Rx: 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. Not for injection.

Device Description

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP. The subject device is offered in various bottle and cup sizes.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline." This device is a wound and device cleansing solution. The summary details information typically found in a regulatory submission rather than a clinical study report. Therefore, much of the requested information regarding a study proving acceptance criteria (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or training set details) is not present.

However, I can extract information related to the acceptance criteria and the types of testing performed to demonstrate conformance.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on conformance to USP (United States Pharmacopeia) monographs for "Water for Irrigation" and "Sodium Chloride," and demonstrating sterility. The device's performance is reported by stating its compliance with these standards.

Acceptance Criteria	Reported Device Performance
Sterile Water for Irrigation:	Conforms to the USP monograph for Water for Irrigation.
- Endotoxin levels	Tested accordingly and met requirements (details not provided).
- Total Organic Carbon (TOC)	Tested accordingly and met requirements (details not provided).
- pH	Tested accordingly and met requirements (details not provided).
- Chloride levels	Tested accordingly and met requirements (details not provided).
- Sulfate levels	Tested accordingly and met requirements (details not provided).
- Ammonia levels	Tested accordingly and met requirements (details not provided).
- Calcium levels	Tested accordingly and met requirements (details not provided).
- Carbon Dioxide	Tested accordingly and met requirements (details not provided).
- Oxidizable Substances	Tested accordingly and met requirements (details not provided).
Sterility	Product was tested accordingly; validation of sterility parameters achieved through a VDmax study.
Sterile Normal Saline (Sodium Chloride):	Conforms to the USP monograph for Sodium Chloride. Chemical analysis was not required due to this conformance.
Biocompatibility	Conformance shown (Yes), similar to predicate devices.
Shelf Life	2 years, similar to predicate devices.
Mechanism of Action	Mechanical action of fluid moving across the wound or device aids in the removal of foreign objects such as dirt and debris. Similar to predicate devices.
Packaging Materials	HDPE w/Foil Seal, HDPE Bottle w/ PP cap. Similar to predicate devices.

Details of the Study/Testing (as provided in the document):

The document describes laboratory testing to demonstrate chemical and sterility conformance against established standards (USP monographs and industry sterilization practices). It does not describe a clinical study or a comparative effectiveness study involving human interpretation or AI.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but the document mentions "a summary of all lots tested can be found in summary tables on page 14-3 and 14-4." These pages are not included in the provided text.
- Data Provenance: The testing was performed on the product itself ("Sterile Water for Irrigation" and "sodium chloride used in the Sterile Normal Saline"). No external data from specific countries or populations are mentioned. The testing is analytical/laboratory-based rather than a retrospective or prospective clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device (chemical purity, sterility) is established by adherence to recognized pharmacopeial standards (USP monographs) and sterilization validation protocols, not by expert consensus on interpretations of complex data like medical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically employed in studies where human readers are making subjective assessments that need to be aggregated or confirmed (e.g., radiology reads). The testing here is objective, analytical, and laboratory-based.
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:
- No. This device is a sterile solution for wound irrigation. It is not an AI-assisted diagnostic or therapeutic device, and therefore, an MRMC comparative effectiveness study is not relevant or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device. The testing described is for the chemical and physical properties and sterility of the solution.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established by conformance to recognized industry and regulatory standards, specifically USP monographs for "Water for Irrigation" and "Sodium Chloride," and validated sterilization parameters.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set is used for this device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

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

June 23, 2017

L S Scientific, Inc. D.B.A. KSE Scientific Mr. Jordan Reynolds Quality Manager 2714 South Miami Blvd. Durham, NC 27703

Re: K170270

Trade/Device Name: Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline Regulatory Class: Unclassified Product Code: FRO Dated: January 20, 2017 Received: June 20, 2017

Dear Mr. Reynolds:

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 device-related adverse events) (21 CFR 803); good manufacturing 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.

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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/Resourcesfor You/Industry/default.htm. 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/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) K170270

Device Name

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

Indications for Use (Describe)

OTC: For moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skins. Not for injection.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Section 5 Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

5 – 510(k) Summary

(In accordance with 21 CFR 807.87(h) and 21 CFR 807.92)

1. Submitter's name and address:

LS Scientific Inc, D.B.A. KSE Scientific 2714 S Miami Blvd Durham, NC 27703

2. Submitter's telephone number and fax number:

Tel: (919) 597-3500 Fax: (919) 597-3510

3. Contact person:

Jordan Reynolds - Quality Manager

4. Date this 510(k) summary prepared:

January 20, 2017

5. Trade/proprietary name of the device:

Aqua Care & Accu-Rinse Sterile Water & Sterile Normal Saline

6. Device classification

Unclassified, pre-amendment device Product Code FRO

7. Legally marketed predicate devices to which substantial equivalence is claimed:

Wound Flush, Sterile Water & Normal Saline; Nurse Assist, Incorporated -K083042
Welcon Sterile Water for Device Irrigation, Welcon Sterile 0.9% Normal Saline; . Nurse Assist, Incorporated - K003402

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510(k) Section 5

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

8. Description of the device that is the subject for this premarket notification:

9. Intended use and indication 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. Not For Injection.

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. Not For Injection.

10. Technological characteristics:

The mechanical action of fluid moving across the wound or device provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris.

11. Summary of testing:

Testing was performed on the Sterile Water for Irrigation to show conformance to the USP monograph for Water for Irrigation. These tests included endotoxin, total organic carbon, pH, chloride, sulfate, ammonia, calcium, carbon dioxide, and oxidizable substances. In addition to the aforementioned testing, as the product is being sold as "sterile", the product was tested accordingly. To achieve validation of sterility parameters, a VDmax study was conducted to determine irradiation parameters. The results of the VDmax study can be found on pages 14-6 through 14-27. A summary of all lots tested can be found in summary tables on page 14-3 and 14-4. As the sodium chloride used in the Sterile Normal Saline conforms to the USP monograph for Sodium Chloride, chemical analysis was not required to show conformance to the monograph.

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12. Conclusion:

At this time, it is the belief of KSE Scientific that our candidate derives show substantial equivalence to the predicate devices. Due to the candidate device showing conformance to the prescribed monographs for each material, establishing the same irradiation parameters, indications of use, packaging materials, and biocompatibility, we have shown the equivalence to the predicate devices. A summary table can be found on the following page showing these substantiated claims.

This concludes the 510(k) Summary.

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Classification Product Code	Intended use:			Packaging Materials	Biocompatiability: Conformance Shown	Sterilization Method	Sterile?	Shelf Life
	Device or	Candidate DeviceAqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline	Predicate DevicesWelcon Sterile Water and Sterile 0.9% Normal Saline	Predicate DevicesNurse Assist Wound Flush, Sterile Water & Normal Saline















510(k) number
510(k) owner/submitter		KSE Scientific	Nurse Assist, Inc	Nurse Assist, Inc
Classification Product Code		Pre-amendment, unclassified, FRO	JOL	Pre-amendment, unclassified, FRO
Intended use:	Irrigation	X	X	X
	Wound Irrigation	X		X
	Over-the-CounterPrescription	X		X
					Cups
					Bottles	HDPE w/Foil SealHDPE Bottle w/ PP cap	HDPE w/Foil SealHDPE Bottle w/ PP cap	HDPE w/Foil SealHDPE Bottle w/ PP cap
					Biocompatiability: Conformance Shown	Yes	Yes	Yes
					Sterilization Method	Terminal (Gamma)	Terminal (Gamma)	Terminal (Gamma)
					Sterile?	Yes	Yes	Yes
					Shelf Life	2 years	2 years	2 years
					Chemical Composition	Sterile Water for Irrigation or 0.9% SterileSaline; no antimicrobial or other substance added	Sterile Water for Irrigation or 0.9% SterileSaline; no antimicrobial or other substance added	Sterile Water for Irrigation or 0.9% SterileSaline; no antimicrobial or other substance added
					Mechanism of Action	Mechanical action of fluid moving across thewound or device aids in the removal offoreign objects such as dirts and debris	Mechanical action of fluid moving across thewound or device aids in the removal offoreign objects such as dirts and debris	Mechanical action of fluid moving across thewound or device aids in the removal offoreign objects such as dirts and debris

Page 5-4

Regulation Number and Section

N/A