(129 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
This device is for the aspiration of fluids, not for treatment or therapy. Its primary feature is a safety mechanism to prevent needle sticks.
No
Reasoning: The device description clearly states its purpose is for "aspiration of fluids for medical purpose" and to "minimize risk of accidental needle sticks." It is a tool for fluid handling and safety, not for identifying the presence or nature of a disease or condition.
No
The device description clearly outlines physical components (syringe, needle, safety sheath) and performance studies focus on physical and material properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aspiration of fluids for medical purpose." This describes a procedure performed on a patient's body, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The description details a syringe and needle for fluid aspiration and safety features. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, diagnostic purposes, or any other typical characteristics of an IVD device.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This syringe and needle are used for directly interacting with the body to withdraw fluids.
N/A
Intended Use / Indications for Use
The Sterile Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
Product codes (comma separated list FDA assigned to the subject device)
FMF, MEG, FMI
Device Description
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
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
Not Found
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 Test Conclusion:
A. Syringe: The sterile, single piston syringe described in this summary were tested and demonstrated to be in conformance with ISO 7886-1: 2017 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use.
B. Anti-Stick Needle: The Sterile Antistick Needles described in this summary were tested and demonstrated to be in conformance with ISO 7864: 2016, Sterile Hypodermic Needles for Single Use; 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 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications -Part 20: Common test methods; ISO 23908: 2011 Sharps injury protection-Requirements and test methods-Sharp protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
C. Biocompatibility: New biocompatibility test was not conducted on the proposed device as patient contact materials are identical to K163161. Bacterial endotoxin limit and particulate testing were evaluated per USP Bacterial Endotoxins Test and USP Particulate Matter in Injections.
D. Sterility, Shipping, and Shelf-life: Devices were sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 per ISO 11135:2014, Annex B. Package integrity testing was conducted per ASTM D4169-16, ASTM F1886/1886M-16, ASTM F88/F88-15, and ASTM F1929-15. Shelf life of 3 years is validated using ASTM F1980-16. EO ECH residue testing was performed per ISO 10993-7:2008.
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.
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 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.
October 14, 2021
Jiangxi Hongda Medical Equipment Group Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K211753
Trade/Device Name: Sterile Syringe with Safety Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, MEG Dated: September 8, 2021 Received: September 14, 2021
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.
1
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 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).
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) K211753
Device Name Sterile Syringe with Safety Needle
Indications for Use (Describe)
The Sterile Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
Type of Use (Select one or both, as applicable):
| 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
K211753.510KSummary
-
- Date of Preparation: 10/14/2021
-
- Sponsor Identification
Jiangxi Hongda Medical Equipment Group Ltd. No. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, 331700, China
Contact Person:
Yang Xiaohua Position: Vice-general Manager Tel: +86-791-85628918 Fax: +86-791-85628881 Email: yxh2821006@126.com
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (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 Subject Device: | Trade Name: Sterile Syringe with Safety Needle |
|---|---|---|
| Common Name: | Safety Piston Syringe with Needle | |
| Classification Name: | Syringe Antistick | |
| Classification: | II | |
| Product Code: | MEG | |
| Regulation Number: | 21 CFR 880.5860 | |
| Review Panel: | General Hospital | |
| Classification Name: | Piston Syringe | |
| Classification: | II | |
| Product Code: | FMF | |
| Regulation Number: | 21 CFR 880.5860 | |
| Review Panel: | General Hospital | |
| Classification Name: | Hypodermic single lumen needle | |
| Classification: | II | |
| Product Code: | FMI | |
| Regulation Number: | 21 CFR 880.5570 | |
| Review Panel: | General Hospital | |
| 5. | Predicate Device | K193526, Syringe with Safety Needle |
Device Description 6.
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
| Gauge | Length | Wall Type |
|---|---|---|
| 26G | 13mm, 16mm | RW |
| 25G | 16mm, 25mm, 38mm | RW |
| 24G | 16mm, 25mm, 38mm | RW |
| 23G | 25mm, 32mm, 38mm | TW |
| 22G | 25mm, 32mm, 38mm | TW |
| 21G | 25mm, 32mm, 38mm | TW |
| 20G | 25mm, 32mm, 38mm | TW |
| 18G | 25mm, 32mm, 38mm | TW |
7. 7. Indication for Use
| Characteristics | Subject Device | Predicate |
|---|---|---|
| ----------------- | ---------------- | ----------- |
5
| | Sterile Syringe with Safety Needle
K211753 | Syringe with Safety Needle
K193526 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | The Sterile Syringe with Safety
Needle is intended for use in the
aspiration and injection of fluids for
medical purpose. After withdrawal of
the needle from the body, the
attached needle safety shield can be
manually activated to cover the
needle immediately after use to
minimize risk of accidental needle
sticks. | The Sterile Disposable Syringe with
Safety Needle is intended for use in
the aspiration and injection of fluids
for medical purpose. After
withdrawal of the needle from the
body, the attached needle safety
shield can be manually activated to
cover the needle immediately after
use to minimize risk of accidental
needle sticks. |
| Prescription
Only or Over
the counter | Prescription Only | Prescription Only |
-
- Technological Characteristics
| Table 1 Comparison of Technology Characteristics | |
|---|---|
| ITEM | Subject Device K211753 | Predicate Device K193526 | Remark |
|---|---|---|---|
| Product Code | FMF | ||
| FMI | |||
| MEG | FMF | ||
| FMI | |||
| MEG | Same | ||
| Regulation No. | 21 CFR 880.5860 | ||
| 21 CFR 880.5570 | 21 CFR 880.5860 | ||
| 21 CFR 880.5570 | Same | ||
| Class | Class II | Class II | Same |
| Indication for Use | The Sterile Syringe with Safety | ||
| Needle is intended for use in the | |||
| aspiration and injection of fluids for | |||
| medical purpose. After withdrawal | |||
| of the needle from the body, the | |||
| attached needle safety shield can be | |||
| manually activated to cover the | |||
| needle immediately after use to | |||
| minimize risk of accidental needle | |||
| sticks. | The Sterile Disposable Syringe | ||
| with Safety Needle is intended | |||
| for use in the aspiration and | |||
| injection of fluids for medical | |||
| purpose. After withdrawal of | |||
| the needle from the body, the | |||
| attached needle safety shield | |||
| can be manually activated to | |||
| cover the needle immediately | |||
| after use to minimize risk of | |||
| accidental needle sticks. | Same | ||
| Configuration | Barrel | ||
| Plunger | |||
| Piston | |||
| Needle hub | |||
| Protective cap | |||
| Needle tube | Barrel | ||
| Plunger | |||
| Piston | |||
| Needle hub | |||
| Protective cap | |||
| Needle tube | Same | ||
| Safety sheath | Safety sheath | ||
| Operation Mode | For manual use only | For manual use only | Same |
| Safety Feature | Slide over the needle to prevent | ||
| from needle sticks | Slide over the needle to prevent | ||
| from needle sticks | Same | ||
| Single Use | Yes | Yes | Same |
| Label/Labeling | Complies with 21 CFR part 801 | Complies with 21 CFR part 801 | Same |
| Syringe Volume | 1ml, 3ml, 5ml, 10ml | 1ml, 2ml, 3ml, 5ml, 10ml, | |
| 20ml, 30ml, 50ml, 60ml | Different/ See | ||
| Comment #1 | |||
| Connector Type | Luer Lock/ Luer slip | Luer Lock | Different/ See |
| Comment #2 | |||
| Syringe | |||
| Performance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same |
| Needle Gauge | 18G, 20G, 21G, 22G, 23G, 24G, | ||
| 25G, 26G | 16G, 18G, 19G, 20G, 21G, | ||
| 22G, 23G, 25G, 26G, 27G, | |||
| 28G, 29G, 30G, 31G | Different/ See | ||
| Comment #3 | |||
| Needle Length | 13mm, 16mm, 25mm, 32mm, | ||
| 38mm | 13mm, 16mm, 20mm, 25mm, | ||
| 32mm, 38mm | Different/ See | ||
| Comment #4 | |||
| Wall Type | TW: 18G, 20G, 21G, 22G, 23G | ||
| RW: 24G, 25G, 26G | TW: 16G, 18G, 19G, 20G, 21G, | ||
| 22G, 23G, 25G, 26G, 27G, | |||
| 28G, 29G, 30G, 31G | |||
| RW: 16G, 18G, 19G, 20G, 21G, | |||
| 22G, 23G, 25G, 26G, 27G, | |||
| 28G, 29G, 30G, 31G | Different/ See | ||
| Comment #5 | |||
| Bevel Design | LB | LB/SB | Different/ See |
| Comment #6 | |||
| Needle | |||
| Performance | Complies with | ||
| ISO 7864 | |||
| ISO 9626 | Complies with | ||
| ISO 7864 | |||
| ISO 9626 | Same | ||
| Luer Connector | |||
| Performance | Complied with | ||
| ISO 80369-7 | Complied with | ||
| ISO 80369-7 | Same | ||
| Patient contact material | |||
| Barrel | Polypropylene (PP) | Polypropylene (PP) | |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | Same |
| Piston | Polyisoprene | Polyisoprene | Same |
| Needle tube | Stainless Steel, SUS304 | Stainless Steel, SUS304 | |
| Biocompatibility | |||
| Cytotoxicity | Comply with ISO 10993 standards, | ||
| biocompatibility was leveraged on | |||
| the data of K163161 | No cytotoxicity | Same | |
| Irritation | No intracutaneous reactivity | ||
| Sensitization | No skin sensitization | ||
| Systemic Toxicity | No systemic toxicity | ||
| Hemolysis | No Hemolysis | ||
| Pyrogen | No Pyrogen | ||
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
6
7
Comment 1 - Syringe Volume
The syringe specification for the subject device is less than the predicate device. However, the specification can be covered by the predicate device. In addition, the syringe performance has been tested and test results demonstrate that the syringe meets the requirements of ISO 7886. Therefore, this difference is not considered to affect substantial equivalence.
Comment 2 - Luer Connector
The subject device is available in luer slip and luer lock two types connectors and luer lock connector is not covered by the predicate device. However, the luer connector has been tested per ISO 80369-7 and the test results demonstrate that the luer connector meets the requirements of ISO 80369-7. Therefore, this difference is not considered to affect substantial equivalence.
Comment 3 - Needle Gauge
The subject device has the additional gauge 24G compared to the predicate device, while other gauges can be covered by the predicate device. The needle performance has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.
Comment 4 - Needle Length
The length specification of the subject device is within the range covered by the predicate device. In addition, the needle performance has been tested and the results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.
Comment 5 - Wall Type
The wall type of the subject device under the same needle gauge can be covered by the predicate device. In addition, the needle performance has been tested and results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.
Comment 6 - Bevel Design
The bevel design of the subject device can be covered by the predicate device. In addition, the needle performance has been tested and the results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.
Non-Clinical Test Conclusion 9.
8
A. Syringe
The sterile, single piston syringe described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- A ISO 7886-1: 2017 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
B. Anti- Stick Needle
The Sterile Antistick Needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
-
ISO 7864: 2016, Sterile Hypodermic Needles for Single Use.
-
ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices
- A ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
-
ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications -Part 20: Common test methods
-
ISO 23908: 2011 Sharps injury protection-Requirements and test methods-Sharp protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
C. Biocompatibility
The patient contact materials of the subject device, Sterile Syringe with Safety Needle, are identical to the material of Sterile Single-Use Syringe With Needle as it was cleared in K163161in 03/20/2017. There are no differences in formulation, processing and sterilization, and no other chemicals have been added. (e.g., plasticizers, filters, cleaning agents, mold release agents, etc.). Therefore, new biocompatibility test was not conducted on the proposed device. Bacterial endotoxin limit and particulate testing were evaluated on the proposed device per following standards
-
USP Bacterial Endotoxins Test
-
USP Particulate Matter in Injections
D. Sterility, Shipping, and Shelf-life
The subject devices were sterilized by Ethylene Oxide Gas to achieve a SAL of 106 and the sterilization method was validated per over kill method as qualified in accordance ISO 11135:2014, Annex B.
Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
Sterile Barrier Packaging Testing performed on the subject device:
○ Visual inspection ASTM F1886/1886M-16
o Seal strength ASTM F88/F88-15
9
oDye penetration ASTM F1929-15
Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
The EO ECH residue testing was performed on the subject device:
- A ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
-
- Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Sterile Syringe with Safety Needle is substantially equivalent to the Syringe with Safety Needle with respect to the indications for use, target populations, treatment method, and technological characteristics.