(152 days)
Hypodermic Safety Needle with Syringe: The Hypodermic Safety Needle with Syringe is intended for use in the aspiration and injection of fluids for medical purpose. 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 sticks.
Hypodermic Safety Needle: The Hypodermic Safety Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. 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 needlestick.
The device is used for subcutaneous injection, intramuscular injection, intravenous injection of blood, and preparation of liquid medicine. The needle tube will be pushed into the safety cap after use. It is designed to aid in the prevention of needlestick injuries.
The device is a disposable anti-needle stick syringe made of the following components: Needle cap, Needle tube, Safety shield, Needle hub, Barrel, Plunger, Plunger stopper.
This document describes the premarket notification (510(k)) for the Hypodermic Safety Needle and Hypodermic Safety Needle with Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the way an AI/ML device would.
However, I can extract the information you've requested based on the regulatory submission's approach to performance and safety, interpreting the "acceptance criteria" as compliance with relevant international standards and the "study" as the non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | Meets all performance standards |
| ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods | Meets all performance standards |
| ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods | Meets all performance standards |
| ISO 594-1: Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 1: General requirements | Meets all performance standards |
| ISO 594-2: Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 2: Lock fittings | Meets all performance standards |
| ISO 23908: Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling | Meets all performance standards |
| ISO 6009: Hypodermic needles for single use - Color coding for identification | Meets all performance standards |
| ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Biocompatibility) | Conforms to ISO 10993-1 (No new testing performed as components unchanged) |
| ISO 11135:2014: Sterilization of health care products - Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices | Conforms to ISO 11135:2014 (No new testing performed as sterilization process unchanged) |
| AAMI TIR28:2016: Product adoption and process equivalence for ethylene oxide sterilization | Conforms to AAMI TIR28:2016 (No new testing performed as sterilization process unchanged) |
| Sterility Assurance Level (SAL) | 10^-6 |
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 performance testing. The "data provenance" for non-clinical performance testing would typically be from in-house or contracted laboratory testing conducted by the manufacturer (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. in China). These are prospective tests designed to show compliance with the standards.
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 is not applicable to this type of device submission. The "ground truth" for these tests are the objective technical requirements and measurement methods defined by the international ISO standards. Compliance is determined by whether the device's measured performance falls within the specified limits of these standards, not by expert consensus on clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of device performance testing does not involve human adjudication in the way clinical diagnostic studies do. Compliance against standards is an objective measurement.
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 a conventional medical device (safety needle/syringe), not an AI/ML diagnostic or assistive device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a conventional physical medical device, not an algorithm or software. No standalone performance testing in this context was performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the objective technical requirements and test methods defined by recognized international standards (ISO standards). Device performance is measured against these established, quantitative benchmarks.
8. The sample size for the training set
Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a conventional medical device, not an AI/ML device.
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October 18, 2021
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd Charles Mack Principal Engineer 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K211555
Trade/Device Name: Hypodermic Safety Needle: Hypodermic Safety Needle with Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Dated: August 13, 2021 Received: August 18, 2021
Dear Charles Mack:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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,
CAPT Alan M. 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)
Device Name Hypodermic Safety Needle Hypodermic Safety Needle with Syringe
Indications for Use (Describe)
Hypodermic Safety Needle with Syringe
The Hypodermic Safety Needle with Syringe is intended for use in the aspiration and injection of fluids for medical purpose. 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 sticks.
Hypodermic Safety Needle
The Hypodermic Safety Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. 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 needlestick.
| 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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Image /page/3/Picture/0 description: The image shows the logo of Anhui Hongyu Wuzhou Medical Manufacturer Co., LTD. The logo consists of a stylized "im" in red and blue, with a plus sign above the "i". To the right of the logo is the company name in Chinese and English. The English name is "ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD".
K211555 510(k) SUMMARY
| Preparation Date: | August 25, 2020 |
|---|---|
| Manufacturer's Name and Address: | Anhui Hongyu Wuzhou MedicalManufacturer Co., Ltd.No. 2 Guanyin Road, EconomicDevelopment Zone, Taihu, Anqing City,Anhui Province, China 246400 |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Hypodermic Safety NeedleHypodermic Safety Needle withSyringe |
| Common Name(s): | syringe, antisticksyringe, pistonneedle, hypodermic, single lumen |
| Regulation Name(s): | Hypodermic single lumen needlePiston syringe |
| Regulation Number(s): | 21CFR880.557021CFR880.5860 |
| Product Code: | MEGFMIFMF |
| Device Class: | Class II |
| Predicate Device: | K190183Anhui Hongyu WuzhouMedical Manufacturer Co., Ltd. |
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Device Description:
The device is used for subcutaneous injection, intramuscular injection, intravenous injection of blood, and preparation of liquid medicine. The needle tube will be pushed into the safety cap after use. It is designed to aid in the prevention of needlestick injuries.
The device is a disposable anti-needle stick syringe made of the following components:
-
- Needle cap: Covers the needle tube until the syringe is to be used.
-
- Needle tube: The needle tube penetrates the patient's skin to inject/withdraw fluid from the body.
-
- Safety shield: It is connected to the needle hub. The needle will be pushed into a safety shield after use, and it is designed to aid in the prevention of needlestick injuries. It is colored to distinguish the gauge of the needle.
-
- Needle hub: The needle hub is connected to the syringe by a 6% luer connector, and it is colored to distinguish the gauge of the needle.
-
- Barrel: The barrel has a scale showing the capacity of the syringe. It is connected to the Hypodermic Safety Needle by a 6% luer connector.
-
- Plunger: Assembled with the plunger stopper to inject/withdraw fluid from the body.
-
- Plunger stopper: Sealing when injecting/withdrawing fluid from the body.
| Name | Material | MaterialSpecification | Manufacturers |
|---|---|---|---|
| Needlecap | PP | 1100N | Advanced PetrochemicalCompany |
| Needletube | StainlessSteel | SUS304 | Zhangjiagang PuxiangStainless Steel Co., Ltd. |
| Needlehub | PP | 1100N | Advanced PetrochemicalCompany |
| Safetyshield | PP | 1100N | Advanced PetrochemicalCompany |
| Barrel | PP | R3260T | Zhejiang Hongji PetrochemicalCo., LTD. |
| Plungerstopper | RubberPiston | / | Changzhou Huawei MedicalSupplies Co., Ltd |
| Plunger | PP | 1100N | Advanced PetrochemicalCompany |
| Colorant-green | PP greenMasterbatch | 2893657 | Seyuan technology (Suzhou)Co., Ltd. |
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| Name | Material | MaterialSpecification | Manufacturers |
|---|---|---|---|
| Colorant-black | PP BlackMasterbatch | PLK 001 Med3 | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-blue | PP BlueMasterbatch | BLU 001 Med3 | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-brown | PP BrownMasterbatch | Brown P608397BN | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-cream | PP YellowMasterbatch | Cream P608369GN | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-medium grey | PP MediumgreyMasterbatch | Medium grey | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-medium purple | PP MediumpurpleMasterbatch | Medium purpleP608366PL | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-Orange | PP OrangeMasterbatch | Orange P608370-10G | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-Pink | PP R3260T | Pink P608536(197C) | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-Red | PP RedMasterbatch | Red P608539(198C) | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Colorant-Yellow | PP YellowMasterbatch | Yellow P608368YL | Anhui Jingwei MedicalMaterials Technology Co. LTD |
| Ink | Organicchemical ink | HBL-100 709-VBlack | Hangzhou Hengji ink coatingco., Ltd. |
| Lubricantofsyringe | Silicone oilfor syringe | Polydimethylsiloxane | Wuhan WuZhao ChemicalIndustry Limited Company |
| Lubricantof needle | Silicone oilfor needles | Polydimethylsiloxane | Wuhan WuZhao ChemicalIndustry Limited Company |
| Adhesive | EpoxyResin | ZS-H-623 | Dongguan zhisheng industrialco., Ltd. |
Patient contact classification: External Communicating Device - Blood Path, Indirect -Prolonged Contact Duration (24 hours -30 days).
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Intended Use / Indications for Use
Hypodermic Safety Needle
The Hypodermic Safety Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. 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 needlestick.
Hypodermic Safety Needle with Syringe
The Hypodermic Safety Needle with Syringe is intended for use in the aspiration and injection of fluids for medical purpose. 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 sticks.
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| Item | Subject Device | Predicate Device | Reference Device | Discussion |
|---|---|---|---|---|
| 510(k) | K211555 | K190183 | K060211 | |
| 510K Owner | Anhui Hongyu Wuzhou MedicalManufacturer Co., Ltd. | Anhui Hongyu Wuzhou MedicalManufacturer Co., Ltd. | Anhui Hongyu Wuzhou MedicalManufacturer Co., Ltd. (currently) | |
| Name | Hypodermic Safety Needle with/withoutSyringe | Hypodermic Safety Needlewith/without Syringe | Wuzhou Syringe with/without Needle | |
| Product code | MEG, FMF, FMI | MEG, FMF, FMI | FMF, FMI | |
| Indication forUse | Hypodermic Safety NeedleThe Hypodermic Safety Needle isintended to be used with a luer locksyringe for aspiration and injection offluids for medical purpose. Afterwithdrawal of the needle from the body,the attached needle safety shield can bemanually activated to cover the needleimmediately after use to minimize risk ofaccidental needlestick.Hypodermic Safety Needle withSyringeThe Hypodermic Safety Needle withSyringe is intended for use in theaspiration and injection of fluids formedical purpose. After withdrawal of theneedle from the body, the attachedneedle safety shield can be manuallyactivated to cover the needle immediatelyafter use to minimize risk of accidentalneedle sticks. | Hypodermic Safety NeedleThe Hypodermic Safety Needle isintended to be used with a luer locksyringe for aspiration and injection offluids for medical purpose. Afterwithdrawal of the needle from thebody, the attached needle safetyshield can be manually activated tocover the needle immediately afteruse to minimize risk of accidentalneedlestick.Hypodermic Safety Needle withSyringeThe Hypodermic Safety Needle withSyringe is intended for use in theaspiration and injection of fluids formedical purpose. After withdrawal ofthe needle from the body, theattached needle safety shield can bemanually activated to cover theneedle immediately after use tominimize risk of accidental needlesticks. | The Wuzhou Syringe, with/withoutneedle for single use only, is intendedto be used for medical purposes toinject fluids into or withdraw fluidsfrom the body. | Identical to thepredicate device(No change) |
| Item | Subject Device | Predicate Device | Reference Device | Discussion |
| Safety feature | The attached needle safety shield can bemanually activated to cover the needleimmediately after use | The attached needle safety shieldcan be manually activated to coverthe needle immediately after use | There is no safety shield. | Identical to thepredicate device(No change) |
| Operation Mode | Manual use only | Manual use only | Manual use only | Identical (Nochange) |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Identical (Nochange) |
| Material | PP, Stainless Steel, Rubber Piston | PP, Stainless Steel, Rubber Piston | PP, Stainless Steel, Rubber Piston | Identical (Nochange) |
| Operation Mode | Manual Use | Manual Use | Manual Use | Identical (Nochange) |
| Performance | Complied with the current applicableperformance standards:- ISO 9626- ISO 7864- ISO 594-1- ISO 594-2- ISO 23908- ISO 7886-1 | Complied with the current applicableperformance standards:- ISO 9626- ISO 7864- ISO 594-1- ISO 594-2- ISO 23908- ISO 7886-1 | Complied with the current applicableperformance standards:- ISO 9626- ISO 7864- ISO 594-1- ISO 594-2- ISO 7886-1 | Identical to thepredicate device(No change) |
| Needle Length | 1/6" ~ 1 1/2" | 21 G x 1 1/2" | 1/6" ~ 1 1/2" | Note 1 |
| Syringe Volume | 1,2,3,5,10,20,30,50,60,100 ml | 5ml | 1,2, 5,10,20,30,60,100 ml | Note 2 |
| Needle Gauge | 18,19,20,21,22,23,24,25,26,27,28,29,30G | 21G | 16,18,20,21,22,23,24,25,26G | Note 3 |
| Needle Hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Note 4 |
| Single PatientUse | Yes | Yes | Yes | Identical (Nochange) |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Identical (Nochange) |
| How Supplied | SterileSingle Patient Use | SterileSingle Patient Use | SterileSingle Patient Use | Identical (Nochange) |
| Method ofSterilization | EO | EO | EO | Identical (Nochange) |
| SAL | 10-6 | 10-6 | 10-6 | Identical (Nochange) |
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Note 1: Needle Length
The needle length of the subject devices is available in more sizes than the predicate device, but they conform to the same applicable performance standards as the predicate device. The difference does not raise new questions of safety and effectiveness.
Note 2: Syringe Volume
The subject devices' syringe volume is different than the predicate device and still conforms to the same applicable performance standards. The difference does not raise new questions of safety and effectiveness.
Note 3: Needle Gauge
The needle gauge of the subject devices has a wider range compared to the predicate device. However, the performance of the needle has been evaluated, and test results demonstrated complicable performance standards. The difference does not raise new questions on the safety and effectiveness of the proposed device.
Note 4: Needle Hub
The needle hub material of the subject device and predicate device all conform to ISO 6009 and ISO10993.
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Performance Testing
Performance testing was provided to support the substantial equivalence determination and validate and verify that the Hypodermic Safety Needle with/without Syringe met all requirements of related international standards, including biocompatibility, sterility, and product specifications. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing
Performance Testing
For Hypodermic Safety Needle with/without Syringe, it meets all performance standards:
- -ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
- ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use - Requirements and test methods
- -ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 1: General requirements
- ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 2: Lock fittings
- ISO 23908 First edition 2011-06-11 Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling
- -ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use -Color coding for identification
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Biocompatibility
There was no change in the device components, which are subject to biocompatibility testing. Therefore no biocompatibility testing was performed. Patient contact classification: externally communicating devices, contact circulating blood for limited contact (<24 h) duration. This remains the same classification as the initial submission.
Sterility Information
There was no change in the sterilization process or materials involved with the sterilization, packaging materials, or product materials. The product adoption was done in accordance with ISO 11135:2014 Sterilization of health care products -Ethylene oxide – Requirements for development, validation and routine control of a sterilization process for medical devices and AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization.
Clinical Test:
No clinical study is included in this submission.
Conclusions:
Based on the verification test results, the subject devices conform to the same applicable standards requirements such as performance, biocompatibility, and sterilization as the predicate device. The subject device uses the same fundamental scientific technology, same indications for use, same safety feature, the same method of sterilization, and the same shelf life and packaging. The differences do not raise new questions of safety and effectiveness, and the devices are substantially equivalent to the predicate.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).