(195 days)
Not Found
No
The device description and performance studies focus on the physical, mechanical, and biological properties of hypodermic needles and their safety features. There is no mention of any computational analysis, algorithms, or learning processes.
No.
A therapeutic device is one that treats or alleviates a disease, injury, or condition. Hypodermic needles are used to administer or withdraw fluids, which are procedures, but the needles themselves do not provide therapy.
No
The document states that the needles are for "aspiration and injection of fluids" and "general purpose fluid injection/aspiration," which are therapeutic or procedural functions, not diagnostic ones. There is no mention of using the device to identify a disease, condition, or health status.
No
The device description clearly outlines physical components (needles, safety shields, packaging) and mentions sterilization and physical/mechanical testing, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the needles are for "aspiration and injection of fluids for medical purpose" and "general purpose fluid injection/aspiration." This describes a device used for administering or withdrawing substances directly from or into the body, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics of the needles, their gauges, lengths, safety features, and sterilization methods. There is no mention of components or functions related to analyzing biological samples or performing diagnostic tests.
- Lack of IVD Language: The text does not use any terminology typically associated with IVDs, such as "assay," "reagent," "sample analysis," "diagnostic test," or "measurement of analytes."
The device is a medical device used for direct patient care (injection and aspiration), not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The proposed devices are provided in two types of configurations; one type is a Sterile Safety Hypodermic Needles for Single Use, the other is Sterile Hypodermic Needles for Single Use. The Sterile Hypodermic Needles also divided into two types, one type is an ordinary disposable needle contained in a sterility maintenance package, the other is self-sealing hypodermic needle with an end cap, the protective cap and end cap form a sterility maintenance package.
The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 28-34 gauge and 4-32 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Needles for Single Use are intended for single use only.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and are supplied in a sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
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 Test Conclusion:
Non-clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 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 skin sensitization.
- ISO 10993-11: 2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dve Penetration
- ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- 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
- ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Test of Ethylene Oxide Residues.
- USP Bacterial Endotoxins Test
- USP Pyrogen Test
- USP Particulate Testing
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and System
Physical, Mechanical, Chemical testing was performed on the proposed device, showing conformance with related standards for cleanliness, acidity/alkalinity limits, extractable metals, size designation, color coding, needle hub, needle cap, needle tube, needle point, bond between hub and needle tube, patency of lumen, surface and appearance, stiffness, resistance to breakage, resistance to corrosion, fluid leakage, sub-atmospheric pressure air leakage, stress cracking, resistance to overriding, resistance to separation from axial load, and resistance to separation from unscrewing.
Sterile barrier packaging testing included visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf-life testing results showed EO/ECH residuals did not exceed ISO 10993-7 limits. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
Biocompatibility testing for indirect blood path contact, limited contact duration (
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 1, 2024
Berpu Medical Technology Co., Ltd. % Diana Hong, General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Shanghai 200120, China
Re: K232165
Trade/Device Name: Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles: Sterile Hypodermic Needles for Single Use-Self-sealing Hypodermic Needles
Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: January 2, 2024 Received: January 2, 2024
Dear Diana Hong:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shruti N. Mistry -S
Shruti Mistry, MS Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232165
Device Name
Sterile Safety Hypodermic Needles for Single Use Sterile Hypodermic Needles for Single Use- Disposable Needles Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
Indications for Use (Describe)
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
| 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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4
K232165 510(k) Summary
-
- Date of Preparation: 2/1/2024
-
- Sponsor Identification
Berpu Medical Technology Co., Ltd.
NO.14 Xingji Road, Yongxing Street, Longwan District, Wenzhou, Zhejiang, China 325000
Establishment Registration Number: 3004496829
Contact Person: Buxin Yu Position: Management Representative Tel: +86-577-86651999 Fax: +86-577-86630389 Email: ybx@berpu.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
5
4. Identification of Proposed Device
Trade Name: Sterile Safety Hypodermic Needles for Single Use Sterile Hypodermic Needles for Single Use- Disposable Needles Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
Regulation Name: Hypodermic, Single Lumen Needle Classification: II Regulation Number: 21 CFR 880.5570 Product Code: FMI
Predicate Device: 510(k) Number: K180417 Product Name: Sterile Hypodermic Needles for Single Use Sterile Safety Hypodermic Needles for Single Use
Indications for use:
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection.
Device Description
The proposed devices are provided in two types of configurations; one type is a Sterile Safety Hypodermic Needles for Single Use, the other is Sterile Hypodermic Needles for Single Use. The Sterile Hypodermic Needles also divided into two types, one type is an ordinary disposable needle contained in a sterility maintenance package, the other is self-sealing hypodermic needle with an end cap, the protective cap and end cap form a sterility maintenance package.
The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 28-34 gauge and 4-32 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is
6
available in 18-34 gauge and 2-40 mm lengths.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 106 and are supplied in a sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
| Needle Type | Needle gauge | Needle Length |
|---|---|---|
| Sterile Safety Hypodermic | ||
| Needles for Single Use | 28G, 29G, 30G, 31G, 32G, | |
| 33G, 34G | 4mm, 5mm, 6mm, 8mm, 9mm, 10mm, | |
| 12mm, 13mm, 16mm, 20mm, 22mm, | ||
| 25mm, 30mm, 32mm | ||
| Sterile Hypodermic Needles | ||
| for Single Use- Disposable | ||
| Needle | 27G, 30G, 31G, 32G, 33G, | |
| 34G | 2mm, 2.5mm, 4mm, 5mm, 6mm, 8mm, | |
| 9mm, 10mm, 12mm, 13mm, 16mm, | ||
| 20mm, 22mm, 25mm, 30mm, 32mm | ||
| Sterile Hypodermic Needles | ||
| for Single Use- Self-sealing | ||
| Hypodermic Needle | 18G, 19G, 20G, 21G, 22G, | |
| 23G, 24G, 25G, 26G, 27G, | ||
| 28G, 29G, 30G, 31G, 32G, | ||
| 33G, 34G | 2mm, 2.5mm, 4mm, 5mm, 6mm, 8mm, | |
| 9mm, 10mm, 12mm, 13mm, 16mm, | ||
| 20mm, 22mm, 25mm, 30mm, 32mm, | ||
| 35mm, 38mm, 40mm |
Table 1 Specifications for Proposed Devices
7
5. Technological Characteristic Table
| ITEM | Proposed Device
K232165 | Predicate Device
K180417 | Remark |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Sterile Safety Hypodermic Needles
for Single Use | Sterile Safety Hypodermic Needles
for Single Use | / |
| Product Code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Sterile Safety Hypodermic Needles for Single Use are intended to
be used with a luer slip or luer lock
syringe for aspiration and injection of
fluids for medical purpose. After
withdrawal of the needle from the
body, the attached needle safety shield
can be manually activated to cover the
needle immediately after use to
minimize risk of accidental
needlestick. | The Sterile Safety Hypodermic Needles for Single Use are intended to
be used with a luer slip or luer lock
syringe for aspiration and injection of
fluids for medical purpose. After
withdrawal of the needle from the
body, the attached needle safety shield
can be manually activated to cover the
needle immediately after use to
minimize risk of accidental
needlestick. | Same |
| Configuration and
material | Needle hub Polypropylene (PP)
Protective cap Polypropylene (PP)
Needle Stainless Steel
Safety sheath Polypropylene (PP) | Needle hub Polypropylene (PP)
Protective cap Polypropylene (PP)
Needle Stainless Steel
Safety sheath Polypropylene (PP) | Same |
| Safety sheath | Image: Safety sheath | | Same |
| Operation Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Needle Gauge | Available in 28G, 29G, 30G, 31G,
32G, 33G, 34G | Available in 18G, 19G, 20G, 21G,
22G, 23G, 24G, 25G, 26G, 27G | Different |
| Needle Length | Available in 4mm, 5mm, 6mm, 8mm,
9mm, 10mm, 12mm, 13mm, 16mm,
20mm, 22mm, 25mm, 30mm, 32mm | Available in 6-50mm | |
| Needle tube colors | Comply with ISO 6009 | Comply with ISO 6009 | Similar |
| | 34G: Orange | 27G: Medium Grey | |
| | 33G: Black | 26G: Brown | |
| | 32G: Deep green | 25G: Orange | |
| | 31G: White | 24G: Medium Purple | |
| | 30G: Yellow | 23G: Dark Blue | |
| | 29G: Red | 22G: Black | |
| | 28G: Blue-green | 21G: Dark Green | |
| | | 20G: Yellow | |
| | | 19G: Cream | |
| | | 18G: Pink | |
| Needle Performance | Complied with
ISO 7864,
ISO 9626 | Complied with
ISO 7864,
ISO 9626 | Same |
| Luer Connector
Performance | Complied with
ISO 80369-7 | Complied with
ISO 594-2 | Different |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No sensitization | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No Pyrogen | No Pyrogen | |
| Particulate | Comply with USP
no more than 6000 /device≥10µm, and
no more than 600 /device≥25µm. | Comply with USP | |
| Sterilization | | | |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Shelf life | 5 years | 5 years | Same |
Table 2 Comparison of Sterile Safety Hypodermic Needles
8
Different Analysis 1-Needle Size and Length
The needle size and length for the proposed device is different from the predicate devices. This difference is just in dimension. Different size and length devices will be selected by the physician per the patient's condition. Moreover, the needle length of the proposed device with safety needle is included in the range of the needle length of the predicate device. The performance of the needle was tested, and the test results showed that it was in accordance with ISO 7864 and ISO 9626 standards. Therefore, this difference does not raise new questions of safety and effectiveness.
Similar Analysis 2-Needle hub color
9
The color of needle hub for proposed devices is different from the predicate devices. The color is indicating the nominal outer diameter of the needle. The proposed device and the predicate device have different needle gauges, so the color of the needle hub is different, but the needle hub complies with the ISO 6009 standard. Therefore, this difference does not raise new questions of safety and effectiveness.
Different Analysis 3-Luer Connector Performance
Although the proposed device and the predicate device follow different luer connector standards, this is because ISO 594-2 is replaced by ISO 80369-7 according to current recognitions. The test results of the proposed device show that the connector performance meets the requirements of ISO 80369-7. Therefore, this difference does not raise new questions of safety and effectiveness.
10
| ITEM | Proposed Device
K232165 | Predicate Device
K180417 | Remark |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Sterile Hypodermic Needles for Single Use- Disposable Needles | Sterile Hypodermic Needles for Single Use | / |
| Product Code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Sterile Hypodermic Needles for Single Use-Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration. | The Sterile Hypodermic Needles for single Use are intended to be used with a luer slip or luer lock syringe and injection devices for general purpose fluid injection/aspiration. | Same |
| Configuration and material | Needle Hub Polypropylene (PP)
Protective cap Polypropylene (PP)
Needle Stainless Steel | Needle hub Polypropylene (PP)
Protective cap Polypropylene (PP)
Needle Stainless Steel | Same |
| Operation Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Needle Gauge | Available in 27G, 30G, 31G, 32G, 33G, 34G | Available in 14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 29G, 30G | Different |
| Needle Length | Available in 2mm, 2.5mm, 4mm, 5mm, 6mm, 8mm, 9mm, 10mm, 12mm, 13mm, 16mm, 20mm, 22mm, 25mm, 30mm, 32mm | Available in 6-60mm | |
| Needle hub color | Complied with ISO 6009
34G: Orange
33G: Black
32G: Deep green
31G: White
30G: Yellow
27G: Medium Grey | Complied with ISO 6009
30G: Yellow
29G: Red
27G: Medium Grey
26G: Brown
25G: Orange
24G: Medium Purple
23G: Dark Blue
22G: Black
21G: Dark Green
20G: Yellow
19G: Cream | Similar |
| | | 17G: Red Purple | |
| | | 16G: White | |
| | | 15G: Blue Grey | |
| | | 14G: Light Green | |
| Needle Performance | Complied with
ISO 7864,
ISO 9626 | Complied with
ISO 7864,
ISO 9626 | Same |
| Luer Connector
Performance | Complied with
ISO 80369-7 | Complied with
ISO 594-2 | Different |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No sensitization | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No Pyrogen | No Pyrogen | |
| Particulate | Comply with USP
no more than 6000 /device≥10µm, and
no more than 600 /device≥25µm. | Comply with USP | |
| Sterilization | | | |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Shelf life | 5 years | 5 years | Same |
Table 3 Comparison of Sterile Hypodermic Needles for Single Use- Disposable Needles
11
Different Analysis 4-Needle Size and Length
The needle size and length for the proposed device is different from the predicate devices. This difference is just in dimension. Different size and length devices will be selected by the physician per the patient's condition. Moreover, the needle length of the proposed device with disposable needle is similar to the needle length of the predicate device. The performance of the needle was tested, and the test results showed that it was in accordance with the ISO 7864 and ISO 9626 standards. Therefore, this difference does not raise new questions of safety and effectiveness.
Similar Analysis 5-Needle hub color
The color of needle hub for the proposed devices is different from the predicate devices. The color is indicating the nominal outer diameter of the tube of the needle. The proposed device and the predicate device have different needle gauges, so the color of the needle hub is different, but the needle hub complies with the ISO6009 standard. Therefore, this difference does not raise new questions of safety and effectiveness.
12
Different-Analysis 6-Luer Connector Performance
Although the proposed device and the predicate device follow different luer connector standards, this is because ISO 594-2 is replaced by ISO 80369-7 according to current recognitions. The test results of the proposed device show that the connector performance meets the requirements of ISO 80369-7. Therefore, this difference does not raise new questions of safety and effectiveness.
13
| | ITEM | Proposed Device
K232165 | Predicate Device
K180417 | Remark |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------|
| Product | Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | Sterile Hypodermic Needles for Single Use | / | |
| Product Code | FMI | FMI | Same | |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same | |
| Class | Class II | Class II | Same | |
| Indication for Use | The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration. | The Sterile Hypodermic Needles for single Use are intended to be used with a luer slip or luer lock syringe and injection devices for general purpose fluid injection/aspiration. | Same | |
| Configuration and material | Needle Hub | Polypropylene (PP) | Needle hub
Polypropylene (PP) | Different |
| | Protective cap | Polypropylene (PP) | Protective cap
Polypropylene (PP) | |
| | Needle | Stainless Steel | Needle
Stainless Steel | |
| | End cap | Polypropylene (PP) | / | |
| Operation Mode | For manual use only | For manual use only | Same | |
| Single Use | Single Use | Single Use | Same | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | |
| Needle Gauge | Available in 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G | Available in 14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 29G, 30G | Different | |
| Needle Length | Available in 2mm, 2.5mm, 4mm, 5mm, 6mm, 8mm, 9mm, 10mm, 12mm, 13mm, 16mm, 20mm, 22mm, 25mm, 30mm, 32mm, 35mm, 38mm, 40mm | Available in 6-60mm | | |
| Needle hub color | Complied with ISO 6009
34G: Orange
33G: Black
32G: Deep green
31G: White
30G: Yellow
29G: Red
28G: Blue-green
27G: Medium Grey
26G: Brown
25G: Orange | Complied with ISO 6009
30G: Yellow
29G: Red
27G: Medium Grey
26G: Brown
25G: Orange
24G: Medium Purple
23G: Dark Blue
22G: Black
21G: Dark Green
20G: Yellow | Similar | |
| | | | | |
| | 24G: Medium Purple | 19G: Cream | | |
| | 23G: Deep Blue | 18G: Pink | | |
| | 22G: Black | 17G: Red Purple | | |
| | 21G: Deep Green | 16G: White | | |
| | 20G: Yellow | 15G: Blue Grey | | |
| | 19G: Cream | 14G: Light Green | | |
| | 18G: Pink | | | |
| Needle Performance | Complied with
ISO 7864,
ISO 9626 | Complied with
ISO 7864,
ISO 9626 | Same | |
| Luer Connector
Performance | Complied with
ISO 80369-7 | Complied with
ISO 594-2 | Different | |
| Biocompatibility | | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same | |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | | |
| Sensitization | No sensitization | No sensitization | | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | | |
| Hemolysis | No Hemolysis | No Hemolysis | | |
| Pyrogen | No Pyrogen | No Pyrogen | | |
| Particulate | Comply with USP
no more than 6000 /device≥10µm, and
no more than 600 /device≥25µm. | Comply with USP | | |
| Sterilization | | | | |
| Method | EO Sterilized | EO Sterilized | Same | |
| SAL | 10-6 | 10-6 | Same | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same | |
| Shelf life | 5 years | 5 years | Same | |
Table 4 Comparison of Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
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Different Analysis 7- Configuration
The configuration of the proposed device is similar as the configurations of the predicate device. The proposed device has an end cap, and the predicate devices do not have an end cap. The end cap is the protection, and it's taken off when it's used. The presence of an end cap does not affect the intended use of the product, nor does it affect its use. Therefore, the differences in configuration does not raise new questions of safety and effectiveness.
Different Analysis 8-Needle Size and Length
The needle size and length for the proposed device is different from the predicate devices. This difference is just in dimension. Different size and length devices will be selected by the physician per the patient's condition. Moreover, the needle length of the proposed device with self-sealing needle is similar to the needle length of the predicate device. The performance of the needle was tested, and the test results showed
15
that it was in accordance with the ISO 7864 and ISO 9626 standards. Therefore, this difference does not raise new questions of safety and effectiveness.
Similar Analysis 9-Needle hub color
The color of needle hub for the proposed devices is different from the predicate devices. The color is indicating the nominal outer diameter of the tube of the needle. The proposed device and the predicate device have different needle gauges, so the color of the needle hub is different, but the needle hub complies with the ISO6009 standard. Therefore, this difference does not raise new questions of safety and effectiveness.
Different Analysis 10-Luer Connector Performance
Although the proposed device and the predicate device follow different luer connector standards, this is because ISO 594-2 is replaced by ISO 80369-7 according to current recognitions. The test results of the proposed device show that the connector performance meets the requirements of ISO 80369-7. Therefore, this difference does not raise new questions of safety and effectiveness.
-
Non-Clinical Test Conclusion 6.
Non-clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
△ 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 skin sensitization.
-
レ ISO 10993-11: 2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
-
▶ ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
-
► ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
► ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
-
♪ ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dve Penetration
-
レ ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
-
レ ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
-
► ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
-
♪ 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
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- レ ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Test of Ethylene Oxide Residues.
- レ USP Bacterial Endotoxins Test
- レ USP Pyrogen Test
- レ USP Particulate Testing
- レ ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and System
Physical, Mechanical, Chemical testing listed in below were performed on the proposed device. The test results show that the device conforms with the requirements of related standards.
| Item | Standard |
|---|---|
| Cleanliness | Clause 4.3 of ISO 7864:2016 |
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 |
| Limits for extractable metals | Clause 4.5 of ISO 7864:2016 |
| Size designation | Clause 4.6 of ISO 7864:2016 |
| Colour coding | Clause 4.7 of ISO 7864:2016 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Needle Cap | Clause 4.9 of ISO 7864:2016 |
| Needle tube | Clause 4.10 of ISO 7864:2016 |
| Needle point | Clause 4.11 of ISO 7864:2016 |
| Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 |
| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
| Item | Standard |
| Surface finish and appearance | Clause 5.2 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 |
| Size designation | Clause 5.5 of ISO 9626:2016 |
| Dimensions | Clause 5.6 of ISO 9626:2016 |
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 |
| Item | Standard |
| Fluid leakage | Clause 6.1 of ISO 80369-7:2021 |
| Sub-atmospheric pressure air leakage | Clause 6.2 of ISO 80369-7:2021 |
| Stress cracking | Clause 6.3 of ISO 80369-7:2021 |
Resistance to overriding
Particulate testing
Resistance to separation form axial load
Resistance to separation form unscrewing
USP
Clause 6.4 of ISO 80369-7:2021
Clause 6.5 of ISO 80369-7:2021
Clause 6.6 of ISO 80369-7:2021
Sterile barrier packaging testing was performed on the proposed device, which included visual inspection
17
(ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf-life testing listed below were performed on the proposed device. EO/ECH residuals did not exceed the limit of ISO 10993-7. The Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP |
| Shelf-Life Evaluation | Physical, Mechanical, Chemical, Package Tests |
| were performed on aging samples to verify the | |
| claimed shelf life of the device |
Biocompatibility testing
The proposed device has an indirect contact with the blood path, and is a limited contact duration ( Acute Systemic Toxicity,
-
Hemolysis.
-
Pyrogen
Simulated Clinical Study
A simulated clinical study was performed on the proposed device according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature", issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrate that the proposed device meets the pre-established criteria.
Safety Feature Test
The safety feature test was performed on both the proposed device and the predicate device to determine its safety feature. The results demonstrate that both the proposed device and predicate device meet the acceptance criteria.
7. Clinical Test Conclusion
No clinical study is included in this submission.
-
- Conclusions
The differences between the predicate device and the subject device do not raise new or different question
- Conclusions
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of safety or effectiveness. The Sterile Safe Safety Hypodermic Needles for Single Use, The Sterile Hypodermic Needles for Single Use-Disposable Needles and The Sterile Hypodermic Needles for Single Use-Self-sealing Hypodermic Needles are substantially equivalent to K180417 Sterile Hypodermic Needles for Single Use and Sterile Safety Hypodermic Needles for Single Use with respect to Indications for Use, target populations, treatment method, and technological characteristics.