K Number

Device Name

LDV((Low Dead Volume )Syringe

Manufacturer

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

Date Cleared

2022-05-25

(135 days)

Product Code

QNQ QNS

Regulation Number

880.5860

Intended Use

The LDV (Low Dead Volume) Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

Device Description

The LDV (Low Dead Volume) Syringe is consistent with the calibrated syringe and permanent needle intended to be used for injection or withdrawal of fluids to or from the human body. The needle is fixed that cannot be removed. The needle cap is colored to differentiate the different types of needle models. The syringe plunger is well-designed to reduce the fluid waste, called low dead volume or low dead space. The LDV (Low Dead Volume) Syringe has various colors, syringe volumes, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the device is sterilized with ethylene oxide and without any pyrogen. Therefore, this is a single-use device that should be immediately discarded after use.

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

K210443, K210444

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics, sterility, and biocompatibility of a standard syringe with a fixed needle and low dead volume design. There is no mention of AI or ML in the intended use, device description, or performance testing sections.

Therapeutic

No
The device is a syringe intended for injecting or withdrawing fluids, which are typically diagnostic or therapeutic substances, but the syringe itself does not perform therapy.

Diagnostic

No
The device description states its purpose is to inject or withdraw fluids, which is a therapeutic or procedural function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical syringe with a fixed needle, plunger, and various physical characteristics (colors, volumes, gauges, lengths). The performance studies also focus on physical, sterility, and biocompatibility testing of a tangible device. There is no mention of software as a component or the primary 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 fluid into or withdraw fluid from body." This describes a device used on the body for therapeutic or diagnostic procedures, not a device used to test samples outside the body (in vitro).
Device Description: The description details a syringe and needle for injecting or withdrawing fluids from the human body. This aligns with the intended use and does not suggest any in vitro testing function.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests to diagnose conditions based on these samples.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The LDV (Low Dead Volume) Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

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

QNQ, QNS

Device Description

The LDV (Low Dead Volume) Syringe is consistent with the calibrated syringe and permanent needle intended to be used for injection or withdrawal of fluids to or from the human body. The needle is fixed that cannot be removed. The needle cap is colored to differentiate the different types of needle models. The syringe plunger is well-designed to reduce the fluid waste, called low dead volume or low dead space.
The LDV (Low Dead Volume) Syringe has various colors, syringe volumes, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the device is sterilized with ethylene oxide and without any pyrogen. Therefore, this is a single-use device that should be immediately discarded after use.

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)

The non-clinical tests of this proposed device are tested in conformance with the following standards.

(1) Physical performance testing:
(a) ISO 7864:2016, Sterile hypodermic needles for single use.
(b) ISO 7886-1:2017 Second edition: Sterile hypodermic syringes for single use Part 1: Syringes for manual use
(c) ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Device.
(d) ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
(2) Sterility, Shipping, and Shelf-Life
(a) ISO 11135:2014 Sterilization of healthcare products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.
(b) ISO 11138-2:2017 Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes.
(c) ISO 11737-1:2018, Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products.
(d) ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
(e) ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
(f) ISO 11607-2:2019, Packaging for terminally sterilized medical devices--Part 2: Validation requirements for forming, sealing and assembly processes
(g) ISO 11140-1:2014, Sterilization of health care products —Chemical indicators —Part 1: General requirements
(h) ISO 10993-7:2008/AMD 1:2019 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants.
(i) ASTM F1140: 2020, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
(j) ASTM F88: 2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
(k) ASTM D3078-2: 2013, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
(I) ASTM F1929: 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
(m) ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices
(n) ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
(3) Biocompatibility testing
(a) ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
(b) ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
(c) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
(d) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization.
(e) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
(f) USP 40, Bacterial Endotoxins Test
(g) USP 40, Sterility Test
(h) USP 40, Particulate matter in injection

No clinical testing is available for this device.

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.

K210443, K210444

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

Image /page/0/Picture/0 description: The image shows 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.

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, Shanghai 201114 China

Re: K220083

Trade/Device Name: LDV(Low Dead Volume )Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNQ, QNS Dated: April 16, 2022 Received: April 25, 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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K220083

Device Name LDV (Low Dead Volume ) Syringe

Indications for Use (Describe)

The LDV (Low Dead Volume) Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K220083 510(k) SUMMARY

1. Preparation Date

5/25/2022

2. Submitter

Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Address: No.2 Guanyin Road, Taihu Economic Development Zone, Anqing City, Anhui Province, 246400, China Contact person: Bingyi Xiang, +86-556 5129666, hwj1@hongyu-wuzhou.cn Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net

3. Device

Trading name: LDV (Low Dead Volume) Syringe Common name: Sterile low dead space piston syringe with fixed hypodermic needle Classification name: Low Dead Space Piston Syringe Classification: Class II Product code: QNQ, QNS

4. Predicate device

Primary predicate device: PLPT LDV (Low Dead Volume) Sterile Syringe – K210443 Secondary predicate device: EZ-Injec LDV Sterile Safety Needle – K210444

5. Indications for Use

The LDV (Low Dead Volume) Syringe is intended to be used for medical purpose to injectfluid into or withdraw fluid from body.

6. Device description

The LDV (Low Dead Volume) Syringe has various colors, syringe volumes, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the device is sterilized with ethylene oxide and without any pyrogen. Therefore, this is a single-use device that should be immediately discarded after use.

Gauge	Needle Bevel	Needle Wall type	Needle length (inch)	Needle cap color
31G	LB
SB	RW
TW
ETW
UTW	1/4, 5/16, 3/8, 1/2, 5/8,	White
	30G	LB
SB	RW
TW
ETW
UTW	1/4, 5/16, 3/8, 1/2, 5/8,	Yellow
		29G	LB
SB	RW
TW
ETW
UTW	1/4, 5/16, 3/8, 1/2, 5/8,	Red
			28G	LB
SB	RW
TW	1/4, 5/16, 3/8, 1/2, 5/8, 3/4, 1	Aquamarine blue
27G			LB
SB	RW
TW	1/4, 5/16, 3/8, 1/2, 5/8, 3/4, 1, 1 1/2,	Medium gray	0.3mL, 0.5mL, 1mL	Type 1, Type 2
26G	LB
SB		RW
TW	1/4, 5/16, 3/8, 1/2, 5/8, 3/4, 1,	Brown
25G	LB
SB	RW
TW	1/4, 5/16, 3/8, 1/2, 5/8, 3/4, 1, 1 1/2,	Orange
24G	LB
SB	RW
TW	1/4, 5/16, 3/8, 1/2, 5/8, 3/4, 1, 1 1/4,	Medium purple
23G	LB
SB	RW
TW
ETW	1/4, 5/16, 3/8, 1/2, 5/8, 3/4, 1, 1 1/8, 1
3/16, 1 1/4, 1 1/2,	Deep blue
22G	LB
SB	RW
TW
ETW	1/4, 5/16, 3/8, 1/2, 5/8, 3/4, 1, 1 3/16, 1
1/4, 1 1/2,	Black
21G	LB
SB	RW
TW
ETW
UTW	1/4, 5/16, 3/8, 1/2, 5/8, 3/4, 1, 1 1/4, 1 1/2	Deep blue

Table. 1. Device specifications

7. Indications for use/Intended use

The LDV (Low Dead Volume) Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.

8. Comparison of technological characteristics between proposed and predicate devices

| Technological

Characteristics	Proposed device	Primary predicate	Secondary predicate	Remark
	LDV (Low Dead Volume)
Syringe
K220083	PLPT LDV (Low Dead
Volume) Sterile Syringe
K210443	EZ-Injec LDV Sterile
Safety Needle
K210444
Indications for
Use	The LDV (Low Dead
Volume) Syringe is
intended to be used for
medical purposes to
inject fluid into or
withdraw fluid from
body.	PLPT LDV (Low Dead
Volume) Sterile Syringe is
intended to be used for
medical purposes to
inject fluid into or
withdraw fluid from
body.	This product is intended
for use to inject fluid into
or withdraw fluids from
parts of the body below
the surface of the skin.	#1
Product code	QNQ, QNS	QNQ	QNS	#2
Regulation No.	21CFR 880.5860,
21 CFR 880.5570	21CFR 880.5860	21 CFR 880.5570	#3
Class	II	II	II	Same
Configuration
and Material	(1) Needle cap (PE)
(2) Needle (SUS 304)
(3) Plunger stopper
(Polyisoprene
rubber)
(4) Plunger (PP)
(5) Barrel (PP)	(1) Barrel: PP
(2) Plunger rod: PP
(3) Plunger: Rubber	(1) needle cap/protector
(PP)
(2) needle (Stainless
Steel 304)
(3) needle hub (PP)	#4
Syringe volume	0.3mL, 0.5mL, 1mL	1mL	-	#5
Needle gauge
and length	21G, 22G, 23G, 24G, 25G,
26G, 27G, 28G, 29G, 30G,
31G
1/4", 5/16", 3/8", 1/2",
5/8", 3/4", 1", 1 1/8", 1
3/16", 1 1/4", 1 1/2"
(6mm, 8mm, 10mm,
13mm. 16mm. 19mm.	-	25G
25mm	#6
	25mm, 28mm, 30mm,
32mm, 38mm)
Need wall type
and bevel	RW, TW, ETW, UTW
LB, SB	-	TW
Beveled	#7
Sharps
prevention
function	No safety guard	-	Safety guard	#8
Needle
performance	Meet ISO 9226 and ISO
7864	-	Meet ISO 9226 and ISO
7864	Same
Syringe
performance	Meet ISO 7886-1	Meet ISO 7886-1	-	Same
Dead space
specification	0.3mL: ≤0.0025g(mL)
0.5mL: ≤0.0035g(mL)
1mL: ≤0.0039g(mL)
Meet ISO 7886-1 clause 8
table 1	1mL: ≤0.023mL with 95%
confidence/95%
reliability
Meet ISO 7886-1 clause 8
table 1	25G-25mm: ≤0.0054ml
Meet ISO 7886-1 clause 8
table 1	#9
Sterility method	EO Sterilized	EO Sterilized	EO Sterilized	Same
Biocompatibility	Meet ISO 10993	Meet ISO 10993	Meet ISO 10993	Same

Table 2. Characteristics comparison

Notes:

#1: Intended use/Indications for use

The operation principle of the proposed device, the primary predicate device, and the secondary predicate device are precisely the same. The differences are the detailed description which does not affect the substantially equivalent of safety and effectiveness.

#2: Product code

The proposed device is a combination of a low dead volume syringe and a fixed needle. So, it combines the syringe and needle product codes, QNQ and QNS, precisely the combination of the primary and secondary predicate devices. According to the product code QNQ description, the product could be with or without a needle. However, the primary predicate device is only a syringe with a low dead volume function, not including a needle that is not entirely consistent with the proposed device. So, a secondary predicate device under the product code QNS, "Low Dead Space Needle, Single Lumen, Hypodermic", is introduced. It is a kind of low dead space needle similar to the proposed device. Tow predicate devices are combined to demonstrate the safety and effectiveness comparison entirely. Therefore, it does not affect the safety and effectiveness comparison that can be considered substantially equivalent.

#3: Regulation No.

According to note #2, the proposed device is a combination of a low dead volume syringe and a fixed needle. So, it combines the syringe and needle product regulations under regulations No. 21CFR 880.5860 and 21 CFR 880.5570, precisely the combination of the primary and secondary predicate devices. It does not affect the safety and efficacy of the proposed device.

#4: Configuration and material

The difference in the configuration is raised from the structure. The proposed device has a permanent needle attached to the syringe that combines a syringe and a needle. However, the primary and secondary predicate devices are two independent parts. So, the performance testing is run to validate the safety and effectiveness of the proposed devices. Results demonstrate that all performance items meet the requirements listed in standards. Therefore, it is considered substantially equivalent.

The different materials do not affect the effectiveness of the proposed device but affect the safety, especially the biocompatibility performance. Therefore, several testing items are run to validate the biosafety of the proposed device. Biocompatibility results demonstrate no hazard to the human body that complies with ISO 10993 serials standards. Therefore, it is considered substantially equivalent.

#5: Syringe volume

The syringe volume is different from the primary predicate. The syringe volume stands for the dimensions of the syringe barrel, like length and diameter. Professionals select different syringe volumes for different clinical usages, not affecting the intended use. In addition, all the syringe volumes comply with ISO 7886-1. So, the difference in syringe volume does not affect the substantially equivalent of safety and effectiveness.

#6: Needle gauge and length

The needle gauge and length condition is the same as the syringe volume, though the proposed device has a wide range of needle gauge and length than the secondary predicate device. Therefore, the difference in needle gauge and length does not affect the substantially equivalent of safety and effectiveness.

#7: Needle wall type and bevel

The secondary predicate device has a TW needle wall type included in the needle wall type range of the proposed device. Generally, there are four commonly used wall types: RW, TW, ETW and UTW, represented for regular, thin, extra-thin, and ultra-thin, respectively. The proposed device has all kinds of needle wall types with ISO 9626, demonstrating the substantially equivalent of safety and effectiveness.

In addition, the secondary predicate device only mentions that the tip is beveled, not specified LB or SB. LB and SB represented for long bevel (11°±2°) and short bevel (17°±2°). The proposed device has both LB and SB that comply with ISO 9626. So, the needle wall type and bevel should be substantially equivalent of safety and effectiveness.

#8: Sharps prevention function

The proposed device has no sharps prevention function compared with the second predicate device. The safety guard protects the needle-sharp injury to users during discarding needles.

It could enhance the safety of needle usage but not affect the safety and effectiveness of the needle itself. Therefore, it is considered substantially equivalent.

#9: Dead Volume Specification

Compared with the primary and secondary predicate devices, the proposed device has two extra low-dead-space-syringe models, 0.3mL and 0.5L. According to ISO 7886-1, 0.3mL 0.5mL and 1mL syringes are categorized in the same group (the nominal capacity of syringe V Bacterial Endotoxins Test

(g) USP 40, Sterility Test
(h) USP 40, Particulate matter in injection

No clinical testing is available for this device.

10. Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The LDV (Low Dead Volume) Syringe is substantially equivalent to the PLPT LDV (Low Dead Volume) Sterile Syringe and EZ Injec LDV

Sterile Safety Needle with respect to indications of use, treatment methods and technical characteristics.