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 plunger can be locked for self-locking.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device: Sterile Auto-Disable Syringes with/without Needle for Single Use. The FDA clearance letter indicates that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (Safety Auto-Disable Syringe with Needle (Auto-Lock), K143497).

However, the provided document does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-driven medical device. The document is a regulatory submission for a physical medical device (syringes) and details its physical, material, and performance characteristics compared to a predicate device.

Specifically, the document discusses:

Device Description: The physical components and mechanism of the auto-disable syringe.
Indications for Use: Aspiration of fluids and fluid injections.
Comparison to Predicate Device: Detailed table comparing features like indications for use, product code, regulation number, class, principle of operation, safety features, intended user, environment of use, syringe volume, nozzle type, lubricant, barrel transparency, graduations legibility, needle length, needle gauge, configuration of the tip, needle hub, single use, performance specifications, sterilization, SAL, materials, pyrogenicity, biocompatibility, and labeling.
Performance Data: Lists various tests conducted to demonstrate the physical device's safety and bio-compatibility, such as biocompatibility testing (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogens, Hemolysis, Particulate Matter), sterilization validation, shipping and shelf-life testing, and performance testing against ISO standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 7886-4, ISO 7886-1).

None of the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device is present in this documentation. The questions about sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment are relevant to AI/ML device evaluations, but not to the type of device described in this 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance and validation using the provided text. The document is about the substantial equivalence of a physical syringe, not a software or AI/ML product.

Summary

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September 8, 2023

Wepon Medical Technology Co., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China

Re: K231727

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: June 8, 2023 Received: June 13, 2023

Dear Esther Zhang:

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

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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,

Alan Guth

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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Indications for Use

510(k) Number (if known) K231727

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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) summary

K231727

l Submitter

Device submitter: Wepon Medical Technology CO., LTD. Floor 4, Building A, No. 58, Jinhu Road, Chengdong Street, Wenling Zhejiang, CN 317500

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

Contact person: Di Zhao

Deputy General Manager Phone: 928-5922380 Email: dizhao@wepon-ppe.com

Date: September 8, 2023

II Correspondent

Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R.China Contact: Esther ZHANG Email: Esther.zhang@llins-tech.com

III 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 21 CFR 880.5570 Regulation Name: Piston Syringe Regulatory Class: II Product code: FMF, FMF, FMI Review Panel: General Hospital

IV Predicate Devices

Trade name:	Safety Auto-Disable Syringe with Needle (Auto-Lock)
Common name:	Piston Syringe

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Classification:	Class II, 21 CFR 880.5860
Product Code:	MEG, FMF, FMI
Premarket Notification:	K143497
Manufacturer:	Guangdong Intmed Medical Appliance Co., Ltd.

V Device description

Syringe Size	Needle Gauge	Needle Length
Available in 1ml, 3ml, 5mland 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"

VI Indications for use

VII 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.

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

Device feature	Subject Device K231727	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 of	The Safety Auto-DisableSyringe with Needle(Auto-Lock) is used foraspiration of fluids from vialsand ampoules and a variety of	DifferentComment #1
Device feature	Subject Device K231727	Predicate Device K143497	Comment
	fluid injections below thesurface of the skin exceptphlebotomy.	fluid 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 allowthe needle to be retractedinside the plunger rod of thesyringe after the operator'sthumb force released. Afteractivation the needle is fullycontained inside the syringeguarding against accidentalneedle sticks during normalhandling and disposal of theused needle/syringecombination.
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	1 ml, 3 ml, 5 ml, 10 ml	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
Device feature	Subject Device K231727	Predicate Device K143497	Comment
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
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: PPPlunger: PPPiston: Silicone RubberNeedle: Stainless steelNeedle hub: PP	Barrel: PolypropylenePlunger: PolypropylenePiston: Isoprene rubberNeedle Hub: PolypropyleneNeedle: Stainless SteelNeedle Sheath: Stainless SteelO Ring : Silicone rubber	DifferentComment #5
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

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Comment #1

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 21g-28g. Performance testing was done per ISO 9626 and ISO 7864 done to demonstrate that the differences in needle gauges do not affect the clinical safety or

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effectiveness of the devices.

Comment #4

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. And the configurations of subject device do not include Needle Sheath compared with predicate device, which does not affect its intended use and does not introduce new materials. However, biocompatibility testing was performed with the subject device and found it to be biocompatible. Therefore, the differences on materials do not raise new questions about safety and effectiveness.

VIII Performance data

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 testing

. 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:
- Seal Strength ASTM F88/F88M-2015 o

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Bubble leak testing ASTM D3078-02(2013) o
Dye Penetration ASTM F1929-2015 o
Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16 . Standard Guide for Accelerated Aging of sterile barrier Systems for Medical 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 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
A ISO 7886-4:2018 sterile hypodermic syringes for single use — part 4: syringes with re-use prevention feature.
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for A manual use

IX Conclusion

The differences between the predicate and subject device do not raise any new or different questions of safety and 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).