(262 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a wound cleansing solution and its delivery system, with no mention of AI/ML capabilities.
No
The device is a wound cleanser, intended for mechanical cleansing and rinsing of dermal wounds. Its mechanism of action is the physical removal of foreign objects through irrigation, not a therapeutic effect on the underlying condition.
No
The device is a wound cleanser, intended for physical cleansing and rinsing of dermal wounds by removing dirt, debris, and contamination. It does not perform any diagnostic functions like detecting, characterizing, or monitoring disease.
No
The device description clearly outlines a physical product (liquid solution in a bottle with a spray nozzle) and its mechanical action, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "cleansing and rinsing of dermal wounds". This is a physical action applied to the body's surface, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the mechanical action of the fluid to remove debris from the wound. It's a topical application for cleaning.
- Lack of Diagnostic Function: There is no mention of analyzing a sample (blood, tissue, etc.) or providing information about a patient's health status or disease.
- Predicate Device: The predicate device (ALLCLENZ Wound Cleanser) is also a wound cleanser, which falls under a different regulatory classification than IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. SynePure Wound Cleanser does not fit this definition.
N/A
Intended Use / Indications for 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.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal wounds (pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin).
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 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ALLCLENZ Wound Cleanser K965120
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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
1
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
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) | |
|---|---|
| ------------------------------------------------- | -- |
| Prescription Use (Part 84 CFR 801 Subpart D) | Over-The-Counter Use (84 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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: 909-447-6858 Fax: 909-447-6801 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
4
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.