Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical safety features and standard biocompatibility/performance testing, with no mention of AI or ML.

Therapeutic

No
This device is a syringe intended for fluid aspiration and minimizes needle sticks, not for treating a disease or condition.

Diagnostic

No

Explanation: The device is described as a "Sterile Safety Syringes for Single Use" intended for "aspiration of fluids for medical purpose" and to "mimimize risk of accidental needle sticks." This indicates it is used for fluid collection and injection, and safety, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of a safety hypodermic needle and a syringe, which are physical hardware components. The performance studies also focus on physical properties and safety features of the hardware.

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 "in the aspiration of fluids for medical purpose." This describes a procedure performed on a patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
Device Description: The device is a "safety hypodermic needle and a luer slip or luer lock syringe." These are tools for administering or withdrawing substances from the body, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples (like blood, urine, tissue), or any other components or processes typically associated with in vitro diagnostics.

The device is clearly described as a medical device used for procedures directly involving the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sterile Safety Syringes for Single Use are intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to mimize risk of accidental needle sticks. The Sterile Safety Syringes for Single Use are single use, disposable devices, provided sterile.

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

MEG, FMF, FMI

Device Description

The proposed device consists of a safety hypodermic needle and a luer slip or luer lock syringe. Models of Sterile Safety Syringes for Single Use shown in Table 11.1 and 11.2 are available in various models according to different syringe volume and needle specifications.

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

Not Found

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 Performance Test Conclusion:
Biocompatibility tests were conducted based on ISO 10993-1, ISO 10993-2:2006, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-10:20101, ISO 10993-11: 2017, ISO 10993-12:2012, and ASTM 756-17. Other non-clinical tests were conducted based on ISO 10993-7:2008, USP 43-NF38:2020 , USP 43-NF38:2020 , ASTM F88/F88M-15, ASTM F1929-15, ASTM F1980 16, ISO 7864:2016, ISO 7886-1:2017, ISO 9626:2016, ISO 80369-7:2021, and ISO 23908:2011. A simulated clinical use study was conducted per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" issued on August 9, 2005. The test results demonstrated that the subject device complies with the requirements of these standards.

Clinical Test Conclusion:
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.

K183665

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, there is a symbol of the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

Shanghai Kindly Enterprise Development Group Co., Ltd % Evan Hu Official Correspondent Shanghai Mind-Link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai, 200040 Cn

Re: K221416

Trade/Device Name: Sterile Safety Syringes for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMI Dated: August 05, 2022 Received: August 08, 2022

Dear Evan Hu:

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

1

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 (OS) 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 mediation-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

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Section 4

Indications for Use Statement

3

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221416

Device Name Sterile Safety Syringes for Single Use

Indications for Use (Describe)

The Sterile Safety Syringes for Single Use are intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to mimize risk of accidental needle sticks. The Sterile Safety Syringes for Single Use are single use, disposable devices, provided sterile.

☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------

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

4

Section 5

510(K) Summary

5

I. SUBMITTER:

Shanghai Kindly Enterprise Development Group Co., Ltd. No.658 Gaochao Road, Shanghai, 201803,China Contact Person: Liu Hualong Title: Technical Director Tel: 86-69118232-8125 Email: henry liu@kdlchina.net

Submission Correspondent: Evan Hu Email: evan.hu@mind-link.net Tel:+86 18616124827

II. Proposed Device

Name of Device: Sterile Safety Syringes for Single Use Regulation Number: 21 CFR PART 880.5860 Common Name: Syringe, Antistick Syringe, Piston Needle, Hypodermic, Single Lumen Classification Name: Piston syringe Regulatory Class: II Product Code: MEG, FMF, FMI

6

III. PREDICATE DEVICE

Name of Device: Safety Needles

Sterile Syringe Sterile Syringe with Safety Needle Sterile Syringe with Needle Hypodermic Needle for Single Use (K183665) Regulation Number: 21 CFR 880.5860 Common Name: Syringe, Antistick Syringe, Piston Needle, Hypodermic, Single Lumen Classification Name: Piston syringe Regulatory Class: II Product Code: MEG, FMF, FMI

IV. DEVICE DESCRIPTION

The proposed device consists of a safety hypodermic needle and a luer slip or luer lock syringe. Models of Sterile Safety Syringes for Single Use shown in Table 11.1 and 11.2 are available in various models according to different syringe volume and needle specifications.

Table 11-1 Models of Sterile Safety Syringes for Single Use (Luer Lock Type)

Syringe	Matched needle
volume	REF	Needle gauge	Needle length	Needle wall	Bevel
1ml	SRS21012325	23G	25mm	Thin wall	$11\pm2^\circ$
	SRS21012525	25G	25mm	Thin wall	11±2°
	SRS21012516	25G	16mm	Thin wall	11±2°
	SRS21012713	27G	13mm	Regular wall	11±2°
	SRS21022325	23G	25mm	Thin wall	11±2°
	SRS21022525	25G	25mm	Thin wall	11±2°
2ml	SRS21022516	25G	16mm	Thin wall	11±2°
	SRS21022713	27G	13mm	Regular wall	11±2°
	SRS21031838	18G	38mm	Thin wall	11±2°
	SRS21032025	20G	25mm	Thin wall	11±2°
	SRS21032038	20G	38mm	Thin wall	11±2°
	SRS21032125	21G	25mm	Thin wall	11±2°
	SRS21032138	21G	38mm	Thin wall	11±2°
3ml	SRS21032225	22G	25mm	Thin wall	11±2°
	SRS21032238	22G	38mm	Thin wall	11±2°
	SRS21032325	23G	25mm	Thin wall	11±2°
	SRS21032338	23G	38mm	Thin wall	11±2°
	SRS21032525	25G	25mm	Thin wall	11±2°
	SRS21032538	25G	38mm	Thin wall	11±2°
	SRS21051838	18G	38mm	Thin wall	11±2°
	SRS21052025	20G	25mm	Thin wall	11±2°
	SRS21052038	20G	38mm	Thin wall	11±2°
	SRS21052125	21G	25mm	Thin wall	11±2°
5ml	SRS21052138	21G	38mm	Thin wall	11±2°
	SRS21052225	22G	25mm	Thin wall	11±2°
	SRS21052238	22G	38mm	Thin wall	11±2°
	SRS21052325	23G	25mm	Thin wall	11±2°
	SRS21052338	23G	38mm	Thin wall	$11\pm2°$
	SRS21052525	25G	25mm	Thin wall	$11\pm2°$
10ml	SRS21052538	25G	38mm	Thin wall	$11\pm2°$
	SRS21102138	21G	38mm	Thin wall	$11\pm2°$
	SRS21102238	22G	38mm	Thin wall	$11\pm2°$

7

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Table 11-2 Models of Sterile Safety Syringes for Single Use (Luer Slip Type)

Syringe	Matched needle
volume	REF	Needle gauge	Needle length	Needle wall	Bevel
1ml	SRS22012325	23G	25mm	Thin wall	11±2°
	SRS22012525	25G	25mm	Thin wall	11±2°
	SRS22012516	25G	16mm	Thin wall	11±2°
	SRS22012713	27G	13mm	Regular wall	11±2°
2ml	SRS22022325	23G	25mm	Thin wall	11±2°
	SRS22022525	25G	25mm	Thin wall	11±2°
	SRS22022516	25G	16mm	Thin wall	11±2°
	SRS22022713	27G	13mm	Regular wall	11±2°
3ml	SRS22031838	18G	38mm	Thin wall	11±2°
	SRS22032025	20G	25mm	Thin wall	11±2°
	SRS22032038	20G	38mm	Thin wall	11±2°
	SRS22032125	21G	25mm	Thin wall	11±2°
	SRS22032138	21G	38mm	Thin wall	11±2°
	SRS22032225	22G	25mm	Thin wall	11±2°
	SRS22032238	22G	38mm	Thin wall	11±2°
	SRS22032325	23G	25mm	Thin wall	11±2°

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	SRS22032338	23G	38mm	Thin wall	11±2°
	SRS22032525	25G	25mm	Thin wall	11±2°
	SRS22032538	25G	38mm	Thin wall	11±2°
5ml	SRS22051838	18G	38mm	Thin wall	11±2°
	SRS22052025	20G	25mm	Thin wall	11±2°
	SRS22052038	20G	38mm	Thin wall	11±2°
	SRS22052125	21G	25mm	Thin wall	11±2°
	SRS22052138	21G	38mm	Thin wall	11±2°
	SRS22052225	22G	25mm	Thin wall	11±2°
	SRS22052238	22G	38mm	Thin wall	11±2°
	SRS22052325	23G	25mm	Thin wall	11±2°
	SRS22052338	23G	38mm	Thin wall	11±2°
	SRS22052525	25G	25mm	Thin wall	11±2°
	SRS22052538	25G	38mm	Thin wall	11±2°
10ml	SRS22102138	21G	38mm	Thin wall	11±2°
	SRS22102238	22G	38mm	Thin wall	11±2°

V. INDICATIONS FOR USE

The Sterile Safety Syringes for Single Use are intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Safety Syringes for Single Use are single use, disposable devices, provided sterile.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

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The Sterile Safety Syringes for Single Use are compared with the predicate device, Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use (K183665). The results are shown below in the Technological Characteristics Comparison Table:

| Device | Sterile Safety Syringes for
Single Use | Safety
Needles,
Sterile
Syringe, Sterile Syringe with
Safety Needle, Sterile Syringe
with
Needle,
Hypodermic
Needle
for
Single
Use
(K183665) | Remark | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Indication for Use | The Sterile Safety Syringes for
Single Use are intended for
use in the aspiration and
injection of fluids for medical
purpose. After withdrawal of
the needle from the body, the
attached needle safety shield
can be manually activated to
cover the needle immediately
after use to minimize risk of
accidental needle sticks. The
Sterile Safety Syringes for
Single Use are single use,
disposable devices, provided
sterile. | The sterile syringe with safety
needle is intended for use in the
aspiration and injection of fluids
for medical purpose.
After withdrawal of the needle
from the body, the attached
needle safety shield can be
manually activated to cover the
needle immediately after use to
minimize risk of accidental
needle sticks. | Same | |
| Classification
Product Code | MEG, FMF,FMI | MEG, FMF,FMI | Same | |
| Prescription Only
Over
or
Counter | Prescription | Prescription | Same | |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same | |
| Class | II | II | Same | |
| Configuration | Barrel | Barrel (Polypropylene) | Same | |
| | | Plunger | Plunger (Polypropylene) | |
| | | Plunger stopper | Stopper (Polyisoprene) | |
| | | Needle tube | Needle cap (Polypropylene) | |
| | | Protective needle hub | Needle tube (SUS304) | |
| | | Protective cap | Hub with protector
(Polypropylene) | |
| Sterility | | EO Sterilized | EO Sterilized | Same |
| Size | Volume | 1ml, 2ml, 3ml, 5ml, 10ml | 1ml, 3ml, 5ml, 10ml, 20ml,
30ml, 50ml, and 60ml | Different
Note 1 |
| | Syringe Type | Luer Lock/Luer Slip | Luer Lock/Luer Slip/Luer slip
Eccentric | |
| | Needle Gauge | 18G, 20G, 21G, 22G, 23G,
25G, 27G | 18G, 20G, 21G, 22G, 23G, 25G,
and 26G | |
| | Needle Length | 13mm, 16mm, 25mm, 38mm | 1/2"-2" | Same |
| Single Use | | Yes | Yes | Same |
| | | No Cytotoxicity | No Cytotoxicity | Same |
| Biocompatibility | | No Irritation to Skin | No Irritation to Skin | Same |
| | | No significant evidence of
sensitization | No significant evidence of
sensitization | Same |
| | | No systemic toxicity | No systemic toxicity | Same |
| | | No Hemolysis
Non pyrogenic | No Hemolysis
Non pyrogenic | Same |
| Performance Test | | Conforms with the
requirements of ISO 7864,
ISO 9626, ISO 7886, and ISO
80369-7.
Needle Safety Feature:Testing | Conforms with the requirements
of ISO 7864, ISO 9626, ISO
7886, and ISO 80369-7.
Needle Safety Feature: Testing
conducted per ISO 23908:2011. | Same |

11

12

| 23908:2011. | Force to activate safety mode:
NMT 10N | |
|-------------|--------------------------------------------------------------|--|
| | Force to disengage safety mode: | |
| | NLT 20N | |
| | Force to separate safety feature
from needle hub: NLT 50N | |

Note 1

Analysis: Although there are differences between proposed device and predicate device in terms of syringe type, syringe volume, needle length and needle gauge, corresponding performance tests were conducted on all the specifications including ISO 7886-1, ISO 7864-1 and ISO 9626-1 to prove it meet the specific requirements. Therefore, this difference does not raise different questions of safety and effectiveness.

VII PERFORMANCE DATA

Non-Clinical Performance Test Conclusion

Biocompatibility

The proposed device is external communicating device, blood path indirect, contact duration is limited (≤24hrs). The biocompatibility tests were conducted to verify that the proposed devices are not adverse to human tissue based on the following standards:

ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process
ISO 10993-2:2006 Biological evaluation of medical devices-Part 2: Animal . welfare requirements
. ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity

13

ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for ● irritation and delayed-type hypersensitivity
ISO 10993-11: 2017 Biological evaluation of medical devices -- Part 11: Tests ● for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample . preparation and reference materials
ASTM 756-17 Standard Practice for Assessment of Hemolytic Properties of . Material

Other non-clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Sterile Safety Syringe for Single Use (Retractable) complies with the following standards:

ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene ● Oxide Sterilization Residuals
. USP 43-NF38:2020 Bacterial Endotoxins Test
USP 43-NF38:2020 Pyrogen Test (USP Rabbit Test) .
. ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous . Medical Package by Dye Penetration
ASTM F1980 16 Standard Guide for Accelerated Aging of Sterile Barrier . Systems for Medical Devices
ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test . method
ISO 7886-1:2017 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
. ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devices-requirements and test method
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare Part 7: Connectors for intravascular or hypodermic applications ---applications

14

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
In addition, a simulated clinical use study was conducted on the subject device, Sterile Safety Syringes for Single Use to evaluate the effect of safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" issued on August 9, 2005. The test results demonstrated that the subject device complies with the requirements.

Clinical Test Conclusion

No clinical study is included in this submission.

VIII CONCLUSION

The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.