(174 days)
Not Found
No
The device description and intended use focus on a mechanical safety feature for a hypodermic needle. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
A therapeutic device is one that treats a disease or condition. This device is used for aspiration and injection of fluids, which are diagnostic or procedural actions, and features a safety mechanism. It does not actively treat a medical condition.
No
The device is a hypodermic needle used for aspiration and injection of fluids, and it includes a safety feature to prevent needle sticks. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (needle hub, needle tube, needle cap, sharp injury protection feature) and performance studies related to physical properties (biocompatibility, sterilization, performance testing), indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the aspiration and injection of fluids for medical purposes." This describes a device used on or in the body for therapeutic or diagnostic procedures involving fluid transfer, not for testing samples in vitro (outside the body).
- Device Description: The description details a hypodermic needle with a safety feature. This aligns with a device used for injecting or withdrawing substances from a living organism.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Disposable Medical Safety Hypodermic Needle is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FMI
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 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.
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
Not Found
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 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 (
§ 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 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
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,
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) 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)
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
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
4
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 |
|---|---|---|---|---|
| Disposable | ||||
| Medical Safety | ||||
| Hypodermic | ||||
| Needle | 1/2", 5/8", 1", 1 | |||
| 1/4", 1 1/2" | 30G, 29G, 28G, | |||
| 27G, 26G, 25G, | ||||
| 24G, 23G, 22G, | ||||
| 21G, 20G, 19G, | ||||
| 18G | TW | |||
| RW | ||||
| ETW | SB | |||
| LB |
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 Device
K191644 | Comments |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 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 | The TK Safety Needle
device is intended for
use in the aspiration and
injection of fluids for
medical purposes. The
TK Safety Needle is
compatible for use with
standard luer slip and
luer lock syringes. | Similar |
| Device feature | Subject Device | Predicate Device K191644 | Comments |
| | 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. | 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. | |
| Product code | FMI | FMI | Similar |
| Regulation
number | 21 CFR 880.5570 | 21 CFR 880.5570 | Similar |
| Class | CLASS II | CLASS II | Similar |
| Principle of
operation | 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 | Substantially
equivalent
Comment 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 or
Extra Thin Wall | From 16G to 23G: Thin
Wall
From 24G to 30G:
Regular Wall | |
| Blade angle | Short bevel or long bevel | Bevel | |
| Materials | Needle Hub Polypropylene
Needle Tube Stainless Steel
Needle Sheath Polypropylene | Needle Hub Polypropylene
Needle Tube Stainless
Steel
Needle Sheath Polypropylene | Similar |
| Sharps injury
Prevention
Features | Needle safety shield | Needle safety shield | Similar |
| Lubricant for
Needle | Silicone Oil | Silicone Oil | Similar |
| Adhesive | Epoxy Sizes | Epoxy Sizes | Similar |
| Performance
specifications | 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 Device
K191644 | Comments |
| | 21 CFR Part 801 | of 21 CFR Part 801 | |
5
6
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 ( 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, ISO | |
| 80369-7 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 luer | ||
| connectors. | Clause 5 of ISO 80369-7: 2021 | |
| Fluid leakage (Positive pressure liquid | ||
| leakage) | 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 from | ||
| unscrewing | 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
8
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.