(225 days)
The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The Sterile Syringes for Single Use with/without Needle are three-piece, sterile, single use hypodermic syringes with a 6% (Luer) male connector/lock fitting in various sizes. Each syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
The provided document is an FDA 510(k) clearance letter and associated summary for a medical device (Sterile syringes for single use with/without needle). This document describes the device, its intended use, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.
However, the document does not describe a study involving an AI/algorithm-driven device with human-in-the-loop performance, nor does it detail acceptance criteria and performance for such a device in the way requested by your prompt. The device cleared is a manual medical device (syringes), not an AI-powered diagnostic or therapeutic tool.
Therefore, many of the requested details regarding AI acceptance criteria, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.
Below is a breakdown of the relevant information found in the document, framed as closely as possible to your prompt's structure, along with clear statements about what information is not available given the nature of the cleared device:
Analysis of Acceptance Criteria and Study for the Sterile Syringes for Single Use with/without Needle
The acceptance criteria and study detailed in the provided FDA 510(k) summary pertain to the physical, chemical, and biological performance of a manual medical device (sterile syringes), not an AI-powered system. As such, information regarding AI-specific criteria, human reader improvement with AI assistance, or expert consensus on AI outputs is not present.
The study proves the device meets the acceptance criteria through demonstrating substantial equivalence to a legally marketed predicate device, primarily by showing compliance with recognized international and national standards for syrings and needles.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are generally established by compliance with a comprehensive set of recognized industry standards. The reported device performance is that it "meets the requirements" or "complies with" these standards.
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 (overall) | The evaluation of the testing items meets the requirements. |
| Cytotoxicity (ISO 10993-5:2009) | Meets requirements | |
| Skin sensitization (ISO 10993-10:2010) | Meets requirements | |
| Hemolysis (ISO 10993-4:2017) | Meets requirements | |
| Intracutaneous reactivity (ISO 10993-10:2010) | Meets requirements | |
| Acute systemic toxicity (ISO 10993-11:2017) | Meets requirements | |
| Pyrogenicity (ISO 10993-11:2017) | Meets requirements (also "Non-pyrogenic" in comparison table) | |
| Particulate (USP <788>) | Meets requirements | |
| Sterilization & Shelf-Life | ISO 11135 (Sterilization) | Validated; thereby determined routine control and monitoring parameters. |
| Shelf Life Evaluation (e.g., physical, chemical, biological, sterility, seal strength, leakage) | 3 years shelf life determined based on stability studies (including accelerated aging). Tests performed: EO residue (ISO 10993-7), ECH residue (ISO 10993-7), Packaging Standards (ISO 11607, ASTM F1980, ASTM D4169, ASTM F88/F88M, ASTM F1140/F1140M, ASTM F1929, ASTM F2096), Microbial Barrier (DIN 58953-6). | |
| Performance Testing (Syringe) | ISO 7886-1:2017 (general) | Complies with the standard. |
| Cleanliness (Cl 6.1) | Complies | |
| Acidity/Alkalinity Limits (Cl 6.2) | Complies | |
| Extractable metals Limits (Cl 6.3) | Complies | |
| Lubricant (Cl 7) | Complies | |
| Graduated capacity tolerance (Cl 8) | Complies | |
| Scale, Numbering, Length, Position (Cl 9.1-9.4) | Complies | |
| Dimensions, Barrel flanges (Cl 10.1-10.2) | Complies | |
| Design (Cl 11.1) | Complies | |
| Conical fitting (Cl 12.1, ISO 80369-7) | Complies | |
| Nozzle position/lumen (Cl 12.2-12.3) | Complies | |
| Dead Space (Cl 13.1) | Complies | |
| Freedom from air/liquid leakage past plunger stopper (Cl 13.2) | Complies | |
| Force to operate piston (Cl 13.3) | Complies | |
| Fit of plunger stopper/plunger (Cl 13.4) | Complies | |
| Performance Testing (Needle) | ISO 7864:2016 (general) | Complies with the standard. |
| Cleanliness (Cl 4.3) | Complies | |
| Acidity/Alkalinity Limits (Cl 4.4) | Complies | |
| Extractable metals Limits (Cl 4.5) | Complies | |
| Tubular needle designation (Cl 4.6) | Complies | |
| Color coding (Cl 4.7) | Complies (Color-coded per ISO 6009) | |
| Needle hub (Cl 4.8, ISO 80369-7, ISO 6009) | Complies | |
| Needle cap (Cl 4.9) | Complies | |
| Needle tube (length, defects, lubricant) (Cl 4.10) | Complies | |
| Needle Point (Cl 4.11) | Complies | |
| Bond between Tube and Hub (Cl 4.12) | Complies | |
| Patency of Lumen (Cl 4.13) | Complies | |
| Performance Testing (Luer Connectors) | ISO 80369-7:2016 (now 2021) (general) | Complies with the standard. |
| Dimensional requirements (Cl 5) | Complies | |
| Fluid leakage (Cl 6.1.3) | Complies | |
| Sub-atmospheric pressure air leakage (Cl 6.2) | Complies | |
| Stress cracking (Cl 6.3) | Complies | |
| Resistance to separation (axial/unscrewing) (Cl 6.4-6.5) | Complies | |
| Resistance to overriding (Cl 6.6) | Complies | |
| Performance Testing (Needle Tube - Materials) | ISO 9626:2016 (general) | Complies with the standard. |
| Surface finish, visual appearance (Cl 5.2) | Complies | |
| Cleanliness (Cl 5.3) | Complies | |
| Acidity/Alkalinity Limits (Cl 5.4) | Complies | |
| Size designation (Cl 5.5) | Complies | |
| Dimensions (Cl 5.6) | Complies | |
| Stiffness (Cl 5.8) | Complies | |
| Resistance to breakage (Cl 5.9) | Complies | |
| Resistance to corrosion (Cl 5.10) | Complies | |
| Labeling | 21 CFR Part 801 | Meets the requirements. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for each test mentioned (e.g., how many syringes were tested for each performance criterion). It generally states that "The Sterile Syringes for Single Use with/without Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body."
- Data Provenance: The testing was conducted by or on behalf of the manufacturer, Zhejiang Kangkang Medical-Devices CO., Ltd., based in China. The data would therefore originate from China and pertain to laboratory testing of the manufactured device. The studies described are prospective laboratory tests performed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the evaluation is based on compliance with harmonized standards for physical and chemical properties of a device, not on clinical interpretation or ground truth established by medical experts for diagnostic accuracy. The "ground truth" here is the pass/fail result against established standard specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical trials involving human interpretation of medical images or data, not for laboratory compliance testing of a physical medical device. The "adjudication" is the assessment of compliance with the specified test methods and criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists, pathologists). The device under review is a manual syringe, which does not involve human readers in this context or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This concept is completely irrelevant to a manual medical device like a syringe.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by the specified physical, chemical, and biological requirements and test methods outlined in the referenced international and national standards (e.g., ISO 7886-1, ISO 10993, USP <788>, etc.). For instance, for sterility, the ground truth is achieving a Sterility Assurance Level (SAL) of $10^{-6}$. For dimensions, the ground truth is meeting the specified dimensional tolerances. This is entirely lab-based and objective measurement.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device (syringe), not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above. There is no AI training set.
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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 and Human Services logo. To the right of that 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.
September 10, 2021
Zhejiang Kangkang Medical-Devices CO., Ltd. Chun Guo General Manager Longwang Industrial District, Chumen Town Yuhuan, Zhejiang 317605 China
Re: K210227
Trade/Device Name: Sterile syringe for single use with/without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 6, 2021 Received: August 12, 2021
Dear Chun Guo:
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.
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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 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.
For Alan 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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Indications for Use
510(k) Number (if known) K210227
Device Name
Sterile syringes for single use with/without needle
Indications for Use (Describe)
The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from 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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K210227 510(k) Summary
Date
September 10, 2021
Submitter
Device submitter: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China
Contact person: Chun Guo General Manager Phone: 13586180908 / 89902728 Fax: 0576-87427630 Email: guochun@vip.126.com
Device
Trade Name of Device: Sterile syringes for single use with/without needle Common Name: Piston Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product code: FMF Review Panel: General Hospital
Predicate Device
| Trade name: | Sterile Hypodermic Syringe for Single use with/withoutNeedle (used as Predicate Device)Sterile Insulin Syringe for single use, with needleSterile Hypodermic Needle for single use |
|---|---|
| Common name: | Piston Syringe |
| Classification: | Class II, 21 CFR 880.5860 |
| Product Code: | FMF |
| Premarket Notification: | K112057 |
| Manufacturer: | Shanghai Kindly Enterprise Division Group Company |
Device description
The Sterile Syringes for Single Use with/without Needle are three-piece, sterile, single use hypodermic syringes with a 6% (Luer) male connector/lock fitting in various sizes. Each syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
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| Items | Specification | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type of nozzle | Central nozzle (1, 2, 3, 5, 10ml),Central nozzle or Eccentric nozzle (20, 30, 50, 60, 100ml) | |||||||||||
| Structure | Three-piece structure | |||||||||||
| Color of needlehub | Yellow | Grey | Medium | Brown | Orange | Purple | Middle blue | Black | Deep green | Yellow | Cream | Pink |
| OD of needletube | 30G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 19 G | 18 G | |
| Length of needletube | 1/2" | 5/8" | 1", 1 1/4", 1 1/2" | |||||||||
| Length of needlecovers (mm) | 12.5 | 12.5,16, 25 | 16,25 | 16,25 | 25, 32, 38 | |||||||
| Color of needlecovers | Transparent | |||||||||||
| Type of wall | Normal wall and thin wall | |||||||||||
| Blade angle | Short bevel and long bevel |
Indications for use
The Sterile Syringes for Single Use with/without Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
Comparison of technological characteristics with the predicate devices
The Sterile Syringes for Single Use with/without Needle have the same intended use, technology, and are substantially equivalent to the predicate device. The differences between the Sterile Syringes for Single Use with/without Needle and the predicate device do not alter suitability of the proposed device for its intended use.
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Table 5-1 Substantial equivalence discussion – Sterile syringes for single use with/without needle
| Device feature | Subject Device | Predicate Device K112057 |
|---|---|---|
| Indications for use | The Sterile Syringes for Single Use with/without Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body. | The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. |
| Product code | FMF | FMF |
| Regulation number | 21 CFR 880.5860 | 21 CFR 880.5860 |
| Class | II | II |
| Principle of operation | For manual use only | For manual use only |
| Intended user | Medical professionals and trained care givers | Medical professionals and trained care givers |
| Environment of use | Hospitals and clinics | Hospitals and clinics |
| Syringe volume1 | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml, 100ml | 1ml, 3ml, 5ml, 6ml, 10ml, 20ml, 30ml, 35ml and 50ml |
| Nozzle type | Luer slip; Luer lock | Luer slip; Luer lock |
| Lubricant for barrel | Silicone oil | Silicone oil |
| Barrel transparency | Transparent and clear | Transparent and clear |
| Gradations | Legible | Legible |
| legibility | ||
| Needle gauge | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 30G | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G |
| Needle hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 |
| Single use | Yes | Yes |
| Performance specifications | Complies with ISO 7886-1:2017 Sterile Hypodermic syringes for single use - Part 1: Syringes for manual use | Complies with ISO 7886-1:2017 Sterile Hypodermic syringes for single use - Part 1: Syringes for manual use |
| Sterilization | EO | EO |
| SAL | 10-6 | 10-6 |
| Materials2 | Barrel: PPPlunger: PPPiston: Silicone RubberNeedle: Stainless 304Needle hub: PP | Barrel: PPPlunger: PPPiston: Isoprene RubberNeedle: Stainless 304Needle hub: PP |
| Pyrogen | Non-pyrogenic | Non-pyrogenic |
| Biocompatibility | The biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA and the "Use of International Standard ISO 10993-1 "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process", June 16, 2016. The syringe of testing included the following tests:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the above testing items meets the requirements | The biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by FDA and the "Use of International Standard ISO 10993-1 "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process", June 16, 2016. The syringe of testing included the following tests:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the above testing items meets the requirements |
| Labeling | Meet the requirements of 21 CFRPart 801 | Meet the requirements of 21 CFR Part801 |
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-
The subject device has larger syringe volume sizes. Differences are addressed through testing per ISO 7886-1:2017.
-
There are material differences between the subject and predicate device. Differences are addressed through biocompatibility testing per ISO 10993.
Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Sterile syringes for single use with/without needle was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device - Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended:
| Cytotoxicity | ISO 10993-5: 2009 |
|---|---|
| Skin sensitization | ISO 10993-10: 2010 |
| Hemolysis | ISO 10993-4: 2017 |
| Intracutaneous reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |
| Particulate | USP <788> |
Sterilization and shelf life testing
The sterilization method has been validated per ISO 11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Sterile syringes for single use with/without needle is 3 years, determined based on stability studies which includes accelerated aging.
Sterilization and shelf life testing listed were performed on the proposed device.
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Shelf Life Evaluation | physical performance, chemicalperformance and biological performance,including sterility, and single package sealstrength test, creep/burst test, leakage test,gross leakage test and antibacterialperformance test were performed |
Shelf-Life Testing conducted per:
ISO 11607 Packaging for Terminally Sterilized Medical Devices
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM D 4169 Standard Practice for Performance Testing of Shipping Containers and Systems ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
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ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
ASTM F1929-15 Standard Test Method for Detecting Deal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
DIN 58953-6-2010 Sterilization-Sterile Supply-Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which are to be Sterilized
Performance testing
Performance testing is performed according to the following standards:
| ISO 7886-1: 2017 | |
|---|---|
| Cleanliness | Clause 6.1 of ISO 7886-1:2017 |
| Limits for acidity or alkalinity | Clause 6.2 of ISO 7886-1:2017 |
| Limits for extractable metals | Clause 6.3 of ISO 7886-1:2017 |
| Lubricant | Clause 7 of ISO 7886-1:2017 |
| Tolerance on Graduated capacity | Clause 8 of ISO 7886-1:2017 |
| Scale | Clause 9.1 of ISO 7886-1:2017 |
| Numbering of scales | Clause 9.2 of ISO 7886-1:2017 |
| Overall length of scale to nominalcapacity line | Clause 9.3 of ISO 7886-1:2017 |
| Position of scale | Clause 9.4 of ISO 7886-1:2017 |
| Dimensions | Clause 10.1 of ISO 7886-1:2017 |
| Barrel flanges | Clause 10.2 of ISO 7886-1:2017 |
| Design | Clause 11.1 of ISO 7886-1:2017 |
| Conical fitting | Clause 12.1 of ISO 7886-1:2017 andISO 80369-7 |
| Position of nozzle on end of barrel | Clause 12.2 of ISO 7886-1:2017 |
| Nozzle lumen | Clause 12.3 of ISO 7886-1:2017 |
| Dead Space | Clause 13.1 of ISO 7886-1:2017 |
| Freedom from air and liquid leakage pastplunger stopper | Clause 13.2 of ISO 7886-1:2017 |
| Force to operate the piston | Clause 13.3 of ISO 7886-1:2017 |
| Fit of plunger stopper/ plunger in barrel | Clause 13.4 of ISO 7886-1:2017 |
| ISO 7864: 2016 | |
| 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 |
| Tubular needle 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, ISO80369-7 and ISO 6009 |
| Needle cap | Clause 4.9 of ISO 7864: 2016 |
| Needle tube (Tolerance on length, | Freedom from defects, Lubricant) |
| Clause 4.10 of ISO 7864: 2016Needle Point | Clause 4.11 of ISO 7864: 2016 |
| Bond between Tube and Hub | Clause 4.12 of ISO 7864: 2016 |
| Patency of Lumen | Clause 4.13 of ISO 7864: 2016 |
| ISO 80369-7:2016Dimensional requirements for luerconnectors. | Clause 5 of ISO 80369-7: 2021 |
| Fluid leakage (Positive pressure liquidleakage) | Clause 6.1.3 of ISO 80369-7: 2021 |
| Sub-atmospheric pressure air leakage | Clause 6.2 of ISO 80369-7: 2021 |
| Stress cracking | Clause 6.3 of ISO 80369-7: 2021 |
| Resistance to separation from axial load | Clause 6.4 of ISO 80369-7: 2021 |
| Resistance to separation fromunscrewing | Clause 6.5 of ISO 80369-7: 2021 |
| Resistance to overriding | Clause 6.6 of ISO 80369-7: 2021 |
| ISO 9626:2016Surface finish and visual 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 |
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-Conclusion
The Sterile Syringes for Single Use with/without Needle are substantially equivalent to its predicate device with respect to the indications for use, target populations, treatment method, and technological characteristics. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Through functional performance testing and biocompatibility testing, the subject device has demonstrated substantial equivalence to the predicate device.
§ 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).