(616 days)
Not Found
No
The device description and intended use are for a standard hypodermic syringe and needle, with no mention of AI, ML, or any computational processing.
No
A syringe is used to deliver substances (like medication or fluid) into the body, but it is the substance being delivered that performs the therapeutic action, not the syringe itself. The syringe is a delivery mechanism.
No
The device is a hypodermic syringe and needle intended for injecting fluids into the body, not for diagnosing conditions. Its intended use is clearly stated as injecting fluid, which is a therapeutic or administrative action, not a diagnostic one.
No
The device description clearly states it is a physical hypodermic syringe with a needle, which are hardware components.
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 body." This describes a device used in vivo (within the body) for administering substances.
- Device Description: The description focuses on the physical components and function of a syringe and needle for aspiration and injection of fluids. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, this device is a standard medical device for injection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.
Product codes
FMF, FMI
Device Description
The Sterile Hypodermic Syringe for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of a hypodermic needle and a luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle gauge (refer to Table 1).
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
Adults and Pediatrics Neonate/Newborn (birth through 28 days) Infant (from 29 days to 2 years of age) Child (from 2 years to 12 years of age) Adolescent (from 12 years to 18 years of age) Transitional Adolescent A (18 through 21 years of age) Transitional Adolescent B (18 through 21 years of age)
Intended User / Care Setting
Medical professionals and trained care givers / Hospital
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Texts for Interactions with Blood
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test methods
- ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical 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
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
- USP Bacterial Endotoxins Test
- USP Particulate Matter in Injections
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
Shandong Weigao Group Medical Polymer Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K212207
Trade/Device Name: Sterile Hypodermic Syringe with needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: November 15, 2022 Received: February 21, 2023
Dear Diana Hong:
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
1
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).
Image /page/1/Picture/4 description: The image shows the word "Sincerely" followed by a signature. The signature appears to be "Alan St" written in a stylized, cursive font. The signature is written in black ink, and the word "Sincerely" is written in a smaller, more standard font.
CAPT Alan M. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212207
Device Name
Sterile Hypodermic Syringe with needle for Single Use
Indications for Use (Describe)
The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.
| Type of Use (Select one or both, as applicable) | XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
- Date of Preparation: 3/18/2023 1.
-
- Sponsor Identification
Shandong Weigao Group Medical Polymer Co., Ltd.
No.18 Xingshan Road, Torch Hi-tech Science Park, 264210 Weihai, Shandong Province, PEOPLE'S REPUBLIC OF CHINA.
Establishment Registration Number: 3007084575
Contact Person: Lina Liu Position: QA Manager Tel: + 86-631-5716818 Fax: + 86-631-5620555 Email: liulina@weigaogroup.com
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Sterile Hypodermic Syringe with needle for Single Use Common Name: Syringe, Piston
Regulatory Information Classification Name: Piston Syringe Classification: II; Product Code: FMF Regulation Number: 21CFR 880.5860 Review Panel: General Hospital
Classification Name: Hypodermic single lumen needle Classification: II; Product Code: FMI Regulation Number: 21CFR 880.5570 Review Panel: General Hospital
Indication for use:
The Sterile Hypodermic Syringe with needle, for Single Use is intended to be used for medical purposes to inject fluid into body.
Patient population:
The patient population of the proposed device is very wide, and it is suitable for all populations. Based on CDRH Premarket Review Submission Cover Sheet (FORM FDA 3514), Section D, the "Intended Use Population" has been updated as following:
Adults and Pediatrics Neonate/Newborn (birth through 28 days) Infant (from 29 days to 2 years of age) Child (from 2 years to 12 years of age) Adolescent (from 12 years to 18 years of age) Transitional Adolescent A (18 through 21 years of age) Transitional Adolescent B (18 through 21 years of age)
Device Description
The Sterile Hypodermic Syringe for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of a hypodermic needle and a luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle gauge (refer to Table 1).
Table 1 Combinations of syringe and needles configurations of the proposed device 1mL luer Lock Syringe with 18G×1-1/2" Needle
2 / 7
5
| 1mL luer Lock Syringe with 23G×1" Needle |
|---|
| 1mL luer Lock Syringe with 23G×1-1/4" Needle |
| 1mL luer Lock Syringe with 25G×3/4" Needle |
| 1mL luer Lock Syringe with 25G×1" Needle |
| 1mL luer Lock Syringe with 25G×1-1/2" Needle |
| 1mL luer Lock Syringe with 26G×5/8" Needle |
| 1mL luer Lock Syringe with 27G×1/2" Needle |
| 30mL luer Lock Syringe with 18G×1-1/2" Needle |
| 30mL luer Lock Syringe with 23G×1" Needle |
| 30mL luer Lock Syringe with 23G×1-1/4" Needle |
| 30mL luer Lock Syringe with 25G×3/4" Needle |
| 30mL luer Lock Syringe with 25G×1" Needle |
| 30mL luer Lock Syringe with 25G×1-1/2" Needle |
| 30mL luer Lock Syringe with 26G×5/8" Needle |
| 30mL luer Lock Syringe with 27G×1/2" Needle |
- ર . Identification of Predicate Device
510(k) Number: K190002
Product Name: Sterile Hypodermic Syringe for Single use, with/without needle
-
- Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization.
-
ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity >
-
ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Texts for Interactions with Blood
-
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
-
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility) >
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
-
ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test methods >
-
ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical 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
6
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals >
-
USP Bacterial Endotoxins Test
-
USP Particulate Matter in Injections
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
Substantially Equivalent (SE) Comparison 8.
| Table 2 Comparison of Technology Characteristics for Sterile Hypodermic Syringe for Single Use | |||
|---|---|---|---|
| ITEM | Proposed Device | Predicate Device
K190002 | Remark | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------|
| Product | Sterile Hypodermic Syringe for
Single Use | Sterile Hypodermic Syringe for Single use, with/without needle | / | | |
| Product Code | FMF, FMI | FMF, FMI | Same | | |
| Regulation
Number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same | | |
| Class | Class II | Class II | Same | | |
| Indication for
Use | The Sterile Hypodermic Syringe with
needle, for Single Use is intended to
be used for medical purposes to
inject fluid into 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. | Difference 1 | | |
| Configuration
and material | Barrel
Plunger
Piston
Needle hub
Protective
cap
Needle tube | Polypropylene
Polypropylene
Polyisoprene rubber
Polypropylene
Polypropylene
Stainless Steel 304 | Barrel
plunger
Piston
Needle hub
Protective cap
Needle tube | Polypropylene
Polypropylene
Isoprene Rubber
Polypropylene
Polypropylene
SUS304 |
Difference 2
|
| Operation Mode | For Manual Use Only, For Single
Use only | For Manual Use Only, For Single Use only | Same | | |
| Environment of
use | Hospital | Hospital | Same | | |
| Intended users | Medical professionals and trained
care givers | Medical professionals and trained care
givers | Same | | |
| Single Use | Single Use | Single Use | Same | | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | |
| Syringe | Volume | 1ml, 30ml | 1ml, 3ml, 5ml, 6ml, 10ml, 20ml, 30ml,
35ml, 50ml and 60 ml | Difference 3 | |
| | Connector
Type | Luer Lock | Luer Lock/ Luer Slip | | |
| | Piston
Type | Conical/Flat Piston | Conical/Flat Piston | Same | |
| Needle | Gauge | 18G, 23G, 25G, 26G,
27G | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G,
26G, 27G, 28G, 29G, 30G | Difference 4 | |
| | Length | 21-45.5mm | 4-38 mm | | |
| Syringe | | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same | |
8
| Performance | |||
|---|---|---|---|
| Needle | |||
| Performance | Complied with | ||
| ISO 7864, | |||
| ISO 9626 | Complied with | ||
| ISO 7864, | |||
| ISO 9626 | Same | ||
| Biocompatibility | |||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Difference 5 |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No skin sensitization | No skin sensitization | |
| Systemic | |||
| Toxicity | No systemic toxicity | No systemic toxicity | |
| Pyrogen | No Pyrogen | No Pyrogen | |
| Subacute | |||
| Toxicity | No Subacute Toxicity | No Subacute Toxicity | |
| Complement | |||
| Activation | No potential activator of the | ||
| complement system | Unknown | ||
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | |
| Endotoxin Limit | 20 EU per device | 20 EU per device |
Difference 1 - Indication for Use
The indication for use for proposed device is different from the predicate device. However, the indication for use of the proposed device is covered by that of the predicate device. Therefore, this difference does not impact the safety and effectiveness of the proposed device.
Difference 2 - Configuration and material
The proposed device has the same configurations as the predicate device K190002. However, some of the configuration materials for proposed device are different from predicate device. This difference does not raise new questions of safety and effectiveness for the proposed device. Biocompatibility test for proposed device was performed and the test result does not show any adverse effect.
3 - Syringe Volume and Connector type
The syringe volume for proposed device is different from the predicate device. However, the predicate device includes 1ml and 30ml syringe. Therefore, this difference on syringe volume does not affect the safety and effectiveness of the proposed device.
The syringe connector type for proposed device is different from the predicate device. However, the predicate device includes type of luer lock. Therefore, this difference on syringe connector type does not affect the safety and effectiveness of the proposed device.
Difference 4 - Needle Gauge and Length
The needle gauge of proposed device is covered by that of the predicate device. The length for proposed device is different from the predicate device K19002. This difference does not raise new questions of safety and effectiveness of the proposed device.
Difference 5 - Biocompatibility
The Biocompatibility test items for the proposed device is different from the predicate device K190002. Considering the test results of biocompatibility testing demonstrate that this difference does not affectiveness between the proposed device and predicate device.
9
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device, Sterile Hypodermic Syringe with needle for Single Use, is determined to be Substantially Equivalent (SE) to the predicate device K190002.