The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

Device Description

The Safety Blood Collection Sets for Single Use are used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately the following venipuncture to aid in the protection against accidental needlestick injury. The Safety Blood Collect Sets is compatible for use with a tube and syringe. The product is to be used by appropriately trained healthcare professionals, only following the product instructions. The Blood Collection needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect to the needle holder, which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber cap and a needle holder. The opposite end of the needle is 3/4" long for withdrawing blood and is fitted with a needle sheath. The needle holder and needle sheath protect the needle. The safety feature is operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially equivalent to the predicate device. The proposed devices are packaged as sterile, single-use, and single patient use only. The proposed device consists of ten components: 1. needle holder 2. rubber sleeve 3. puncture needle 4. needle hub (male luer lock connector) 5. connect base (female luer lock connector) 6. flexing tube 7. safety shield 8. wings 9. patient-end tube needle 10. needle sheath

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Safety Blood Collection Sets for Single Use). It details the device's characteristics, comparison to a predicate device, and various performance, biocompatibility, and sterility tests conducted. However, it does NOT describe a study that proves the device meets specific acceptance criteria in terms of AI or algorithm performance, nor does it involve human readers, expert consensus for ground truth, or an MRMC study.

The document discusses "acceptance criteria" only in the context of the physical and biological testing of the blood collection set (e.g., sterilization, biocompatibility, mechanical performance). It explicitly states: "No clinical study is included in this submission." This type of 510(k) submission generally relies on demonstrable substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than novel clinical performance studies involving human subjects or AI algorithms.

Therefore, many of the requested bullet points, particularly those related to AI/algorithm performance, human readers, sample sizes for test/training sets for AI, ground truth establishment for AI, and MRMC studies, are not applicable to the content of this document.

I will address the applicable parts based on the provided text, and explicitly state when information is not present or not relevant to the document's content.

Description of Acceptance Criteria and Proving Device Meets Them

The document describes the acceptance criteria in the context of various performance, biocompatibility, and sterility tests for a physical medical device (blood collection set). It does not pertain to the performance of an AI/algorithm-based device.

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 tests, but it does not provide a specific table with the acceptance criteria values alongside numerical performance results for the device. It generally states compliance with relevant ISO and ASTM standards.

Here's a summary of the stated compliance:

Test Category	Standards Complied With	Reported Device Performance
Performance Testing	ISO 9626 (Stainless steel needle tubing), ISO 7864 (Sterile hypodermic needles), ISO 80369-7 (Small-bore connectors for intravascular/hypodermic applications), ISO 80369-20 (Common test methods for small-bore connectors), ISO 23908 (Sharps injury protection), ISO 6009 (Color coding for identification)	Complies with all noted standards. (e.g., Hub/Needle bond strength for 21G > 44N, complying with ISO7864)
Biocompatibility	ISO10993-1 (Biological evaluation of medical devices, specifically for externally communicating devices, contact circulating blood for <24h duration). Specific tests mentioned: In Vitro Cytotoxicity (ISO10993-5), Skin Sensitization (ISO10993-10), Intracutaneous Reactivity Test (ISO10993-10), Acute Systemic Toxicity (ISO10993-11), Hemocompatibility, Pyrogenicity.	Complies with ISO10993-1 requirements; verification tests show compliance.
Sterility Information	ISO11135-1 (EO sterilization), ISO11737-1/2 (Sterilization Microbiological Methods), ISO 10993-7 (Ethylene Oxide Residuals), ANSI/AAMI ST72 (Bacterial endotoxins Test methods)	All pre-determined acceptance criteria were met. Device is EO sterilized with SAL of 10-6.
Package and Shelf Life	AAMI/ANSI/ISO 11137-1 (Radiation sterilization), AAMI/ANSI/ISO11737-2 (Sterility tests), AAMI/ANSI/ISO 11607-1 (Packaging), ASTM F1929 (Seal Leaks by Dye Penetration), ASTM F1980 (Accelerated Aging), ASTM D3078 (Leaks by Bubble Emission), ASTM F88/F88M (Seal Strength).	All pre-determined acceptance criteria were met. Test results support shelf life claim.

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

Sample Sizes: The document does not specify the exact sample sizes used for each of the non-clinical performance, biocompatibility, or sterility tests. It confirms that the tests were conducted.
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 data relates to the physical device's characteristics and performance, not patient data. These were laboratory tests, not retrospective or prospective clinical studies involving patients.

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

This question is not applicable as the document describes the testing of a physical medical device (blood collection set) and not an AI or algorithm-based device that would require expert-established ground truth from images or other data.

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

This question is not applicable for the same reasons as point 3.

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 question is not applicable. The submission explicitly states, "No clinical study is included in this submission," and the device is a physical blood collection set, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is not an algorithm.

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

This question is not applicable in the context of AI/algorithm ground truth. For the physical device, the "ground truth" or "acceptance criteria" are defined by compliance with established international standards (ISO, ASTM) for material properties, mechanical strength, sterility, biocompatibility, and safety features.

8. The sample size for the training set:

This question is not applicable as there is no training set for an AI/algorithm described.

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

This question is not applicable as there is no training set for an AI/algorithm described.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 23, 2021

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

Re: K202188

Trade/Device Name: Safety Blood Collection Sets for Single Use Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FMI

Dear Charles Mack:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 19, 2021. Specifically, FDA is updating this SE Letter to include the secondary product code (FMI) as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6029, Payal.Patel@fda.hhs.gov.

Sincerely,

James M. Simpson Jr -

S7

For Payal Patel Acting 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

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 19, 2021

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

Re: K202188

Trade/Device Name: Safety Blood Collection Sets for Single Use Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: January 8, 2021 Received: January 19, 2021

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 mav, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James M. Simpson Jr -

S7

For Payal Patel Acting 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) K202188

Device Name Safety Blood Collection Sets for Single Use

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K202188 510(k) SUMMARY

Preparation Date:	February 23, 2021
Manufacturer's Name and Address:	Anhui Hongyu Wuzhou MedicalManufacturer Co., Ltd.No. 2 Guanyin Road, EconomicDevelopment Zone, Taihu, Anqing City,Anhui Province China246400Mr. Bingyi XiangGeneral ManagerTel: +86-556 5129666Fax: +86-556 4249999Email: birrell@hongyu-wuzhou.com,FDA Establishment Registration No.:3012116434
Corresponding Official:	IRC USA2950 E Lindrick Dr., Chandler, Arizona85249, USAMr. Charles MackPRINCIPAL ENGINEERTel: 931-6254938Email: charliemack@irc-us.com
Telephone Number:	931-625-4938
Email Address:	charliemack@irc-us.com
Trade Name:	Safety Blood Collection Sets for Single-Use
Common Name(s):	Blood collection
Regulation Name(s):	Blood specimen collection device
Regulation Number(s):	21CFR862.1675
Product Code:	JKA (Primary)FMI (Secondary)
Device Class:	Class II
Predicate Device:	Innovative Medical Technologies, Inc.Improsafe Blood Collection SetK133097

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Device Description:

The Blood Collection needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub.

The hub is threaded on one side to connect to the needle holder, which is used to । guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber cap and a needle holder.
The opposite end of the needle is 3/4" long for withdrawing blood and is fitted with a needle sheath.

The needle holder and needle sheath protect the needle.

The safety feature is operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially equivalent to the predicate device.

The proposed devices are packaged as sterile, single-use, and single patient use only.

The proposed device consists of ten components:

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

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The subject device is classified as externally communicating devices, contact circulating blood for limited contact (<24 h) duration according to ISO10993-1 Fourth edition 2009-10-15 Annex A Table A.1-Evaluation tests for consideration.

Intended Use / Indications for Use

The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needle stick injury.

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Feature	Subject Device	Predicate Device	Discussion /Comment
Company	Anhui Hongyu Wuzhou MedicalManufacturer Co., Ltd.	Innovative Medical Technologies,Incorporated	N/A
FDA510(K) Number	K202188	K123987	N/A
Device Name	Safety Blood Collection Set for Single-Use	Improsafe Blood Collection Set	N/A
Primary product code	21CFR862.1675, JKA	21CFR862.1675, JKA	N/A
Secondary product code	21CFR880.5570, FMI
Indication for Use	The Safety Blood Collection Set forSingle Use and blood collectiontube/syringe are used together for thecollection of venous blood. Thewinged needle is designed with asafety shield which can be activated tocover the needle immediatelyfollowing blood collection to aid in theprotection against accidental needlestick injury.	Improve Blood Collection Set andImprosafe Blood Collection Set arewinged blood collection needles withflexible tubing and a female luer adapterintended for venipuncture to obtainblood samples from patients. Somereorder numbers are provided with amale luer adapter. The male lueradapter contains a non-patient needleend for puncturing the stopper of anevacuated blood collection tube. Thosewithout a male luer adapter areprovided with a protective cap on theend of the female luer adapter.The Improsafe Blood Collection Set isprovided with an attached safety shieldfor covering the used needle prior todisposal. After withdrawal of the needlefrom the patient's vein, the attachedsafety shield can be manually activatedto cover the needle immediately afteruse to minimize risk of accidentalneedle stick.The Improve Blood Collection Set andImprosafe Blood Collection Set is alsoindicated for short-term (up to 2 hours)intravenous administration of fluids andmay be used for any patient populationwith consideration given to patient size,appropriateness for the solution beinginfused and duration of therapy. Fordevices that include the male literadapter: after removing the attachedmale luer adapter from the bloodcollection set, connect the female lueradapter to a syringe or othercompatible/appropriate device.	The indications for use ofvenipuncture to obtain blood samplesfrom patients are the same betweenthe subject device and the predicatedevice.The predicate device can beprovided without a male luer adapter,where this is not available in thesubject devices.The predicate device is indicated forshort-term (up to 2 hours)intravenous administration of fluids,while subject device is not indicatedfor intravenous administration offluids.
Feature	Subject Device	Predicate Device	Discussion /Comment
Safe Feature	The needle is locked in a safetysheath by slide the safety shieldforward with pulling the tubingbackward until an audible click isheard.	The needle is wholly retracted andlocked by slide the safety shield forwardby pulling the tubing backward until anaudible click is heard.	Both devices have the sameoperation.
Material
Needle sheath	HDPE	HDPE	Same material
Needle tube	SUS304	SUS304	Same material
Needle holder	Polypropylene	None.	The subject device is available with aneedle holder, while the predicate isnot.
Safety shield	Polypropylene	Polypropylene	Same material
Flexing tube	PVC	PVC	Same material
Rub sleeve	Gather Isoprene Rubber	Rubber (Synthetic)	Although the rub sleeve material isdifferent between subject device andthe predicate device, both conform tothe same ISO10993-1 standardsrequirement.
Luer adapter	ABS	ABS	Same Material
Lubricant	Silicone oil	Unknown	Although the predicate device'slubricant material is unknown, bothconform to the same ISO10993-1standards requirement.
Adhesive	Epoxy Resin	Unknown	Although the predicate device'sadhesive material is unknown, bothconform to the same ISO10993-1standards requirement.
Colors of wing	Green	Green	Same color, no difference.
Colors of the safety shield	Translucent blue	Translucent yellow	The color of the safety shield isdifferent. The subject device istranslucent blue, while the predicatedevice is translucent yellow. Bothconform to the same ISO 10993-1standard.
Length	3/4" x 12"(needle length x tube length)	3/4" x 12"(needle length x tube length)	No differences.
Gauge	21G	21G, 23G, 25G	The predicate has two additionalsizes. There is no difference in the21G.
Hub/Needle bondstrength	Complies with ISO7864:21G>44N	Complies with ISO7864:21G>44N23G>34N25G>22N	Both comply with ISO7864.
Biocompatibility	Complies with ISO10993-1	Complies with ISO10993-1	There is no difference, as bothcomply with ISO10993-1
Performance	Complies withISO 9626ISO 7864ISO 80369-7ISO 80369-20ISO 23908ISO 6009	Complies withISO 9626ISO 7864ISO 594-1ISO 594-2ISO 23908:2011ISO 10555-1ASTM F2132- Needle penetration	Both devices demonstratecompliance with ISO standardsshowing safe and effective use perthe Indications for use.
Sterilization	EO	EO	Same sterilization method, nodifferences.
Sterile	Yes	Yes	Subject and predicate are deliveredsterile.
SAL	10-6	10-6	Subject and predicate have the sameSAL.
Disposable	Yes	Yes	Subject and predicate aredisposable.
Single Patient Use	Yes	Yes	Subject and predicate are for singlepatient use.

Comparison of Technological Characteristics with the Predicate Device

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Note 1:

Although the material of proposed and the predicate device is not available, the patient-contact material of the proposed device material conforms to the ISO 10993 series of standards the same as predicate device. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.

Note 2:

Both devices conform to the same performance standards.

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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 sets for single use met all requirements of related international standards, including biocompatibility, sterility, and product specifications. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.

Non-clinical Testing

Performance Testing

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 Color coding for identification

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) -

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Intracutaneous Reactivity Test (ISO10993-10: 2010) -
-Acute Systemic toxicity (ISO10993-11:2006)
-Hemocompatibiltiy
-Pyrogenicity

All of the pre-determined acceptance criteria were met.

Sterility Information

The devices are EO sterilized. The sterilization 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.
-ISO 10993-7 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 below standards:

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 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

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The tests were conducted as noted 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 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 Sets for Single Use is substantially equivalent to the Innovative Medical Technologies, Inc. Improsafe Blood Collection Set cleared under K123987 with respect to the indications for use, target populations, treatment method, and technological characteristics.

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.