(183 days)
The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
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.
The provided document is a 510(k) summary for a medical device called the "TK Sterile Hypodermic Needle." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the performance of an AI/ML algorithm. Therefore, many of the requested items related to AI/ML studies are not applicable to this document.
However, I can extract information regarding the safety and performance testing conducted to support the substantial equivalence claim.
1. Table of acceptance criteria and the reported device performance:
The document primarily states that the device's performance "conforms to" or "meets the requirements" of various ISO and ASTM standards. The specific quantitative acceptance criteria (e.g., maximum force, minimum flow rate) are not listed in this summary, nor are the precise numerical results of the tests. The summary indicates compliance rather than detailed performance metrics.
| Test Category | Standard(s) | Reported Device Performance |
|---|---|---|
| Chemical Properties | ISO7864 | Results conform to ISO7864 (Limits for acidity/alkalinity, extractable metals) |
| Sterility | USP<71> | No microbial growth was observed, in line with USP<71> requirements |
| Biocompatibility | ISO 10993-1, -4, -5, -10, -11, -12; FDA Blue Book #G95-1 | Evaluation meets the requirements for Cytotoxicity, endotoxin, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity |
| Needle Dimensions | ISO9626 | (Implied compliance, not explicitly stated as "conforms" but part of the comparison) |
| General Requirements | ISO7864 | (Implied compliance, part of comparison) |
| Small-Bore Connectors | ISO80369-7 | (Implied compliance, part of comparison) |
| Color Coding | ISO 6009 | (Implied compliance, part of comparison) |
| Packaging | ISO11607-1, ISO11607-2, ASTM F1980, ASTM F1929, ASTM F88 | (Implied compliance, part of comparison) |
| Sterilization Process | ISO11135 | (Implied compliance, part of comparison) |
| Labeling | 21 CFR Part 801 | Meets the requirements of 21 CFR Part 801 |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for the non-clinical tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective, though they are inherently prospective tests designed to prove compliance with standards for the device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes non-clinical laboratory testing against established international standards, not studies involving expert evaluation for ground truth like in AI/ML performance testing.
4. Adjudication method for the test set:
This is not applicable. Laboratory tests against standards do not typically involve adjudication in the way AI/ML studies do (e.g., 2+1 reader consensus). The tests yielded objective physical, chemical, or biological results.
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:
This is not applicable. There is no AI/ML component described for the TK Sterile Hypodermic Needle, and thus no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established within the referenced international standards (e.g., ISO, ASTM, USP). For example, for sterility, the ground truth is the absence of microbial growth as detected by USP<71>. For biocompatibility, it's the satisfactory outcome of specific biological tests as per ISO 10993.
8. The sample size for the training set:
This is not applicable. There is no AI/ML component, and therefore no training set.
9. How the ground truth for the training set was established:
This is not applicable. There is no AI/ML component, and therefore no training set or ground truth for it.
Summary of Study:
The studies described are non-clinical bench and lab tests performed to demonstrate that the TK Sterile Hypodermic Needle meets the safety and performance requirements of established international and national standards relevant to hypodermic needles. These tests include:
- Chemical properties inspection according to ISO7864.
- Sterility inspection according to USP<71>.
- Biocompatibility evaluation according to ISO 10993 series and FDA Blue Book Memorandum #G95-1, covering tests like Cytotoxicity, endotoxin, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, and Pyrogenicity.
- Conformity to other design and performance standards such as ISO7864 (general requirements), ISO80369-7 (small-bore connectors), ISO 6009 (color coding), ISO9626 (stainless steel needle tubing), and packaging standards (ISO11607-1, ISO11607-2, ASTM F1980, ASTM F1929, ASTM F88).
- Compliance with sterilization process standards (ISO11135) and labeling regulations (21 CFR Part 801).
The conclusion of the submission is that the TK Sterile Hypodermic Needle is substantially equivalent to the predicate device (U&U Sterile Hypodermic Needle K132552) based on the comparison of technological characteristics and the non-clinical testing demonstrating compliance with relevant standards.
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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
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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 (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) 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 ,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 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.
| RefNumber | ModelNumber | 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
| RefNumber | ModelNumber | 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 DEVICEK132552 |
|---|---|---|
| Intended Use | TK Sterile HypodermicNeedle is intended for usewith syringes and injectiondevices for general purposefluid injection / aspiration. | The U&U HypodermicNeedle is intended for usewith syringes and injectiondevices for general purposefluid 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 performancesinspection are based onISO7864, inspection itemsare as follows:Limits for acidity oralkalinity,Limits forextractable metals.Results conform to ISO7864. | Chemical performancesinspection are based onISO7864, inspection itemsare as follows:Limits for acidity oralkalinity,Limits forextractable metals.Results conform to ISO7864. |
| Labeling | Meet the requirements of 21CFR Part 801 | Meet the requirements of 21CFR Part 801 |
| Element of Comparison | SUBJECT DEVICE | PREDICATE DEVICE |
| K132552 | ||
| Sterility | Sterility inspection is basedon the methods stipulated inUSP<71>, and the resultsare in line with requirementsof USP<71>: No microbialgrowth was observed. | Sterility inspection is basedon the methods stipulated inUSP<71>, and the resultsare in line with requirementsof USP<71>: No microbialgrowth was observed. |
| Biocompatibility | The biocompatibilityevaluation for the TK SterileHypodermic Needle wasconducted in accordancewith the FDA Blue BookMemorandum #G95-1 "Useof International StandardISO-10993, 'BiologicalEvaluation of MedicalDevices Part 1: Evaluationand Testing,'" May 1, 1995,and International StandardISO 10993-1 "BiologicalEvaluation of MedicalDevices - Part 1: Evaluationand Testing Within a RiskManagement Process," asrecognized by FDA. TheNeedle of testing includedthe following tests:CytotoxicityendotoxinSkin sensitizationHemolysisIntracutaneous reactivityAcute systemic toxicityPyrogenicityThe evaluation of the abovetesting items meets therequirements. | The biocompatibilityevaluation for the TK SterileHypodermic Needle wasconducted in accordancewith the FDA Blue BookMemorandum #G95-1 "Useof International StandardISO-10993, 'BiologicalEvaluation of MedicalDevices Part 1: Evaluationand Testing,'" May 1, 1995,and International StandardISO 10993-1 "BiologicalEvaluation of MedicalDevices - Part 1: Evaluationand Testing Within a RiskManagement Process," asrecognized by FDA. TheNeedle of testing includedthe following tests:CytotoxicityendotoxinSkin sensitizationHemolysisIntracutaneous reactivityAcute systemic toxicityPyrogenicityThe evaluation of the abovetesting items meets therequirements. |
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.
§ 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).