(238 days)
Not Found
No
The summary describes a simple mechanical device (hypodermic needle) and makes no mention of AI, ML, image processing, or any data-driven algorithms.
No
The device is a hypodermic needle used for fluid injection/aspiration, which is not a therapeutic function. Therapeutic devices are meant to treat or cure a disease or condition.
No
The device, a sterile hypodermic needle, is intended for fluid injection/aspiration, not for identifying or diagnosing a disease or condition.
No
The device description clearly states it is composed of physical components (needle hub, protective cover, needle tube, jointing) and is intended for physical fluid injection/aspiration, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose fluid injection/aspiration" using a syringe. This describes a procedure performed directly on or within the patient's body, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: The description details the physical components of a needle designed for injection/aspiration, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing biological materials.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment. This device's function is purely for delivering or withdrawing fluids from the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals and trained care givers; Hospitals and clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ( 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.
Performance testing: Performed according to ISO 7864:2016, ISO 9626:2016, and ISO 80369-7:2016.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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 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 |
| 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.
4
| Device | Needle length | Needle gauge | Type of wall | Blade angle |
|---|---|---|---|---|
| Sterile | ||||
| Hypodermic | ||||
| Needles for | ||||
| Single Use | 1/2", 5/8", 1", | |||
| 1 1/4", 1 1/2" | 30G, 27G, 26G, | |||
| 25G, 24G, 23G, | ||||
| 22G, 21G, 20G, | ||||
| 19G, 18G | Normal wall | |||
| and thin wall | Short bevel | |||
| and 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.
| Device
| feature | Subject Device | Predicate Device K180417 | Comments |
|---|---|---|---|
| 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. | Same | ||
| Product code | FMI | FMI | Same |
| Regulation | |||
| number | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |
| Principle of | |||
| operation | For manual use only | For manual use only | Same |
| Intended user | Medical professionals and | ||
| trained care givers | Medical professionals and | ||
| trained care givers | Same | ||
| Environment | |||
| of 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 | Difference | ||
| 1 | |||
| 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 hub | ||
| Polypropylene | Needle hub | ||
| Polypropylene | Same |
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| Device
feature | Subject Device | | Predicate Device K180417 | | Comment
s |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------|
| main structure
and materials | Needle
tube | Stainless steel | Needle
tube | Stainless steel | |
| | protective
cover | Polypropylene | protective
cap | Polypropylene | |
| Needle hub | Color-coded per ISO 6009 | | Color-coded per ISO 6009 | | Same |
| Single use | Yes | | Yes | | Same |
| Performance
specifications | Complies with ISO 7864; ISO
9626; 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 |
| Biocompatibili
ty | The biocompatibility evaluation
for the subject device was
conducted in accordance with
the International Standard ISO
10993-1 "Biological Evaluation
of Medical Devices - Part 1:
Evaluation and Testing Within
a Risk Management Process,"
as recognized by FDA and the
"Use of International Standard
ISO 10993-1 "Biological
evaluation of medical devices-
Part 1: Evaluation and testing
within a risk management
process", June 16, 2016. The
syringe of testing included the
following tests:
Cytotoxicity;
Skin sensitization:
Hemolysis:
Intracutaneous reactivity;
Acute systemic toxicity;
Pyrogenicity.
The evaluation of the above
testing items meets the
requirements | | Comply with ISO 10993.
The test is as follows:
The devices meet
biocompatibility endpoints
for cytotoxicity, irritation,
sensitization, systemic
toxicity,
hemolysis and material-
mediated pyrogens. | | Same |
| Labeling | Meet the requirements of 21
CFR Part 801 | | Meet the requirements of 21
CFR 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
6
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 ( 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
7
- 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.