(414 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
This device is a safety needle intended for aspiration and injection of fluids, which is a diagnostic or procedural tool, not a device that directly administers therapy or modifies physiological processes. Its primary therapeutic aspect relates to minimizing accidental needle-sticks, which is for user safety rather than patient treatment.
No
The device is described as a safety needle for aspiration and injection of fluids, and there is no mention of it being used for diagnosis or generating diagnostic information.
No
The device description clearly outlines a physical hypodermic needle with a hinged safety sheath, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration and injection of fluids for medical purposes" and minimizing needle-stick risk. This describes a device used for direct patient care and sample collection/delivery, not for testing samples in vitro (outside the body).
- Device Description: The description details a hypodermic needle with a safety mechanism. This is a medical device used for procedures on a patient, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on the physical act of aspiration and injection, and safety during these procedures.
N/A
Intended Use / Indications for Use
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 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 (comma separated list FDA assigned to the subject device)
FMI
Device Description
The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation.
The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath 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)
Functional Performance Testing:
The sterile, single lumen hypodermic needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 7864:2016, Sterile hypodermic needles for single use (Fragmentation test, Determination of flow rate, Penetration force and drag force, Bonding strength)
- ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications-part 7: Connectors for intravascular or hypodermic applications (Leakage by pressure decay, Falling drop positive-pressure liquid leakage, Subatmospheric-pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding)
- ISO 9626 Stainless Steel Needle Tubing for the Manufacture of medical Devices
- ISO 23908 Sharps Injury protection-Requirements and test methods (Sharps injury testing per FDA guidance Medical Devices with Sharps Injury Prevention Features)
Sterility:
EO sterilization testing conducted (ISO11135:2014, ISO11607-1:2006, ISO11607:2006, ISO10993-7:2008)
Biocompatibility Testing:
In accordance with ISO 10993-1:2018, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ()
Clinical Testing:
N/A
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
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August 6, 2020
Anhui Tiankang Medical Technology Co., Ltd. Bai Baodong RA Manager No.228 Weiyi Road, Economic Development Zone Tianchang City Anhui China 239300
Re: K191644
Trade/Device Name: TK Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 7, 2020 Received: July 7, 2020
Dear Bai Baodong:
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.
1
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 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 (OS) 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 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) K191644
Device Name TK Safety Needle
Indications for Use (Describe)
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 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) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K191644 510(K) Summary
Date revised: 8.5.2020
1. Submitter Name and Address:
| Owner Name: | Anhui Tiankang Medical Technology Co.,Ltd. |
|---|---|
| Address: | No.228 Weiyi Road .Economic Development Zone ,Tianchang |
| City.Anhui,China | |
| Contactor Name: | Bai Baodong |
| TEL: | +86-550-7309187 |
| E-mail: | tkquality@126.com |
| Manufacturer Name: | Anhui Tiankang Medical Technology Co.,Ltd |
|---|---|
| Address: | No.228 Weiyi Road ,Economic Development Zone ,Tianchang |
| City,Anhui,China |
US Agent:
| US Agent: | James H . Liao |
|---|---|
| Address: | 6775 Verde Ridge Rd Rancho Palos Verdes, CA 90275 |
| TEL: | 310 3758169 Ext |
| Email: | James@Sino2us.Com |
2. Submission Devices Information:
Trade/Proprietary Name: TK Safety Needle Classification name: Needle, Hypodermic, Single Lumen Class: II. Panel:80. Product codes: FMI Regulation number: 21CFR880.5570 Submission Type: 510(K)
3. Predicate Device Information:
Company Name: U&U Medical Technology Co.,Itd Address:Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG Trade Name: TM Safety Needle 510(K) Number: K142765
4. Device Description:
TK Safety Needle
The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually
4
pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation.
The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.
| Ref
Number | Model
Number | Description | Length | Size |
|---------------|-----------------|--------------------------|-------------|------|
| TKSN001 | TKSN | Safety Hypodermic Needle | 1/2 to 1" | 30G |
| TKSN002 | TKSN | Safety Hypodermic Needle | 1/2 to 1" | 29G |
| TKSN003 | TKSN | Safety Hypodermic Needle | 1/2 to 1" | 28G |
| TKSN004 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 27G |
| TKSN005 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 26G |
| TKSN006 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 25G |
| TKSN007 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 24G |
| TKSN008 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 23G |
| TKSN009 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 22G |
| TKSN010 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 21G |
| TKSN011 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 20G |
| TKSN012 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 19G |
| TKSN013 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 18G |
| TKSN014 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 17G |
| TKSN015 | TKSN | Safety Hypodermic Needle | 1 to 1 1/2" | 16G |
Table 1_Subject device
Table 2_Predicate device
| Ref
Number | Model
Number | Description | Length | Size |
|---------------|-----------------|--------------------------|-------------|------|
| TMSN001 | TMSN | Safety Hypodermic Needle | 1/2 to 1" | 30G |
| TMSN002 | TMSN | Safety Hypodermic Needle | 1/2 to 1" | 29G |
| TMSN003 | TMSN | Safety Hypodermic Needle | 1/2 to 1" | 28G |
| TMSN004 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 27G |
| TMSN005 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 26G |
| TMSN006 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 25G |
| TMSN007 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 24G |
| TMSN008 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 23G |
| TMSN009 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 22G |
| TMSN010 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 21G |
| TMSN011 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 20G |
5
Anhui Tiankang Medical Technology Co.,Ltd. 510(k) Submission
No.228 Weiyi Road ,Economic Development Zone ,Tianchang City,Anhui,China [TK Safety Needles]
| TMSN012 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 19G |
|---|---|---|---|---|
| TMSN013 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 18G |
| TMSN014 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 17G |
| TMSN015 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 16G |
5. Indications for use:
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. 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.
6. Comparison of technological characteristics with the predicate:
Through comparisons between the submitted devices with the predicate devices as follows Tables. We believe the applicant devices are substantially equivalent with the predicate devices.
| | SUBJECT DEVICE | PREDICATE DEVICE
K142765 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element of Comparison | | |
| Intended Use | 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. 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 TM Safety Needle
device is intended for use in
the aspiration and injection of
fluids for medical purposes.
The TM Safety 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. |
| Principle of Operation | Normal | Normal |
| Needle Gauge and Length | Refer to table 1 | Refer to table 2 |
| Lubricant for Needle | Silicone Oil | Silicone Oil |
| Adhesive | Epoxy Sizes | Epoxy Sizes |
| Needle Hub Colors | Various Colors | Various Colors |
| Tip configuration | Bevel | Bevel |
| Wall Type | From 16G to 23G: thin wall
From 24G to 30G:
regular wall | Unknown |
TK Safety Needle Comparison Table
6
Anhui Tiankang Medical Technology Co.,Ltd. 510(k) Submission No.228 Weiyi Road ,Economic Development Zone ,Tianchang City,Anhui,China [TK Safety Needles]
| Materials
Needle Hub
Needle
Needle Sheath | Polypropylene
Stainless Steel
Polypropylene | Polypropylene
Stainless Steel
Polypropylene |
|----------------------------------------------------|---------------------------------------------------|---------------------------------------------------|
| Sharps injury Prevention
Features | Needle safety shield | Needle safety shield |
| Performance | Conforms to ISO 7864 | Conforms to ISO 7864 |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 |
| Labeling | Meet the requirements of 21
CFR Part 801 | Meet the requirements of 21
CFR Part 801 |
7
7. Non-Clinical Testing
Functional Performance Testing
The sterile, single lumen hypodermic needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
ISO 7864:2016, Sterile hypodermic needles for single use
- Fragmentation test (ISO 7864: 2016)
- Determination of flow rate(ISO 7864: 2016)
- Penetration force and drag force(ISO 7864: 2016)
- Bonding strength(ISO 7864: 2016) ●
ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications-part 7: Connectors for intravascular or hypodermic applications
- Leakage by pressure decay(ISO80369-7:2016) ●
- Falling drop positive-pressure liquid leakage(ISO80369-7:2016)
- Subatmospheric-pressure air leakage(ISO80369-7:2016) ●
- Stress cracking(ISO80369-7:2016) .
- Resistance to separation from axial load(ISO80369-7:2016)
- Resistance to separation from unscrewing(ISO80369-7:2016)
- Resistance to overriding(ISO80369-7:2016) ●
ISO 9626 Stainless Steel Needle Tubing for the Manufacture of medical Devices
ISO 23908 Sharps Injury protection-Requirements and test methods
Sharps injury testing per FDA guidance Medical Devices with Sharps Injury Prevention Features
Sterility
EO sterilization testing conducted(ISO11135:2014,ISO11607-1:2006,ISO11607:2006,ISO10993-7:2008)
Biocompatibility Testing(ISO10993-1:2018)
In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ()
8. Clinical Testing
N/A
9. Conclusions
The TK Safety Needle is substantially equivalent to TM Safety Needle. The intended use, materials, performance and operational features of the TK safety needle are substantially equivalent to the predicate devices.