For Prescription Use: For moistening absorbent wound dressings and for mostening acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

Device Description

The subject devices are 100 mL, 250 mL or 500 mL sterile normal saline (0.9% Sodium Chloride). The design of these single-use devices incorporates clear, high density polyethylene (HDPE) bottles filled and sealed with a sterile, preservative-free, clear, colorless, aqueous solution, as labeled for device irrigation and wound debridement (not for injection). The subject device will function by means of mechanical action; specifically, by the mechanical mechanism of action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

The chemical composition of its aqueous solution is either sterile saline (0.9% Sodium Chloride in sterile water) for irrigation, which have been substantiated to each meet their respective USP monograph criteria, and its formulation contains no additives. The components of the subject device's container and closure system, made from polyethylene (PE) resins and an induction-heat seal and liner, meet the requirements of the Agency's food additive regulations.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP. This document asserts substantial equivalence to a predicate device (Nurse Assist Wound Flush, Sterile Water and Sterile Normal Saline, K083042) rather than proving device performance against specific acceptance criteria through a clinical study.

Therefore, the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established" is not available in this document.

The document explicitly states: "Summary of Clinical Testing: Not applicable. No clinical testing was done on the proposed device." (Page 9)

Instead, the submission relies on non-clinical testing (bench testing) and a comparison of technological characteristics to demonstrate substantial equivalence to a legally marketed predicate device.

Here's the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

This document does not present acceptance criteria for a clinical study or a table of reported device performance from such a study. It focuses on demonstrating equivalence through non-clinical means.
The "Comparison of Proposed and Predicate Devices" (Table 1 on page 6) lists characteristics like product name, K number, product owner, product code, indications for use, regulation number, technological characteristics, chemical composition, design configurations, and performance specifications. The "Comparison Analysis" column for most entries is "Same" or "Similar," indicating that the proposed device matches the predicate in these aspects.

2. Sample sized used for the test set and the data provenance:

Not applicable, as no clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set with human ground truth was established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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:

Not applicable. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for this 510(k) submission is demonstrated through adherence to USP monographs for sterile water and saline, and safety standards for medical device materials, as assessed through bench testing and comparison to a predicate device.

8. The sample size for the training set:

Not applicable, as there was no training set for an algorithm.

9. How the ground truth for the training set was established:

Not applicable.

Summary of Non-Clinical Testing provided:

Biocompatibility Evaluation: Conducted according to ANSI/AAMI/ISO 10993-1:2009. The device is classified as a surface device with limited contact (<24 hours) on potentially breached or compromised surfaces.
- Tests performed:
  - ISO 10993-5: 2009 (in vitro cytotoxicity)
  - ISO 10993-10 (irritation and delayed-type hypersensitivity)
  - ISO 10993-10 (irritation and skin sensitization) - Note: This is listed twice.
  - ISO 10993-11 (systemic toxicity)
  - USP <151> Pyrogen Test Procedure, Material-Mediated Rabbit Pyrogen Testing
Shelf Life and Sterilization:
- Sterilized by gamma radiation in accordance with AAMI TIR33 (Sterilization of healthcare products - Radiation - Substantiation of a selected sterilization dose - Method VDmax) to achieve a Sterility Assurance Level (SAL) of 10^-6.
- Aging studies conducted in accordance with ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) to verify shelf life and maintained sterility.
Performance Testing (Bench): Mentioned generally as being conducted to evaluate safety, performance, and functionality, demonstrating overall safety. Specific details of these bench tests are not provided in this summary.

In conclusion, this 510(k) submission establishes substantial equivalence through non-clinical testing and comparison to a predicate device, as permitted for certain low-to-moderate risk medical devices. It explicitly states that no clinical (human) testing was performed.

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). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, which features a stylized depiction of human figures. To the right of this symbol, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, while "U.S. FOOD & DRUG" is in a slightly smaller font, and "ADMINISTRATION" is in an even smaller font below.

Medline Industries, Inc. Claire Pigman Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K173276

Trade/Device Name: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Regulatory Class: Unclassified Product Code: FRO Dated: June 1, 2018 Received: June 5, 2018

Dear Claire Pigman:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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K173276

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 mediation-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, Neil R Oaden -5 For Binita S. Ashar, M.D., M.B.A., F.A.C 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) K173276

Device Name

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP

Indications for Use (Describe)

For Over-the-Counter Use:

For moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skin.

For Prescription Use:

For moistening absorbent wound dressings and for mostening acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic 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)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo features the word "MEDLINE" in white, bold, sans-serif font, positioned to the left of a white, stylized starburst symbol. The background is a solid dark blue color. The logo is simple, clean, and professional, reflecting the company's focus on medical supplies and services.

Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093

K173276

SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592

Contact Person

Claire Pigman Sr. Regulatory Affairs Specialist Phone: 847-643-4071 Email: cpigman@medline.com

Summary Preparation Date October 9, 2017

Type of 510(k) Submission Traditional

Device Name / Classification

Name of Device: Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Device Common Name: Sterile Water and Sterile Saline Classification Name: Dressing, Wound, Drug Product Code: FRO Classification Panel: General and Plastic Surgery Devices Device Classification: Unclassified Regulation Number: Pre-Amendment

Predicate Device

Predicate Device Name: Wound Flush, Sterile Water and Sterile Normal Saline Predicate Device Sponsor: Nurse Assist, Inc. Predicate Device K Number: K083042

Device Description

The subject devices are 100 mL, 250 mL or 500 mL sterile normal saline (0.9% Sodium Chloride). The design of these single-use devices incorporates clear, high density polyethylene (HDPE)

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a white star-like symbol above it. The star symbol has four points, and it is positioned so that the word "MEDLINE" is centered below it.

edline Industries. hree Lakes Drive Northfield II 60093

bottles filled and sealed with a sterile, preservative-free, clear, colorless, aqueous solution, as labeled for device irrigation and wound debridement (not for injection). The subject device will function by means of mechanical action; specifically, by the mechanical mechanism of action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

Medline Item Number	Description
RDI30295	Medline Sterile Water, USP - 100 mL
PCS1550	Medline Sterile Water, USP - 250 mL
DYND500MLW	Medline Sterile Water, USP - 500 mL
RDI30296	Medline Sterile 0.9% Normal Saline, USP - 100 mL
PCS1650	Medline Sterile 0.9% Normal Saline, USP - 250 mL
DYND500MLS	Medline Sterile 0.9% Normal Saline, USP - 500 mL

Please note that all six of these configurations are designed to consist of either sterile water USP or sterile normal saline (0.9% Sodium Chloride) USP, packaged and sealed in HDPE bottles and terminally sterilized using gamma irradiation. Please refer to Section 11 of this Premarket Notification for a more comprehensive description of this device.

Indications for Use

For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

For Prescription Use: For moistening absorbent wound dressings 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.

Summary of Technological Characteristics

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP are single-use devices and their design incorporates clear, high density polyethylene (HDPE) bottles filled and sealed with a sterile, preservative-free, clear, colorless, aqueous solution, as labeled for device irrigation and wound debridement (not for injection). The chemical composition of its aqueous solution is either sterile water

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, bold, sans-serif font. Above the word is a white, stylized star shape with four points. The star is oriented so that one point is facing upwards.

ledline Industries, Inc. Three Lakes Drive Northfield. IL 60093

or sterile saline (0.9% Sodium Chloride) for irrigation, which have been substantiated to each meet their respective USP monograph criteria, and its formulation contains no additives.

In addition, the subject device is similar in design, intended use and function to the predicate device, Nurse Assist Wound Flush, Sterile Water and Sterile Normal Saline, cleared under K083042. The table below provides a side-by-side comparison of the proposed and predicate devices. Please refer to Section 12 for a further discussion of the similarities and differences between the two devices.

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Table 1: Comparison of Proposed and Predicate Devices

DeviceCharacteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline Sterile Water USP and Medline Sterile 0.9% Normal SalineUSP	Nurse Assist Wound Flush, Sterile Water and Sterile NormalSaline	N/A
510(k) Reference	K173276	K083042	N/A
Product Owner	Medline Industries, Inc.	Nurse Assist Incorporated	N/A
Product Code	FRO	FRO	Same
Indication for Use	Over-the-Counter Use: For moistening absorbent wound dressingsand cleaning minor cuts, minor burns, superficial abrasions andminor irritations of the skin	Over-the-Counter Use: For moistening absorbent wound dressingsand cleaning minor cuts, minor burns, superficial abrasions andminor irritations of the skin.	Same
	For Prescription Use: For moistening absorbent wound dressings andfor moistening, debriding and cleaning acute and chronic dermallesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabeticulcers, foot ulcers, post-surgical wounds, first and second degreeburns, cuts, abrasions and minor skin irritations and for deviceirrigation.	For Prescription Use: For moistening absorbent wound dressingsand for moistening, debriding and cleaning acute and chronicdermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers,diabetic ulcers, foot ulcers, post-surgical wounds, first and seconddegree burns, cuts, abrasions and minor skin irritations and fordevice irrigation.	Same
Regulation Number	Pre-Amendment	Pre-Amendment	Same
TechnologicalCharacteristics:	Principle mechanism of action is through the mechanical actionassociated with the application and movement of fluid (either SterileWater or Saline) across a wound or device surface to facilitate themoisturizing, debridement and irrigation of these surfaces.	Mechanical action of fluid moving across the wound or deviceprovides for the mechanism of action and aids in the removal offoreign objects such as dirt and debris.	Same
ChemicalComposition	Sterile Saline (0.9% Sodium Chloride) or Sterile Water for irrigationsubstantiated to meet USP; no antimicrobial or other substanceadded.	Sterile Saline (0.9% Sodium Chloride) or Sterile Water forirrigation substantiated to meet USP; no antimicrobial or othersubstance added.	Same
DesignConfigurations	CONTENTS100 mL Sterile Water, USP250 mL Sterile Water, USP100 mL Normal Saline, USP250 mL Normal Saline, USP500 mL Sterile Water, USP500 mL Normal Saline, USP	CONTAINERHDPE Bottles made frompolyethylene (PE) resin.Include an induction-heatseal and liner with apolypropylene (PP) screwcap closure	CONTENTS100 mL USP Sterile Water250 mL USP Sterile Water100 mL USP Normal Saline250 mL USP Normal Saline	Similar
			CONTAINERHDPE Bottles made frompolyethylene (PE) resin.Include an induction sealedinner pull tab with apolypropylene (PP) screw capclosure
			120 mL USP Sterile Water120 mL USP Normal Saline210 mL USP Normal Saline	White polypropylene (PP) cupwith heat sealed foil lidNitrogen pressurizedaluminum bottle with latex-free inner bag
PerformanceSpecifications	The sterile water and sterile saline is manufactured from Water forIrrigation that is designed, tested and operated in accordance withthe USP monograph for Water for Irrigation, as specified in USPGeneral Chapter: Water for Pharmaceutical Purposes <1231>		The sterile water and sterile saline is manufactured from Water forIrrigation that is designed, tested and operated in accordance withthe USP monograph for Water for Irrigation, as specified in USPGeneral Chapter: Water for Pharmaceutical Purposes <1231>		Same

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Table 1: Comparison of Proposed and Predicate Devices

DeviceCharacteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Prescription vs. OTC	Prescription Use & OTC Use	Prescription Use & OTC Use	Similar
Contact Durations	<24 hours	<24 hours	Same
Sterile vs. Non-Sterile	Sterile	Sterile	Same
Sterilization Method	Gamma Radiation	Gamma Radiation	Same
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs.Reusable	Single Use	Single Use	Same
Shelf Life	í year	2 years	Different

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Image /page/8/Picture/0 description: The image features the Medline logo set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points. A small gray rectangle is visible in the upper right corner of the image.

Medline Industries. Inc Three I akes Drive

Shelf Life and Sterilization

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP are sterilized by gamma radiation and its sterilization has been conducted in accordance with AAMI TIR33, Sterilization of healthcare products - Radiation - Substantiation of a selected sterilization dose - Method VDmax.to ensure that the determined minimum irradiation dose achieves a Sterility Assurance Level (SAL) of 10-0.

Additionally, in accordance with ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, aging studies have been conducted to verify the shelf life of the subject device and ensure its sterility is successfully maintained throughout its shelf life.

Summary of Non-Clinical Testing

Non-clinical verification of Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination.

The biocompatibility evaluation for the Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The proposed device is classified as a surface device with a limited duration of contact (<24 hours) on potentially breached or compromised surfaces. Based on this classification, the following tests were performed to evaluate the biocompatibility of the Medline Sterile Water USP and Sterile 0.9% Normal Saline USP:

ISO 10993-5: 2009 Biological evaluation of medical devices- Part 5: Tests for in vitro ● cytotoxicity
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests for irritation and ● delayed-type hypersensitivity
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests for irritation and ● skin sensitization
ISO 10993-11 Biological evaluation of medical devices- Part 11: Tests for systemic ● toxicity
USP <151> Pyrogen Test Procedure, Material-Mediated Rabbit Pyrogen Testing ●

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Image /page/9/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. A white star-like symbol is in the center of the square, and the word "MEDLINE" is written in white letters across the top of the star. There is a gray bar on the right side of the square.

Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093

Performance Testing (Bench)

Non-clinical verification of Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP has been conducted to evaluate the safety, performance and functionality of the proposed device. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination.

Summary of Clinical Testing

Not applicable. No clinical testing was done on the proposed device.

Conclusion

In accordance with 21 CFR Part 807. and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP are as safe and as effective for their intended use as the predicate device Nurse Assist Wound Flush, Sterile Water and Sterile Normal Saline (K083042).

Regulation Number and Section

N/A