TK Sterile Hypodermic Needle

K191643 · Anhui Tiankang Medical Technology Co., Ltd. · FMI · Dec 19, 2019 · General Hospital

Device Facts

• Record ID: K191643
• Device Name: TK Sterile Hypodermic Needle
• Applicant: Anhui Tiankang Medical Technology Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Dec 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Story

TK Sterile Hypodermic Needle is a single-lumen, disposable, non-pyrogenic device used for fluid injection or aspiration. It consists of a stainless steel needle with a bevel tip, attached to a polypropylene (PP) hub, and includes a PP needle cap. The device is lubricated with silicone oil and assembled using epoxy. It is sterilized via ethylene oxide (EtO) gas. The needle is available in various gauge sizes (16G to 30G) and lengths. It is intended for use by healthcare professionals or patients in clinical or home settings for general infusion or injection procedures. The device does not incorporate a safety mechanism. It functions as a standard hypodermic needle, facilitating the delivery of fluids into or withdrawal of fluids from the body.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (cytotoxicity, sensitization, hemolysis, systemic toxicity, pyrogenicity), sterility, and performance testing per ISO 7864, ISO 80369-7, and ISO 9626.

Technological Characteristics

Single-lumen hypodermic needle; stainless steel tubing (ISO 9626); polypropylene (PP) hub and cap; silicone oil lubricant; epoxy adhesive. Sterilization: Ethylene oxide (ISO 11135). Compliance: ISO 7864 (chemical/performance), ISO 80369-7 (connectors), ISO 6009 (color coding), ISO 10993 (biocompatibility). Packaging validated per ISO 11607 and ASTM F1980/F1929/F88.

Indications for Use

Indicated for general purpose fluid injection/aspiration using syringes and injection devices. Suitable for users of all ages.

Regulatory Classification

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.

Predicate Devices

• U&U Sterile Hypodermic Needle (K132552)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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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<br>City.Anhui,China |
| Contactor Name: | Bai Baodong |
| TEL: | [phone] |
| E-mail: | [e-mail] |

| Manufacturer Name: | Anhui Tiankang Medical Technology Co.,Ltd |
|--------------------|-----------------------------------------------------------------------------|
| Address: | No.228 Weiyi Road ,Economic Development Zone ,Tianchang<br>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

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of infusion. And the device does not have the safety mechanism.

| Ref<br>Number | Model<br>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<br>Number | Model<br>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 |

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#### 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<br>K132552 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | TK Sterile Hypodermic<br>Needle is intended for use<br>with syringes and injection<br>devices for general purpose<br>fluid injection / aspiration. | The U&U Hypodermic<br>Needle is intended for use<br>with syringes and injection<br>devices for general purpose<br>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<br>inspection are based on<br>ISO7864, inspection items<br>are as follows:<br>Limits for acidity or<br>alkalinity,Limits for<br>extractable metals.<br>Results conform to ISO7864. | Chemical performances<br>inspection are based on<br>ISO7864, inspection items<br>are as follows:<br>Limits for acidity or<br>alkalinity,Limits for<br>extractable metals.<br>Results conform to ISO7864. |
| Labeling | Meet the requirements of 21<br>CFR Part 801 | Meet the requirements of 21<br>CFR Part 801 |
| Element of Comparison | SUBJECT DEVICE | PREDICATE DEVICE |
| | | K132552 |
| Sterility | Sterility inspection is based<br>on the methods stipulated in<br>USP<71>, and the results<br>are in line with requirements<br>of USP<71>: No microbial<br>growth was observed. | Sterility inspection is based<br>on the methods stipulated in<br>USP<71>, and the results<br>are in line with requirements<br>of USP<71>: No microbial<br>growth was observed. |
| Biocompatibility | The biocompatibility<br>evaluation for the TK Sterile<br>Hypodermic Needle was<br>conducted in accordance<br>with the FDA Blue Book<br>Memorandum #G95-1 "Use<br>of International Standard<br>ISO-10993, 'Biological<br>Evaluation of Medical<br>Devices Part 1: Evaluation<br>and Testing,'" May 1, 1995,<br>and International Standard<br>ISO 10993-1 "Biological<br>Evaluation of Medical<br>Devices - Part 1: Evaluation<br>and Testing Within a Risk<br>Management Process," as<br>recognized by FDA. The<br>Needle of testing included<br>the following tests:<br>Cytotoxicity<br>endotoxin<br>Skin sensitization<br>Hemolysis<br>Intracutaneous reactivity<br>Acute systemic toxicity<br>Pyrogenicity<br>The evaluation of the above<br>testing items meets the<br>requirements. | The biocompatibility<br>evaluation for the TK Sterile<br>Hypodermic Needle was<br>conducted in accordance<br>with the FDA Blue Book<br>Memorandum #G95-1 "Use<br>of International Standard<br>ISO-10993, 'Biological<br>Evaluation of Medical<br>Devices Part 1: Evaluation<br>and Testing,'" May 1, 1995,<br>and International Standard<br>ISO 10993-1 "Biological<br>Evaluation of Medical<br>Devices - Part 1: Evaluation<br>and Testing Within a Risk<br>Management Process," as<br>recognized by FDA. The<br>Needle of testing included<br>the following tests:<br>Cytotoxicity<br>endotoxin<br>Skin sensitization<br>Hemolysis<br>Intracutaneous reactivity<br>Acute systemic toxicity<br>Pyrogenicity<br>The evaluation of the above<br>testing items meets the<br>requirements. |

# TK Sterile Hypodermic Needles Comparison Table

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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

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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

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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.