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.

Device Description

The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP <38>. The devices are offered in 100 mL, 250 mL and 500 mL bottles and 120 mL cups

AI/ML Overview

The provided text describes a 510(k) premarket notification for "USP Sterile Water" and "USP Sterile Normal Saline (0.9% Sodium Chloride)." This document is a regulatory submission for medical devices, primarily focusing on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria.

As such, the document does not contain the detailed information requested regarding:

A table of acceptance criteria and reported device performance.
Sample size used for a test set or its provenance.
Number of experts and their qualifications for establishing ground truth.
Adjudication method for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
Standalone (algorithm-only) performance.
Type of ground truth used.
Sample size for a training set.
How ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K083042, Sterile Water and Sterile Normal Saline from Nurse Assist, Inc.) based on:

Intended Use: The device shares the same intended uses as the predicate, which includes moistening absorbent wound dressings, cleaning minor cuts/burns/abrasions/irritations (OTC use), and moistening/debriding/cleaning acute/chronic dermal lesions and device irrigation (Prescription Use).
Technological Characteristics: The devices have the same technological characteristics (sterile water or sterile normal saline meeting USP <38> and providing mechanical action for cleaning).
Mechanism of Action: The mechanism of action is identical – mechanical action of fluid for removing foreign objects.
Composition: Supplied sterile in containers of identical composition.
Biocompatibility Testing: The devices were tested according to ISO 10993 standards and found to be non-cytotoxic, non-irritating, and non-sensitizing, with results similar to those reported for the predicate devices.

Conclusion:

The submission concludes that "Based on a comparison of composition, technological characteristics, intended use and biocompatibility test results, we conclude that Sterile Normal Saline perform at least as well as the predicate devices. Sterile Water and Sterile Normal Saline are therefore considered to be substantially equivalent to the above-mentioned predicate devices."

Therefore, for this specific submission, the "acceptance criteria" revolve around demonstrating comparable characteristics and safety to a legally marketed predicate device, rather than quantitative performance metrics against pre-defined clinical thresholds typically seen for more complex diagnostic or therapeutic devices. The "study" that proves the device meets "acceptance criteria" (i.e., substantial equivalence) consists of the comparative analysis described above and the biocompatibility testing.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2016

Strukmyer Medical LLC % Mr. Richard Hamer Richard Hamer Associates LLC 705 Spring Lakes Blvd. Bradenton, Florida 34210

Re: K161311

Trade/Device Name: USP Sterile Water. 120 Ml Cup, USP Sterile Normal Saline (0.9% Sodium Chloride), 120 Ml Cup, USP Sterile Water, 100 Ml,250 Ml And 500 Ml Bottles, USP Sterile Normal Saline (0.9% Sodium Chloride), 100 Ml, 250 Ml And 500 Ml Bottles Regulatory Class: Unclassified

Product Code: FRO Dated: August 4, 2016 Received: August 9, 2016

Dear Mr. Hamer:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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) K161311

Device Name

Sterile Water and Sterile Normal Saline

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	X Over-The-Counter Use (21 CFR 801 Subpart C)

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. The seat comments of the comments of the comments of the comments of the comments of the comments of

510(k) SUMMARY

I. ADMINISTRATIVE

Submitter: Strukmyer Medical 1801 Big Town, Suite 100 Mesquite, TX 75149

(214) 275-9595

Contact Person: Robert (Bob) Delk

Date of Preparation: August 5, 2016

II. DEVICE NAME

Proprietary Name: Sterile Water and Sterile Normal Saline

Classification Name: Unclassified, pre-amendment device; Product Code FRO

III.PREDICATE DEVICE

Sterile Water and Sterile Normal Saline ; K083042, Nurse Assist, Inc.

IV. DEVICE DESCRIPTION

V. INTENDED 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.

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. 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, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

VI.COMPARISON TO PREDICATE DEVICE

Sterile Water and Sterile Normal Saline have the same technological characteristics and provide the same mechanism of action as the predicate devices; i.e., the mechanical action of fluid moving across the wound or device aids in the removal of foreign objects such as dirt and debris. They are labeled for the same intended uses and are supplied sterile in containers of identical composition. Biocompatibility testing of Sterile Water and Sterile Normal Saline has been conducted. The devices were found to be non-cytotoxic, non-irritating and nonsensitizing in ISO 10993 standard tests; results which are similar to those reported for the predicate devices.

VI. CONCLUSION

Based on a comparison of composition, technological characteristics, intended use and biocompatibility test results, we conclude that Sterile Normal Saline perform at least as well as the predicate devices. Sterile Water and Sterile Normal Saline are therefore considered to be substantially equivalent to the above-mentioned predicate devices.

Regulation Number and Section

N/A