(139 days)
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.
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.
This document describes the premarket notification (510(k)) for the AMSafe® Pre-Filled Normal Saline Flush Syringe. The information provided outlines the device's technical characteristics, intended use, and comparison to a legally marketed predicate device (K183473). The study performed is a non-clinical bench testing study, not an AI/ML-based clinical study, therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are detailed in "Table 5-2" on page 6 of the document.
| 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<791> | PH: 4.5-7.0 | Pass | |
| Chemical Identification Tests | USP<191> | USP<191> | 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<241> | < 2ppm | Pass | |
| Ammonium | USP<191> | USP<191> | Pass | |
| Calcium | USP<191> | USP<191> | Pass | |
| Carbonate | USP<191> | USP<191> | Pass | |
| Sulfate | USP<191> | USP<191> | Pass | |
| Total organic carbon | USP<643> | USP<643> | Pass | |
| Limits of extractable metals | USP<233> USP<232> | USP<233> USP<232> | Pass | |
| 3 | Particulate matter | USP<788> | ≥10um, ≤6000 ≥25um, ≤600 | Pass |
| 4 | Biocompatibility testing | |||
| Bacterial endotoxins test | USP<85> | 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 |
Additionally, shelf life was evaluated:
- Test: Shelf life
- Method: ASTM F1980-16
- Acceptance Criteria/Conclusion: Verify that the device will remain within specification during the prescribed shelf life when stored under labeled conditions. (Implied Pass, as per overall conclusion).
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing of manufacturing characteristics and chemical composition, not an AI/ML-based study with a "test set" composed of patient data. Therefore, the concept of sample size for a test set (e.g., number of images, patient records) and data provenance (country of origin, retrospective/prospective) as typically understood for AI/ML studies are not applicable. The tests were performed on samples of the device itself. The specific number of units tested for each criterion is not provided, but it would typically be a predetermined number based on the statistical requirements of the specific test methods (e.g., ISO, ASTM, USP standards).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This was a bench study, not an AI/ML study requiring expert labeling of data. The "ground truth" for these tests are the established physical, chemical, and biological standards and methodologies outlined in the referenced ISO, ASTM, and USP documents.
4. Adjudication Method for the Test Set
Not Applicable. This was a bench study; there was no human-in-the-loop expert adjudication process as would be typical for AI/ML algorithm evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This is a review of a physical medical device (pre-filled syringe), not an AI/ML diagnostic or assistive tool where human reader performance would be a relevant metric.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not Applicable. This document describes the performance of a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established industry standards and pharmacopeial specifications. This includes:
- Physical Properties: Standards like ISO7886-1, ISO80369-7, ASTM F2338-09.
- Chemical Composition: United States Pharmacopeia (USP) monographs such as USP<791>, USP<191>, USP6-466, USP6-471, USP<241>, USP<643>, USP<233>, USP<232>.
- Biocompatibility: ISO10993 series (ISO10993-11, ISO10993-10, ISO10993-5) and ASTM F756-17.
- Sterility Assurance: The mention of 10-6 SAL (Sterility Assurance Level) indicates adherence to established sterilization standards.
8. The Sample Size for the Training Set
Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for a physical device, there is no ground truth establishment process in that context.
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March 22, 2022
Amsino International, Inc. Jane Gao VP of R&D 708 Corporate Center Drive Pomona, California 91768
Re: K213522
Trade/Device Name: AMSafe® Pre-Filled Normal Saline Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: March 8, 2022 Received: March 14, 2022
Dear Jane Gao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
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Indications for Use
510(k) Number (if known) K213522
Device Name
AMSafe® Pre-Filled Normal Saline Flush Syringe
Indications for Use (Describe)
The AMSafe® Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K213522 Summary
a) Submitter Information:
| Submitter: | Amsino International Inc.708 Corporate Center DrivePomona, CA 91768Phone: +1 (909)626-5888Fax: +1 (909)626-3888 |
|---|---|
| Contact Person: | Jane GaoVP of R&D of Amsino InternationalCell phone: +86 139 1614 7664Jane_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
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sterile field.
- Technological characteristics: The subject device has the same technological characteristics and provide the same principle of operation as the predicate device.
- Intended use: The subject device has the same intended use as the predicate device.
Comparison between subject device and predicate device.
| able | 15 |
|---|---|
| DeviceCharacteristic | Subject device | Predicate device(K183473) | Discussion |
|---|---|---|---|
| Indicationsfor Use | The AMSafe® Pre-Filled Normal SalineFlush Syringe, isintended for use influshing compatibleintravenousadministration setsand indwellingintravenous accessdevices. Useaccording to therecommendations ofthe manufacturer forthe appropriatedevice. | The AMSafe 0.9%sodium chloride pre-filled normal salineflush syringe, isintended for use influshing compatibleintravenousadministration setsand indwellingintravenous accessdevices. Useaccording to therecommend at ionsof the manufacturerfor the appropriatedevice. | Identical |
| Prescription/over-thecounter use | For Rx only | For Rx only | Identical |
| OperationPrinciple | The AMSafe® Pre-Filled Normal SalineFlush Syringe is athree-piece, sterile,single use syringewith a 6% (Luer)connector pre-filledwith 0.9% SodiumChloride Injection,USP, and sealedwith a tip cap. | The AMSafe® Pre-Filled Normal SalineFlush Syringe is athree-piece, sterile,single use syringewith a 6% (Luer)connector pre-filledwith 0.9% SodiumChloride Injection,USP, and sealedwith a tip cap. | Identical |
| Design | The subject devicehas modified to addan extra thread tothe plunger rod andinside of plungerstopper, the femaleLuer cap has | Prefilled NormalSaline plastic pistonsyringe with Luerlock connectionfitting and non-vented, female Luerlock tip cap | Identical |
| changed to screwtype. | |||
| Chemicalcomposition | 0.9% Sodiumchloride injection,USP | 0.9% Sodiumchloride injection,USP | Identical |
| Syringematerial | Barrel and plunger:polypropyleneStopper:Chlorobutyl rubber(not made withnatural rubber latex)Tip cap:polypropylene withwhite colorant | Barrel and plunger:polypropyleneStopper: Butylrubber (not madewith natural rubberlatex)Tip cap:polypropylene withwhite colorant | Different |
| Syringe Sizeand FillVolumes | Fill 3ml, 5ml, 10mlin 10cc syringeFill 3ml, 5ml in 5ccsyringe | Fill 3ml, 5ml, 10mlvolume in 12ccsyringeFill 20ml volume in20cc syringe | Different |
| Syringepackaging | PP wrap | PP wrap or Sterilebarrier Plastic peelpouch | |
| Sterilizationmethod andSAL Level | Terminally sterilizedby steam, 10-6 SAL | Terminally sterilizedby Gammaradiation, 10-6 SAL | Different |
| Labeled non-pyrogenic | Yes | Yes | Identical |
| Single useonly | Yes | Yes | Identical |
| Shelf Life | 3 years | 2 years | Different |
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g) Summary of Non-clinical Testing (Bench):
The non-clinical testing for AMSafe® Pre-Filled Normal Saline Flush Syringe was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
The following performance testing was conducted on the proposed device:
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Table 5-2
| ID# | Test | Method | Acceptance criteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical testing ofsyringe | ISO7886-1ISO80369-7 | ISO7886-1ISO80369-7 | Pass |
| Integrity test ofpackage | ASTM F2338-09 | No leakage | Pass | |
| Dimension test | ISO80369-7 | ISO80369-7 | Pass | |
| Lubricant of syringetest | ISO7886-1 | ISO7886-1 | Pass | |
| Dead space test | ISO7886-1 | ISO7886-1 | Pass | |
| Limits of acidity oralkalinity of syringe | ISO7886-1 | ISO7886-1 | Pass | |
| 2 | Sodium Chloride Injection, USP Testing | |||
| pH value | USP<791> | PH: 4.5-7.0 | Pass | |
| ChemicalIdentification Tests | USP<191> | USP<191> | Pass | |
| 0.9% normal salinecontent test | USP6-466 | 0.86% -- 0.94% | Pass | |
| Oxidizablesubstance test | USP6-471 | USP6-471 | Pass | |
| Iron test | USP<241> | < 2ppm | Pass | |
| Ammonium | USP<191> | USP<191> | Pass | |
| Calcium | USP<191> | USP<191> | Pass | |
| Carbonate | USP<191> | USP<191> | Pass | |
| Sulfate | USP<191> | USP<191> | Pass | |
| Total organic carbon | USP<643> | USP<643> | Pass | |
| Limits of extractablemetals | USP<233>USP<232> | USP<233>USP<232> | Pass | |
| 3 | Particulate matter | USP<788> | ≥10um, ≤6000≥25um, ≤600 | Pass |
| 4 | Biocompatibility testing | |||
| Bacterial endotoxinstest | USP<85> | Bacterialendotoxins≤0.5EU/mL | Pass | |
| Acute systemictoxicity | ISO10993-11 | No systemic toxicity | Pass | |
| Intracutaneousreactivity | ISO10993-10 | Non-irritant | Pass | |
| Pyrogen test | ISO10993-11 | Non-pyrogen | Pass | |
| Skin sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| In vitro hemolysis properties | ASTM F756-17 | Non-hemolytic | Pass |
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The shelf life of the final finished sterilized device was evaluated according to the recognized consensus standard ASTM F1980-16 to verify that the subject device will remain within specification during the prescribed shelf life when stored under the labeled storage conditions.
h) Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the AMSafe® Pre-Filled Normal Saline Flush syringe is as safe as effective, and performs as well as or better than the legally marketed device
§ 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).