(257 days)
K163161 Sterile Single-use Syringe with Needle
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a manual syringe and needle, with no mention of AI or ML.
No
The device is solely intended for injecting or withdrawing fluids, which is a diagnostic or procedural function, not a therapeutic one that treats or cures a condition.
No
This device is a syringe and needle, which is used for injection or withdrawal of fluids, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of physical components (barrel, plunger, piston, needle hub, needle cap) and is operated manually, indicating it is a hardware device, not software-only.
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 fluids into or withdraw fluids from the body." This describes a device used for direct interaction with the body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a syringe and needle, which are tools for administering or collecting substances from a living organism.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens such as blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical for fluid transfer to or from the body.
N/A
Intended Use / Indications for Use
Sterile single-use syringe with needle is intended to inject fluids into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
Device Description
The subject device is for single use only, which is comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consist of needle hub, needle cap. The proposed devices shall be operated manually, and are not intended for use with syringe pumps. The proposed devices are available in a variety combination of needle size and syringe volume. The syringe sizes, needle gauges and lengths are provided in the following table.
| Syringe Size | Needle Gauge | Needle Length |
|---|---|---|
| Available in 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml | Available in 18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G, 28G, 29G, 30G | Available in 1/2", 5/8", 1", 1 1/4", 1 1/2" |
The subject device is provided sterile and is for single use only. The EO gas sterilization process is validated with a resulting sterility assurance level (SAL) of 10-6. It meets requirements of ISO 11135, sterilization of health-care products for ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices.
Below is the list of different combinations:
| No. | Syringe Size | Needle Gauge & Length |
|---|---|---|
| 1 | 1 ml | 30G1/2", 29G1/2", 28G*5/8" |
| 2 | 2 ml | 27G1/2", 26G1/2", 25G*1" |
| 3 | 3 ml | 25G1", 23G1 1/4", 22G*1 1/4" |
| 4 | 5 ml | 23G1 1/4", 22G1 1/2", 21G*1 1/2" |
| 5 | 10 ml | 22G1 1/2", 21G1 1/2", 20G*1 1/2" |
| 6 | 20 ml | 22G1 1/2", 21G1 1/2", 20G1 1/2", 18G1 1/2" |
| 7 | 30 ml | 21G1 1/2", 20G1 1/2", 18G*1 1/2" |
| 8 | 50 ml | 21G1 1/2", 20G1 1/2", 18G*1 1/2" |
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
Prescription Use
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)
Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that proposed device complies with the following standards:
| Test Item | Standard |
|---|---|
| Syringe | ISO 7886-1: 2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| Needle | ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| Needle | ISO 7864: 2016 Sterile hypodermic needles for single use - Requirements and test methods |
| Luer connector | ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
A. Physical, Mechanical and Chemical Tests performed on the proposed device: (No specific tests listed under this heading, only referring to the standards above.)
B. Sterile Barrier Packaging Testing performed on the proposed device:
| Test Item | Standard |
|---|---|
| Seal strength | ASTM F88/F88M-2015 |
| Detecting seal leaks | ASTM F1929-2015 |
| Determining integrity of seals | ASTM F1886/F1886M-2016 |
C. Sterilization and Shelf Life Testing performed on the proposed device:
| Test Item | Standard |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 36-NF 31 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and Sterility Tests were performed on aging samples to verify the shelf life of 3 years for the subject device |
D. The hub is made of pigmented material and the hub color for different needle gauge comply with ISO 6009:2016.
E. Biocompatibility Testing is conducted according to ISO 10993-1:2018:
| Test Item | Standard |
|---|---|
| Cytotoxicity Test | ISO 10993-5:2009 |
| Skin Sensitization Test | ISO 10993-10:2010 |
| Intracutaneous Reactivity Test | ISO 10993-10:2010 |
| Acute Systemic Toxicity Test | ISO 10993-11:2017 |
| Pyrogen Test | ISO 10993-11:2017 |
| Hemolysis Test | ISO 10993-4:2017 |
| Particulate | USP |
Key Results: The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject Device, Disposable Syringe with Needle, K211482 is substantially equivalent to the predicate Device, Sterile Single-use Syringe with Needle, K163161.
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.
K163161 Sterile Single-use Syringe with Needle
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
January 24, 2022
Image /page/0/Picture/1 description: The image contains 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 Qinkai Medical Industry Co., Ltd. Alice Gong Manager South Section of Quancheng Road, Medical Equipment Industrial Park, Chengwu County Heze Citv. Shandong Province 274200 China
Re: K211482
Trade/Device Name: Disposable Syringe with Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: December 14, 2021 Received: December 27, 2021
Dear Alice Gong:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 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,
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) K211482
Device Name Disposable Syringe with Needle
Indications for Use (Describe)
Sterile single-use syringe with needle is intended to inject fluids into or withdraw fluids from the 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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3
K211482 510(K) SUMMARY
| Preparation Date: | January 24, 2022 |
|---|---|
| Submitter Name: | Shandong Qinkai Medical Industry Co., Ltd., |
| South Section of Quancheng Road, | |
| Medical Equipment Industrial Park, | |
| Chengwu County, Heze City, | |
| Shandong Province, | |
| China 274200 | |
| Contact Person: | Mr. Ou Kai Jiang |
| General Manager | |
| Telephone Number: | (86) 0530-6112108 |
| Fax Number: | (86) 0530-6112108 |
| E-mail Address: | 490566042@qq.com |
| Trade Name: | Disposable Syringe with Needle |
| Regulation Name: | Syringe, Piston |
| Regulation Number: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Device Class: | Class II |
| Regulation Name: | Hypodermic Single Lumen Needle |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Device Class: | Class II |
| Predicate Device: | K163161 Sterile Single-use Syringe with Needle |
Device Description
The subject device is for single use only, which is comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consist of needle hub, needle cap. The proposed devices shall be operated manually, and are not intended for use with syringe pumps. The proposed devices are available in a variety combination of needle size and syringe volume. The syringe sizes, needle gauges and lengths are provided in the following table.
| Syringe Size | Needle Gauge | Needle Length |
|---|---|---|
| Available in 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml | Available in 18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G, 28G, 29G, 30G | Available in 1/2", 5/8", 1", 1 1/4", 1 1/2" |
The subject device is provided sterile and is for single use only. The EO gas sterilization process is validated with a resulting sterility assurance level (SAL) of 106. It meets requirements of ISO 11135, sterilization of
4
health-care products for ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices.
Below is the list of different combinations:
| No. | Syringe Size | Needle Gauge & Length |
|---|---|---|
| 1 | 1 ml | 30G1/2", 29G1/2", 28G*5/8" |
| 2 | 2 ml | 27G1/2", 26G1/2", 25G*1" |
| 3 | 3 ml | 25G1", 23G1 1/4", 22G*1 1/4" |
| 4 | 5 ml | 23G1 1/4", 22G1 1/2", 21G*1 1/2" |
| 5 | 10 ml | 22G1 1/2", 21G1 1/2", 20G*1 1/2" |
| 6 | 20 ml | 22G1 1/2", 21G1 1/2", 20G1 1/2", 18G1 1/2" |
| 7 | 30 ml | 21G1 1/2", 20G1 1/2", 18G*1 1/2" |
| 8 | 50 ml | 21G1 1/2", 20G1 1/2", 18G*1 1/2" |
Indications for Use
| Characteristic | Predicate Device
Sterile Single-use Syringe with
Needle K163161 | Subject Device
Disposable Syringe with Needle
K211482 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Sterile Single-use Syringe with
Needle is intended to inject fluids
into or withdraw fluids from the
body. | Sterile single-use syringe with
needle is intended to inject fluids
into or withdraw fluids from the
body. |
| Prescription Only
or
Over the Counter | Prescription Only | Prescription Only |
Discussions of differences in Indications for Use statement
The indications for use statement for the subject device is identical to the predicate device.
Technological Characteristics
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
| Technological
Characteristic | Predicate Device
Sterile Single-use Syringe
with Needle
K163161 | Subject Device
Disposable Syringe with
Needle
K211482 | Comments |
|---------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------|----------|
| Product Code | FMF and FMI | FMF and FMI | Same |
| Regulation
Number | 21 CFR 880.5860, 21 CFR
880.5570 | 21 CFR 880.5860, 21 CFR
880.5570 | Same |
| Class | II | II | Same |
5
| Configuration
and material | Barrel, Plunger, Needle hub
and Needle cap is made of
Polypropylene (PP).
Piston is made of
Polyisoprene.
Needle tube is made of
Stainless Steel, SUS304 | Barrel, Plunger, Needle hub
and Needle cap is made of
Polypropylene (PP).
Piston is made of
Polyisoprene.
Needle tube is made of
Stainless Steel, SUS304 | Same |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Operation Mode | For manual use only | For manual use only | Same |
| Syringe Volume | 1ml, 3ml, 5ml, 10ml, 20ml,
60ml | 1ml, 2ml, 3ml, 5ml, 10ml,
20ml, 30ml, 50ml | Similar
Comment 1 |
| Connector Type | Luer Slip and Luer Lock | Luer Slip and Luer Lock | Same |
| Needle Gauge | 18G, 20G, 21G, 22G, 23G,
25G, 26G, 27G, 28G, 29G,
30G | 18G, 20G, 21G, 22G, 23G,
25G, 26G, 27G, 28G, 29G,
30G | Same |
| Needle Length | 1/2", 5/8", 1", 1 1/4", 1 1/2" | 1/2", 5/8", 1", 1 1/4", 1 1/2" | Same |
| Biocompatibility | meet ISO 10993
requirements. | meet ISO 10993 requirements. | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part
801 | Complied with 21 CFR part
801 | Same |
Discussions of differences in technological characteristics
Comment 1
The subject device has more syringe volume specification than the predicated device, however the subject device has met the requirements of product performance standards and biocompatibility standards. The volume specifications are also within the overall range included in the predicate. This difference does not affect intended use, so it will not raise new questions of safety or effectiveness.
Performance Testing
Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that proposed device complies with the following standards:
| Test Item | Standard |
|---|---|
| Syringe | ISO 7886-1: 2017 Sterile hypodermic syringes for single use - Part 1: |
| Syringes for manual use | |
| Needle | ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical |
| devices - Requirements and test methods | |
| Needle | ISO 7864: 2016 Sterile hypodermic needles for single use - Requirements and |
| test methods | |
| Luer connector | ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare |
| applications - Part 7: Connectors for intravascular or hypodermic | |
| applications |
A. Physical, Mechanical and Chemical Tests performed on the proposed device:
6
B. Sterile Barrier Packaging Testing performed on the proposed device:
| Test Item | Standard |
|---|---|
| Seal strength | ASTM F88/F88M-2015 |
| Detecting seal leaks | ASTM F1929-2015 |
| Determining integrity of seals | ASTM F1886/F1886M-2016 |
- C. Sterilization and Shelf Life Testing performed on the proposed device:
| Test Item | Standard |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 36-NF 31 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and |
| Sterility Tests were performed on aging samples | |
| to verify the shelf life of 3 years for the subject | |
| device |
- D. The hub is made of pigmented material and the hub color for different needle gauge comply with ISO 6009:2016.
- E. Biocompatibility Testing is conducted according to ISO 10993-1:2018:
| Test Item | Standard |
|---|---|
| Cytotoxicity Test | ISO 10993-5:2009 |
| Skin Sensitization Test | ISO 10993-10:2010 |
| Intracutaneous Reactivity Test | ISO 10993-10:2010 |
| Acute Systemic Toxicity Test | ISO 10993-11:2017 |
| Pyrogen Test | ISO 10993-11:2017 |
| Hemolysis Test | ISO 10993-4:2017 |
| Particulate | USP |
Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject Device, Disposable Syringe with Needle, K211482 is substantially equivalent to the predicate Device, Sterile Single-use Syringe with Needle, K163161.