Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe 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.
Hypodermic Safety Needle: The Hypodermic Safety Needle is intended to be used with a 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.

Device Description

The device is used for subcutaneous injection, intravenous injection of blood and preparation of liquid medicine. The needle tube will be pushed into safety cap after use. It is designed to aid in the prevention of needle stick injuries. This device is a single use device, which is delievered sterile. The device is a disposable anti-needle stick syringe made of the following components: Needle cap, Needle tube, Safety shield, Needle hub, Barrel, Plunger, Plunger stopper.

AI/ML Overview

The provided document describes the acceptance criteria and the studies conducted for the Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.'s Hypodermic Safety Needle and Hypodermic Safety Needle with Syringe.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The document states that "All of the pre-determined acceptance criteria were met" for each of the performance tests, biocompatibility tests, and sterility information tests. Specific numerical acceptance criteria are generally not explicitly detailed in this type of summary report but are implied by adherence to the referenced standards.

Type of Test	Acceptance Criteria (Implied by standard adherence)	Reported Device Performance
Performance Testing	Met requirements of referenced ISO standards	All pre-determined acceptance criteria were met.
ISO 9626: 2016-08-01	(Stainless steel needle tubing requirements)	Met.
ISO 7864: 2016-08-01	(Sterile hypodermic needles requirements)	Met.
ISO 594-1:1986-06-15	(Luer taper fittings - General requirements)	Met.
ISO 594-2: 1998-09-01	(Luer taper fittings - Lock fittings)	Met.
ISO 23908: 2011-06-11	(Sharps injury protection requirements)	No failures of the safety feature were demonstrated.
ISO 7886-1: 2017-05	(Sterile hypodermic syringes requirements)	Met.
ISO 6009: 2016-08-01	(Needle color coding requirements)	Met.
Simulated Clinical Study	No failures of the safety feature	No failures of the safety feature of the Hypodermic Safety Needle with Syringe. All pre-determined acceptance criteria were met.
Biocompatibility Testing	Met requirements of referenced ISO/ASTM standards	All pre-determined acceptance criteria were met.
In Vitro Cytotoxicity	(ISO10993-5: 2009)	Met.
Skin Sensitization	(ISO10993-10: 2010)	Met.
Intracutaneous Reactivity Test	(ISO10993-10: 2010)	Met.
Acute Systemic Toxicity	(ISO10993-11; 2006)	Met.
Coagulation test	(ISO10993-4: 2002 Amd1:2006(E))	Met.
Complement activity Test	(ISO10993-4: 2002 Amd1:2006(E))	Met.
Hemolytic Properties Test	(ASTM F756-13)	Met.
Pyrogen Test	(ISO 10993-11:2006)	Met.
Subacute/Subchronic Toxicity Testing	(Implied by ISO10993-1 and ISO10993-11)	Met.
USP 788 Particulate Matter	(USP 788 standard)	Met.
Sterility Information	Met requirements of referenced ISO/ANSI/AAMI standards	All pre-determined acceptance criteria were met.
Package and Shelf Life	Met requirements of referenced ISO/ASTM standards to support 5-year shelf life	The test result supports the 5 years shelf life claim. All pre-determined acceptance criteria were met.

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

The document does not explicitly state the specific sample sizes used for each test set. It mentions a "simulated clinical study" but does not provide details on the number of devices tested.
The data provenance is implied to be from internal testing conducted by the manufacturer, Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., likely in China (Anhui Province China is listed as the manufacturer's location). The studies are retrospective as they were conducted to support a premarket notification.

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

This information is not provided in the document. The document describes bench testing, simulated clinical studies, biocompatibility, sterility, and packaging tests, which typically rely on standardized methods and laboratory results rather than expert consensus on ground truth in the way a clinical imaging study might.

4. Adjudication method for the test set

This information is not applicable and is not provided. The testing described does not involve expert adjudication or interpretation for ground truth.

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 to the device described. The device is a medical hardware product (safety needle/syringe), not an AI diagnostic or assistive tool.

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

This is not applicable to the device described as it is not an algorithm or AI product. The "simulated clinical study" refers to testing the physical safety feature of the needle/syringe.

7. The type of ground truth used

For the performance testing, biocompatibility, sterility, and package/shelf life, the "ground truth" is defined by adherence to specific international and national standards (ISO, ASTM, USP, AAMI, ANSI). For example, for sharps injury prevention, the ground truth is whether the safety feature prevents accidental needle sticks as per ISO 23908 requirements. For biocompatibility, the ground truth is that the materials do not elicit adverse biological responses as per ISO 10993.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is not an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

October 4, 2019

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K190183

Trade/Device Name: Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMI Dated: September 03, 2019 Received: September 06, 2019

Dear Charles Mack:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For 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) K190183

Device Name

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe

Indications for Use (Describe)

Hypodermic Safety Needle with Syringe

The Hypodermic Safety Needle with Syringe 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.

Hypodermic Safety Needle

The Hypodermic Safety Needle is intended to be used with a 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.

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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K190183 510(K) SUMMARY

Preparation Date:	October 3rd 2019
Manufacturer's Name:	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.No. 2 Guanyin Road, Economic Development Zone, Taihu, Anqing CityAnhui Province China 246400
Corresponding Official:	Mr. Charles MackPrincipal Engineer
Telephone Number:	931-625-4938
E-mail Address:	charliemack@irc-us.com
Trade Name:	Hypodermic Safety Needle with SyringeHypodermic Safety Needle
Common Name(s):	syringe, antisticksyringe, pistonneedle, hypodermic, single lumen
Regulation Name(s):	Piston syringeHypodermic single lumen needle
Regulation Number(s):	21 CFR 880.586021 CFR 880.5570
Product Code:	MEGFMFFMI
Device Class:	Class II
Primary Predicate Device:	K113422; Terumo Surguard 3Safety Needle Terumo Surguard 3 Hypodermic Syringe With SafetyNeedle
Secondary Predicate Device:	K051865, Teumo Surguard 2 Safety Needle

Device Description

This device is a single use device, which is delievered sterile.

The device is a disposable anti-needle stick syringe made of the following components:

1. Needle cap: Covers the needle tube until the syringe is to be used.

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1. Needle tube: The needle tube penetrates the patient's skin to inject/withdraw fluid from the body.
1. Safety shield: It is connected to the needle will be pushed into safety shield after use, it is designed to aid in the prevention of needle stick injuries. It is colored to distinguish the gauge of the needle.
1. Needle hub: The needle hub is connected to the syringe by 6% luer connector, and it is colored to distinguish the gauge of the needle.
న్. Barrel: The barrel has a scale showing the capacity of the syringe. It is connected to the Hypodermic Safety Needle by 6% luer connector.
1. Plunger: Assembled with the plunger stopper to inject/withdraw fluid from the body.
1. Plunger stopper: Sealing when injecting/withdrawing fluid from the body.

Name	Material	Material Specification
Needle cap	Polypropylene	1100N
Needle tube	Stainless Steel	SUS304
Needle hub	Polypropylene	1100N
Safety shield	Polypropylene	1100N
Barrel	Polypropylene	R3260T
Plunger stopper	Rubber Piston	n/a
Plunger	Polypropylene	1100N
Hub colorant	Colorant	PP-S1003
Ink	Organic chemical ink	HBL-100 709-V Black
Lubricant ofsyringe	Silicone oil for syringe	Polydimethylsiloxane
Lubricant of needle	Silicone oil for needles	Polydimethylsiloxane
Adhesive	Epoxy Resin	ZS-H-623

Indications for Use

Hypodermic Safety Needle with Syringe:

The Hypodermic Safety Needle with Syringe is intended for use in the aspiration 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.

Hypodermic Safety Needle:

The device is prescription only.

Intended Use

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This device is intended to be used in a clinical environment by a medical professional.

Substantial Equivalence Discussion

Intended Use Comparison

The table below includes a comparison of the intended use between the new device and those of the predicate device:

Characteristic	Predicate DeviceTERUMO® SurGuard®3 K133422	Predicate DeviceTERUMO® SurGuard2TMSAFETY NEEDLEK051865	Subject DeviceHypodermic Safety Needlewith/without SyringeK190183	TechnologicalCharacteristic	Predicate DeviceTERUMO® SurGuard®3 Safety NeedleTERUMO® SurGuard®3 HypodermicSyringe withSafety NeedleK113422	Subject DeviceHypodermic Safety Needlewith/without SyringeK190183	Comments
Indications for Use	The TERUMO® SurGuard®3Safety Needle device is intendedfor use in the aspiration andinjection of fluids for medicalpurposes. The TERUMO®SurGuard®3 Safety Needle iscompatible for use with standardluer slip and luer lock syringes.Additionally, after withdrawal ofthe needle from the body, theattached needle safety shield canbe manually activated to coverthe needle immediately after useto minimize risk of accidentalneedlestick.	The TERUMO®SurGuard2TM SAFETYNEEDLEdevice is intended for use inthe aspiration andinjection of fluids formedical purposes. TheTerumo Safety Needle iscompatible for use withstandard luer slip and luerlock syringes.Additionally, afterwithdrawal of the needlefrom the body, the attachedneedle safety shield can bemanually activated to coverthe needle immediatelyafter use to minimize risk ofaccidental needlestick.	Hypodermic Safety Needlewith SyringeThe Hypodermic SafetyNeedle with Syringe isintended for use inthe aspiration and injectionof fluids for medicalpurpose. After withdrawalof the needle from the body,the attached needle safetyshield can be manuallyactivated to cover the needleimmediatelyafter use to minimize riskof accidental needle sticks.Hypodermic Safety NeedleThe Hypodermic SafetyNeedle is intended to beused with a luer locksyringe for aspiration andinjection of fluids formedical purpose. Afterwithdrawal of the needlefrom the body, the attachedneedle safety shield can bemanually activated to coverthe needle immediately afteruse to minimize risk ofaccidental needlestick.	Principles ofoperation	The Hypodermic Needle is a devicethat is composed of a typicalhypodermic needle with a one-piecehub/adapter and pivoting cover that isconnected to the adapter. The pivotingcover can be manually rotated forwardafter use allowing for secureencapsulation of the needlepoint,making the product safe for disposal.These needles have a regular, short, orintradermal bevel type. The needleassembly is protected with apolypropylene shield.The Hypodermic Needle contains amechanism that covers the needlepointafter use. In the activated position, theneedle cover guards against accidentalneedle sticks during normal handlingand disposal of the used needle/syringe combination.	The Hypodermic Needle is a devicethat is composed of a typicalhypodermic needle with a one-piecehub/adapter and pivoting cover that isconnected to the adapter. Thepivoting cover can be manuallyrotated forward after use allowing forsecure encapsulation of theneedlepoint, making the product safefor disposal. These needles have aregular, short, or intradermal beveltype. The needle assembly isprotected with a polypropylene shield.The Hypodermic Needle contains amechanism that covers theneedlepoint after use. In the activatedposition, the needle cover guardsagainst accidental needle sticksduring normal handling and disposalof the used needle/ syringecombination.	Same
Prescription Only orOver the Counter	Prescription Use	Prescription Use	Prescription Use	Safety feature	The attached needle safety shield canbe manually activated to cover theneedle immediately after use	The attached needle safety shield canbe manually activated to cover	Same
Intended Population	Adult	Adult	Adult
Environment of Use	Clinical Use	Clinical Use	Clinical Use

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Discussions of differences in Indications for Use statement

The major difference between the Subject Device's Indications for Use and the predicate deviices lies in the use of the syringe. The Subject device can be provided with a syringe, where this is not identified in the predicate devices. All other aspects of the Indications for Use are the same.

Discussions of differences in intended population

The intended population for the subject device is identical to the predicate device.

Discussions of differences in environment of use

The environment of use for the subject device is identical to the predicate device.

Technological Characteristics

The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:

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TechnologicalCharacteristic	Predicate DeviceTERUMO® SurGuard®3 SafetyNeedleTERUMO® SurGuard®3 HypodermicSyringe withSafety NeedleK113422	Subject DeviceHypodermic Safety Needlewith/without SyringeK190183	Comments
Operation Mode	Manual use only	Manual use only	Same
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Syringe Volume	3,5,10 ml	5 ml	Comment 1
Connector Type	Luer Lock and luer slip	Luer Lock	Comment 2
SyringePerformance	Complied with ISO 7886-1: 1993	Complied with ISO 7886-1: 2017	Same
Configuration	A hypodermic needle with a hingedsafety sheath attached to the connectorhub with or without an attachedhypodermic syringe.	A hypodermic needle with a hingedsafety sheath attached to the connectorhub with or without an attachedhypodermic syringe.	Same
Marking/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
Material	Polypropylene, Stainless Steel, RubberPiston	Polypropylene, Stainless Steel,Rubber Piston	Same
Operation Mode	Manual Use	Manual Use	Same
Lubricant forneedle	None	Silicone oil	N/A
Adhesive	Epoxy Resin	N/A	N/A
Needle Hubcolors	Complies with ISO 6009-2010	Complies with ISO 6009-2010	Same
Single PatientUse	Yes	Yes	Same
Needle Gaugeand Length	18G-25G 1" - 2"	21G x 1 1/2"	Comment 3
How Supplied	Sterile Single Patient Use	Sterile Single Patient Use	Same
Method ofSterilization	Rx	Ethylene Oxide	Comment 4
SAL	10-6	10-6	Same
TechnologicalCharacteristic	Predicate DeviceTERUMO SURGUARD 2 SAFETYNEEDLE OR SIMILARK051865	Subject DeviceHypodermic Safety Needlewith/without SyringeK190183	Comments
Principles ofoperation	The Terumo SurGuard2TM SafetyNeedle device with and withoutsyringe manufactured by Terumo(Philippines) Corporation and TerumoMedicalCorporation, USA (K040531 andK031453) and all referenced predicatedevices are operated manually.	The Hypodermic Needle is a devicethat is composed of a typicalhypodermic needle with a one-piecehub/adapter and pivoting cover that isconnected to the adapter. Thepivoting cover can be manuallyrotated forward after use allowing forsecure encapsulation of theneedlepoint, making the product safefor disposal. These needles have aregular, short, or intradermal beveltype. The needle assembly isprotected with a polypropylene shield.The Hypodermic Needle contains amechanism that covers theneedlepoint after use. In the activatedposition, the needle cover guardsagainst accidental needle sticksduring normal handling and disposalof the used needle/ syringecombination.	Same
	Safety feature	The attached needle safety shield canbe manually activated to cover theneedle immediately after use	The attached needle safety shield canbe manually activated to cover	Same
			Predicate Device	Subject Device
		Technological	TERUMO SURGUARD 2 SAFETY	Hypodermic Safety Needle
	Characteristic	NEEDLE OR SIMILAR	with/without Syringe
		K051865	K190183	Comments
	Operation Mode	Manual use only	Manual use only	Same
	Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same
	Syringe Volume	1,3,5,10 ml	5 ml	Comment 5
	Connector Type	Luer Lock and luer slip	Luer Lock	Comment 6
	Syringe	Complied with ISO 7886-1: 1993	Complied with ISO 7886-1: 2017	Same
Performance
Configuration	A hypodermic needle with a hingedsafety sheath attached to the connectorhub with or without an attachedhypodermic syringe.	A hypodermic needle with a hingedsafety sheath attached to the connectorhub with or without an attachedhypodermic syringe.	Same
Marking/	Complied with 21 CFR part 801	Complied with 21 CFR part 801	Same

Labeling
Material	Polypropylene, Stainless Steel, RubberPiston	N/A	N/A
Operation Mode	Manual Use	Manual Use	Same
Lubricant forneedle	None	Silicone oil	N/A
Adhesive	Epoxy Resin	N/A	N/A
Needle Hubcolors	Complies with ISO 6009-2010	Complies with ISO 6009-2010	Same
Single PatientUse	Yes	Yes	Same
Needle Gaugeand Length	18G-25G 1" - 2"	21G x 1 ½"	Comment 7
How Supplied	Sterile Single Patient Use	Sterile Single Patient Use	Same
Method ofSterilization	Rx	Ethylene Oxide	Comment 8
SAL	10-6	10-6	Same

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Discussions of differences in technological characteristics

Comment 1

The predicate devices are offered with a wider variety of syringe volumes. This does not affect the operation of the device.

Comment 2

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The subject is only offered in luer lock and the predicate is offered in luer slip. This does not affect operation.

Comment 3

The submitted device is only offered in 21G x 1 ½", where the predicate is offered in a wider range of needle options.

Comment 4

The submitted device is sterilized by Ethylene Oxide, where the predicate is sterilized by radiation. The submitted device achieves the same level of sterility.

Comment 5

The predicate devices are offered with a wider variety of syringe volumes. This does not affect the operation of the device.

Comment 6

The subject is only offered in luer lock and the predicate is offered in luer slip. This does not affect operation.

Comment 7

The submitted device is only offered in 21G x 1 ½", where the predicate is offered in a wider range of needle options.

Comment 8

The submitted device is sterilized by Ethylene Oxide, where the predicate is sterilized by radiation. The submitted device achieves the same level of sterility.

Performance Testing

The following bench testing was performed and reviewed to support the substantial equivalence of the subject device:

ISO 9626: 2016-08-01, Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods.
ISO 7864: 2016-08-01, Sterile hypodermic needles for single use Requirements and test methods. -
ISO 594-1:1986-06-15, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements.
-ISO 594-2: 1998-09-01, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.
ISO 23908: 2011-06-11, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
-ISO 7886-1: 2017-05, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
ISO 6009 Fourth edition 2016-08-01, Hypodermic needles for single use Colour coding for identification. -

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Simulated Clinical Study

We conducted the simulated clinical study per the FDA Guidance titled "Medical Devices with Sharps Injury Prevention Features" (Issued on August 9, 2005) for the subject devices, and the testing result demonstrated that there were no failures of the safety feature of the Hypodermic Safety Needle with Syringe.

All of the pre-determined acceptance criteria were met.

Biocompatibility

The new device complies with the biocompatibility requirement defined in ISO10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). Patient contact classification: External Communicating Device - Blood Path. Indirect - Prolonged Contact Duration (24 hours -30 days). The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate devices.

In Vitro Cytotoxicity (ISO10993-5: 2009) -
Skin Sensitization (ISO10993-10: 2010) -
Intracutaneous Reactivity Test (ISO10993-10: 2010) -
Acute Systemic Toxicity (ISO10993-11; 2006) -
-Coagulation test (ISO10993-4: 2002Amd1:2006(E)
-Complement activity Test (ISO10993-4: 2002 Amd1: 2006(E)
-Hemolytic Properties Test (ASTM F756-13)
Pyrogen Test (ISO 10993-11:2006) -
Subacute/Subchronic Toxicity Testing -
USP 788 Particulate Matter in Injections

All of the pre-determined acceptance criteria were met.

Sterility Information

The devices are EO sterilized. The sterilization conducted according to the standards noted below:

ISO11135-1:Second Edition 2014, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO11737-1: 2006, Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO11737-2: 2009, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 10993-7: 2008(R) 2012, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ANSI/AAMI ST72:2011 (R ) 2016, Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing

Package and Shelf Life:

We conducted the below package and shelf life verification test to support the shelf life claim according standards noted below::

AAMI/ANSI/ISO 11137-1:2006/(R) 2010, Sterilization of health care products - Radiation - Part 2: i Requirements for development, validation, and routine control of a sterilization process for medical devices.

AAMI/ANSI/ISO 11737-2:2009, Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

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AAMI/ANSI/ISO 11607-1:2006/(R) 2010, Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems.
ASTM F1929-98 (2004), Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye -Penetration.
-ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
-ASTM D3078-02 (2008) , Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
-ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials

The test conducted as below:

Product Performance Inspection (Chemical performance and Physical performance) -
-Sterile Test
-Vacuum Leak Test
Dye penetration test -
Agar Contact-Attack Test -
Tensile Seal Strength Test -
-Accelerated Aging Test

The test result supports the 5 years shelf life claim for the subject device from the sterilization date.

All of the pre-determined acceptance criteria were met.

Clinical Tests

Not Applicable

Conclusions

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Hypodermic Safety Needle with Syringe and Hypodermic Safety Needle is substantially equivalent to the Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe With Safety Needle cleared under K 1 1 3422 and the Terumo Surguard 2 Safety Needle cleared under K051865 with respect to the indications for use, target populations, treatment method, 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).