SynePure Wound Cleanser

K143444 · Synedgen, Inc. · FRO · Aug 21, 2015 · SU

Device Facts

• Record ID: K143444
• Device Name: SynePure Wound Cleanser
• Applicant: Synedgen, Inc.
• Product Code: FRO · SU
• Decision Date: Aug 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

Device Story

SynePure is a biocompatible aqueous cleansing solution for dermal wounds. Provided in LDPE bottles with a nozzle spray top; allows irrigation to remove dirt, debris, and contamination. Mechanical action of fluid flow across the wound surface facilitates cleaning. Used in clinical or home settings; applied by patients or healthcare providers. Benefits include effective wound irrigation to aid healing. No complex electronics or software.

Clinical Evidence

Bench testing only. Performance testing confirmed fluid spray duration and delivery of >90% of bottle contents. Biocompatibility testing conducted per ISO 10993 series, including cytotoxicity, delayed-type hypersensitivity (sensitization), and acute systemic toxicity, showed no adverse results.

Technological Characteristics

Aqueous-based solution containing polymers and sorbitol. Delivered via LDPE bottle with nozzle spray top. Mechanical irrigation principle. Biocompatible per ISO 10993. Non-sterile/preserved solution.

Indications for Use

Indicated for cleansing and rinsing dermal wounds including pressure, stasis, diabetic, and foot ulcers, post-surgical wounds, first/second degree burns, cuts, abrasions, and minor skin irritations.

Predicate Devices

• ALLCLENZ Wound Cleanser (K965120)

Reference Devices

• PosiSep and PosiSep X Hemostat Dressings (K120958)
• AQUANOVA Ag Super-Absorbent Dressing (K100693)

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

August 21, 2015

Synedgen Incorporated Shenda Baker, Ph.D. President and Chief Operating Officer 1420 North Claremont Boulevard, Suite 105D Claremont, California 91711

Re: K143444

Trade/Device Name: SynePure Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: July 23, 2015 Received: July 24, 2015

Dear Dr. Baker:

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

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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 [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

510(k) Number (if known) K143444

Device Name SynePure Wound Cleanser

Indications for Use (Describe)

SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

| Type of Use (Select one or both, as applicable) | |
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| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> </span> <span>Prescription Use (Part 84 CFR 801 Subpart D)</span> </div> | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> <span>Over-The-Counter Use (84 CFR 801 Subpart C)</span> </div> |
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> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary

#### Submitter

Synedgen. Inc. 1420 North Claremont Blvd, Suite 105D Claremont, CA 91711 Phone: [phone] Fax: [phone] Contact Person: Shenda Baker, Ph.D. Date Prepared: August 20, 2015

#### Device

Name of Device: SynePure WoundCleanser Common or Usual Name: SynePure™ Classification: Unclassified Product Code: FRO

#### Predicate Device

ALLCLENZ Wound Cleanser K965120

#### Reference Devices:

The PosiSep and PosiSep X Hemostat Dressings (K120958) AQUANOVA Ag Super-Absorbent Dressing (K100693)

#### Device Description

SynePure is a biocompatible, cleansing solution that is intended for rinsing and cleansing dermal wounds through irrigation. The solution is preserved and provided in flexible low density polyethylene (LDPE) bottles with a nozzle spray top to allow for easy delivery of a stream of liquid to remove dirt, debris and contamination from a wound. A screw cap is used to secure the device when not in use. The cap/bottle assembly is sealed with a strip to indicate tampering.

The wound cleanser is supplied as 125mL single-use or 250mL multiple-use bottle. The mechanical action of fluid moving across the wound provides for the mechanism of action to aid in the removal of foreign objects, such as dirt and debris, from the wound.

#### Indications for Use

SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

#### Comparison with Predicate

The candidate device, SynePure, has the same intended use and the substantially equivalent technological characteristics as the following predicate device: ALLCLENZ Wound Cleanser. Both the predicate and the proposed device are aqueous based solutions that use polymers to assist in the removal of debris through irrigation. The proposed device and predicate use sorbitol to balance the solution and to provide a denser solution. The proposed device and predicate are preserved to control microbial content. The proposed device and predicate are delivered with a pH that is not significantly acidic or basic. Like the predicate device, SynePure utilizes the mechanical action of fluid moving

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across the wound to aid in the removal of foreign objects such as dirt and debris. Based on the comparison of technological characteristics, indications for use, biocompatibility and mechanism of action, SynePure Wound Cleanser is substantially equivalent to the Predicate Device.

#### Performance Data

Testing was done to assure the fluid spray from the bottle exceeds a minimum duration of delivery. Testing was also done to assure that greater than 90% of the solution is delivered from the bottle.

#### Biocompatibility Testing

Biocompatibility testing was completed according to the ISO 10993 series.

Cytotoxicity of the SynePure device was evaluated and the data indicate that the device is not cytotoxicity.

The ability of SynePure solution to cause delayed-type hypersensitivity was evaluated and the results of the study show no sensitization. These results indicate that the device is not sensitizing.

Acute systemic toxicity evaluation of the SynePure device showed no abnormalities in all animals at all observation times, indicating that the device has no acute systemic toxicity.