(254 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a pre-filled saline syringe, with no mention of AI or ML.
No.
The device is intended for flushing intravenous administration sets and access devices, not for treating a disease or condition.
No
The device is a pre-filled syringe containing normal saline intended for flushing intravenous administration sets and indwelling intravenous access devices. Its function is to clear lines, not to diagnose a medical condition.
No
The device description clearly states it is a physical syringe filled with saline, consisting of hardware components like a barrel, piston, and plunger. The performance studies focus on physical and chemical properties of the syringe and saline.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for flushing intravenous administration sets and indwelling intravenous access devices. This is a direct interaction with the patient's circulatory system for maintenance and preparation, not for analyzing a sample from the body to diagnose a condition.
- Device Description: The device is a pre-filled syringe with saline. This is a delivery system for a substance, not a tool for performing a diagnostic test on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
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, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
Product codes (comma separated list FDA assigned to the subject device)
NGT
Device Description
Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.
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)
The non-clinical testing for Pre-Filled Normal Saline Flush Syringe was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below. Real time aged samples from three non-consequtive lots were tested for all performance criteria. Key results show "Pass" for all tested criteria including Physical Testing of Syringe, Sodium Chloride Injection, USP Testing, Particulate Contamination, and Biocompatibility Testing.
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(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.
August 12, 2023
Anhui Tianyang Pharmaceutical Co., Ltd. Zhang Shunlin Quality Manager 46 Tiantong Road, Tianchang City, Anhui Province Tianchang. Anhui China
Re: K223584
Trade/Device Name: Pre-Filled Normal Saline Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: July 13, 2023 Received: July 14, 2023
Dear Zhang Shunlin:
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
1
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,
Bifeng Qian -S
Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223584
Device Name Pre-Filled Normal Saline Flush Syringe
Indications for Use (Describe)
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
| 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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3
510(k) Summary (K223584)
l 510(k) Submitter
| Device Submitter: | Anhui Tianyang Pharmaceutical Co., LTD. |
|---|---|
| No.46, Tiantong Road, Tianchang City, Anhui Province |
| Contact Person: | Zhang Sunlin |
|---|---|
| Quality Manager | |
| Phone: | +86-15805509075 |
| E-mail: | 752322508@qq.com |
II Device
| Trade Name of Device: | Pre-Filled Normal Saline Flush Syringe |
|---|---|
| Regulation Number: | 21 CFR 880.5200 |
| Classification Name: | Saline, Vascular Access Flush |
| Product Code: | NGT |
| Regulation Number: | 21 CFR 880.5200 |
| Regulatory Class | II |
| Review Panel | General Hospital |
III Predicate Devices
| 510k Number | K213522 |
|---|---|
| Trade Name of Device: | AMSafe® Pre-Filled Normal Saline Flush Syringe |
| Regulation Number: | 21 CFR 880.5200 |
| Regulation Name: | Intravascular Catheter |
| Regulatory Class | II |
| Product Code: | NGT |
IV Device Description
Pre-Filled Normal Saline Flush Syringe is a polypropylene syringe filled with 0.9% sodium chloride for injection. It contains 3ml, 5ml and 10ml and consists of tip cap, barrel, piston, and plunger. This is a single use, disposable device(s), provided sterile.
V Indications for use
Pre-Filled Normal Saline Flush Syringe is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
VI Technological Characteristics Comparison
VI-1: Comparison of Pre-Filled 0.9% Normal Saline Flush Syringe
4
| Device
Characteristic | Subject Device
(K223584) | Predicate Device
(K213522) | Discussion |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indications for
Use | Pre-Filled Normal Saline Flush
Syringe is intended for use in
flushing compatible
intravenous administration
sets and indwelling
intravenous access devices.
Use according to the
recommendations of the
manufacturer for the
appropriate device. | The AMSafe® PreFilled
Normal Saline Flush
Syringe, is intended for use
in flushing compatible
intravenous
administration sets and
indwelling intravenous
access devices. Use
according to the
recommendations of the
manufacturer for the
appropriate device. | Similar
Comment 1 |
| Prescription/
over-the counter
use | For Rx only | For Rx only | Identical |
| Operation
Principle | The Pre-Filled Normal Saline
Flush Syringe is flushed after
the locking connector is
connected to the medical
catheter connector for clinical
use the liquid medicine (0.9%
sodium chloride injection) was
pushed into the medical
catheter and used to close
and flush the end of the
catheter in the gap between
different drugs. | The AMSafe® PreFilled
Normal Saline Flush Syringe
is a three-piece, sterile,
single use syringe with a 6%
(Luer) connector pre-filled
with 0.9% Sodium Chloride
Injection, USP, and sealed
with a tip cap. | Identical |
| Design | The subject device with Luer
lock connection fitting and
nonvented, female Luer lock
tip cap. | The device has modified to
add an extra thread to the
plunger rod and inside of
plunger stopper, the female
Luer cap has Changed to
screw type. | Different
Comment 2 |
| Chemical
composition | 0.9% Sodium chloride
injection, USP | 0.9% Sodium chloride
injection, USP | Identical |
| Syringe material | Tip Cap, Barrel and Plunger:
polypropylene;
Piston: Bromobutyl rubber | Barrel and plunger:
polypropylene
Stopper: Butyl rubber (not
made with natural rubber | Identical |
| Device
Characteristic | Subject Device | Predicate Device
(K213522) | Discussion |
| | | latex) | |
| | | Tip cap: polypropylene with
white colorant | |
| Syringe Size
and Fill Volumes | Fill 3ml, 5ml, 10ml in 10cc
syringe | Fill 3ml, 5ml, 10ml in 10cc
syringe | Identical |
| | Fill 3ml, 5ml in 5cc syringe | Fill 3ml, 5ml in 5cc syringe | |
| Syringe
Packaging | BOPP heat sealing film | PP wrap | Different
Comment 3 |
| Sterilization
method and
SAL Level | Terminally sterilized by steam,
10-6 SAL | Terminally sterilized by
steam, 10-6 SAL | Identical |
| Labeled
nonpyrogenic | Yes | Yes | Identical |
| Singe Use Only | Yes | Yes | Identical |
| Shelf Life | 2 Years | 3 Years | Similar |
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Comment 1: The Indications for Use of the predicate and subject device are same and the intended use is same, which does not affect the safety and effectiveness of the product.
Comment 2: The Luer cap of the predicate device has been modified, and the subject device is a standard Luer connector that meets the requirements of ISO 80369-7, so it does not affect the safety and effectiveness of the product.
Comment 3: The packaging materials of the subject and predicate are different, but the packaging of the subject device has been verified, and the sterility of the product can be guaranteed within the claimed shelf life of 2 years. Therefore, the safety and effectiveness of the product will not be affected.
VII Summary of Non-clinical Testing (Bench)
The non-clinical testing for Pre-Filled Normal Saline Flush Syringe was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below. Real time aged samples from three non-consequtive lots were tested for all performance criteria.
| Table VII-1. Performance testing was conducted on the subject device | |||||
|---|---|---|---|---|---|
| ID# | Test | Method | Acceptance Criteria | Conclusion | |
| 1 | Physical Testing of Syringe | ||||
| 1.1 | Lubricant | ISO7886-1 | ISO7886-1 | Pass | |
| 1.2 | Dead Space | ISO7886-1 | ISO7886-1 | Pass | |
| 1.3 | Limits for acidity or | ||||
| alkalinity | ISO7886-1 | ISO7886-1 | Pass | ||
| 1.4 | Syringe Luer | ||||
| Performance | ISO 80369-7 | ISO 80369-7 | Pass | ||
| 1.5 | Sealing | ||||
| performance | ISO7886-1 | ISO7886-1 | Pass | ||
| 2 | Sodium Chloride Injection, USP Testing | ||||
| 2.1 | pH value | USP | PH: 4.5-7.0 | Pass | |
| 2.2 | Oxidizable | ||||
| substance test | USP6-471 | USP6-471 | Pass | ||
| 2.3 | Carbonate | USP | USP | Pass | |
| 2.4 | Sulfate | USP | USP | Pass | |
| 2.5 | Calcium | USP | USP | Pass | |
| 2.6 | Ammonium | USP | USP | Pass | |
| 2.7 | Iron test | USP | |||
| USP | USP | ||||
| USP | Pass | ||||
| 3 | Particulate | ||||
| Contamination | AAMI TIR42:2021 | ≥10μm, ≤6000 | |||
| ≥25μm, ≤600 | ≥10μm, ≤361.5 | ||||
| ≥25μm, ≤0.0 | |||||
| 4 | Biocompatibility Testing | ||||
| 4.1 | Bacterial | ||||
| Endotoxins Test | USP 43 | Bacterial endotoxins≤ | |||
| 0.5EU/mL | Pass | ||||
| 4.2 | In Vitro Cytotoxicity | ISO 10995-5:2009 | Non-cytotoxic | Pass | |
| 4.3 | Intracutaneous | ||||
| Reactivity Test | ISO 10995-23:2021 | Non-irritant | Pass | ||
| 4.4 | Skin Sensitization | ||||
| Test | ISO 10993-10:2021 | Non-sensitizer | Pass | ||
| 4.5 | Acute Systemic | ||||
| Toxicity Test | ISO 10993-11:2017 | No systemic toxicity | Pass | ||
| 4.6 | Pyrogen Test | ISO 10993-11:2017 | Non-pyrogen | Pass | |
| 4.7 | In Vitro Hemolysis | ||||
| Test | ISO 10993-4:2017 | Non-hemolytic | Pass |
Table VII-1: Performance testing was conducted on the subject device
6
VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject Pre-Filled Normal
7
Saline Flush Syringe is as safe as effective, and performs as well as or better than the legally marketed device.
Date of Summary: August 8, 2023