(130 days)
Not Found
No
The device description and performance studies focus on the physical, mechanical, and safety features of a manual syringe, with no mention of AI or ML.
No.
The device is a syringe and needle used for injection or withdrawal of fluids, and its primary function is not to treat or alleviate a disease, injury, or disability. The safety feature is for injury prevention during use, not for therapeutic effect on the patient.
No
The device is a sterile hypodermic safety syringe used for injecting or withdrawing fluids from the body; its function is interventional (delivery/extraction), not diagnostic (identifying a condition).
No
The device description clearly states it is comprised of syringes and needles, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to inject fluids into or withdraw fluids from the body." This describes a device used on the body for therapeutic or diagnostic procedures, not a device used with samples taken from the body to diagnose conditions.
- Device Description: The description focuses on the physical components (syringes and needles) and their function in injecting and withdrawing fluids. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information based on sample analysis.
The device described is a medical device used for administering substances or collecting samples directly from a patient, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.
Product codes
MEG, FMI
Device Description
The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The proposed devices are available in a variety combination of needle sizes and syringe volumes. All specifications of proposed devices subject to the same design. The proposed devices are intended for manual use only.
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 device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test provided in this submission include:
Physical, Mechanical and Chemical Tests performed on the proposed device according to ISO 9626:1991/AMD-1:2001, ISO 7886:1993, ISO 594-2:1998, ISO 7864:1993, and ISO 594-1:1986.
Sterile Barrier Packaging Testing performed on the proposed device using ASTM F88/F88-09 and ASTM F1140/F1140M-13.
Sterilization and Shelf Life Testing performed on the proposed device using ISO 10993-7:2008, ISO 11737-2: 2009, and USP 36-NF 31. Shelf Life Evaluation involved Physical, Mechanical, Chemical, Package and Sterility Tests performed on real time aging samples.
Biocompatibility Testing: performed according to ISO 10993 standards.
Simulated Clinical Study: Performed on proposed device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism. The results demonstrated that the proposed device met the pre-established criteria.
Safety Feature Test: performed on both proposed device and predicate device. The results demonstrated that the proposed device did not show a significant difference from predicate device.
No clinical study is included in this submission.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and movement.
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: K163162
Trade/Device Name: Sterile Hypodermic Safety Syringes for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, 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
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Indications for Use
510(k) Number (if known) K163162
Device Name
Sterile Hypodermic Safety Syringes for Single Use
Indications for Use (Describe)
The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.
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) |
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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: K163162
-
- Date of Preparation: 03/15/2017
-
- 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) Ms. Ying Xu (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
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4. Identification of Proposed Device
Trade Name: Sterile Hypodermic Safety Syringes for Single Use Common Name: Piston Syringe with Needle
Regulatory Information Classification Name: Syringe Antistick Classification: II Product Code: MEG Subsequent Product Code: FMI Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
Indication for Use:
The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.
Device Description
The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The proposed devices are available in a variety combination of needle sizes and syringe volumes. All specifications of proposed devices subject to the same design. The proposed devices are intended for manual use only.
5. Identification of Predicate Device
510(k) Number: K072739 Product Name: Retractable Auto-Disable 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 provided in this submission include:
- Non-Clinical Test Conclusion
Physical, Mechanical and Chemical Tests performed on the proposed device
| Materials | Clause 3 of ISO 9626:1991/AMD-1:200 |
|---|---|
| Surface finish | Clause 4 of ISO 9626:1991/AMD-1:200 |
| Cleanliness | Clause 5 of ISO 9626:1991/AMD-1:200 |
5
| 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
- Limits for acidity or alkalinity Limits for extractable metals Size designation Colour coding Needle hub Sheath Needle tube Needle point Performance
Cleanliness
| 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 Gauging Liquid leakage Air leakage Separation force Stress cracking
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
Clause 4 of ISO 7864:1993 Clause 5 of ISO 7864:1993 Clause 6 of ISO 7864:1993 Clause 7 of ISO 7864:1993
Clause 8 of ISO 7864:1993 Clause 9 of ISO 7864:1993 Clause 10 of ISO 7864:1993 Clause 11 of ISO 7864:1993 Clause 12 of ISO 7864:1993 Clause 13 of ISO 7864:1993
Clause 5 of ISO 7886:1993
ISO 7886:1993 ISO 7886:1993 ISO 7886:1993 f ISO 7886:1993 f ISO 7886:1993 f ISO 7886:1993 f ISO 7886:1993 f ISO 7886:1993 Clause 3 of ISO 594-1:1986 Clause 4.1 of ISO 594-1:1986 Clause 4.2 of ISO 594-1:1986
Clause 4.3 of ISO 594-1:1986 Clause 4.4 of ISO 594-1:1986 Clause 4.5 of ISO 594-1:1986
6
| 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 |
| Sterility test | ISO 11737-2: 2009 |
| 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 |
Biocompatibility Testing
The patient-contact materials of Sterile Hypodermic Safety Syringes for Single Use are identified and biocompatibility testing is performed according to ISO 10993 standards
Simulated Clinical Study
A simulated clinical study was performed on proposed device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Safety Feature Test
The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that the proposed device did not show a significant difference from predicate device.
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7. Clinical Test Conclusion
No clinical study is included in this submission.
Substantially Equivalent (SE) Comparison 8.
Table 1 Comparison of Technology Characteristics
| Item | Proposed Device | Predicate Device
K072739 | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------|
| Product Code | MEG | Same | |
| Regulation Number | 21 CFR 880.5860 | Same | |
| Class | II | Same | |
| Indication for Use | The Sterile Hypodermic Safety Syringes for
Single Use is intended to be used for medical
purpose to inject fluids into or withdraw fluids
from the body. After injection, the
anti-needlestick feature is manually activated to
aid in the prevention of accidental needle stick
injuries. | Similar | |
| Configuration
and material | Barrel | Polypropylene (PP) | Same |
| | Plunger | Polypropylene (PP) | |
| | Piston | Polyisoprene | |
| | Needle hub | Polypropylene (PP) | |
| | Needle cap | Polypropylene (PP) | |
| | Needle tube | Stainless Steel, SUS304 | |
| Operation Mode | For manual use only | | Same |
| Syringe Volume | 5ml | | 3ml, 5ml, 10ml |
| Connector Type | Luer Lock | | Same |
| Needle Gauge and
Length | Gauge:21G, 22G, 23G
Length: 1", 1 1/4", 1 1/2" | | Similar |
| Biocompatibility | Cytotoxicity | No cytotoxicity | Same |
| | Irritation | No intracutaneous reactivity | |
| | Sensitization | No skin sensitization | |
| | Systemic Toxicity | No systemic toxicity | |
| | Hemolysis | No Hemolysis | |
| | Pyrogen | No Pyrogen | |
| Sterilization | EO Sterilization | | Same |
| SAL | $10^{-6}$ | | Same |
| Single Use | Yes | Same | |
| Label/Labeling | Complied with 21 CFR part 801 | Same | |
8
The Sterile Hypodermic Safety Syringe for Single Use 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 non-safety svringes but the subject device is claiming substantial equivalence to the predicates safety syringe. Through performance testing comparison the subject device and predicate device have demonstrated substantial equivalence.
9. Substantially Equivalent (SE) Conclusion
Based on the bench performance testing, comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.