(197 days)
No
The document describes standard blood collection devices and does not mention any AI or ML components or functionalities.
No
The device is described as a blood collection set for venous blood samples, intended for diagnostic purposes rather than therapeutic treatment.
No
Explanation: The devices described are blood collection sets and needles used for the collection of venous blood, which is a preliminary step to diagnostic testing, but the devices themselves do not perform a diagnostic function.
No
The device description clearly outlines physical components such as needles, tubing, and safety mechanisms, indicating it is a hardware device for blood collection. There is no mention of software as a component or the primary function.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are for the collection of venous blood. They are the tools used to obtain the sample.
- Device Description: The description details the physical components of the blood collection sets and needles, which are designed to facilitate the physical act of drawing blood.
- Lack of Diagnostic Function: There is no mention of these devices being used to perform any test or analysis on the collected blood sample. They do not provide any diagnostic information themselves.
- Performance Studies: The performance studies focus on the physical properties of the devices (seal strength, sterility, biocompatibility, etc.) and their ability to collect blood safely and effectively. They do not involve evaluating the accuracy or performance of a diagnostic test.
IVD devices are used in vitro (outside the body) to examine specimens (like blood) to provide information for diagnosis, monitoring, or screening. These blood collection devices are used in vivo (on the body) to obtain the specimen for potential subsequent in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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:
MPROSAFE® 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. (for Pre-attached Holder), 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. (for Safety Mechanism), Visible Flash Back
IMPROVACUTER® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A. (for Pre-attached Holder), N.A. (for Safety Mechanism), Visible Flash Back
IMPROSAFE® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A. (for Flexible Tubing), Pre-attached Holder, Safety Mechanism, N.A. (for Visible Flash Back)
IMPROSAFE® Multi Sample Needle (Flashback): Patient-End Needle, Non-Patient End Needle, N.A. (for Flexible Tubing), X (for Pre-attached Holder), X (for Safety Mechanism), X (for Visible Flash Back)
IMPROVACUTER® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A. (for Flexible Tubing), N.A. (for Pre-attached Holder), N.A. (for Safety Mechanism), N.A. (for Visible Flash Back)
Needle Gauge: 21G, 22G, 23G, 25G, 27G
Needle Length: 3/4", 2/5", 1", 1 1/4", 1 1/2"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Venous blood collection (implies human veins)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
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 Bacterial Endotoxins Limit.
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
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
No clinical study is included in this submission.
Key results: Conform with ISO 9626:1991 AMD 2001 and ISO 7864: 1993; EO sterilized; Single Use; Conform with ISO 10993; Conform with 21 CFR Part 801.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) | |
|---|---|
| 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
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.
| ☑ 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.
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
-
- Sponsor Identification
Guangzhou Improve Medical Instruments Co., Ltd. No.102, Kaiyuan Avenue, Science City, Guangzhou Economic & Technological Development District, Guangzhou, 510530, CHINA
- Sponsor Identification
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 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 |
-
- 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.
- Identification of Predicate Devices
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 .
-
- 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:
- Device Description
| 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 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
-
- 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. | ||||
| 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® 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. | consideration given to patient size, | |||
| appropriateness for the solution being infused | ||||
| and 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 Needle
Safety Shield
Needle Holder | | Non-patient End Needle
Safety Shield | |
|------------------|--------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Performance | Conform with ISO 9626:1991 AMD
2001 and ISO 7864: 1993 | Conform with ISO 9626:1991 AMD
2001 and ISO 7864: 1993 | Conform with ISO 9626:1991 AMD 2001
and ISO 7864: 1993 | Conform with ISO 9626:1991 AMD
2001 and ISO 7864: 1993 |
| Specification | 21G, 22G, 23G, 25G, 27G
3/4", 2/5", 1", 1 1/4" and 1 1/2" | 21G, 22G
1.25" | 21G, 23G, 25G
0.75" | 21G, 22G, 23G
1" 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.