AMSafe(R) Pre-Filled Normal Saline Flush Syringe

K183473 · Amsino International, Inc. · NGT · Jul 12, 2019 · General Hospital

Device Facts

• Record ID: K183473
• Device Name: AMSafe(R) Pre-Filled Normal Saline Flush Syringe
• Applicant: Amsino International, Inc.
• Product Code: NGT · General Hospital
• Decision Date: Jul 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

AMSafe® Pre-Filled Normal Saline Flush Syringe This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. It is intended for single use only.

Device Story

AMSafe® Pre-Filled Normal Saline Flush Syringe is a single-use, pre-filled polypropylene syringe containing 0.9% sodium chloride for injection, USP. The device is used by clinicians to flush compatible intravenous administration sets and indwelling intravenous access devices. It features a Luer lock connection and is terminally sterilized via gamma radiation. The device is available in 12mL (3mL, 5mL, 10mL fill) and 20mL (20mL fill) sizes. It is supplied in either a sterile blister package for use in a sterile field or a polypropylene wrapper for non-sterile field use. The device facilitates maintenance of intravenous access lines by providing a sterile saline flush, reducing the risk of occlusion and ensuring line patency.

Clinical Evidence

Bench testing only. Testing included ISO 7886-2017 syringe performance, USP 40 chemical/physical testing (pH, extractable metals, saline content, particulate matter), and biocompatibility (ISO 10993-4, 5, 10, 11). Packaging integrity was validated via ASTM F88/F88M-15 and ASTM F1929-15. All tests met acceptance criteria.

Technological Characteristics

Materials: Polypropylene (barrel, tip cap), butyl rubber (plunger). Design: Piston syringe with Luer lock fitting. Sterilization: Gamma radiation (10^-6 SAL). Shelf life: 2 years. Standards: ISO 7886-2017, USP <791>, <233>, <232>, <191>, <788>, <85>, ISO 10993-11, -10, -5, -4 (ASTM F756), ASTM F88/F88M-15, ASTM F1929-15, ISO 11607-1.

Indications for Use

Indicated for flushing compatible intravenous administration sets and indwelling intravenous access devices. For use by clinicians per manufacturer recommendations.

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

• AM USA 0.9% Sodium Chloride Flush Syringe (K133685)

Reference Devices

• AM USA 0.9% Sodium Chloride Flush Syringe (K111034)
• AM USA 0.9% Sodium Chloride Flush Syringe (K120836)

Submission Summary (Full Text)

{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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 12, 2019

Amsino International, Inc. Jim Barley RA/QA Consultant 708 Corporate Center Drive Pomona, California 91768

Re: K183473

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: June 6, 2019 Received: June 13, 2019

Dear Jim Barley:

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 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,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K183473

Device Name

AMSafe® Pre-Filled Normal Saline Flush Syringe

Indications for Use (Describe)

The AMSafe® 0.9% Sodium Chloride 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)

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for AMSINO, a healthcare company. The logo is in blue and white, with the company name in large, bold letters. Below the name is the tagline "Advancing Healthcare Worldwide." The logo is simple and professional, and it conveys a sense of trust and reliability.

Amsino International. Inc. 708 Corporate Center Dr. Pomona, CA91768 USA

Tel:[phone] Fax:[phone] Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: [e-mail]

# Traditional 510(k) Summary (As required by 21 CFR 807.92(a)) For K183473

## a) Submitter Information:

| Submitter: | Richard Lee, CEO of Amsino<br>Amsino International Inc.<br>708 Corporate Center Drive Pomona,<br>CA 91768<br>Phone: [phone]<br>Fax: [phone] |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jim Barley, RA/QA Consultant<br>Cell phone: [phone]<br>[e-mail] |
| Date of Summary: | July 9, 2019 |

## b) Device Information:

| Trade or Proprietary Name: | AMSafe® Pre-Filled Normal Saline Flush Syringe |
|----------------------------|------------------------------------------------|
| Common or Usual Name: | Pre-Filled Normal Saline Flush Syringe |
| Regulation Number: | 21 CFR 880.5200 |
| Classification: | II |
| Product Code: | NGT |

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

Predicate Device: AM USA 0.9% Sodium Chloride Flush Syringe, 510(k) number K133685, 20 cc Syringe with 20 cc fill volume

### Reference Devices:

- For Fluid Path Only Sterile: AM USA 0.9% Sodium Chloride Flush Syringe, 510(k) ● number K111034, 12 cc Syringe with 3, 5, 10 cc fill volumes
- For Device provided Sterile: AM USA 0.9% Sodium Chloride Flush Syringe, 510(k) ● number K120836, 12 cc Syringe with 3, 5, 10 cc fill volumes

### 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 cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12mL syringe with a 3mL, 5mL, or 10mL fill volume, and a 20mL syringe with 20mL fill volume. The products are in two different packages, one is poly blister package and the entire packaged device are gamma radiation sterilized for sterile delivery to a sterile field; another is PP wrapper as a dust cover for non-sterile field.

The solution is sterile normal saline for injection and meets the requirements of

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for AMSINO. The logo is in blue and white, with the word "AMSINO" in large, bold letters. Below the word "AMSINO" is the phrase "Advancing Healthcare Worldwide." The logo is simple and professional, and it conveys a sense of trust and reliability.

Advancing Healthcare Worldwi

Amsino International. Inc. 708 Corporate Center Dr. Pomona, CA91768 USA

Tel:[phone] Fax:[phone] Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: [e-mail]

USP<40>.

#### e) Intended Use:

AMSafe® Pre-Filled Normal Saline Flush Syringe

This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. It is intended for single use only.

### f) Technological Characteristics

Shown below is a side by side comparison of the subject device with the predicate device.

#### Table 5-1

| Device<br>Characteristic | Proposed device | Primary<br>Predicate<br>device<br>(K133685) | Reference<br>device 1<br>(K120836) | Reference<br>device 2<br>(K111034) | Results |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indications for<br>Use | The AMSafe 0.9%<br>sodium chloride<br>pre- filled normal<br>saline flush<br>syringe, is<br>intended for use<br>in flushing<br>compatible<br>intravenous<br>administration<br>sets and<br>indwelling<br>intravenous<br>access devices.<br>Use according to<br>the recommend<br>at ions of the<br>manufacturer for<br>the appropriate<br>device. | Intended<br>use: 0.9%<br>sodium<br>chloride flush<br>syringes are<br>intended for<br>use in<br>flushing<br>compatible<br>intravenous<br>administratio<br>n sets and<br>indwelling<br>intravenous<br>access<br>devices. Use<br>according to<br>the<br>recommend<br>at ions of the<br>manufacturer<br>for the<br>appropriate<br>device | Intended<br>use: 0.9%<br>sodium<br>chloride flush<br>syringes are<br>intended for<br>use in<br>flushing<br>compatible<br>intravenous<br>administratio<br>n sets and<br>indwelling<br>intravenous<br>access<br>devices. Use<br>according to<br>the<br>recommend<br>at ions of the<br>manufacturer<br>for the<br>appropriate<br>device. | Intended<br>use: 0.9%<br>sodium<br>chloride<br>flush<br>syringes are<br>intended for<br>use in<br>flushing<br>compatible<br>intravenous<br>administrati<br>on sets and<br>indwelling<br>intravenous<br>access<br>devices.<br>Use<br>according to<br>the<br>recommend<br>at ions of<br>the<br>manufacturer<br>for the<br>appropriate<br>device. | Same |
| Design | Prefilled plastic<br>piston syringe with<br>Luer lock<br>connection | Prefilled<br>plastic piston<br>syringe with<br>Luer lock<br>connection | Prefilled<br>plastic piston<br>syringe with<br>Luer lock<br>connection | Prefilled<br>plastic piston<br>syringe with<br>Luer lock<br>connection | Same |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "AMSINO" in large, bold, sans-serif font. The letters are white and are set against a blue background. There are two horizontal blue lines, one above and one below the word, that appear to be part of a logo.

Advancing Healthcare Worldw

Amsino International. Inc. 708 Corporate Center Dr. Pomona, CA91768 USA

Te1:909-626-5888 Fax:[phone] Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: [e-mail]

| | fitting and<br>non-vented,<br>female Luer<br>lock tip cap | fitting and<br>non-vented,<br>female Luer<br>lock tip cap | fitting and<br>non-vented,<br>female Luer<br>lock tip cap | fitting and<br>non-vented,<br>female Luer<br>lock tip cap | |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|---------|
| Syringe Size<br>and Fill<br>Volumes | 3ml, 5ml,<br>10ml in 12cc<br>syringe<br>20ml in 20cc<br>syringe | 20ml in 20cc<br>syringe | 3ml, 5ml,<br>10ml in 12cc<br>syringe | 3ml, 5ml,<br>10ml in 12cc<br>syringe | Similar |
| Fill Volume<br>Graduations | On syringe<br>label | On syringe<br>label | On syringe<br>label | On syringe<br>label | Same |
| Syringe<br>Content | 0.9% Sodium<br>chloride<br>injection,<br>USP | 0.9% Sodium<br>chloride<br>injection,<br>USP | 0.9% Sodium<br>chloride<br>injection,<br>USP | 0.9% Sodium<br>chloride<br>injection,<br>USP | Same |
| Labeled non-<br>pyrogenic | Yes | Yes | Yes | Yes | Same |
| Single<br>use only | Yes | Yes | Yes | Yes | Same |
| Sterile | Yes | Yes | Yes | Yes | Same |
| Devices<br>with Fluid<br>Path<br>Only Sterile<br>Or<br>Devices<br>provided<br>sterile | Devices with<br>Fluid Path<br>Only Sterile<br>Or Devices<br>provided<br>sterile | Devices<br>provided<br>sterile | Devices<br>provided<br>sterile | Devices with<br>Fluid Path<br>Only Sterile | Same |
| Shelf Life | 2 years | 2 years | 2 years | 2 years | Same |
| Sterilization<br>method | Terminally<br>sterilized by<br>Gamma<br>radiation, 10-6<br>SAL | Terminally<br>sterilized by<br>Gamma<br>radiation, 10-6<br>SAL | Terminally<br>sterilized by<br>Gamma<br>radiation, 10-6<br>SAL | Terminally<br>sterilized by<br>Gamma<br>radiation, 10-6<br>SAL | Same |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for AMSINO. The logo is in blue and white. The word "AMSINO" is written in large, bold letters. There are two horizontal lines underneath the word.

Advancing Healthcare Worldy

Amsino International. Inc. 708 Corporate Center Dr. Pomona, CA91768 USA

Tel:[phone] Fax:[phone] Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: [e-mail]

| | USA | | | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------|
| | email: [e-mail] | | | | |
| | Barrel and<br>plunger:<br>polypropyle ne | Barrel and<br>plunger:<br>polypropylene | Barrel and<br>plunger:<br>polypropylene | Barrel and<br>plunger:<br>polypropylene | |
| Syringe<br>material | Plunger: Butyl<br>rubber (not<br>made with<br>natural rubber<br>latex)<br>Tip cap:<br>polypropylene<br>with white<br>colorant | Plunger: Butyl<br>rubber (not<br>made with<br>natural rubber<br>latex)<br>Tip cap:<br>polypropylene<br>and TPE | Plunger: Butyl<br>rubber (not<br>made with<br>natural rubber<br>latex)<br>Tip cap:<br>polypropylene<br>and TPE | Plunger: Butyl<br>rubber (not<br>made with<br>natural rubber<br>latex)<br>Tip cap:<br>polypropyle<br>ne<br>and TPE | Similar |
| Syringe<br>packaging | PP wrap or<br>Sterile<br>barrier<br>Plastic peel<br>pouch | Sterile barrier<br>Plastic peel<br>pouch | Sterile barrier<br>Plastic peel<br>pouch | PP wrap | Same |
| Content of<br>Syringe<br>Package | One syringe per<br>pouch | One syringe<br>per pouch | One syringe<br>per pouch | One syringe<br>per pouch | Same |

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

The non-clinical testing for AMSafe® Pre-Filled Normal Saline Flush Syringe was performed to demonstrate verification and validation testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below. Table 5-2

| ID# | Test | Method | Acceptance criteria | Result/Conclusion |
|----------------------------------------|-------------------------------------------------------|-----------------|---------------------|-------------------|
| 1 | Plastic syringe | ISO7886-2017 | ISO7886-2017 | Conforms/Pass |
| Sodium Chloride Injection, USP Testing | | | | |
| 2 | pH value | USP40<791> | PH: 4.5-7.0 | Pass |
| | Limits of<br>extractable metals<br>of saline solution | USP<233>, <232> | USP<233>, <232> | Pass |
| | Chemical<br>Identification Tests | USP <191> | USP <191> | Pass |
| | 0.9% normal saline<br>content test | VP200 | 0.86% -- 0.94% | Pass |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "AMSINO" in large, white, sans-serif font. The word is set against a blue background. There are two horizontal white lines underneath the word, adding a sense of structure to the design.

Advancing Healthcare Worldwide

Amsino International. Inc. 708 Corporate Center Dr. Pomona, CA91768 USA

Tel:[phone] Fax:[phone] Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: [e-mail]

| | Oxidizable<br>substance test | VP200 | VP200 | Pass |
|---|----------------------------------------------|---------------------------|------------------------------------------------------------|------|
| | Iron test | USP40<241> | < 2ppm | Pass |
| | Ammonium | USP40<191> | USP40<191> | Pass |
| | Calcium | USP40<191> | USP40<191> | Pass |
| | Carbonate | USP40<191> | USP40<191> | Pass |
| | Sulfate | USP40<191> | USP40<191> | Pass |
| | Particulate matter | USP 40 <788> | ≥10um, ≤6000;<br>≥25um, ≤600. | Pass |
| 3 | Biocompatibility testing | | | |
| | Bacterial<br>endotoxins test | USP40<85> | Bacterial<br>endotoxins≤0.25<br>EU/mL | Pass |
| | Acute system<br>toxicity | ISO10993-11 | The device extracts did not<br>ellicit a systemic response | Pass |
| | Irritation /<br>Intracutaneous<br>reactivity | ISO10993-10 | Non-irritant | Pass |
| | Material-mediated<br>pyrogenicity | ISO10993-11 | Non-pyrogenic response | Pass |
| | Sensitization | ISO10993-10 | Non-sensitizer | Pass |
| | Cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass |
| | Hemolysis | ISO10993-4<br>(ASTM F756) | Non-hemolytic | Pass |
| | Chemical<br>characterization | USP<232>,<br>USP<233> | Acceptable<br>extractable /<br>leachable profile | Pass |
| 4 | Blister package integrity | | | |
| | Seal strength test | ASTM F88/F88M-<br>15 | Should<br>not be<br>less than 2 N/ inch | Pass |
| | Dye integrity test | ASTM F1929-15 | ASTM F1929-15 | Pass |

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for AMSINO. The logo is in blue and white, with the word "AMSINO" in large, bold letters. There are two horizontal lines above and below the word "AMSINO". The logo is simple and clean, and it is likely used to represent the company or organization.

Advancing Healthcare Worldwide®

Amsino International. Inc. 708 Corporate Center Dr. Pomona, CA91768 USA

Tel:[phone] Fax:[phone] Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: [e-mail]

The shelf life of the final finished sterilized device was evaluated using the recognized consensus standard on the requirements for materials, sterile barrier systems and packaging systems for terminally sterilized medical devices (ISO11607-1)

#### h) Conclusions:

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