Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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.

Therapeutic

No
The device is described as a pre-filled normal saline flush syringe for flushing intravenous lines, which is a supportive rather than therapeutic function.

Diagnostic

No

The device is a pre-filled syringe intended for flushing intravenous lines and devices. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a polypropylene plastic syringe filled with 0.9% sodium chloride, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the AMSafe® Pre-Filled Normal Saline Flush Syringe 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 therapeutic or maintenance purposes, not for diagnosing a condition based on in vitro analysis of a sample.
Device Description: The device is a syringe filled with saline solution. This is a delivery system for a substance, not a device designed to analyze biological samples.
Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) outside of the body. There's no mention of reagents, assays, or any diagnostic measurements.
Performance Studies: The performance studies focus on the physical properties of the syringe, the quality of the saline solution, and biocompatibility – all relevant to a device used for direct patient interaction, not for in vitro diagnostics.

In summary, the AMSafe® Pre-Filled Normal Saline Flush Syringe is a medical device used for flushing intravenous lines, which is a therapeutic/maintenance procedure, not an in vitro diagnostic procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

NGT

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.

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 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.

The following performance testing was conducted on the proposed device:

Physical testing of syringe (ISO7886-1, ISO80369-7)
Integrity test of package (ASTM F2338-09)
Dimension test (ISO80369-7)
Lubricant of syringe test (ISO7886-1)
Dead space test (ISO7886-1)
Limits of acidity or alkalinity of syringe (ISO7886-1)
Sodium Chloride Injection, USP Testing (pH value, Chemical Identification Tests, 0.9% normal saline content test, Oxidizable substance test, Iron test, Ammonium, Calcium, Carbonate, Sulfate, Total organic carbon, Limits of extractable metals)
Particulate matter (USP)
Biocompatibility testing (Bacterial endotoxins test, Acute systemic toxicity, Intracutaneous reactivity, Pyrogen test, Skin sensitization, In vitro cytotoxicity, In vitro hemolysis properties)

All tests passed their respective acceptance criteria.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K183473

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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.
708 Corporate Center Drive
Pomona, CA 91768
Phone: +1 (909)626-5888
Fax: +1 (909)626-3888 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jane Gao
VP of R&D of Amsino International
Cell phone: +86 139 1614 7664
Jane_gao@amsino.com |
| 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

4

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
5 |
|------|--------|
| | |

| Device
Characteristic | Subject device | Predicate device
(K183473) | Discussion |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| 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. | 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
recommend at ions
of the manufacturer
for the appropriate
device. | Identical |
| Prescription/
over-the
counter use | For Rx only | For Rx only | Identical |
| Operation
Principle | The AMSafe® Pre-
Filled 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. | The AMSafe® Pre-
Filled 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
has modified to add
an extra thread to
the plunger rod and
inside of plunger
stopper, the female
Luer cap has | Prefilled Normal
Saline plastic piston
syringe with Luer
lock connection
fitting and non-
vented, female Luer
lock tip cap | Identical |
| | changed to screw
type. | | |
| Chemical
composition | 0.9% Sodium
chloride injection,
USP | 0.9% Sodium
chloride injection,
USP | Identical |
| Syringe
material | Barrel and plunger:
polypropylene
Stopper:
Chlorobutyl rubber
(not made with
natural rubber latex)
Tip cap:
polypropylene with
white colorant | Barrel and plunger:
polypropylene
Stopper: Butyl
rubber (not made
with natural rubber
latex)
Tip cap:
polypropylene with
white colorant | Different |
| Syringe Size
and Fill
Volumes | Fill 3ml, 5ml, 10ml
in 10cc syringe
Fill 3ml, 5ml in 5cc
syringe | Fill 3ml, 5ml, 10ml
volume in 12cc
syringe
Fill 20ml volume in
20cc syringe | Different |
| | Syringe
packaging | PP wrap | PP wrap or Sterile
barrier Plastic peel
pouch |
| Sterilization
method and
SAL Level | Terminally sterilized
by steam, 10-6 SAL | Terminally sterilized
by Gamma
radiation, 10-6 SAL | Different |
| Labeled non-
pyrogenic | Yes | Yes | Identical |
| Single use
only | Yes | Yes | Identical |
| Shelf Life | 3 years | 2 years | Different |

5

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
syringe	ISO7886-1
ISO80369-7	ISO7886-1
ISO80369-7	Pass
	Integrity test of
package	ASTM F2338-09	No leakage	Pass
	Dimension test	ISO80369-7	ISO80369-7	Pass
	Lubricant of syringe
test	ISO7886-1	ISO7886-1	Pass
	Dead space test	ISO7886-1	ISO7886-1	Pass
	Limits of acidity or
alkalinity of syringe	ISO7886-1	ISO7886-1	Pass
2	Sodium Chloride Injection, USP Testing
	pH value	USP	PH: 4.5-7.0	Pass
	Chemical
Identification Tests	USP	USP	Pass
	0.9% normal saline
content test	USP6-466	0.86% -- 0.94%	Pass
	Oxidizable
substance test	USP6-471	USP6-471	Pass
	Iron test	USP		USP
	Calcium	USP	USP	Pass
	Carbonate	USP	USP	Pass
	Sulfate	USP	USP	Pass
	Total organic carbon	USP	USP	Pass
	Limits of extractable
metals	USP
USP	USP
USP	Pass
3	Particulate matter	USP	≥10um, ≤6000
≥25um, ≤600	Pass
4	Biocompatibility testing
	Bacterial endotoxins
test	USP	Bacterial
endotoxins≤0.5EU/mL	Pass
	Acute systemic
toxicity	ISO10993-11	No systemic toxicity	Pass
	Intracutaneous
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

7

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