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

K170270 · Ls Scientific Inc. D.B.A. Kse Scientific · FRO · Jun 23, 2017 · SU

Device Facts

• Record ID: K170270
• Device Name: Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
• Applicant: Ls Scientific Inc. D.B.A. Kse Scientific
• Product Code: FRO · SU
• Decision Date: Jun 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Device Story

Aqua Care & Accu-Rinse consists of sterile water or sterile 0.9% normal saline solution packaged in various HDPE bottle and cup sizes. Device functions via mechanical action of fluid irrigation to remove foreign objects, dirt, and debris from wounds or medical devices. Used in clinical or home settings by clinicians or patients. No antimicrobial or other substances added. Output is the physical irrigation fluid; healthcare providers use this to clean or debride wounds and irrigate devices, facilitating healing and maintaining wound hygiene.

Clinical Evidence

Bench testing only. Conformance to USP monographs for Water for Irrigation (endotoxin, TOC, pH, chloride, sulfate, ammonia, calcium, CO2, oxidizable substances) and Sodium Chloride. Sterility validated via VDmax study for terminal gamma irradiation.

Technological Characteristics

Sterile water or 0.9% sodium chloride solution. Packaging: HDPE bottles with PP caps or foil seals. Mechanism: Mechanical fluid irrigation. Sterilization: Terminal gamma irradiation. Shelf life: 2 years. No antimicrobial additives.

Indications for Use

Indicated for OTC use for moistening absorbent wound dressings and cleaning minor cuts, burns, superficial abrasions, and skin irritations. Indicated for Rx use for moistening absorbent wound dressings; moistening, debriding, and cleaning acute/chronic dermal lesions (Stage I-IV pressure ulcers, stasis/diabetic/foot ulcers, post-surgical wounds, first/second degree burns, cuts, abrasions, minor skin irritations); and device irrigation. Not for injection.

Predicate Devices

• Wound Flush, Sterile Water & Normal Saline (K083042)
• Welcon Sterile Water for Device Irrigation, Welcon Sterile 0.9% Normal Saline (K003402)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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.

Type of Use (*Select one or both, as applicable*)

| <div> <span> <span style="border: 1px solid black;">☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="border: 1px solid black;">☑</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </div> |

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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: [phone] Fax: [phone]

## 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:

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.

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

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