(167 days)
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 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.
The document describes the acceptance criteria and performance data for the "Sterile syringes for single use with/without needle," but it does not involve a study with a test set of data, ground truth, or expert consensus in the way that AI/ML device studies typically do. This is a traditional medical device (syringes) rather than an AI/ML diagnostic or prognostic tool.
Therefore, many of the requested fields are not applicable.
Here's the information extracted from the provided text, focusing on the available details:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated by compliance with various international standards and specific tests. The "acceptance criteria" are implied by the requirements of these standards.
| Test/Characteristic | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of ISO 10993-1:2018 for "External communication device - Blood path indirect" (contact duration < 24 hours) | All evaluation acceptance criteria were met for Cytotoxicity, Skin sensitization, Hemolysis, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity. |
| Sterilization (EO residue) | Complies with ISO 10993-7:2008 | Testing performed and results imply compliance. |
| Sterilization (ECH residue) | Complies with ISO 10993-7:2008 | Testing performed and results imply compliance. |
| Package Integrity | Acceptable for protection of product and sterility maintenance after environmental conditioning and simulated transportation | All packaging was deemed acceptable. |
| Shelf Life | Determined based on stability studies and aging test (ASTM F1980-16) | 5-year shelf life determined. |
| Seal Strength | Complies with ASTM F88/F88M-15 | Testing performed and results imply compliance. |
| Dye Penetration | Complies with ASTM F 1929-2015 | Testing performed and results imply compliance. |
| Hypodermic Needles | Complies with ISO 7864:2016 | Testing performed and results imply compliance. |
| Stainless Steel Tubing | Complies with ISO 9626:2016 | Testing performed and results imply compliance. |
| Small-bore Connectors | Complies with ISO 80369-7:2016 | Testing performed and results imply compliance. |
| Hypodermic Syringes (Manual Use) | Complies with ISO 7886-1:2017 | Testing performed and results imply compliance. |
| Particulate Matter | Complies with USP <788> | Testing performed and results imply compliance. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "testing" and "evaluations" according to various standards, which would define the sample sizes for those specific tests.
- Data Provenance: Not explicitly stated, but the testing was conducted to comply with international standards (ISO, ASTM, USP), indicating standard laboratory and manufacturing quality control procedures. The manufacturer is Zhejiang Kangkang Medical-Devices CO., Ltd. in China, so likely some testing occurred there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device, not an AI/ML system requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This does not involve adjudication of expert readings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device's performance is established by its adherence to the technical and safety specifications outlined in the referenced international standards (e.g., ISO, ASTM, USP). For instance, the ground truth for "sterilization" is the result of tests confirming a certain sterility assurance level; for "biocompatibility," it's the outcome of biological tests.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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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
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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) 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)
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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
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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 DeviceK112057 | 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 |
| Performancespecifications | Complies with ISO 7886-1:2017 Sterile Hypodermicsyringes for single use -Part 1: Syringes for manualuse | Complies with ISO 7886-1:2017 Sterile Hypodermicsyringes for single use -Part 1: Syringes for manualuse | Same |
| Sterilization | EO | EO | Same |
| SAL | 10-6 | 10-6 | Same |
| Materials | Barrel: PP Plunger: PPPiston: Silicone RubberNeedle: Stainless 304Needle hub: PP | Barrel: PP Plunger: PPPiston: Isoprene RubberNeedle: Stainless 304Needle hub: PP | Difference 2 |
| Pyrogen | Non-pyrogenic | Non-pyrogenic | Same |
| Biocompatibility | The biocompatibilityevaluation for the subjectdevice was conducted inaccordance with theInternational Standard ISO10993-1 "BiologicalEvaluation of MedicalDevices - Part 1:Evaluation and TestingWithin a Risk ManagementProcess," as recognized byFDA and the "Use ofInternational Standard ISO10993-1 "Biologicalevaluation of medicaldevices- Part 1: Evaluationand testing within a riskmanagement process",June 16, 2016. The syringeof testing included thefollowing tests:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of theabove testingitems meets the | The biocompatibilityevaluation for the subjectdevice was conducted inaccordance with theInternational Standard ISO10993-1 "BiologicalEvaluation of MedicalDevices - Part 1:Evaluation and TestingWithin a Risk ManagementProcess," as recognized byFDA and the "Use ofInternational Standard ISO10993-1 "Biologicalevaluation of medicaldevices- Part 1: Evaluationand testing within a riskmanagement process",June 16, 2016. The syringeof testing included thefollowing tests: Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of theabove testing items meetsthe requirements | Same |
| Labeling | Meet the requirements of21 CFR Part 801 | Meet the requirements of21 CFR Part 801 | Same |
Table 5-1 Substantial equivalence discussion – Sterile syringes for single use with/without needle
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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
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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
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- 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.
§ 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).