(263 days)
The Sterile Syringe for Single Use is intended for use by health care professionals for general purpose aspiration and injection of fluids.
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.
The provided document is a 510(k) Summary for a Sterile Syringe for Single Use. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, training set details, or ground truth establishment for AI models) are not applicable.
However, based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, interpreted within the context of a medical device clearance:
1. A table of acceptance criteria and the reported device performance
The document defines "acceptance criteria" through compliance with recognized standards and the demonstration of substantial equivalence to a predicate device. The performance is reported as meeting these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference or Characteristic) | Reported Device Performance (Compliance) |
|---|---|---|
| Biocompatibility | ISO 10993-5 (in Vitro Cytotoxicity) | No cytotoxicity |
| ISO 10993-10 (Irritation and skin sensitization) | No intracutaneous reactivity, No skin sensitization | |
| ISO 10993-11 (Systemic toxicity) | No systemic toxicity | |
| ISO 10993-4 & ASTM F756-17 (Interaction with Blood, Hemolytic Properties) | No Hemolysis | |
| Pyrogenicity Test | No Pyrogen (Implied acceptance criterion for sterile devices) | |
| Material Safety | Endotoxin Limit | 20 EU per device |
| Sterilization | Sterilization Method | EO Sterilization (Ethylene Oxide) |
| Sterility Assurance Level (SAL) | 10-6 | |
| Packaging Integrity | ASTM F88/F88M-15 (Seal Strength) | Complies |
| ASTM F1929-15 (Seal Leaks by Dye Penetration) | Complies | |
| Particulate Matter | USP<788> (Particulate Matter for Injections, Method 1) | Complies |
| Syringe Performance | ISO 7886-1:2017 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | Complies with ISO 7886-1 |
| Needle Performance | ISO 7864:2016 (Sterile hypodermic needles for single use - Requirements and test methods) | Complies with ISO 7864 |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Complies with ISO 9626 | |
| ISO 6009:2016 (Hypodermic needles for single use - Colour coding) | Complies with ISO 6009 | |
| Connector Compatibility | ISO 80369-7:2016 (Small-bore connectors for intravascular or hypodermic applications) | Complies with ISO 80369-7 |
| ISO 80369-20:2015 (Common test methods for small-bore connectors) | Complies with ISO 80369-20 | |
| General Requirements | Operation Mode | For manual use only (Same as predicate) |
| Single Use | Single Use (Same as predicate) | |
| Label/Labeling | Complies with 21 CFR part 801 (Same as predicate) |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test conducted. It states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is implied to be from internal testing conducted by Jiangsu Suyun Medical Material Co., Ltd. or its contracted labs, with the country of origin being China (where the manufacturer is located). The testing is prospective for the purpose of this submission, meaning the tests were performed on the proposed device to gather data for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for a medical device like a sterile syringe is based on established engineering and biological standards (e.g., ISO, ASTM, USP) and laboratory measurements, not subjective expert assessment in the way it would be for an AI diagnostic tool. The "experts" involved are the certified laboratory technicians and quality control personnel who perform and interpret these standardized tests. Their qualifications are inherent in their ability to conduct these specific tests according to recognized protocols.
4. Adjudication method for the test set
This is not applicable in the context of this device and type of testing. The tests are typically objective measurements against defined pass/fail criteria in the standards. There is no mention of a human adjudication process for resolving conflicting results, as would be common in image interpretation studies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a physical sterile syringe, not an AI/ML-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical sterile syringe, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance relies on objective measurements from standardized non-clinical tests. These include:
- Biological/Chemical endpoint measurements: e.g., cell viability (cytotoxicity), skin reactions (irritation/sensitization), blood cell lysis (hemolysis), particulate counts, endotoxin levels.
- Physical performance measurements: e.g., seal strength, leak detection, plunger force, barrel integrity, needle sharpness and elasticity.
- Sterility verification: Growth/no-growth tests for sterility assurance.
The "ground truth" is defined by the Pass/Fail criteria specified within the referenced ISO, ASTM, and USP standards.
8. The sample size for the training set
This is not applicable. There is no AI/ML component or "training set" for this sterile syringe device. The document describes non-clinical performance testing.
9. How the ground truth for the training set was established
This is not applicable. As there is no AI/ML component, there is no training set and no ground truth established for one.
{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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ |
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
"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}------------------------------------------------
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<788> 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 DeviceK113241 | Remark |
|---|---|---|---|
| Product | Sterile Syringe for Single Use | BD EmeraldTM, Single Use, Hypodermic Syringe | / |
| Product Code | FMF | FMF | Same |
| RegulationNumber | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | Class II | Class II | Same |
| Indication forUse | The Sterile Syringe for Single Useis intended for use by health careprofessionals for general purposeaspiration and injection of fluids. | The BD EmeraldTM Single Use,Hypodermic Syringe is intendedfor use by health careprofessionals for general purposeaspiration and injection of fluids. | Same |
| Components andmaterials | Barrel | Polypropylene (PP) | |
| Plunger | Polypropylene (PP) | ||
| Piston | Synthetic rubber | ||
| Needle hub | Polypropylene (PP) | Different | |
| Protectivecap | Polypropylene (PP) | ||
| Needle tube | Stainless SteelSUS304 | ||
| Barrel | Polypropylene (PP) | ||
| plunger | Polypropylene (PP) | ||
| Piston | Unknown | ||
| Needle hub | Polypropylene (PP) | ||
| Protectivecap | 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 DeviceK113241 | 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 withISO 7886-1 | Complied withISO 7886-1 | Same | |
| Needle Performance | Complied withISO 7864,ISO 9626 | Complied withISO 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 DeviceK113241 | Remark |
|---|---|---|---|
| Product | Sterile Syringe for Single Use | BD Emerald™, Single Use, HypodermicSyringe | / |
| Patient-contact Material | |||
| Barrel | Polypropylene (PP) | BarrelPolypropylene (PP) | / |
| Plunger | Polypropylene (PP) | PlungerPolypropylene (PP) | / |
| Piston | Synthetic rubber | PistonUnknown | Different |
| Needle tube | Stainless Steel SUS304 | Needle tubeStainless Steel | / |
| Needle hub | Polypropylene (PP) | Needle hubPolypropylene (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
§ 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).