(174 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterilization, and basic performance of a hypodermic needle, with no mention of AI or ML.
No.
The device is a needle used for injection/aspiration, which is a delivery mechanism, not a device that itself provides therapy for a disease or condition.
No
The device, Sterile Hypodermic Needles for Single Use, is described for "general purpose fluid injection/aspiration." This function is for administering or withdrawing substances, not for identifying or diagnosing a condition.
No
The device description clearly outlines physical components (needle hub, protective cover, needle tube, jointing) and mentions sterilization, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose fluid injection/aspiration" using a syringe. This describes a procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details the physical components of a needle used for injection/aspiration. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a patient's health status
Therefore, the Sterile Hypodermic Needles for Single Use are a medical device used for administering or withdrawing fluids from the body, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing. The Sterile Hypodermic Needles for Single Use is for single use only. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
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
Medical professionals and trained care givers / Hospitals and clinics
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Sterile Hypodermic Needles for Single Use, Sterile Safety Hypodermic Needles for Single Use were evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device – Blood path indirect" with a contact duration of "Limited (. The following tests were performed, as recommended:
Cytotoxicity (ISO 10993-5: 2009)
Skin sensitization (ISO 10993-10: 2010)
Hemolysis (ISO 10993-4: 2017)
Intracutaneous reactivity (ISO 10993-10: 2010)
Acute systemic toxicity (ISO 10993-11: 2017)
Pyrogenicity (ISO 10993-11: 2017)
All evaluation acceptance criteria were met.
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
Sterilization and shelf-life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf-life of the Sterile Hypodermic Needles for Single Use, Sterile Safety Hypodermic Needles for Single Use is determined based on stability study which includes ageing test. The shelf-life of the Sterile Hypodermic Needles for Single Use, Sterile Safety Hypodermic Needles for Single Use is five (5) years.
Sterilization Evaluation (ISO11135: 2014)
EO residue (ISO 10993-7:2008)
ECH residue (ISO 10993-7:2008)
Bacterial Endotoxin testing (USP42-NF37)
Sterile Barrier Packaging Testing & Shelf-Life Evaluation (Seal Strength ASTM F88/F88M-15, Dye Penetration ASTM F1929-15, Creep/Burst Testing ASTM F1140/F1140M-13, Gross Leakage ASTM F2096-11, Antibacterial Testing DIN 58953-6:2010)
Performance testing
Performance testing is performed according to the following standards:
- ISO 7864: 2016 A (Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Tubular needle designation, Colour coding, Needle hub, Needle cap, Needle tube (Tolerance on length, Freedom from defects, Lubricant), Needle Point, Bond between Tube and Hub, Patency of Lumen)
- ISO 9626:2016 (Surface finish and visual appearance, Cleanliness, Limits for acidity and alkalinity, Size designation, Dimensions, Stiffness, Resistance to breakage, Resistance to corrosion)
- ISO 80369-7:2016 (Dimensional requirements for luer connectors, Fluid leakage (Positive pressure liquid leakage), Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding)
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
October 14, 2021
Azur Medical Company Inc. Di Zhao General Manager 6710 Everglades Dr. Richmond, Virginia 23838
Re: K211214
Trade/Device Name: Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 9, 2021 Received: August 20, 2021
Dear Di Zhao:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
For CAPT Alan Stevens 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
Enclosure
2
Indications for Use
510(k) Number (if known) K211214
Device Name
Sterile Hypodermic Needles for Single Use
Indications for Use (Describe)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe 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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3
K211214 510(k) summary
Preparation Date: October 14, 2021
l Submitter
Device submitter: Azur Medical Company Inc. 6710 Everglades Dr., Richmond, Virginia, VA 23838, USA
Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030
Contact person: Di Zhao
General Manager Phone: 928-5922380 Email: dzhao@azur-ppe.com
II Device
Trade Name of Device: Sterile Hypodermic Needles for Single Use Common Name: Hypodermic Single Lumen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product code: FMI Review Panel: General Hospital
III Predicate Device
| Trade name: | Self-destruction Safety Syringes for Single Use;
Sterile Hypodermic Syringes for Single Use;
Sterile Hypodermic Needles for Single Use (used as the predicate device);
Sterile Safety Hypodermic Needles for Single Use |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Hypodermic single lumen needle |
| Classification: | Class II, 21 CFR 880.5570 |
| Product Code: | FMI |
| 510(K) Number: | K180417 |
| Manufacturer: | Berpu Medical Technology Co., Ltd |
4
IV Device description
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing. The Sterile Hypodermic Needles for Single Use is for single It is provided sterile. The sterilization method is EO sterilization and the use only, sterilization assurance level is 10-6.
| Gauge
| Length | 30G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 19G | 18G |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1/2" | ● | ● | ● | ||||||||
| 5/8" | ● | ● | ● | ||||||||
| 1" | ● | ● | ● | ● | ● | ● | ● | ● | |||
| 1 1/4" | ● | ● | ● | ● | ● | ● | |||||
| 1 1/2" | ● | ● | ● | ● |
Table 1 specification of proposed device
V Indications for use
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer lock or luer slip syringe and injection devices for general purpose fluid injection/aspiration.
VI Comparison of technological characteristics with the predicate devices
The Sterile Hypodermic Needles for Single Use have intended use, technology, and design; and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Hypodermic Needles for Single Use and predicate devices do not alter suitability of the proposed device for its intended use.
| Device feature | Subject Device | Predicate Device K180417 |
|---|---|---|
| Indications for use | The Sterile Hypodermic Needles for Single Use are intended to be used with a luer lock or luer slip syringe 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 slip syringe and injection devices for general purpose fluid injection/aspiration. |
| Product code | FMI | FMI |
| Regulation number | 21 CFR 880.5570 | 21 CFR 880.5570 |
| Class | II | II |
| Principle of operation | For manual use only | For manual use only |
| Intended user | Medical professionals and trained care givers | Medical professionals and trained care givers |
5
| Device feature | Subject Device | Predicate Device K180417 | ||
|---|---|---|---|---|
| Environment of | ||||
| use | Hospitals and clinics | Hospitals and clinics | ||
| Needle gauge | 30G, 27G, 26G, 25G, 24G, 23G, | |||
| 22G, 21G, 20G, 19G, 18G | 14G, 15G, 16G, 17G, 18G, 19G, | |||
| 20G, 21G, 22G, 23G, 24G, 25G, | ||||
| 26G, 27G, 29G, 30G | ||||
| Length | 1/2", 5/8", 1", 1 1/4", 1 1/2" | 1/4", 5/16", 1/2", 5/8", 3/4", 1", 1 1/2", 2", 2 | ||
| 1/2" | ||||
| Type of wall | Normal wall or thin wall | Not provided | ||
| blade angle | Short bevel or long bevel | Not provided | ||
| Main structure and | ||||
| materials | Needle hub | |||
| Needle tube | ||||
| Protective | ||||
| cover | Polypropylene | |||
| Stainless steel | ||||
| Polypropylene | Needle hub | |||
| Needle | ||||
| Protective cap | Polypropylene | |||
| Stainless steel | ||||
| Polypropylene | ||||
| Needle hub Color | Color-coded per ISO 6009 | Color-coded per ISO 6009 | ||
| Single use | Yes | Yes | ||
| Performance | ||||
| specifications | Complies with 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 - | ||||
| Requirements and test methods, | ||||
| ISO 80369-7:2021 Small-bore | ||||
| connectors for liquids and gases in | ||||
| healthcare applications — Part 7: | ||||
| Connectors for intravascular or | ||||
| hypodermic applications, ISO | ||||
| 80369-20:2015 Small-bore | ||||
| connectors for liquids and gases in | ||||
| healthcare applications - Part 20: | ||||
| Common test methods | Complies with 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 - Requirements and test | ||||
| methods | ||||
| Sterilization | EO | EO | ||
| SAL | 10-6 | 10-6 | ||
| Pyrogen | Non-pyrogenic | Non-pyrogenic | ||
| Biocompatibility | The biocompatibility evaluation for | |||
| the subject device was conducted | ||||
| in accordance with the | ||||
| International Standard ISO 10993- | ||||
| 1 "Biological Evaluation of Medical | Complies with ISO 10993. | |||
| The testing is as follows: | ||||
| The devices meet biocompatibility | ||||
| endpoints for cytotoxicity, irritation, | ||||
| sensitization systemic toxicity |
6
| Device feature | Subject Device | Predicate Device K180417 |
|---|---|---|
| Devices - Part 1: Evaluation and | ||
| Testing Within a Risk Management | ||
| Process," as recognized by FDA | ||
| and the “Use of International | ||
| Standard ISO 10993-1 “Biological | ||
| evaluation of medical devices- Part | ||
| 1: Evaluation and testing within a | ||
| risk management process", June | ||
| 16, 2016. The syringe of testing | ||
| included the following tests: | ||
| Cytotoxicity; | ||
| Skin sensitization; | ||
| Hemolysis; | ||
| Intracutaneous reactivity; | ||
| Acute systemic toxicity; | ||
| Pyrogenicity. | ||
| The evaluation of the above testing | ||
| items meets the requirements | hemolysis and material-mediated | |
| pyrogens. | ||
| Labeling | Meets the requirements of 21 CFR | |
| Part 801 | Meets the requirements of 21 CFR | |
| Part 801 |
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Sterile Hypodermic Needles for Single Use, Sterile Safety Hypodermic Needles for Single Use were evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device – Blood path indirect" with a contact duration of "Limited (. The following tests were performed, as recommended:
| Cytotoxicity | ISO 10993-5: 2009 |
|---|---|
| Skin sensitization | ISO 10993-10: 2010 |
| Hemolysis | ISO 10993-4: 2017 |
| Intracutaneous reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |
All evaluation acceptance criteria were met.
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
7
Sterilization and shelf-life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf-life of the Sterile Hypodermic Needles for Single Use, Sterile Safety Hypodermic Needles for Single Use is determined based on stability study which includes ageing test. The shelf-life of the Sterile Hypodermic Needles for Single Use, Sterile Safety Hypodermic Needles for Single Use is five (5) years.
| Sterilization Evaluation | ISO11135: 2014 |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacterial Endotoxin testing | USP42-NF37 |
| Sterile Barrier Packaging Testing & | |
| Shelf-Life Evaluation | Seal Strength ASTM F88/F88M-15 |
| Dye Penetration ASTM F1929-15 | |
| Creep/Burst Testing ASTM | |
| F1140/F1140M-13 | |
| Gross Leakage ASTM F2096-11 | |
| Antibacterial Testing DIN 58953-6:2010 |
Performance testing
Performance testing is performed according to the following standards:
- ISO 7864: 2016 A
| 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 |
| Tubular needle 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, ISO 80369-7 and ISO 6009 |
| Needle cap | Clause 4.9 of ISO 7864: 2016 |
| Needle tube (Tolerance on length, | |
| Freedom from defects, Lubricant) | Clause 4.10 of ISO 7864: 2016 |
| Needle Point | Clause 4.11 of ISO 7864: 2016 |
| Bond between Tube and Hub | Clause 4.12 of ISO 7864: 2016 |
| Patency of Lumen | Clause 4.13 of ISO 7864: 2016 |
| ISO 9626:2016 | |
| Surface finish and visual 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 |
8
| 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 |
| ISO 80369-7:2016 | |
| Dimensional requirements for luer connectors. | Clause 5 of ISO 80369-7: 2021 |
| Fluid leakage (Positive pressure liquid leakage) | Clause 6.1.3 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 separation from axial load | Clause 6.4 of ISO 80369-7: 2021 |
| Resistance to separation from unscrewing | Clause 6.5 of ISO 80369-7: 2021 |
| Resistance to overriding | Clause 6.6 of ISO 80369-7: 2021 |
VIII Conclusion
The Sterile Hypodermic Needles for Single Use are substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.