulation Number: 880.5860

Intended 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.

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.

Predicate Devices

K103736

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML capabilities.

Therapeutic

No
The device is a syringe intended for injecting drugs into the body, which is a delivery mechanism, not a treatment itself.

Diagnostic

No

An injection syringe is used for administering substances into the body, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (barrel, plunger, piston, connector) and materials of construction, indicating it is a hardware device. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is for the "injection of drug into the body." This describes a device used for administering substances to the body, not for testing samples from the body to diagnose conditions.
• Device Description: The description details the physical components of a syringe (barrel, plunger, piston) and its function in delivering fluid. This aligns with a medical device for administration, not a diagnostic test.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This syringe's function is purely for delivering medication.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

FMF

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, include1ml, 3ml, 10ml, 20ml and 30ml.

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

general medicine in clinical, hospital, or other settings of healthcare 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 test conclusion based on the following standards:

• ISO 7886-1:2017 Sterile hypodermic syringes for single use Part 1: Syringes for manual use
• ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7 : Connectors for intravascular or hypodermic applications.
• Biocompatibility testing 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". Tests included: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemolysis, and Particulate Testing using USP Particulate Matter in Injection.
• Sterilization, Shipping, Shelf-life: evaluated for sterility using ISO 11135, Packaging Integrity Testing (ASTM F88/F88M-15 and ASTM F1929-15), Seal Strength (ASTM F00-09), Dye Penetration (ASTM F1929), Simulated Shipping (ISTA 3A:2018), and Shelf-life of 5 years validated using ASTM F1980-16.

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K103736

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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

0

Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

1

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

| Courtney | Digitally signed by
Courtney Evans -S | |
|----------|------------------------------------------|--|
| Evans -S | Date: 2023.02.09
11:34:59-05'00' | |

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

2

Indications for Use

510(k) Number (if known) K223678

Device Name Sterile Syringes for Single Use

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

3

K223678- 510(K) Summary

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

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

Contact Person: Hualong Liu Position: Technology Director Tel: [phone] Email: [e-mail]

• 3. Designated submission correspondent
     Ms.Amy Lee(Primary Contact Person) Mind-Link Consulting Co., Ltd. Tel: [phone] Email: [e-mail]
• 4. 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
• 5. 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.
• 6. Device description

4

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, include1ml, 3ml, 10ml, 20ml and 30ml.

• 7. 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 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.	DMC Medical piston type
syringes are single use
syringes, intended for
injecting fluids into or
withdrawing fluids from the
body.
K103736	Similar
Please see
Comment 1
Description of Submitted
Device	Sterile syringes for single
use are composed of barrel,
plunger, and a moveable
piston. The plunger does	DMC Medical Sing-Use
Polycarbonate Syringe is
offered in the same
configurations as the	Same
	not contact any part of the
fluid path, rather the plunger
which attaches to the piston
and the barrel are fluid path
components. Individual
components are made from
properly tested materials
included in this submission.
Additionally, there is a small
amount of lubricant for
moving the plunger
smoothly along the inside
surface of 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.	predicate. It is made from a
calibrated hollow barrel,
and a moveable piston with
a plunger tip at the end of
the piston. The piston shaft
does not contact any part of
the fluid path, rather the tip
which attaches to the shaft
and the barrel are fluid path
components. Individual
components are made from
properly tested materials
included in this submission.
Additionally, there is a small
amount of lubricant for
moving the piston shaft
smoothly along the inside
surface of 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.
			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 Single
Use, the user connects the
syringe via the threaded
luer, then manually
advancing or withdrawing
the plunger internal to the
barrel, is able to express or
withdraw fluids. Fluids are
measured via the printed
external scale of the barrel;
measurements are
indicated in ml(milliliters)	The user connects the
syringe via the threaded
luer, then manually
advancing or withdrawing
the plunger internal to the
barrel, is able to express or
withdraw fluids. Fluids are
measured via the printed
external housing of the
barrel; measurements are
indicated in ml(milliliters).
operation is similar for most	Same
		all piston syringes whether
fitted with a threaded luer or
a slip-fit only end.
Safety and Performances	Conforms to ISO
7886-1:2017.
SAL:10-6
Complies with:
ISO 10993-1: Evaluation
and Testing;
Part 4: Selection of tests for
interactions with blood;
Part 5: Tests for in vitro
cytotoxicity;
Part 7: Ethylene oxide
sterilization residuals;
Part 10: Tests for irritation
and delayed type
hypersensitivity;
Part 11: Tests for systemic
toxicity, tests for Bacterial
endotoxins, Tests for
Pyrogenicity
And Conforms to USP
:
Particulate Matter for
injection
No re-use	DMC Medical syringes
conform to the
requirements of ISO
7886-1, an FDA recognized
standard. Additionally, the
Sterility Assurance Level,
(SAL) has been established
to meet the 10-6 level. The
single use syringes are
packaged in a way as to
ensure conformity with ISO
10993-1, including
minimizing residual gases
as well as discourage
re-use.	Similar
Please see
comment 2.
Length (mm)	1ml: 86.6±0.5
3ml: 80.85±0.5
5ml: 83.5±0.5
10ml: 88.45±0.5
20ml: 96.4±0.5
30ml: 106.8±0.5	Not Clear.	Difference
Please see
comment 3.
Diameter(mm)	1ml:
OD:9.45±0.1
ID: 4.7±0.1
3ml:
OD:11.7±0.1
ID: 9.13±0.1
5ml:
OD: 15.5±0.1
ID:12.83±0.1
10ml:
OD: 19.45±0.1	Not Clear.	Difference
Please see
comment 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.	Difference
Please see
comment 5.
Luer Lock	ISO 80369-7	ISO 594-2	Difference
Please see
comment 6.
Prescription (Rx) or
over the counter	Prescription	Prescription	Same

Table 3-1 Technological Comparison Table

5

510(K)

6

7

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 testing. However, all models are tested in accordance with ISO 7886-1 and USP 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

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.

8

SE Comment 5: Size of Syringes

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 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.

• 8. 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 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

9

• 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.
• 9. Clinical test conclusion

No clinical study is included in this submission.

• 10. 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).