(123 days)
The Sterile hypodermic syringes for single use are intended to inject fluids into or withdraw fluids from the body.
The Sterile hypodermic syringes for single use are intended for manual and single use only to aspirate and inject of fluids for medical purpose, and consist of syringe (barrel, plunger, piston) and hypodermic needle (needle tube, hub, needle cap). The proposed device is available in a variety of syringe and needle sizes.
The provided text describes the 510(k) summary for "Sterile hypodermic syringes for single use" and does not contain information about an AI/ML powered medical device. Therefore, it's not possible to extract information related to acceptance criteria or studies performed for such a device.
The document focuses on demonstrating the substantial equivalence of the subject device (syringes) to a predicate device based on material, design, performance, and compliance with established standards (ISO, ASTM, USP).
Specifically, the provided information does not include:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size for a test set or data provenance for an AI/ML device.
- Number of experts or their qualifications for establishing ground truth for an AI/ML device.
- Adjudication methods for an AI/ML device.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size for AI assistance.
- Standalone performance for an AI/ML algorithm.
- Type of ground truth used for an AI/ML device study.
- Sample size for a training set for an AI/ML device.
- How ground truth for the training set was established for an AI/ML device.
The 'Performance data' section lists various tests performed on the syringes, such as biocompatibility, sterilization, shelf-life, and physical performance tests according to ISO and ASTM standards. These are standard tests for physical medical devices to ensure their safety and effectiveness.
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October 5, 2021
Jiangsu Kangyou Medical Instrument Co., Ltd. Xiang Yao Product Manager Tangzhuang Yaotang Town Jintan, Jiangsu 213223 China
Re: K211728
Trade/Device Name: Sterile hypodermic syringes for single use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 20, 2021 Received: August 30, 2021
Dear Xiang Yao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT 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) K211728
Device Name
Sterile hypodermic syringes for single use
Indications for Use (Describe)
The Sterile hypodermic syringes for single use are intended to inject fluids into or withdraw fluids from the body.
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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K211728 510(k) summary
Preparation Date: October 5, 2021
l Submitter
Device submitter: Jiangsu Kangyou Medical Instrument Co., Ltd. Tangzhuang, Yaotang Town 213223 Jintan, Jiangsu, People's Republic of China
Contact person: Xiang Yao Product Manager Phone: 13813652889 Fax: 86 519 82582461 Email: export@kym.cn
II Device
Trade Name of Device: Sterile hypodermic syringes for single use Common Name: Piston Syringe with Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe with Needle Regulatory Class: II Product code: FMF Review Panel: General Hospital
III Predicate Devices
| Trade name: | Sterile Single-use Syringe with Needle |
|---|---|
| Common name: | Piston Syringe with Needle |
| Classification: | Class II, 21 CFR 880.5860 |
| Product Code: | FMF |
| Premarket Notification: | K163161 |
| Manufacturer: | JiangXi HongDa Medical Equipment Group Ltd |
IV Device description
The Sterile hypodermic syringes for single use are intended for manual and single use only to aspirate and inject of fluids for medical purpose, and consist of syringe (barrel, plunger, piston) and hypodermic needle (needle tube, hub, needle cap). The proposed device is available in a variety of syringe and needle sizes.
| Syringe Size | Needle Gauge | Needle Length |
|---|---|---|
| Available in 1ml、2ml、3ml、 | Available in 16G, 18G, | Available in 8mm (5/16"), |
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| 5ml、10ml、20ml、30ml、 | 20G, 21G, 22G, 23G, | 13mm (1/2"), 15mm (3/5"), |
|---|---|---|
| 50ml, 60ml | 24G, 25G, 26G, 27G, | 20mm (4/5"), 25mm (1"), |
| 29G, 30G | 30mm (1 1/6"), 32mm (1 1/4"),33mm(1 3/10"), 38mm (11/2") |
The different gauge of needles could fit every specification of syringes. The needle is optional.
| GaugeSyringe | 30G | 29G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 18G | 16G |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| 2ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| 3ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| 5ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| 10ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| 20ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| 30ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| 50ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| 60ml | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
V Indications for use
The Sterile hypodermic syringes for single use are intended to inject fluids into or withdraw fluids from the body.
VI Comparison of technological characteristics with the predicate devices
The Sterile hypodermic syringes for single use have intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between Sterile hypodermic syringes for single use and predicate devices are the specification of syringe volume, needle gauge and needle length. However, syringes will be selected by physician per injection requirement and this difference does not affect indication for use. Additionally, the performance of syringe and needle has been evaluated and the test results met the requirements of ISO 7886-1 and ISO 7864. Therefore, this difference does not affect substantially equivalency on safety and effectiveness.
| Table 6-1 Substantial equivalence discussion | ||
|---|---|---|
| Devicefeature | Subject Device | Predicate Device K163161 | Comment |
|---|---|---|---|
| Device feature | Subject Device | Predicate Device K163161 | Comment |
| Syringe type | Standard piston syringe | Standard piston syringe | Same |
| Indications for use | The Sterile hypodermic syringes for single use are intended to inject fluids into or withdraw fluids from the body. | Sterile Single-use Syringe with Needle is intended to inject fluids into or withdraw fluids from the body. | Same |
| Product code | FMF | FMF | Same |
| Regulation number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Principle of operation | For manual use only | For manual use only | Same |
| Needle gauge | 16G, 18G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 29G, 30G, | 18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G, 28G, 29G, 30G | Difference 1 |
| Needle Length | 5/16", 1/2", 3/5", 4/5", 1", 1 1/6", 1 1/4", 1 3/10", 1 1/2" | 1/2", 5/8", 1", 1 1/4", 1 1/2" | |
| Syringe Volume | 1ml、2ml、3ml、5ml、10ml、20ml、30ml、50ml、60ml | 1ml, 3ml, 5ml, 10ml, 20ml, 60ml | |
| Connector Type | Luer Slip and Luer Lock | Luer Slip and Luer Lock | Same |
| main structure and materials | BarrelPolypropyle ne | BarrelPolypropyle ne (PP) | Same |
| PlungerPolypropyle ne | PlungerPolypropyle ne (PP) | ||
| PistonPolyisopren e | PistonPolyisopren e | ||
| Needle tubeStainless steel | Needle tubeStainless Steel, SUS304 | ||
| HubPolypropyle ne | Needle hubPolypropyle ne (PP) | ||
| Needle capPolypropyle ne | Needle capPolypropyle ne (PP) | ||
| Performance specifications | Complies with ISO 7886-1 | Complies with ISO 7886-1 | Same |
| Single Use | Yes | Yes | Same |
| Devicefeature | Subject Device | Predicate Device K163161 | Comment |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | CytotoxicityNo cytotoxicity | CytotoxicityNo cytotoxicity | Same |
| Intracutaneous reactivityNo intracutaneous reactivity | IrritationNo intracutaneous reactivity | Same | |
| SensitizationNo skin sensitization | SensitizationNo skin sensitization | Same | |
| Systemic ToxicityNo systemic toxicity | Systemic ToxicityNo systemic toxicity | Same | |
| HemolysisNo Hemolysis | HemolysisNo Hemolysis | Same | |
| PyrogenNo Pyrogen | PyrogenNo Pyrogen | Same | |
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
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Difference 1
The syringe volume, needle gauge and length of subject devices are different from the predicate device. However, this difference is just in dimension. Different needle specification will be selected by physician per patient's condition. This difference does not affect intended use. In addition, differences were addressed through ISO 7886-1, ISO 7864, ISO 9626 and ISO 80369-7. Therefore, the differences on syringe volume, needle gauge and length do not raise different question of safety and effectiveness.
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Sterile hypodermic syringes for single use were 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 |
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Particulate matter
USP <788>
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. Bacteria Endotoxin Limit is carried out according to USP42-NF37 <85> Bacterial Endotoxins Test.
The testing is performed according to the following standards:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin | USP42-NF37 <85> |
The shelf life of 5 year is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16.
Package integrity testing was conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging deemed acceptable for protection of product and sterility maintenance.
The testing is performed according to the following standards:
| Seal strength | ASTM F88/F88M-15 |
|---|---|
| Seal integrity | ASTM F 1929-2015 |
Performance testing
Performance testing is performed according to the following standards:
| ➤ ISO 7886-1: 2017 | |
|---|---|
| Appearance | Clause 5 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- 9.4 of ISO 7886-1:2017 |
| Barrel flanges | Clause 10.2 of ISO 7886-1:2017 |
| Plunger stopper / Plunger assembly | Clause 11 of ISO 7886-1:2017 |
| Nozzle | Clause 12 of ISO 7886-1:2017 and ISO 80369-7 |
| Dead Space | Clause 13.1 of ISO 7886-1:2017 |
| Freedom from air and liquid leakage past plunger 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 |
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| 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, ISO 80369-and ISO 6009 |
| Needle cap | Clause 4.9 of ISO 7864: 2016 |
| Needle tube | Clause 4.10 of ISO 7864: 2016 and ISO9626:2016 |
| Needle 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 80369-7:2016 | |
| Leakage by pressure decay | Clause 6.1.2 of ISO 80369-7: 2021 |
| Positive pressure liquid leakage | 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 from unscrewing | Clause 6.5 of ISO 80369-7: 2021 |
| Resistance to overriding | Clause 6.6 of ISO 80369-7: 2021 |
| > ISO 9626:2016 | |
|---|---|
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
VIII Conclusion
The Sterile hypodermic syringes for single use are substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed 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).