K Number

Device Name

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

Manufacturer

LS Scientific Inc. D.B.A. KSE Scientific

Date Cleared

2017-06-23

(147 days)

Product Code

FRO

Regulation Number

N/A

Intended Use

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K083042, K003402

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical and sterility properties of sterile water and saline solutions for wound cleansing and irrigation. There is no mention of AI, ML, or any computational analysis of data.

Therapeutic

No.

The device is a wound and device cleansing solution that moistens, debrides, and cleans dermal wounds and is used for device irrigation. It does not perform a therapeutic function but rather aids in the cleansing process.

Diagnostic

Explanation: The device description states its purpose is for moistening, debriding, and cleaning dermal wounds and for device irrigation. It does not mention any function related to diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "wound and device cleansing solution" and is offered in "various bottle and cup sizes," indicating it is a physical product (sterile water or saline) and not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for moistening, debriding, and cleaning wounds and for device irrigation. This is a direct application to the body or medical devices, not for testing samples taken from the body to diagnose a condition.
Device Description: The device is a sterile solution (water or saline) for wound and device cleansing. This aligns with a therapeutic or procedural use, not a diagnostic one.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Performance Studies: The performance studies focus on the sterility and chemical composition of the solution itself, not on its ability to diagnose a condition.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is entirely external and procedural.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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.

Product codes (comma separated list FDA assigned to the subject device)

FRO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083042, K003402

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

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.

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

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.

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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

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:

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.

510(k) number	510(k) owner/submitter	Classification Product Code	Intended use:			Packaging Materials	Biocompatiability: Conformance Shown	Sterilization Method	Sterile?	Shelf Life
			Device or	Candidate Device
Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline	Predicate Devices
Welcon Sterile Water and Sterile 0.9% Normal Saline	Predicate Devices
Nurse 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-Counter
Prescription	X		X
							Cups
							Bottles	HDPE w/Foil Seal
HDPE Bottle w/ PP cap	HDPE w/Foil Seal
HDPE Bottle w/ PP cap	HDPE w/Foil Seal
HDPE 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% Sterile
Saline; no antimicrobial or other substance added	Sterile Water for Irrigation or 0.9% Sterile
Saline; no antimicrobial or other substance added	Sterile Water for Irrigation or 0.9% Sterile
Saline; no antimicrobial or other substance added
							Mechanism of Action	Mechanical action of fluid moving across the
wound or device aids in the removal of
foreign objects such as dirts and debris	Mechanical action of fluid moving across the
wound or device aids in the removal of
foreign objects such as dirts and debris	Mechanical action of fluid moving across the
wound or device aids in the removal of
foreign objects such as dirts and debris

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