(210 days)
No
The device is a pre-filled syringe for flushing, and the description focuses on material properties, sterilization, and fill volumes. There is no mention of AI or ML capabilities.
No
The device is a pre-filled syringe for flushing intravenous lines, not for treating any medical condition.
No
Explanation: The device is a pre-filled saline flush syringe used for flushing intravenous lines, not for diagnosing medical conditions. Its intended use is described as "flushing compatible intravenous administration sets and indwelling intravenous access devices."
No
The device description clearly states it is a physical syringe filled with saline solution, made of polypropylene plastic, and terminally sterilized. This indicates a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to flush intravenous administration sets and indwelling intravenous access devices. This is a direct interaction with the patient's circulatory system, not a test performed on a sample taken from the body.
- Device Description: The device is a pre-filled syringe containing saline solution for injection. This is a medical device used for administering a substance into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test a sample (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition. The purpose is purely for flushing and maintaining the patency of IV lines.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
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 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 USP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular
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 and validation testing in conformance with the acceptance criteria of test methods and recognized consensus standards. Tests included: Plastic syringe (ISO7886-2017), Sodium Chloride Injection, USP testing (pH value USP40, Limits of extractable metals USP, , Chemical Identification Tests USP , 0.9% normal saline content test VP200, Oxidizable substance test VP200, Iron test USP40, Ammonium USP40, Calcium USP40, Carbonate USP40, Sulfate USP40, Particulate matter USP 40 ), Biocompatibility testing (Bacterial endotoxins test USP40, Acute system toxicity ISO10993-11, Irritation / Intracutaneous reactivity ISO10993-10, Material-mediated pyrogenicity ISO10993-11, Sensitization ISO10993-10, Cytotoxicity ISO10993-5, Hemolysis ISO10993-4 (ASTM F756), Chemical characterization USP, USP), and Blister package integrity (Seal strength test ASTM F88/F88M-15, Dye integrity test ASTM F1929-15). All tests conformed/passed their respective acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Reference Device(s):
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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:909-626-5888 Fax:909-626-3888 Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: amsino@amsino.com
Traditional 510(k) Summary (As required by 21 CFR 807.92(a)) For K183473
a) Submitter Information:
| Submitter: | Richard Lee, CEO of Amsino
Amsino International Inc.
708 Corporate Center Drive Pomona,
CA 91768
Phone: +1 (909)626-5888
Fax: +1 (909)626-3888 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jim Barley, RA/QA Consultant
Cell phone: 949-4333058
jimbarley@aol.com |
| 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:909-626-5888 Fax:909-626-3888 Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: amsino@amsino.com
USP.
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
Characteristic | Proposed device | Primary
Predicate
device
(K133685) | Reference
device 1
(K120836) | Reference
device 2
(K111034) | Results |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indications for
Use | 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. | Intended
use: 0.9%
sodium
chloride flush
syringes are
intended for
use in
flushing
compatible
intravenous
administratio
n sets and
indwelling
intravenous
access
devices. Use
according to
the
recommend
at ions of the
manufacturer
for the
appropriate
device | Intended
use: 0.9%
sodium
chloride flush
syringes are
intended for
use in
flushing
compatible
intravenous
administratio
n sets and
indwelling
intravenous
access
devices. Use
according to
the
recommend
at ions of the
manufacturer
for the
appropriate
device. | Intended
use: 0.9%
sodium
chloride
flush
syringes are
intended for
use in
flushing
compatible
intravenous
administrati
on sets and
indwelling
intravenous
access
devices.
Use
according to
the
recommend
at ions of
the
manufacturer
for the
appropriate
device. | Same |
| Design | Prefilled plastic
piston syringe with
Luer lock
connection | Prefilled
plastic piston
syringe with
Luer lock
connection | Prefilled
plastic piston
syringe with
Luer lock
connection | Prefilled
plastic piston
syringe with
Luer lock
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:909-626-3888 Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: amsino@amsino.com
| | fitting and
non-vented,
female Luer
lock tip cap | fitting and
non-vented,
female Luer
lock tip cap | fitting and
non-vented,
female Luer
lock tip cap | fitting and
non-vented,
female Luer
lock tip cap | |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|---------|
| Syringe Size
and Fill
Volumes | 3ml, 5ml,
10ml in 12cc
syringe
20ml in 20cc
syringe | 20ml in 20cc
syringe | 3ml, 5ml,
10ml in 12cc
syringe | 3ml, 5ml,
10ml in 12cc
syringe | Similar |
| Fill Volume
Graduations | On syringe
label | On syringe
label | On syringe
label | On syringe
label | Same |
| Syringe
Content | 0.9% Sodium
chloride
injection,
USP | 0.9% Sodium
chloride
injection,
USP | 0.9% Sodium
chloride
injection,
USP | 0.9% Sodium
chloride
injection,
USP | Same |
| Labeled non-
pyrogenic | Yes | Yes | Yes | Yes | Same |
| Single
use only | Yes | Yes | Yes | Yes | Same |
| Sterile | Yes | Yes | Yes | Yes | Same |
| Devices
with Fluid
Path
Only Sterile
Or
Devices
provided
sterile | Devices with
Fluid Path
Only Sterile
Or Devices
provided
sterile | Devices
provided
sterile | Devices
provided
sterile | Devices with
Fluid Path
Only Sterile | Same |
| Shelf Life | 2 years | 2 years | 2 years | 2 years | Same |
| Sterilization
method | Terminally
sterilized by
Gamma
radiation, 10-6
SAL | Terminally
sterilized by
Gamma
radiation, 10-6
SAL | Terminally
sterilized by
Gamma
radiation, 10-6
SAL | Terminally
sterilized by
Gamma
radiation, 10-6
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:909-626-5888 Fax:909-626-3888 Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: amsino@amsino.com
| USA | |||||
|---|---|---|---|---|---|
| email: amsino@amsino.com | |||||
| Barrel and | |||||
| plunger: | |||||
| polypropyle ne | Barrel and | ||||
| plunger: | |||||
| polypropylene | Barrel and | ||||
| plunger: | |||||
| polypropylene | Barrel and | ||||
| plunger: | |||||
| polypropylene | |||||
| Syringe | |||||
| material | Plunger: Butyl | ||||
| rubber (not | |||||
| made with | |||||
| natural rubber | |||||
| latex) | |||||
| Tip cap: | |||||
| polypropylene | |||||
| with white | |||||
| colorant | Plunger: Butyl | ||||
| rubber (not | |||||
| made with | |||||
| natural rubber | |||||
| latex) | |||||
| Tip cap: | |||||
| polypropylene | |||||
| and TPE | Plunger: Butyl | ||||
| rubber (not | |||||
| made with | |||||
| natural rubber | |||||
| latex) | |||||
| Tip cap: | |||||
| polypropylene | |||||
| and TPE | Plunger: Butyl | ||||
| rubber (not | |||||
| made with | |||||
| natural rubber | |||||
| latex) | |||||
| Tip cap: | |||||
| polypropyle | |||||
| ne | |||||
| and TPE | Similar | ||||
| Syringe | |||||
| packaging | PP wrap or | ||||
| Sterile | |||||
| barrier | |||||
| Plastic peel | |||||
| pouch | Sterile barrier | ||||
| Plastic peel | |||||
| pouch | Sterile barrier | ||||
| Plastic peel | |||||
| pouch | PP wrap | Same | |||
| Content of | |||||
| Syringe | |||||
| Package | One syringe per | ||||
| pouch | One syringe | ||||
| per pouch | One syringe | ||||
| per pouch | One syringe | ||||
| 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 | PH: 4.5-7.0 | Pass |
| Limits of | ||||
| extractable metals | ||||
| of saline solution | USP, | USP, | Pass | |
| Chemical | ||||
| Identification Tests | USP | USP | Pass | |
| 0.9% normal saline | ||||
| content test | VP200 | 0.86% -- 0.94% | Pass |
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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:909-626-5888 Fax:909-626-3888 Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: amsino@amsino.com
| | Oxidizable
substance test | VP200 | VP200 | Pass |
|---|----------------------------------------------|---------------------------|------------------------------------------------------------|------|
| | Iron test | USP40 | | USP40 | Pass |
| | Calcium | USP40 | USP40 | Pass |
| | Carbonate | USP40 | USP40 | Pass |
| | Sulfate | USP40 | USP40 | Pass |
| | Particulate matter | USP 40 | ≥10um, ≤6000;
≥25um, ≤600. | Pass |
| 3 | Biocompatibility testing | | | |
| | Bacterial
endotoxins test | USP40 | Bacterial
endotoxins≤0.25
EU/mL | Pass |
| | Acute system
toxicity | ISO10993-11 | The device extracts did not
ellicit a systemic response | Pass |
| | Irritation /
Intracutaneous
reactivity | ISO10993-10 | Non-irritant | Pass |
| | Material-mediated
pyrogenicity | ISO10993-11 | Non-pyrogenic response | Pass |
| | Sensitization | ISO10993-10 | Non-sensitizer | Pass |
| | Cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass |
| | Hemolysis | ISO10993-4
(ASTM F756) | Non-hemolytic | Pass |
| | Chemical
characterization | USP,
USP | Acceptable
extractable /
leachable profile | Pass |
| 4 | Blister package integrity | | | |
| | Seal strength test | ASTM F88/F88M-
15 | Should
not be
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:909-626-5888 Fax:909-626-3888 Toll Free: 1-800-MD-AMSINO http://www.amsino.com email: amsino@amsino.com
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.