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

Azur Medical Company, Inc. filed the 510(k) submission for Sterile syringes for single use with/without needle (K211211).

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

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

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

K211211 · Azur Medical Company, Inc. · FMF · Oct 7, 2021 · General Hospital

Device Facts

Record ID	K211211
Device Name	Sterile syringes for single use with/without needle
Applicant	Azur Medical Company, Inc.
Product Code	FMF · General Hospital
Decision Date	Oct 7, 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 polypropylene barrel with graduated scale, synthetic rubber stopper, and polypropylene plunger rod. Features 6% (Luer) male connector/lock fitting. Operated manually by medical professionals or trained caregivers in hospitals and clinics. Physician aspirates fluids by pulling back plunger or injects/expels fluids by depressing plunger. Device facilitates fluid delivery or withdrawal; benefits patient through sterile, controlled fluid administration or sampling.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via ISO 7886-1 (syringes), ISO 7864 (needles), ISO 9626 (tubing), ISO 80369-7 (connectors), and USP <788> (particulate matter). Biocompatibility confirmed per ISO 10993-1 (cytotoxicity, sensitization, hemolysis, intracutaneous reactivity, systemic toxicity, pyrogenicity). Sterilization validated per ISO 11135; shelf life validated per ASTM F1980-16.

Technological Characteristics

Materials: Polypropylene barrel/plunger, silicone rubber piston, stainless steel 304 needle. Luer slip/lock connector. EO sterilization (SAL 10^-6). Complies with ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ASTM F88/F88M-15, ASTM F1929-2015, ASTM F1980-16. Manual operation; no energy source.

Indications for Use

Indicated for medical purposes to inject fluid into or withdraw fluid from the body. For use by medical professionals and trained caregivers 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

K231729 — Sterile syringes for single use with/without needle · Wepon Medical Technology Co., Ltd. · Sep 8, 2023
K210227 — Sterile syringe for single use with/without needle · Zhejiang Kangkang Medical-Devices Co., Ltd. · Sep 10, 2021
K151766 — BD Single Use, Hypodermic Syringe · Becton, Dickinson and Company · Sep 2, 2015
K191642 — TK Sterile Piston Syringe without Needle · Anhui Tiankang Medical Technology Co., Ltd. · Jan 6, 2020
K231727 — Sterile Auto-Disable Syringes with/without Needle for Single Use · Wepon Medical Technology Co., Ltd. · Sep 8, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text. October 7, 2021 Azur Medical Company Inc. Di Zhao General Manager 6710 Everglades Dr. Richmond, Virginia 23838 Re: K211211 Trade/Device Name: Sterile syringes 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 26, 2021 Received: September 1, 2021 Dear Di Zhao: 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211211 #### 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}------------------------------------------------ # K211211 510(k) summary Date Prepared: 10.07.2021 #### 510(K) Number: K211211 #### I Submitter Device submitter: Azur Medical Company Inc. 6710 Everglades Dr., Richmond, Virginia, VA 23838, USA Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030 Contact person: Di Zhao General Manager Phone: 928-5922380 Email: dzhao@azur-ppe.com #### II 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 Traditional 510(k) - New device, no prior submission. #### III Predicate Devices | Trade name: | Sterile Hypodermic Syringe for Single use with/without | |-------------------------|--------------------------------------------------------| | | Needle | | Common name: | Piston Syringe | | Classification: | Class II, 21 CFR 880.5860 | | Product Code: | FMF | | Premarket Notification: | K112057 | | Manufacturer: | Shanghai Kindly Enterprise Division Group Company | #### IV Device description The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The {4}------------------------------------------------ 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. ### V 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. # VI Comparison of technological characteristics with the predicate devices The Sterile Syringes for Single Use with/without Needle have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Syringes for Single Use with/without Needle and predicate devices do not alter suitability of the proposed device for its intended use. | Device feature | Subject Device | Predicate Device K112057 | Comments | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Indications for use | The Sterile Syringes for Single Use with/without Needle is 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. | Same | | Product code | FMF | FMF | Same | | Regulation number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same | | Principle of operation | For manual use only | For manual use only | Same | | Intended user | Medical professionals and trained care givers | Medical professionals and trained care givers | Same | | Environment of use | Hospitals and clinics | Hospitals and clinics | Same | | Nozzle type | Luer slip; Luer lock | Luer slip; Luer lock | Same | | Lubricant for barrel | Silicone oil | Silicone oil | Same | | Barrel transparency | Transparent and clear | Transparent and clear | Same | | Gradations legibility | Legible | Legible | Same | | Syringe volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml, 100ml | 1ml, 3ml, 5ml, 6ml, 10ml, 20ml, 30ml, 35ml and 50ml | Difference 1 | | 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 length | 1/2", 5/8", 1", 1 1/4", 11/2" | Not available | | | Needle hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Same | | Single use | Yes | Yes | Same | | 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 | Same | | Sterilization | EO | EO | Same | | SAL | 10-6 | 10-6 | Same | | Materials | 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 | Difference 2 | | Pyrogen | Non-pyrogenic | Non-pyrogenic | Same | | 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 | 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 | Same | | Labeling | Meet the requirements of 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 | Same | Table 5-1 Substantial equivalence discussion – Sterile syringes for single use with/without needle {5}------------------------------------------------ Discussion: Difference 1 The syringe volume and length of subject devices are different from the predicate device. However, this difference is just in dimension. Different needle specification will be {6}------------------------------------------------ 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. ### Difference 2 The material of subject device is similar as predicted device. However, the subject devices were tested and comply with ISO 10993 series standards. The differences on material do not affect substantial equivalence. # VII 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; Skin sensitization; Hemolysis; Intracutaneous reactivity; Acute systemic toxicity; Pyrogenicity. All evaluation acceptance criteria were met. # Sterilization and shelf life testing The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The testing is performed according to the following standards: | EO residue | ISO 10993-7:2008 | |-------------|------------------| | ECH residue | ISO 10993-7:2008 | Package integrity testing was conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging was deemed acceptable for protection of product and sterility maintenance. The shelf life of 5 year is determined based on stability studies which include aqeing test according to FDA recognized standard ASTM F1980-16. The testing is performed according to the following standards: | Seal strength | ASTM F88/F88M-15 | |-----------------|------------------| | Dye penetration | ASTM F 1929-2015 | # Performance testing Performance testing is performed according to the following standards: - A ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods {7}------------------------------------------------ - ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical A Devices - > ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications - > ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use. - > USP <788> Particulate Matter in Injections # VIII Conclusion The predicate device submission was cleared with Sterile Hypodermic Syringe for Single use with/without Needle, Sterile Insulin Syringe for single use, with needle and Sterile Hypodermic Needle for single use. The subject device is being compared to only the predicate Sterile Hypodermic Syringe for Single use with/without Needle. The subject device, Sterile Syringes for Single Use with/without Needle, is substantially equivalent to its predicate devices (Sterile Hypodermic Syringe for Single use with/without Needle). The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.