(130 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a manual syringe and needle, with no mention of AI or ML.
No
The device is described as a sterile single-use syringe with needle intended to inject or withdraw fluids from the body, which is a diagnostic or delivery tool, not a therapeutic agent itself.
No
The device is described as a sterile single-use syringe with a needle intended to inject or withdraw fluids, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description explicitly states it is comprised of physical components (syringes and needles) 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 direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details the physical components of a syringe and needle, which are used for administering or collecting substances directly from a living organism.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings to test samples.
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
Sterile Single-use Syringe with Needle is intent fluids into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
Device Description
The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consists of needle tube, needle hub, needle cap. The proposed devices shall be operated manually, are not intended for use with syringe pumps. All specifications of proposed devices subject to the same design and the difference between each specification is syringe volume and needle size. The proposed devices are available in a variety combination of needle size and syringe volume. The syringe size, needle gauges and lengths is provided in following table
| Syringe Size | Needle Gauge | Needle Length |
|---|---|---|
| Available in 1ml, 3ml, 5ml, 10ml, 20ml, 60ml | 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" |
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 tests were conducted to verify that the proposed devices met all design specifications and are Substantially Equivalent (SE) to the predicate device. The non-clinical tests conducted on the proposed devices include: Physical, Mechanical and Chemical Tests, Sterile Barrier Packaging Testing, and Sterilization and Shelf Life Testing. Biocompatibility testing was also performed. Based on the bench performance testing, comparison and analysis, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2017
JiangXi HongDa Medical Equipment Group Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120 CHINA
Re: K163161
Trade/Device Name: Sterile Single-use Syringe with Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: February 14, 2017 Received: February 15, 2017
Dear Ms. 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. The general controls provisions of the Act include requirements for annual registration. Isting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation 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)
Device Name
Sterile Single-use Syringe with Needle
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
Sterile Single-use Syringe with Needle is intent fluids into or withdraw fluids from the body.
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 Druq 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
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: K163161
-
- Date of Preparation: 3/15/2017
-
- Sponsor Identification
JiangXi HongDa Medical Equipment Group Ltd.
No. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, 331700, China
Establishment Registration Number: Not yet registered
Contact Person: Yang Xiaohua Position: Vice-general Manager Tel: +86-791-85628918 Fax: +86-791-85628881 Email: yxh2821006@126.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Sterile Single-use Syringe with Needle Common Name: Piston Syringe with Needle
Regulatory Information
Classification Name: Piston Syringe Classification: II Product Code: FMF Subsequent Product Code: FMI Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
5. Identification of Predicate Device
510(k) Number: K072739 Product Name: Sterile Hypodermic Syringe for single use, with/without needle
Indications for Use; Sterile Single-use Syringe with Needle is intended to inject fluids into or withdraw fluids from the body.
Device Description
The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consists of needle tube, needle hub, needle cap. The proposed devices shall be operated manually, are not intended for use with syringe pumps. All specifications of proposed devices subject to the same design and the difference between each specification is syringe volume and needle size. The proposed devices are available in a variety combination of needle size and syringe volume. The syringe size, needle gauges and lengths is provided in following table
| Syringe Size | Needle Gauge | Needle Length |
|---|---|---|
| Available in 1ml, 3ml, 5ml, 10ml, 20ml, 60ml | 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" |
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed devices met all design specifications and are Substantially Equivalent (SE) to the predicate device. The non-clinical tests conducted on the
5
proposed devices include:
Physical, Mechanical and Chemical Tests performed on the proposed device
| Materials | Clause 3 of ISO 9626:1991/AMD-1:2001 |
|---|---|
| Surface finish | Clause 4 of ISO 9626:1991/AMD-1:2001 |
| Cleanliness | Clause 5 of ISO 9626:1991/AMD-1:2001 |
| Limits for acidity and alkalinity | Clause 6 of ISO 9626:1991/AMD-1:2001 |
| Size designation | Clause 7 of ISO 9626:1991/AMD-1:2001 |
| Dimensions | Clause 8 of ISO 9626:1991/AMD-1:2001 |
| Stiffness | Clause 9 of ISO 9626:1991/AMD-1:2001 |
| Resistance to breakage | Clause 10 of ISO 9626:1991/AMD-1:2001 |
| Resistance to corrosion | Clause 11 of ISO 9626:1991/AMD-1:2001 |
| Cleanliness | Clause 4 of ISO 7864:1993 |
|---|---|
| Limits for acidity or alkalinity | Clause 5 of ISO 7864:1993 |
| Limits for extractable metals | Clause 6 of ISO 7864:1993 |
| Size designation | Clause 7 of ISO 7864:1993 |
| Colour coding | Clause 8 of ISO 7864:1993 |
| Needle hub | Clause 9 of ISO 7864:1993 |
| Sheath | Clause 10 of ISO 7864:1993 |
| Needle tube | Clause 11 of ISO 7864:1993 |
| Needle point | Clause 12 of ISO 7864:1993 |
| Performance | Clause 13 of ISO 7864:1993 |
| Cleanliness | Clause 5 of ISO 7886:1993 |
|---|---|
| Limits for acidity or alkalinity | Clause 6 of ISO 7886:1993 |
| Limits for extractable metals | Clause 7 of ISO 7886:1993 |
| Lubricant | Clause 8 of ISO 7886:1993 |
| Tolerance on graduated capacity | Clause 9 of ISO 7886:1993 |
| Graduated scale | Clause 10 of ISO 7886:1993 |
| Barrel | Clause 11 of ISO 7886:1993 |
| Piston/plunger assembly | Clause 12 of ISO 7886:1993 |
| Nozzle | Clause 13 of ISO 7886:1993 |
| Performance | Clause 14 of ISO 7886:1993 |
| Dimension | Clause 3 of ISO 594-1:1986 |
|---|---|
| Gauging | Clause 4.1 of ISO 594-1:1986 |
| Liquid leakage | Clause 4.2 of ISO 594-1:1986 |
| Air leakage | Clause 4.3 of ISO 594-1:1986 |
6
| Separation force | Clause 4.4 of ISO 594-1:1986 |
|---|---|
| Stress cracking | Clause 4.5 of ISO 594-1:1986 |
| Gauging | Clause 4.1 of ISO 594-2:1998 |
| Leakage | Clause 4.2 of ISO 594-2:1998 |
| Separation force | Clause 4.3 of ISO 594-2:1998 |
| Unscrewing torque | Clause 4.4 of ISO 594-2:1998 |
| Ease of assembly | Clause 4.5 of ISO 594-2:1998 |
| Resistance to overriding | Clause 4.6 of ISO 594-2:1998 |
| Stress cracking | Clause 4.7 of ISO 594-2:1998 |
Sterile Barrier Packaging Testing performed on the proposed device:
| Seal strength | ASTM F88/F88-09 |
|---|---|
| Internal pressure | ASTM F1140/F1140M-13 |
Sterilization and Shelf Life Testing performed on the proposed device:
| 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 real time aging samples to | |
| verify the claimed shelf life of the device |
The hub is made of pigmented material and the hub color for different needle gauge comply with ISO 6009.
Biocompatibility Testing
The patient-contact materials of Sterile Hypodermic Safety Syringes for Single Use are identified and biocompatibility testing was performed according to ISO 10993-1 standards.
7. Clinical Test Conclusion
No clinical study is included in this submission.
7
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | FMF | Same |
| Regulation Number | 21 CFR 880.5860 | Same |
| Class | II | Same |
| Indications for Use | Sterile Single-use Syringe with Needle is intended | |
| to inject fluids into or withdraw fluids from the | ||
| body. | Similar | |
| Configuration and | ||
| material | Barrel |
| Same |
| | Plunger | |
| | Piston | |
| | Needle tube | |
| | Needle hub | |
| | Needle cap | |
| Operation Mode | For manual use only | Same |
| Syringe Volume | 1ml, 3ml, 5ml, 10ml, 20ml, 60ml | Similar |
| Connector Type | Luer Slip and Luer Lock | Same |
| Needle Gauge and
length | Gauge: 18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G,
28G, 29G, 30G
Length: 1/2", 5/8", 1", 1 1/4", 1 1/2" | Similar |
| Biocompatibility | Cytotoxicity | Same |
| | Irritation | |
| | Sensitization | |
| | Systemic Toxicity | |
| | Hemolysis | |
| | Pyrogen | |
| Sterilization | EO Sterilization | Same |
| SAL | 10-6 | Same |
| Single Use | Yes | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Same |
Table 1 Comparison of Technology Characteristics
The Sterile Single-use Syringe with Needle is similar to the predicate device in device design, Indications for use, materials, sterilization, method of operation and technological characteristics. The differences are in needle lengths/gauges and barrel sizes. The predicate device submission K072739 also includes insulin syringes and safety syringes but the subject device is claiming substantial equivalence to the predicates standard syringe. Through performance testing comparison the subject
8
device and predicate device have demonstrated substantial equivalence.
-
- Substantially Equivalent (SE) Conclusion
Based on the bench performance testing, comparison and analysis, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion