(263 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML capabilities.
No
The device is used for "general purpose aspiration and injection of fluids," which are diagnostic or procedural actions, not necessarily therapeutic. It is a delivery/collection tool rather than a therapeutic agent itself.
No
The device is described as a sterile syringe for aspiration and injection of fluids, which are typically medical procedures, not diagnostic ones. Diagnostics usually involve identifying a disease or condition.
No
The device description clearly outlines physical components (Barrel, Plunger, Piston, Needle Tube, Protective Cap, Needle Hub) and mentions sterilization and packaging, 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 is "for general purpose aspiration and injection of fluids." This describes a device used on a patient for delivering or withdrawing substances, not for testing samples in vitro (outside the body).
- Device Description: The description details the physical components of a syringe and needle, which are tools for administering or collecting fluids from a living organism.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
The Sterile Syringe for Single Use is intended for use by health care professionals for general purpose aspiration and injection of fluids.
Product codes
FMF
Device Description
The Syringe with needle is intended for manual and single use only. It consists of six components 1) Barrel (luer lock or luer slip) 2) Plunger 3) Piston 4) Needle Tube 5) Protective Cap and 6) Needle Hub.
The proposed device is available in various combination of syringe volume, connector type (luer lock or luer slip), connector location (central type or eccentric type) and needle size.
The Syringe without needle is intended for manual and single use only. It consists of three components 1) Barrel (luer lock or luer slip) 2) Plunger and 3) Piston.
The proposed syringe is available in various combination of syringe volume, connector type (luer lock or luer slip), and connector location (central type or eccentric type).
The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
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
health care professionals
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 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 skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ISO 10993-4:2017 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
- USP Particulate Matter for Injections (Method 1 Light Obscuration Particle Count Test)
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
- A ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods
- ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use
The proposed device had been tested for biocompatibility and the result does not show any adverse effect.
All specifications of proposed device had been tested for performance and the test results could meet the requirements according to ISO 7886-1:2017.
The needles have been tested and the test results comply with related standards requirements.
Biocompatibility tests were conducted on the material consisted of the proposed device and the test result shows that the material are biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The logo is simple and professional, conveying the agency's authority and mission.
December 17, 2021
Jiangsu Suyun Medical Material Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K210914
Trade/Device Name: Sterile Syringe for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 10, 2021 Received: November 17, 2021
Dear Diana Hong:
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
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/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 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210914
Device Name Sterile Syringe for Single Use
Indications for Use (Describe)
The Sterile Syringe for Single Use is intended for use by health care professionals for general purpose aspiration and injection of fluids.
| 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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3
Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section
807.92. The assigned 510(k) Number: _ _ _ K210914_
- Date of Preparation: 9/3/2021 1.
-
- Sponsor Identification
Jiangsu Suyun Medical Materials Co., Ltd. No.18 Jinqiao Road, Dapu Industrial Park, Lianyungang City, Jiangsu, 222000, China
Establishment Registration Number: 3003717263
Contact Person: Guangning Xu Position: Management Representative Tel: +86-518-85462073 Fax: +86-518-85608151 Email: quality@suyunmedical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
510(k) Summary
4. Identification of Proposed Device
Trade Name: Sterile Syringe for Single Use Common Name: Piston Syringe
Regulatory Information
Classification Name: Syringe, Piston Classification: II; Product Code: FMF; Regulation Number: 21CFR 880.5860 Review Panel: General Hospital;
Indication for Use Statement:
The Sterile Syringe for Single Use is intended for use by health care professionals for general purpose aspiration and injection of fluids.
Device Description
Syringe with needle
The Syringe with needle is intended for manual and single use only. It consists of six components 1) Barrel (luer lock or luer slip) 2) Plunger 3) Piston 4) Needle Tube 5) Protective Cap and 6) Needle Hub.
The proposed device is available in various combination of syringe volume, connector type (luer lock or luer slip), connector location (central type or eccentric type) and needle size.
Syringe without needle
The Syringe without needle is intended for manual and single use only. It consists of three components 1) Barrel (luer lock or luer slip) 2) Plunger and 3) Piston.
The proposed syringe is available in various combination of syringe volume, connector type (luer lock or luer slip), and connector location (central type or eccentric type).
The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
- ડ. Identification of Predicate Device
510(k) Number: K113241 Product Name: BD Emerald™, Single Use, Hypodermic Syringe
5
6. Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
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 skin sensitization
-
ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
-
ISO 10993-4:2017 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
-
USP Particulate Matter for Injections (Method 1 Light Obscuration Particle Count Test)
-
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
-
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
-
ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
- A ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification
-
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications
-
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods
-
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use
7. Clinical Test Conclusion
No clinical study is included in this submission.
6
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device
K113241 | Remark |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Sterile Syringe for Single Use | BD EmeraldTM, Single Use, Hypodermic Syringe | / |
| Product Code | FMF | FMF | Same |
| Regulation
Number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | Class II | Class II | Same |
| Indication for
Use | The Sterile Syringe for Single Use
is intended for use by health care
professionals for general purpose
aspiration and injection of fluids. | The BD EmeraldTM Single Use,
Hypodermic Syringe is intended
for use by health care
professionals for general purpose
aspiration and injection of fluids. | Same |
| Components and
materials | Barrel | Polypropylene (PP) | |
| | Plunger | Polypropylene (PP) | |
| | Piston | Synthetic rubber | |
| | Needle hub | Polypropylene (PP) | Different |
| | Protective
cap | Polypropylene (PP) | |
| | Needle tube | Stainless Steel
SUS304 | |
| | Barrel | Polypropylene (PP) | |
| | plunger | Polypropylene (PP) | |
| | Piston | Unknown | |
| | Needle hub | Polypropylene (PP) | |
| | Protective
cap | Unknown | |
| | Needle tube | Stainless Steel | |
| Operation Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
Table 1 General Comparison of the Sterile Syringe for Single Use
Different - Components and materials
The components of the proposed device are same with the predicate device but the materials are not exactly the same. However, the proposed device had been tested for biocompatibility and the result does not show any adverse effect. Therefore, the difference on the proposed device doesn't raise new questions of safety and effectiveness.
7
| ITEM | | Proposed Device | Predicate Device
K113241 | Remark |
|--------------------|---------------------|----------------------------------------|----------------------------------------------|-----------|
| Product | | Sterile Syringe for Single Use | BD EmeraldTM, Single Use, Hypodermic Syringe | / |
| | Volume | 1ml, 2ml, 5ml, 10ml, 20ml, 30ml, 50ml | 2ml, 3ml, 5ml, 10ml | Different |
| Syringe | Connector Type | Luer Lock/ Luer Slip | Luer Lock/ Luer Slip | |
| | Connector location | Central/Eccentric | Central | |
| Needle | Gauge | 22G | 21G | Different |
| | Length | 30mm, 32mm | 40mm | |
| | Syringe Performance | Complied with
ISO 7886-1 | Complied with
ISO 7886-1 | Same |
| Needle Performance | | Complied with
ISO 7864,
ISO 9626 | Complied with
ISO 7864,
ISO 9626 | Same |
Table 2 Performance Comparison of the Sterile Syringe for Single Use
Different - Syringe
The volume and connector location of proposed device is different from the predicate device. For the volume, the proposed device has more volumes, 1ml, 30ml and 50ml. For the connector location, the proposed device has more connector locations. In addition, all specifications of proposed device had been tested for performance and the test results could meet the requirements according to ISO 7886-1:2017. The differences do not raise new questions of safety and effectiveness.
Different- Needle Gauge and Length
The needle gauge and length of the proposed device is different from the predicate device. However, the needle with a diameter of 0.7mm (21G) and a length of 30mm or 32mm are covered by the performance standards. The needles have been tested and the test results comply with related standards requirements. The differences do not raise new questions of safety and effectiveness.
8
| ITEM | Proposed Device | Predicate Device
K113241 | Remark |
|--------------------------|--------------------------------|------------------------------------------------|-----------|
| Product | Sterile Syringe for Single Use | BD Emerald™, Single Use, Hypodermic
Syringe | / |
| Patient-contact Material | | | |
| Barrel | Polypropylene (PP) | Barrel
Polypropylene (PP) | / |
| Plunger | Polypropylene (PP) | Plunger
Polypropylene (PP) | / |
| Piston | Synthetic rubber | Piston
Unknown | Different |
| Needle tube | Stainless Steel SUS304 | Needle tube
Stainless Steel | / |
| Needle hub | Polypropylene (PP) | Needle hub
Polypropylene (PP) | / |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | Conforms to ISO 10993 series standards | Different |
| Irritation | No intracutaneous reactivity | | |
| Sensitization | No skin sensitization | | |
| Systemic Toxicity | No systemic toxicity | / | |
| Hemolysis | No Hemolysis | / | |
| Pyrogen | No Pyrogen | / | / |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
Table 3 Safety Comparison of the Sterile Syringe for Single Use
Different- Patient-contact material
The patient-contact material of piston of the predicate device is unknown. However, the biocompatibility tests were conducted on the material consisted of the proposed device and the test result shows that the material are biocompatible.
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
- Substantially Equivalent (SE) Conclusion