(183 days)
The Sterile Disposable 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.
The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.
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 safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.
The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.
Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.
Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
The provided document describes the 510(k) premarket notification for "Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle" (K221247) by Jiangsu Kangbao Medical Equipment Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K170651) based on non-clinical testing.
Here's a breakdown of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various international and ASTM standards that the device was tested against. The acceptance criterion for each standard is implicit within the standard itself (e.g., "complies with the requirements of related standards," "no cytotoxicity," "no hemolysis"). The reported performance consistently states that the proposed device met these criteria.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Biocompatibility Testing | |
| ISO 10993-5:2009 (Cytotoxicity) | No cytotoxicity |
| ISO 10993-10:2010 (Sensitization) | No sensitization |
| ISO 10993-10:2010 (Irritation) | No intracutaneous reactivity |
| ISO 10993-11:2017 (Acute Systemic Toxicity) | No systemic toxicity |
| ASTM F756-17 (Hemolysis) | No hemolysis |
| ISO 10993-4:2017 (Complement activation) | Not show potentials to activate complete system |
| ISO 10993-4:2017 (Thromboresistance study) | No thrombogenicity |
| USP<151> (Pyrogen Test) | No pyrogen |
| Physical, Mechanical, Chemical Testing | |
| ISO 7886-1:2017 (General requirements, Extraneous matter, Lubricant, Tolerance on graduated capacity, Graduated scale, Barrel, Piston/plunger assembly, Nozzle, Performance) | Complies with the requirements of related standards |
| ISO 7864:2016 (Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Size designation, Colour coding, Needle hub, Needle Cap, Needle tube, Needle point, Bond between hub and needle tube, Patency of lumen) | Complies with the requirements of related standards |
| ISO 9626:2016 (Surface finish and appearance, Cleanliness, Limits for acidity and alkalinity, Size designation, Dimensions, Stiffness, Resistance to breakage, Resistance to corrosion) | Complies with the requirements of related standards |
| ISO 80369-7:2016 (Fluid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation form unscrewing, Resistance to overriding) | Complies with the requirements of related standards |
| USP <788> (Particulate testing) | Complies with the requirements of related standards |
| Sterile Barrier Packaging Testing | |
| ASTM F1886 / F1886M-16 (Visual inspection) | Device package can maintain its integrity |
| ASTM F88/F88M-15 (Seal strength) | Device package can maintain its integrity |
| ASTM F1929-15 (Dye penetration test) | Device package can maintain its integrity |
| Sterilization and Shelf Life Testing | |
| ISO 10993-7:2008 (EO residue) | EO ECH residue did not exceed the limit |
| ISO 10993-7:2008 (ECH residue) | EO ECH residue did not exceed the limit |
| USP <85> (Bacteria Endotoxin Limit) | Endotoxin limit did not exceed 20EU/device |
| Shelf Life Evaluation (Physical, Mechanical, Chemical, Package Test) | Device can maintain its performance during the claimed shelf life (5 years) |
| Simulated Clinical Study | |
| FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, ISO 23908:2011 (Safety mechanism evaluation) | Proposed device met the pre-established criteria |
| Safety Feature Test | |
| (Specific criteria not detailed, but states "acceptance criteria") | The proposed device met the acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each non-clinical test performed on the test set. It mentions "non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device." Similarly, for biocompatibility and packaging tests, it states "The proposed device was evaluated for the following tests" and "Sterile barrier packaging testing were performed on the proposed device."
The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Jiangsu Kangbao Medical Equipment Co., Ltd. from China. The studies are non-clinical, meaning they are lab-based and not involving human subjects. They are inherently prospective in nature as they test the new device against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this submission. The "ground truth" for non-clinical performance and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP). These standards define the test methods and acceptance criteria, and the device's performance is measured against these objective criteria rather than expert consensus on a clinical outcome.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the tests are against objective engineering and biological standards, there is no need for an adjudication method typically used in clinical studies involving human interpretation or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The submission focuses on non-clinical performance, biocompatibility, and substantial equivalence to a predicate device based on these non-clinical tests. Therefore, there is no effect size reported for human readers with or without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical medical instrument (syringe and needle), not an algorithm or AI-powered system. No standalone "algorithm only" performance was evaluated.
7. The type of ground truth used:
The type of "ground truth" used for this submission is based on established international and national standards and their defined acceptance criteria. For example:
- Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, complement activation, and thrombogenicity as defined by the respective ISO and USP standards.
- Physical/Mechanical/Chemical Performance: Compliance with the specifications and performance requirements outlined in ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, and USP <788>.
- Packaging Integrity: Maintenance of sterility barrier as per ASTM F1886/F1886M-16, ASTM F88/F88M-15, and ASTM F1929-15.
- Sterilization: EO/ECH residue within limits (ISO 10993-7), endotoxin limit (USP <85>), and sterile assurance level (SAL) of 10-6.
- Safety Feature: Meeting pre-established criteria as per FDA Guidance and ISO 23908:2011.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" to establish.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2022
Jiangsu Kangbao Medical Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K221247
Trade/Device Name: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMF. FMI Dated: September 30, 2022 Received: September 30, 2022
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
{1}------------------------------------------------
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Sterile Disposable Syringe with Safety Needle; Sterile Disposable Syringe with Needle; Sterile Disposable Safety Needle; Sterile Disposable Needle
Indications for Use (Describe)
The Sterile Disposable 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.
The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.
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 safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection 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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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: K221247
-
- Date of Preparation: November 1, 2022
-
- Sponsor Identification
Jiangsu Kangbao Medical Equipment Co., Ltd.
78#, North Suzhong Road Baoying 225800 Yangzhou PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: 3009742443
Contact Person: Rujun Tang
Position: Management Representative
Tel: +86-514-88223540
Fax: +86-514-88232089
Email: 76823131@qq.com
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person)
Ms. Tingting Su (Alternative Contact Person)
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
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4. Identification of Proposed Device
Trade Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe with Needle Sterile Disposable Safety Needle Sterile Disposable Needle
Common Name: Syringes with Needle
Regulatory Information Classification Name: Syringe, Piston Classification: II; Product Code: FMF; Regulation Number: 21CFR 880.5860; Review Panel: General Hospital;
Classification Name: Needle, Hypodermic, Single Lumen Classification: II Product Code: FMI; Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;
Classification Name: Piston Syringe Classification: II; Product Code: MEG; Regulation Number: 21 CFR 880. 5860; Review Panel: General Hospital
Indications for use:
The Sterile Disposable 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 Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose.
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
{5}------------------------------------------------
minimize risk of accidental needle sticks.
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.
Device Description
The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.
| Needle Gauge | Needle length |
|---|---|
| 18G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 20G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 21G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 22G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 25G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 27G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
Needle specification:
Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.
Syringe volume: 0.5ml,1ml,2ml,3ml,5ml,10ml,20ml,30ml,50ml and 60ml Needle specification:
| Needle Gauge | Needle length |
|---|---|
| 18G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 20G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 21G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 22G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 25G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
| 27G | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" |
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Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
- રું. Identification of Predicate Device
Predicate Device
510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe with Needle Sterile Disposable Syringe Sterile Disposable Safety Needle Sterile Disposable Needle
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
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
-
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
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-
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 >
-
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
-
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
-
ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide Sterilization Residuals
-
ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
-
USP<85> Bacterial Endotoxins Test
-
USP<151> Pyrogen Test
-
USP<788> Particulate Matter in Injections
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems (DC-13, Level II)
Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device. The test results show that the device conforms with the requirements of related standards.
| General requirements | Clause 5 of ISO 7886-1:2017 |
|---|---|
| Extraneous matter | Clause 6 of ISO 7886-1:2017 |
| Lubricant | Clause 7 of ISO 7886-1;2017 |
| Tolerance on graduated capacity | Clause 8 of ISO 7886-1:2017 |
| Graduated scale | Clause 9 of ISO 7886-1:2017 |
| Barrel | Clause 10 of ISO 7886-1:2017 |
| Piston/ plunger assembly | Clause 11 of ISO 7886-1:2017 |
| Nozzle | Clause 12 of ISO 7886-1:2017 |
| Performance | Clause 13 of ISO 7886-1:2017 |
| Cleanliness | Clause 4.3 of ISO 7864:2016 |
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 |
| Limits for extractable metals | Clause 4.5 of ISO 7864:2016 |
| Size designation | Clause 4.6 of ISO 7864:2016 |
| Colour coding | Clause 4.7 of ISO 7864:2016 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Needle Cap | Clause 4.9 of ISO 7864:2016 |
| Needle tube | Clause 4.10 of ISO 7864:2016 |
| Needle point | Clause 4.11 of ISO 7864:2016 |
| Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 |
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| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
|---|---|
| Surface finish and appearance | Clause 5.2 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 |
| Size designation | Clause 5.5 of ISO 9626:2016 |
| Dimensions | Clause 5.6 of ISO 9626:2016 |
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 |
| Item | Standard |
| Fluid leakage | Clause 6.1 of ISO 80369-7:2016 |
| Sub-atmospheric pressure air leakage | Clause 6.2 of ISO 80369-7:2016 |
| Stress cracking | Clause 6.3 of ISO 80369-7:2016 |
| Resistance to separation form axial load | Clause 6.4 of ISO 80369-7:2016 |
| Resistance to separation form unscrewing | Clause 6.5 of ISO 80369-7:2016 |
| Resistance to overriding | Clause 6.6 of ISO 80369-7:2016 |
| Particulate testing | USP <788> |
Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP <85> |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Testwere performed on aging samples to verify theclaimed shelf life of the device |
Biocompatibility testing
The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (<24 hours). The proposed device was evaluated for the following tests. The results for the
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biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.
-
Cytotoxicity,
-
Sensitization,
-
Irritation,
- Acute Systemic Toxicity, >
-
Hemolysis,
-
Complement activation,
-
Thromboresistance study
-
Pyrogen
Simulated Clinical Study
A simulated clinical study was performed on proposed device according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Safety Feature Test
The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that both the proposed device and predicate device meet the acceptance criteria.
7. Clinical Test Conclusion
No clinical study is included in this submission.
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Summary of Technology Characteristics 8.
| ITEM | Proposed Device | Predicate DeviceK170651 | Remark |
|---|---|---|---|
| Product | Sterile Disposable Syringe withSafety Needle | Sterile Disposable Syringe withSafety Needle | / |
| Product Code | FMFFMIMEG | FMFFMIMEG | Same |
| RegulationNumber | 21 CRF 880.586021 CRF 880.5570 | 21 CRF 880.586021 CRF 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indications forUse | The Sterile Disposable Syringewith Safety Needle is intendedfor use in the aspiration andinjection of fluids for medicalpurpose. After withdrawal of theneedle from the body, theattached needle safety shield canbe manually activated to coverthe needle immediately after useto minimize risk ofaccidental needle sticks. | The Sterile Disposable Syringewith Safety Needle is intended foruse in the aspiration and injectionof fluids for medical purpose.After withdrawal of the needlefrom the body, the attached needlesafety shield can be manuallyactivated to cover the needleimmediately after use tominimize risk ofaccidental needle sticks. | Same |
| Configuration | Syringe | Barrel (luer lock/ luer slip) | Different |
| PlungerPistonNeedle hubNeedle tubeNeedle capSafety sheath | |||
| Operation Mode | For manual use only | For manual use only | Same |
| Sterilized | Yes | Yes | Same |
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| Single Use | Single Use | Single Use | Same | |
|---|---|---|---|---|
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | |
| Syringe | Volume | 0.5ml, 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | 1ml, 2ml 3ml, 5ml, 10ml, 20ml, 30ml, 50ml,60ml | Different |
| Connector Type | 0.5ml,1ml: Luer Lock, Luer Slip, Fixed needle; Others: Luer Lock and Luer Slip | Luer Lock/ Luer slip | ||
| Needle | Size | 18G, 20G, 21G, 22G, 25G, 27G | 16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | Different |
| Length | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" | 5/16", 1/2", 5/8", 1", 1-1/4", 1-1/2" 3/4", | ||
| 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 | |
| Luer Connector Performance | Complied with ISO 80369-7 | Complied with ISO 594-2 | Different | |
| Barrel | Polypropylene (PP) | Polypropylene (PP) | ||
| Plunger | Polypropylene (PP) | Polypropylene (PP) | ||
| Piston | Polyisoprene | Polyisoprene | ||
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same | |
| Needle tube | Stainless Steel SUS 304 | Stainless Steel SUS 304 | Same | |
| Lubricants | Silicone oil | Silicone Oil | ||
| Adhesive | UV adhesive | UV glue | ||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | ||
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | ||
| Sensitization | No sensitization | No skin sensitization | Same | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity |
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| Hemolysis | No Hemolysis | No Hemolysis | No Hemolysis | |
|---|---|---|---|---|
| Pyrogen | No Pyrogen | No Pyrogen | No Pyrogen | |
| ComplementActivation | Not show potentials toactivate complete system | Not show potentials toactivate complete system | Not show potentials toactivate completesystem | |
| In-vivoThrombogenicity | No thrombogenicity | No thrombogenicity | No thrombogenicity | |
| Sterilization | ||||
| Method | EO Sterilized | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | 10-6 | Same |
| EndotoxinLimit | 20 EU per device | 20 EU per device | 20 EU per device | Same |
Different - Configuration
The configuration of proposed device is similar to the configurations of predicate device. For 0.5ml and 1ml syringe, the proposed device has luer lock connector and fixed needle, the other volumes have luer lock and luer slip connector. The predicate device only has luer slip connector. The proposed device has luer lock connector, luer slip connector and fixed needle have been tested and meet the requirements of relevant standards. Based on above analysis, the difference on configuration will not raise new questions on safety and effectiveness of the proposed device.
Different -Syringe Volume
The syringe volume for proposed device is similar to the predicate devices. The predicate device does not have a 0.5ml syringe. This difference will not raise new questions on safety and effectiveness of the proposed device.
Different - Syringe Connector Type
The syringe connector type of proposed device is similar as the predicate device. For 0.5ml and 1ml syringe, the proposed device has luer lock connector, luer slip connector and fixed needle, the other volumes have luer lock connector and luer slip. The predicate device has luer lock or luer slip connector.
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In addition, the proposed device has luer lock connector, luer slip connector and fixed needle have been tested and meet the requirements of relevant standards. Based on above analysis, the difference on connector type will not raise new questions on safety and effectiveness of the proposed device.
Different -Needle Size and Length
The needle size and length for proposed device is different from the predicate device. The needle length is very close to that of the predicate device. This difference will not raise new questions on safety and effectiveness of the proposed device.
Different -Luer Connector Performance
Although the proposed device and the predicate device follow different luer connector standards - this is because ISO 594-1,594-2 is replaced by ISO 80369-7. The test results of the proposed device show that the connector performance meet the requirements of ISO 80369-7. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.
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| ITEM | Proposed Device | Predicate DeviceK170651 | Remark |
|---|---|---|---|
| Product | Sterile Disposable Syringe withSafety Needle | Sterile Disposable Syringe withSafety Needle | / |
| Product Code | FMFFMI | FMFFMI | Same |
| Regulation Number | 21 CRF 880.586021 CRF 880.5570 | 21 CRF 880.586021 CRF 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Sterile Disposable Syringe withNeedle is intended for use in theaspiration and injection of fluidsfor medical purpose. | The Sterile Disposable Syringewith Needle is intended for use inthe aspiration and injection offluids for medical purpose. | Same |
| Configuration | Syringe | Barrel (luer lock/luerslip)PlungerPiston | Different |
| Syringe | Barrel (luer lock/ luerslip/ fixed needle)PlungerPiston | ||
| Needle | Needle hubNeedle tubeNeedle cap | ||
| Needle | Needle hubNeedle tubeNeedle cap | ||
| Operation Mode | For manual use only | Same | |
| Sterilized | Yes | Same | |
| Single Use | Single Use | Same | |
| Label/Labeling | Complied with 21 CFR part 801 | Same | |
| Syringe | Volume | 0.5ml, 1ml, 2ml, 3ml, 5ml, 10ml,20ml, 30ml, 50ml, 60ml | Different |
| Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml,30ml, 50ml, 60ml | ||
| Syringe | ConnectorType | Luer Lock and Luer Slip | Same |
| Needle | Size | 18G, 20G, 21G, 22G, 25G, 27G | Different |
| Needle | Size | 16G, 18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G,28G, 29G, 30G | |
| Length | 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" | ||
| Length | 5/16", 1/2", 5/8", 3/4", 1", 1-1/4",1-1/2" | ||
| SyringePerformance | Complied withISO 7886-1 | Same | |
| Needle Performance | Complied with ISO 7864 | Same | |
| ISO 9626 | ISO 9626 | ||
| LuerConnectorPerformance | Complied withISO 80369-7 | Complied withISO 594-2 | Different |
| Patient-contact materials | |||
| Barrel | Polypropylene (PP) | Polypropylene (PP) | |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | |
| Piston | Polyisoprene | Polyisoprene | |
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same |
| Needle tube | Stainless Steel SUS 304 | Stainless Steel SUS 304 | |
| Lubricants | Silicone oil | Silicone Oil | |
| Adhesive | UV adhesive | UV glue | |
| Biocompatibility | |||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No skin sensitization | Same |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | |
| Hemolysis | No Pyrogen | No Pyrogen | |
| Pyrogen | Not show potentials to activatecomplete system | Not show potentials to activatecomplete system | |
| ComplementActivation | No thrombogenicity | No thrombogenicity | |
| In-vivoThrombogenicity | No thrombogenicity | No thrombogenicity | |
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | |
| EndotoxinLimit | 20 EU per device | 20 EU per device |
Table 2. Comparison of Sterile Disposable Syringe with Needle
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510(k) Summary
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Different -Syringe Volume
The syringe volume for proposed device is similar to the predicate devices. The predicate device does not have a 0.5ml syringe. This difference will not raise new questions on safety and effectiveness of the proposed device.
Different -Needle Size and Length
The needle size and length for proposed device is different from the predicate device. This difference will not raise new questions on safety and effectiveness of the proposed device.
Different - Luer Connector Performance
The luer connector performance of proposed device is complied with ISO 80369-7, the predicate device is complied with complied with ISO 594-2. They are all the test standards of luer connector. At present, ISO 594-2 has been replaced by ISO 80369-7. The predicate device was tested according to ISO 594-2 because the application time was earlier. The proposed devices are tested according to the latest version of the standard ISO 80369-7. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.
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| ITEM | Proposed Device | Predicate Device K170651 | Remark | |
|---|---|---|---|---|
| Product | Sterile Disposable SafetyNeedle | Sterile Disposable SafetyNeedle | / | |
| Product Code | FMI | FMI | Same | |
| Regulation Number | 21 CRF 880.5860 | 21 CRF 880.5860 | Same | |
| Class | Class II | Class II | Same | |
| Indication for Use | The Sterile Disposable SafetyNeedle is intended to be usedwith a luer slip or luer locksyringe for aspiration andinjection of fluids for medicalpurpose. After withdrawal ofthe needle from the body, theattached needle safety shieldcan be manually activated tocover the needle immediatelyafter use to minimize risk ofaccidental needlestick. | The Sterile Disposable SafetyNeedle is intended to be usedwith a luer slip or luer locksyringe for aspiration andinjection of fluids for medicalpurpose. After withdrawal ofthe needle from the body, theattached needle safety shieldcan be manually activated tocover the needle immediatelyafter use to minimize risk ofaccidental needlestick. | Same | |
| Configuration | Needle hub | Needle hub | Same | |
| Needle tube | Needle tube | |||
| Needle cap | Needle cap | |||
| Safety machine | Safety sheath | |||
| Operation Mode | For manual use only | For manual use only | Same | |
| Sterilized | Yes | Yes | Same | |
| Single Use | Single Use | Single Use | Same | |
| Label/Labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | Same | |
| Needle | Size | 18G, 20G, 21G, 22G, 25G,27G | 16G, 18G, 19G, 20G, 21G,22G, 23G, 24G, 25G, 26G,27G, 28G, 29G, 30G | Different |
| Length | 1/2", 5/8", 3/4", 1", 1-1/4",1-1/2" | 5/16", 1/2", 5/8", 3/4", 1",1-1/4", 1-1/2" | ||
| Needle Performance | Complied with ISO 7864,ISO 9626 | Complied with ISO 7864,ISO 9626 | Same | |
| Patient-contact Materials | ||||
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same | |
| Needle tube | Stainless Steel SUS 304 | Stainless Steel SUS 304 | ||
| Lubricants | Silicone oil | Silicone oil | ||
| Adhesive | UV adhesive | UV glue | ||
| Biocompatibility | ||||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | ||
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | ||
| Sensitization | No sensitization | No skin sensitization | ||
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | ||
| Hemolysis | No Hemolysis | No Hemolysis | Same | |
| Pyrogen | No Pyrogen | No Pyrogen | ||
| Complement Activation | Not show potentials to activate complete system | Not show potentials to activate complete system | ||
| In vivo Thrombogenicity | No thrombogenicity | No thrombogenicity | ||
| Sterilization | ||||
| Method | EO Sterilized | EO Sterilized | ||
| SAL | 10-6 | 10-6 | Same | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same | |
| ITEM | Proposed Device | Predicate Device K170651 | Remark | |
| Product | Sterile Disposable Needle | Sterile Disposable Needle | / | |
| Product Code | FMI | FMI | Same | |
| Regulation Number | 21 CRF 880.5860 | 21 CRF 880.5860 | Same | |
| Class | Class II | Class II | Same | |
| Indication for Use | The Sterile Disposable Needleis intended to be used with a | The Sterile Disposable Needleis intended to be used with a | Same | |
| luer slip or luer lock syringe for | luer slip or luer lock syringe | |||
| aspiration and injection of | for aspiration and injection of | |||
| fluids for medical purpose. | fluids for medical purpose. | |||
| Configuration | Needle hub | Needle hub | Same | |
| Needle tube | Needle tube | |||
| Needle cap | Needle cap | |||
| Operation Mode | For manual use only | For manual use only | Same | |
| Sterilized | Yes | Yes | Same | |
| Single Use | Single Use | Single Use | Same | |
| Label/Labeling | Complied with 21 CFR part801 | Complied with 21 CFR part801 | Same | |
| Needle | Size | 18G, 20G, 21G, 22G, 25G,27G | 16G, 18G, 19G, 20G, 21G,22G, 23G, 24G, 25G, 26G,27G, 28G, 29G, 30G | Different |
| Length | 1/2", 5/8", 3/4", 1", 1-1/4",1-1/2" | 5/16", 1/2", 5/8", 3/4", 1",1-1/4", 1-1/2" | ||
| Needle Performance | Complied withISO 7864,ISO 9626 | Complied withISO 7864,ISO 9626 | Same | |
| Patient-contact Materials | ||||
| Needle hub | Polypropylene (PP) | Polypropylene (PP) | Same | |
| Needle tube | Stainless Steel SUS 304 | Stainless Steel SUS 304 | ||
| Lubricants | Silicone oil | Silicone oil | Same | |
| Adhesive | UV adhesive | UV glue | ||
| Biocompatibility | ||||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same | |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | ||
| Sensitization | No sensitization | No skin sensitization | ||
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | ||
| Hemolysis | No Hemolysis | No Hemolysis | ||
| Pyrogen | No Pyrogen | No Pyrogen | ||
| Complement Activation | Not show potentials to activate complete system | Not show potentials to activate complete system | ||
| In vivo Thrombogenicity | No thrombogenicity | No thrombogenicity | ||
| Sterilization | ||||
| Method | EO Sterilized | EO Sterilized | Same | |
| SAL | 10-6 | 10-6 | Same | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
Table 3. Comparison of Sterile Disposable Safety Needle
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Different -Needle Size and Length
The needle size and length for proposed device is different from the predicate device. This difference will not raise new questions on safety and effectiveness of the proposed device.
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Table 4. Comparison of Sterile Disposable Needle
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Different -Needle Size and Length
The needle size and length for proposed device is different from the predicate devices. This difference will not raise new questions on safety and effectiveness of the proposed device.
9. Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission, Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle and Sterile Disposable is as safe and effective as the legally marketed predicate device cleared under K170651.
§ 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).