Saline Wound Wash is intended for use by or under the direction of a professional health care provider in moistening and lubricating absorbent wound dressings, cleansing and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts abrasions and minor burns.

Indications for Over the Counter (OTC) Use:

Saline Wound Wash is intended for use in moistening and lubricating absorbent wound dressings and for cleansing minor wounds, scrapes and minor burns. If redness, swelling or bleeding continues please seek the help of a nurse, nurses aid, doctor or other medical professional.

Device Description

Saline Wound Wash is a multi-use, isotonic, sterile saline solution packaged in a bag-in-can aerosol system. Actuation of the device (product can) delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15, AHCPR, US Department of Health and Human Services). The mechanical action of isotonic saline solution moving across the wound aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudates, and other extraneous matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements (Sterilization of health care products - Requirements for validation and routine control - radiation sterilization).

Saline Wound Wash passes the USP<71> Sterility Test.

Saline Wound Wash is an Rx and OTC device and will only be labeled for use in wounds.

AI/ML Overview

The Premier Brands of America Inc. Saline Wound Wash (K090848) is a sterile, isotonic saline solution in an aerosol system. The 510(k) summary indicates that the device's performance is demonstrated through its compliance with existing standards and comparison to predicate devices, rather than a clinical study with a specific set of acceptance criteria and a test dataset as might be seen for a novel diagnostic or therapeutic device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Sterility: Must pass USP<71> Sterility Test.	Passes USP<71> Sterility Test. (Paragraph 2, Page 2/3)
Sterilization Validation: Sterilized according to validated parameters for radiation sterilization (ISO/AAMI 11137 requirements).	Sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements. (Paragraph 2, Page 2/3)
Wound Impact Pressure: Delivers consistent flow at safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15, AHCPR, US Department of Health and Human Services).	Actuation of the device delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15, AHCPR, US Department of Health and Human Services). (Paragraph 5, Page 1/3)
Purity/Composition: 0.9% sodium chloride solution prepared from sodium Chloride, USP, and purified water, USP. (Implicit from description)	Saline Wound Wash is a clear, colorless 0.9% sodium chloride solution prepared from sodium Chloride, USP, and purified water. USP. (Paragraph 8, Page 2/3)
No Preservatives: No preservatives added.	No preservatives are added... (Paragraph 5, Page 1/3)
Safety and Effectiveness: As safe and effective as predicate devices. (Implicit from substantial equivalence claim)	Saline Wound Wash is as safe and effective as the predicate devices. Saline Wound Wash has the same intended uses, technological characteristics, and basic principles of operation as its predicate devices and raises no new issues of safety or effectiveness. (Paragraph 9, Page 3/3)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a "test set" in the context of a clinical performance study with human subjects, images, or diagnostic outcomes. The performance is assessed against established physical and chemical standards and through direct comparison of technological characteristics to already approved predicate devices. Therefore, these metrics are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable as there is no "test set" requiring expert ground truth establishment for this type of device. The ground truth for the "performance" aspects is based on established scientific and regulatory standards (e.g., USP<71>, ISO/AAMI 11137, AHCPR guidelines).

4. Adjudication Method for the Test Set:

This is not applicable as there is no "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The device is a wound wash, not a diagnostic or interventional imaging device where human reader performance would be a primary metric.

6. Standalone (Algorithm Only) Performance Study:

This is not applicable. The device is a physical product (saline wound wash), not an algorithm or AI system. Its performance is intrinsic to its physical and chemical properties and dispensing mechanism.

7. Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on:

Established Scientific Standards: e.g., USP<71> for sterility, ISO/AAMI 11137 for sterilization, Clinical Practice Guideline Number 15, AHCPR for wound impact pressures.
Chemical and Physical Specifications: 0.9% sodium chloride solution purity, absence of preservatives, bag-in-can aerosol system design.
Substantial Equivalence to Predicate Devices: This implies that the predicate devices themselves have demonstrated acceptable safety and effectiveness.

8. Sample Size for the Training Set:

This is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable as there is no "training set."

Summary of the Study:

The document describes a 510(k) premarket notification for a Saline Wound Wash. The "study" for this device's acceptance is primarily based on bench testing against established standards and demonstration of substantial equivalence to legally marketed predicate devices.

The device's performance is shown through:

Compliance with Sterility Standards: Passing the USP<71> Sterility Test.
Validated Sterilization Process: Sterilization by gamma irradiation validated per ISO/AAMI 11137.
Controlled Dispensing Pressure: Delivery of saline at scientifically recognized safe and effective wound impact pressures (4-15 psi) as per AHCPR guidelines.
Material Composition: Use of USP-grade Sodium Chloride and purified water, and an inert bag-in-can system.
Comparison to Predicate Devices: The submission asserts that "Saline Wound Wash is as safe and effective as the predicate devices. Saline Wound Wash has the same intended uses, technological characteristics, and basic principles of operation as its predicate devices and raises no new issues of safety or effectiveness." The predicate devices mentioned are Wound Wash Saline (K083355), Dermacyn™ Wound Dressing (K041161), and Sterile Saline (K082330).

Essentially, the "study" is a demonstration that the new device meets the same safety and performance profiles as similar, already approved devices and complies with relevant industry standards for sterility and product characteristics. This is a common approach for Class II medical devices in the 510(k) pathway, where a direct clinical trial demonstrating efficacy might not be required if substantial equivalence can be demonstrated.

Summary

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Premier Brands of America Inc. Saline Wound Wash

K090848

510(k) SUMMARY

JUN 17 2009

SALINE WOUND WASH

1. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Premier Brands of America Inc. 120 Pearl St. Mount Vernon, NY 10550

(718) 325-3000 Telephone No .: Facsimile No .: (718) 325-1050

Contact Person:

Mack Cauthen mcauthen@premier-brands.com

May 26, 2009 . Date Prepared:

2. Name of Device and Name/Address of Sponsor

Premier Saline Wound Wash

Premier Brands of America Inc. 120 Pearl St. Mount Vernon, NY 10550

3. Name of Device

Proprietary: Premier Sterile Saline Wound Cleanser Classification Name: Lavage, Jet (21 CFR 880.5475) Product Code: FQH

4. Classification of Device: 2

5. Description

CONFIDENTIAL

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Premier Brands of America Inc. Saline Wound Wash

K090848 page 2/3

is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements (Sterilization of health care products - Requirements for validation and routine control - radiation sterilization).

Saline Wound Wash passes the USP<71> Sterility Test.

Saline Wound Wash is an Rx and OTC device and will only be labeled for use in wounds.

6. Predicate Device

OTC: Wound Wash Saline; Blairex Laboratories, Inc. (K083355)

Dermacyn™ Wound Dressing (K041161) RX: Sterile Saline (K082330)

7. Intended Use/Indication for Use

Indications for Rx (Prescription) Use:

Indications for Over the Counter (OTC) Use:

8. Technological Characteristics

Saline Wound Wash is an aerosol bag-in-can system. The propellant, compressed air, is charged into the container between bag and the can creating a means to dispense the contents of the bag, isotonic sterile saline solution. The bag is a 4-Laver laminate system including a sandwiched polyethylene layer establishing an impermeable barrier between the propellant (compressed air) and the bag contents (sterile isotonic saline). The isotonic saline solution is in contact with either a polyethylene or polypropylene layer. Saline Wound Wash is a clear, colorless 0.9% sodium chloride solution prepared from sodium Chloride, USP, and purified water. USP. After filling and pressurizing, the device is sterilized by gamma irradiation. The product is tested against established specifications and meets USP sterility requirements.

CONFIDENTIAL

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Premier Brands of America Inc.
Saline Wound Wash

. .

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Ko9o8ye

ge 3/3

9. Substantial Equivalence

Saline Wound Wash is as safe and effective as the predicate devices. Saline Wound Wash has the same intended uses, technological characteristics, and basic principles of operation as its predicate devices and raises no new issues of safety or effectiveness. Thus Saline Wound Wash is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.

Public Health Service

JUN 17 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Premier Brands of America. Incorporated % Mr. Mack Cauthen Manager, Quality and Regulatory Affairs 120 Pearl Street Mount Vernon, New York 10550

Re: K090848

Trade/Device Name: Saline Wound Wash Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: II Product Code: FQH, FRO Dated: May 26, 2009 Received: June 3, 2009

Dear Mr. Cauthen: -

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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing

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Page 2-Mr. Mack Cauthen

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Ror

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090848

Indications for Use

510(k) Number (if known): K090848

Device Name: Saline Wound Wash

Indications for Prescription (Rx) Use:

Indications for Over the Counter (OTC) Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Daniel Krone for MVM
(Division Sign-Off)

Division of Surgical, Orthopedic, Concurrence of CDRH, Office of Device Evaluation of Surgical, OFfices

510(k) Number K090846

Page 1 of 1

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.