(315 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical aspects of a blood collection device with a safety mechanism, with no mention of AI or ML capabilities.
No
The device is primarily for blood collection and short-term infusion of intravenous fluids. While infusion of fluids can be part of a therapeutic process, the device itself is a delivery mechanism and not a therapeutic agent or treatment modality.
No
The device is described as a "winged venipuncture needle bonded to a flexible tubing" used for "blood collection and/or the short-term infusion of intravenous fluids." It is a tool for collecting samples or administering fluids, not for analyzing or interpreting data to diagnose a condition.
No
The device description clearly outlines a physical medical device (needle, tubing, luer adapter, tube holder) used for blood collection and fluid infusion. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "blood collection and/or the short-term infusion of intravenous fluids". This describes a device used to obtain a sample or deliver a substance to the body, not a device used to perform a test on a sample outside of the body.
- Device Description: The description focuses on the physical components for blood collection and fluid infusion (needle, tubing, luer adapter, tube holder). It doesn't mention any reagents, test strips, or analytical components typically associated with IVDs.
- Lack of IVD Language: The text does not use any terminology related to diagnostic testing, analyzing samples, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for obtaining the specimen or administering treatment, not for performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is a single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The venipuncture needle is designed to be covered with a safety mechanism, which can be activated to cover needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
Product codes (comma separated list FDA assigned to the subject device)
FMI, FPA
Device Description
The Safety Blood Collection Device for Single Use is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The Safety Blood Collection/Infusion Set is individually wrapped, sterile, non-pyrogenic and is designed for collection of blood specimens or short-term intravenous administration of fluid (up to 2 hours under direct clinical supervision). When it's equipped with male luer adapter and/ or tube holder, it can be used for taking samples from the patients through vacuum tubes. It is also indicated for short-term intravenous fluids (up to 2 hours under direct clinical supervision) after attaching to an IV set, a transfusion set or to other compatible/appropriate device.
Three models were included in this submission, which are JT-HSQ, JT-HSQ-B, and JT-HSQ-Z.
JT-HSQ: The packed JT-HSQ has been assembled with Tubing, Luer Adapter and Tube Holder. JT-HSQ can be used for blood collection directly without connecting with other part. The tubing keeps proper distance between user and patient which is convenient for user's operation. For short-term infusion purposes (up to 2 hours), aseptically remove "Luer Adapter and Holder" from JT-HSQ prior to attaching to an IV set, a transfusion set or to other compatible/appropriate device.
JT-HSQ-B: The packed JT-HSQ-B has been assembled with tubing and luer adapter,but no tube holder. Using JT-HSQ-B without tube holder's protection is OK to collect blood but may have the risk of stick injury from blood collection needle. It's suggested to connect JT-HSQ-B with tube holder first before blood collection.The tubing keeps proper distance between user and patient which is convenient for user's operation. For short-term infusion purposes (up to 2 hours), aseptically remove "Luer Adapter" from JT-HSQ-B prior to attaching to an IV set, a transfusion set or to other compatible/appropriate device
JT-HSQ-Z: JT-HSQ-Z can be used for collection of blood specimens after attachng to the additional luer adapter and tube holder, it can also be used for short-term intravenous fluids (up to 2 hours) after attaching to an IV set, a transfusion set or to other compatible/appropriate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
Conducted in accordance with ISO 10993-1:2009/(R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Tests included: Cytotoxicity, Skin Sensitization, Irritation, Acute Systemic Toxicity, Haemolysis, Pyrogenicity, Bacterial Endotoxins.
The device is classified as direct blood path with contact duration less than 24 hours.
Test results complied with ISO 10993 standards (ISO 10993-4:2002+Amd 1:2006, ISO 10993-5: 2009, ISO 10993-10: 2010, and ISO 10993-11: 2006).
Performance testing:
Conducted according to the following standards and guidance:
(1) ISO 8536-4:2010. Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed.
Tests conducted: Particulate contamination, leakage, tensile strength, tubing appearance, flow rate, protective caps, chemical requirements, reducing (oxidizable) matter, metal ions, titration acidity or alkalinity, residue on evaporation, uv absorption of extract solution.
(2) ISO 80369-7:2016. Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications.
Tests conducted: Dimensional requirement, gauging test, fluid leakage, sub-atmospheric pressure air leakage, stress cracking, resistance to separation from axial load, resistance to separation from unscrewing, resistance to overriding.
(3) ISO 9626:2016. Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods.
Tests conducted: Surface finish and visual appearance, cleanliness, limits for acidity and alkalinity, size designation, dimensions, stiffness, resistance to breakage, resistance to corrosion.
(4) ISO 7864:2016. Sterile hypodermic needles for single use -- Requirements and test method.
Tests conducted: Cleanliness, limits for acidity and alkalinity, limits for extractable metals, size designation, colour coding, needle hub requirement, needle cap requirement, needle tube requirement, needle point requirement, bond between hub and needle tube requirement, patency of lumen, sharps injury protection.
(5) ISO 23908:2011. Sharps injury protection -- Requirements and test methods --Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Tests conducted: Simulated clinical performance validation of sharp protection features.
(6) FDA Guidance-Simulated Clinical Use Testing of the FDA Guidance on Medical Devices with Sharps Injury Prevention Features.
All requirements of the above standards and guidance were met.
Comparative performance testing was conducted between the proposed device and the predicate device (VACUETTE® SAFETY Infusion Set). Both devices met the requirements of the listed ISO standards and FDA guidance, demonstrating substantial equivalence.
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.
Not Found
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
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December 11, 2017
Gemtier Medical (Shanghai) Inc. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Quinglan Street, Panyu Dis Guangdong, 510006 CHINA
Re: K170276
Trade/Device Name: Safety Blood Collection Device for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FPA Dated: November 7, 2017 Received: November 9, 2017
Dear Mike Gu:
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tina Kiang
-s
Tina Kiang, Ph.D. 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
Indications for Use
510(k) Number (if known) K170276
Device Name
Safety Blood Collection Device for Single Use
Indications for Use (Describe)
The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is a single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The venipuncture needle is designed to be covered with a safety mechanism, which can be activated to cover needle immediately following venipuncture to aid in the protection against accidental needlestick 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) |
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3
Image /page/3/Picture/0 description: The image shows the Gemtier logo. The logo consists of a stylized blue and yellow symbol on the left, followed by the word "GEMTIER" in blue with a yellow underline. The symbol appears to be a stylized flame or feather design. There is a registered trademark symbol above and to the right of the symbol and a trademark symbol above and to the right of the word "GEMTIER".
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
- SUBMITTER
Gemtier Medical (Shanghai) Inc. No.18, Jianding Road, Fengjing Town, Jinshan District, 201502 Shanghai, China. Tel: (+86) 021-67360886 Fax: (+86) 021-57365666
| Primary Contact
Person: | Mike Gu
Regulatory Affairs Manager
Guangzhou Osmunda Medical Device Technical Service
Co., Ltd.
Tel: (+86)-20-6231 6262
Fax: (+86) -20-8633 0253 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Contact
Person: | Lenny Cao
Sales Manager
Gemtier Medical (Shanghai) Inc.
Tel: (+86) 021-67360886
Fax: (+86) 021-57365666 |
Date prepared Nov 30, 2017
- DEVICE
| Device Name: | Safety Blood Collection Device for Single Use |
|---|---|
| Common/Usual Name: | Safety Blood Collection Device for Single Use |
| Regulation number | 21 CFR 880.5570 |
| Regulation Name | Hypodermic single lumen needle |
| Regulation Class: | II |
| Product Code: | FMI, FPA |
| Classification Name | Needle, Hypodermic, Single Lumen |
4
Image /page/4/Picture/0 description: The image shows the logo for GemTier. The logo consists of a blue abstract shape on the left, resembling a stylized flower or a series of angled lines. To the right of the shape is the word "GEMTIER" in blue, with the "T" in yellow. A small "R" in a circle is located above and to the right of the blue shape, and a "TM" symbol is located above and to the right of the word "GEMTIER".
3. PREDICATE DEVICES
Predicate device: K121908, VACUETTE® SAFETY Infusion Set
These predicates have not been subject to a design-related recall.
DEVICE DESCRIPTION 4.
The Safety Blood Collection Device for Single Use is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The Safety Blood Collection/Infusion Set is individually wrapped, sterile, non-pyrogenic and is designed for collection of blood specimens or short-term intravenous administration of fluid (up to 2 hours under direct clinical supervision). When it's equipped with male luer adapter and/ or tube holder, it can be used for taking samples from the patients through vacuum tubes. It is also indicated for short-term intravenous fluids (up to 2 hours under direct clinical supervision) after attaching to an IV set, a transfusion set or to other compatible/appropriate device.
Three models were included in this submission, which are JT-HSQ, JT-HSQ-B, and JT-HSQ-Z.
11-HSQ:
The packed JT-HSQ has been assembled with Tubing, Luer Adapter and Tube Holder. JT-HSQ can be used for blood collection directly without connecting with other part. The tubing keeps proper distance between user and patient which is convenient for user's operation. For short-term infusion purposes (up to 2 hours), aseptically remove "Luer Adapter and Holder" from JT-HSQ prior to attaching to an IV set, a transfusion set or to other compatible/appropriate device.
JT-HSQ-B:
The packed JT-HSQ-B has been assembled with tubing and luer adapter,but no tube holder. Using JT-HSQ-B without tube holder's protection is OK to collect blood but may have the risk of stick injury from blood collection needle. It's suggested to connect JT-HSQ-B with tube holder first before blood collection.The tubing keeps proper distance between user and patient which is convenient for user's operation. For short-term infusion purposes (up to 2 hours), aseptically remove "Luer Adapter" from JT-HSQ-B prior to attaching to an IV set, a transfusion set or to other compatible/appropriate device
JT-HSQ-Z:
JT-HSQ-Z can be used for collection of blood specimens after attachng to the additional luer adapter and tube holder, it can also be used for short-term
5
Image /page/5/Picture/0 description: The image shows the Gemtier logo. The logo consists of a blue abstract shape on the left, followed by the word "GEMTIER" in blue and yellow. The "TI" in "GEMTIER" is colored yellow. There is a registered trademark symbol above and to the right of the abstract shape, and a trademark symbol above and to the right of the word "GEMTIER".
intravenous fluids (up to 2 hours) after attaching to an IV set, a transfusion set or to other compatible/appropriate device.
5. INDICATIONS FOR USE
The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is a single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The venipuncture needle is designed to be covered with a safety mechanism, which can be activated to cover needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE
| Specification | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Device name | VACUETTE® SAFETY Infusion
Set | SAFETY BLOOD COLLECTION
DEVCIE FOR SINGLE USE | |
| K number | K121908 | | |
| Product code and
classification name | FMI, Needle, Hypodermic,
Single Lumen | FMI, Needle, Hypodermic, Single
Lumen | |
| Manufacturer | Greiner Bio-One GmbH | Gemtier Medical (Shanghai) Inc. | |
| Indications for use | The VACUETTE® SAFETY
Infusion Set is a single-use,
sterile, winged blood collection
needle bonded to a flexible
tubing* with a luer connector.
The VACUETTE® SAFETY
Infusion Set is used for blood
collection and/or the
short-term infusion of
intravenous fluids. The winged
needle is designed with a safety
shield, which can be activated
to cover the needle
immediately following
venipuncture to aid in the
protection against accidental
needlestick injury. | The SAFETY BLOOD COLLECTION
DEVCIE FOR SINGLE USE is a
single-use, sterile, winged blood
collection needle bonded or not to
a flexible tubing with or without a
luer adapter and/or tube holder.
The SAFETY BLOOD COLLECTION
DEVCIE FOR SINGLE USE is used
for blood collection and/or the
short-term infusion of intravenous
fluids. The venipuncture needle is
designed to be covered with a
safety mechanism, which can be
activated to cover needle
immediately following
venipuncture to aid in the
protection against accidental
needlestick injury. | Identical |
| Specification | Predicate Device | Proposed Device | Discussion of
Differences |
| Indicated for infusion | | Yes | Identical |
| Single use | | Yes | Identical |
| Mechanism of safety blood
collection | | Latch mechanism for sharps injury protection | Identical |
| Materials | | | |
| Venipuncture Needle | Stainless steel | Stainless steel | Identical |
| Blood Collection Needle | | Stainless steel | Identical |
| Tubing | PVC | PVC | Identical |
| Wing | PVC | PVC | Identical |
| Sleeve | PE | PE | Identical |
| Retractable Cartridge | PC | PC | Identical |
| Female luer connector | ABS | ABS | Identical |
| Male luer protector | PP | PP | Identical |
| Male Luer adapter | N/A | ABS | Identical |
| Tube holder | N/A | PP | Identical |
| Blood collection needle
protector | N/A | PP | |
| Rubber cover | N/A | Synthetic Rubber | |
| Components | | | |
| Tubing,
Wing,
Female luer connector
Male luer protector | | Yes | Identical |
| Plastic Sleeve,
Venipuncture Needle Stand | | Yes | Identical |
| Specification | Predicate Device | Proposed Device | Discussion of
Differences |
| Mechanism of safety blood
collection | Yes,
slide the safety mechanism to
activate | Yes,
Press both sides of the safety
mechanism to release the lock
first and slide the safety
mechanism to activate | Similar
This difference
does not raise
difference
questions of safety
and effectiveness. |
| Male Luer adapter,
Tube holder,
Blood Collection Needle,
Blood collection needle
protector structure | No | Yes | |
| Performance Specifications | | | |
| Needle Gauge Size(s) | 21G, 23G, 25G | | Identical |
| Needle Wall | Thin Wall | | Identical |
| Needle Length Size(s) | 19mm | 20mm | Similar
This difference
does not raise
difference
questions of safety
and effectiveness. |
| Needle Point | 3 bevel | | Identical |
| Tubing Length | From 10cm to 30cm | From 10cm to 35cm | Similar
This difference
does not raise
difference
questions of safety
and effectiveness. |
| Sterile | Yes | | Identical |
| Sterilization Method | EO Sterilization | | Identical |
| Non-pyrogen | Yes | | Identical |
| Shelf Life | 5 years | 3 years | Similar
This difference
does not raise
difference
questions of safety
and effectiveness. |
| Specification | Predicate Device | Proposed Device | Discussion of
Differences |
| Biocompatibility | Cytotoxicity, Skin Sensitization, Irritation, Acute Systemic Toxicity,
Haemolysis, Pyrogenicity, Bacterial Endotoxins | | Identical |
Table 6.1 Comparison with Predicate Device
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Image /page/6/Picture/0 description: The image shows the Gemtier logo. The logo consists of a blue and yellow abstract shape on the left, followed by the word "GEMTIER" in blue with a yellow "T". There is a registered trademark symbol above and to the right of the abstract shape, and a trademark symbol above and to the right of the word "GEMTIER".
7
Image /page/7/Picture/0 description: The image is a logo for Gemtier. The logo consists of a blue and yellow abstract shape on the left, followed by the word "GEMTIER" in blue with a yellow "T". There is a registered trademark symbol above and to the right of the abstract shape, and a trademark symbol above and to the right of the word "GEMTIER".
8
Image /page/8/Picture/0 description: The image shows the Gemtier logo. The logo consists of a stylized blue and yellow symbol on the left, followed by the word "GEMTIER" in blue and yellow. The "T" in "GEMTIER" is yellow, while the rest of the letters are blue. There is a registered trademark symbol above and to the right of the stylized symbol, and a trademark symbol to the right of the word "GEMTIER".
Compared with the predicate device, VACUETTE® SAFETY Infusion Set (K121908), the proposed device is identical in indications for use, mechanism of action, materials, needle wall and point, sterilization method, and biocompatibility.
The proposed device has the same components, except for adding male luer adapter, tube holder, blood collection needle protector and rubber cover.
The proposed device has the same performance specifications, except for additional needle gauge sizes, similar needle length, similar tubing length and a shorter shelf life. Through performance bench testing the proposed device and the predicate device demonstrated to be substantial equivalence.
7. NON-CLINICAL DATA
The following non-clinical data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Safety Blood Collection Device for Single Use was conducted in accordance with the International Standard ાડભ 10993-1:2009/(R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity
- Haemolysis
- Pyrogenicity
- Bacterial Endotoxins
The device is classified as direct blood path. The duration of contact is less than 24 hours. The test results of cytotoxicity, skin sensitization, acute systemic toxicity, haemolysis, pyrogenicity and bacterial endotoxins complied with ISO 10993 standards, including ISO 10993-4:2002+Amd 1:2006, Biological Evaluation of medical
9
Image /page/9/Picture/0 description: The image shows the logo for Gemtier. The logo consists of a stylized blue and yellow symbol on the left, followed by the word "GEMTIER" in blue and yellow. The "T" in "GEMTIER" is yellow, while the rest of the letters are blue. There is a registered trademark symbol above and to the right of the stylized symbol, and a trademark symbol above and to the right of the word "GEMTIER".
devices. Part 4: Selection of tests for interactions with blood; 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: Tests for Irritation and skin sensitization; and ISO 10993-11: 2006. Biological evaluation of medical devices - Part 11: Test for Systemic Toxicity. They demonstrate substantial equivalences to the predicate device.
Performance testing
Performance tests were conducted on the Safety Blood Collection Device for Single Use, according to the following standards and guidance,
(1) ISO 8536-4:2010. Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed.
Tests conducted: Particulate contamination, leakage, tensile strength, tubing appearance, flow rate, protective caps, chemical requirements, reducing (oxidizable) matter, metal ions, titration acidity or alkalinity, residue on evaporation, uv absorption of extract solution.
(2) ISO 80369-7:2016. Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications.
Tests conducted: Dimensional requirement, gauging test, fluid leakage, sub-atmospheric pressure air leakage, stress cracking, resistance to separation from axial load, resistance to separation from unscrewing, resistance to overriding.
(3) ISO 9626:2016.Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods.
Tests conducted: Surface finish and visual appearance, cleanliness, limits for acidity and alkalinity, size designation, dimensions, stiffness, resistance to breakage, resistance to corrosion.
(4) ISO 7864:2016. Sterile hypodermic needles for single use -- Requirements and test method
Tests conducted: Cleanliness, limits for acidity and alkalinity, limits for extractable metals, size designation, colour coding, needle hub requirement, needle cap requirement, needle tube requirement, needle point requirement, bond between hub and needle tube requirement, patency of lumen, sharps injury protection.
(5) ISO 23908:2011. Sharps injury protection -- Requirements and test methods --Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Tests conducted: Simulated clinical performance validation of sharp protection features.
10
Image /page/10/Picture/0 description: The image shows the Gemtier logo. The logo consists of a blue abstract shape on the left, followed by the word "GEMTIER" in a stylized font. The "TIE" portion of the word is colored yellow. There is a registered trademark symbol above and to the right of the abstract shape, and a trademark symbol to the right of the word "GEMTIER".
(6) FDA Guidance-Simulated Clinical Use Testing of the FDA Guidance on Medical Devices with Sharps Injury Prevention Features.
The requirements of the above standards and guidance were met in all test devices.
Comparative performance testing was conducted between the proposed device and the predicate device, VACUETTE® SAFETY Infusion Set, to evaluate the physical and chemical performance specifications. Both the proposed device and predicate device met the requirements of ISO 8536-4: 2010, ISO 80369-7: 2016, ISO 9626: 2016, ISO 7864: 2016, ISO 23908: 2011 and FDA guidance Simulated Clinical Use Testing of the FDA Guidance on Medical Devices with Sharps Injury Prevention Features, and the testing results demonstrated substantial equivalences between the proposed device with the predicate device.
8. CONCLUSION
The non-clinical data demonstrate that the Safety Blood Collection Device for Single Use performed as intended in the specified use conditions. Through performance bench testing the subject device has demonstrated that they are substantially equivalent to the predicate device.