(167 days)
['K112057']
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a standard syringe, with no mention of AI or ML capabilities.
No
The device is a syringe for injecting or withdrawing fluids, which is a diagnostic or procedural tool, not inherently therapeutic.
No
Explanation: The device, a sterile syringe, is used to inject or withdraw fluids, which are actions related to administering treatment or collecting samples, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (barrel, stopper, plunger rod) and performance testing related to material properties and physical standards (ISO, ASTM, USP), indicating it is a hardware device.
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 the body, not for performing tests on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) in vitro (in a test tube or lab setting) to diagnose a condition. IVD devices are designed for testing samples to provide information about a patient's health status.
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 (comma separated list FDA assigned to the subject device)
FMF
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 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)
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 ( Particulate Matter in Injections.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 ( 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 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.