Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use

• K Number: K212920
• Device Name: Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
• Manufacturer: Shandong Weigao Group Medical Polymer Co., Ltd.
• Date Cleared: 2022-03-11 ( 178 days)
• Product Code: FMF , FMI , MEG
• Regulation Number: 880.5860
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K170651 , K201234
• Predicate For: N/A

Intended Use

The Sterile Safety Syringe with Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The Sterile Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.

Device Description

The Sterile Safety Syringe with Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Safety Hypodermic Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. The Sterile Auto-Disable Syringe with Needle for Single Use is available in various capacities of syringes.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

AI/ML Overview

The provided text describes a 510(k) summary for Sterile Safety Syringes and Needles. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a multi-reader multi-case (MRMC) study.

Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment for AI/ML device validation are not present in this document, as this is a traditional medical device submission.

However, I can extract information related to the non-clinical performance tests that serve as acceptance criteria for this type of device and how the device proved it met them.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this non-AI/ML device are primarily based on compliance with established international standards and demonstration of substantial equivalence to predicate devices through various non-clinical tests. The reported device performance is presented as meeting these standards and showing similar performance to predicates.

Acceptance Criteria (Standard/Test)	Reported Device Performance
Sterile Safety Syringe with Needle for Single Use	Complied with
ISO 7886-1: 2017 (Sterile hypodermic syringes for manual use)	Complied with
ISO 9626: 2016 (Stainless steel needle tubing)	Complied with
ISO 80369-7: 2016 (Small-bore connectors)	Complied with
Sterile Safety Hypodermic Needle for Single Use	Complied with
ISO 7864: 2016 (Sterile hypodermic needles)	Complied with
ISO 9626: 2016 (Stainless steel needle tubing)	Complied with
Sterile Auto-Disable Syringe with Needle for Single Use	Complied with
ISO 7886-3: 2020 (Auto-disabled syringes for fixed-dose immunization)	Complied with
Sterile Barrier Packaging Tests	Results Met Criteria
Visual inspection (ASTM F1886/F1886M-16)	Integrity maintained
Seal strength (ASTM F88/F88-15)	Integrity maintained
Dye penetration test (ASTM F1929-15)	Integrity maintained
Sterilization and Shelf Life Tests	Results Met Criteria
EO residue (ISO 10993-7:2008)	Did not exceed limit
ECH residue (ISO 10993-7:2008)	Did not exceed limit
Bacteria Endotoxin Limit (USP<85>)	Did not exceed 20 EU/device
Shelf Life Evaluation (Physical, Mechanical, Chemical, Package Tests on aging samples)	Device maintained performance during claimed shelf life (3 years)
Biocompatibility Tests	Results Showed No Negative Impacts
Cytotoxicity	No cytotoxicity
Sensitization	No skin sensitization
Intracutaneous (Irritation)	No intracutaneous reactivity
Acute Systemic Toxicity	No systemic toxicity
Hemolysis	No Hemolysis
Pyrogen	No Pyrogen
Particulate testing	(Presence of particulars not explicitly stated as an acceptance criterion in table, but noted as evaluated)
Simulated Clinical Study	The proposed device met the pre-established criteria according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism.
Safety Feature Test (Comparison to Predicate)	Test data of the proposed device is "very close" to the test data of the predicate device.
Simulated Distribution (ASTM D4169-16)	Packing can protect the proposed device from damage during storage and distribution environments.

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Additional Details (Based on available information and the nature of this submission):

2. Sample sizes used for the test set and the data provenance:

   • The document does not specify exact sample sizes for each non-clinical test performed (e.g., how many syringes were tested for each performance characteristic, or how many samples for biocompatibility).
   • The data provenance is implied to be from non-clinical testing conducted by the manufacturer, Shandong Weigao Group Medical Polymer Co., Ltd. (China). These are laboratory tests, not human data. The document does not specify if the tests were performed retrospectively or prospectively relative to the submission date, but typical device testing for 510(k) is performed as part of the development and validation process.

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

   • N/A. This is a submission for a traditional medical device (syringes and needles), not an AI/ML device that requires human expert review to establish "ground truth" for interpretive tasks (like image classification). The "ground truth" for this device's performance is established by objective measurements and compliance with international standards in laboratory settings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. This concept applies to human reader studies often conducted for AI/ML devices where there might be disagreement among readers. For physical device testing, adjudication methods generally involve standardized measurement protocols and calibration, not expert consensus.

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:

   • No. This is not an AI/ML device, so an MRMC study is not applicable or mentioned.

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

   • N/A. This is not an AI/ML device. The "standalone" performance here refers to the device itself meeting the defined physical and performance criteria.

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

   • The "ground truth" for this device's performance is based on objective, measurable criteria as defined by international standards (e.g., ISO, ASTM). For example:
     • Needle sharpness and bend resistance are measured via mechanical tests.
     • Syringe flow rates and accuracy are measured via fluid dynamics tests.
     • Biocompatibility is assessed through standardized biological assays.
     • Sterility is validated through microbiological testing (SAL).
     • Safety mechanism effectiveness is assessed via simulated use tests following FDA guidance and ISO standards.

8. The sample size for the training set:

   • N/A. This is a manufactured physical device, not an AI/ML algorithm that requires a "training set."

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

   • N/A. Not applicable.

Summary

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March 11, 2022

Shandong Weigao Group Medical Polymer Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China

Re: K212920

Trade/Device Name: Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use.Sterile Auto-Disable Syringe with Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF. FMF. MEG Dated: February 9, 2022 Received: February 11, 2022

Dear Diana Hong:

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

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

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

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] 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) K212920

Device Name

Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use, Sterile Auto-Disable Syringe With Needle for Single Use

Indications for Use (Describe)

The Sterile Safety Syringe with Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The Sterile Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.

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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K212920 510(k) Summary

• 1. Date of Preparation: March 11, 2022
• 2. Sponsor Identification:

Shandong Weigao Group Medical Polymer Co., Ltd.

No.18 Xingshan Road, Torch Hi-tech Science Park, 264210 Weihai, Shandong Province, PEOPLE'S REPUBLIC OF CHINA.

Establishment Registration Number: 3007084575

Contact Person: Lina Liu Position: QA Manager Tel: [phone] Fax: [phone] Email: [e-mail]

• 3. Designated Submission Correspondent:
     Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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• Identification of Proposed Device: 4.
  Trade Name: Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use Sterile Auto-Disable Syringe with Needle for Single Use Common Name: Piston syringe and antistick needle

Classification Name: Piston Syringe Syringe Antistick Classification: II Product Code: FMF; MEG Regulation Number: 21CFR 880.5860

Classification Name: Hypodermic Single Lumen Needle Classification: II Product Code: FMI Regulation Number: 21 CFR 880.5570

• 5. Identification of Predicate Devices:
     510(k) Number: K170651

Product Name: Sterile Disposable Syringe with Safety Needle (used as predicate device) Sterile Disposable Syringe with Needle Sterile Disposable Syringe Sterile Disposable Safety Needle (used as predicate device) Sterile Disposable Needle

510(k) Number: K201234 Product Name: BD SoloShot Mini Syringe/ BD Auto Disable Syringe

Indications for Use:

The Sterile Safety Syringe with Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The Sterile Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately

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after use to minimize risk of accidental needlesticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.

Device Description:

The Sterile Safety Syringe with Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Safety Hypodermic Needle for Single Use is intended for manual and single use only, which consists of a hypodermic needle with a safety shield attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids. The Sterile Auto-Disable Syringe with Needle for Single Use is available in various capacities of syringes.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The specifications of the proposed devices are provided in following table.

Needle Gauge	Needle Length
30G	13mm, 16mm, 19mm
29G	13mm, 16mm, 19mm
28G	13mm, 16mm, 19mm
27G	13mm, 16mm, 19mm
26G	13mm, 16mm, 19mm
25G	16mm, 19mm, 25mm, 38mm
24G	16mm, 19mm, 25mm
23G	19mm, 25mm, 32mm, 38mm
22G	19mm, 25mm, 32mm, 38mm

Table 1. Specifications of the Sterile Safety Hypodermic Needle for Single Use

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21G	19mm, 22mm, 25mm, 32mm, 38mm
20G	19mm, 22mm, 25mm, 32mm, 38mm
19G	25mm, 32mm, 38mm
18G	19mm, 22mm, 32mm, 38mm

Table 2. Specifications of the Sterile Safety Syringe with Needle for Single Use

Syringe volume	Needle Gauge	Needle Length
1mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm, 19mm
	26G	13mm, 16mm, 19mm
	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm
2mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm, 19mm
	26G	13mm, 16mm, 19mm
	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
18G	19mm, 22mm, 32mm, 38mm
2.5mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm, 19mm
	26G	13mm, 16mm, 19mm
	25G	16mm, 19mm, 25mm, 38mm
3mL	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm
5mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm, 19mm
	26G	13mm, 16mm, 19mm
	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm
10mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm, 19mm
	26G	13mm, 16mm, 19mm
	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm
20mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm, 19mm
	26G	13mm, 16mm, 19mm
	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm
25mL	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm
30mL	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm
50mL	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm
100mL	25G	16mm, 19mm, 25mm, 38mm
	24G	16mm, 19mm, 25mm
	23G	19mm, 25mm, 32mm, 38mm
	22G	19mm, 25mm, 32mm, 38mm
	21G	19mm, 22mm, 25mm, 32mm, 38mm
	20G	19mm, 22mm, 25mm, 32mm, 38mm
	19G	25mm, 32mm, 38mm
	18G	19mm, 22mm, 32mm, 38mm

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Table 3. Specifications of the Sterile Auto-Disable Syringe with Needle for Single Use

Syringe volume	Needle Gauge	Needle Length
0.2mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm
	26G	16mm, 19mm
	25G	16mm, 19mm, 32mm, 38mm
	24G	16mm, 19mm
	23G	19mm, 25mm, 32mm, 38mm
0.5mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm
	26G	16mm, 19mm
	25G	16mm, 19mm, 32mm, 38mm
	24G	16mm, 19mm
	23G	19mm, 25mm, 32mm, 38mm
1mL	30G	13mm, 16mm, 19mm
	29G	13mm, 16mm, 19mm
	28G	13mm, 16mm, 19mm
	27G	13mm, 16mm
	26G	16mm, 19mm
	25G	16mm, 19mm, 32mm, 38mm
	24G	16mm, 19mm

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	23G	19mm, 25mm, 32mm, 38mm
--	-----	------------------------

• 6. Substantially Equivalent (SE) Comparison:

		Table 4. General Comparison of Sterile Safety Syringe with Needle for Single Use

ITEM	Proposed Device	Predicate Device K170651	Comments
Product	Sterile Safety Syringe with Needle for Single Use	Sterile Disposable Syringe with Safety Needle	/
Product Code	FMFFMIMEG	FMFFMIMEG	Same
Regulation Number	21 CRF 880.586021 CRF 880.5570	21 CRF 880.586021 CRF 880.5570	Same
Class	Class II	Class II	Same
Indication for Use	The Sterile Safety Syringe with Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.	The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.	Same
Configuration	Syringe Barrel (luer lock/luer slip)PlungerPistonNeedle HubNeedle tubeNeedle capSafety shield	Syringe Barrel (luer lock/luer slip)PlungerPistonNeedle HubNeedle tubeNeedle capSafety shield	Same
Operation Mode	For manual use only	For manual use only	Same
Single Use	Single Use	Single Use	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Syringe	1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 20ml, 25ml, 30ml, 50ml, 100ml	1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml	DifferentComment #1
Syringe Volume
The Syringe volume for proposed device is different from the predicate device. This difference does not affectintended use and this technological difference does not raise new questions of safety and effectiveness.
Syringeperformance	Complied withISO 7886-1	Complied withISO 7886-1	Same
Needle Type	Connector Luer Lock/Luer Slip	Luer Lock /Luer Slip	Same
	Size	18G, 19G, 20G, 21G, 22G, 23G,24G, 25G, 26G, 27G, 28G, 29G,30G	16G,18G, 19G, 20G, 21G, 22G, 23G,24G, 25G, 26G, 27G, 28G, 29G, 30G	DifferentComment #2
	Length	13mm, 16mm, 19mm, 22mm,25mm, 32mm, 38mm	8mm(5/16"), 13mm(1/2"),16mm(5/8"), 20mm(3/4"), 25mm(1"),32mm(1-1/4"), 38mm(1-1/2")	DifferentComment #2
	Needlehub	Color-coded per ISO 6009	Color-coded per ISO 6009	Same
Comment #2
Needle Size and Length
The needle size and length for proposed device is different from the predicate device. However, the needle sizeand length of the proposed device is included in the range of the needle size and length of the predicate device.
Therefore, this difference does not affect safety and effectiveness of the proposed device.
NeedlePerformance	Syringe	Complied withISO 7886-1Iso 9626-1	Complied withISO 7886-1Iso 9626-1	Same
Material		Barrel Polypropylene (PP)	Barrel Polypropylene (PP)	Same
		Plunger Polypropylene (PP)	Plunger Polypropylene (PP)	Same
		Piston Polyisoprene	Piston Polyisoprene	Same
		Hub Polypropylene (PP)	Hub Polypropylene (PP)	Same
		Needletube Stainless Steel	Needletube Stainless Steel	Same
		Needlecap Polypropylene (PP)	Needlecap Polypropylene (PP)	Same
		Safetyshield Polypropylene (PP)	Safetyshield Polypropylene (PP)	Same
Cytotoxicity		No cytotoxicity	No cytotoxicity	Same
Irritation		No intracutaneous reactivity	No intracutaneous reactivity	Same
Sensitization		No skin sensitization	No skin sensitization	Same
Systemic Toxicity		No systemic toxicity	No systemic toxicity	Same
Hemolysis		No Hemolysis	No Hemolysis	Same
Pyrogen		No Pyrogen	No Pyrogen	Same
Method
SAL	10-6	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	Same

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Table 5. General Comparison of Sterile Safety Hypodermic Needle for Single Use

ITEM	Proposed Device	Predicate Device K170651	Comment
Product	Sterile Safety Hypodermic Needle for Single Use	Sterile Disposable Safety Needle	/
Product Code	FMI	FMI	Same
Regulation No.	21 CRF 880.5570	21 CRF 880.5570	Same
Class	Class II	Class II	Same
Indication for Use	The Sterile Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.	The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.	Same
Configuration	HubNeedle tubeNeedle capSafety shield	HubNeedle tubeNeedle capSafety shield	Same
Operation Mode	For manual use only	For manual use only	Same
Single Use	Single Use	Single Use	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Connector Type	Luer Lock/Luer Slip	Luer Lock /Luer Slip	Same
Needle Gauge	18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G	16G,18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G	DifferentComment #3
Needle Length	13mm, 16mm, 19mm, 22mm, 25mm, 32mm, 38mm	8mm(5/16"),13mm(1/2"), 16mm(5/8"), 20mm(3/4"), 25mm(1"), 32mm(1-1/4"), 38mm(1-1/2")	DifferentComment #3
Comment #3Needle Gauge and length

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Needle Hub
Needle Performance	Complied withISO 7864ISO 9626	Complied withISO 7864,ISO 9626	Same
Safety mechanism	Similar safety shield and same manual activated mechanism.	Similar safety shield and same manual activated mechanism.	Same
Material	Needle hub	Polypropylene (PP)	Needle hub	Polypropylene (PP)	Same
	Needle tube	Stainless Steel	Needle tube	Stainless Steel	Same
	Safety Shield	Polypropylene (PP)	Safety Shield	Polypropylene (PP)	Same
	Needle Cap	Polypropylene (PP)	Needle Cap	Polypropylene (PP)	Same
Biocompatibility
Cytotoxicity	No cytotoxicity	No cytotoxicity	Same
Irritation	No intracutaneous reactivity	No intracutaneous reactivity	Same
Sensitization	No skin sensitization	No skin sensitization	Same
Systemic Toxicity	No systemic toxicity	No systemic toxicity	Same
Hemolysis	No Hemolysis	No Hemolysis	Same
Pyrogen	No Pyrogen	No Pyrogen	Same
Sterilization
Method	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	Same

Table 6. General Comparison of Sterile Auto-Disable Syringe with Needle for Single Use

ITEM	Proposed Device	Predicate Device K201234	Comment
Product	Sterile Auto-Disable Syringe withNeedle for Single Use	BD SoloShot™ Mini Syringe/BDAuto Disable Syringe	/
Product Code	FMF	FMF	Same
RegulationNumber	21 CRF 880.5860	21 CRF 880.5860	Same
Class	Class II	Class II	Same

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Indicationfor	The Sterile Auto-Disable Syringewith Needle for Single Use isintended for aspiration and injectionof fluids.	The BD SoloShot™ Mini Syringe/ BDAuto Disable Syringe is intended foraspiration and injection of fluids.	Same
Use
Configuration	BarrelPlungerPistonIntegral needleNeedle capCard	BarrelOne-piece plunger rod (without rubberstopper)Clip affixed to the plunger rodIntegral needleShield cover	DifferentComment#4

Comment #4

Configuration

The configuration for proposed device is different from the predicate device. The main difference is that the proposed device contains rubber stopper. This technological difference may impact performance or biocompatibility. However, these are not new questions of safety and effectiveness from the predicate device.

ReusePrevention(Safety) Feature	Auto-disabled (Miniature size),prevents syringe re-use	Auto-disabled (Miniature size),prevents syringe re-use	Same
Dose SavingFeature	Low Dead Space/Volume	Low Dead Space/Volume	Same
IntegratedNeedle	Yes	Yes	Same
DoseSetting/Volumes	Fixed doses: 0.2ml, 0.5 ml, 1ml	Fixed doses: 0.5 ml	DifferentComment#5

Comment #5

Dose Setting/Volumes

The dose volumes for proposed device is different from the predicate device. This technological difference does not raise new questions of safety and effectiveness of the proposed device.

		Single Use	Single Use	Same
	Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
	Syringe performance	Complied with ISO 7886-3	Complied with ISO 7886-3	Same
Needle	Gauge	23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G	23G, 24G, 25G	DifferentComment #6
	Length	13mm, 16mm, 19mm, 25mm, 32mm, 38mm	16mm(5/8"), 20mm(3/4"), 25mm(1")	DifferentComment

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					#6
Comment #6
Needle Gauge and Length
The needle gauge and length for proposed device is different from the reference device. This difference does
not affect intended use and the technological difference does not raise new questions of safety and effectiveness
of the proposed device.
Needle Hub		Color-coded per ISO 6009	Color-coded per ISO 6009	Same
Material		Barrel: Polypropylene (PP)	Barrel: Plastic	Different
		Plunger: Polypropylene (PP)	Plunger: Plastic + Colorant (blue,	Comment
		Piston: Polyisoprene	violet,	#7
		Integral needle: Stainless Steel	orange)
		Card: Stainless Steel	Clip: Stainless Steel
		Needle Cap: Polypropylene (PP)	Integrated Cannula: Stainless Steel
			Shield: Plastic
Comment #7
Material
The material for proposed device is different from the reference device. This difference does not raise new
questions of safety and effectiveness.
Cytotoxicity		No cytotoxicity	No cytotoxicity	Same
Irritation		No intracutaneous reactivity	No intracutaneous reactivity	Same
Sensitization		No skin sensitization	No skin sensitization	Same
Systemic		No systemic toxicity	No systemic toxicity	Same
Toxicity
Hemolysis		No Hemolysis	No Hemolysis	Same
Pyrogen		No Pyrogen	No Pyrogen	Same
Sterilization		EO Sterilized	EO Sterilized	Same
Method
SAL		10-6	10-6	Same

• 7. Non-Clinical Test Conclusion
     Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device and reference device.

Performance Test

The test results demonstrated that the proposed device complies with the following standards:

• ▲ ISO 7864: 2016 Sterile hypodermic needles for single use - Requirements and test methods

• ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods

• ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7:

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Connectors for intravascular or hypodermic applications

• ISO 7886-1: 2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

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

Sterile Barrier Packaging Test

Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.

Sterilization and Shelf Life Test

Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.

Item	Standard
EO residue	ISO 10993-7:2008
ECH residue	ISO 10993-7:2008
Bacteria Endotoxin Limit	USP<85>
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package Tests wereperformed on aging samples to verify the claimedshelf life of the device

Biocompatibility Test

The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (<24 hours). The proposed device was evaluated for the following tests. The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.

• Cytotoxicity,

• Sensitization,

• Intracutaneous,

• Acute Systemic Toxicity,

• Hemolysis,

• Pyrogen

• Particulate testing

Simulated Clinical Study

A simulated clinical study was performed on proposed device according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results

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demonstrated that the proposed device met the pre-established criteria.

Safety Feature Test

The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that both the test data of the proposed device is very close to the test data of the predicate device.

Simulated Distribution

The simulated shipping distribution performed on proposed device according to ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. The test results demonstrate that packing can protect the proposed device from damage during storage and distribution environments.

Clinical Test Conclusion 8.

No clinical study is included in this submission.

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the differences between the subject devices and the predicate devices do not raise new or different questions of safety or effectiveness. The subject devices are Substantially Equivalent (SE) to the predicate devices 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).