The IMPROSAFE® Blood Collection Sets with Pre-attached to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood.
The IMPROSAFE® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood.
The IMPROSAFE® Multi-Sample Needles (Flashback) are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Multi-Sample Needles are used with holder and vacuum blood collection tube for the venous blood collection.

Device Description

The proposed devices are blood collection sets form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood. They are available in different configurations as follows:
IMPROSAFE® Blood Collection Set with Pre-attached holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, Safety Mechanism, Visible Flash Back
IMPROSAFE® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., Safety Mechanism, Visible Flash Back
IMPROVACUTER® Blood Collection Set with Pre-attached Holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, N.A., Visible Flash Back
IMPROVACUTER® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., N.A., Visible Flash Back
IMPROSAFE® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, N.A.
IMPROSAFE® Multi Sample Needle (Flashback): Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, Visible Flash Back
IMPROVACUTER® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., N.A., N.A., N.A.

AI/ML Overview

The provided text is a 510(k) Summary for several blood collection devices. It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving a device meets specific acceptance criteria through an independent clinical study for AI software.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or not provided in this document, as it pertains to medical hardware (needles and collection sets) and not AI software.

However, I can extract information related to non-clinical tests and the general equivalence claims.

Here's the breakdown of the information provided in the document:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pre-defined manner for performance metrics. Instead, it refers to conformity with established international and ASTM standards. The "reported device performance" is essentially that the device "conforms" to these standards.

Acceptance Criteria (Implied by Standards)	Reported Device Performance (Conformity)
Material (Stainless steel needle tubing): Conforms to ISO 9626:1991+AMENDMENT 1 2001	Conforms to ISO 9626:1991 AMD 2001 (and ISO 7864:1993 for sterile hypodermic needles)
Sterile Hypodermic Needles: Conforms to ISO 7864: 1993	Conforms to ISO 7864: 1993 (and ISO 9626:1991 AMD 2001 for needle tubing)
Ethylene Oxide Sterilization residuals: Conforms to ISO 10993-7:2008	Conforms with ISO 10993
Seal Strength of Flexible Barrier Materials: Conforms to ASTM F 88/F88M-09	Conforms to ASTM F 88/F88M-09
Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration: Conforms to ASTM F1929-12	Conforms to ASTM F1929-12
Bacterial Endotoxins Limit: Conforms to USP38-NF33 <85>	Conforms to USP38-NF33 <85>
Tests for in vitro cytotoxicity: Conforms to ISO 10993-5:2009	Conform with ISO 10993
Tests for irritation and delayed-type hypersensitivity: Conforms to ISO 10993-10:2010	Conform with ISO 10993
Tests for systemic toxicity: Conforms to ISO 10993-11:2006	Conform with ISO 10993
Assessment of hemolytic properties of materials: Conforms to ASTM F 756-13	Conform to ASTM F 756-13
Sharps Injury Prevention Features: Conforms to Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features	Conforms to Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features
Labeling Requirements: Conforms to 21 CFR Part 801	Conform with 21 CFR Part 801
Sterility: EO sterilized	EO sterilized
Single Use: Single Use	Single Use

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

Not provided. This document does not detail specific sample sizes for non-clinical tests or data provenance. The tests are general compliance tests for medical 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):

Not applicable/Not provided. This is not an AI device or a diagnostic device relying on expert interpretation for "ground truth." The tests are for physical/biological properties and compliance with engineering standards.

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

Not applicable/Not provided. This concept is not relevant to the non-clinical testing of blood collection devices described.

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:

Not applicable. This device is a blood collection set/needle, not an AI-powered diagnostic tool, so MRMC studies are irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. The "ground truth" for this type of device is compliance with specific material, sterility, performance (e.g., seal strength, endotoxin limits), and biocompatibility standards, as measured by established laboratory test methods.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning device.

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

Not applicable. There is no "training set" or corresponding ground truth for this type of device.

Summary of the Study (Non-Clinical Test Conclusion) from the document:

The non-clinical tests were conducted to verify that the proposed devices met all design specifications and were Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

ISO 9626:1991+AMENDMENT 1 2001 (Stainless steel needle tubing)
ISO 7864: 1993 (Sterile hypodermic needles for single use)
ISO 10993-7:2008 (Biological evaluation - Ethylene oxide sterilization residuals)
ASTM F 88/F88M-09 (Seal strength of flexible barrier materials)
ASTM F1929-12 (Detecting seal leaks in porous medical packaging by dye penetration)
USP38-NF33 <85> (Bacterial Endotoxins Limit)
ISO 10993-5:2009 (Biological evaluation - Tests for in vitro cytotoxicity)
ISO 10993-10:2010 (Biological evaluation - Test for irritation and delayed-type hypersensitivity)
ISO 10993-11:2006 (Biological evaluation - Tests for systemic toxicity)
ASTM F 756-13 (Assessment of hemolytic properties of materials)
Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features

Clinical Test Conclusion:
"No clinical study is included in this submission."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2016

Guangzhou Improve Medical Instruments Co., Ltd. % Dianna Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K153388

Trade/Device Name: IMPROSAFE® Blood Collection Set With Pre-attached Holder, IMPROVACUTER® Blood Collection Set Pre-attached Holder, IMPROSAFE® Blood Collection Set, IMPROVACUTER® Blood Collection Set, IMPROSAFE® Multi Sample Needle, IMPROSAFE® Multi Sample Needle (flashback), IMPROVACUTER® Multi Sample Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 3, 2015 Received: February 23, 2016

Dear Dianna Hong:

This letter corrects our substantially equivalent letter of June 7, 2016.

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. 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

{1}------------------------------------------------

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, PhD Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K153388

Device Name

IMPROSAFE® Blood Collection Set with Pre-attached Holder

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{3}------------------------------------------------

510(k) Number (if known) K153388

Device Name IMPROSAFE® Multi Sample Needle

Indications for Use (Describe)

The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{4}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153388

Device Name

IMPROVACUTER® Blood Collection Set

Indications for Use (Describe)

The IMPROVACUTER® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{5}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153388

Device Name

IMPROSAFE® Blood Collection Set

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The IMPROSAFE® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{6}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153388

Device Name

IMPROVACUTER® Blood Collection Set with Pre-attached Holder

Indications for Use (Describe)

The IMPROVACUTER® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood.

☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Type of Use (Select one or both, as applicable)

{7}------------------------------------------------

510(k) Number (if known) K153388

Device Name

IMPROSAFE® Multi Sample Needle (Flashback)

Indications for Use (Describe)

The IMPROSAFE® Multi-Sample Needles (Flashback) are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{8}------------------------------------------------

510(k) Number (if known) K153388

Device Name IMPROVACUTER® Multi Sample Needle

Indications for Use (Describe)

The IMPROVACUTER® Multi-Sample Needles are used with holder and vacuum blood collection tube for the venous blood collection.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{9}------------------------------------------------

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K153388 Date of Preparation: 08/15/2016

1. Sponsor Identification
  Guangzhou Improve Medical Instruments Co., Ltd. No.102, Kaiyuan Avenue, Science City, Guangzhou Economic & Technological Development District, Guangzhou, 510530, CHINA

Establishment Registration Number: 3008449424

Contact Person: Bangfu Sun Position: Quality Manager Tel: +86-20-32312660 Fax: +86-20-32312667 Email: qd9@improve-medical.com

Identification of Proposed Device

Trade Name: IMPROSAFE® Blood Collection Set with Pre-attached Holder IMPROVACUTER® Blood Collection Set with Pre-attached Holder IMPROVACUTER® Blood Collection Set IMPROSAFE® Blood Collection Set IMPROSAFE® Multi Sample Needle IMPROVACUTER® Multi Sample Needle IMPROSAFE® Multi Sample Needle (Flashback) Common Name: Blood Collection Set Classification Name: Needle, Hypodermic, Single Lumen Classification: II Product Code: FMI Regulation Number: 21CFR 880.5570 Review Panel: General Hospital

{10}------------------------------------------------

Proposed Device	Predicate Device
IMPROSAFE® Blood Collection Setwith Pre-attached holder	510(k) Number: K980414Product Name: VACUTAINER® Brand Blood CollectionSet and Safety-LokTM Blood Collection Set
IMPROSAFE® Blood Collection Set	510(k) Number: K980414Product Name: VACUTAINER® Brand Blood CollectionSet and Safety-LokTM Blood Collection Set
IMPROVACUTER® Blood CollectionSet with Pre-attached Holder	510(k) Number: K980414Product Name: VACUTAINER® Brand Blood CollectionSet and Safety-LokTM Blood Collection Set
IMPROVACUTER® Blood CollectionSet	510(k) Number: K980414Product Name: VACUTAINER® Brand Blood CollectionSet and Safety-LokTM Blood Collection Set
IMPROSAFE® Multi Sample Needle	510(k) Number: K982541Product Name: VACUTAINER® Brand ECLIPSETM BloodCollection Needle
IMPROSAFE® Multi Sample Needle(Flashback)	510(k) Number: K982541Product Name: VACUTAINER® Brand ECLIPSETM BloodCollection Needle
IMPROVACUTER® Multi SampleNeedle	510(k) Number: K090426Product Name: VAKU-8TM Blood Collection Needle

1. Identification of Predicate Devices
  The IMPROSAFE® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The IMPROVACUTER® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood.

The IMPROVACUTER® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood.

{11}------------------------------------------------

The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of yenous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The IMPROVACUTER® Multi-Sample Needles are used with holder and vacuum blood collection tube for the venous blood collection.

Indication for Use Statement:

The proposed device IMPROSAFE® Blood Collection Set with Pre-attached Holder, IMPROVACUTER® Blood Collection Set with Pre-attached Holder, IMPROVACUTER® Blood Collection Set, IMPROSAFE® Blood Collection Set are not indicated for intravenous administration of fluids compared to predicate device. However, both proposed devices and predicate device are indicated for collection of venous blood. Therefore, this difference does not affect safety and effectiveness.

The indication for use of proposed devices IMPROSAFE® Multi Sample Needle, IMPROVACUTER® Multi Sample Needle, IMPROSAFE® Multi Sample Needle (Flashback) are identical to predicate device .

1. Device Description
  The proposed devices are blood collection sets form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood. They are available in different configurations as follows:

Model	Patient-EndNeedle	Non-PatientEnd Needle	FlexibleTubing	Pre-attachedHolder	SafetyMechanism	Visible FlashBack
MPROSAFE® Blood CollectionSet with Pre-attached holder	X	X	X	X	X	X
IMPROSAFE® Blood CollectionSet	X	X	X	N.A.	X	X
IMPROVACUTER® BloodCollection Set with Pre-attachedHolder	X	X	X	X	N.A.	X
IMPROVACUTER® BloodCollection Set	X	X	X	N.A.	N.A.	X
IMPROSAFE® Multi SampleNeedle	X	X	N.A.	X	X	N.A.

{12}------------------------------------------------

IMPROSAFE® Multi Sample Needle (Flashback)	X	X	N.A.	X	X	X
IMPROVACUTER® Multi Sample Needle	X	X	N.A.	N.A.	N.A.	N.A.

Model	Needle Gauge	Needle Length
MPROSAFE® Blood Collection Set with Pre-attached holder	21G, 23G, 25G, 27G	3/4", 2/5"
IMPROSAFE® Blood Collection Set	21G, 23G, 25G, 27G	3/4", 2/5"
IMPROVACUTER® Blood Collection Set with Pre-attached Holder	21G, 23G, 25G, 27G	3/4", 2/5"
IMPROVACUTER® Blood Collection Set	21G, 23G, 25G, 27G	3/4", 2/5"
IMPROSAFE® Multi Sample Needle	21G, 22G	1", 1 1/2"
IMPROSAFE® Multi Sample Needle (Flashback)	21G, 22G	1", 1 1/4"
IMPROVACUTER® Multi Sample Needle	21G, 22G	1", 1 1/2"

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 9626:1991+AMENDMENT 1 2001 Stainless steel needle tubing for the manufacture of medical devices;
ISO 7864: 1993 Sterile hypodermic needles for single use
ア ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
A ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
USP38-NF33 <85> Bacterial Endotoxins Limit.
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
A ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials
Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features
- 1. Clinical Test Conclusion

No clinical study is included in this submission.

{13}------------------------------------------------

8. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device	Reference Device 1	Reference Device 2
		K982541	K980414	K090426
Class	II	II	II	II
Intended Use	The IMPROSAFE® Blood CollectionSets with Pre-attached holder areintended to be used with evacuatedblood collection tube for the collectionof venous blood. The safety shield isintended to aid in the protection againstaccidental needle stick injury.The IMPROVACUTER® BloodCollection Sets with Pre-attachedholder are intended to be used withevacuated blood collection tube for thecollection of venous blood.The IMPROVACUTER® BloodCollection Sets are intended to be usedwith evacuated blood collection tubefor the collection of venous blood.The IMPROSAFE® Blood CollectionSets are intended to be used withevacuated blood collection tube for thecollection of venous blood. The safetyshield is intended to aid in the	VACUTAINER® Brand ECLIPSE™Blood Collection Needle is designedfor use with VACUTAINER® BrandBlood Collection Needle Holders inperforming venipuncture to obtainblood samples. After venipuncture,the safety shied is activated withthumb pressure. The hinged safetyshield pivots up and over the needle,locking into place. In the activatedposition, the safety shield protectsagainst accidental needle stick duringnormal handling and disposal.	The VACUTAINER® Brand Blood CollectionSet and Safety-Lok™ Blood Collection Setare winged blood collection needles withflexible tubing and a female luer adapterintended for venipuncture to obtain bloodsamples from patients or monitoring bloodpressure. The Safety-Lok™ Blood CollectionSet is provided with a safety shield forcovering the used needle prior to disposal.Some reorder numbers are provided with amale luer adapter. The male luer adaptercontains a non-patient needle end forpuncturing the stopper of an evacuated bloodcollection tube. Those without a male lueradapter are provided with a protective cap onthe end of the female luer adapter.The VACUTAINER® Brand BloodCollection Set and Safety-Lok™ BloodCollection Set is also indicated for theintravenous administration of fluids and maybe used for any patient population with	VAKU-8™ Blood Collection Needlesare designed for routine bloodcollection by q qualified practitioner.

	protection against accidental needlestick injury.The IMPROSAFE® Multi-SampleNeedles are intended to be used withevacuated blood collection tube for thecollection of venous blood. The safetyshield is intended to aid in theprotection against accidental needlestick injury.The IMPROVACUTER® Multi-SampleNeedles are used with holder andvacuum blood collection tube for thevenous blood collection.The IMPROSAFE® Multi-SampleNeedles (Flashback) are intended to beused with evacuated blood collectiontube for the collection of venous blood.The safety shield is intended to aid inthe protection against accidental needlestick injury.		consideration given to patient size,appropriateness for the solution being infusedand duration of therapy.
Configuration	Protective Cover of Patient end Needle	Protective Cover of Patient end Needle	Protective Cover of Patient end Needle	Top Cover
	Patient end Needle	Needle	Patient end Needle	Needle
	Double Wing Needle Handle	Needle	Double Wing Needle Handle	Button Cover
	Flexible Tubing	Needle Hub	Flexible Tubing	Needle Hub
	Conical Fitting Connector	Rubber Sleeve	Conical Fitting Connector	Rubber Sleeve
	Conical Fitting	Safety Shield	Conical Fitting
	Rubber Sleeve		Rubber Sleeve

Table 1 Comparison of Technology Characteristics

{14}------------------------------------------------

{15}------------------------------------------------

	Non-patient end NeedleSafety ShieldNeedle Holder		Non-patient End NeedleSafety Shield
Performance	Conform with ISO 9626:1991 AMD2001 and ISO 7864: 1993	Conform with ISO 9626:1991 AMD2001 and ISO 7864: 1993	Conform with ISO 9626:1991 AMD 2001and ISO 7864: 1993	Conform with ISO 9626:1991 AMD2001 and ISO 7864: 1993
Specification	21G, 22G, 23G, 25G, 27G3/4", 2/5", 1", 1 1/4" and 1 1/2"	21G, 22G1.25"	21G, 23G, 25G0.75"	21G, 22G, 23G1" and 1.5"
Sterile	EO sterilized	EO sterilized	EO sterilized	EO sterilized
Single Use	Single Use	Single Use	Single Use	Single Use
Biocompatibility	Conform with ISO 10993	Conform with ISO 10993	Conform with ISO 10993	Conform with ISO 10993
Label/Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801

The intended use of proposed device IMPROSAFE® Blood Collection Set with Pre-attached Holder, MPROVACUTER® Set with Pre-attached Holder, IMPROVACUTER® Blood Collection Set, IMPROSAFE® Blood Collection Set are sterile single use needle with without holder for the collection of venous blood. Although the indication for use are not identical to the predicate devices, it does not change the intended use beause they are both single use devices intended for collection of venous blood.

9. Substantially Equivalent (SE) Conclusion

Comparison results demonstrations and performance of the device are substantially equivalent to the legally market predicate device. Therefore, it is concluded that IMPROSAFE® Multi Sample Needle, MPROVACUTER® Multi Sample Needle (Flashback) are substantially equivalent to the legally marketed predicate devices.

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).