(238 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, connected with a syringe for general purpose fluid injection/aspiration.
The provided document K210232 "Sterile Hypodermic Needles for Single Use" is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This document focuses on demonstrating substantial equivalence rather than proving performance against specific acceptance criteria for a new, non-comparative device.
Therefore, the information presented in the document is primarily related to comparison with a predicate device and adherence to recognized standards, rather than a standalone performance study with detailed acceptance criteria and results for the device itself.
Based on the provided text, I can infer some aspects related to acceptance criteria and the "study" (mostly non-clinical testing) that proves the device meets the criteria.
Acceptance Criteria and Device Performance for Sterile Hypodermic Needles for Single Use (K210232)
1. Table of Acceptance Criteria and Reported Device Performance:
The document defines "acceptance criteria" primarily through compliance with established international standards for hypodermic needles and related medical device characteristics. The "performance" is reported as demonstrating compliance with these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 (Cytotoxicity, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity) | Meets requirements; evaluation of testing items meets requirements. |
| Sterilization | ISO 11135:2014 (Ethylene oxide sterilization validation) | Method validated to ISO 11135; determined routine control and monitoring parameters. |
| Sterilization Residuals | ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Implied compliance through use of standard |
| Sterility Assurance Level (SAL) | 10⁻⁶ | Achieved (stated in comparison table). |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic (stated in comparison table). |
| Shelf-life | ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems) | Determined based on stability study including aging test. |
| Packaging integrity | ISO 11607-1:2019, ISO 11607-2:2019 | Implied compliance through use of standards. |
| Packaging Test Methods | ASTM D4169-16 (Shipping Containers), ASTM F88/F88M-15 (Seal Strength), ASTM F1140/F1140M-13 (Internal Pressurized Failure), ASTM F1929-15 (Seal Leaks), ASTM F2096-11 (Gross Leakage) | Implied compliance through use of standards. |
| Physical Performance (Needles) | ISO 7864:2016 (Sterile hypodermic needles - Requirements and test methods) | Complies with ISO 7864. |
| Material (Stainless Steel Tubing) | ISO 9626:2016 (Stainless Steel Needle Tubing) | Complies with ISO 9626. |
| Small-bore Connectors | ISO 80369-7:2016 (Connectors for intravascular or hypodermic applications) | Complies with ISO 80369-7. |
| Labeling | 21 CFR Part 801 | Meets the requirements of 21 CFR Part 801. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each test. For medical devices like hypodermic needles, sample sizes for performance testing (e.g., force to penetrate, cannula rigidity) are typically defined by the relevant ISO standards (e.g., ISO 7864) and would vary based on the specific test and lot size. Biocompatibility testing often involves a smaller number of samples for each specific assay.
- Data Provenance: The testing is non-clinical/bench testing. The manufacturer is Zhejiang Kangkang Medical-Devices CO., Ltd. in China. The data would originate from their internal testing labs or contract research organizations (CROs) in China or elsewhere, conducting tests according to the specified international standards. The data is retrospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the "ground truth" for hypodermic needles is established by objective, quantitative measurements against published international consensus standards (e.g., ISO 7864, ISO 9626) and regulatory requirements (e.g., 21 CFR 801, ISO 10993 for biocompatibility). There is no "ground truth" established by human experts in the sense of image interpretation or diagnostic accuracy for this type of device. The "experts" involved would be technicians and engineers skilled in performing the standardized tests and interpreting their results according to the defined specifications.
4. Adjudication Method for the Test Set:
- Not applicable. Performance is objectively measured against a quantifiable pass/fail criterion defined by the relevant standards (e.g., "force shall not exceed X N," "no hemolysis greater than Y," "no pyrogenicity detected"). No human adjudication of results is described, nor is it typically necessary for these types of physical and chemical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study (comparative effectiveness, MRMC, human-in-the-loop with AI) is relevant for diagnostic devices, especially those incorporating AI, where human interpretation affects clinical outcomes. This document is for a physical medical device (hypodermic needle) where performance is determined by physical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, this is not applicable. The device is a physical hypodermic needle, not an algorithm or software-as-a-medical-device (SaMD). Its performance is inherently physical and does not involve an "algorithm" operating independently.
7. The Type of Ground Truth Used:
- The "ground truth" is established by international consensus standards and regulatory guidelines. For example, the ground truth for biocompatibility is whether the device materials pass specific biological tests (cytotoxicity, irritation, sensitization) as defined by ISO 10993. The ground truth for needle performance is whether it meets the physical and mechanical specifications (e.g., dimensions, penetration force, corrosion resistance) outlined in standards like ISO 7864 and ISO 9626.
8. The Sample Size for the Training Set:
- Not applicable. This device is a manufactured medical product that undergoes physical and biological performance testing, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains 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.
September 23, 2021
Zhejiang Kangkang Medical-Devices CO., Ltd. Chun Guo Ouality Manager Longwang Industrial District, Chumen Town Yuhuan, Zhejiang 317605 China
Re: K210232
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 23, 2021 Received: August 27, 2021
Dear Chun Guo:
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
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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) 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 (QS) 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 medical devices and radiation-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 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) K210232
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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K210232 510(k) summary
l Submitter
Device submitter: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China
Contact person: Chun Guo General Manager Phone: 13586180908 / 89902728 Fax: 0576-87427630 Email: guochun@vip.126.com
Date: 09/23/2021
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 Devices
| Trade name: | Self-destruction Safety Syringes for Single Use;Sterile Hypodermic Syringes for Single Use;Sterile Hypodermic Needles for Single Use (used as thepredicate device);Sterile Safety Hypodermic Needles for Single Use |
|---|---|
| Common name: | Hypodermic single lumen needle |
| Classification: | Class II, 21 CFR 880.5570 |
| Product Code: | FMI |
| Premarket Notification: | K180417 |
| Manufacturer: | Berpu Medical Technology Co., Ltd |
IV Device description
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a syringe for general purpose fluid injection/aspiration.
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| Device | Needle length | Needle gauge | Type of wall | Blade angle |
|---|---|---|---|---|
| SterileHypodermicNeedles forSingle Use | 1/2", 5/8", 1",1 1/4", 1 1/2" | 30G, 27G, 26G,25G, 24G, 23G,22G, 21G, 20G,19G, 18G | Normal walland thin wall | Short beveland long bevel |
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 the same or equivalent intended use, technology, design and performance specifications 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.
| Devicefeature | Subject Device | Predicate Device K180417 | Comments |
|---|---|---|---|
| Indications for use | The Sterile HypodermicNeedles for Single Use areintended to be used with a luerlock or luer slip syringe andinjection devices for generalpurpose fluidinjection/aspiration. | The Sterile HypodermicNeedles forSingle Use are intended tobe used with a luer slip orluer slip syringe andinjection devices for generalpurpose fluidinjection/aspiration. | Same |
| Product code | FMI | FMI | Same |
| Regulationnumber | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |
| Principle ofoperation | For manual use only | For manual use only | Same |
| Intended user | Medical professionals andtrained care givers | Medical professionals andtrained care givers | Same |
| Environmentof use | Hospitals and clinics | Hospitals and clinics | Same |
| 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 | Difference1 |
| Length | $1/2", 5/8", 1", 1 1/4", 1 1/2"$ | 6-60mm | |
| Type of wall | normal wall or thin wall | not provided | |
| blade angle | short bevel or long bevel | not provided | |
| Needle hub | Needle hubPolypropylene | Needle hubPolypropylene | Same |
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| Devicefeature | Subject Device | Predicate Device K180417 | Comments | ||
|---|---|---|---|---|---|
| main structureand materials | Needletube | Stainless steel | Needletube | Stainless steel | |
| protectivecover | Polypropylene | protectivecap | Polypropylene | ||
| Needle hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Same | ||
| Single use | Yes | Yes | Same | ||
| Performancespecifications | Complies with ISO 7864; ISO9626; ISO 80369-7 | Complies with ISO 7864;ISO 9626; ISO 80369-7 | Same | ||
| Sterilization | EO | EO | Same | ||
| SAL | 10-6 | 10-6 | Same | ||
| Pyrogen | Non-pyrogenic | Non-pyrogenic | Same | ||
| Biocompatibility | The biocompatibility evaluationfor the subject device wasconducted in accordance withthe International Standard ISO10993-1 "Biological Evaluationof Medical Devices - Part 1:Evaluation and Testing Withina Risk Management Process,"as recognized by FDA and the"Use of International StandardISO 10993-1 "Biologicalevaluation of medical devices-Part 1: Evaluation and testingwithin a risk managementprocess", June 16, 2016. Thesyringe of testing included thefollowing tests:Cytotoxicity;Skin sensitization:Hemolysis:Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the abovetesting items meets therequirements | Comply with ISO 10993.The test is as follows:The devices meetbiocompatibility endpointsfor cytotoxicity, irritation,sensitization, systemictoxicity,hemolysis and material-mediated pyrogens. | Same | ||
| Labeling | Meet the requirements of 21CFR Part 801 | Meet the requirements of 21CFR Part 801 | Same |
Difference 1
The needle gauge and length of subject devices are different from the predicate device, and the type of wall and needle bevel are unknown. However, this difference is just in dimension. Different needle specifications will be selected by the HCP per the patient's condition. This difference does not affect intended use. In addition, differences were addressed through ISO 7864, ISO 9626 and ISO 80369-7. Therefore, these differences do not affect safety and effectiveness
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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)". The following tests were performed, as recommended:
USP <788> Particulate Matter Testing
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 testing is performed according to the following standards:
- △ ISO 11135:2014 Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
- A ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
-
ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
-
ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
-
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
-
ASTM F88/F88M-15 – Standard Test Method for Seal Strength of Flexible Barrier Materials
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- ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurized Failure A of Unrestrained Packages
-
ASTM F1929-15 – Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by De Penetration
-
ASTMF2096-11 – Standard Test Method for Detecting Gross Leakes in Packaging by Internal Pressurization (Bubble Test)
Performance testing
Performance testing is performed according to the following standards:
-
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
- A ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices
-
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
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).