AMSafe Pre-Filled Normal Saline Flush Syringe

K213522 · Amsino International, Inc. · NGT · Mar 22, 2022 · General Hospital

Device Facts

• Record ID: K213522
• Device Name: AMSafe Pre-Filled Normal Saline Flush Syringe
• Applicant: Amsino International, Inc.
• Product Code: NGT · General Hospital
• Decision Date: Mar 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The AMSafe® 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

AMSafe® Pre-Filled Normal Saline Flush Syringe is a sterile, single-use, three-piece polypropylene syringe pre-filled with 0.9% sodium chloride injection, USP. It features a 6% (Luer) connector and is sealed with a tip cap. The device is used in clinical settings to flush intravenous administration sets and indwelling access devices. It is operated by healthcare professionals. The device functions by manual injection of the saline solution to maintain patency of the access device. The design includes an extra thread on the plunger rod and inside the plunger stopper for secure connection. The device is terminally sterilized by steam. It is available in various fill volumes (3mL, 5mL, 10mL) within 5cc or 10cc syringe barrels.

Clinical Evidence

Bench testing only. Performance testing included physical testing (ISO 7886-1, ISO 80369-7), package integrity (ASTM F2338-09), chemical analysis of saline (USP <791>, <191>, <643>, <241>, <233>, <232>), particulate matter (USP <788>), and biocompatibility (ISO 10993-5, -10, -11, USP <85>, ASTM F756-17). Shelf life was validated per ASTM F1980-16.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, tip cap), Chlorobutyl rubber (stopper). Sterilization: Steam (10^-6 SAL). Connectivity: None. Form factor: 3-piece syringe with 6% (Luer) connector. Design: Modified plunger rod/stopper threading. Standards: ISO 7886-1, ISO 80369-7, ASTM F2338-09, USP <791>, USP <191>, USP <643>, USP <241>, USP <233>, USP <232>, USP <788>, USP <85>, ISO 10993-5, ISO 10993-10, ISO 10993-11, ASTM F756-17, ASTM F1980-16.

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 (K183473)

Submission Summary (Full Text)

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March 22, 2022

Amsino International, Inc. Jane Gao VP of R&D 708 Corporate Center Drive Pomona, California 91768

Re: K213522

Trade/Device Name: AMSafe® Pre-Filled Normal Saline Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: March 8, 2022 Received: March 14, 2022

Dear Jane Gao:

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 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

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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 mediation-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,

Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213522

Device Name

AMSafe® Pre-Filled Normal Saline Flush Syringe

Indications for Use (Describe)

The AMSafe® 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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## K213522 Summary

## a) Submitter Information:

| Submitter: | Amsino International Inc.<br>708 Corporate Center Drive<br>Pomona, CA 91768<br>Phone: [phone]<br>Fax: [phone] |
|------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jane Gao<br>VP of R&D of Amsino International<br>Cell phone: [phone]<br>[e-mail] |
| Date of Summary: | March 22, 2022 |

#### b) Device Information:

| Trade or Proprietary Name: | AMSafe® Pre-Filled Normal Saline Flush Syringe |
|----------------------------|------------------------------------------------|
| Common or Usual Name: | Pre-Filled Normal Saline Flush Syringe |
| Classification Name: | Saline, vascular access flush |
| Product Code: | NGT |
| Regulation Number: | 880.5200 |
| Device Classification: | II |
| Review Panel: | General Hospital |

### c) Identification of Legally Marketed Device(s):

AMSafe® Pre-Filled Normal Saline Flush Syringe, 510(k) number K183473.

### d) Device Description:

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap.

### e) Indications for Use:

The AMSafe® 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.

### f) Technological Characteristics Comparison:

The main difference between subject device and the predicate device are different material suppliers and adding an extra thread to the plunger rod and inside of plunger stopper, and subject device is terminally sterilized by steam sterilization. The device will be marketed as 10mL syringe with a 3mL, 5mL or 10mL fill volume, and a 5mL syringe with 3mL or 5mL fill volume according to the market needs. The products are in PP wrapper as a dust cover for non

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sterile field.

- Technological characteristics: The subject device has the same technological characteristics and provide the same principle of operation as the predicate device.
- Intended use: The subject device has the same intended use as the predicate device.

Comparison between subject device and predicate device.

| able | 1<br>5 |
|------|--------|
| | |

| Device<br>Characteristic | Subject device | Predicate device<br>(K183473) | Discussion |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indications<br>for Use | The AMSafe® Pre-<br>Filled Normal Saline<br>Flush Syringe, is<br>intended for use in<br>flushing compatible<br>intravenous<br>administration sets<br>and indwelling<br>intravenous access<br>devices. Use<br>according to the<br>recommendations of<br>the manufacturer for<br>the appropriate<br>device. | The AMSafe 0.9%<br>sodium chloride pre-<br>filled normal saline<br>flush syringe, is<br>intended for use in<br>flushing compatible<br>intravenous<br>administration sets<br>and indwelling<br>intravenous access<br>devices. Use<br>according to the<br>recommend at ions<br>of the manufacturer<br>for the appropriate<br>device. | Identical |
| Prescription/<br>over-the<br>counter use | For Rx only | For Rx only | Identical |
| Operation<br>Principle | The AMSafe® Pre-<br>Filled Normal Saline<br>Flush Syringe is a<br>three-piece, sterile,<br>single use syringe<br>with a 6% (Luer)<br>connector pre-filled<br>with 0.9% Sodium<br>Chloride Injection,<br>USP, and sealed<br>with a tip cap. | The AMSafe® Pre-<br>Filled Normal Saline<br>Flush Syringe is a<br>three-piece, sterile,<br>single use syringe<br>with a 6% (Luer)<br>connector pre-filled<br>with 0.9% Sodium<br>Chloride Injection,<br>USP, and sealed<br>with a tip cap. | Identical |
| Design | The subject device<br>has modified to add<br>an extra thread to<br>the plunger rod and<br>inside of plunger<br>stopper, the female<br>Luer cap has | Prefilled Normal<br>Saline plastic piston<br>syringe with Luer<br>lock connection<br>fitting and non-<br>vented, female Luer<br>lock tip cap | Identical |
| | changed to screw<br>type. | | |
| Chemical<br>composition | 0.9% Sodium<br>chloride injection,<br>USP | 0.9% Sodium<br>chloride injection,<br>USP | Identical |
| Syringe<br>material | Barrel and plunger:<br>polypropylene<br>Stopper:<br>Chlorobutyl rubber<br>(not made with<br>natural rubber latex)<br>Tip cap:<br>polypropylene with<br>white colorant | Barrel and plunger:<br>polypropylene<br>Stopper: Butyl<br>rubber (not made<br>with natural rubber<br>latex)<br>Tip cap:<br>polypropylene with<br>white colorant | Different |
| Syringe Size<br>and Fill<br>Volumes | Fill 3ml, 5ml, 10ml<br>in 10cc syringe<br>Fill 3ml, 5ml in 5cc<br>syringe | Fill 3ml, 5ml, 10ml<br>volume in 12cc<br>syringe<br>Fill 20ml volume in<br>20cc syringe | Different |
| | Syringe<br>packaging | PP wrap | PP wrap or Sterile<br>barrier Plastic peel<br>pouch |
| Sterilization<br>method and<br>SAL Level | Terminally sterilized<br>by steam, 10-6 SAL | Terminally sterilized<br>by Gamma<br>radiation, 10-6 SAL | Different |
| Labeled non-<br>pyrogenic | Yes | Yes | Identical |
| Single use<br>only | Yes | Yes | Identical |
| Shelf Life | 3 years | 2 years | Different |

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# g) Summary of Non-clinical Testing (Bench):

The non-clinical testing for AMSafe® 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.

The following performance testing was conducted on the proposed device:

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Table 5-2

| ID# | Test | Method | Acceptance criteria | Conclusion |
|-------------------------------|-----------------------------------------------|-------------------------|----------------------------------|------------|
| 1 | Physical testing of<br>syringe | ISO7886-1<br>ISO80369-7 | ISO7886-1<br>ISO80369-7 | Pass |
| | Integrity test of<br>package | ASTM F2338-09 | No leakage | Pass |
| | Dimension test | ISO80369-7 | ISO80369-7 | Pass |
| | Lubricant of syringe<br>test | ISO7886-1 | ISO7886-1 | Pass |
| | Dead space test | ISO7886-1 | ISO7886-1 | Pass |
| | Limits of acidity or<br>alkalinity of syringe | ISO7886-1 | ISO7886-1 | Pass |
| 2 | Sodium Chloride Injection, USP Testing | | | |
| | pH value | USP<791> | PH: 4.5-7.0 | Pass |
| | Chemical<br>Identification Tests | USP<191> | USP<191> | Pass |
| | 0.9% normal saline<br>content test | USP6-466 | 0.86% -- 0.94% | Pass |
| | Oxidizable<br>substance test | USP6-471 | USP6-471 | Pass |
| | Iron test | USP<241> | < 2ppm | Pass |
| | Ammonium | USP<191> | USP<191> | Pass |
| | Calcium | USP<191> | USP<191> | Pass |
| | Carbonate | USP<191> | USP<191> | Pass |
| | Sulfate | USP<191> | USP<191> | Pass |
| | Total organic carbon | USP<643> | USP<643> | Pass |
| | Limits of extractable<br>metals | USP<233><br>USP<232> | USP<233><br>USP<232> | Pass |
| 3 | Particulate matter | USP<788> | ≥10um, ≤6000<br>≥25um, ≤600 | Pass |
| 4 | Biocompatibility testing | | | |
| | Bacterial endotoxins<br>test | USP<85> | Bacterial<br>endotoxins≤0.5EU/mL | Pass |
| | Acute systemic<br>toxicity | ISO10993-11 | No systemic toxicity | Pass |
| | Intracutaneous<br>reactivity | ISO10993-10 | Non-irritant | Pass |
| | Pyrogen test | ISO10993-11 | Non-pyrogen | Pass |
| | Skin sensitization | ISO10993-10 | Non-sensitizer | Pass |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| In vitro hemolysis properties | ASTM F756-17 | Non-hemolytic | Pass | |

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The shelf life of the final finished sterilized device was evaluated according to the recognized consensus standard ASTM F1980-16 to verify that the subject device will remain within specification during the prescribed shelf life when stored under the labeled storage conditions.

# h) Conclusions:

The conclusions drawn from the nonclinical tests demonstrate that the AMSafe® Pre-Filled Normal Saline Flush syringe is as safe as effective, and performs as well as or better than the legally marketed device