The subject AMSure® Single Use Saline Topical Solution device is normal saline 0.9% w/v Sodium Chloride. It is used in moistening and lubricating absorbent wound dressings for cuts, bruises, and minor burns prior to removal from the wound area. They are intended to be used in clinical and should only be used by clinicians familiar with the treatment of possible complications.

The subject device of normal saline topical solution 0.9% w/v is a unit-dose low density polyethylene (LDPE) vial contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives. The subject device is using blow fill seal technology. The devices are offered in 15mL, 35mL, 50mL.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for a medical device called "AMSure® Single Use Saline Topical Solution". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance-based acceptance criteria through an independent study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, ground truth establishment, expert involvement, or adjudication methods.
Information about MRMC effectiveness studies or standalone algorithm performance.
Details on training set sample size or how its ground truth was established.

Instead, the document details:

Device Name: AMSure® Single Use Saline Topical Solution
Regulatory Class: Unclassified
Product Code: FRO
Intended Use: For use in moistening and lubricating absorbent wound dressings for cuts, bruises, and minor burns prior to removal from the wound area.
Predicate Device: K993969 SALJET single dose sterile saline topical solution.
Substantial Equivalence Discussion: The document argues that the subject device is substantially equivalent to the predicate device based on:
- Similar Technological Characteristics: Both are 0.9% w/v Sodium Chloride solutions in LDPE vials. The principle of operation is the mechanical action of fluid for removing foreign objects.
- Similar Intended Use: Both are used for moistening and lubricating wound dressings.
- Difference in Sterility: The subject device uses aseptic blow-fill-seal technology, while the predicate is terminally sterilized. The submission argues this difference does not affect safety or effectiveness due to aseptic process validation and biocompatibility testing.
Nonclinical Testing (Bench):
- Design Verification Testing: Tests performed to ensure predetermined acceptance criteria were met for:
  - Identify Assay % NaCl
  - pH
  - Endotoxin
  - Sterility
  - Leak Testing
  - Net Fill Volume
  - (Note: Specific acceptance criteria values and reported performance values are NOT provided in this summary.)
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including:
  - In Vitro Cytotoxicity (ISO 10993-5)
  - Acute Systemic Toxicity (ISO 10993-11)
  - Intracutaneous Reactivity (ISO 10993-10)
  - Skin Sensitization (ISO 10993-10)
  - Material-mediated pyrogenicity (USP <151>)
  - Chemical characterization and toxicological risk assessment.

In summary, this document is a regulatory submission for a medical device demonstrating substantial equivalence, not a clinical study report or a detailed performance validation study with specific acceptance criteria and results. The "performance testing" mentioned is bench testing for design verification and biocompatibility, not a clinical study involving human patients, algorithms, or expert readers.

Summary

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April 14, 2021

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Amsino Medical Inc. Torsten Nilson President N.A. 700 Enterprise St. Aurora Aurora, Illinois 60504

Re: K201138

Trade/Device Name: AMSure® Single Use Saline Topical Solution Regulatory Class: Unclassified Product Code: FRO Dated: February 8, 2021 Received: February 24, 2021

Dear Torsten Nilson:

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/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 medical devices and radiation-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,

Lixin Liu. Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201138

Device Name

AMSure® Single Use Saline Topical Solution

Indications for Use (Describe)

For use in moistening and lubricating absorbent wound dressings for cuts, bruises and minor burns prior to removal from the wound area

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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Traditional 510(k) Summary for K201138

a) Submitter Information:

Submitter:	Amsino Medical Inc.700 Enterprise St. Aurora, IL60504Phone: +1 (847)7721958
Contact Person:	Torsten NilsonPresident of North America OperationsMobil phone: Tel: +1 847 772 1958Email: Torsten_nilson@amsino.com
Date of Preparation:	April 10th, 2021

b) Device Information:

Device Trade Name:	AMSure® Single Use Saline Topical Solutio
Common or Usual Name:	Single Use Saline Topical Solution
Classification Name:	Dressing, Wound, Drug
Product Code:	FRO
Regulation Number:	No
Device Class:	Unclassified
Review Panel:	General & Plastic Surgery panel

c) Identification of Legally Marketed Device(s):

Predicate device: K993969 SALJET single dose sterile saline topical solution.

d) Device Description:

e) Indications for Use:

For use in moistening and lubricating absorbent wound dressings for cuts, bruises and minor burns prior to removal from the wound area.

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f) Substantial Equivalence Discussion:

Technological Characteristics: The subject device has the similar technological characteristics and provide the similar principle of operation as the predicate device.
Intended Use: The subject device has the similar intended use as the predicate device.

Comparison between Subject Device and Predicate Devices

	Subject	Predicate
Manufacturer	Amsino International Inc.	Winchester Laboratories LLC.
510k Number	K201138	K993969
Classification	Unclassified	Unclassified
	Pre-amendment	Pre-amendment
Product Code	FRO	FRO
Indications forUse	For use in moisteningand lubricating absorbentwound dressings for cuts,bruises and minor burnsprior to removal from thewound area.	For use in moistening andlubricating absorbent wounddressings for traumaticwounds, cuts, bruises andminor burns prior to removalfrom the wound area.
Type of Use	For Rx only	For Rx only
Principle ofOperation	Mechanical action of fluidmoving across the woundor device aids in theremoval of foreign objectssuch as dirt and debris.	Mechanical action of fluidmoving across the wound ordevice aids in the removal offoreign objects such as dirtand debris.
Chemicalcomposition	Solution: 0.9% normalsaline, no antimicrobial orother substance added	Solution: 0.9% sterile saline,no antimicrobial or othersubstance added
	Container: Low densitypolyethylene	Container: Low densitypolyethylene
Models	AS0159: 15 mL SingleUse Saline TopicalSolution	Saljet 6
	AS0359: 35 mL SingleUse Saline TopicalSolution	30ml of sterile normal saline0.9% w/v, six vials per carton
	AS0509: 50mL SingleUse Saline TopicalSolution	Saljet 4030ml of sterile normal saline0.9% w/v, 40 vials per carton

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Sterility	Aseptic blow fill seal	Sterile
SingleUse/Reusable	Single Use	Single Use
Shelf life	2 years	n/a

The subiect device is similar in both indications for use and technological characteristics when compared to the predicate device. The subject device and the predicate device have similar labeling, instructions for use and packaging. The difference between the subject device and the predicate is the sterility status. The subject device undergoes aseptic process with blow-fill-seal technology during manufacturing process while the predicate device is terminal sterilized. However, this difference does not affect the safety of the device as evidenced by the aseptic process validation and biocompatibility testing conducted on the subject device. This difference does not affect the effectiveness of the subject device based on the fact that the mechanism of action for both the predicate device and the subject device is provided by mechanical action of fluid moving across the wound or device aids in the removal of foreign objects such as dirt and debris.

g) Nonclinical Testing (Bench):

The following performance testing was conducted on the selected representative device:

Design verification testing was conducted to ensure the device met the predetermined acceptance criteria for the following tests: Identify Assay % NaCl. pH. Endotoxin. Sterility. Leak Testing. Net Fill Volume were performed to demonstrate that the subject device met predetermined acceptance criteria per specification of AMSure® Single Use Saline Topical Solution.
Biocompatibility testing: Biocompatibility evaluation was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests and assessments. In Vitro Cytotoxicity (per ISO10993-5), Acute Systemic Toxicity (per ISO10993-11). Intracutaneous Reactivity (per ISO10993-10), Skin Sensitization (per ISO10993-10), material-mediated pyrogenicity (per USP <151>) and chemical characterization and toxicological risk assessment.

h) Conclusions:

Based on a comparison of composition, technological characteristics, intended use and biocompatibility test results. we conclude that AMSure® Single Use Saline Topical Solution is as safe and effective and is substantially equivalent to the predicate device.

Regulation Number and Section

N/A