Pre-Filled Normal Saline Flush Syringe

K223584 · Anhui Tianyang Pharmaceutical Co., Ltd. · NGT · Aug 12, 2023 · General Hospital

Device Facts

• Record ID: K223584
• Device Name: Pre-Filled Normal Saline Flush Syringe
• Applicant: Anhui Tianyang Pharmaceutical Co., Ltd.
• Product Code: NGT · General Hospital
• Decision Date: Aug 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended 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.

Device Story

Pre-Filled Normal Saline Flush Syringe is a single-use, sterile, disposable device consisting of a polypropylene barrel, plunger, and piston (bromobutyl rubber), pre-filled with 0.9% sodium chloride injection. Available in 3ml, 5ml, and 10ml volumes. Used by clinicians in clinical settings to flush and clear intravenous catheters and administration sets between drug administrations. The device features a Luer lock connector for secure attachment to catheter ports. Operation involves connecting the syringe to the catheter and manually depressing the plunger to deliver the saline flush. This process maintains catheter patency and prevents drug incompatibility by clearing the catheter lumen.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included physical syringe testing (ISO 7886-1, ISO 80369-7), USP chemical testing for sodium chloride injection, particulate contamination (AAMI TIR42:2021), and comprehensive biocompatibility testing (ISO 10993 series including cytotoxicity, sensitization, systemic toxicity, and hemolysis).

Technological Characteristics

Materials: Polypropylene (barrel, plunger, tip cap), Bromobutyl rubber (piston). Luer lock connection per ISO 80369-7. Sterilization: Steam (10^-6 SAL). Packaging: BOPP heat sealing film. Sizes: 3ml, 5ml, 10ml. Non-pyrogenic, single-use.

Indications for Use

Indicated for flushing compatible intravenous administration sets and indwelling intravenous access devices in patients requiring such maintenance.

Regulatory Classification

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.

Predicate Devices

• AMSafe® Pre-Filled Normal Saline Flush Syringe (K213522)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 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: | [phone] |
| E-mail: | [e-mail] |

#### 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

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| Device<br>Characteristic | Subject Device<br>(K223584) | Predicate Device<br>(K213522) | Discussion |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indications for<br>Use | Pre-Filled Normal Saline Flush<br>Syringe is intended for use in<br>flushing compatible<br>intravenous administration<br>sets and indwelling<br>intravenous access devices.<br>Use according to the<br>recommendations of the<br>manufacturer for the<br>appropriate device. | The AMSafe® PreFilled<br>Normal Saline Flush<br>Syringe, is intended for use<br>in flushing compatible<br>intravenous<br>administration sets and<br>indwelling intravenous<br>access devices. Use<br>according to the<br>recommendations of the<br>manufacturer for the<br>appropriate device. | Similar<br>Comment 1 |
| Prescription/<br>over-the counter<br>use | For Rx only | For Rx only | Identical |
| Operation<br>Principle | The Pre-Filled Normal Saline<br>Flush Syringe is flushed after<br>the locking connector is<br>connected to the medical<br>catheter connector for clinical<br>use the liquid medicine (0.9%<br>sodium chloride injection) was<br>pushed into the medical<br>catheter and used to close<br>and flush the end of the<br>catheter in the gap between<br>different drugs. | The AMSafe® PreFilled<br>Normal Saline Flush Syringe<br>is a three-piece, sterile,<br>single use syringe with a 6%<br>(Luer) connector pre-filled<br>with 0.9% Sodium Chloride<br>Injection, USP, and sealed<br>with a tip cap. | Identical |
| Design | The subject device with Luer<br>lock connection fitting and<br>nonvented, female Luer lock<br>tip cap. | The device has modified to<br>add an extra thread to the<br>plunger rod and inside of<br>plunger stopper, the female<br>Luer cap has Changed to<br>screw type. | Different<br>Comment 2 |
| Chemical<br>composition | 0.9% Sodium chloride<br>injection, USP | 0.9% Sodium chloride<br>injection, USP | Identical |
| Syringe material | Tip Cap, Barrel and Plunger:<br>polypropylene;<br>Piston: Bromobutyl rubber | Barrel and plunger:<br>polypropylene<br>Stopper: Butyl rubber (not<br>made with natural rubber | Identical |
| Device<br>Characteristic | Subject Device | Predicate Device<br>(K213522) | Discussion |
| | | latex) | |
| | | Tip cap: polypropylene with<br>white colorant | |
| Syringe Size<br>and Fill Volumes | Fill 3ml, 5ml, 10ml in 10cc<br>syringe | Fill 3ml, 5ml, 10ml in 10cc<br>syringe | Identical |
| | Fill 3ml, 5ml in 5cc syringe | Fill 3ml, 5ml in 5cc syringe | |
| Syringe<br>Packaging | BOPP heat sealing film | PP wrap | Different<br>Comment 3 |
| Sterilization<br>method and<br>SAL Level | Terminally sterilized by steam,<br>10-6 SAL | Terminally sterilized by<br>steam, 10-6 SAL | Identical |
| Labeled<br>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<br>alkalinity | ISO7886-1 | ISO7886-1 | Pass | |
| 1.4 | Syringe Luer<br>Performance | ISO 80369-7 | ISO 80369-7 | Pass | |
| 1.5 | Sealing<br>performance | ISO7886-1 | ISO7886-1 | Pass | |
| 2 | Sodium Chloride Injection, USP Testing | | | | |
| 2.1 | pH value | USP<791> | PH: 4.5-7.0 | Pass | |
| 2.2 | Oxidizable<br>substance test | USP6-471 | USP6-471 | Pass | |
| 2.3 | Carbonate | USP<191> | USP<191> | Pass | |
| 2.4 | Sulfate | USP<191> | USP<191> | Pass | |
| 2.5 | Calcium | USP<191> | USP<191> | Pass | |
| 2.6 | Ammonium | USP<191> | USP<191> | Pass | |
| 2.7 | Iron test | USP<241> | < 2ppm | Pass | |
| 2.8 | Limits of<br>extractable metals | USP<233><br>USP<232> | USP<233><br>USP<232> | Pass | |
| 3 | Particulate<br>Contamination | AAMI TIR42:2021 | ≥10μm, ≤6000<br>≥25μm, ≤600 | ≥10μm, ≤361.5<br>≥25μm, ≤0.0 | |
| 4 | Biocompatibility Testing | | | | |
| 4.1 | Bacterial<br>Endotoxins Test | USP 43<85> | Bacterial endotoxins≤<br>0.5EU/mL | Pass | |
| 4.2 | In Vitro Cytotoxicity | ISO 10995-5:2009 | Non-cytotoxic | Pass | |
| 4.3 | Intracutaneous<br>Reactivity Test | ISO 10995-23:2021 | Non-irritant | Pass | |
| 4.4 | Skin Sensitization<br>Test | ISO 10993-10:2021 | Non-sensitizer | Pass | |
| 4.5 | Acute Systemic<br>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<br>Test | ISO 10993-4:2017 | Non-hemolytic | Pass | |

Table VII-1: Performance testing was conducted on the subject device

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## 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

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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