(174 days)
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.
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.
The provided document, K211214, is an FDA 510(k) summary for a medical device: Sterile Hypodermic Needles for Single Use. This document outlines the manufacturer's claims that their device is substantially equivalent to an existing legally marketed predicate device (K180417 from Berpu Medical Technology Co., Ltd).
However, it's crucial to understand that this document describes a conventional medical device (a hypodermic needle), NOT an AI/ML-based device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI, ground truth establishment for training set) are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a physical medical device like a hypodermic needle are based on performance testing against recognized industry standards (ISO standards, USP standards), and biocompatibility, sterilization, and shelf-life testing. These are fundamentally different from the validation methods for AI/ML algorithms.
Here's a breakdown of the requested information based on the provided document, addressing what is relevant and explicitly stating what is not applicable:
Acceptance Criteria and Device Performance (for a Hypodermic Needle)
1. Table of Acceptance Criteria and Reported Device Performance
For this conventional medical device, the "acceptance criteria" are compliance with various ISO and USP standards for physical and biological properties. The "reported device performance" is a statement that the device "meets the requirements" or "acceptance criteria" of these standards.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance Statement |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 (for "External communication device – Blood path indirect" with contact duration "Limited (< 24 hours)") covering: 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 | USP <788> Particulate Matter in Injections | "met the USP acceptance criteria." |
| Sterilization | ISO 11135:2014 (Validation of sterilization method) | "The sterilization method has been validated to ISO11135" |
| EO/ECH Residue | ISO 10993-7:2008 | Not explicitly stated as "met," but implied by "The following tests were performed... and met..." |
| Bacterial Endotoxin | USP42-NF37<85> | Not explicitly stated as "met," but implied by "The following tests were performed... and met..." |
| Shelf-Life/Packaging | 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) | Determined the shelf-life to be five (5) years based on stability study. |
| Performance (ISO 7864) | Clause 4.3 (Cleanliness), 4.4 (Acidity/Alkalinity), 4.5 (Extractable Metals), 4.6 (Designation), 4.7 (Color Coding), 4.8 (Needle Hub), 4.9 (Needle Cap), 4.10 (Needle Tube), 4.11 (Needle Point), 4.12 (Bond), 4.13 (Patency) | "All evaluation acceptance criteria were met." / Implied by "Performance testing is performed according to the following standards:" |
| Performance (ISO 9626) | Clause 5.2 (Surface Finish), 5.3 (Cleanliness), 5.4 (Acidity/Alkalinity), 5.5 (Size Designation), 5.6 (Dimensions), 5.8 (Stiffness), 5.9 (Resistance to Breakage), 5.10 (Resistance to Corrosion) | "All evaluation acceptance criteria were met." / Implied by "Performance testing is performed according to the following standards:" |
| Performance (ISO 80369-7) | Clause 5 (Dimensional requirements), 6.1.3 (Fluid leakage), 6.2 (Sub-atmospheric air leakage), 6.3 (Stress cracking), 6.4 (Axial load separation), 6.5 (Unscrewing separation), 6.6 (Overriding) | "All evaluation acceptance criteria were met." / Implied by "Performance testing is performed according to the following standards:" |
| Labeling | 21 CFR Part 801 | "Meets the requirements of 21 CFR Part 801." |
Information Relevant to AI/ML Device Testing (Not Applicable to this Device)
The following points are typically relevant for AI/ML-based medical devices but are not applicable to this 510(k) submission concerning a sterile hypodermic needle.
- Sample size used for the test set and the data provenance: Not applicable. Testing involves physical samples of needles, not 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 a needle is based on objective physical and chemical measurements against standards, not expert interpretation of AI outputs.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is involved in assessing a needle's compliance with ISO standards.
- 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 is for AI-assisted diagnostic or interpretative devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a hypodermic needle, "ground truth" is established by the specifications and performance requirements defined in the international standards (e.g., ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 for biocompatibility) and direct physical/chemical measurements. It's not expert consensus on an image or pathology.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable. There is no AI model to train.
In summary: K211214 describes the regulatory clearance for a traditional medical device (hypodermic needle). The "acceptance criteria" and supporting "study" are engineering and biological validations demonstrating the device meets established international safety and performance standards for its physical form and intended use. The questions posed in your prompt are tailored for Artificial Intelligence/Machine Learning (AI/ML) medical devices, which operate under a entirely different set of validation and regulatory expectations than conventional devices.
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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
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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
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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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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 |
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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.
| GaugeLength | 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 |
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| Device feature | Subject Device | Predicate Device K180417 | ||
|---|---|---|---|---|
| Environment ofuse | 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", 21/2" | ||
| Type of wall | Normal wall or thin wall | Not provided | ||
| blade angle | Short bevel or long bevel | Not provided | ||
| Main structure andmaterials | Needle hubNeedle tubeProtectivecover | PolypropyleneStainless steelPolypropylene | Needle hubNeedleProtective cap | PolypropyleneStainless steelPolypropylene |
| Needle hub Color | Color-coded per ISO 6009 | Color-coded per ISO 6009 | ||
| Single use | Yes | Yes | ||
| Performancespecifications | Complies with ISO 7864:2016Sterile hypodermic needles forsingle use - Requirements and testmethods, ISO 9626:2016 Stainlesssteel needle tubing for themanufacture of medical devices -Requirements and test methods,ISO 80369-7:2021 Small-boreconnectors for liquids and gases inhealthcare applications — Part 7:Connectors for intravascular orhypodermic applications, ISO80369-20:2015 Small-boreconnectors for liquids and gases inhealthcare applications - Part 20:Common test methods | Complies with ISO 7864:2016 Sterilehypodermic needles for single use -Requirements and test methods, ISO9626:2016 Stainless steel needletubing for the manufacture of medicaldevices - Requirements and testmethods | ||
| Sterilization | EO | EO | ||
| SAL | 10-6 | 10-6 | ||
| Pyrogen | Non-pyrogenic | Non-pyrogenic | ||
| Biocompatibility | The biocompatibility evaluation forthe subject device was conductedin accordance with theInternational Standard ISO 10993-1 "Biological Evaluation of Medical | Complies with ISO 10993.The testing is as follows:The devices meet biocompatibilityendpoints for cytotoxicity, irritation,sensitization systemic toxicity |
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| Device feature | Subject Device | Predicate Device K180417 |
|---|---|---|
| Devices - Part 1: Evaluation andTesting Within a Risk ManagementProcess," as recognized by FDAand the “Use of InternationalStandard ISO 10993-1 “Biologicalevaluation of medical devices- Part1: Evaluation and testing within arisk management process", June16, 2016. The syringe of testingincluded the following tests:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the above testingitems meets the requirements | hemolysis and material-mediatedpyrogens. | |
| Labeling | Meets the requirements of 21 CFRPart 801 | Meets the requirements of 21 CFRPart 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 (< 24 hours)" and USP <788>. 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 <788> Particulate Matter in Injections and met the USP acceptance criteria.
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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<85> |
| Sterile Barrier Packaging Testing &Shelf-Life Evaluation | Seal Strength ASTM F88/F88M-15Dye Penetration ASTM F1929-15Creep/Burst Testing ASTMF1140/F1140M-13Gross Leakage ASTM F2096-11Antibacterial 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 |
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| 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.
§ 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).