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

Q: Who is the manufacturer of 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?

Guangzhou Improve Medical Instruments Co., Ltd. filed the 510(k) submission for 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 (K153388).

Q: What is the FDA product code for 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?

FMI. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for 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?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like 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?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K153388 · Guangzhou Improve Medical Instruments Co., Ltd. · FMI · Jun 7, 2016 · General Hospital

Device Facts

Record ID	K153388
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
Applicant	Guangzhou Improve Medical Instruments Co., Ltd.
Product Code	FMI · General Hospital
Decision Date	Jun 7, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5570
Device Class	Class 2

Intended Use

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.

Device Story

Blood collection sets and multi-sample needles facilitate venous blood collection into evacuated tubes. Devices consist of patient-end needle, non-patient-end needle, and optional flexible tubing, pre-attached holder, and safety shield. Some models include flashback visualization. Used in clinical settings by healthcare professionals. Safety shields protect against accidental needle stick injuries during handling and disposal. Devices are sterile, single-use, and disposable. No electronic or software components.

Clinical Evidence

Bench testing only. No clinical data included.

Technological Characteristics

Stainless steel needle tubing (ISO 9626:1991); sterile hypodermic needles (ISO 7864:1993). Biocompatibility per ISO 10993 (parts 5, 7, 10, 11). Seal strength and leak testing per ASTM F88/F88M-09 and ASTM F1929-12. Hemolytic properties per ASTM F756-13. EO sterilization. Single-use. No software or electronic components.

Indications for Use

Indicated for the collection of venous blood using evacuated blood collection tubes. Intended for use by qualified practitioners.

Regulatory Classification

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.

Predicate Devices

VACUTAINER® Brand Blood Collection Set and Safety-Lok™ Blood Collection Set (K980414)
VACUTAINER® Brand ECLIPSE™ Blood Collection Needle (K982541)
VAKU-8™ Blood Collection Needle (K090426)

Related Devices

K202188 — Safety Blood Collection Sets for Single Use · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Feb 19, 2021
K182146 — Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set · Sol-Millennium Medical, Inc. · Dec 3, 2018
K230080 — Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood · Yangzhou Medline Industry, Co., Ltd. · Jul 7, 2023
K212019 — Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single · Jiangsu Micsafe Medical Technology Co., Ltd. · Nov 4, 2021
K113505 — VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER · Greiner Bio-One North America, Inc. · Feb 17, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ 510(k) Number (if known) K153388 #### Device Name IMPROSAFE® Blood Collection Set with Pre-attached Holder Indications for Use (Describe) 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. | 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) | | |---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | | | | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## 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 {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.* 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 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. | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| **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) | | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | | <input type="checkbox"/> 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 {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.* 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 {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 2. 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 Set with Pre-attached holder | 510(k) Number: K980414 Product Name: VACUTAINER® Brand Blood Collection Set and Safety-LokTM Blood Collection Set | | IMPROSAFE® Blood Collection Set | 510(k) Number: K980414 Product Name: VACUTAINER® Brand Blood Collection Set and Safety-LokTM Blood Collection Set | | IMPROVACUTER® Blood Collection Set with Pre-attached Holder | 510(k) Number: K980414 Product Name: VACUTAINER® Brand Blood Collection Set and Safety-LokTM Blood Collection Set | | IMPROVACUTER® Blood Collection Set | 510(k) Number: K980414 Product Name: VACUTAINER® Brand Blood Collection Set and Safety-LokTM Blood Collection Set | | IMPROSAFE® Multi Sample Needle | 510(k) Number: K982541 Product Name: VACUTAINER® Brand ECLIPSETM Blood Collection Needle | | IMPROSAFE® Multi Sample Needle (Flashback) | 510(k) Number: K982541 Product Name: VACUTAINER® Brand ECLIPSETM Blood Collection Needle | | IMPROVACUTER® Multi Sample Needle | 510(k) Number: K090426 Product Name: VAKU-8TM Blood Collection Needle | - 3. 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. 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. {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. 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. 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 . - 5. 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-End Needle | Non-Patient End Needle | Flexible Tubing | Pre-attached Holder | Safety Mechanism | Visible Flash Back | |-------------------------------------------------------------------|-----------------------|---------------------------|--------------------|------------------------|---------------------|-----------------------| | MPROSAFE® Blood Collection Set with Pre-attached holder | X | X | X | X | X | X | | IMPROSAFE® Blood Collection Set | X | X | X | N.A. | X | X | | IMPROVACUTER® Blood Collection Set with Pre-attached Holder | X | X | X | X | N.A. | X | | IMPROVACUTER® Blood Collection Set | X | X | X | N.A. | N.A. | X | | IMPROSAFE® Multi Sample Needle | 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 - 7. 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 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. 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 | VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is designed for use with VACUTAINER® Brand Blood Collection Needle Holders in performing venipuncture to obtain blood samples. After venipuncture, the safety shied is activated with thumb pressure. The hinged safety shield pivots up and over the needle, locking into place. In the activated position, the safety shield protects against accidental needle stick during normal handling and disposal. | The VACUTAINER® Brand Blood Collection Set and Safety-Lok™ Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients or monitoring blood pressure. The Safety-Lok™ Blood Collection Set is provided with a safety shield for covering the used needle prior to disposal. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non-patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter. The VACUTAINER® Brand Blood Collection Set and Safety-Lok™ Blood Collection Set is also indicated for the intravenous administration of fluids and may be used for any patient population with | VAKU-8™ Blood Collection Needles are designed for routine blood collection by q qualified practitioner. | | | | |…

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

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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

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