(253 days)
Not Found
No
The device description and performance testing focus on mechanical and material properties of syringes and needles, with no mention of AI or ML.
No
The devices are intended for aspiration and injection of fluids, and needle safety. They are not described as providing therapy or treatment.
No.
The devices described are syringes and needles used for aspiration and injection of fluids, which are fluid delivery devices, not diagnostic devices.
No
The device description and performance studies clearly indicate that this submission is for physical medical devices (needles and syringes) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of all the listed devices (safety needles, sterile syringes, sterile syringes with safety needles, sterile syringes with needles, and hypodermic needles) is for the aspiration and injection of fluids for medical purposes. This involves introducing or withdrawing substances from the body, which is a direct medical procedure performed on a patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro) to provide information about a patient's health.
- Device Description: The device descriptions detail the physical components and function of needles and syringes, which are tools for administering or collecting substances from the body, not for analyzing samples in a laboratory setting.
- Performance Studies: The performance studies focus on the physical and biological properties of the needles and syringes (biocompatibility, dimensions, strength, leakage, etc.) and the functionality of the safety features. These are relevant to the safe and effective use of these devices for aspiration and injection, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of any components, reagents, or processes related to analyzing biological samples for diagnostic purposes.
In summary, the devices described are medical devices used for direct patient care (aspiration and injection), not for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Safety Needles
The safety needles are intended to be used with a luer slip or 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.
Sterile Syringe
The sterile syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Syringe with Safety Needle
The sterile syringe with safety needle is intended for use in the aspiration 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.
Sterile Syringe with Needle
The sterile syringe with needle is intended for use the aspiration of fluids for medical purpose.
Hypodermic Needles for Single Use
The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration of fluids for medical purpose.
Product codes (comma separated list FDA assigned to the subject device)
MEG, FMF, FMI
Device Description
(1)Safety Needles
The Safety Needles are intended for manual and single use only. They consist of a needle cap, needle tube and hub with protector. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
(2)Sterile Syringe
The Sterile Syringe is intended for manual and single use only. It consists of a Barrel, Plunger, and Piston. The syringes are available with luer slip and luer lock connector types and are available in different sizes. They are intended to be connected to a safety/hypodermic needle.
(3)Sterile Syringe with Safety Needle
This product is intended for manual and single use only. The Sterile Syringe with Safety Needle consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
(4)Sterile Syringe with Needle
The Sterile Syringe with Needle is intended for manual and single use only. It consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes.
(5)Hypodermic Needles for Single Use
The Hypodermic Needle is intended for manual and single use only. It consists of a hub, needle tube, needle cap. The proposed device is compatible for use with a luer slip or luer lock syringe.
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
Not Found
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)
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
- Biocompatibility:
Needle: Externally communicating, blood path indirect with limited patient contact
Syringe: Externally communicating, blood path indirect with prolonged patient contact
Testing according to:
- ANSI AAMI ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices Part ● 5: Tests For In Vitro Cytotoxicity;
- ANSI AAMI ISO 10993-10:2010/(R)2014. Biological Evaluation Of Medical Devices Part ● 10: Tests For Irritation And Skin Sensitization;
- ANSI AAMI ISO 10993-11:2006/(R)2010, Biological Evaluation Of Medical Devices Part ● 11: Tests For Systemic Toxicity;
- . ISO 10993-4:Third Edition 2017-04, Biological Evaluation Of Medical Devices--Part 4: Selection Of Tests For Interactions With Blood;
- ASTM F756-17, Standard Practice For Assessment Of Hemolytic Properties Of Materials.
- Performance testing according to ISO 7864 Fourth Edition 2016-08-01, Sterile Hypodermic Needles For Single Use - Requirements And Test Methods:
- Cleanliness ●
- Limits for acidity or alkalinity ●
- Limits for extractable metals ●
- Color coding ●
- Conical fitting ●
- Color of hub
- Needle cap ●
- Tolerances on length
- Freedom from defects
- Lubricant ●
- Needle point ●
- Bond between hub and needle tube
- Patency of lumen
- Sharps injury protection
- Performance testing according to ISO 7886-1 Second Edition 2017-05, Sterile Hypodermic Syringes For Single Use - Part 1: Syringes For Manual Use:
- Limits for acidity or alkalinity .
- Limits for extractable metals ●
- Lubricant ●
- Tolerance on graduated capacity ●
- Scale ●
- Numbering of scales
- Overall length of scale to nominal capacity line ●
- . Position of scale
- Barrel flanges
- Minimum length between barrel flanges and plunger push-button
- Conical fitting
- Position of nozzle on end of barrel
- Nozzle lumen
- Dead space
- Freedom from air and liquid leakage past plunger stopper
- Force to operate the position
- Fit of plunger stopper/plunger in barrel ●
- Performance testing according to ISO 80369-7 First Edition 2016-10-15, Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular Or Hypodermic Applications:
- Leakage by pressure decay
- Positive pressure liquid leakage ●
- Sub-atmospheric pressure air leakage ●
- Stress cracking
- Resistance to separation from axial load ●
- Resistance to unscrewing ●
- Resistance to overriding
- Performance testing according to ISO 9626 Second Edition 2016-08-01, Stainless Steel Needle Tubing For The Manufacture Of Medical Devices - Requirements And Test Methods:
- . Dimensions
- Stiffness ●
- Resistance to breakage ●
- Resistance to corrosion ●
- Additional Performance testing for the Safety Needles/ Sterile Syringe/Sterile Syringe with Safety Needle/Sterile Syringe with Needle/Hypodermic Needle for Single Use:
- Conical fitting to ISO 80369-7 ●
- Sharps Injury Protection Test Report to ISO 23908:2011 ●
- Particulate Testing per USP
The subject and predicate device have similar technological characteristics, are provided sterile, and are intended for single use. Differences in configurations and sizes have been evaluated by non-clinical bench testing per ISO 7864, ISO 9626, ISO 7886 and ISO 80369-7. Furthermore, both devices were tested for biocompatibility per ISO 10993-1. Hence, we conclude that the subject device was demonstrated to be substantially equivalent to the predicate device.
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.
Not Found
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 ADMINISTRATION" in blue text.
September 6, 2019
Jiangsu Micsafe Medical Technology Co., Ltd. Tony Yang General Manager Xituan Industrial Park, Dafeng District Yancheng, 224125 Cn
Re: K183665
Trade/Device Name: Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Dated: July 30, 2019 Received: July 30, 2019
Dear Tony Yang:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For CAPT Alan 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) K183665
Device Name
Safety Needles, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
Indications for Use (Describe)
Safety Needles
The safety needles are intended to be used with a luer slip or 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.
Sterile Syringe
The sterile syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Syringe with Safety Needle
The sterile syringe with safety needle is intended for use in the aspiration 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.
Sterile Syringe with Needle
The sterile syringe with needle is intended for use the aspiration of fluids for medical purpose.
Hypodermic Needles for Single Use
The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration of fluids for medical purpose.
| 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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Image /page/3/Picture/1 description: The image contains the logo for Micsafe med. The logo consists of a red and blue square symbol to the left of the text "Micsafe" in a bold, sans-serif font. Below "Micsafe" is the word "med" in a smaller font size.
510(k) Summary (K183665)
Submitter Information
Company: Jiangsu Micsafe Medical Technology Co., Ltd. Address: Xituan Industrial Park, Dafeng District, Yancheng City, Jiangsu Province, 224125, China Phone: 086-13651929266 Contact: Tony Yang, General Manager Date: Sept 3, 2018
Device Information
Trade/Device Name: Safety Needles Sterile Syringe Sterile Syringe with Safety Needle Sterile Syringe with Needle Hypodermic Needle for Single Use
Classification: Class II Regulation Number: 880.5860 Regulation Name: Piston syringe Product Code(s): MEG, FMF, FMI
Common Name(s):Syringe, Antistick Syringe, Piston Needle, Hypodermic, Single Lumen
Type of use: Prescription use only
Predicate Device: Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (K170651)
Device Description
(1)Safety Needles
The Safety Needles are intended for manual and single use only. They consist of a needle cap, needle tube and hub with protector. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
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Image /page/4/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square design on the left, followed by the word "Micsafe" in black, and the word "med" in smaller black font below the "safe" portion of the word. The red and blue square design is made up of four squares, with the top two squares being red and the bottom two squares being blue.
(2)Sterile Syringe
The Sterile Syringe is intended for manual and single use only. It consists of a Barrel, Plunger, and Piston. The syringes are available with luer slip and luer lock connector types and are available in different sizes. They are intended to be connected to a safety/hypodermic needle.
(3)Sterile Syringe with Safety Needle
This product is intended for manual and single use only. The Sterile Syringe with Safety Needle consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
(4)Sterile Syringe with Needle
The Sterile Syringe with Needle is intended for manual and single use only. It consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes.
(5)Hypodermic Needles for Single Use
The Hypodermic Needle is intended for manual and single use only. It consists of a hub, needle tube, needle cap. The proposed device is compatible for use with a luer slip or luer lock syringe.
| (1)Safety Needles | |
|---|---|
| 18G; 20G; 21G; 22G; 23G; 25G; 26G | |
| (2)Sterile Syringe | |
| Luer Slip | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml |
| Luer Slip Eccentric | 20ml, 30ml, 50ml |
| Luer Lock | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml |
| (3)Sterile Syringe with Safety Needle | |
| Luer Slip | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml |
| Luer Slip Eccentric | 20ml, 30ml, 50ml |
| Luer Lock | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml |
| Needle Size:18G; 20G; 21G; 22G; 23G; 25G; 26G | |
| (4)Sterile Syringe with Needle | |
| Luer Slip | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml |
| Luer Slip Eccentric | 20ml, 30ml, 50ml |
| Luer Lock | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml |
| Needle Size:18G ; 19G; 20G; 21G; 22G; 23G; 24G; 25G; 26G; 27G; 28G; | |
| 29G; 30G; 31G |
Configurations and Sizes
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Image /page/5/Picture/1 description: The image shows the logo for MicSafe med. The logo consists of a square divided into four smaller squares, with the top two squares in red and the bottom two squares in blue. To the right of the square is the text "MicSafe" in black, with a red dot over the "i". Below "MicSafe" is the text "med" in black.
(5)Hypodermic Needles for Single Use
18G; 19G; 20G; 21G; 22G; 23G; 24G; 25G; 26G; 27G; 28G; 29G; 30G; 31G
Needle lengths
| Safety Needle | ||||||
|---|---|---|---|---|---|---|
| 1/2" | 3/4" | 1" | 1 1/4" | 1 1/2" | 2" | |
| 18G | • | • | • | • | • | • |
| 20G | • | • | • | • | • | • |
| 21G | • | • | • | • | • | • |
| 22G | • | • | • | • | • | • |
| 23G | • | • | • | • | • | |
| 25G | • | • | • | |||
| 26G | • | • |
| Hypodermic Needles for Single Use | |||||||
|---|---|---|---|---|---|---|---|
| 1/2" | 5/8" | 3/4" | 1" | 1 1/4" | 1 1/2" | 2" | |
| 18G | • | • | • | • | • | • | |
| 19G | • | • | • | • | • | • | |
| 20G | • | • | • | • | • | • | |
| 21G | • | • | • | • | • | • | |
| 22G | • | • | • | • | • | • | |
| 23G | • | • | • | • | • | • | |
| 24G | • | • | • | • | • | • | |
| 25G | • | • | • | • | |||
| 26G | • | • | • | • | |||
| 27G | • | • | • | • | |||
| 28G | • | • | • | • | |||
| 29G | • | • | • | • | |||
| 30G | • | • | • | • | |||
| 31G | • | • | • | • |
Indications for Use
(1)Safety Needles
The safety needles are intended to be used with a luer slip or 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.
(2)Sterile Syringe
The sterile syringe is a sterile luer lock or luer slip syringe which is intended to be used with a
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Image /page/6/Picture/1 description: The image contains the logo for "Micsafe med". The logo consists of a red and blue square design on the left, followed by the word "Micsafe" in bold, black letters. Below "Micsafe" is the word "med" in a smaller font size, also in black.
hypodermic needle for the aspiration and injection of fluids for medical purpose.
(3)Sterile Syringe with Safety Needle
The sterile syringe with safety needle 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.
(4)Sterile Syringe with Needle
The sterile syringe with needle is intended for use the aspiration and injection of fluids for medical purpose.
(5)Hypodermic Needles for Single Use
The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.
| Comparison
| Items | Subject Device (K183665) | Predicate Device (K170651) |
|---|---|---|
| Identification | Safety needle for single use | The sterile disposable safety needle- |
| K170651 | ||
| Classification | Product Code: FMI Class: 2 | Product Code: MEG,FMF,FMI |
| Class: 2 | ||
| Intended Use | The safety needles are intended to be used with a luer slip or 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 sterile disposable safety needle is intended to be used with a luer slip or 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 needestick. |
| Configurations | ||
| and Materials | Needle cap (Polypropylene) | |
| Needle tube (SUS304) | Needle cap(Polypropylene) | |
| Needle tube (SUS304) | ||
| Comparison | ||
| Items | Subject Device (K183665) | Predicate Device (K170651) |
| Hub with protector | ||
| (Polypropylene) | Needle hub with safety | |
| sheath(Polypropylene) | ||
| Size | 18G, 20G, 21G, 22G, 23G, 25G, | |
| and 26G | ||
| Needle length: | ||
| 1/2"-2" | 16G, 18G, 19G, 20G, 21G, 22G, 23G, | |
| 24G, 25G, 26G, 27G, 28G, 29G, and 30G | ||
| Needle length: | ||
| 5/16"-1 1/2" | ||
| Sterile | Yes (EO) | Yes (EO) |
| Single Use | Yes | Yes |
| Biocompatibility | Conforms to the requirement of | |
| ISO 10993 series Standards | ||
| No Cytotoxicity | ||
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | ||
| No systemic toxicity | ||
| No Hemolysis | ||
| Non pyrogenic | Conforms to the requirement of ISO | |
| 10993 series Standards | ||
| No Cytotoxicity | ||
| No Irritation to Skin | ||
| No significant evidence of sensitization | ||
| No systemic toxicity | ||
| No Hemolysis | ||
| Non pyrogenic | ||
| Performance | ||
| safety & | ||
| effectiveness | Conforms with the requirements | |
| of ISO 7864 and ISO 9626. | ||
| Needle Safety Feature: Testing | ||
| conducted per ISO 23908:2011. | ||
| Force to activate safety mode: | ||
| NMT 10N | ||
| Force to disengage safety mode: | ||
| NLT 20N | ||
| Force to separate safety feature | ||
| from needle hub: NLT 50N | Conforms with the requirements of ISO | |
| 7864 and ISO 9626. | ||
| Needle Safety Feature: Specifications | ||
| not provided. |
Comparison of Indications for Use and Technological Characteristics
(1)Safety Needles
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Image /page/7/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the word "Micsafe" in bold, black letters. Below "Micsafe" is the word "med" in smaller, black letters.
The indications for use statement for the subject device is identical to the predicate. Differences in needle lengths and gauges were addressed through ISO 7864 and ISO 9626 testing. Differences in needle safety specifications were addressed through simulated needle safety activation and verification of the specifications. The differences identified do not raise different questions of safety and effectiveness.
(2) Sterile Syringe
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Image /page/8/Picture/0 description: The image shows the text "MICSAFE MEDICAL GROUP" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.
Image /page/8/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in bold, black font. Below "Micsafe" is the word "med" in a smaller, black font.
| Comparison
| Items | Subject Device (K183665) | Predicate Device (K170651) | |
|---|---|---|---|
| Identification | Sterile Syringe | The sterile disposable syringe- | |
| K170651 | |||
| Classification | Product Code: FMF | ||
| Class: 2 | Product Code: MEG,FMF,FMI | ||
| Class: 2 | |||
| Intended Use | The sterile syringe is a sterile luer | ||
| lock or luer slip syringe which is | |||
| intended to be used with a | |||
| hypodermic needle for the | |||
| aspiration and injection of fluids for | |||
| medical purpose. | The sterile disposable syringe is a | ||
| sterile luer lock or luer slip syringe | |||
| which is intended to be used with a | |||
| hypodermic needle for the aspiration | |||
| and injection of fluids for medical | |||
| purpose. | |||
| Configurations | |||
| and Materials | Barrel (Polypropylene) | ||
| Plunger (Polypropylene) | |||
| Stopper (Polyisoprene) | Barrel (Polypropylene) | ||
| Plunger (Polypropylene) | |||
| Stopper (Polyisoprene) | |||
| Size | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, | ||
| 50ml, and 60ml | |||
| Luer Lock/Luer Slip/Luer slip | |||
| Eccentric | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, | ||
| 30ml, 50ml, and 60ml | |||
| Luer Lock/Luer Slip | |||
| Sterile | Yes (EO) | Yes (EO) | |
| Single Use | Yes | Yes | |
| Biocompatibility | Conforms to the requirement of ISO | ||
| 10993 series Standards | |||
| No Cytotoxicity | |||
| No Irritation to Skin | |||
| No significant evidence of | |||
| sensitization | |||
| No systemic toxicity | |||
| No Hemolysis | |||
| Non pyrogenic | Conforms to the requirement of ISO | ||
| 10993 series Standards | |||
| No Cytotoxicity | |||
| No Irritation to Skin | |||
| No significant evidence of | |||
| sensitization | |||
| No systemic toxicity | |||
| No Hemolysis | |||
| Non pyrogenic | |||
| Performance | |||
| safety & | |||
| effectiveness | Conforms with the requirements of | ||
| ISO 7886 and ISO 80369-7. | Conforms with the requirements of | ||
| ISO 7886 and ISO 594-1/-2. | |||
| Comparison | |||
| Items | Subject Device (K183665) | Predicate Device (K170651) | |
| Identification | Sterile syringe with safety needles | The sterile disposable syringe with | |
| safety needle- K170651 | |||
| Classification | Product Code: MEG,FMF,FMI | ||
| Class: 2 | Product Code: MEG,FMF,FMI | ||
| Class: 2 | |||
| Intended Use | The sterile syringe with safety | ||
| needle 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 sterile disposable syringes with | ||
| Safety Needle 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. | |||
| Configurations | |||
| and Materials | Barrel (Polypropylene) | ||
| Plunger (Polypropylene) | |||
| Stopper (Polyisoprene) | |||
| Needle cap (Polypropylene) | |||
| Needle tube (SUS304) | |||
| Hub with protector (Polypropylene) | Barrel (Polypropylene) | ||
| Plunger (Polypropylene) | |||
| Stopper (Polyisoprene) | |||
| Needle cap (Polypropylene) | |||
| Needle tube (SUS304) | |||
| Needle hub with safety sheath | |||
| (Polypropylene) | |||
| Size | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, | ||
| 50ml, and 60ml | |||
| Luer Lock/Luer Slip/Luer slip | |||
| Eccentric | |||
| 18G, 20G, 21G, 22G, 23G, 25G, and | |||
| 26G | |||
| Needle length: | |||
| 1/2"-2" | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, | ||
| 30ml, 50ml, and 60ml | |||
| Luer Lock/Luer Slip 16G, 18G, 19G, | |||
| 20G, 21G, 22G, 23G, 24G, 25G, 26G, | |||
| 27G, 28G, 29G, and 30G | |||
| Needle length: | |||
| 5/16"-1 1/2" | |||
| Sterile | Yes (EO) | Yes (EO) | |
| Comparison | |||
| Items | Subject Device (K183665) | Predicate Device (K170651) | |
| Biocompatibility | Conforms to the requirement of ISO | ||
| 10993 series Standards | |||
| No Cytotoxicity | |||
| No Irritation to Skin | |||
| No significant evidence of | |||
| sensitization | |||
| No systemic toxicity | |||
| No Hemolysis | |||
| Non pyrogenic | Conforms to the requirement of ISO | ||
| 10993 series Standards | |||
| No Cytotoxicity | |||
| No Irritation to Skin | |||
| No significant evidence of | |||
| sensitization | |||
| No systemic toxicity | |||
| No Hemolysis | |||
| Non pyrogenic | |||
| Performance | |||
| safety & | |||
| effectiveness | Conforms with the requirements of | ||
| ISO 7864, ISO 9626, ISO 7886, and | |||
| ISO 80369-7. | |||
| Needle Safety Feature: Testing | |||
| conducted per ISO 23908:2011. | |||
| Force to activate safety mode: NMT | |||
| 10N | |||
| Force to disengage safety mode: | |||
| NLT 20N | |||
| Force to separate safety feature from | |||
| needle hub: NLT 50N | Conforms with the requirements of | ||
| ISO 7864, ISO 9626, ISO 7886, and | |||
| ISO 594-1/-2. | |||
| Needle Safety Feature: Specifications | |||
| not provided. |
The indications for use statement for the subject device is identical to the predicate. Differences
9
Image /page/9/Picture/0 description: The image shows the text "MICSAFE MEDICAL GROUP" in a bold, serif font. The text is centered and appears to be the name of a medical organization. The words are all capitalized and evenly spaced, giving the image a professional and clean look. The background is plain white, which makes the text stand out.
Image /page/9/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of two parts: a symbol on the left and the text on the right. The symbol is made up of four squares, with the top two squares in red and the bottom two squares in blue. The text "Micsafe" is in bold, black letters, with a small red square above the "i". Below "Micsafe" is the word "med" in smaller, black letters.
in connections (i.e., addition of eccentric luer slip models) were addressed through ISO 7886 and ISO 80369 testing. The technological differences do not raise different questions of safety and effectiveness.
(3) Sterile Syringe with Safety Needle
10
Image /page/10/Picture/0 description: The image shows the text "MICSAFE MEDICAL GROUP" in all caps. The text is in a bold, serif font. The words are arranged in a single line, with the word "MICSAFE" appearing first, followed by "MEDICAL" and then "GROUP".
Image /page/10/Picture/1 description: The image shows the logo for Micsafe med. The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the text "Micsafe" in bold, black letters, with the word "med" in smaller, gray letters below it. The logo is simple and modern, and the colors are bright and eye-catching.
The indications for use statement for the subject device is identical to the predicate. Differences in needle gauges, needle lengths and addition of eccentric luer slip models were addressed through ISO 7864, ISO 9626, ISO 7886, and ISO 80369-7 testing. Differences in needle safety specifications were addressed through simulated needle safety activation and verification of the specifications. The differences identified do not raise different questions of safety and effectiveness.
(4)Sterile Syringe with Needle
| Comparison Items | Subject Device (K183665) | Predicate Device (K170651) |
|---|---|---|
| Identification | Sterile syringe with needles | The sterile disposable syringe with |
| needle- K170651 | ||
| Classification | Product Code: MEG,FMF,FMI | Product Code: MEG,FMF,FMI |
| Comparison Items | Subject Device (K183665) | Predicate Device (K170651) |
| Class: 2 | Class: 2 | |
| Intended Use | The sterile syringe with needle is | |
| intended for use the aspiration and | ||
| injection of fluids for medical | ||
| purpose. | The sterile disposable syringe with | |
| needle is intended for use in the | ||
| aspiration and injection of fluids for | ||
| medical purpose. | ||
| Configurations and | ||
| Materials | Barrel (Polypropylene) | |
| Plunger (Polypropylene) | ||
| Stopper (Polyisoprene) | ||
| Needle cap (Polypropylene) | ||
| Needle tube (SUS304) | ||
| Needle hub (Polypropylene) | Barrel (Polypropylene) | |
| Plunger (Polypropylene) | ||
| Stopper (Polyisoprene) | ||
| Needle cap (Polypropylene) | ||
| Needle tube (SUS304) | ||
| Needle hub (Polypropylene) | ||
| Size | 1ml, 3ml, 5ml, 10ml, 20ml, 30ml, | |
| 50ml, and 60ml | ||
| Luer Lock/Luer Slip/Luer slip | ||
| Eccentric | ||
| 18G, 19G, 20G, 21G, 22G, 23G, | ||
| 24G, 25G, 26G, 27G, 28G, 29G, | ||
| 30G, and 31G | ||
| Needle length: | ||
| 1/2"-2" | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, | |
| 30ml, 50ml, and 60ml | ||
| Luer Lock/Luer Slip 16G, 18G, 19G, | ||
| 20G, 21G, 22G, 23G, 24G, 25G, 26G, | ||
| 27G, 28G, 29G, and 30G | ||
| Needle length: | ||
| 5/16"-1 1/2" | ||
| Sterile | Yes (EO) | Yes (EO) |
| Single Use | Yes | Yes |
| Biocompatibility | Conforms to the requirement of | |
| ISO 10993 series Standards | ||
| No Cytotoxicity | ||
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | ||
| No systemic toxicity | ||
| No Hemolysis | ||
| Non pyrogenic | Conforms to the requirement of ISO | |
| 10993 series Standards | ||
| No Cytotoxicity | ||
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | ||
| No systemic toxicity | ||
| No Hemolysis | ||
| Non pyrogenic | ||
| Performance safety | ||
| & effectiveness | Conforms with the requirements of | |
| ISO 7864, ISO 9626, ISO 7886, | ||
| and ISO 80369-7 | Conforms with the requirements of | |
| ISO 7864, ISO 9626, ISO 7886, and | ||
| ISO 594-1/-2 | ||
| Comparison | ||
| Items | Subject Device (K183665) | Predicate Device (K170651) |
| Identification | Hypodermic needle for single use | The sterile disposable needle- |
| K170651 | ||
| Classification | Product Code: FMI Class: 2 | Product Code: MEG,FMF,FMI, |
| Class: 2 | ||
| Intended Use | The hypodermic needle is intended | |
| to be used with a luer slip or luer | ||
| lock syringe for aspiration and | ||
| injection of fluids for medical | ||
| purpose. | The sterile disposable needle is | |
| intended to be used with a luer slip | ||
| or luer lock syringe for aspiration | ||
| and injection of fluids for medical | ||
| purpose. | ||
| Configuration | Needle cap (Polypropylene) | |
| Needle tube (SUS304) | ||
| Needle hub (Polypropylene) | Needle cap (Polypropylene) | |
| Needle tube (SUS304) | ||
| Needle hub (Polypropylene) | ||
| Size | 18G, 19G, 20G, 21G, 22G, 23G, 24G, | |
| 25G, 26G, 27G, 28G, 29G, 30G, and | ||
| 31G Needle length: | ||
| 1/2"-2" | 16G, 18G, 19G, 20G, 21G, 22G, 23G, | |
| 24G, 25G, 26G, 27G, 28G, 29G, and | ||
| 30G Needle length: | ||
| 5/16"-1 1/2" | ||
| Sterile | Yes (EO) | Yes (EO) |
| Single Use | Yes | Yes |
| Biocompatibility | Conforms to the requirement of | |
| ISO 10993 series Standards | ||
| No Cytotoxicity | ||
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | ||
| No systemic toxicity | ||
| No Hemolysis | ||
| Non pyrogenic | Conforms to the requirement of ISO | |
| 10993 series Standards | ||
| No Cytotoxicity | ||
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | ||
| No systemic toxicity | ||
| No Hemolysis | ||
| Non pyrogenic |
11
Image /page/11/Picture/0 description: The image shows the text "MICSAFE MEDICAL GROUP" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.
Image /page/11/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the word "Micsafe" in bold, black letters. Below "Micsafe" is the word "med" in smaller, lighter letters.
12
Image /page/12/Picture/1 description: The image shows the logo for "Micsafe med". The logo has two red squares on the top row and two blue squares on the bottom row. To the right of the squares is the text "Micsafe" in bold black font, with the "i" in "Micsafe" being red. Below "Micsafe" is the text "med" in a smaller black font.
The indications for use statement for the subject device is identical to the predicate. Differences in luer connection (i.e., addition of luer slip Eccentric), needle gauges and needle lengths were addressed through ISO 7864, ISO 9626, ISO 7886, and ISO 80369 testing. The differences identified do not raise different questions of safety and effectiveness.
(5)Hypodermic Needles for Single Use
13
Image /page/13/Picture/0 description: The image shows the text "MICSAFE MEDICAL GROUP" in a serif font. To the right of the text is a logo consisting of two stacked rectangles, the top one red and the bottom one blue. The rectangles are angled slightly to the right, creating a sense of forward motion.
| Image: red and blue squares | Micsafe |
|---|---|
| med |
| Comparison
| Items | Subject Device (K183665) | Predicate Device (K170651) |
|---|---|---|
| & effectiveness | ISO 7864 and ISO 9626. | ISO 7864 and ISO 9626. |
The indications for use statement for the subject device is identical to the predicate. Differences in needle gauges and lengths were addressed through ISO 7864 and ISO 9626 testing. The differences identified do not raise different questions of safety and effectiveness.
Performance Testing
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
- Biocompatibility:
Needle: Externally communicating, blood path indirect with limited patient contact Syringe: Externally communicating, blood path indirect with prolonged patient contact Testing according to:
- ANSI AAMI ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices Part ● 5: Tests For In Vitro Cytotoxicity;
- ANSI AAMI ISO 10993-10:2010/(R)2014. Biological Evaluation Of Medical Devices Part ● 10: Tests For Irritation And Skin Sensitization;
- ANSI AAMI ISO 10993-11:2006/(R)2010, Biological Evaluation Of Medical Devices Part ● 11: Tests For Systemic Toxicity;
- . ISO 10993-4:Third Edition 2017-04, Biological Evaluation Of Medical Devices--Part 4: Selection Of Tests For Interactions With Blood;
- ASTM F756-17, Standard Practice For Assessment Of Hemolytic Properties Of Materials.
- Performance testing according to ISO 7864 Fourth Edition 2016-08-01, Sterile Hypodermic Needles For Single Use - Requirements And Test Methods:
- Cleanliness ●
- Limits for acidity or alkalinity ●
- Limits for extractable metals ●
- Color coding ●
- Conical fitting ●
- Color of hub
- Needle cap ●
- Tolerances on length
- Freedom from defects
- Lubricant ●
- Needle point ●
- Bond between hub and needle tube
14
Image /page/14/Picture/1 description: The image shows the logo for Micsafe med. The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in black, and "med" in smaller black font below the "safe" portion of the name. The red and blue square symbol is made up of four smaller squares, with the top two squares being red and the bottom two squares being blue.
- Patency of lumen
- Sharps injury protection
- Performance testing according to ISO 7886-1 Second Edition 2017-05, Sterile Hypodermic Syringes For Single Use - Part 1: Syringes For Manual Use:
- Limits for acidity or alkalinity .
- Limits for extractable metals ●
- Lubricant ●
- Tolerance on graduated capacity ●
- Scale ●
- Numbering of scales
- Overall length of scale to nominal capacity line ●
- . Position of scale
- Barrel flanges
- Minimum length between barrel flanges and plunger push-button
- Conical fitting
- Position of nozzle on end of barrel
- Nozzle lumen
- Dead space
- Freedom from air and liquid leakage past plunger stopper
- Force to operate the position
- Fit of plunger stopper/plunger in barrel ●
- Performance testing according to ISO 80369-7 First Edition 2016-10-15, Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular Or Hypodermic Applications:
- Leakage by pressure decay
- Positive pressure liquid leakage ●
- Sub-atmospheric pressure air leakage ●
- Stress cracking
- Resistance to separation from axial load ●
- Resistance to separation from unscrewing ●
- Resistance to overriding
- Performance testing according to ISO 9626 Second Edition 2016-08-01, Stainless Steel Needle Tubing For The Manufacture Of Medical Devices - Requirements And Test Methods:
- . Dimensions
- Stiffness ●
- Resistance to breakage ●
- Resistance to corrosion ●
15
Image /page/15/Picture/1 description: The image shows the logo for Micsafe med. The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in bold, black letters. Below "Micsafe" is the word "med" in a smaller, lighter font.
- Additional Performance testing for the Safety Needles/ Sterile Syringe/Sterile Syringe with Safety Needle/Sterile Syringe with Needle/Hypodermic Needle for Single Use:
- Conical fitting to ISO 80369-7 ●
- Sharps Injury Protection Test Report to ISO 23908:2011 ●
- Particulate Testing per USP
Clinical Testing
Not applicable
Conclusion
The subject and predicate device have similar technological characteristics, are provided sterile, and are intended for single use. Differences in configurations and sizes have been evaluated by non-clinical bench testing per ISO 7864, ISO 9626, ISO 7886 and ISO 80369-7. Furthermore, both devices were tested for biocompatibility per ISO 10993-1. Hence, we conclude that the subject device was demonstrated to be substantially equivalent to the predicate device.