(152 days)
No
The device description and intended use are purely mechanical, focusing on a safety mechanism for a needle and syringe. There is no mention of any computational or analytical capabilities that would suggest AI/ML.
No
The device is a Hypodermic Safety Needle with Syringe, intended for the aspiration and injection of fluids and to prevent accidental needle sticks. It does not exert any therapeutic effect on the body but rather serves as a delivery or collection tool.
No
The device is intended for the aspiration and injection of fluids, and for the prevention of needlestick injuries. It does not perform any diagnostic function.
No
The device description explicitly lists physical components like a needle cap, needle tube, safety shield, needle hub, barrel, plunger, and plunger stopper, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "aspiration and injection of fluids for medical purpose" and to "minimize risk of accidental needle sticks." This describes a device used for administering or withdrawing substances directly from the body, not for testing samples in vitro (outside the body).
- Device Description: The description details the components of a syringe and needle, which are instruments used for direct interaction with the body. It also mentions subcutaneous, intramuscular, and intravenous injection and blood withdrawal, all of which are in vivo procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing biological specimens in vitro.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MEG, FMF, FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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
Biocompatibility: There was no change in the device components, which are subject to biocompatibility testing. Therefore no biocompatibility testing was performed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Medical |
| Manufacturer Co., Ltd. | |
| No. 2 Guanyin Road, Economic | |
| Development 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 Needle |
| Hypodermic Safety Needle with | |
| Syringe | |
| Common Name(s): | syringe, antistick |
| syringe, piston | |
| needle, hypodermic, single lumen | |
| Regulation Name(s): | Hypodermic single lumen needle |
| Piston syringe | |
| Regulation Number(s): | 21CFR880.5570 |
| 21CFR880.5860 | |
| Product Code: | MEG |
| FMI | |
| FMF | |
| Device Class: | Class II |
| Predicate Device: | K190183 |
| Anhui Hongyu Wuzhou | |
| Medical Manufacturer Co., Ltd. |
4
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 | Material
Specification | Manufacturers |
|--------------------|-------------------------|---------------------------|---------------------------------------------------|
| Needle
cap | PP | 1100N | Advanced Petrochemical
Company |
| Needle
tube | Stainless
Steel | SUS304 | Zhangjiagang Puxiang
Stainless Steel Co., Ltd. |
| Needle
hub | PP | 1100N | Advanced Petrochemical
Company |
| Safety
shield | PP | 1100N | Advanced Petrochemical
Company |
| Barrel | PP | R3260T | Zhejiang Hongji Petrochemical
Co., LTD. |
| Plunger
stopper | Rubber
Piston | / | Changzhou Huawei Medical
Supplies Co., Ltd |
| Plunger | PP | 1100N | Advanced Petrochemical
Company |
| Colorant-
green | PP green
Masterbatch | 2893657 | Seyuan technology (Suzhou)
Co., Ltd. |
5
| Name | Material | Material
Specification | Manufacturers |
|----------------------------|------------------------------------|----------------------------|-------------------------------------------------------|
| Colorant-black | PP Black
Masterbatch | PLK 001 Med3 | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-blue | PP Blue
Masterbatch | BLU 001 Med3 | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-brown | PP Brown
Masterbatch | Brown P608397BN | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-cream | PP Yellow
Masterbatch | Cream P608369GN | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-medium grey | PP Medium
grey
Masterbatch | Medium grey | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-medium purple | PP Medium
purple
Masterbatch | Medium purple
P608366PL | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-Orange | PP Orange
Masterbatch | Orange P608370-
10G | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-Pink | PP R3260T | Pink P608536
(197C) | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-Red | PP Red
Masterbatch | Red P608539
(198C) | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Colorant-Yellow | PP Yellow
Masterbatch | Yellow P608368YL | Anhui Jingwei Medical
Materials Technology Co. LTD |
| Ink | Organic
chemical ink | HBL-100 709-V
Black | Hangzhou Hengji ink coating
co., Ltd. |
| Lubricant
of
syringe | Silicone oil
for syringe | Polydimethylsiloxane | Wuhan WuZhao Chemical
Industry Limited Company |
| Lubricant
of needle | Silicone oil
for needles | Polydimethylsiloxane | Wuhan WuZhao Chemical
Industry Limited Company |
| Adhesive | Epoxy
Resin | ZS-H-623 | Dongguan zhisheng industrial
co., Ltd. |
Patient contact classification: External Communicating Device - Blood Path, Indirect -Prolonged Contact Duration (24 hours -30 days).
6
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.
7
| Item | Subject Device | Predicate Device | Reference Device | Discussion |
|---|---|---|---|---|
| 510(k) | K211555 | K190183 | K060211 | |
| 510K Owner | Anhui Hongyu Wuzhou Medical | |||
| Manufacturer Co., Ltd. | Anhui Hongyu Wuzhou Medical | |||
| Manufacturer Co., Ltd. | Anhui Hongyu Wuzhou Medical | |||
| Manufacturer Co., Ltd. (currently) | ||||
| Name | Hypodermic Safety Needle with/without | |||
| Syringe | Hypodermic Safety Needle | |||
| with/without Syringe | Wuzhou Syringe with/without Needle | |||
| Product code | MEG, FMF, FMI | MEG, FMF, FMI | FMF, FMI | |
| Indication 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. | 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. | The Wuzhou Syringe, with/without | |||
| needle for single use only, is intended | ||||
| to be used for medical purposes to | ||||
| inject fluids into or withdraw fluids | ||||
| from the body. | Identical to the | |||
| predicate device | ||||
| (No change) | ||||
| Item | Subject Device | Predicate Device | Reference Device | Discussion |
| Safety feature | The attached needle safety shield can be | |||
| manually activated to cover the needle | ||||
| immediately after use | The attached needle safety shield | |||
| can be manually activated to cover | ||||
| the needle immediately after use | There is no safety shield. | Identical to the | ||
| predicate device | ||||
| (No change) | ||||
| Operation Mode | Manual use only | Manual use only | Manual use only | Identical (No |
| change) | ||||
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Identical (No |
| change) | ||||
| Material | PP, Stainless Steel, Rubber Piston | PP, Stainless Steel, Rubber Piston | PP, Stainless Steel, Rubber Piston | Identical (No |
| change) | ||||
| Operation Mode | Manual Use | Manual Use | Manual Use | Identical (No |
| change) | ||||
| Performance | Complied with the current applicable | |||
| performance standards: |
- ISO 9626
- ISO 7864
- ISO 594-1
- ISO 594-2
- ISO 23908
- ISO 7886-1 | Complied with the current applicable
performance standards: - ISO 9626
- ISO 7864
- ISO 594-1
- ISO 594-2
- ISO 23908
- ISO 7886-1 | Complied with the current applicable
performance standards: - ISO 9626
- ISO 7864
- ISO 594-1
- ISO 594-2
- ISO 7886-1 | Identical to the
predicate 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 Patient
Use | Yes | Yes | Yes | Identical (No
change) |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Identical (No
change) |
| How Supplied | Sterile
Single Patient Use | Sterile
Single Patient Use | Sterile
Single Patient Use | Identical (No
change) |
| Method of
Sterilization | EO | EO | EO | Identical (No
change) |
| SAL | 10-6 | 10-6 | 10-6 | Identical (No
change) |
8
9
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.
10
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
11
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 (