(210 days)
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.
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<40>.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the AMSafe® Pre-Filled Normal Saline Flush Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of an AI-powered diagnostic device. Therefore, much of the requested information regarding acceptance criteria and study design for an AI device is not applicable to this document.
However, I can extract information related to the device's acceptance criteria for performance (bench testing) and the testing done to prove it meets those criteria.
Here's an attempt to answer your questions based only on the provided text, recognizing its limitations for an "AI-powered diagnostic device":
Device: AMSafe® Pre-Filled Normal Saline Flush Syringe
Type of Device: Prefilled plastic piston syringe with 0.9% sodium chloride for injection, USP, intended for flushing intravenous administration sets and indwelling intravenous access devices. This is a medical device, not an AI-powered diagnostic device.
Study Type: Non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. No clinical study with human subjects, AI assistance, or MRMC design was conducted.
1. A table of acceptance criteria and the reported device performance
| ID# | Test | Method | Acceptance Criteria | Reported Device Performance (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 extractable metals of saline solution | USP<233>, <232> | USP<233>, <232> | Pass | |
| Chemical Identification Tests | USP <191> | USP <191> | Pass | |
| 0.9% normal saline content test | VP200 | 0.86% -- 0.94% | Pass | |
| Oxidizable 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; ≥25um, ≤600. | Pass | |
| 3 | Biocompatibility testing | |||
| Bacterial endotoxins test | USP40<85> | Bacterial endotoxins ≤ 0.25 EU/mL | Pass | |
| Acute system toxicity | ISO10993-11 | The device extracts did not elicit 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<232>, USP<233> | 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 |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document describes "non-clinical testing" and lists various tests, each presumably with its own sample size of syringes or solution, but these specific sample sizes are not detailed in the provided text.
- Data Provenance: The tests are standard industry bench tests (e.g., ISO, USP, ASTM standards). The country of origin for the data is not explicitly stated within the context of the testing, but the company is Amsino International Inc., based in Pomona, CA, USA, suggesting testing likely occurred in or for a US regulatory submission. The data is from prospective bench testing, not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is not an AI diagnostic, so there is no concept of "ground truth" derived from expert consensus of images/data in the way it applies to AI devices. The "ground truth" for the performance tests (e.g., pH, chemical content, sterility) is established by the specified reference standards (USP, ISO, ASTM) and the inherent measurable properties of the device and its contents. The results are objective, quantitative measurements following validated methods, not subjective interpretations by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI diagnostic device requiring human expert adjudication of diagnostic outcomes. The results are objective measurements against pre-defined criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a pre-filled saline syringe, not an AI-powered diagnostic. This type of study is irrelevant to its purpose and regulatory pathway.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or AI. The tests performed are standalone bench tests of the physical and chemical properties of the syringe and its contents.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is based on established scientific and engineering standards and methods (e.g., USP monographs for chemical purity and content, ISO standards for device properties, ASTM for packaging). It is a direct measurement against defined physical, chemical, and biological specifications, not a diagnostic ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device, no ground truth needed to be established for it.
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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
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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 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
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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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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 AmsinoAmsino International Inc.708 Corporate Center Drive Pomona,CA 91768Phone: +1 (909)626-5888Fax: +1 (909)626-3888 |
|---|---|
| Contact Person: | Jim Barley, RA/QA ConsultantCell phone: 949-4333058jimbarley@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
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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<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
| DeviceCharacteristic | Proposed device | PrimaryPredicatedevice(K133685) | Referencedevice 1(K120836) | Referencedevice 2(K111034) | Results |
|---|---|---|---|---|---|
| Indications forUse | The AMSafe 0.9%sodium chloridepre- filled normalsaline flushsyringe, isintended for usein flushingcompatibleintravenousadministrationsets andindwellingintravenousaccess devices.Use according tothe recommendat ions of themanufacturer forthe appropriatedevice. | Intendeduse: 0.9%sodiumchloride flushsyringes areintended foruse influshingcompatibleintravenousadministration sets andindwellingintravenousaccessdevices. Useaccording totherecommendat ions of themanufacturerfor theappropriatedevice | Intendeduse: 0.9%sodiumchloride flushsyringes areintended foruse influshingcompatibleintravenousadministration sets andindwellingintravenousaccessdevices. Useaccording totherecommendat ions of themanufacturerfor theappropriatedevice. | Intendeduse: 0.9%sodiumchlorideflushsyringes areintended foruse influshingcompatibleintravenousadministration sets andindwellingintravenousaccessdevices.Useaccording totherecommendat ions ofthemanufacturerfor theappropriatedevice. | Same |
| Design | Prefilled plasticpiston syringe withLuer lockconnection | Prefilledplastic pistonsyringe withLuer lockconnection | Prefilledplastic pistonsyringe withLuer lockconnection | Prefilledplastic pistonsyringe withLuer lockconnection | Same |
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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 andnon-vented,female Luerlock tip cap | fitting andnon-vented,female Luerlock tip cap | fitting andnon-vented,female Luerlock tip cap | fitting andnon-vented,female Luerlock tip cap | ||
|---|---|---|---|---|---|
| Syringe Sizeand FillVolumes | 3ml, 5ml,10ml in 12ccsyringe20ml in 20ccsyringe | 20ml in 20ccsyringe | 3ml, 5ml,10ml in 12ccsyringe | 3ml, 5ml,10ml in 12ccsyringe | Similar |
| Fill VolumeGraduations | On syringelabel | On syringelabel | On syringelabel | On syringelabel | Same |
| SyringeContent | 0.9% Sodiumchlorideinjection,USP | 0.9% Sodiumchlorideinjection,USP | 0.9% Sodiumchlorideinjection,USP | 0.9% Sodiumchlorideinjection,USP | Same |
| Labeled non-pyrogenic | Yes | Yes | Yes | Yes | Same |
| Singleuse only | Yes | Yes | Yes | Yes | Same |
| Sterile | Yes | Yes | Yes | Yes | Same |
| Deviceswith FluidPathOnly SterileOrDevicesprovidedsterile | Devices withFluid PathOnly SterileOr Devicesprovidedsterile | Devicesprovidedsterile | Devicesprovidedsterile | Devices withFluid PathOnly Sterile | Same |
| Shelf Life | 2 years | 2 years | 2 years | 2 years | Same |
| Sterilizationmethod | Terminallysterilized byGammaradiation, 10-6SAL | Terminallysterilized byGammaradiation, 10-6SAL | Terminallysterilized byGammaradiation, 10-6SAL | Terminallysterilized byGammaradiation, 10-6SAL | Same |
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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 andplunger:polypropyle ne | Barrel andplunger:polypropylene | Barrel andplunger:polypropylene | Barrel andplunger:polypropylene | ||
| Syringematerial | Plunger: Butylrubber (notmade withnatural rubberlatex)Tip cap:polypropylenewith whitecolorant | Plunger: Butylrubber (notmade withnatural rubberlatex)Tip cap:polypropyleneand TPE | Plunger: Butylrubber (notmade withnatural rubberlatex)Tip cap:polypropyleneand TPE | Plunger: Butylrubber (notmade withnatural rubberlatex)Tip cap:polypropyleneand TPE | Similar |
| Syringepackaging | PP wrap orSterilebarrierPlastic peelpouch | Sterile barrierPlastic peelpouch | Sterile barrierPlastic peelpouch | PP wrap | Same |
| Content ofSyringePackage | One syringe perpouch | One syringeper pouch | One syringeper pouch | One syringeper 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 ofextractable metalsof saline solution | USP<233>, <232> | USP<233>, <232> | Pass | |
| ChemicalIdentification Tests | USP <191> | USP <191> | Pass | |
| 0.9% normal salinecontent 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
| Oxidizablesubstance 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;≥25um, ≤600. | Pass | |
| 3 | Biocompatibility testing | |||
| Bacterialendotoxins test | USP40<85> | Bacterialendotoxins≤0.25EU/mL | Pass | |
| Acute systemtoxicity | ISO10993-11 | The device extracts did notellicit a systemic response | Pass | |
| Irritation /Intracutaneousreactivity | ISO10993-10 | Non-irritant | Pass | |
| Material-mediatedpyrogenicity | 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 | |
| Chemicalcharacterization | USP<232>,USP<233> | Acceptableextractable /leachable profile | Pass | |
| 4 | Blister package integrity | |||
| Seal strength test | ASTM F88/F88M-15 | Shouldnot beless than 2 N/ inch | Pass | |
| Dye integrity test | ASTM F1929-15 | ASTM F1929-15 | Pass |
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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.
§ 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).