The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

Device Description

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Sterile Auto-Disable Syringes with/without Needle for Single Use." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. The information details the device, its intended use, and a comparison to the predicate, along with performance testing conducted.

Here's an analysis of the provided text in relation to your request for acceptance criteria and the study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" with numerical targets in a tabular format as you might expect for a specific performance metric (e.g., "accuracy > 90%"). Instead, it states that the device's performance "complies with" or "conforms to" various ISO standards. For medical devices like syringes, these standards themselves define the performance requirements and test methods. Therefore, the "acceptance criteria" are implicitly the requirements set forth by these international standards, and the "reported device performance" is that the device meets those standards.

Below is a table constructed from the "Performance testing" section, indicating the relevant standards as acceptance criteria and the reported performance as compliance with these standards.

Acceptance Criterion (ISO Standard)	Reported Device Performance
ISO 10993-1 (Biocompatibility: Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity (Irritation), Acute Systemic Toxicity, Material-Mediated Pyrogens, Hemolysis, Particulate Matter per USP <788>)	Conforms to ISO 10993 (specific tests conducted)
ISO 11135:2014 (EO sterilization validation)	EO sterilization validated per ISO 11135:2014
USP <85> (Pyrogen testing - Bacterial Endotoxin Test)	Pyrogen testing performed per USP <85>
ISO 10993-7 (EO residuals)	EO residuals tested per ISO 10993-7
ASTM D4169 (Simulated shipping)	Simulated shipping performed per ASTM D4169
ASTM F88/F88M-2015 (Seal Strength)	Seal Strength testing performed
ASTM D3078-02(2013) (Bubble leak testing)	Bubble leak testing performed
ASTM F1929-2015 (Dye Penetration)	Dye Penetration testing performed
ASTM F1980-16 (Accelerated Aging of sterile barrier systems)	Shelf life of 5 years validated using ASTM F1980-16
ISO 7864:2016 (Sterile hypodermic needles for single use Requirements and test methods)	Complies with ISO 7864
ISO 9626:2016 (Stainless Steel Needle Tubing For The Manufacture of Medical Devices)	Complies with ISO 9626
ISO 80369-7:2016 (Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications)	Complies with ISO 80369-7
ISO 7886-1:2017 (Sterile hypodermic syringes for single use- Part 1: Syringes for manual use)	Complies with ISO 7886-1
ISO 7886-4:2018 (Sterile hypodermic syringes for single use — part 4: syringes with re-use prevention feature)	Complies with ISO 7886-4
SAL (Sterility Assurance Level)	10-6

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any of the performance tests.
The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). These details are typically found in the full test reports, which are summarized here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. The testing for a syringe involves physical, chemical, and biological performance against standardized criteria, not interpretation by human experts to establish a "ground truth" like in imaging or diagnostic studies. The "ground truth" is defined by the parameters and thresholds in the ISO and ASTM standards themselves.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) when establishing ground truth for subjective assessments. Since this study relies on objective performance against defined standards, there's no need for adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is relevant for diagnostic or AI-assisted interpretation devices. This submission concerns sterile auto-disable syringes, which are physical medical devices, not diagnostic software.

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

This is not applicable. This is not an algorithmic device.

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

The "ground truth" for the performance of the syringe device is defined by the requirements and test methods specified in the cited international ISO and ASTM standards. For example, for "Seal Strength," the ISO/ASTM standard dictates the method and acceptable range, which serves as the objective ground truth. For "Biocompatibility," the ground truth is whether the device materials elicit a toxic response beyond defined limits, as determined by standardized biological tests.

8. The sample size for the training set

This is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

This is not applicable for the reason stated above.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 27, 2022

Azur Medical Company Inc. Di Zhao General Manager 6710 Everglades Dr. Richmond, Virginia 23838

Re: K211210

Trade/Device Name: Sterile Auto-Disable Syringes with/without Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: December 14, 2021 Received: December 21, 2021

Dear Di Zhao:

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

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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,

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211210

Device Name

Sterile Auto-Disable syringes with/without needle for single use

Indications for Use (Describe)

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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K211210

510(k) summary

January 27, 2022

I Submitter

Device submitter: Azur Medical Company Inc. 6710 Everglades Dr., Richmond, Virginia, VA 23838, USA

Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030

Contact person: Di Zhao General Manager Phone: 928-5922380 Email: dzhao@azur-ppe.com

II Device

Trade Name of Device: Sterile Auto-Disable syringes with/without needle for single use Common Name: Piston Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product code: FMF, FMF, FMI Review Panel: General Hospital

III Predicate Devices

Trade name:	Safety Auto-Disable Syringe with Needle (Auto-Lock)
Common name:	Piston Syringe
Classification:	Class II, 21 CFR 880.5860
Product Code:	MEG, FMF, FMI
Premarket Notification:	K143497
Manufacturer:	Guangdong Intmed Medical Appliance Co., Ltd.

IV Device description

The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male

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connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse.

Syringe Size	Needle Gauge	Needle Length
Available in 1ml, 2ml, 3ml, 5ml and 10ml.	Available in 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 30G	Available in 1/2", 5/8", 1", 1 1/4", 1 1/2"

V Indications for use

VI Comparison of technological characteristics with the predicate devices

The Sterile Auto-Disable syringes with/without needle for single use have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Auto-Disable syringes with/without needle for single use and predicate devices do not alter suitability of the proposed device for its intended use.

Device feature	Subject Device	Predicate Device K143497	Comment
Indications for use	The Sterile Auto-Disablesyringes with/without needlefor single use is used foraspiration of fluids from vialsand ampoules and a variety offluid injections below thesurface of the skin exceptphlebotomy.	The Safety Auto-DisableSyringe with Needle(Auto-Lock) is used foraspiration of fluids from vialsand ampoules and a variety offluid injections below thesurface of the skin exceptphlebotomy.It has a detachable needle witha dedicated fitting. The SafetyAuto-Disabled Syringe withNeedle (Auto-Lock) contains aninner mechanism used to allow	DifferentComment #1
Device feature	Subject Device	Predicate Device K143497	Comment
		the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Product code	FMF, FMI	MEG, FMF, FMI	DifferentComment #2
Regulationnumber	21 CFR 880.5860	21 CFR 880.5860	Same
Class	II	II	Same
Principle ofoperation	For manual use only	For manual use only	Same
Safety Features	Active safety feature, manuallyactivated by user	Active safety feature, manuallyactivated by user	Same
Intended user	Medical professionals andtrained care givers	Medical professionals andtrained care givers	Same
Environment ofuse	Hospitals and clinics	Hospitals and clinics	Same
Syringe volume	1 ml, 3 ml, 5 ml, 10 ml	1ml, 3ml, 5ml, 10ml	Same
Nozzle type	Luer slip; Luer lock	Needle hub Luer connector	Same
Lubricant	Silicone oil	PDMS	Same
Barreltransparency	Transparent and clear	Clear as required byISO 7886-1	Same
Gradationslegibility	Legible	Legible according toISO 7886-1	Same
Needle Length	1/2", 5/8", 1", 1 1/4", 1 1/2"	12-38mm	Same
Needle Gauge	18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G,30G	21G, 22G, 23G, 24G, 25G,26G, 27G, 28G	DifferentComment #3
Configuration ofthe tip	Short bevel, long bevel.	15 °C regular point	DifferentComment #4
Needle hub	Color-coded per ISO 6009	Colorless according to ISO7864	Same
Device feature	Subject Device	Predicate Device K143497	Comment
Single use	Yes	Yes	Same
Performancespecifications	Complies with ISO 7864, ISO7886-1, ISO 7886-4	Conforms to ISO 7864, ISO7886-1, ISO 7886-4	Same
Sterilization	EO	EO	Same
SAL	10-6	10-6	Same
Materials	Barrel: PP	Barrel: Polypropylene	DifferentComment #5
	Plunger: PP	Plunger: Polypropylene
	Piston: Silicone Rubber	Piston: Isoprene rubber
	Needle: Stainless steel	Needle Hub: Polypropylene
	Needle hub: PP	Needle: Stainless SteelNeedle Sheath: Stainless SteelO Ring: Silicone rubber

Pyrogen	Non-pyrogenic	Non-pyrogenic	Same
Biocompatibility	Conforms to ISO 10993 Seebelow	Conforms to ISO10993	Same

Labeling	Meet the requirements of 21CFR Part 801	Meet the requirements of 21CFR Part 801	Same

Table 5-1 Substantial equivalence discussion – Sterile Auto-Disable syringes with/without needle for single use

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Comment #1

The subject device and the predicate device have the same intended use, to aspirate and inject fluids into a patient. The predicate device has a needle safety feature which after use allows the needle to be encapsulated into the plunger rod of the syringe to prevent needle sticks, thus preventing re-use of the syringe. The subject device does not have a needle safety feature but has a disc on the plunger which could be stuck by the buckle of the syringe to prevent re-use of the syringe. The subject device and the predicate device both have the same intended use, this difference does not affect the clinical safety of the subject device.

Comment #2

The subject device and the predicate device are both syringes that render the syringe unusable after injection, the predicate device also has a needle safety feature.

Comment #3

The subject device is available in gauges 18g-30g and the predicate device is available in Performance testing was done per ISO 9626 and ISO 7864 done to 21g-28g. demonstrate that the differences in needle gauges do not affect the clinical safety or effectiveness of the devices.

Comment #4

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The bevel of subject device is different from the predicate device. However, this difference does not affect intended use. The difference was addressed through ISO 9626 and ISO 7864. Therefore, the differences on bevel do not raise different question of safety and effectiveness.

Comment #5

The material of subject device is different from the predicate device. The piston of subject device is silicone rubber while the predicate device is isoprene rubber. The configurations of subject device do not include Needle Sheath compared with predicate device, which was not affect intended use and did not introduce new materials. However, the materials of subject device were demonstrated to be equivalently biocompatible by the biocompatibility tests done. Therefore, the differences on materials do not raise new questions about safety and effectiveness.

VII Performance Testing

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

In accordance with ISO 10993-1, the device is classified as Externally Communicating Device, Blood Path Indirect, Limited Contac (<24 hours). The following tests were conducted:

Cytotoxicity
Skin Sensitization ●
Intracutaneous Reactivity (Irritation) ●
Acute Systemic Toxicity
Material-Mediated Pyrogens
Hemolysis
Particulate Matter per USP <788> ●

Sterilization, Shipping and shelf-life

. EO sterilization validation per ISO11135:2014
. Pyrogen testing per USP <85> Bacterial Endotoxin Test
EO residuals per ISO 10993-7 ●
. Simulated shipping per ASTM D4169
Sterile Barrier Package testing performed on the proposed device: .
- o Seal Strength ASTM F88/F88M-2015
- o Bubble leak testing ASTM D3078-02(2013)
- o Dye Penetration ASTM F1929-2015
. Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16 Standard Guide for Accelerated Aging of sterile barrier Systems for Medical

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Devices

Performance testing

Performance testing is performed according to the following standards:

ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test A methods
A ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
A ISO 7886-4:2018 sterile hypodermic syringes for single use — part 4: syringes with re-use prevention feature.

VIII Conclusion

The differences between the predicate and subject device do not raise any new or different questions of safety or effectiveness. The Sterile Auto-Disable syringes with/without needle for single use are substantially equivalent to The Safety Auto-Disable Syringe with Needle (Auto-Lock) with respect to indications for use, target population, and technological characteristics.

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).