For over the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

Device Description

AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water and sterile normal saline for wound flush are intended to be used in clinical or home care and should only be used by clinicians familiar with the treatment of possible complications.
The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP<40>. The bottle and cap are made by HDPE, the inner induction sealed film is foil. The devices are offered in 100mL bottles.

AI/ML Overview

The provided text is an FDA 510(k) summary for a medical device: "AMSure Sterile Water, and Sterile Normal Saline for Wound Flush." This document outlines the manufacturer's claim that their device is substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information about an AI/algorithm-driven device, nor does it present data from a "study that proves the device meets the acceptance criteria" in the way one would for an AI-powered diagnostic tool.

The acceptance criteria mentioned are related to:

Biocompatibility: Ensuring the materials are safe for patient contact.
Performance: Meeting USP standards for sterile saline and sterile water.
Stability: Maintaining properties after accelerated aging.

The "studies" are described as "Nonclinical Testing (Bench)" and include:

Biocompatibility testing: Demonstrated biological safety.
Performance testing: Demonstrated meeting USP standards.
Stability testing: Evaluated properties after accelerated aging.

The conclusion is that the device "passed all acceptance criteria."

Given this, I cannot provide the detailed information requested in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) because this information is not present in the provided text. The device in question is a simple medical product (sterile water/saline for wound flush), not a complex AI diagnostic system.

Therefore, the table and other detailed points will reflect the lack of this information from the provided document.

Acceptance Criteria and Device Performance (Based on provided document)

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Biocompatibility	Biological safety for direct/indirect patient contact (ISO10993 standard)	Demonstrated as non-cytotoxic, non-irritating, and non-sensitizing.
Performance	Meet USP<40> requirements for sterile saline and sterile water.	Demonstrated that proposed devices meet the standard on USP Sterile Saline and USP Sterile Water.
Stability	Maintain properties after accelerated aging.	Evaluated properties after accelerated aging in support of the labeling; results shown to pass acceptance criteria.

Study Details (Information Not Available or Applicable for this type of device)

Sample size used for the test set and the data provenance: Not applicable. The "tests" were benchtop performance, biocompatibility, and stability testing on the product itself, not a clinical study on patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound flush solution is based on chemical composition and sterility standards (USP<40>), not expert clinical review of images or data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring adjudication of clinical findings.
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: Not applicable. This device is sterile water/saline, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component to this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was based on established industry standards and regulations for medical devices, specifically USP<40> for chemical composition and sterility, and ISO10993 for biocompatibility.
The sample size for the training set: Not applicable. There is no training set as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

September 7, 2018

Amsino International Inc. Jane Gao VP of R&D 708 Corporate Center Drive Pomona, California 91768

Re: K181423

Trade/Device Name: AMSure Sterile Water, and Sterile Normal Saline for Wound Flush Regulatory Class: Unclassified Product Code: FRO Dated: July 9, 2018 Received: July 11, 2018

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181423

Device Name

AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush

Indications for Use (Describe)

AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush

For over the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

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 company that advances healthcare worldwide. The logo is in blue and white, with the word "AMSINO" in large, bold letters. Below the company name is the tagline "Advancing Healthcare Worldwide" in a smaller font. The logo is simple and professional, and it conveys the company's mission to improve healthcare around the world.

Section 5: 510(k) Summary (K181423)

a) Submitter Information:

Submitter:	Amsino International Inc.708 Corporate Center DrivePomona, CA 91768Phone: +1 (909)626-5888Fax: +1 (909)626-3888
Contact Person:	Jane GaoVice President of R&D, Amsino International Inc.Cell phone: +86 - 139 -1614 - 7664E-mail: Jane_gao@amsino.com
Date of Summary:	August 30, 2018

b) Device Information:

Trade or Proprietary Name:	AMSure ® Sterile Water, and Sterile Normal Salinefor Wound Flush
Common or Usual Name:	Sterile Water and Sterile Saline for Wound flush
Regulatory Class:	Unclassified, pre-amendment device
Product Code:	FRO

c) Identification of Legally Marketed Device(s):

K172486: Anexa Wound Flush, Sterile Water and Sterile Normal Saline
K083042: Wound Flush, Sterile Water and Sterile Normal Saline

d) Device Description:

The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP<40>. The bottle and cap are made by HDPE,

the inner induction sealed film is foil. The devices are offered in 100mL bottles.

e) Statement of Device Intended Use:

AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush

Amsino International Inc.

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Image /page/4/Picture/0 description: The image shows the logo for AMSINO, a healthcare company. The logo features the company name in large, bold, blue letters above a blue line. Below the line, the company's slogan, "Advancing Healthcare Worldwide," is written in a smaller font.

For over-the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

f) Substantial Equivalence Discussion:

Technological Characteristics: The proposed device has the same technological characteristics and provide the same mechanism of action as the predicates' devices.
Intended Use: The proposed device also labeled as same intended use as the predicates' devices.
Material: The proposed device use same USP grade saline and water, same type of resin for the container. The biocompatibility testing of proposed device has been conducted and has been proof as non-cytotoxic, non-irritating and non-sensitizing with ISO10993 standard.

Comparison table between proposed device and Predicate Devices:

Table 5-1

	Subject	Predicate 1	Predicate 2	Results
Manufacturer	AmsinoInternationalInc.	AnexaBiomedical, Inc.	Nurse Assist,Inc.
K Number	K181423	K172486	K083042
Classification	UnclassifiedPre-amendment	UnclassifiedPre-amendment	UnclassifiedPre-amendment	Same
Product Code	FRO	FRO	FRO	Same
Indications forUse	1. For OTC2. For Rx	1. For OTC2. For Rx	1. For OTC2. For Rx	Same
Principle ofOperation	Mechanicalaction of fluidmoving acrossthe wound ordevice aids inthe removal offoreign objectssuch as dirt anddebris.	Mechanicalaction of fluidmoving acrossthe wound ordevice aids inthe removal offoreign objectssuch as dirt anddebris.	Mechanicalaction of fluidmoving acrossthe wound ordevice aids inthe removal offoreign objectssuch as dirt anddebris.	Same

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Image /page/5/Picture/0 description: The image shows the AMSINO logo. The logo is in blue and white. Below the logo is the text "Advancing Healthcare Worldwide".

Chemicalcomposition	0.9% sterilesaline or sterilewater, noantimicrobial orother substanceadded	0.9% sterilesaline or sterilewater, noantimicrobial orother substanceadded	0.9% sterilesaline or sterilewater, noantimicrobial orother substanceadded	Same
Models	AS398 100mLUSP NormalSalineAS399 100mLUSP SterileWater	8100-100mLUSP Sterilewater9100- 100mLUSP SterileSaline8250- 250mLUSP SterileWater9250- 250mLUSP SterileSaline8500- 500mLUSP SterileWater9500- 500mLUSP SterileSaline8120- 120mLUSP SterileWater9120- 120mLUSP Sterilesaline	6250- 100mLUSP SterileWater6240- 100mLUSP sterileSaline6260- 250mLUSP SterileWater6270- 250mLUSP SterileSaline6290- 500mLUSP SterileWater6280- 500mLUSP SterileSaline6210-120mLUSP SterileWater6220- 120mLUSP SterileSaline	Similar
	Sterility	GammaSterilization	Unsure	GammaSterilization	Same withK083042
	SingleUse/Reusable	Single Use	Single Use	Single Use	Same

Conclusion:

Sterile water and sterile normal saline have the same technological characteristics and provide the same mechanism of action as the predicates' devices. According to the above analysis, there's no major difference between the proposed devices and the predicated devices would impact the effectiveness and safety. The AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush devices are therefore considered to be substantially equivalent to the above-mentioned predicates' devices.

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Image /page/6/Picture/0 description: The image shows the AMSINO logo. The logo is in blue and white. The text "AMSINO" is in large, bold letters, and the text "Advancing Healthcare Worldwide" is in smaller letters below.

g) Nonclinical Testing (Bench):

The following performance testing was conducted on the proposed device:

Biocompatibility testing has demonstrated the biological safety of the proposed devices which may directly or indirectly contact the patients.
Performance testing has demonstrated the proposed devices which meet the standard on USP Sterile Saline and USP Sterile Water.
Stability testing evaluated the properties of the AMSure® Sterile Water, and Sterile Saline for Wound Flush after accelerated aging in support of the labeling.

Performance testing conclusion: The results of the performance evaluation tests showed the AMSure® sterile water, and sterile normal saline for wound flush passed all acceptance criteria.

h) Conclusions:

The information provided within this pre-market notification demonstrates that AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush has no difference that would affect the safety or effectiveness of the devices as compared

to the predicate device and provide reasonable assurance of the safety and effectiveness of the devices to demonstrate substantial equivalency.

Regulation Number and Section

N/A