(417 days)
Not Found
No
The description focuses on mechanical features for safety and filtration, with no mention of AI or ML.
Yes
The device is intended to inject drug solutions into the human body and filters the solutions to remove foreign substances, which falls under therapeutic intervention.
No.
The device is a syringe designed to inject drug solutions and prevent needle stick injuries, not to diagnose a condition.
No
The device description clearly outlines physical components (plunger, barrel, needle, Luer Assembly, Adapter) and mechanical actions (pulling, pushing, engaging, fracturing), indicating it is a hardware device. There is no mention of software as a component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject the drug solutions into the human body" and "prevent needle stick injuries." This describes a device used for administering substances into the body, not for examining specimens from the body to diagnose conditions.
- Device Description: The description details the mechanical components of a syringe designed for injection and safety features to prevent needle sticks. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring specific analytes (e.g., glucose, antibodies, DNA).
- Providing information for diagnosis, monitoring, or screening of diseases.
- Reagents or test kits.
The device is clearly intended for therapeutic or preventative purposes (drug administration and injury prevention), not for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Greenmedi safety filter syringe is intended to inject the drug solutions into the human body. It is designed to prevent needle stick injuries. The 0.5um filter operates when into the human body to remove foreign substances from the drug solutions.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The Greenmedi safety filter syringe consists of a plunger that fits tightly within a barrel and a needle. The plunger can be linearly pulled and pushed along the inside of the tube, allowing the syringe to take in and expel liquid through a needle. After use, the health care professional fully depresses the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a sharps container.
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)
Performance Testing: The Greenmedi Safety Filter Syringe has been designed and successfully tested to meet the applicable requirements outlined in ISO 7886-1 and ISO 7864 (Normative Reference -ISO 6009, ISO 9626, ISO 594).
- ISO 7886-1 (graduated scale, freedom from air and liquid leakage, lubricant, dead space, piston/plunger assembly)
- ISO 7864:2016 (color coding (ISO 6009), conical fitting (ISO 594), bond between hub and needle, patency of lumen, stiffness (ISO 9626), resistance to breakage (ISO 9626), resistance to corrosion (ISO 9626), simulated use testing (see below))
Simulated Use Testing: Simulated use test was conducted with intended users according to ISO 23908 and the FDA Guidance, "Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff". The simulated test results demonstrated that the GreenMedi Safety Filter syringe's sharps injury prevention feature for its intended use.
Biocompatibility Testing: The Greenmedi Safety Filter Syringe has successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and Sensitization . 5.4 Intracutaneous reactivity test
- ISO 10993-10 2010 Biological evaluation of medical devices Part 10: Teat for Irritation and Sensitization ● 6.2 Maximization sensitization test
- ISO 10993-11 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity 6.5 ● Acute systemic toxicity
- ISO 10993-4:2002 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood.
- The United States Pharmacopeia (Pyrogen test)
- USP 39-NF34:2016, Pyrogen Test (USP Rabbit Test). (Biocompatibility) ●
Sterilization and Shelf-life Testing: The sterilization of the Greenmedi Safety Filter Syringe has been validated using the half-cycle method as outlined in ISO11135. The maximum levels of residues of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in ISO10993-7. Shelf-life testing supports a shelf-life of 5-years after sterilization.
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 shows 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 features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Sang-A Frontec Co., Ltd % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620
Re: K173743
Trade/Device Name: Greenmedi Safety Filter Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: December 20, 2018 Received: December 26, 2018
Dear Priscilla Chung:
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 mav, 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 avare 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sarah B. Mollo -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173743
Device Name Greenmedi Safety Filter Syringe
Indications for Use (Describe)
The Greenmedi safety filter syringe is intended to inject the drug solutions into the human body. It is designed to prevent needle stick injuries. The 0.5um filter operates when into the human body to remove foreign substances from the drug solutions.
| 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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510(k) SUMMARY (K173743)
Date of preparation: January 24, 2019
1. Submitted by:
Contact: Jung-soon, Park / Quality Management Representative SANG-A FRONTEC CO., LTD. 18, Namdong-daero 369beon-gil, Namdong-gu Incheon, Republic, Korea 21629 Tel: +82 32 451 7854 Fax: +82 32 822 1869
2. US Agent Contact:
Contact: Priscilla Chung, Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Tel: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
3. Device Name:
| Trade Name: | Greenmedi Safety Filter Syringe |
|---|---|
| Classification: | Class II |
| Classification Name: | Syringe, Antistick |
| Product Code: | MEG |
| Regulation Number: | 21 CFR 880.5860 |
| Review Panel: | General Hospital |
4. Predicate Device:
| 510k #: | K092430 |
|---|---|
| Manufacturer: | Inviro Medical, Inc. |
| Device Name: | InviroSnap Safety Syringe |
5. Device Description:
The Greenmedi safety filter syringe consists of a plunger that fits tightly within a barrel and a needle. The plunger can be linearly pulled and pushed along the inside of the tube, allowing the syringe to take in and expel liquid through a needle. After use, the health care professional fully depresses the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a sharps container.
6. Indications for Use:
The Greenmedi safety filter syringe is intended to inject the drug solutions into the human body. It is designed to prevent needle stick injuries. The 0.5um filter operates when into the drug into the human body to remove foreign substances from the drug solutions.
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7. Technological Characteristics:
Substantial Equivalence Discussion
The Greenmedi safety filter syringe is substantially equivalent to the predicate device, InviroSnap Safety Syringe (K092430) manufactured by Inviro Medical, Inc. in terms of the device design, indications for use, and device materials.
| Device Name | Subject Device | Primary Predicate Device | Comparison column | |
|---|---|---|---|---|
| Manufacturer | SANG-A FRONTEC CO., | |||
| LTD. | Inviro Medical, Inc. | - | ||
| Device Name | Greenmedi safety filter syringe | InviroSnap Safety Syringe | - | |
| 510(k) Number | N/A | K092430 | - | |
| Product Code | MEG | MEG | Same | |
| Indications for Use | The Greenmedi safety filter syringe is intended to inject the drug solutions into the human body. It is designed to prevent needle stick injuries. The 0.5um filter operates when injecting the drug into the human body to remove foreign substances from the drug solutions. | The InviroSnap Safety Syringe is used to inject fluids into or withdraw fluids from, the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries. | Similar | |
| Design | Syringe type | Piston syringe | Piston syringe | Same |
| Tip type | Luer lock | Luer lock | Same | |
| Syringe volume | 2ml, 3ml, 5ml, 10ml | 1ml, 3ml, 5ml, 10ml, 20ml | Similar | |
| Needle gauge | 23G | 21G, 22G, 23G, 25G, 27G | Same | |
| Needle length | 17mm | 12.7mm, 15.8mm, 25.4mm, 38.1mm | Similar | |
| Needle | STS304 | STS304 | Same | |
| Materials | Lubricant For needle | Silicone Oil | Silicone Oil | Same |
| Hub | Polypropylene | Polypropylene | Same | |
| Protective cap | Polypropylene | Polypropylene | Same | |
| Barrel | Polypropylene | Polypropylene | Same | |
| Lubricant For barrel | Silicone Oil | Silicone Oil | Same | |
| Plunger | Polypropylene (green) | Polypropylene | Different | |
| Gasket | Thermoplastic elastomer | Thermoplastic elastomer | Same | |
| Filter | Membrane | - | Different | |
| Check | ||||
| valve | Silicon | Different | ||
| Principle of | ||||
| operation | Normal | Normal | Same | |
| Safety Features | The retractable type piston | |||
| syringe (anti-needlestick | ||||
| feature) | The retractable type piston | |||
| syringe (anti-needlestick | ||||
| feature) | Same | |||
| Filter spec. | 5μm | - | Different | |
| Biocompatibility | Conform ISO10993-1 | Conform ISO10993-1 | Same | |
| Particulate | ||||
| Testing | Conforms to USP | |||
| Sterilization | ||||
| method | ||||
| and SAL | Sterilized by ethylene | |||
| oxide gas SAL = 10-6 | Sterilized by ethylene | |||
| oxide gas SAL = 10-6 | Same |
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The differences between the subject device and the predicate are the following features: check valve, filter membrane and color of the plunger. The check valve allows the fluid to pass through the needle when withdrawing from the drug solutions. During injection, the check valve is blocked, and the drug solutions passes through the filter allowing removal of particles. The subject device conforms to relevant international stated in Section 7. In addition, performance testing was done on the filter to ensure that the filter achieve its intended use without affecting the flow of the drug solutions into the body. Another difference is the green color of the plunger. Biocompatibility testing were performed, and the green plunger is biocompatible. Therefore, these features do not raise additional questions of safety and effectiveness, hence, it will not affect substantial equivalence between the subject device and predicate device.
8. Non-clinical testing
Performance Testing
The Greenmedi Safety Filter Syringe has been designed and successfully tested to meet the applicable requirements outlined in ISO 7886-1and ISO 7864 (Normative Reference -ISO 6009, ISO 9626, ISO 594).
- . ISO 7886-1 (graduated scale, freedom from air and liquid leakage, lubricant, dead space, piston/plunger assembly)
- ISO 7864:2016 (color coding (ISO 6009), conical fitting (ISO 594), bond between hub and needle, patency of . lumen, stiffness (ISO 9626), resistance to breakage (ISO 9626), resistance to corrosion (ISO 9626), simulated use testing (see below)
Simulated Use Testing
Simulated use test was conducted with intended users according to ISO 23908 and the FDA Guidance, "Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff". The simulated test results demonstrated that the GreenMedi Safety Filter syringe's sharps injury prevention feature for its intended use.
Biocompatibility Testing
The Greenmedi Safety Filter Syringe has successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
6
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and Sensitization . 5.4 Intracutaneous reactivity test
- ISO 10993-10 2010 Biological evaluation of medical devices Part 10: Teat for Irritation and Sensitization ● 6.2 Maximization sensitization test
- ISO 10993-11 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity 6.5 ● Acute systemic toxicity
- ISO 10993-4:2002 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood.
- . The United States Pharmacopeia (Pyrogen test)
- USP 39-NF34:2016, Pyrogen Test (USP Rabbit Test). (Biocompatibility) ●
Sterilization and Shelf-life Testing
The sterilization of the Greenmedi Safety Filter Syringe has been validated using the half-cycle method as outlined in ISO11135. The maximum levels of residues of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in ISO10993-7. Shelf-life testing supports a shelf-life of 5-years after sterilization.
Conclusion
Based on the information provided in this premarket notification of SANG-A FRONTEC CO., LTD. concludes that the Greenmedi Safety Filter Syringe is substantially equivalent to predicate devices.