(183 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterilization, and biocompatibility of a standard hypodermic needle. There is no mention of AI, ML, or any computational processing.
No
A therapeutic device is one that performs or supports a therapeutic action. This device is a hypodermic needle used for fluid injection/aspiration, which is a diagnostic or procedural tool, not a therapeutic device.
No
The device description clearly states its intended use is for "fluid injection/aspiration" and "Hypodermic injection," which are procedural functions, not diagnostic ones. It is a tool for delivering or withdrawing substances, not for identifying or assessing a medical condition.
No
The device description clearly indicates it is a physical hypodermic needle, a hardware component, and the performance studies focus on physical and biological properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with syringes and injection devices for general purpose fluid injection/aspiration." This describes a device used to introduce or withdraw substances from the body, which is a direct interaction with the patient's body, not an in vitro test.
- Device Description: The description focuses on the physical characteristics of a hypodermic needle used for injection and aspiration. It doesn't mention any components or functions related to testing samples outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
- Performing tests in a laboratory setting
The device is clearly intended for direct medical procedures involving the patient's body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Product codes
FMI
Device Description
The TK Sterile Hypodermic Needle is a hypodermic single lumen needle, designed for use with syringe and injection devices for general purpose fluid injection / aspiration. The TK Sterile Hypodermic Needle are offered in various gauge sizes and needle lengths. The TK Sterile Hypodermic Needle is sterilized by EtO gas. The TK Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use. Hypodermic needle for single use can be used Hypodermic injection. It suits users of different age and is the basic methods of infusion. And the device does not have the safety mechanism.
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
It suits users of different age
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 19, 2019
Anhui Tiankang Medical Technology CO.,Ltd Bai Baodong RA Manager NO.228 Weiyi Road, Economic Development Zone Tianchang, 239300 Cn
Re: K191643
Trade/Device Name: TK Sterile Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 21, 2019 Received: November 21, 2019
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.
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
1
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 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) K191643
Device Name TK Sterile Hypodermic Needle
Indications for Use (Describe)
The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Anhui Tiankang Medical Technology Co.,Ltd.
No.228 Weiyi Road .Economic Development Zone .Tianchang City,Anhui,China [TK Sterile Hypodermic Needles]
510(K) Summary: K191643
Date prepared: 05.16.2019 Date revised: 12.19.2019
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 Sterile Hypodermic Needle Classification name: Hypodermic single lumen Class: II. Product codes: FMI Regulation number: 21CFR880.5570 Submission Type: 510(K)
3. Predicate Device Information:
Trade Name: U&U Sterile Hypodermic Needle 510(K) Number: K132552
4. Device Description:
TK Sterile Hypodermic Needle
The TK Sterile Hypodermic Needle is a hypodermic single lumen needle, designed for use with syringe and injection devices for general purpose fluid injection / aspiration. The TK Sterile Hypodermic Needle are offered in various gauge sizes and needle lengths. The TK Sterile Hypodermic Needle is sterilized by EtO gas. The TK Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use. Hypodermic needle for single use can be used Hypodermic injection. It suits users of different age and is the basic methods
4
of infusion. And the device does not have the safety mechanism.
| Ref
Number | Model
Number | Description | Length | Size |
|---------------|-----------------|---------------------------------|-------------|------|
| TKHM001 | TKHM | Hypodermic Needle Normal-walled | 1/2 to 1" | 30G |
| TKHM002 | TKHM | Hypodermic Needle Normal-walled | 1/2 to 1" | 29G |
| TKHM003 | TKHM | Hypodermic Needle Normal-walled | 1/2 to 1" | 28G |
| TKHM004 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 27G |
| TKHM005 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 26G |
| TKHM006 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 25G |
| TKHM007 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 24G |
| TKHM008 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 23G |
| TKHM009 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 22G |
| TKHM010 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 21G |
| TKHM011 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 20G |
| TKHM012 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 19G |
| TKHM013 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 18G |
| TKHM014 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 17G |
| TKHM015 | TKHM | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 16G |
Table 1_Subject device
Table 2_Predicate device
| Ref
Number | Model
Number | Description | Length | Size |
|---------------|-----------------|---------------------------------|-------------|------|
| TKHN_001 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 30G |
| TKHN_002 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 29G |
| TKHN_003 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 28G |
| TKHN_004 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 27G |
| TKHN_005 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 26G |
| TKHN_006 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 25G |
| TKHN_007 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 24G |
| TKHN_008 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 23G |
| TKHN_009 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 22G |
| TKHN_010 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 21G |
| TKHN_011 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 20G |
| TKHN_012 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 19G |
| TKHN_013 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 18G |
| TKHN_014 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 17G |
| TKHN_015 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 16G |
5
5. Indications for use:
TK Sterile Hypodermic Needle is intended for use with syringes and injection devices for qeneral purpose fluid injection/ aspiration.
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. There are no technological differences between the subject and predicate.
| Element of Comparison | SUBJECT DEVICE | PREDICATE DEVICE
K132552 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | TK Sterile Hypodermic
Needle is intended for use
with syringes and injection
devices for general purpose
fluid injection / aspiration. | The U&U Hypodermic
Needle is intended for use
with syringes and injection
devices for general purpose
fluid injection / aspiration. |
| 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 |
| Materials | | |
| Needle Hub | PP | PP |
| Needle | Stainless Steel | Stainless Steel |
| Needle Cap | PP | PP |
| Sterilization method | Sterilization method: EO | Sterilization method: EO |
| Chemical properties | Chemical performances
inspection are based on
ISO7864, inspection items
are as follows:
Limits for acidity or
alkalinity,Limits for
extractable metals.
Results conform to ISO7864. | Chemical performances
inspection are based on
ISO7864, inspection items
are as follows:
Limits for acidity or
alkalinity,Limits for
extractable metals.
Results conform to ISO7864. |
| Labeling | Meet the requirements of 21
CFR Part 801 | Meet the requirements of 21
CFR Part 801 |
| Element of Comparison | SUBJECT DEVICE | PREDICATE DEVICE |
| | | K132552 |
| Sterility | Sterility inspection is based
on the methods stipulated in
USP, and the results
are in line with requirements
of USP: No microbial
growth was observed. | Sterility inspection is based
on the methods stipulated in
USP, and the results
are in line with requirements
of USP: No microbial
growth was observed. |
| Biocompatibility | The biocompatibility
evaluation for the TK Sterile
Hypodermic Needle was
conducted in accordance
with the FDA Blue Book
Memorandum #G95-1 "Use
of International Standard
ISO-10993, 'Biological
Evaluation of Medical
Devices Part 1: Evaluation
and Testing,'" May 1, 1995,
and International Standard
ISO 10993-1 "Biological
Evaluation of Medical
Devices - Part 1: Evaluation
and Testing Within a Risk
Management Process," as
recognized by FDA. The
Needle of testing included
the following tests:
Cytotoxicity
endotoxin
Skin sensitization
Hemolysis
Intracutaneous reactivity
Acute systemic toxicity
Pyrogenicity
The evaluation of the above
testing items meets the
requirements. | The biocompatibility
evaluation for the TK Sterile
Hypodermic Needle was
conducted in accordance
with the FDA Blue Book
Memorandum #G95-1 "Use
of International Standard
ISO-10993, 'Biological
Evaluation of Medical
Devices Part 1: Evaluation
and Testing,'" May 1, 1995,
and International Standard
ISO 10993-1 "Biological
Evaluation of Medical
Devices - Part 1: Evaluation
and Testing Within a Risk
Management Process," as
recognized by FDA. The
Needle of testing included
the following tests:
Cytotoxicity
endotoxin
Skin sensitization
Hemolysis
Intracutaneous reactivity
Acute systemic toxicity
Pyrogenicity
The evaluation of the above
testing items meets the
requirements. |
TK Sterile Hypodermic Needles Comparison Table
6
Anhui Tiankang Medical Technology Co.,Ltd.
No.228 Weiyi Road ,Economic Development Zone ,Tianchang City,Anhui,China [TK Sterile Hypodermic Needles]
7. Non-Clinical Test
7
ISO7864: 2016 ,Sterile hypodermic needles for single use - Requirements and test methods
ISO80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications-Part7: Connectors for intravascular or hypodermic applications
ISO 6009: 2016, Hypodermic needles for single use - Colour coding for identification
ISO11607-1: 2006, Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO11607-2: 2006, Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
ISO10993-1: 2018, Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
ISO10993-4: 2017, Biological evaluation of medical devices-Part 4:Seclection of tests for interactions with blood
ISO10993-5: 2009, Biological evaluation of medical devices-Part 5:Ethylene oxide sterilization residuals
ISO10993-10: 2010, Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
ISO10993-11: 2017, Biological evaluation of medical devices-Part 11:Tests for systemic toxicity
ISO10993-12: 2012, Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
ISO11135: 2014, Sterilization of health care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
ASTM F1980- 2016, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1929- 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F88- 2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
8
ISO9626: 2016,Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
8. Clinical Test
None.
9. Conclusions
TK Sterile Hypodermic Needle is substantially equivalent to U&U Sterile Hypodermic Needle. The materials, performance, and operational features of both the subject device and the predicate device are substantially equivalent.