(315 days)
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.
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.
The provided text is a 510(k) Summary for a medical device called "Safety Blood Collection Device for Single Use." This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than presenting a clinical study with acceptance criteria and comparative human reader performance as one might find for an AI/ML medical device.
Therefore, many of the requested details, such as sample size for test sets (in the context of clinical studies), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or not provided in this document. The document describes bench testing of physical and chemical properties and biocompatibility, not clinical performance for diagnostic accuracy or human-in-the-loop performance.
Here's an analysis based on the provided text, addressing what can be inferred and highlighting what is absent:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
The acceptance criteria are implicitly defined by the successful adherence to recognized international standards and FDA guidance documents for medical devices of this type. The reported device performance is that it met the requirements of these standards and guidance documents.
| Acceptance Criteria (Implicit from Standards and Guidance) | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility (in accordance with ISO 10993 series): | |
| - Cytotoxicity compliance (ISO 10993-5) | Complied with ISO 10993-5 standards |
| - Skin Sensitization compliance (ISO 10993-10) | Complied with ISO 10993-10 standards |
| - Irritation compliance (ISO 10993-10) | Complied with ISO 10993-10 standards |
| - Acute Systemic Toxicity compliance (ISO 10993-11) | Complied with ISO 10993-11 standards |
| - Haemolysis compliance (ISO 10993-4) | Complied with ISO 10993-4 standards |
| - Pyrogenicity compliance (ISO 10993-4) | Complied with ISO 10993-4 standards |
| - Bacterial Endotoxins compliance (ISO 10993-4) | Complied with ISO 10993-4 standards |
| Performance Testing (Adherence to relevant ISO standards and FDA guidance): | |
| - ISO 8536-4:2010 (Infusion equipment): 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. | Met requirements of ISO 8536-4:2010 |
| - ISO 80369-7:2016 (Small-bore connectors): Dimensional requirement, gauging test, fluid leakage, sub-atmospheric pressure air leakage, stress cracking, resistance to separation from axial load, resistance to unscrewing, resistance to overriding. | Met requirements of ISO 80369-7:2016 |
| - ISO 9626:2016 (Stainless steel needle tubing): Surface finish and visual appearance, cleanliness, limits for acidity and alkalinity, size designation, dimensions, stiffness, resistance to breakage, resistance to corrosion. | Met requirements of ISO 9626:2016 |
| - ISO 7864:2016 (Sterile hypodermic needles): 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. | Met requirements of ISO 7864:2016 |
| - ISO 23908:2011 (Sharps injury protection): Simulated clinical performance validation of sharp protection features. | Met requirements of ISO 23908:2011 |
| - FDA Guidance-Simulated Clinical Use Testing of Medical Devices with Sharps Injury Prevention Features: Specific requirements related to simulated clinical use of sharps injury prevention features. | Met requirements of FDA Guidance-Simulated Clinical Use Testing of Medical Devices with Sharps Injury Prevention Features. |
| Comparative Performance (Proposed vs. Predicate Device): | |
| - The proposed device meets the same standards as the predicate device for physical and chemical performance specifications, demonstrating substantial equivalence. | Both proposed and predicate device met the listed standard requirements, and testing results demonstrated substantial equivalences. |
Since this premarket notification is for a conventional medical device (safety blood collection device) and not an AI/ML-based diagnostic or imaging device, the following points are largely not applicable or not detailed in the submission.
-
Sample size used for the test set and the data provenance:
- The document mentions "test devices" for performance testing and "samples" for biocompatibility but does not specify the number of units or lot sizes tested for each standard.
- Data provenance (e.g., country of origin, retrospective/prospective) is not applicable given this is hardware testing against engineering standards, not patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance and biocompatibility is established by adherence to international engineering and biological safety standards, not expert consensus on clinical data.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical bench testing.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Ground truth is established by the results of standardized biological tests (e.g., cell cultures, animal irritability tests) that comply with ISO 10993 series.
- For performance: Ground truth is established by meeting the quantified specifications and thresholds defined within various ISO engineering standards (e.g., tensile strength, flow rate, dimensions).
-
The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
-
How the ground truth for the training set was established: Not applicable, as there is no training set for a physical device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health and Human Services, featuring a stylized eagle. To the right of that is the logo for the U.S. Food and Drug Administration (FDA). The FDA logo has the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
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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
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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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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 ContactPerson: | Mike GuRegulatory Affairs ManagerGuangzhou Osmunda Medical Device Technical ServiceCo., Ltd.Tel: (+86)-20-6231 6262Fax: (+86) -20-8633 0253 |
|---|---|
| Secondary ContactPerson: | Lenny CaoSales ManagerGemtier Medical (Shanghai) Inc.Tel: (+86) 021-67360886Fax: (+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 |
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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
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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 ofDifferences |
|---|---|---|---|
| Device name | VACUETTE® SAFETY InfusionSet | SAFETY BLOOD COLLECTIONDEVCIE FOR SINGLE USE | |
| K number | K121908 | ||
| Product code andclassification name | FMI, Needle, Hypodermic,Single Lumen | FMI, Needle, Hypodermic, SingleLumen | |
| Manufacturer | Greiner Bio-One GmbH | Gemtier Medical (Shanghai) Inc. | |
| Indications for use | The VACUETTE® SAFETYInfusion Set is a single-use,sterile, winged blood collectionneedle bonded to a flexibletubing* with a luer connector.The VACUETTE® SAFETYInfusion Set is used for bloodcollection and/or theshort-term infusion ofintravenous fluids. The wingedneedle is designed with a safetyshield, which can be activatedto cover the needleimmediately followingvenipuncture to aid in theprotection against accidentalneedlestick injury. | The SAFETY BLOOD COLLECTIONDEVCIE FOR SINGLE USE is asingle-use, sterile, winged bloodcollection needle bonded or not toa flexible tubing with or without aluer adapter and/or tube holder.The SAFETY BLOOD COLLECTIONDEVCIE FOR SINGLE USE is usedfor blood collection and/or theshort-term infusion of intravenousfluids. The venipuncture needle isdesigned to be covered with asafety mechanism, which can beactivated to cover needleimmediately followingvenipuncture to aid in theprotection against accidentalneedlestick injury. | Identical |
| Specification | Predicate Device | Proposed Device | Discussion ofDifferences |
| Indicated for infusion | Yes | Identical | |
| Single use | Yes | Identical | |
| Mechanism of safety bloodcollection | 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 needleprotector | N/A | PP | |
| Rubber cover | N/A | Synthetic Rubber | |
| Components | |||
| Tubing,Wing,Female luer connectorMale luer protector | Yes | Identical | |
| Plastic Sleeve,Venipuncture Needle Stand | Yes | Identical | |
| Specification | Predicate Device | Proposed Device | Discussion ofDifferences |
| Mechanism of safety bloodcollection | Yes,slide the safety mechanism toactivate | Yes,Press both sides of the safetymechanism to release the lockfirst and slide the safetymechanism to activate | SimilarThis differencedoes not raisedifferencequestions of safetyand effectiveness. |
| Male Luer adapter,Tube holder,Blood Collection Needle,Blood collection needleprotector structure | No | Yes | |
| Performance Specifications | |||
| Needle Gauge Size(s) | 21G, 23G, 25G | Identical | |
| Needle Wall | Thin Wall | Identical | |
| Needle Length Size(s) | 19mm | 20mm | SimilarThis differencedoes not raisedifferencequestions of safetyand effectiveness. |
| Needle Point | 3 bevel | Identical | |
| Tubing Length | From 10cm to 30cm | From 10cm to 35cm | SimilarThis differencedoes not raisedifferencequestions of safetyand effectiveness. |
| Sterile | Yes | Identical | |
| Sterilization Method | EO Sterilization | Identical | |
| Non-pyrogen | Yes | Identical | |
| Shelf Life | 5 years | 3 years | SimilarThis differencedoes not raisedifferencequestions of safetyand effectiveness. |
| Specification | Predicate Device | Proposed Device | Discussion ofDifferences |
| 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".
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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".
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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
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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.
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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.
§ 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).