Who is the manufacturer of Sterile syringe for single use with/without needle?

Zhejiang Kangkang Medical-Devices Co., Ltd. filed the 510(k) submission for Sterile syringe for single use with/without needle (K210227).

What is the FDA product code for Sterile syringe for single use with/without needle?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Sterile syringe for single use with/without needle?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Sterile syringe for single use with/without needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sterile syringe for single use with/without needle

K210227 · Zhejiang Kangkang Medical-Devices Co., Ltd. · FMF · Sep 10, 2021 · General Hospital

Device Facts

Record ID	K210227
Device Name	Sterile syringe for single use with/without needle
Applicant	Zhejiang Kangkang Medical-Devices Co., Ltd.
Product Code	FMF · General Hospital
Decision Date	Sep 10, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Sterile, three-piece, single-use hypodermic syringe; includes lubricated polypropylene barrel, synthetic rubber stopper, and polypropylene plunger rod. Features 6% (Luer) male connector/lock fitting. Available in various volumes (1ml to 100ml) with optional needles. Operated manually by medical professionals or trained caregivers in hospitals and clinics. Plunger rod is pulled to aspirate fluids or depressed to inject/expel fluids. Device facilitates fluid delivery or withdrawal, aiding clinical procedures. Benefits include sterile, single-use delivery of fluids.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 7886-1:2017 (syringes), ISO 7864:2016 (needles), ISO 80369-7:2016 (Luer connectors), and ISO 9626:2016 (needles). Biocompatibility testing conducted per ISO 10993-1:2018 (cytotoxicity, sensitization, hemolysis, intracutaneous reactivity, acute systemic toxicity, pyrogenicity). Sterilization validated per ISO 11135. Shelf life (3 years) supported by accelerated aging (ASTM F1980-16) and package integrity testing (ASTM F88, F1929, F2096).

Technological Characteristics

Materials: Polypropylene (barrel/plunger), silicone rubber (piston), stainless steel 304 (needle). Manual operation. Luer slip/lock nozzle. EO sterilization (SAL 10^-6). Complies with ISO 7886-1, ISO 7864, ISO 80369-7, and ISO 9626. No software or electronic components.

Indications for Use

Indicated for medical professionals and trained caregivers to inject fluid into or withdraw fluid from the body of patients in hospitals and clinics.

Regulatory Classification

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.

Predicate Devices

Sterile Hypodermic Syringe for Single use with/without Needle (K112057)

Related Devices

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K151766 — BD Single Use, Hypodermic Syringe · Becton, Dickinson and Company · Sep 2, 2015
K213811 — Sterile Hypodermic Syringes for Single Use · Berpu Medical Technology Co., Ltd. · May 12, 2022
K210229 — Sterile Auto-Disable Syringes with/without Needle for Single Use · Zhejiang Kangkang Medical-Devices Co., Ltd. · Feb 15, 2022

Submission Summary (Full Text)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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}------------------------------------------------ 1) The subject device has larger syringe volume sizes. Differences are addressed through testing per ISO 7886-1:2017. 2) 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, 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.