The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Device Description

The Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector. The Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.

The Safety Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation, ensuring the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.

The safety feature is easily operated by releasing a latch mechanism whereby the user slides a winged cover over the needle removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.

The Blood Collection / Infusion Set (with/without needle holder) and Safety Blood Collection / Infusion Set (with/without needle holder) are used for venous blood collection and/or the short-term infusion of intravenous fluids. It can be used with an intravascular administration set or a syringe or other device to administer fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "Safety Blood Collection / Infusion Set (with/without needle holder) and Blood Collection / Infusion Set (with/without needle holder)". It is a submission to the FDA for market clearance, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets acceptance criteria in the sense of a clinical trial for an AI/ML product.

Therefore, many of the requested items (sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, etc.) are not applicable to this type of regulatory submission for this class of device.

This document focuses on non-clinical performance testing and biocompatibility to show that the new device performs as intended and is as safe and effective as the predicate device.

Here's the information that can be extracted and a breakdown of why some questions are not directly answerable from this document:

1. A table of acceptance criteria and the reported device performance

The document states that "All of the pre-determined acceptance criteria were met" for various categories of non-clinical testing. While it lists the standards to which the device was tested, it does not provide the specific numerical acceptance criteria within those standards or the exact reported performance values (e.g., a specific tensile strength value that passed the ISO 7864 requirement).

However, it does implicitly describe acceptance criteria as compliance with established international standards for similar devices.

Category of Testing	Specific Standards/Tests	Acceptance Criteria (Implicit)	Reported Device Performance
Performance Testing	ISO 8536-4 (Infusion sets), ISO 9626 (SS needle tubing), ISO 7864 (Sterile hypodermic needles), ISO 80369-7 (Small-bore connectors), ISO 80369-20 (Common test methods), ISO 23908 (Sharps injury protection), ISO 6009 (Colour coding), ISO 2859-1 (Sampling procedures), USP 788 (Particulate Matter), Flowrate and Priming volume of tubing	Compliance with all listed international standards.	"met all requirements of related international standards", "All of the pre-determined acceptance criteria were met."
Biocompatibility	ISO10993-1 (General), ISO10993-5 (Cytotoxicity), ISO10993-10 (Skin Sensitization, Intracutaneous Reactivity), ISO10993-11 (Acute Systemic Toxicity), ISO10993-4 (Coagulation, Complement Activity, Hemolytic Properties), ISO10993-3 (Ames Test, Mammalian Chromosome Aberration, Mammalian Erythrocyte Micronucleus)	Compliance with ISO10993-1 and specific substantiating tests.	"The new device complies with the biocompatibility requirement defined in ISO10993-1", "The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1", "All of the pre-determined acceptance criteria were met."
Sterility	ISO11135-1 (Ethylene Oxide Sterilization), ISO11737-1 (Microorganisms on product), ISO11737-2 (Tests of sterility), ISO10993-7 (EO Residuals), ANSI/AAMI ST72 (Bacterial endotoxins)	Sterilization validated per ISO11135, achieving a SAL of 10^-6.	"The sterilization was conducted according to the following standards", "achieves the same SAL of 10^-6 as the predicate device", "All of the pre-determined acceptance criteria were met."
Package and Shelf Life	AAMI/ANSI/ISO 11137-1 (Radiation), AAMI/ANSI/ISO11737-2 (Sterility), AAMI/ANSI/ISO 11607-1 (Packaging), ASTM F1929 (Dye Penetration), ASTM F1980 (Accelerated Aging), ASTM D3078 (Bubble Emission), ASTM F88/F88M (Seal Strength)	Support the stated shelf life claim, maintaining package integrity and sterility.	"The test result supports the shelf life claim for the subject device from the sterilization date.", "All of the pre-determined acceptance criteria were met."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for specific tests beyond general adherence to standards (e.g., ISO 2859-1 for sampling procedures). For medical device clearances like this, testing typically involves a sufficient number of units to demonstrate compliance with the relevant standards for the device type, rather than statistical sampling for clinical performance.
Data Provenance: The manufacturer is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in Anhui Province, China. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the underlying data for the standard compliance comes from prospective or retrospective studies, but given it's non-clinical testing, it would be prospective testing of newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This is a non-clinical device clearance. Ground truth in the context of expert review for medical imaging or AI performance is not relevant here. The "ground truth" for the device's acceptable performance is defined by its adherence to established international engineering, materials, and sterility standards.

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

N/A. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or expert reviews. Non-clinical performance tests have objective, measurable endpoints defined by standards.

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

N/A. This is a physical medical device (blood collection/infusion set), not an AI/ML product. MRMC studies are not relevant.

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

N/A. This is a physical medical device, not an AI algorithm.

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

The "ground truth" for this device's safety and effectiveness is its compliance with internationally recognized consensus standards (e.g., ISO, ASTM, USP) for the performance, materials, sterility, and biocompatibility of hypodermic needles and infusion sets. These standards define the acceptable physical, chemical, and biological properties.

8. The sample size for the training set

N/A. This is a physical device, not an AI/ML product that undergoes "training."

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

N/A. Not applicable, as it's not an AI/ML product.

Summary

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

April 12, 2022

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

Re: K214075

Trade/Device Name: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FPA Dated: March 18, 2022 Received: March 24, 2022

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,

Gang Peng for Payal Patel 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) K214075

Device Name

Safety Blood Collection / Infusion Set (with/without needle holder) Blood Collection / Infusion Set (with/without needle holder)

Indications for Use (Describe)

The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healtheare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the shortterm infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

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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K214075 510(k) SUMMARY

Submitter Information:

Preparation Date:	April 3, 2022
Manufacturer's Name and Address:	Anhui Hongyu Wuzhou MedicalManufacturer Co., Ltd.No. 2 Guanyin Road, EconomicDevelopment Zone, Taihu, Anqing City,Anhui Province, China 246400Mr. Bingyi XiangGeneral ManagerTel: +86-556 5129666Fax: +86-556 4249999birrell@hongyu-wuzhou.com
Submission Corresponding Official:	Charles Mack
Telephone Number:	931-625-4938
Email Address:	charliemack@irc-us.com
Trade Name:	Safety Blood Collection / Infusion Set(with/without needle holder)
	Blood Collection / Infusion Set(with/without needle holder)
Common Name(s):	Needle, hypodermic, single lumenIntravascular administration set
Regulation Name(s):	Needle, hypodermic, single lumenIntravascular administration set
Regulation Number(s):	21CFR 880.5570
Product Code:	FMI, FPA
Device Class:	Class II
Predicate Device:	K173757VACUETTE EVOPROTECT Safety BloodCollection/Infusion SetGreiner Bio-One NA Inc

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Device Description:

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Blood Collection / Infusion Set	Individually wrapped and sterile, allowing set to be used with a luer system.
Blood Collection Set (without needle holder)	Individually wrapped and sterile with Luer Adapter (for use with e.g. Standard Needle holder).
Blood Collection Set (with needle holder)	Individually wrapped and sterile, ready to be used forblood collection.
Safety Blood Collection / Infusion Set	Individually wrapped and sterile, allowing set to be used with a luer system.
Safety Blood Collection Set (without needle holder)	Individually wrapped and sterile with Luer Adapter (for use with e.g. Standard Needle holder).
Safety Blood Collection Set (with needle holder)	Individually wrapped and sterile, ready to be used forblood collection.

The proposed device consists of the components defined below:

1. needle holder
1. rubber sleeve
1. puncture needle
1. needle hub (male luer lock connector)
1. connect base (female luer lock connector)
1. flexing tube
1. safety shield
1. wings
1. patient-end tube needle
1. needle sheath
1. Protective cap

Indications for Use

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SE Comparison Table

Feature	Subject Device	Predicate Device	Discussion
Company	Anhui Hongyu WuzhouMedical Manufacturer Co., Ltd.	Greiner Bio-One NA Inc	-
FDA510(K)Number	K214075	K173757	-
Device Name	Safety Blood Collection /Infusion Set (with/withoutneedle holder);Blood Collection / Infusion Set(with/without needle holder)	VACUETTEEVOPROTECTSafety BloodCollection / InfusionSet	-
Product code	FMI, FPA	FMI, FPA	-
CFR	880.5570	880.5570	-
Indication forUse	The Safety Blood Collection /Infusion Set (with/withoutneedle holder) is indicated forvenous blood collection and/orthe short-term infusion ofintravenous fluids for 2 hoursor less. It is to be used byappropriately trainedhealthcare professionals inaccordance with theinstructions. The safety shieldis intended to aid in theprotection against accidentalneedle stick injury.The Blood Collection / InfusionSet (with/without needleholder) is indicated for venousblood collection and/or theshort-term infusion ofintravenous fluids for 2 hoursor less. It is to be used byappropriately trainedhealthcare professionals inaccordance with theinstructions.	The VACUETTEEVOPROTECTSafety BloodCollection/InfusionSet is indicated forvenous bloodcollection and/or theshort-term infusion ofintravenous fluids. Itis to be used byappropriately trainedhealthcareprofessionals inaccordance with theinstructions.	Note 1
Feature	Subject Device	Predicate Device	Discussion
Safe Feature	For the Safety Blood Collection / Infusion Set(with/without needle holder), the needle is locked in thesafety sheath after using the safety shield by pulling thetubing backward until an audible click is heard.There is no safety mechanism for the Blood Collection /Infusion Set (with/without needle holder).	The needle is completely retracted and locked by slidingthe safety shield forward and pulling the tubing backwarduntil an audible click is heard.	Note 2
Material
Needle tube	SUS304	SUS304	Identical
Flexing tube	PVC	PVC	Identical
Luer adapter	ABS	ABS	Identical
Needle sheath	HDPE	PP	Note 3
Safety shield	Polypropylene	PC
Rub sleeve	Gather Isoprene Rubber	Unknown
Lubricate	Silicone oil	Unknown
Adhesive	Epoxy Resin	UV cured adhesive
Needle Gauge	18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G;	21G, 23G, 25G	Note 4
Needle Length	1/2" - 1 1/8"	3/4'
Flexing tubingLength	7½"; 12"	4"; 7½"; 12"	Note 5
Hub/Needlebond strength	Complies with ISO7864	Complies withISO7864	Identical
Biocompatibility	Complies with ISO10993-1	Complies withISO10993-1	Identical
Performance	Complies withISO 9626ISO 7864ISO 80369-7ISO 80369-20ISO 23908ISO 6009ISO 8536-4	Complies withISO 9626ISO 7864ISO 80369-7ISO 80369-20ISO 23908ISO 6009ISO 8536-4	Identical
Sterilization	EO	Rx	Note 6
Sterile	Yes	Yes	Identical
SAL	10^-6	10^-6	Identical
Disposable	Yes	Yes	Identical
Single PatientUse	Yes	Yes	Identical

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Note 1

The subject devices include two configurations, with the safety mechanism and without safety mechanism, but the predicate device only includes one configuration with a safety mechanism. Although the configuration is different, the indication for use is the same, and both can be used for blood collection and infusion. Therefore, the difference is not determined to affect substantially equivalence on safety and effectiveness.

Note 2

For the Safety Blood Collection / Infusion Set (with/without needle holder), the safety mechanism is the same as predicate device:

There is no safety mechanism for the Blood Collection / Infusion Set (with/without needle holder).

Whether there is a safety mechanism will not affect the indication for the use of the devices; both can be used for blood collection and infusion. Therefore, the difference is not determined to affect substantially equivalence on safety and effectiveness.

Note 3

Although the material of these components of subject devices are different from predicate devices (or some unknown for predicate device), they conform to the same ISO10993-1 biocompatibility standards; Therefore, the difference does not raise new questions on the safety and effectiveness of the proposed method device.

Note 4

The subject devices' needle gauge and needle length are available in more sizes than the predicate device, but they conform to the same applicable performance standards as the predicate device; Therefore, the difference does not raise new questions on the safety and effectiveness of the proposed method device.

Note 5

The subject device has two sizes, same as the predicate device, but the predicate device has an additional one size:

They conform to the same applicable performance standards. Therefore, this difference is not considered to affect safety and effectiveness substantially.

Note 6

The sterilization method is different; The subject device's sterilization is validated per ISO11135 and achieves the same SAL of 10° as the predicate device. The difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device

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Performance Testing

Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Safety Blood Collection / Infusion Set (with/without needle holder) and Blood Collection/Infusion set (with/without needle holder) met all requirements of related international standards, including biocompatibility, sterility, and product specifications. These tests demonstrate compliance with the requirements of the consensus standards noted below.

Non-clinical Testing

Performance Testing

ISO 8536-4-2019 Infusion equipment for medical use —Part 4: Infusion sets for single-use, gravity feed
ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
-ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods
ISO 80369-7 First edition 2016-10-15 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 80369-20 First edition 2015-05-15, small-bore connectors for liquids and gases in healthcare applications part 20: common test methods. (General I (QS/RM))
ISO 23908 First edition 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 6009 Fourth edition 2016-08-01 Hypodermic needles for single use Colour coding for identification
ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
USP 788 Particulate Matter in Injections -
Flowrate and Priming volume of tubing l

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Biocompatibility

The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: externally communicating devices, contact circulating blood for limited contact (<24 h) duration. The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate device.

In Vitro Cytotoxicity (ISO10993-5: 2009) -
Skin Sensitization (ISO10993-10: 2010) -
-Intracutaneous Reactivity Test (ISO10993-10: 2010)
Acute Systemic toxicity (ISO10993-11:2006) -
Coagulation (ISO10993-4:2017) -
Complement Activity Test (ISO10993-4: 2017) -
Hemolytic Properties Test (ISO10993-4: 2017, ASTM F756-17) -
-Ames Test (ISO10993-3:2014)
Mammalian Chromosome Aberration Test (ISO10993-3:2014) -
-Mammalian Erythrocyte Micronucleus Test (ISO10993-3:2014)

All of the pre-determined acceptance criteria were met.

Sterility Information

The devices are EO sterilized. The sterilization was conducted according to the following standards:

ISO11135-1 Sterilization of health care products ethylene oxide part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices.
ISO11737-1 Sterilization of medical devices-Microbiological Methods-Part 1: -Determination of the population of microorganisms on the product.
-ISO11737-2 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process.
-ISO10993-7 Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals.
ANSI/AAMI ST72 Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing.

All of the pre-determined acceptance criteria were met.

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Package and Shelf Life:

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

AAMI/ANSI/ISO 11137-1:2006/(R) 2010 Sterilization of health care products - - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
AAMI/ANSI/ISO11737-2:2009 Sterilization of 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, 3ed.
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. (Sterility)
-ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials

The tests were conducted as noted below:

Accelerated Aging Test
Simulated shipping distribution testing
Visual inspection
Performance Inspection
Sterile Test
Vacuum Leak Test
Dye penetration test
Agar Contact-Attack Test
Tensile Seal Strength Test

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

All of the pre-determined acceptance criteria were met.

Clinical Test:

No clinical study is included in this submission.

Conclusions:

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Safety Blood Collection / Infusion Set (with/without needle holder) and Blood Collection/Infusion set (with/without needle holder) are substantially equivalent to the Greiner Bio-One NA Inc VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set cleared under K173757 with respect to the indications for use, target populations, treatment method, and technological characteristics.

END

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).