(225 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts.
No
The device, a sterile syringe, is used to inject or withdraw fluids. It does not provide therapy itself but is a delivery mechanism or collection tool.
No
Explanation: The device description states its purpose is to "inject fluid into or withdraw fluid from body," which is a therapeutic or delivery function, not a diagnostic one. There is no mention of analysis, measurement, or detection of a medical condition.
No
The device description clearly outlines physical components (polypropylene barrel, synthetic rubber stopper, polypropylene plunger rod) and performance studies related to physical properties (biocompatibility, sterilization, shelf life, functional performance testing). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to inject fluid into or withdraw fluid from body." This describes a direct interaction with the body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a syringe, which is a tool for administering or collecting substances from or into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living organism) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing blood, urine, tissue, or other body fluids in a laboratory setting.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals and trained care givers; Hospitals and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ().
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. EO residue and ECH residue tests were performed per ISO 10993-7:2008. Shelf Life Evaluation included physical performance, chemical performance and biological performance, including sterility, and single package seal strength test, creep/burst test, leakage test, gross leakage test and antibacterial performance test. These were conducted per ISO 11607, ASTM F1980-16, ASTM D 4169, ASTM F88/F88M-15, ASTM F1140/F1140M-13, ASTM F1929-15, ASTM F2096-11, and DIN 58953-6-2010.
Performance testing: Performance testing was performed according to ISO 7886-1: 2017, ISO 7864: 2016, ISO 80369-7:2016, and ISO 9626:2016 covering aspects such as cleanliness, limits for acidity or alkalinity, extractable metals, lubricant, tolerance on graduated capacity, scale, numbering of scales, overall length of scale to nominal capacity line, position of scale, dimensions, barrel flanges, design, conical fitting, position of nozzle on end of barrel, nozzle lumen, dead space, freedom from air and liquid leakage past plunger stopper, force to operate the piston, fit of plunger stopper/plunger in barrel, tubular needle designation, colour coding, needle hub, needle cap, needle tube, needle point, bond between tube and hub, patency of lumen, dimensional requirements for luer connectors, fluid leakage, sub-atmospheric pressure air leakage, stress cracking, resistance to separation from axial load, resistance to separation from unscrewing, resistance to overriding, surface finish and visual appearance, size designation, stiffness, resistance to breakage, and resistance to corrosion.
Key results: 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 evaluation of biocompatibility testing items meets the requirements. Differences in syringe volume sizes and materials are addressed through testing per ISO 7886-1:2017 and biocompatibility testing per ISO 10993, respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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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3
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/without
Needle (used as Predicate Device)
Sterile Insulin Syringe for single use, with needle
Sterile 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.
4
| 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 needle | ||||||||||||
| hub | Yellow | Grey | Medium | Brown | Orange | Purple | Middle blue | Black | Deep green | Yellow | Cream | Pink |
| OD of needle | ||||||||||||
| tube | 30G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 19 G | 18 G | |
| Length of needle | ||||||||||||
| tube | 1/2" | 5/8" | 1", 1 1/4", 1 1/2" | |||||||||
| Length of needle | ||||||||||||
| covers (mm) | 12.5 | 12.5, | ||||||||||
| 16, 25 | 16, | |||||||||||
| 25 | 16, | |||||||||||
| 25 | 25, 32, 38 | |||||||||||
| Color of needle | ||||||||||||
| covers | 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.
5
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: PP | |
| Plunger: PP | ||
| Piston: Silicone Rubber | ||
| Needle: Stainless 304 | ||
| Needle hub: PP | Barrel: PP | |
| Plunger: PP | ||
| Piston: Isoprene Rubber | ||
| Needle: Stainless 304 | ||
| Needle 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 CFR | |
| Part 801 | Meet the requirements of 21 CFR Part | |
| 801 |
6
7
-
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 ( |
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, chemical |
| performance and biological performance, | |
| including sterility, and single package seal | |
| strength test, creep/burst test, leakage test, | |
| gross leakage test and antibacterial | |
| performance 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
8
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 nominal | |
| capacity 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 and |
| ISO 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 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 |
| 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 |
| 80369-7 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: 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 | |
| Dimensional requirements for luer | |
| connectors. | Clause 5 of ISO 80369-7: 2021 |
| Fluid leakage (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 | |
| Surface 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 |
9
-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.