(472 days)
Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.
Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle cap.
All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume.
The provided text describes the 510(k) summary for a Disposable Sterile Syringe (K221777) and its substantial equivalence to a predicate device. This document is a regulatory submission for a medical device that does not involve AI or complex software, and therefore, many of the requested details regarding acceptance criteria, study methodologies for AI/software performance (e.g., sample size for test sets, expert adjudication, MRMC studies, standalone performance, ground truth for AI), and training set information are not applicable.
The device is a simple, physical product (a syringe) and its "performance" is assessed through adherence to established international and ASTM standards for physical, chemical, and biological properties, as well as sterility and packaging integrity. The acceptance criteria for such a device are primarily defined by these international standards.
Here's an attempt to address the points based on the provided document, highlighting what is applicable and what isn't:
Device: Disposable Sterile Syringe (K221777)
Purpose: Intended to inject fluids into or withdraw fluids from the body.
This device is a traditional medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to compliance with recognized standards and biocompatibility testing, rather than performance metrics like sensitivity, specificity, or AUC for an AI algorithm.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are its compliance with various ISO and ASTM standards. The "reported device performance" is essentially that the device "meets the requirements of related standards" and that "there are no negative impacts from the materials that are used in the proposed device."
| Item / Test Category | Standard / Acceptance Criteria (Derived from document) | Reported Device Performance (Summary from document) |
|---|---|---|
| Physical/Mechanical Performance | ||
| Cleanliness | ISO 7864:2016 Clause 4.3; ISO 9626:2016 Clause 5.3 | Meets requirements (Implied by "complies with") |
| Acidity/Alkalinity | ISO 7864:2016 Clause 4.4; ISO 9626:2016 Clause 5.4 | Meets requirements |
| Extractable Metals | ISO 7864:2016 Clause 4.5 | Meets requirements |
| Size Designation | ISO 7864:2016 Clause 4.6; ISO 9626:2016 Clause 5.5 | Meets requirements |
| Color Coding | ISO 7864:2016 Clause 4.7; ISO 6009:2016 | Meets requirements |
| Needle Hub | ISO 7864:2016 Clause 4.8 | Meets requirements |
| Sheath | ISO 7864:2016 Clause 4.9 | Meets requirements |
| Needle Tube | ISO 7864:2016 Clause 4.10 | Meets requirements |
| Needle Point | ISO 7864:2016 Clause 4.11 | Meets requirements |
| Bond (hub/tube) | ISO 7864:2016 Clause 4.12 | Meets requirements |
| Patency of Lumen | ISO 7864:2016 Clause 4.13 | Meets requirements |
| Surface Finish | ISO 9626:2016 Clause 5.1 | Meets requirements |
| Dimensions | ISO 9626:2016 Clause 5.6 | Meets requirements |
| Stiffness | ISO 9626:2016 Clause 5.7 | Meets requirements |
| Resistance to Breakage | ISO 9626:2016 Clause 5.8 | Meets requirements |
| Resistance to Corrosion | ISO 9626:2016 Clause 5.9 | Meets requirements |
| Extraneous Matter | ISO 7886-1:2017 Clause 6 | Meets requirements |
| Lubricant | ISO 7886-1:2017 Clause 7 | Meets requirements |
| Graduated Capacity Tolerance | ISO 7886-1:2017 Clause 8 | Meets requirements |
| Graduated Scale | ISO 7886-1:2017 Clause 9 | Meets requirements |
| Barrel | ISO 7886-1:2017 Clause 10 | Meets requirements |
| Piston/Plunger Assembly | ISO 7886-1:2017 Clause 11 | Meets requirements |
| Nozzle | ISO 7886-1:2017 Clause 12 | Meets requirements |
| General Performance | ISO 7886-1:2017 Clause 13 | Meets requirements |
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 | No cytotoxicity / No negative impacts |
| Irritation | ISO 10993-10:2010 | No intracutaneous reactivity / No negative impacts |
| Sensitization | ISO 10993-10:2010 | No skin sensitization / No negative impacts |
| Systemic Toxicity | ISO 10993-11:2017 | No systemic toxicity / No negative impacts |
| Hemolysis | ISO 10993-4:2017 | No Hemolysis / No negative impacts |
| Pyrogen | Performed (Result is "No Pyrogen" listed in Table 2) | No Pyrogen / No negative impacts |
| Sterilization & Packaging | ||
| EO residue | ISO 11737-2:2019 | Did not exceed the limit |
| Endotoxin limit | Not specified standard, but a limit of 20EU/device | Did not exceed 20EU/device |
| Visual Inspection | ASTM F1886/F1886M-16 | Package can maintain its integrity |
| Seal Strength | ASTM F88/F88M-15 | Package can maintain its integrity |
| Dye Penetration Test | ASTM F1929-15 | Package can maintain its integrity |
| Shelf-Life | Physical, Mechanical, Chemical, Package Tests | Device can maintain its performance during claimed shelf life |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for each test. For medical device testing, samples are typically chosen according to relevant standard methods (e.g., lot-based sampling conforming to AQL – Acceptable Quality Level).
- Data Provenance: Not explicitly stated regarding country of origin for the non-clinical test data. The tests were performed by "Weihai Shengjie Medical Technology Co., Ltd." in China, where the manufacturing entity is located. The tests are "nonclinical" (laboratory-based) and are implicitly prospective for the purpose of demonstrating compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a physical device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is provided by the universally recognized and standardized test methods and their defined acceptance limits (e.g., ISO, ASTM standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human interpretation or adjudication of case data is involved for this type of device submission. Compliance is determined by objective physical, chemical, and biological test results against predefined standard thresholds.
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
- Not Applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this medical device's performance is compliance with established international and national standards (ISO, ASTM). These standards define the acceptable physical, mechanical, chemical, and biological properties for the device. For example, for biocompatibility, the ground truth is "no cytotoxicity" as per ISO 10993-5, determined by validated laboratory methods.
8. The sample size for the training set
- Not Applicable. This device uses traditional manufacturing and testing, not machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 6, 2023
Weihai Shengjie Medical Technology Co., Ltd Huihui Wang Manager No.58. Chuhe South Road High-Tech Industrial District, Weihai Weihai. Shandong 264210 China
Re: K221777
Trade/Device Name: Disposable Sterile Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: August 28, 2023 Received: August 29, 2023
Dear Huihui Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,
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General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221777
Device Name Disposable Sterile Syringe
Indications for Use (Describe)
Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Tab #5 510(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: K221777
-
- Date of Preparation: 03/20/2022
-
- Sponsor Identification
Weihai Shengjie Medical Technology Co., Ltd.
No.58, Chuhe South Road, High-Tech Industrial District, Weihai, Shandong, China
Establishment Registration Number:3014632157
Contact Person: Huihui Wang Position: Manager Tel: +86-631-5679637 Fax: +86-631-5623812 Email: 383291896@qq.com
3.Identification of Proposed Device
Trade Name: Disposable Sterile Syringe Common Name: Piston Syringe Common Name: Hypodermic Single Lumen Needle
Regulatory Information: Classification: II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
Regulatory Information:
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Classification: II Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital
Indications for use:
Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.
Device Description:
Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle сар.
All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume. The syringe size, needle gauges and lengths are provided in following table.
| Syringe Size | Needle Gauge | Needle Length |
|---|---|---|
| 0.5 ML | 27G,28G,29G,30G | 1/2",3/8",5/8" |
| 1 ML | 26G | 1/2",5/8",3/8",1" |
| 25G,24G | 5/8",3/8",3/4",1" | |
| 23G | 3/4",1" | |
| 2 ML,2.5 ML,3 ML,5 ML | 26G | 1/2",5/8",3/8",1" |
| 25G,24G | 5/8",3/8",3/4",1" | |
| 23G | 3/4",1" | |
| 22G | 1",1 1/4",1 1/5" | |
| 10 ML,20 ML,30 ML,50 ML,60 ML | 18G,19G,20G,21G,22G | 1",1 1/4",1 1/2",1 1/5" |
| 100 ML | 16G,18G,19G,20G,21G | 1 1/4",1 1/2",1 1/5" |
4.Predicate Device Identification
510(k) Number: K163161
Product Name: Sterile Single-use Syringe with Needle Manufacturer: JiangXi HongDa Medical Equipment Group Ltd.
- Comparison of technological characteristics with the predicate devices
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| Item | Proposed Device | Predicate Device (K163161) | Remark |
|---|---|---|---|
| Disposable Sterile Syringe | Sterile Single-use Syringe with | ||
| Needle | |||
| Product Code | FMF, FMI | FMF, FMI | SAME |
| Regulation | 21 CFR 880.5860 | 21 CFR 880.5860 | SAME |
| Number | 21 CRF 880.5570 | 21 CRF 880.5570 | SAME |
| Class | II | II | SAME |
| Indicationsfor Use | Disposable Sterile Syringe isintended to inject fluids into orwithdraw fluids from the body. | Sterile Single-use Syringe withNeedle is intended to inject fluidsinto or withdraw fluids from thebody. | SAME |
| OperationMod | For manual use only | For manual use only | SAME |
| Principleofoperation | The syringe is composed of asyringe with a small hole at thefront end and a matching pistoncore rod. It uses the "hydraulic"principle to transport liquid.Through the action of force, whenthe core rod is pushed in, the liquidis pushed from the place with highpressure to the place where thepressure is high. Low pressureplace. Inject a small amount offluidintoamuscle,subcutaneously, or into a vein. Orwhen the mandrel is pulled out, theliquid or gas is sucked from thesmall hole at the front end of thesyringe. | The syringe is composed of asyringe with a small hole at thefront end and a matching pistoncore rod. It uses the "hydraulic"principle to transport liquid.Through the action of force, whenthe core rod is pushed in, the liquidis pushed from the place with highpressure to the place where thepressure is high. Low pressureplace. Inject a small amount offluid into a muscle,subcutaneously, or into a vein. Orwhen the mandrel is pulled out, theliquid or gas is sucked from thesmall hole at the front end of thesyringe. | SAME |
| Intended user | Medical professionals and trainedcare givers | Medical professionals and trainedcare givers | SAME |
| Environmentof use | Hospitals and clinics | Hospitals and clinics | SAME |
| Item | Proposed Device | Predicate Device (K163161) | Remark |
| Disposable Sterile Syringe | Sterile Single-use Syringe with | ||
| Needle | |||
| SyringeVolume | 0.5,1,2,2.5,3,5,10,20,30,50,60,100ml | 1ml, 3ml, 5ml, 10ml, 20ml, 60ml | DifferentComment#1 |
| Nozzle type | Luer Slip and Luer Lock | Luer Slip and Luer Lock | SAME |
| Lubricant | Silicone oil | Silicone oil | SAME |
| Barreltransparency | Clear as required by ISO 7886-1 | Clear as required by ISO 7886-1 | SAME |
| Gradationslegibility | Clear as required by ISO 7886-1 | Clear as required by ISO 7886-1 | SAME |
| NeedleLength | 1/2",5/8",3/8",1",1 1/4",1 1/2" | 1/2", 5/8", 1", 1 1/4", 1 1/2" | DifferentComment#2 |
| NeedleGauge | 16G, 18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G,28G,29G, 30G | 18G, 20G, 21G, 22G, 23G, 25G,26G, 27G,28G, 29G, 30G | DifferentComment#3 |
| Configurationof the tip | Short bevel, long bevel. | Short bevel, long bevel. | SAME |
| Needle hub | Colorless according to ISO 7864 | Colorless according to ISO 7864 | SAME |
| Single Use | Yes | Yes | SAME |
| Performance | Complies with ISO 7864, ISO | Complies with ISO 7864, ISO | SAME |
| specifications | 7886-1, ISO 7886-4 | 7886-1, ISO 7886-4 | |
| Sterilization | EO Sterilization | EO Sterilization | SAME |
| SAL | 10-6 | 10-6 | SAME |
Table 1 General Comparison
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Table 2 Performance Comparison
Comment #1
Differences in specifications and models can provide users with more flexible choices in terms of injection volume and injection accuracy, and have no impact on clinical applications.
Comment #2
The subject device is available in gauges 16G-30G and the predicate device is available in 18G-30G. Performance testing was done per ISO 9626 and ISO 7864 done to demonstrate that the differences in needle gauges do not affect the clinical safety or effectiveness of the devices.
Comment #3
Differences in specifications and models can provide users with more flexible choices in terms of injection volume and injection accuracy, and have no impact on clinical applications.
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| Item | Proposed DeviceDisposable Sterile Syringe | Predicate Device (K163161)Sterile Single-use Syringe withNeedle | Remark | ||
|---|---|---|---|---|---|
| Configurationand material | Barrel | Polypropylene(PP) | Barrel | Polypropylene(PP) | |
| Plunger | Polypropylene(PP) | Plunger | Polypropylene(PP) | ||
| Piston | Polyisoprene | Piston | Polyisoprene | ||
| Needle tube | Stainless Steel,SUS304 | Needle tube | Stainless Steel,SUS304 | SAME | |
| Needle hub | Polypropylene(PP) | Needle hub | Polypropylene(PP) | ||
| Needle cap | Polypropylene(PP) | Needle cap | Polypropylene(PP) | ||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | SAME | ||
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | SAME | ||
| Sensitization | No skin sensitization | No skin sensitization | SAME | ||
| SystemicToxicity | No systemic toxicity | No systemic toxicity | SAME | ||
| Hemolysis | No Hemolysis | No Hemolysis | SAME | ||
| Pyrogen | No Pyrogen | No Pyrogen | SAME | ||
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | SAME |
6.Performance data
Nonclinical 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:
- A ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- A ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Test for irritation and skin sensitization.
- A ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- A ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood
- A ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for
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Flexible Packaging by Visual Inspection
- A 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 A by Dye Penetration
- A 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 6009:2016 Hypodermic needles for single use – Colour coding for identification
-
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use
- ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part > 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device.
The test results show that the device meets the requirements of related standards.
| Item | Standard |
|---|---|
| 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 |
| Color coding | Clause 4.7 of ISO 7864:2016 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Sheath | 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 |
| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
| Item | Standard |
|---|---|
| Surface finish | Clause 5.1 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
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Premarket Notification 510(k) Submission
| 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 5.7 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.8 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.9 of ISO 9626:2016 |
| Item | Standard |
|---|---|
| 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 |
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 de vice. EO residue did not exceed the limit of ISO 11737-2:2019. Endotoxin limit did not exceed 20EU/device. Shelf-life test result showed that the device can maintain its performance during the claimed shelf life.
| Item | Standard |
|---|---|
| EO residue | ISO 11737-2:2019 |
| Shelf-Life Evaluation | Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed 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 ●
- Skin Sensitization
- Intracutaneous Reactivity (Irritation) ●
- Acute Systemic Toxicity ●
- Material-Mediated Pyrogens ●
- Hemolysis
7.Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject Device, Disposable Sterile Syringe, is substantially equivalent to the predicate Device, Sterile Single-use Syringe with Needle, K163161.
§ 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).