(414 days)
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.
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.
The provided text describes a 510(k) submission for the "TK Safety Needle," which is a single lumen hypodermic needle with a safety shield. The submission aims to demonstrate substantial equivalence to a predicate device, the "TM Safety Needle" (K142765).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document details non-clinical testing performed against recognized ISO standards. These standards implicitly contain the acceptance criteria for various functional and safety aspects of a hypodermic needle. The report states that the device was "demonstrated to be in conformance" with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Functional Performance Testing (ISO 7864:2016) | Conforms to ISO 7864 |
| Fragmentation test | Conforms |
| Determination of flow rate | Conforms |
| Penetration force and drag force | Conforms |
| Bonding strength | Conforms |
| Small-bore Connectors (ISO 80369-7:2016) | Conforms to ISO 80369-7 |
| Leakage by pressure decay | Conforms |
| Falling drop positive-pressure liquid leakage | Conforms |
| Subatmospheric-pressure air leakage | Conforms |
| Stress cracking | Conforms |
| Resistance to separation from axial load | Conforms |
| Resistance to separation from unscrewing | Conforms |
| Resistance to overriding | Conforms |
| Needle Tubing (ISO 9626) | Conforms to ISO 9626 |
| Sharps Injury Protection (ISO 23908) | Conforms to ISO 23908 |
| Sharps injury testing per FDA guidance | Conforms |
| Sterility (ISO 11135:2014, ISO 11607-1:2006, ISO 11607:2006, ISO 10993-7:2008) | EO sterilization testing conducted |
| Biocompatibility Testing (ISO 10993-1:2018) | Conforms to ISO 10993-1 |
| Cytotoxicity (ISO 10993-5:2017) | Conforms |
| Sensitization (ISO 10993-10:2017) | Conforms |
| Irritation (ISO 10993-10:2017) | Conforms |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Conforms |
| Pyrogenicity (ISO 10993-4:2017) | Conforms |
| Hemocompatibility (ISO 10993-4:2017) | Conforms |
| Particulate matter testing (USP<788>) | Conforms |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the functional, sterility, or biocompatibility tests. It only indicates that "the sterile, single lumen hypodermic needles described in this summary were tested." The data provenance is implied to be from Anhui Tiankang Medical Technology Co., Ltd. in China, as they are the submitter and manufacturer. The testing described is prospective, as it was conducted specifically for this submission to demonstrate conformance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of device (hypodermic needle) does not typically involve human expert interpretation for "ground truth" in the way an AI diagnostic device would. The "ground truth" for the tests performed is based on the objective measurements and pass/fail criteria defined by the cited ISO standards and USP<788>. Therefore, no experts in the sense of medical diagnosticians were used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the assessment of these types of medical devices against performance standards involves objective measurements and predefined pass/fail criteria, not subjective interpretation requiring an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The TK Safety Needle is a physical medical device, not an AI-powered diagnostic tool, and therefore an MRMC comparative effectiveness study is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As a physical medical device, this question is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the defined specifications and limits set by the referenced international standards (e.g., ISO 7864, ISO 80369-7, ISO 10993, USP<788>). For example, the fragmentation test would have a specific maximum allowable fragmentation, and the flow rate test would have a specified range of acceptable flow rates. The device's performance is measured against these objective, predefined criteria.
8. The sample size for the training set
Not applicable. This device is a physical product and does not utilize a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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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.
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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
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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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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 ,TianchangCity.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 ,TianchangCity,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
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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.
| RefNumber | ModelNumber | 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
| RefNumber | ModelNumber | 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 |
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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 DEVICEK142765 | |
|---|---|---|
| Element of Comparison | ||
| Intended Use | The TK Safety Needle deviceis intended for use in theaspiration and injection offluids for medical purposes.The TK Safety Needle iscompatible for use withstandard luer slip and luerlock syringes. Additionally,after withdrawal of the needlefrom the body, the attachedneedle safety shield can bemanually activated to coverthe needle immediately afteruse to minimize risk ofaccidental needle-stick. | The TM Safety Needledevice is intended for use inthe aspiration and injection offluids for medical purposes.The TM Safety Needle iscompatible for use withstandard luer slip and luerlock syringes. Additionally,after withdrawal of the needlefrom the body, the attachedneedle safety shield can bemanually activated to coverthe needle immediately afteruse to minimize risk ofaccidental 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 wallFrom 24G to 30G:regular wall | Unknown |
TK Safety Needle Comparison Table
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Anhui Tiankang Medical Technology Co.,Ltd. 510(k) Submission No.228 Weiyi Road ,Economic Development Zone ,Tianchang City,Anhui,China [TK Safety Needles]
| MaterialsNeedle HubNeedleNeedle Sheath | PolypropyleneStainless SteelPolypropylene | PolypropyleneStainless SteelPolypropylene |
|---|---|---|
| Sharps injury PreventionFeatures | 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 21CFR Part 801 | Meet the requirements of 21CFR Part 801 |
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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 (<24 hours). The following testing was conducted:
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Cytotoxicity(ISO10993-5:2017) Sensitization(ISO10993-10:2017) Irritation(ISO10993-10:2017) Acute Systemic Toxicity(ISO10993-11:2017) Pyrogenicity(ISO10993-4:2017) Hemocompatibility(ISO10993-4:2017) Particulate matter testing(USP<788>)
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.
§ 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).