(174 days)
The Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, 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 needle-stick.
The Disposable Medical Safety Hypodermic Needle is composed of a needle hub, a needle tube, a needle cap and a sharp injury protection feature. The sharp injury protection feature is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The sharp injury protection feature is activated with one-hand operation by pressing the sharp injury protection feature either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sharp injury protection feature. The hinge feature(sharp injury protection feature) allows the medical practitioner the flexibility to adjust the sharp injury protection feature to its desired position for use.
This document describes the FDA's 510(k) clearance for the Hantech Medical Device Co., Ltd.'s Disposable Medical Safety Hypodermic Needle. The clearance is based on the device being substantially equivalent to a legally marketed predicate device (TK Safety Needle, K191644).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through adherence to various international ISO standards, indicating it meets the acceptance criteria defined within those standards. The document doesn't provide specific numerical targets for "acceptance criteria" but rather states conformity to the clauses of these standards, which implicitly define the acceptance thresholds.
| Acceptance Criteria (Standard & Clause) | Reported Device Performance (Conformity) | Comments |
|---|---|---|
| Biocompatibility: | ||
| Cytotoxicity (ISO 10993-5: 2009) | Performed in accordance with ISO 10993-1:2018 (body contact: "External communication device - Blood path indirect", < 24 hours) | Device evaluated according to recommended tests for biocompatibility. |
| Skin sensitization (ISO 10993-10: 2010) | Performed in accordance with ISO 10993-1:2018 (body contact: "External communication device - Blood path indirect", < 24 hours) | |
| Hemolysis (ISO 10993-4: 2017) | Performed in accordance with ISO 10993-1:2018 (body contact: "External communication device - Blood path indirect", < 24 hours) | |
| Intradermal reactivity (ISO 10993-10: 2010) | Performed in accordance with ISO 10993-1:2018 (body contact: "External communication device - Blood path indirect", < 24 hours) | |
| Acute systemic toxicity (ISO 10993-11: 2017) | Performed in accordance with ISO 10993-1:2018 (body contact: "External communication device - Blood path indirect", < 24 hours) | |
| Pyrogenicity (ISO 10993-11: 2017) | Performed in accordance with ISO 10993-1:2018 (body contact: "External communication device - Blood path indirect", < 24 hours) | |
| Sterilization & Shelf Life: | ||
| Sterilization (ISO 11135:2014) | Validated to ISO 11135, routine control and monitoring parameters determined | Demonstrates effective sterilization. |
| Ethylene oxide residuals (ISO 10993-7:2008) | Conforms | Ensures safe residual levels of sterilant. |
| Packaging materials (ISO 11607-1: 2019) | Performed | Ensures packaging maintains sterility. |
| Packaging validation (ISO 11607-2: 2019) | Performed | Ensures packaging integrity. |
| Accelerated Aging (ASTM F1980-16) | Used for shelf life determination | Supports shelf life claims. |
| Performance Testing (ISO 7864: 2016 - Sterile Hypodermic Needles): | ||
| Cleanliness (Clause 4.3) | Conforms | Ensures product is free from contaminants. |
| Limits for acidity or alkalinity (Clause 4.4) | Conforms | Ensures biocompatibility and stability. |
| Limits for extractable metals (Clause 4.5) | Conforms | Ensures patient safety. |
| Tubular needle designation (Clause 4.6) | Conforms | Ensures correct labeling and identification. |
| Colour coding (Clause 4.7) | Conforms | Follows industry standards for easy identification. |
| Needle hub (Clause 4.8, ISO 80369-7 & ISO 6009) | Conforms | Ensures proper connection and compatibility. |
| Needle cap (Clause 4.9) | Conforms | Ensures protection of the needle. |
| Needle tube (Tolerance on length, Freedom from defects, Lubricant) (Clause 4.10) | Conforms | Ensures proper function and ease of use. |
| Needle Point (Clause 4.11) | Conforms | Ensures sharpness and smooth penetration. |
| Bond between Tube and Hub (Clause 4.12) | Conforms | Ensures structural integrity. |
| Patency of Lumen (Clause 4.13) | Conforms | Ensures unobstructed fluid flow. |
| Performance Testing (ISO 9626:2016 - Stainless steel needle tubing): | ||
| Surface finish and visual appearance (Clause 5.2) | Conforms | Ensures quality and usability. |
| Cleanliness (Clause 5.3) | Conforms | |
| Limits for acidity and alkalinity (Clause 5.4) | Conforms | |
| Size designation (Clause 5.5) | Conforms | |
| Dimensions (Clause 5.6) | Conforms | |
| Stiffness (Clause 5.8) | Conforms | Ensures needle rigidity. |
| Resistance to breakage (Clause 5.9) | Conforms | Ensures needle integrity during use. |
| Resistance to corrosion (Clause 5.10) | Conforms | Ensures material durability and patient safety. |
| Performance Testing (ISO 80369-7:2016 - Luer connectors): | ||
| Dimensional requirements for luer connectors (Clause 5) | Conforms (2021 version mentioned implies adherence to latest standards) | Ensures universal compatibility. |
| Fluid leakage (Positive pressure liquid leakage) (Clause 6.1.3) | Conforms (2021 version mentioned implies adherence to latest standards) | Prevents leakage during aspiration/injection. |
| Sub-atmospheric pressure air leakage (Clause 6.2) | Conforms (2021 version mentioned implies adherence to latest standards) | Prevents air aspiration. |
| Stress cracking (Clause 6.3) | Conforms (2021 version mentioned implies adherence to latest standards) | Ensures material resilience. |
| Resistance to separation from axial load (Clause 6.4) | Conforms (2021 version mentioned implies adherence to latest standards) | Ensures secure connection. |
| Resistance to separation from unscrewing (Clause 6.5) | Conforms (2021 version mentioned implies adherence to latest standards) | Ensures secure connection. |
| Resistance to overriding (Clause 6.6) | Conforms (2021 version mentioned implies adherence to latest standards) | Ensures proper connection. |
| Performance Testing (ISO 23908 & Sharps Injury Prevention Guidance): | Specific to the safety feature. | |
| Activation torque | Performed | Ensures proper function of safety mechanism. |
| Protection features separating force | Performed | Ensures integrity of safety mechanism. |
| Resistance to breakage | Performed | Ensures durability of safety mechanism. |
| Simulated Clinical Use Testing Report | Performed | Simulates real-world use to confirm safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. Instead, it indicates that testing was performed according to various ISO standards. These standards typically define appropriate sample sizes and methodologies for testing.
The data provenance is from China, as the submitting company, Hantech Medical Device Co., Ltd., is located in Ningbo, People's Republic of China. The studies are pre-market studies conducted to support the 510(k) submission, indicating a controlled, laboratory or simulated environment, rather than prospective clinical trials in humans.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies primarily involve objective performance testing against established international standards rather than expert-driven ground truth establishment for a diagnostic or AI device.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are for the physical and functional performance of a hypodermic needle, not for diagnostic interpretation or a device requiring expert adjudication of results.
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 is typically conducted for diagnostic or imaging devices to assess the impact of AI on human reader performance. The device in question is a medical needle, not an AI or diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance evaluation in the context of an algorithm or AI was not done. The device is a physical medical instrument.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" is defined by the specifications and requirements set forth in the referenced ISO and ASTM standards. These standards prescribe acceptable ranges, physical properties, and functional outcomes. For example, the cleanliness clause of ISO 7864 dictates the "ground truth" for acceptable levels of contamination.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical product and not an AI/machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.
August 23, 2022
Hantech Medical Device Co., Ltd. Arnold YANG Mr. No 288, Sanheng Road Changhe Industridal Park, Cixi Ningbo, Zhejiang 315326 China
Re: K220603
Trade/Device Name: Disposable Medical Safety Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 15, 2022 Received: July 19, 2022
Dear Arnold YANG:
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,
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) K220603
Device Name Disposable Medical Safety Hypodermic Needle
Indications for Use (Describe)
The Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, 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 needle-stick.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| For Activities Under 31 CFR 501 Subpart D ☐ For Transaction Under 31 CFR 501 Subpart C |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K220603 510(k) summary
l Submitter
Device submitter: Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industridal Park, Cixi 315326, Ningbo PEOPLE'S REPUBLIC OF CHINA
Contact person: Name: Arnold YANG Title: Regulatory Affairs Phone: +86 189 1736 8988 Fax: +86 574 5899 5557 E-mail: arnoldyang@hantechmedical.com
Date: 07/15/2022
II Device
Trade Name of Device: Disposable Medical Safety Hypodermic Needle 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: | 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. |
IV Device description
The Disposable Medical Safety Hypodermic Needle is composed of a needle hub, a needle tube, a needle cap and a sharp injury protection feature. The sharp injury protection feature is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The sharp injury protection feature is activated with one-hand operation by pressing the
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sharp injury protection feature either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sharp injury protection feature. The hinge feature(sharp injury protection feature) allows the medical practitioner the flexibility to adjust the sharp injury protection feature to its desired position for use.
| Device | Needle length | Needle gauge | Type of wall | Blade angle |
|---|---|---|---|---|
| DisposableMedical SafetyHypodermicNeedle | 1/2", 5/8", 1", 11/4", 1 1/2" | 30G, 29G, 28G,27G, 26G, 25G,24G, 23G, 22G,21G, 20G, 19G,18G | TWRWETW | SBLB |
V Indications for use
The Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, 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 needle-stick.
VI Comparison of technological characteristics with the predicate devices
The Disposable Medical Safety Hypodermic Needle have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate device. The differences between the Disposable Medical Safety Hypodermic Needle and predicate device do not alter suitability of the proposed device for its intended use.
| Device feature | Subject Device | Predicate DeviceK191644 | Comments |
|---|---|---|---|
| Indications for use | The Disposable MedicalSafety Hypodermic Needleis intended for use in theaspiration and injection offluids for medical purposes.The Disposable MedicalSafety Hypodermic Needleis compatible for use withstandard luer slip and luer | The TK Safety Needledevice is intended foruse in the aspiration andinjection of fluids formedical purposes. TheTK Safety Needle iscompatible for use withstandard luer slip andluer lock syringes. | Similar |
| Device feature | Subject Device | Predicate Device K191644 | Comments |
| lock syringes.Additionally, afterwithdrawal of the needlefrom the body, the attachedneedle safety shield can bemanually activated to coverthe needle immediatelyafter use to minimize risk ofaccidental needle-stick. | 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 | Similar |
| Regulationnumber | 21 CFR 880.5570 | 21 CFR 880.5570 | Similar |
| Class | CLASS II | CLASS II | Similar |
| Principle ofoperation | Normal | Normal | Similar |
| Needle gauge | 30G, 29G, 28G, 27G, 26G,25G, 24G, 23G, 22G, 21G,20G, 19G, 18G | 16G, 17G, 18G, 19G,20G, 21G, 22G, 23G,24G, 25G, 26G, 27G,28G, 29G, 30G | SubstantiallyequivalentComment 1 |
| Length | 1/2", 5/8", 1", 1 1/4", 1 1/2" | 1/2 to 1", 1 to 1 1/2" | |
| Type of wall | Thin Wall, Regular Wall orExtra Thin Wall | From 16G to 23G: ThinWallFrom 24G to 30G:Regular Wall | |
| Blade angle | Short bevel or long bevel | Bevel | |
| Materials | Needle Hub PolypropyleneNeedle Tube Stainless SteelNeedle Sheath Polypropylene | Needle Hub PolypropyleneNeedle Tube StainlessSteelNeedle Sheath Polypropylene | Similar |
| Sharps injuryPreventionFeatures | Needle safety shield | Needle safety shield | Similar |
| Lubricant forNeedle | Silicone Oil | Silicone Oil | Similar |
| Adhesive | Epoxy Sizes | Epoxy Sizes | Similar |
| Performancespecifications | Conforms to ISO 7864 | Conforms to ISO 7864 | Similar |
| Sterilization | EO sterilization | EO sterilization | Similar |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Similar |
| Labeling | Meet the requirements of | Meet the requirements | Similar |
| Device feature | Subject Device | Predicate DeviceK191644 | Comments |
| 21 CFR Part 801 | of 21 CFR Part 801 |
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Discussion:
The subject device's needle gauge, needle length, type of wall and needle bevel are different from the predicate device. However, this difference is just in dimension. Different needle specification will be selected by physician per 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, the differences on needle length, gauge, wall type and bevel does not affect substantially equivalence on safety and effectiveness.
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Disposable Medical Safety Hypodermic Needle was 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 |
|---|---|
| Skin sensitization | ISO 10993-10: 2010 |
| Hemolysis | ISO 10993-4: 2017 |
| Intradermal reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |
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 Disposable Medical Safety Hypodermic Needle 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
- △ ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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- ISO 11607-1: 2019 Packaging for terminally sterilized medical devices Part 1: A 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:
| > | ISO 7864: 2016 | |
|---|---|---|
| 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, ISO80369-7 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 | |
| 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 luerconnectors. | Clause 5 of ISO 80369-7: 2021 | |
| Fluid leakage (Positive pressure liquidleakage) | 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 fromunscrewing | Clause 6.5 of ISO 80369-7: 2021 | |
| Resistance to overriding | Clause 6.6 of ISO 80369-7: 2021 |
- ISO 23908 and Medical Devices with Sharps Injury Prevention Features Guidance A for Industry and FDA Staff
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Activation torque Protection features separating force Resistance to breakage Simulated Clinical Use Testing Report
VIII Conclusion
The Disposable Medical Safety Hypodermic Needle is substantially equivalent to its predicate device (TK Safety Needle). 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).