K Number

Device Name

VeriSafe Safety sterile syringes

Manufacturer

Promisemed Hangzhou Meditech Co., Ltd.

Date Cleared

2023-09-28

(100 days)

Product Code

FMF MEG

Regulation Number

880.5860

Intended Use

It is intended to inject fluids into the body or withdraw blood for medical purposes. After injection, the needle tube will be retracted into the barrel when the safety features are manually activated to minimize the risk of accidental sharps injury.

Device Description

Safety Sterile Syringes is a sterile device consisting of a calibrated barrel, plunger, piston, push button, retraction cylinder, sealing ring, spring and a needle. It is made of plastic, stainless steel and silicone materials. Safety Sterile Syringes have two types: Type F and type D. Type F is a syringe with a fixed needle. Type D is a syringe with a detachable needle. The detachable needle is secured by rotating it through the front needle hub into the back needle hub located on the syringe. Safety Sterile Syringes is using plunger to fill syringe as well as discharge the fluid. After use, by continuing to press the push-button down to depress the plunger all of the way within the barrel, the safety mechanism will be triggered, then the needle tube, needle hub and retraction cylinder will be retracted into the barrel completely under the force of the spring to minimize the risk of accidental sharps injury. Product is delivered sterilization process is validated according to EN ISO 11135. This is a single-use device. Safety Sterile Syringes is intended to be used in professional healthcare facility/hospital and transport environment.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K213560

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

Explanation: The device is a syringe intended for injecting fluids or withdrawing blood, which are diagnostic or procedural uses, not therapeutic actions in themselves. Its design focuses on safety features (needle retraction) rather than delivering a therapeutic effect.

Diagnostic

Explanation: The device is a safety sterile syringe intended for injecting fluids or withdrawing blood. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components made of plastic, stainless steel, and silicone, and the performance studies focus on bench testing of these physical attributes and materials. There is no mention of software as a component or function of the device.

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 to "inject fluids into the body or withdraw blood for medical purposes." This describes a device used for administering substances or collecting samples from the body, not for performing tests on samples outside the body.
Device Description: The description details a syringe with a needle and safety features for injection and blood withdrawal. This aligns with a device used for direct interaction with the patient's body.
Lack of IVD Characteristics: There is no mention of the device being used to analyze samples, detect analytes, or provide diagnostic information based on testing biological specimens in vitro (outside the living organism).

IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device is a tool for administering or collecting substances from the body, which falls under a different category of medical devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FMF, MEG

Device Description

Safety Sterile Syringes is using plunger to fill syringe as well as discharge the fluid. After use, by continuing to press the push-button down to depress the plunger all of the way within the barrel, the safety mechanism will be triggered, then the needle tube, needle hub and retraction cylinder will be retracted into the barrel completely under the force of the spring to minimize the risk of accidental sharps injury.

Product is delivered sterilization process is validated according to EN ISO 11135. This is a single-use device. Safety Sterile Syringes is intended to be used in professional healthcare facility/hospital and transport environment.

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

Professional healthcare facility/hospital and transport environment.

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

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

ISO 7886-1:2017, Sterile hypodermic syringes for single use Part 1: Syringes for manual use
- Extraneous matter, Limits for acidity or alkalinity, Limits for extractable metals, Lubrication, Tolerance on graduated capacity, Graduated Scale, Numbering of Scales, Overall length of scale to Nominal capacity line, Position of scale, Barrel, Plunger stopper/ plunger assembly, Nozzle, Dead space, Freedom from air and liquid leakage past plunger stopper, Force to operate the piston, Fit of the plunger stopper/plunger in barrel.
· ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
Stiffness, Resistance to breakage, Resistance to corrosion
· ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
. Cleanliness, Colour coding, Needle tube-Outside diameter, Tolerance on length,Freedom from defects, Needle points, Fragmentation test, Penetration force and drag force, Bond between hub and needle tube, Patency od lumen
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
- Safety mechanism activation. Safety overriding and unlocking force after activation, Simulated clinical Use
USP Bacterial Endotoxin Test

Biocompatibility tests:

ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5:Tests for in Vitro Cytotoxicity
ISO 10993-10:2021 Biological Evaluation of Medical Devices -- Part 10: Tests for Skin Sensitization
ISO 10993-23:2021 Biological Evaluation of Medical Devices -Part 23: Test for irritation
ISO 10993-11:2017- Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
ASTM F756-17- Standard practice for assesment of hemolytic properties of materials
ISO 10993-7:2008- Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
USP42-NF37 Pyrogen Test
USP Particulate matter in injections

Sterility, Shipping, and Shelf-Life:

ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP38-NF33_C71
Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Key Metrics

Not Found

Predicate Device(s)

K213560

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

September 28, 2023

Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China

Re: K231792

Trade/Device Name: VeriSafe Safety sterile syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: August 29, 2023 Received: August 30, 2023

Dear Wei Hsu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about 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,

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K231792

Device Name VeriSafe Safety Sterile Syringes

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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K231792-510(K)Summary

Date Prepared 1

September 18, 2023

2 Submitter's Information

Name of Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

Address:

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou

City, 311121 Zhejiang, China

Contact Name:

Zearou Yang

Telephone No.:

+86 571 88772985

Fax No.:

+86 571 88772985

Email Address:

zearou.yang@promisemed.ca

ന Trade Name, Common Name, Classification

Trade/Product Name: VeriSafe Safety sterile syringes Common Name: Piston Syringe Classification name: Syringe, Piston; Syringe, Antistick Regulation Number: 21 CFR 880.5860 Device Class: Class II Product Code: FMF, MEG

ব ldentification of Predicate Device K213560 Verifine Safety Syringe with Fixed Needle

Description of the Device റ

Coding rule:
MWS-032525
Type	Capacity	Gauge	Nominal length of needle tube	Wall
Type D	1mL,2mL,	18G, 20G, 22G,
23G, 25G,
27G,28G, 29G,
30G, 31G, 32G	6mm,8mm,12mm,
25mm,38mm	Regular wall (RW)
Type F	3mL,5mL,10mL			Thin wall (TW)

6 Indication

lt is intended to inject fluids into the body or withdraw blood for medical purposes. After injection, the needle tube will be retracted into the barrel when the safety features are manually activated to minimize the risk of accidental sharps injury.

7 Similarities and Differences of the Proposed Devices to the Predicate Devices

The VeriSafe Safety sterile syringe is substantially equivalent to the predicate device, Verifine Safety Syringe with Fixed Needle (K213560) in that these devices have same intended use and technological characteristics. Using plunger to fill syringe as well as discharge the fluid is the technological principle of both the subject device and predicate device. The needle of both devices is made of stainless steel (X5CrNi18-10). The performance of both devices fulfills the requirement of ISO 7886-1, ISO 9626, ISO 7864 and ISO 23908. Both the subject and predicate devices are disposable, EO sterilized, single patient use devices. Both the subject and predicate device are used in Professional healthcare facility and transport environment.

	Subject Device	Predicate Device (K213560)
Trade Name	VeriSafe Safety Sterile Syringes	Verifine Safety Syringe
with Fixed Needle
Manufacturer	Promisemed Hangzhou
Meditech Co., Ltd	Promisemed Hangzhou
Meditech Co., Ltd
Device Class	Class II	Class II	Same
Product Code	FMF, MEG	FMF, MEG	Same
Regulation number	880.5860	880.5860	Same
Regulation Name	Piston syringe	Piston syringe	Same
Intended Use/
Indications for Use	It is intended to inject fluids
into the body or withdraw
blood for medical purposes.
After injection, the needle
tube will be retracted into the
barrel when the safety
features are manually
activated to minimize the risk
of accidental sharps injury.	It is intended to inject
fluids into or withdraw
fluids from the body for
medical purposes.	Same
Operating
Principle	Plunger is used to fill syringe
as well as discharge the fluid.
After use, the needle tube will
be retracted into the barrel by
pressing the push-button to
depress the plunger all of the
way within the barrel.	Plunger is used to fill
syringe as well as discharge
the fluid.
The protective shield will
permanently be locked in
place by pulling forward
till click, providing
protection against needle
sticks.	Different-
See Comment #1
Safety mechanism	The safety mechanism is
activated by pressing the push-
button down to depress the
plunger all of the way within	The safety mechanism is
activated by pushing the
sliding sleeves. When	Different
See Comment#2
	the barrel. When activated,
needle is retracted into the
barrel.	activate, needle is covered
by sliding sleeves.
Volume	1mL,2mL,3mL,5mL,10mL	0.5ml,1.0ml	Different
			See Comment #3
Tip type	Fixed Needle and detachable
needle	Fixed Needle	Different
			See Comment #4
Needle and
syringe tip
configuration	Type F
Image: Type F syringe
Type D
Image: Type D syringe	Image: Syringe	Different
			See Comment #5
Gauge	18G, 20G, 22G, 23G, 25G,
27G,28G, 29G, 30G, 31G, 32G	21G, 22G, 23G, 24G, 25G,
26G, 27G, 28G	Different
			See Comment #6
Needle Length	6mm,8mm,12mm,
25mm,38mm	12mm, 16mm, 25 mm,
32mm, 38mm	Different
			See Comment #7
Gradations
legibility	Legible	Legible	Same
Lubricant	Silicone oil	Silicone oil	Same
Barrel
transparency	Transparent	Transparent	Same
Reuse durability	Single Use	Single Use	Same
Biocompatibility	Complied with ISO10993 series
standards, and the following
tests are performed	Complied with ISO10993
series standards, and the
following tests are
performed	Same
	- Cytotoxicity: No cytotoxicity
	- Skin Irritation: No evidence
of skin irritation	- Cytotoxicity: No
cytotoxicity
		- Skin Irritation: No
evidence of skin irritation
	- Skin Sensitization: No
evidence of sensitization	- Skin Sensitization: No
evidence of sensitization
	-Acute Systemic Toxicity: No
systemic toxicity	-Acute Systemic Toxicity:
No systemic toxicity
	-Hemolysis: No evidence of
hemolysis	-Hemolysis: No evidence of
hemolysis
	-Pyrogen: Non pyrogenic	-Pyrogen: Non pyrogenic
	-USP Particulate matter	-USP Particulate
matter
Configuration and
Materials	Needle, spring: Stainless Steel
(X5CrNi18-10)	Needle: Stainless Steel
(X5CrNi18-10)	Similar
	Barrel/push-button:
Polypropylene	Barrel/push-button:
Polypropylene	See Comment# 8
	Plunger: Polypropylene	Plunger: Polypropylene
	Needle cap: Polypropylene	Needle cap: Polyethylene
	Piston: Nitrile butadiene
rubber/Thermoplastic
elastomer	Piston: Polyisoprene rubber
		Sliding Sleeve, Cover:
Polypropylene
	Retraction cylinder sealing
ring: Silicone rubber	Plunger stopper, Tight ring:
Acrylonitrile Butadiene
Styrene
	Needle hub: Polypropylene
	Needle hub sealing ring:
Thermoplastic elastomer
	Retraction cylinder:
Acrylonitrile Butadiene Styrene


Performance	Complied with ISO 7886-1, ISO
9626, ISO 7864, ISO 23908	Complied with ISO 7886-1,
ISO 9626, ISO 7864, ISO
23908	Same
Sterilization
method and SAL	EO Sterilization
SAL = 10 $-6$	EO Sterilization
SAL = 10 $-6$	Same
Environment of
use	Professional healthcare facility
and transport environment.	Professional healthcare
facility and transport
environment.	Same
shelf life	3 years	5 years	Different $9$
See Comment# 9

A detailed comparison to the predicate is provided in Table 1.

Discussions of differences in technological characteristics

Comment #1 and #2 : The subject device has different safety mechanisms to protect against sharps injury. The sharps protection feature of both devices are addressed through testing per ISO 23908. The difference in sharps protection feature does not affect the effectiveness and safety of the device.

Comment #3 : The subject device has a different capacity range. The specification of capacity of both devices fulfils the requirement of ISO 7886-1. The difference in capacity does not affect the effectiveness and safety of the device.

Comment # 4 : The subject device has an additional type of detachable needle tip. The performance of detachable needle type fulfils the requirement of ISO 9626:2016, ISO 7864:2016 and ISO 7886-1. The difference in tip type does not affect the effectiveness and safety of the device.

Comment # 5: Needle and syringe tip configuration of the subject device is different from that of predicate device. The performance of the subject device fulfill the requirements of ISO 9626:2016, ISO 7886-1:2016, ISO 7864:2016, ISO 23908:2011. The difference in needle and syringe tip configuration does not affect the effectiveness and safety of the device.

Comment #6 and #7 : The gauge and needle length of the subject device is different from the predicate device. The specification of gauge and needle length of both devices fulfil the requirement of ISO 9626:2016 and ISO 7864:2016. The difference in gauge and needle length does not affect the effectiveness and safety of the device.

Comment #8: The syringe bodies of subject device and predicate device have material differences. The biocompatibility tests conducted demonstrated the subject device. The difference in materials does not affect the effectiveness and safety of the device.

Comment # 9 : The subject device has shorter shelf life. The performance of aged subject device has been validated in accordance with ASTM F1980-16, ISO 9626:2016, ISO 7886-1:2016, ISO 7864:2016, ISO 23908:2011. The difference in shelf life does not affect the effectiveness and safety of the device.

The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question

is raised regarding effectiveness and safety. The subject device is substantially equivalent to the identified predicate device.

8 Performance Testing Summary

ISO 7886-1:2017, Sterile hypodermic syringes for single use Part 1: Syringes for manual use
- Extraneous matter, Limits for acidity or alkalinity, Limits for extractable metals, Lubrication, Tolerance on graduated capacity, Graduated Scale, Numbering of Scales, Overall length of scale to Nominal capacity line, Position of scale, Barrel, Plunger stopper/ plunger assembly, Nozzle, Dead space, Freedom from air and liquid leakage past plunger stopper, Force to operate the piston, Fit of the plunger stopper/plunger in barrel.
· ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
Stiffness, Resistance to breakage, Resistance to corrosion
· ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
. Cleanliness, Colour coding, Needle tube-Outside diameter, Tolerance on length,Freedom from defects, Needle points, Fragmentation test, Penetration force and drag force, Bond between hub and needle tube, Patency od lumen
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
- Safety mechanism activation. Safety overriding and unlocking force after activation, Simulated clinical Use
USP Bacterial Endotoxin Test

Biocompatibility

In accordance with ISO 10993-1 the device is classified as Externalcommunicating device, Blood path, indirect, with limited contactduration (≤ 24h). The biosafety tests that required consideration were validated:

ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5:Tests for in Vitro Cytotoxicity
ISO 10993-10:2021 Biological Evaluation of Medical Devices -- Part 10: Tests for Skin Sensitization
ISO 10993-23:2021 Biological Evaluation of Medical Devices -Part 23: Test for irritation
ISO 10993-11:2017- Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
ASTM F756-17- Standard practice for assesment of hemolytic properties of materials
ISO 10993-7:2008- Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
USP42-NF37 Pyrogen Test
USP Particulate matter in injections

Sterility, Shipping, and Shelf-Life

ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
· Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP38-NF33_C71
Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
の Conclusion

Based on the information provided within this 510(k) submission, the differences between the predicate and the subject device do not raise any new or different questions of safety

or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.