Anexa Wound Flush, Sterile Water & Sterile Normal Saline

K161658 · Anexa Biomedical, Inc. · FRO · Sep 14, 2016 · SU

Device Facts

• Record ID: K161658
• Device Name: Anexa Wound Flush, Sterile Water & Sterile Normal Saline
• Applicant: Anexa Biomedical, Inc.
• Product Code: FRO · SU
• Decision Date: Sep 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.

Device Story

Device consists of sterile water or 0.9% sterile normal saline solution; provided in various bottle (100ml, 250ml, 500ml) and cup (120ml) sizes. Used for moistening absorbent wound dressings and irrigating wounds to remove loose debris and dirt. Mechanical action of fluid moving across wound surface provides mechanism of action. Gamma sterilized. Used in clinical or home settings; operated by healthcare providers or patients. Output is physical irrigation of wound site; aids in cleaning and preparation of wound bed.

Clinical Evidence

Bench testing only. Biocompatibility testing performed including cytotoxicity, dermal sensitization, intracutaneous test (direct injection), acute systemic toxicity, and bacterial endotoxin testing. All tests passed.

Technological Characteristics

Sterile 0.9% saline or sterile water solution. Packaging: induction sealed pull tab bottles or high impact polystyrene cups with heat-sealed foil lids. Sterilization: Gamma radiation. Standards: ASTM F1980-07, ISO 11607-1/2, ISO 11137-1/2, ISO 11737-1/2, ISO 10993-1/5/10/11, AAMI TIR 22, AAMI TIR 33, ISO TIR 13004.

Indications for Use

Indicated for moistening absorbent wound dressings and irrigation to remove loose debris and dirt from wounds in patients requiring wound care.

Predicate Devices

• Nurse Assist, Inc. Wound Flush, Sterile Water & Sterile Normal Saline (K083042)

Submission Summary (Full Text)

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

September 14, 2016

Anexa Biomedical, Inc. % Ms. Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K161658

Trade/Device Name: Anexa Wound Flush, Sterile Water & Sterile Normal Saline Regulatory Class: Unclassified Product Code: FRO Dated: June 14, 2016 Received: June 16, 2016

Dear Ms. Smith:

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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K161658

Device Name

Wound Flush, Sterile Water & Normal Saline

Indications for Use (Describe)

For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) Summary K161658 (As Per 21 CFR 807.92)

SPONSOR CompanyName: Anexa Biomedical, Inc. Company Address: 40423 Air Time Ave Zephyrhills, Florida 33542 Telephone: [phone] Fax: ContactPerson: Lenny Budloo SummaryPrepared September 12, 2016 TradeName: Anexa Sterile Water, Normal Saline Sterile Water, Normal Saline, Wound Common/UsualName: Flush Solution Classification Name: Dressing, Wound, Drug Product Code: FRO Device Class: Unclassified Regulation Number: Predicate Device Company Product 510(k)# Nurse Assist, Inc. Wound Flush, Sterile Water

& Sterile Normal Saline

K083042

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#### Device Description

The Wound Flush, Sterile Water & Sterile Normal Saline device can be used 1) for moistening a dry sterile dressing for wound cleansing and 2) irrigation to remove loose debris and dirt from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of loose foreign material such as dirt and debris. The product has a shelf life of 2-years.

The solution is available as sterile saline for irrigation and is gamma sterilized. The subject device is offered in various bottle sizes of 100ml, 250ml, and 500ml and cup sizes of 120ml.

#### Indications for Use

For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.

#### Comparison of Technological Characteristics

| | Subject | Predicate<br>Nurse Assist, Inc. | Similarities<br>and<br>Difference |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| K Number | | K083042 | |
| Brand Name | Anexa Wound Flush, Sterile Water<br>& Sterile Normal Saline | Nurse Assist Wound Flush, Sterile<br>Water & Sterile Normal Saline | |
| Classification<br>Product Code | FRO | FRO | Same |
| Classification | Pre-amendment | Pre-amendment | Same |
| Indications<br>for Use | For moistening of absorbent wound<br>dressings and irrigation to remove<br>loose debris and dirt from the<br>wound. | Over the counter Use<br>For moistening absorbent wound<br>dressings and cleaning minor cuts,<br>minor burns, superficial abrasions<br>and minor irritations of the skin.<br><br>For Prescription Use<br>For moistening absorbent wound<br>dressings and for moistening,<br>debriding and cleaning acute and<br>chronic dermal lesions, such as<br>Stage I-IV pressure ulcers, stasis<br>ulcers, diabetic ulcers, foot ulcers,<br>post-surgical wounds, first and<br>second degree burns, cuts,<br>abrasions and minor skin irritations<br>and for device irrigation. | Similar |
| Principle of<br>Operation | Mechanical action of fluid moving<br>across the wound or device aids<br>in the removal of foreign objects<br>such as loose dirt and debris | Mechanical action of fluid moving<br>across the wound or device aids<br>in the removal of foreign objects<br>such as dirt and debris | Similar |
| Chemical<br>Composition | 0.9% Sterile Saline or Sterile<br>Water; no antimicrobial or other<br>substance added | 0.9% Sterile Saline or Sterile<br>Water; no antimicrobial or other<br>substance added | Same |

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| Models | 8100 100 mL Sterile Water | 6210 120 mL Sterile Water | Same |
|--------|----------------------------|---------------------------|------|
| | 9100 100 mL Sterile Saline | 6220 120 mL Normal Saline | |
| | 8250 250 mL Sterile Water | 6240 100 mL Normal Saline | |
| | 9250 250 mL Sterile Saline | 6250 100 mL Sterile Water | |
| | 8500 500 mL Sterile Water | 6260 250 mL Sterile Water | |
| | 9500 500 mL Sterile Saline | 6270 250 mL Normal Saline | |
| | 8120 120 mL Sterile Water | 6280 500 mL Normal Saline | |
| | 9120 120 mL Sterile Saline | 6290 500 mL Sterile Water | |

#### Discussion of Technological Differences

The subject device and the predicate have similar indications for use and intended use. Both offer bottles with induction sealed pull tab with screw cap closure and high impact polystyrene cups with heat sealed foil lid. The mechanical action is the same for both the subject device and the predicate, as it relates to Sterile Water and Normal Saline bottles and cups. The materials and methods used in the manufacturing and sterilization (gamma) are the same for both devices.

#### Non Clinical Testing

| ASTM F1980-07 (Reapproved 2011) |
|----------------------------------------|
| AAMI/ANSI/ISO 11607-1:2006/(R)2010 |
| AAMI/ANSI/ISO 11607-2:2006/(R)2010 |
| AAMI/ANSI / ISO 11137-1:2006/(R)2010 |
| AAMI/ANSI/ ISO 11137-2:2013 |
| AAMI / ANSI / ISO 11737-1:2006 (R)2011 |
| AAMI / ANSI / ISO 11737-2:2009/(R)2014 |
| AAMI/ANSI/ISO 10993-1:2009/(R) 2013 |
| AAMI / ANSI/ISO 10993-5:2009/(R) 2014 |
| ISO 10993-10 Third Edition 2010-08-01 |
| AAMI/ANSI/ISO 10993-11:2006/(R)2010 |
| AAMI TIR 22:2007 |
| AAMI TIR 33:2005 |
| AAMI/ANSI/ISO TIR 13004:2013 |

Anexa conducted and passed the following biocompatibility tests; cytotoxicity, dermal sensitization, intracutaneous test (direct injection), acute systemic toxicity and bacterial endotoxin test.

#### Substantial Equivalence Conclusion

The Anexa products passed all the referenced biocompatibility tests, uses the same materials and container designs, same method of sterilization, same principle of operation, and the same intended use(s). Through safety and performance testing, Anexa Biomedical has concluded that the device does not introduce any significant new questions of safety and is substantially equivalent to the predicate device.