(87 days)
The Sterile Safety Hypodermic Needles for Single Use are intended for use in the aspiration 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 needlesticks.
The Sterile Safety Hypodermic Needles for Single Use are composed of a hypodermic needle with a needle safety shield attached to the needle hub, which can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The device is compatible for use with standard luer slip and luer lock syringes. The Sterile Safety 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.
This is an FDA 510(k) clearance letter for a medical device, specifically Sterile Safety Hypodermic Needles for Single Use. The primary purpose of this document is to establish substantial equivalence to a predicate device, not to present a detailed study on the device's original performance against a specific set of acceptance criteria with explicit human reader performance metrics, as would be typical for an AI/ML medical device.
Therefore, many of the requested items (e.g., sample size for test set with ground truth, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device clearance and the information provided in this document.
However, I can extract the acceptance criteria and performance data that are relevant to this type of conventional medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard & Clause) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5:2009) | Compliant |
| Skin sensitization (ISO 10993-10:2010) | Compliant |
| Hemolysis (ISO 10993-4:2017) | Compliant |
| Intracutaneous reactivity (ISO 10993-10:2010) | Compliant |
| Acute systemic toxicity (ISO 10993-11:2017) | Compliant |
| Pyrogenicity (ISO 10993-11:2017) | Compliant |
| Particulate Matter (USP <788> Method 1) | Met USP acceptance criteria |
| Sterilization & Shelf Life: | |
| EO Sterilization Validation (ISO 11135:2014) | Validated |
| EO Sterilization Residuals (ISO 10993-7:2008) | Compliant |
| Packaging Requirements (ISO 11607-1:2019) | Compliant |
| Packaging Validation (ISO 11607-2:2019) | Compliant |
| Accelerated Aging for Packaging (ASTM F1980-16) | Used for shelf life determination |
| Performance Testing: | |
| Sterile Single-Use Hypodermic Needles (ISO 7864:2016) | Compliant |
| Stainless Steel Needle Tubing (ISO 9626:2016) | Compliant |
| Small-bore Connectors (ISO 80369-7:2016) | Compliant |
| Sharps Injury Protection (ISO 23908) | Compliant |
| Medical Devices with Sharps Injury Prevention Features Guidance for Industry and FDA Staff | Compliant (implicitly, as part of sharps injury protection) |
| Labeling (21 CFR Part 801) | Met requirements |
2. Sample size used for the test set and the data provenance:
This document describes a premarket notification for a conventional medical device (hypodermic needles), not an AI/ML device. Therefore, there isn't a "test set" in the context of diagnostic performance evaluation with specific data provenance (country of origin, retrospective/prospective clinical data) as requested. The performance is assessed through engineering and biological testing against established international and national standards. The sample sizes for these tests would be determined by the specific standards and protocols followed (e.g., number of units tested for particulate matter, tensile strength, sterility, etc.), but are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of AI/ML, refers to a definitive diagnosis or finding. For this device, ground truth is established by objective measurements and standardized testing against predefined physical, chemical, and biological properties as specified in the referenced ISO, ASTM, and USP standards. The "experts" involved would be the qualified personnel performing the laboratory and engineering tests, whose qualifications are implicit in their ability to conduct these standardized tests accurately.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This device does not involve human interpretation of outputs that would require adjudication for establishing ground truth in a diagnostic context.
5. 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 not an AI/ML device, and no human reader studies are mentioned or relevant for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by objective measurements and results from standardized laboratory and engineering tests (e.g., sterility testing, material strength, biocompatibility assays, particulate counts, sharps injury prevention mechanism functionality) against predefined acceptance criteria established in international and national standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of medical device clearance.
9. How the ground truth for the training set was established:
Not applicable.
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Wepon Medical Technology Co., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China
September 8, 2023
Re: K231723
Trade/Device Name: Sterile Safety 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: June 8, 2023 Received: June 13, 2023
Dear Esther Zhang:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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
Sincerely,
Alan Stern
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) K231723
Device Name
Sterile Safety Hypodermic Needles for Single Use
Indications for Use (Describe)
The Sterile Safety Hypodermic Needles for Single Use are intended for use in the aspiration 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 needlesticks
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K231723
Section 5 510(k) summary
l Submitter
Device submitter: Wepon Medical Technology CO., LTD. Floor 4, Building A, No. 58, Jinhu Road, Chengdong Street, Wenling Zhejiang, CN 317500
Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030
Contact person: Di Zhao Deputy General Manager Phone: 928-5922380 Email: dizhao@wepon-ppe.com
II Correspondent
Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R.China Contact: Esther ZHANG Email: Esther.zhang@llins-tech.com
III Device
| Trade Name: | Sterile Safety Hypodermic Needles for Single Use |
|---|---|
| Common Name: | Hypodermic Single Lumen Needle |
| Regulation Number: | 21 CFR 880.5570 |
| Regulation Name: | Hypodermic Single Lumen Needle |
| Device Class: | Class II |
| Product code: | FMI |
IV Predicate Devices
| Trade name: | TK Safety Needle |
|---|---|
| Common name: | Hypodermic Single Lumen Needle |
| Classification: | Class II, 21 CFR 880.5570 |
| Product Code: | FMI |
| Premarket Notification: | K191644 |
| Manufacturer: | Anhui Tiankang Medical Technology Co., Ltd |
V Device description
The Sterile Safety Hypodermic Needles for Single Use are composed of a hypodermic
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needle with a needle safety shield attached to the needle hub, which can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The device is compatible for use with standard luer slip and luer lock syringes. The Sterile Safety 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.
| Connection type | Luer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Color of needle hub | Yellow | Medium Grey | Brown | Orange | Middle Purple | Deep blue | Black | Deep green | Yellow | Cream | Pink | |
| Gauge | 30G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 19 G | 18 G | |
| Length of needle tube | 1/2" | 1/2",5/8", 1" | 5/8",1" | 5/8",1" | 1", 1 1/4", 1 1/2" | |||||||
| Length of needle covers (mm) | 12.5 | 12.5,16, 25 | 16, 25 | 16,25 | 25, 32, 38 | |||||||
| Color of needle covers | Transparent | |||||||||||
| Type of wall | Normal wall and thin wall | |||||||||||
| Blade angle | Short bevel and long bevel |
VI Indications for use
The Sterile Safety Hypodermic Needles for Single Use are intended for use in the 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 needlesticks.
VII Comparison of technological characteristics with the predicate devices
The Sterile Safety Hypodermic Needles for Single Use have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Safety 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 DeviceK191644 | Comments |
|---|---|---|---|
| Indications for use | The Sterile SafetyHypodermic Needles forSingle Use are intended foruse in the aspiration andinjection of fluids for | The TK Safety Needledevice is intended foruse in the aspiration andinjection of fluids formedical purposes. The | Comment 1 |
Table 5-1 Substantial equivalence discussion
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| Device feature | Subject Device | Predicate DeviceK191644 | Comments | ||
|---|---|---|---|---|---|
| medical purpose. Afterwithdrawal of the needlefrom the body, the attachedneedle safety shield can bemanually activated to coverthe needle immediatelyafter use to minimize risk ofaccidental needlesticks. | TK Safety Needle iscompatible for use withstandard luer slip andluer lock syringes.Additionally, afterwithdrawal of the needlefrom the body, theattached needle safetyshield can be manuallyactivated to cover theneedle immediately afteruse to minimize risk ofaccidental needle-stick. | ||||
| Product code | FMI | FMI | Identical | ||
| Regulationnumber | 21 CFR 880.5570 | 21 CFR 880.5570 | Identical | ||
| Class | CLASS II | CLASS II | Identical | ||
| Principle ofoperation | Normal | Normal | Identical | ||
| Needle gauge | 18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G,30G | 16G、17G、18G、19G、20G、21G、22G、23G、24G、25G、26G、27G、28G、29G、30G | SubstantiallyequivalentComment 2 | ||
| Length | 1/2", 5/8", 1", 11/4", 11/2" | 1/2" to 1 1/2" | |||
| Type of wall | Thin wall and normal wall | From 16G to 23G: thinwallFrom 24G to 30G :regular wall | |||
| blade angle | Short bevel and long bevel | Bevel | |||
| main structureand materials | Needle hubNeedle tubeprotective cover | PolypropyleneStainless steelPolypropylene | Needle HubNeedleNeedle Sheath | PolypropyleneStainless SteelPolypropylene | Identical |
| Needle hubColors | Various Colors | Various Colors | Identical | ||
| Sharps injury | Needle safety shield | Needle safety shield | Identical |
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| Device feature | Subject Device | Predicate DeviceK191644 | Comments |
|---|---|---|---|
| PreventionFeatures | |||
| Lubricant forNeedle | Silicone Oil | Silicone Oil | Identical |
| Performancespecifications | Conforms to ISO 7864 | Conforms to ISO 7864 | Identical |
| Sterilization | EO sterilization | EO sterilization | Identical |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Identical |
| Labeling | Meet the requirements of21CFR Part 801 | Meet the requirements of21 CFR Part 801 | Identical |
Discussion:
Comment 1
Minor rewording of the Intended use statement has been made. However, the general purpose of the device and its function remain unchanged. The subject devices are also compatible with standard slip tip and luer lock syringes, even though the IFU does not exclusively say that. The minor rewording of the Intended use statement does not raise different questions of safety and effectiveness.
Comment 2
The subject device's needle gauge and needle length are smaller than the predicate device's needle gauge range of 16G to 30G and length range of 1/2" to 1 1/2". The type of wall and needle bevel are different from the predicate device. The range is within the same range as the predicate device. The differences do not raise new questions of safety and effectiveness.
VIII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the 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:
Cytotoxicity
ISO 10993-5: 2009
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| 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 |
Particulate matter testing was conducted in accordance with Method 1 of USP <788> 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 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:
- A 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
- A 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
Performance testing
Performance testing is performed according to the following standards:
- A ISO 7864:2016 Sterile Safety Hypodermic Needles for Single Use — Requirements and test methods
- A ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
- A ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
-
ISO 23908 Sharps Injury protection- Requirements and test methods
- A Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff
IX Conclusion
The minor differences between the predicate and subject device do not raise any new or
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different questions of safety or effectiveness. The Sterile Safety Hypodermic Needles for Single Use are substantially equivalent to its predicate device (TK Safety Needle) with respect to the indications for use, treatment method and technological characteristics. 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).