(189 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.
The provided text describes the regulatory clearance of "Sterile Safety Hypodermic Needles for Single Use" (K213535) and does not contain detailed information about a study proving the device meets specific acceptance criteria in the format requested.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (K191644, TK Safety Needle), rather than providing a detailed report of a single study designed to directly prove acceptance criteria.
The "Performance testing" section lists the standards to which the device conforms, implying that testing was conducted to meet the requirements of these standards. However, it does not provide:
- A table of specific acceptance criteria values with corresponding reported device performance values.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets/ground truth for any specific performance study.
Instead, it broadly states that "Performance testing is performed according to the following standards," and that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device."
Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding specific acceptance criteria and a study proving the device meets them. The document asserts compliance with established medical device standards but does not detail the individual test results against specific criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Zhejiang Kangkang Medical-Devices CO., Ltd. Chun Guo Quality Manager Longwang Industrial District, Chumen Town Yuhuan. Zhejiang 317605 China
Re: K213535
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: March 23, 2022 Received: April 12, 2022
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 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
{1}------------------------------------------------
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,
For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K213535 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: 5/13/2022
II 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 |
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 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
{4}------------------------------------------------
| Connection type | Luer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Color of needle hub | Yellow | Medium Grey | Brown | Orange | Purple | Middle blue | Deep blue | Black | Deep green | Yellow | Cream | Pink |
| Gauge | 30G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 19G | 18G | |
| Length of needle tube | 1/2" | 1/2",5/8", 1" | 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 |
single use only. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
V 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 us e to minimize risk of accidental needlesticks.
VI 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 foruse | The Sterile SafetyHypodermic Needles forSingle Use are intendedfor use in the aspirationand injection of fluids formedical purpose. Thedevice After withdrawalof the needle from thebody, the attachedneedle safety shield canbe manually activated tocover the needleimmediately after use tominimize risk ofaccidental needlesticks. | The TK Safety Needledevice is intended for usein the aspiration andinjection of fluids formedical purposes. The TKSafety Needle iscompatible for use withstandard luer slip and luerlock 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. | Comment 1 |
{5}------------------------------------------------
| Device feature | Subject Device | Predicate DeviceK191644 | Comments | ||
|---|---|---|---|---|---|
| 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 | 5/8", 1", 1 1/4", 1 1/2" | 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 hub | Polypropylene | NeedleHub | Polypropylene | Identical |
| Needle tube | Stainless steel | Needle | StainlessSteel | ||
| Protectivecover | Polypropylene | NeedleSheath | Polypropylene | ||
| Needle hubColors | Various Colors | Various Colors | Identical | ||
| Sharps injuryPreventionFeatures | Needle safety shield | Needle safety shield | Identical | ||
| 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 of21 CFR Part 801 | Meet the requirementsof 21 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
{6}------------------------------------------------
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. 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 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 |
|---|---|
| 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, 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
{7}------------------------------------------------
- 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
- A 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
-
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
-
ISO 23908 Sharps Injury protection- Requirements and test methods
-
Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff
VIII Conclusion
The minor differences between the predicate and subject device do not raise any new or 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).