(78 days)
Sterile Hypodermic Needle for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
The proposed device, Sterile Hypodermic Needles For Single Use consists of needle tube, needle hub and hard pack(Butt-end lower protective cap and Upper needle protective cap) or protective cap for needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the colour complies with ISO 6009. Sterile Hypodermic Needles for Single Use have two kinds of sterile barrier type, paper-film package type and hard-pack package. Besides the sterile barrier, the materials of middle package and outer package are same. Middle package is made of 350g ivory board and the outer package is made from double-corrugated paper. The conical fitting of Sterile Hypodermic Needles for Single Use is luer can be used with syringes or other medical device which have 6% conical fitting. It is provided as sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6. Additionally, each component is made from properly tested raw materials.
This is a 510(k) premarket notification for a medical device (Sterile Hypodermic Needles for Single Use), which focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against predefined acceptance criteria for a new AI or diagnostic device. As such, most of the requested information regarding acceptance criteria and study details for an AI/diagnostic device is not applicable or cannot be extracted from this document.
However, I can provide information based on the reported performance specifications (which serve as acceptance criteria for basic device characteristics) and the non-clinical performance testing conducted to demonstrate compliance with relevant standards.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
For a medical device like a hypodermic needle, acceptance criteria are typically defined by compliance with recognized international standards for manufacturing, materials, and specific performance attributes. The document states that the proposed device complies with these standards, thus the reported performance meets the acceptance criteria.
| Acceptance Criterion (Standard/Test) | Reference Standard / Performance | Reported Device Performance |
|---|---|---|
| Material/Design Specifications | ||
| Needle tube material | Stainless Steel (SUS 304) | Stainless Steel (SUS 304) |
| Needle hub material | Polypropylene (PP) | Polypropylene (PP) |
| Protective cap material | Polypropylene (PP) | Polypropylene (PP) |
| Conical fitting | Luer | Luer |
| Color coding | Per ISO 6009 | Color-coded per ISO 6009 |
| Single use | Yes | Yes |
| Sterilization | ||
| Sterilization method | EO | EO |
| Sterilization Assurance Level (SAL) | $10^{-6}$ | $10^{-6}$ |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Biocompatibility | Per ISO 10993-1, -4, -5, -7, -10, -11 | Evaluation conducted per ISO 10993-1, -4, -5, -7, -10, -11. Tests included Cytotoxicity, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity. Evaluation meets requirements. |
| Per USP <788> | Conforms to USP <788>: Particulate Matter for injection | |
| Physical Performance/Dimensions | Per ISO 7864:2016 (Requirements and test methods) | Complies with ISO 7864:2016 |
| Per ISO 9626:2016 (Stainless steel needle tubing) | Complies with ISO 9626:2016 | |
| Per ISO 80369-7:2021 (Small-bore connectors) | Complies with ISO 80369-7:2021 | |
| Per ISO 80369-20:2015 (Common test methods) | Complies with ISO 80369-20:2015 | |
| Packaging/Sealing | Per ASTM F88/F88M-15 (Seal Strength) | Complies with ASTM F88/F88M-15 |
| Per ASTM F1929-15 (Seal Leaks) | Complies with ASTM F1929-15 | |
| Needle Gauge & Length (Specific Measurements) | All test results meet acceptance criteria per standards (ISO 7864, ISO 9626) | All test results meet acceptance criteria per standards. Specific dimensions are provided in Table 19-1. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test conducted to demonstrate compliance with the standards (e.g., number of needles tested for bend strength, fluid leakage, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and "all test results meet the acceptance criteria per the standards." The provenance of the testing data (e.g., country of origin, retrospective/prospective) is not detailed, though the manufacturer is based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a mechanical medical device (hypodermic needle), not an AI or diagnostic device that relies on expert interpretation for ground truth. Compliance is determined by physical and chemical testing against established international standards.
4. Adjudication method for the test set
Not applicable. Testing is against objective criteria defined by international standards rather than subjective human assessment requiring adjudication.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used
The ground truth is established by international standards and their specified test methods, such as ISO 7864 (Sterile hypodermic needles), ISO 9626 (Stainless steel needle tubing), ISO 80369 series (Small-bore connectors), ISO 10993 series (Biocompatibility), ASTM standards for packaging, and USP <788> for particulate matter. These standards define the acceptable performance limits and methodologies for testing.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zhejiang Kindly Medical Device Co., Ltd. % Amy Li Technical Director Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. Jingan 201803 China
Re: K233037
Trade/Device Name: Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 19, 2023 Received: September 25, 2023
Dear Amy Li:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. 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
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Indications for Use
510(k) Number (if known) K233037
Device Name Sterile Hypodermic Needles For Single Use
Indications for Use (Describe)
Sterile Hypodermic Needle for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K233037 510k Summary
-
- Date of preparation: December 1, 2023
-
- Sponsor Identification
Name: Zhejiang Kindly Medical Device Co., Ltd.
Add.: No 758, 5th Binhai Road, Binhai Industrial Park, Longwan, Wenzhou City, Zhejiang Province.
Contact Person: Zhang Qian
Position: Technical Manager
Tel: +86 13858871856
Email: zhangqian@kdIchina.com
-
- Designated submission correspondent
Ms. Amy Lee (Primary Contact Person)
- Designated submission correspondent
Mind-Link Consulting Co., Ltd.
Tel: +86 15721449974
Email: amy.li@mind-link.net
4. Identification of Proposed Device
Trade Name: Sterile Hypodermic Needles For Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Review Panel: General hospital
5. Predicate devices
- (1) 510(K) number: K180417
Trade Name: Sterile Hypodermic Needles For Single Use
Regulation Number: 21 CFR 880.5570
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Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Review Panel: General hospital
(2) 510(K) number: K223334
Trade Name: Sterile Hypodermic Needles For Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Review Panel: General hospital
Indication for use statement 6.
Sterile Hypodermic Needle for Single Use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
7. Device description
The proposed device, Sterile Hypodermic Needles For Single Use consists of needle tube, needle hub and hard pack(Butt-end lower protective cap and Upper needle protective cap) or protective cap for needle tube is made from stainless steel (SUS 304), the needle hub made of Polypropylene material (abb. PP) and the colour complies with ISO 6009. Sterile Hypodermic Needles for Single Use have two kinds of sterile barrier type, paper-film package type and hard-pack package. Besides the sterile barrier, the materials of middle package and outer package are same. Middle package is made of 350g ivory board and the outer package is made from double-corrugated paper.
The conical fitting of Sterile Hypodermic Needles for Single Use is luer can be used with syringes or other medical device which have 6% conical fitting. It is provided as sterile with EO sterilization, and the sterilization assurance level (SAL) is 10-6.
Additionally, each component is made from properly tested raw materials.
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- 6.1 The proposed device includes different specifications.
Models of Sterile Hypodermic Needles For Single Use shown in Table 19-1 are available in various models according to different needle gauge and different needle length.
| Nozzletype | NeedleGauge(G) | Wall type | Designatedmetric size(mm) | ID min(mm) | Needlelength(mm) | LongBevel | ShortBevel | Color ofneedle hub |
|---|---|---|---|---|---|---|---|---|
| Luer lock | 14 | RW | 2.10 | 1.500 | 25, 32, 38,50 | 11°±2° | 17°±2° | Pale Green |
| TW | 2.10 | 1.600 | 25, 32, 38,50 | 11°±2° | 17°±2° | |||
| Luer lock | 15 | RW | 1.80 | 1.300 | 25, 32, 38,50 | 11°±2° | 17°±2° | Blue-grey |
| TW | 1.80 | 1.460 | 25, 32, 38,50 | 11°±2° | 17°±2° | |||
| Luer lock | 16 | RW | 1.60 | 1.100 | 25, 32, 38,50 | 11°±2° | 17°±2° | White |
| TW | 1.60 | 1.283 | 25, 32, 38,50 | 11°±2° | 17°±2° | |||
| Luer lock | 17 | RW | 1.40 | 0.950 | 25, 32, 38,50 | 11°±2° | 17°±2° | Red-violet |
| TW | 1.40 | 1.156 | 25, 32, 38,50 | 11°±2° | 17°±2° | |||
| Luer lock | 18 | RW | 1.20 | 0.790 | 13, 25, 32,38, 50 | 11°±2° | 17°±2° | Pink |
| TW | 1.20 | 0.910 | 13, 25, 32,38, 50 | 11°±2° | 17°±2° | |||
| Luer lock | 19 | RW | 1.10 | 0.648 | 25, 32, 38,50 | 11°±2° | 17°±2° | Cream |
| TW | 1.10 | 0.750 | 25, 32, 38,50 | 11°±2° | 17°±2° | |||
| Luer lock | RW | |||||||
| Luer lock | 20 | RW | 0.90 | 0.560 | 25, 32, 38, 50 | 11°±2° | / | Yellow |
| TW | 0.635 | 11°±2° | / | |||||
| Luer lock | 21 | RW | 0.80 | 0.490 | 25, 32, 38, 50 | 11°±2° | / | Deep Green |
| TW | 0.547 | 11°±2° | / | |||||
| Luer lock | 22 | RW | 0.70 | 0.390 | 25, 32, 38, 50 | 11°±2° | / | Black |
| TW | 0.440 | 11°±2° | / | |||||
| Luer lock | 23 | RW | 0.60 | 0.317 | 8, 25, 38 | 11°±2° | / | Deep Blue |
| TW | 0.370 | 11°±2° | / | |||||
| Luer lock | 24 | RW | 0.50 | 0.280 | 20, 25 | 11°±2° | / | Med Purple |
| Luer lock | 25 | RW | 0.55 | 0.232 | 11°±2° | / | Orange | |
| TW | 0.292 | 16, 25, 38 | 11°±2° | / | ||||
| Luer lock | 26 | RW | 0.50 | 0.232 | 9, 13, 16 | / | 17°±2° | Brown |
| TW | 0.292 | 11°±2° | / | |||||
| Luer lock | 27 | RW | 0.45 | 0.184 | 6, 8, 9, 12, 13, 15, 20 | / | 17°±2° | Medium gery |
| TW | 0.241 | 11°±2° | / | |||||
| Luer lock | 28 | RW | 0.40 | 0.133 | 6, 8, 12, 15 | / | 17°±2° | Blue-green |
| TW | 0.190 | 11°±2° | / | |||||
| Luer lock | 29 | RW | 0.36 | 0.133 | 6, 8, 12, 15 | 11°±2° | 17°±2° | Red |
| TW | 0.190 | 11°±2° | 17°±2° | |||||
| Luer lock | 30 | RW | 0.30 | 0.133 | 6, 8, 9, 12, 13, 15 | 11°±2° | 17°±2° | Yellow |
| TW | 0.165 | 11°±2° | 17°±2° | |||||
| Luer lock | 31 | RW | 0.25 | 0.114 | 20,13, 8, 6, 5,4 | 11°±2° | 17°±2° | White |
| TW | 0.125 | 11°±2° | 17°±2° | |||||
| Luer lock | 32 | TW | 0.23 | 0.105 | 20,13, 8, 6, 5, 4 | 11°±2° | 17°±2° | Deepgreen |
| Luer lock | 33 | RW | 0.20 | 0.089 | 13, 8, 6, 5, 4 | 11°±2° | 17°±2° | Black |
| TW | 0.105 | 11°±2° | 17°±2° | |||||
| Luer lock | 34 | RW | 0.18 | 0.064 | 13, 8, 6, 5, 4 | 11°±2° | 17°±2° | Orange |
| TW | 0.091 | 11°±2° | 17°±2° |
Table 19-1 Models of Sterile Hypodermic Needles For Single Use
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-
- Comparison of technological characteristics with the predicate devices
The Sterile Hypodermic Needles for Single Use have intended use, technology, and design; and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Hypodermic Needles for Single Use and predicate devices do not alter suitability of the proposed device for its intended use.
- Comparison of technological characteristics with the predicate devices
| Component | Proposed device | Predicate device K180417 | Predicate device K223334 | Comment |
|---|---|---|---|---|
| Indication for use | Sterile Hypodermic Needles for single use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | The Sterile Hypodermic Needles for Single Use are intended to be used with a luer lock or luer slip syringe and injection devices for general purpose fluid injection/aspiration. | The Sterile Hypodermic Needles for single use are intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | Same |
| Product code | FMI | FMI | FMI | Same |
| Regulation number | 21 CFR 880.5570 | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | II | Same |
| Principle of operation | For manual use only | For manual use only | For manual use only | Same |
| Intended user | Medical professionals and trained care givers | Medical professionals and trained care givers | Medical professionals and trained care givers | Same |
| Environment of use | Hospitals and clinics | Hospital and clinics | Hospitals and clinics | Same |
| Needle gauge | 14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G | 14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | 31G, 32G, 33G, 34G | Different. Analysis 1. |
| Length | 4-50mm. | / | 4mm, 5mm, 6mm, 8mm, 13mm, 20mm, | Different. Analysis 2. |
| Type of wall | Normal wall or thin wall. | Normal wall or thin wall. | Normal wall or thin wall. | Same |
| Blade angle | Short bevel and long bevel. | Short bevel and long bevel. | Short bevel and long bevel. | Same |
| Main structure and materials | Needle hubPolypropylene | Needle hubPolypropylene | Needle hubPolypropylene | Same |
| Needle tubeStainless steel | Needle tubeStainless steel | Needle tubeStainless steel | Same | |
| Protective capPolypropylene | Protective capPolypropylene | Protective capPolypropylene | Different. Analysis 3. | |
| Hard pack (Butt-end | ||||
| lowerprotectivecap, upperneedleprotectivecap) | ||||
| Needle hubcolor | Color-coded per ISO 6009. | Color-coded per ISO 6009. | Color-coded per ISO 6009. | Same |
| Single use | Yes | Yes | Yes | Yes |
| Performancespecifications | Comply with:ISO 7864 Sterilehypodermic needles forsingle use - Requirementsand test methods;ISO 9626:2016 Stainlesssteel needle tubing for themanufacture of medicaldevices -Requirements andtest methods;ISO 80369-7:2021Small-bore connectors forliquids and gases inhealthcare applications –Part 7: Connectors forintravascular or hypodermicapplications;ISO 80369-20:2015Small-bore connectors forliquids and gases inhealthcare applications -Part 20: Common testmethods | Complies with:ISO 7864:2016 Sterilehypodermic needles for singleuse - Requirements and testmethods;ISO 9626:2016 Stainless steelneedle tubing for themanufacture of medicaldevices -Requirements andtest methods;ISO 80369-7:2021Small-bore connectors forliquids and gases inhealthcare applications –Part 7: Connectors forintravascular or hypodermicapplications;ISO 80369-20:2015Small-bore connectors forliquids and gases inhealthcare applications - Part20: Common test methods | Comply with:ISO 7864 Sterile hypodermicneedles for single use -Requirements and testmethods;ISO 9626:2016 Stainlesssteel needle tubing for themanufacture of medicaldevices -Requirements andtest methods;ISO 80369-7:2021Small-bore connectors forliquids and gases inhealthcare applications –Part 7: Connectors forintravascular or hypodermicapplications;ISO 80369-20:2015Small-bore connectors forliquids and gases inhealthcare applications - Part20: Common test methods | Same |
| Sterilization | EO | EO | EO | Same |
| SAL | 10-6 | 10-6 | 10-6 | Same |
| Pyrogen | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Same |
| Biocompatibility | The biocompatibilityevaluation for the subjectdevice was conductedin accordance with theInternational Standard ISO10993-1 "BiologicalEvaluation of MedicalDevices - Part 1: Evaluationand Testing Within a RiskManagement Process” as | The biocompatibilityevaluation for the subjectdevice was conductedin accordance with theInternational Standard ISO10993-1 "BiologicalEvaluation of Medical Devices- Part 1: Evaluation andTesting Within a RiskManagement Process” as | The biocompatibilityevaluation for the subjectdevice was conductedin accordance with theInternational Standard ISO10993-1 "BiologicalEvaluation of MedicalDevices - Part 1: Evaluationand Testing Within a RiskManagement Process” as | Different.Analysis 4. |
| Labeling | recognized by FDA and the"Use of InternationalStandard ISO 10993-1"Biological evaluation ofmedical devices- Part 1:Evaluation and testingwithin a risk managementprocess", June 16, 2016.The Sterile HypodermicNeedle for Single Use oftesting included following:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the abovetesting items meets therequirementsAnd Conforms to USP<788>: Particulate Matterfor injection | recognized by FDA and the"Use of International StandardISO 10993-1 "Biologicalevaluation of medical devices-Part 1: Evaluation and testingwithin a risk managementprocess", June 16, 2016.The syringe of testingincluded the following tests:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the abovetesting items meets therequirements | recognized by FDA and the"Use of InternationalStandard ISO 10993-1"Biological evaluation ofmedical devices- Part 1:Evaluation and testingwithin a risk managementprocess", June 16, 2016.The Sterile HypodermicNeedle for Single Use oftesting included following:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the abovetesting items meets therequirementsAnd Conforms to USP <788>:Particulate Matter for injection | |
| Meets the requirements of21 CFR Part 801. | Meets the requirements of 21CFR Part 801. | Meets the requirements of 21CFR Part 801. | Same |
Table 19-2 Comparison of Technology Characteristics
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SE Analysis 1: Needle gauge
The subject device has additional needle gauge sizes(31-34) compared with predicate device(K180417), so add the secondary predicate(223334) to cover the smaller 31G-34G sizes. However, the all needle gauge(14G-34G) has been registered in FDA. And the proposed needles were tested in accordance with ISO 7864 and ISO 9626 and all test results meet the acceptance criteria per the standards. Therefore, this difference does not raise new or different questions of safety or effectiveness.
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SE Analysis 2: Needle length
The subject device has different needle lengths compared with two predicate devices, but the needles were tested in accordance with ISO 7864 and ISO 9626 including the needle length, outer diameter and inner diameter, and all test results meet the acceptance criteria per the standards. Therefore, this difference does not raise new or different questions of safety or effectiveness.
SE Analysis 3: Main Structure
The proposed device and predicate device were both have protective cap to prevent needle sharpness, but the proposed device have another cap which is butt-end lower protective and assembled with upper needle protective cap sealing with a sticker as the sterile barrier to keep product sterility. Howeve, the main structure still same as predicate device. Therefore, this different is not considered to affect the Substantially Equivalency (SE) between the proposed and predicate devices.
SE Analysis 4: Biocompatibility
The proposed device and the two predicate devices all were tested per the ISO 10993-series. The proposed device also tested particulates per USP <788>. Particulate testing per USP <788> is required to ensure the safe clinical application. Therefore, this difference is not considered to affect the Substantially Equivalency (SE) between the proposed and predicate devices.
9. Non-clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
-
ISO 9626:2016 Hypodermic needles for single use - Colour coding for identification
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ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare application --
Part 7: Connectors for intravascular or hypodermic application
A ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
A ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
A USP <788>: Particulate Matter for injection
ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials.(Sterility)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical A Package by Dye Penetration
10. Clinical Testing
No clinical study is included in this submission.
11. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Sterile Hypodermic Needles for Single Use is substantially equivalent to the Sterile Hypodermic Needles for Single Use (K180417, K223334) with respect to the indications for use, materials, design, and technological characteristics.
§ 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).