The HWJECT Auto-Disable Syringe is intended for aspiration of fluids. Additionally, it features autodisable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.

Device Description

The auto-disable syringe is intended for aspiration and injection of fluids. The subject device is composed of needle cap, barrel, plunger, clip, plunger stopper, and needle tube. The clip cooperates with plunger and barrel to complete self-destruction of the device. It is nonpyrogenic and intended for single use. The auto-disable feature (no sharp injury) involves a design where the syringe automatically becomes inoperable by locking the plunger with the clip after injection to prevent syringe reuse. The capacity of the auto-disable syringe is available in 0.05 mL, 0.1 mL, 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube ranges from 22G to 27G. The needle length ranges from 10 mm to 38 mm.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "HWJECT Auto-disable syringe." The FDA's review concludes that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence to an existing device, rather than proving a novel device's safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the study conducted is primarily non-clinical performance testing and biocompatibility testing, aiming to show that the new device performs comparably to the predicate device and meets established safety standards. There is no information about AI/ML models or human reader studies in this document. The term "acceptance criteria" here refers to the performance standards and regulatory requirements the device must meet to demonstrate substantial equivalence, not statistical measures for an AI model's performance.

Here's an analysis based on the provided text, while explicitly noting that the request for information on AI/ML-specific criteria (like MRMC studies, expert adjudication for ground truth of an AI model, and training/test set sample sizes for AI) is not applicable to this document as it does not describe an AI/ML medical device.

Acceptance Criteria and Device Performance for HWJECT Auto-disable syringe

The acceptance criteria for this device are largely defined by adherence to recognized international and national standards for medical devices, particularly those for hypodermic syringes and needles. The "study" refers to a series of non-clinical tests performed to demonstrate compliance with these standards and substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Standard Compliance/Requirement)	Reported Device Performance
Performance Testing
ISO 7886-3:2020 (Sterile Hypodermic Syringes for Single Use Part 3: Auto-disabled syringes for fixed-dose immunization)	- Limits for acidity or alkalinity- Limits for extractable metals- Lubricant- Tolerance on nominal capacity- Graduated scale- Barrel- Design- Fit of the plunger stopper/plunger in the barrel- Fiducial line- Dead space- Freedom from air and liquid leakage- Auto-disable syringe feature	Performance testing results met the requirements of the standard, demonstrating substantial equivalence to the predicate device. Specific numerical results are not provided in this summary, but the conclusion is conformance. For the auto-disable feature, "Activation force: 2-4 N," and "Auto-disabled, prevents syringe re-use" are explicitly stated as characteristics matching the predicate device.
ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods)	- Stiffness- Resistance to breakage- Resistance to corrosion- Needle O.D.- Needle inner diameter	Performance testing results met the requirements of the standard. For the 22G needle gauge (a difference from the predicate), specific testing was conducted to verify that this difference does not raise new questions of safety and effectiveness, and it was found to be "in accordance with ISO 9626."
ISO 7864:2016 (Sterile hypodermic needles for single use-Requirements and test methods)	- Needle point- Bond between hub and needle tube- Patency of lumen- Cleanliness- Needle length- Testing for measuring the penetration force and drag force for needles	Performance testing results met the requirements of the standard. For needle bonding strength, a range of "62-100 N" is reported, conforming to ISO 7864:2016 requirements. For differences in needle length (extra specifications compared to predicate), non-clinical performance testing validated that these do not raise new safety/effectiveness questions.
USP <788> (Particulate matter in injections)	USP acceptance criteria for particulate matter.	Particulate testing results met the USP acceptance criteria.
Biocompatibility Testing	Compliance with ISO 10993-1 for an Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours), addressing: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity.	The proposed device was tested in compliance with ISO 10993-1, covering all listed parameters. The implication is that the tests passed, allowing the substantial equivalence determination.
Sterility	Achievement of 10^-6^ Sterility Assurance Level (SAL), per ISO 11135:2014 (ethylene oxide sterilization)	Sterilization process confirmed the device reached 10^-6^ SAL, and performance/packaging post-sterilization aligned with expectations.
Shelf Life	Maintain complete sterile state within the five-year labeling period (evaluated under accelerated aging per ASTM F1980).	Shelf-life validation study conducted showing conformance for a five-year period.
Package Integrity	Compliance with ASTM D4169-22 for simulated shipping conditions, ASTM D3078-02 (Vacuum Leak Test), ASTM F1929-15 (Dye Penetration Test), DIN 58953-6:2016 (Microbial Barrier Properties Test), ASTM F88/F88M-21 (Seal Strength Test).	Testing was conducted. "All packaging was deemed acceptable for the protection of product and sterility maintenance."
Simulated Clinical Use Testing	Compliance with FDA Guidance for industry and FDA Stuff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005.	Simulated clinical use testing of the proposed device has been conducted in compliance with the guidance. This likely means the auto-disable mechanism functioned as intended in simulated use.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. These details are typically found in the full test reports referenced by the summary. Standard practices for medical device testing often involve statistical sampling plans (e.g., AQL levels for lot acceptance) rather than a fixed "test set" in the AI sense.
Data Provenance: The manufacturer, Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., is located in China. The testing was conducted in conformance with internationally recognized standards (ISO, ASTM, USP, DIN) and FDA guidance. The data is prospective, generated specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable as the document does not describe a study involving human experts establishing ground truth for an AI/ML model for diagnostic or predictive purposes. The "ground truth" here is the adherence to engineering and material science standards (e.g., a needle's bond strength, a syringe's sterility, the function of the auto-disable feature), verified through objective testing methods.

4. Adjudication Method for the Test Set

This is not applicable. There is no "adjudication" (in the sense of expert consensus on complex data interpretations) because the tests are governed by clear, objective, and measurable parameters defined by international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is a clinical study design used to evaluate the diagnostic accuracy of a radiology AI/ML device, often comparing human readers with and without AI assistance. This document is for an auto-disable syringe, which is a mechanical medical device, not an AI/ML diagnostic software. Therefore, such a study was not conducted.

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

This is not applicable. There is no AI algorithm being evaluated. The device's performance is inherently "standalone" in that its mechanical functions (auto-disable, fluid aspiration/injection) are tested directly.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" is defined by:
- Engineering and Performance Specifications: As set forth in standards like ISO 7886-3, ISO 9626, ISO 7864, which define acceptable parameters for physical and functional properties (e.g., specific ranges for "Activation force," limits for "extractable metals," "freedom from liquid leakage").
- Material Science Properties: Adherence to material specifications (e.g., "stainless steel" for needle/clip, "PP" for barrel/plunger).
- Sterility Assurance: Demonstrated through documented sterilization processes and testing to achieve a specific SAL.
- Biocompatibility: Demonstrated through specific tests (cytotoxicity, sensitization, etc.) as per ISO 10993.
- Functional Success: The auto-disable feature either successfully locks the plunger after injection or it does not.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable. There is no AI/ML model or corresponding training data/ground truth in this submission.

Summary

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March 19, 2024

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd % Tanya Wang, Technical Manager Shanghai Mind-Link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang District Shanghai, 201114, China

Re: K234024

Trade/Device Name: HWJECT Auto-disable syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: December 6, 2023 Received: December 20, 2023

Dear Tanya Wang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Shruti N. Mistry -S

Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K234024

Device Name HWJECT Auto-disable syringe

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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510(k) Summary

1. Preparation date: February 17, 2024

2. Submitter

Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd Address: No.2 Guanyin Road, Taihu Economic Development Zone Contact person: Xiang Bingyi, 86-556 5129666, hwj1@hongyu-wuzhou.cn Submission correspondent: Tanya Wang, 86-15216694647, tanya.wang@mind-link.net

3. Device

Trading name: HWJECT Auto-disable syringe Common name: Auto-disable syringe Regulation No.: 21 CFR 880.5860 Classification name: Piston Syringe Classification: Class II Product code: FMF

4. Predicate device

Predicate device: K210464, Auto Disable Syringe

5. Device description

The auto-disable feature (no sharp injury) involves a design where the syringe automatically becomes inoperable by locking the plunger with the clip after injection to prevent syringe reuse. The capacity of the auto-disable syringe is available in 0.05 mL, 0.1 mL, 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube ranges from 22G to 27G. The needle length ranges from 10 mm to 38 mm.

Table 1 Device specification
Syringe volume	Needle Gauge	Needle Length
0.05 mL	27G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm, 28 mm
	26G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm, 28 mm
0.1 mL	27G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm, 28 mm, 30 mm, 32 mm, 38 mm
	26G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	25G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	24G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	23G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	22G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
0.3 mL	27G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	26G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	25G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	24G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	23G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	22G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
0.5 mL	27G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	26G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	25G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	24G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	23G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	22G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
1 mL	27G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	26G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	25G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	24G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	23G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm
	22G	10 mm, 13 mm, 16 mm, 20 mm, 25 mm,28 mm, 30 mm, 32 mm, 38 mm

Table 1 Device specification

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6. Indications for use

The HWJECT Auto-Disable Syringe is intended for aspiration and injection of fluids. Additionally, it features auto-disable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.

7. Comparison of technological characters between proposed and predicate device

7.1 Comparison of technological characters Table Characters comparison

Characters	Subject device, (K234024, HWJECTAuto-disable syringe)	Predicate device, (K210464,AutoDisable Syringe)	Remark
Product code	FMF	FMF	Same
Regulation No.	21 CFR 880.5860	21 CFR 880.5860	Same
Classification	II	II	Same
Indications foruse	The HWJECT Auto-Disable Syringeis intended for aspiration andinjection of fluids. Additionally, itfeatures auto-disable feature (nosharp injury protection feature)that involves a design where thesyringe automatically becomesinoperable by locking the plungerwith clip after injection to preventsyringe reuse.	The AUTO DISABLE SYRINGE isintended for use in the suctionand injection of vaccine formedical purposes. Additionally,after injection to the body, theplunger can be automaticallylocked by the triggeredmechanism to prevent the re-useof this syringe.	Different#1
Principle ofoperation	The subject device has auto-disablefeature that avoids reuse of syringeby locking the plunger with metalclip after injection. The metal clipcooperates with plunger and barrelto complete self-destruction of theauto-disable syringe.	The syringe consists of acalibrated hollow barrel, amovable plunger, a rubberstopper assembled at the end ofthe plunger, and a steel clipinstalled between the barrel andthe plunger that functions toprevent re-use of the syringe.	Different#2
Single-use	Single-use	Single-use	Same
Labeling	Meet the requirements of 21 CFRPart 801	Meet the requirements of 21 CFRPart 801	Same
Non-pyrogenic	Non-pyrogenic	Non-pyrogenic	Same
Sterilizationmethod	EO sterilization	EO sterilization	Same
SAL 10-6	10-6	10-6	Same
Capacity	0.05 mL, 0.10 mL, 0.3 mL, 0.5 mL, 1mL	0.05 mL, 0.10 mL, 0.20 mL, 0.25mL, 0.30 mL, 0.40 mL, 0.50 mL,1.0 mL	Same

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Gauge size	22G, 23G, 24G, 25G, 26G, 27G	23G, 24G, 25G, 26G, 27G, 28G,29G, 30G	Different #3
Needle length	10 mm, 13 mm, 16 mm, 20 mm, 25mm, 28 mm, 30 mm, 32 mm, 38mm	10 mm, 13 mm, 25 mm	Different #4
Tip Type	Fixed Needle	Fixed Needle	Same
Needle bondingstrength	62-100 NConforming to the requirements ofISO 7864:2016	Conforming to the requirementsof ISO 7864:2016	Same
Configurationand materials	Barrel: PPPlunger: PPNeedle: stainless steelPiston: Syntheticrubber(Polyisoprene Rubber)Clip: stainless steel	Barrel: PPPlunger: PPPiston: Latex Free(Polyisoprene Rubber)Needle: stainless steelClip: stainless steel	Same
ReusePrevention(Safety Feature)	Activation force: 2-4 NAuto-disabled, prevents syringe re-use	Auto-disabled, prevents syringere-use	Same
Lubricant forbarrel	Silicone oil	Silicone oil	Same
Barreltransparency	Clear	Clear	Same
GraduationLegibility	Bold Markings	Bold Markings	Same
Performance	Conforming to the requirements ofISO 7886-3, ISO 7886-1, ISO 9626,and ISO 7864	Conforming to the requirementsof ISO 7886-3, ISO 7886-1, ISO9626, and ISO 7864	Same
Biocompatibility	• Cytotoxicity• Sensitization• Irritation• Acute Systemic Toxicity• Pyrogenicity• Hemocompatibility	• Cytotoxicity• Sensitization• Irritation• Acute Systemic Toxicity• Pyrogenicity• Hemocompatibility	Same
Shelf life	5 years	5 years	Same

7.2 Substantial equivalence analysis

Different #1

The indications for use are generally identical, while the predicate device provides additional details for vaccine injection. However, both the predicate device and the subject device have the same configuration. The non-clinical performance testing has been conducted to verify the similarity.

In conclusion, the subject device and the predicate device are substantially equivalent.

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Different #2

The principle of operation for the subject device and predicate device are generally identical. The metal clip cooperates with the plunger and barrel to complete the self-destruction of the auto-disable syringe. This difference does not raise new questions of safety and effectiveness when compared to the predicate device.

Different #3

The 22G needle gauge of the subject device isn't within the range of the predicate device. The subject device of the above needle gauge is in accordance with ISO 9626. The performance of the 22G subject device has been conducted to verify that this difference does not raise new questions of safety and effectiveness when compared to the predicate device. In conclusion, the subject device and the predicate device are substantially equivalent.

Different #4

The needle length of the subject device is different from the predicate device, that has extra specifications. Both of them fulfill the requirements of ISO 9626 and ISO 7864. The non-clinical performance testing has been conducted to verify that the subject device's extra specifications do not raise new questions of safety and effectiveness of the when compared to the predicate device.

In conclusion, the subject device and the predicate device are substantially equivalent.

8. Non-clinical testing

Performance Testing

The subject device was tested and demonstrated to be in conformance with the following FDA-recognized standards. The performance testing results met the requirements of the following standards demonstrating that the device is substantially equivalent to the predicate device.

ISO 7886-3:2020: Sterile hypodermic syringes for single use Part 3: Auto-disabled syringes for fixed-dose immunization

Limits for acidity or alkalinity
Limits for extractable metals
Lubricant
Tolerance on nominal capacity
Graduated scale
Barrel
Design
Fit of the plunger stopper/plunger in the barrel
Fiducial line
Dead space
Freedom from air and liquid leakage
Auto-disable syringe feature

ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of

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medical devices-Requirements and test methods

Stiffness ●
Resistance to breakage
Resistance to corrosion
Needle O.D.
Needle inner diameter

ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use-Requirements and test methods

. Needle point
Bond between hub and needle tube
Patency of lumen
. Cleanliness
Needle length ●
Testing for measuring the penetration force and drag force for needles

Particulate testing was conducted in accordance with USP <788>. The testing results met the USP acceptance criteria.

Biocompatibility Testing

The proposed device was tested in compliance with ISO 10993-1, as the Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours).

Cytotoxicity
Sensitization
Irritation
. Acute Systemic Toxicity
Hemocompatibility
Pyrogen

Sterility and Shelf life

The sterilization process has been conducted to confirm that the subject device reached 10° sterility assurance level and the performance of the products and packaging are in line with expectations after sterilization requirements per ISO 11135:2014.

The shelf-life validation study was conducted under the accelerated aging condition according to ASTM F1980 to determine the auto-disable syringe maintain a complete sterile state within the five-year labeling period.

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Package Integrity

Package integrity testing under simulated shipping conditions was conducted to satisfy the requirements in ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging was deemed acceptable for the protection of product and sterility maintenance.

Sterile barrier testing was conducted in compliance with the following FDA-recognized consensus standards.

Vacuum Leak Test, ASTM D3078-02;
. Dye Penetration Test ASTM F1929-15;
Microbial Barrier Properties Test DIN 58953-6: 2016;
. Seal Strength Test ASTM F88/F88M-21.

Simulated clinical use testing

Simulated clinical use testing of the proposed device has been conducted in compliance with the FDA Guidance for industry and FDA Stuff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005.

9. Clinical testing

Not applicable for this submission.

10. Conclusion

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