Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical safety features and standard medical device testing, with no mention of AI or ML.

Therapeutic

No
Explanation: The device is a safety needle and syringe intended for fluid aspiration and injection, and for preventing accidental needle sticks, not for treating any medical condition.

Diagnostic

No

The device is described for the aspiration and injection of fluids, which are therapeutic and procedural uses, not diagnostic. Its purpose is for fluid delivery or withdrawal, and includes a safety feature to prevent needle sticks, which is a safety feature for the user, not a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components such as a needle cap, needle tube, safety shield, needle hub, barrel, plunger, and plunger stopper, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "aspiration and injection of fluids for medical purpose." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
Device Description: The description details the components of a syringe and needle designed for injecting and withdrawing fluids from the body, with a safety feature to prevent needlesticks. This aligns with a device used for direct patient care.
Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information. The focus is on the physical act of aspiration and injection and the safety feature.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MEG, FMF, FMI

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:

1. Needle cap: Covers the needle tube until the syringe is to be used.
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.
1. 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 of syringe	Silicone oil for syringe	Polydimethylsiloxane
Lubricant of needle	Silicone oil for needles	Polydimethylsiloxane
Adhesive	Epoxy Resin	ZS-H-623

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Simulated Clinical Study:
A simulated clinical study was conducted per the FDA Guidance titled "Medical Devices with Sharps Injury Prevention Features" (Issued on August 9, 2005) for the subject devices. 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.
Tests performed:

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:
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: 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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113422, K051865

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

1

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

2

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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3

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 City
Anhui Province China 246400
Corresponding Official:	Mr. Charles Mack
Principal Engineer
Telephone Number:	931-625-4938
E-mail Address:	charliemack@irc-us.com
Trade Name:	Hypodermic Safety Needle with Syringe
Hypodermic Safety Needle
Common Name(s):	syringe, antistick
syringe, piston
needle, hypodermic, single lumen
Regulation Name(s):	Piston syringe
Hypodermic single lumen needle
Regulation Number(s):	21 CFR 880.5860
21 CFR 880.5570
Product Code:	MEG
FMF
FMI
Device Class:	Class II
Primary Predicate Device:	K113422; Terumo Surguard 3
Safety Needle Terumo Surguard 3 Hypodermic Syringe With Safety
Needle
Secondary Predicate Device:	K051865, Teumo Surguard 2 Safety Needle

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:

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

4

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 of
syringe	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 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.

The device is prescription only.

Intended Use

5

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 Device
TERUMO® SurGuard®3 K133422 | Predicate Device
TERUMO® SurGuard2TM
SAFETY NEEDLE
K051865 | Subject Device
Hypodermic Safety Needle
with/without Syringe
K190183 | Technological
Characteristic | Predicate Device
TERUMO® SurGuard®3 Safety Needle
TERUMO® SurGuard®3 Hypodermic
Syringe with
Safety Needle
K113422 | Subject Device
Hypodermic Safety Needle
with/without Syringe
K190183 | Comments |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Indications for Use | The TERUMO® SurGuard®3
Safety Needle device is intended
for use in the aspiration and
injection of fluids for medical
purposes. The TERUMO®
SurGuard®3 Safety Needle is
compatible for use with standard
luer slip and luer lock syringes.
Additionally, 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. | The TERUMO®
SurGuard2TM SAFETY
NEEDLE
device is intended for use in
the aspiration and
injection of fluids for
medical purposes. The
Terumo Safety Needle is
compatible for use with
standard luer slip and luer
lock syringes.
Additionally, 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. | 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. | Principles of
operation | The Hypodermic Needle is a device
that is composed of a typical
hypodermic needle with a one-piece
hub/adapter and pivoting cover that is
connected to the adapter. The pivoting
cover can be manually rotated forward
after use allowing for secure
encapsulation of the needlepoint,
making the product safe for disposal.
These needles have a regular, short, or
intradermal bevel type. The needle
assembly is protected with a
polypropylene shield.

The Hypodermic Needle contains a
mechanism that covers the needlepoint
after use. In the activated position, the
needle cover guards against accidental
needle sticks during normal handling
and disposal of the used needle/
syringe combination. | The Hypodermic Needle is a device
that is composed of a typical
hypodermic needle with a one-piece
hub/adapter and pivoting cover that is
connected to the adapter. The
pivoting cover can be manually
rotated forward after use allowing for
secure encapsulation of the
needlepoint, making the product safe
for disposal. These needles have a
regular, short, or intradermal bevel
type. The needle assembly is
protected with a polypropylene shield.

6

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:

7

| Technological
Characteristic | Predicate Device
TERUMO® SurGuard®3 Safety
Needle
TERUMO® SurGuard®3 Hypodermic
Syringe with
Safety Needle
K113422 | Subject Device
Hypodermic Safety Needle
with/without Syringe
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 | 3,5,10 ml | 5 ml | Comment 1 | | |
| Connector Type | Luer Lock and luer slip | Luer Lock | Comment 2 | | |
| Syringe
Performance | Complied with ISO 7886-1: 1993 | Complied with ISO 7886-1: 2017 | Same | | |
| Configuration | A hypodermic needle with a hinged
safety sheath attached to the connector
hub with or without an attached
hypodermic syringe. | A hypodermic needle with a hinged
safety sheath attached to the connector
hub with or without an attached
hypodermic syringe. | Same | | |
| Marking/
Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | |
| Material | Polypropylene, Stainless Steel, Rubber
Piston | Polypropylene, Stainless Steel,
Rubber Piston | Same | | |
| Operation Mode | Manual Use | Manual Use | Same | | |
| Lubricant for
needle | None | Silicone oil | N/A | | |
| Adhesive | Epoxy Resin | N/A | N/A | | |
| Needle Hub
colors | Complies with ISO 6009-2010 | Complies with ISO 6009-2010 | Same | | |
| Single Patient
Use | Yes | Yes | Same | | |
| Needle Gauge
and Length | 18G-25G 1" - 2" | 21G x 1 1/2" | Comment 3 | | |
| How Supplied | Sterile Single Patient Use | Sterile Single Patient Use | Same | | |
| Method of
Sterilization | Rx | Ethylene Oxide | Comment 4 | | |
| SAL | 10-6 | 10-6 | Same | | |
| Technological
Characteristic | Predicate Device
TERUMO SURGUARD 2 SAFETY
NEEDLE OR SIMILAR
K051865 | Subject Device
Hypodermic Safety Needle
with/without Syringe
K190183 | Comments | | |
| Principles of
operation | The Terumo SurGuard2TM Safety
Needle device with and without
syringe manufactured by Terumo
(Philippines) Corporation and Terumo
Medical
Corporation, USA (K040531 and
K031453) and all referenced predicate
devices are operated manually. | The Hypodermic Needle is a device
that is composed of a typical
hypodermic needle with a one-piece
hub/adapter and pivoting cover that is
connected to the adapter. The
pivoting cover can be manually
rotated forward after use allowing for
secure encapsulation of the
needlepoint, making the product safe
for disposal. These needles have a
regular, short, or intradermal bevel
type. The needle assembly is
protected with a polypropylene shield.

8

9

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

10

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. -

11

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.