(204 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and standard performance metrics of a disposable syringe, with no mention of AI or ML capabilities.
No.
The device is a syringe used for administering medicine; it does not directly provide therapy.
No
The device is a disposable neuraxial syringe used for administering medication (anesthesia) and does not perform any diagnostic function.
No
The device description clearly states it is a disposable neuraxial syringe consisting of physical components (piston, plunger, barrel) and is used to inject medicine. It also mentions sterilization and physical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of medication (anesthesia) through injection into specific anatomical locations (wound infiltrations, peripheral nerve block, epidural block). This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a syringe, designed for delivering liquids into the body. This is a common medical device for administration, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This syringe is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The device is indicated for local administration, and regional administration, specifically, wound infiltrations, peripheral nerve block, and epidural block. The device is not indicated for subarachnoid/spinal blocks.
Product codes
QEH
Device Description
The proposed device is a disposable neuraxial syringe consist of three components: piston, plunger and barrel; and provided in a variety of volumes: 1ml, 3ml, 5ml, 6ml, 10ml, 20ml, 35ml, 50ml and 60 ml. The barrel of the syringe is printed with graduated markings indicating the volume of liquid inside the barrel.
The proposed device is used to inject anesthesia medicine with the cooperation of the spinal anesthesia needles and epidural anesthesia needles which has an NRFit connectors in compliance with ISO 80369-6. The NRFit tip could help to reduce the residual risk of misconnections.
The proposed device is provided in two statuses: sterile. The non-sterile NRFit syringe is intended to be sterilized prior to use to repackagers/medical device manufacturers, and the sterile NRFit syringe is supplied to the end user. The sterilized product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
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
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 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
- USP 39-NF34 Bacterial Endotoxins Test
- ISO 7886-1:1993 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
- ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications -Part 6: Connectors for neuraxial applications
- ISO 80369-20:2015 Small bore connectors for liquids and gases in healthcare applications- Part 20: Common test methods
- USP Particulate Matter in Injections (Method 1)
Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-6:2016, using the test methods provided in ISO 80369-20. The testing demonstrates the proposed devices conform to the requirements of ISO 80369-6:2016.
- Fluid Leakage (Clause 6.1 in ISO 80369-6; Annex C in ISO 80369-20)
- Stress Cracking (Clause 6.3 in ISO 80369-6; Annex E in ISO 80369-20)
- Resistance to separation from axial load (Clause 6.4 in ISO 80369-6; Annex F in ISO 80369-20)
- Resistance to separation from unscrewing (Clause 6.5 in ISO 80369-6; Annex G in ISO 80369-20)
- Resistance to overriding (Clause 6.6 in ISO 80369-6; Annex H in ISO 80369-20)
Syringe testing performed on the proposed device included the items listed below, in accordance with ISO 7886-1:1993. Sterile hypodermic syringe for syringe use-Part 1: Syringe for manual use, using the test methods provided in ISO 7886-1:1993. The testing demonstrates the proposed devices conform to the requirements of ISO 7886-1:1993.
- Cleanliness (Clause 5)
- Limits for acidity or alkalinity (Clause 6)
- Limits for extractable metals (Clause 7)
- Lubricant (Clause 8)
- Tolerance on graduated capacity (Clause 9)
- Graduated scale (Clause 10)
- Barrel (Clause 11)
- Piston/plunger assembly (Clause 12)
- Dead space (Clause 14.1)
- Freedom from air and liquid leakage past piston (Clause 14.2)
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/0 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.
December 14, 2018
Jiangsu Caina Medical Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn
Re: K181374
Trade/Device Name: NRFit Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QEH Dated: October 31, 2018 Received: November 13, 2018
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 mav, 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 avare 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sarah B. Mollo -S
for 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
Indications for Use
510(k) Number (if known) K181374
Device Name NRFit Syringe
Indications for Use (Describe)
The device is indicated for local administration, and regional administration, specifically, wound infiltrations, peripheral nerve block, and epidural block. The device is not indicated for subarachnoid/spinal blocks.
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
510(k) Summary
K181374
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K181374
-
- Date of Preparation: 12/12/2018
- Sponsor Identification 2.
Jiangsu Caina Medical Co., Ltd.
No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214425, China
Establishment Registration Number: 3005670221
Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: junlu@cainamedical.com
3. Designated Submission Correspondent
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: 001-3609253199 Email: info@mid-link.net
4
-
- Device
Trade Name: NRFit Syinge Common Name: Syringe, piston Model(s): 1ml, 3ml, 5ml, 6ml, 10ml, 20ml, 35ml, 50ml and 60 ml
- Device
Regulatory Information
Classification Name: Piston Syringe Classification: II Product Code: QEH Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
5. Predicate Device
510(k) Number: K170218 Product Name: Vesco Medical NRFitTM Syringes
6. Device Description
The proposed device is a disposable neuraxial syringe consist of three components: piston, plunger and barrel; and provided in a variety of volumes: 1ml, 3ml, 6ml, 10ml, 30ml, 35ml, 50ml, 30ml and 60 ml. The barrel of the syringe is printed with graduated markings indicating the volume of liquid inside the barrel.
The proposed device is used to inject anesthesia medicine with the cooperation of the spinal anesthesia needles and epidural anesthesia needles which has an NRFit connectors in compliance with ISO 80369-6. The NRFit tip could help to reduce the residual risk of misconnections.
The proposed device is provided in two statuses: sterile. The non-sterile NRFit syringe is intended to be sterilized prior to use to repackagers/medical device manufacturers, and the sterile NRFit syringe is supplied to the end user. The sterilized product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
-
- Indications for Use:
The device is indicated for local administration and regional administration, specifically, wound infiltrations, peripheral nerve block, and epidural block. The device is not indicated for subarachnoid/spinal blocks.
- Indications for Use:
5
-
- 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
-
A ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
-
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
-
A ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
-
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
-
USP 39-NF34 Bacterial Endotoxins Test
-
ISO 7886-1:1993 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
-
A ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications -Part 6: Connectors for neuraxial applications
-
ISO 80369-20:2015 Small bore connectors for liquids and gases in healthcare applications- Part 20: Common test methods
-
USP Particulate Matter in Injections (Method 1)
Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-6:2016, using the test methods provided in ISO 80369-20. The testing demonstrates the proposed devices conform to the requirements of ISO 80369-6:2016.
| Individual test Defined in ISO 80369-6 | Requirement Defined in | Test Method Defined |
|---|---|---|
| ISO 80369-6 | in ISO 80369-20 | |
| Fluid Leakage | Clause 6.1 | Annex C |
| Stress Cracking | Clause 6.3 | Annex E |
| Resistance to separation from axial load | Clause 6.4 | Annex F |
| Resistance to separation from unscrewing | Clause 6.5 | Annex G |
| Resistance to overriding | Clause 6.6 | Annex H |
Syringe testing performed on the proposed device included the items listed below, in accordance with ISO 7886-1:1993. Sterile hypodermic syringe for syringe use-Part 1: Syringe for manual use, using the test methods provided in ISO 7886-1:1993. The testing demonstrates the proposed devices conform to the requirements of ISO 7886-1:1993.
| Individual test Defined in ISO 7886-1:1993 | Requirement Defined in ISO 7886-1:1993 |
|---|---|
| Cleanliness | Clause 5 |
| Limits for acidity or alkalinity | Clause 6 |
6
| Limits for extractable metals | Clause 7 |
|---|---|
| Lubricant | Clause 8 |
| Tolerance on graduated capacity | Clause 9 |
| Graduated scale | Clause 10 |
| Barrel | Clause 11 |
| Piston/plunger assembly | Clause 12 |
| Dead space | Clause 14.1 |
| Freedom from air and liquid leakage past piston | Clause 14.2 |
9. Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device
K170218 | Remark |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------|
| Product name | NRFit Syringe | Vesco Medical NRFitTM Tip / Syringes | |
| Product code | FMF | FMF | SE |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | SE |
| Class | II | II | SE |
| Indications for Use | The device is indicated for local administration, and regional administration, specifically, wound infiltrations, peripheral nerve block, and epidural block. The device is not indicated for subarachnoid/spinal blocks. | The Vesco Medical NRFitTM Tip Syringes are intended to inject fluids into or withdraw fluids from the body. | Analysis is provided below |
| Configuration | Piston
Plunger
Barrel | Piston
Plunger
Barrel | SE |
| Sterility condition | EO Sterilized/ Non-sterilized | EO Sterilized | Analysis is provided below |
| Environment of use | Hospital | Hospital | SE |
Table 1 Substantial Equivalence
7
| Intended users | Medical professionals and trained care givers | Medical professionals and trained care givers | SE |
|---|---|---|---|
| Single use | Yes | Yes | SE |
| Type of placement | Used with catheter or needle with Neuraxial compliant connector | Used with catheter or needle with Neuraxial compliant connector | SE |
| NRFit Connector | Yes; compliant with ISO 80369-6 | Yes; compliant with ISO 80369-6 | SE |
| Operation mode | For Manual Use Only, For Single Use only | For Manual Use Only, For Single Use only | SE |
| Label/labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | SE |
Comparison summary
The differences between the proposed device and predicate device are the volume and sterilization status. The proposed device has a larger range of volumes than the predicate device. Both the proposed device and the predicate device comply with the relevant international stated in Section 8, which includes verification of attributes that could be impacted by syringe volume/barrel size. Therefore, the difference in syringe volume will not raise different questions of safety and effectiveness. The proposed device is provided in two presentations: sterile. The non-sterile NRFit syringe is intended to be sterilized prior to use to repackagers/medical device manufacturers and the sterile NRFit syringe is supplied to the end user. The sterilized product is sterilized by Ethylene Oxide Gas to achieve a SAL of 106, which is the same as the predicate device. The non-sterile product is clearly labeled and validated cycle conditions for EO sterilization are provided to the repackagers/medical device manufacturers. Therefore, the differences will not affect the substantial equivalence between the proposed device and predicate device.
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.
- Substantially Equivalent (SE) Conclusion