(46 days)
Not Found
No
The device description and intended use focus solely on the mechanical action of sterile saline solution for wound cleansing. There is no mention of AI, ML, or any computational analysis of data.
Yes
The device is intended to cleanse wounds, scrapes, and minor burns by removing foreign material, tissue debris, and exudate, which aids in the natural healing process. This direct action on the wound to promote healing classifies it as a therapeutic device.
No
Explanation: The device is intended for cleansing dermal wounds by mechanical action, not for diagnosing medical conditions.
No
The device description clearly states it is a "multi-use, isotonic sterile saline solution packaged in a bag-incan aerosol system," which is a physical product, not software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleansing dermal wounds, scrapes, and minor burns. This is a physical action on the wound itself, not a test performed on a sample taken from the body to provide information about a physiological state or disease.
- Device Description: The description focuses on the mechanical action of the saline solution for wound cleansing and the sterile nature of the product. There is no mention of analyzing a sample or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Predicate Devices: The listed predicate devices are all wound cleansing solutions, which are not IVDs.
The device is a wound care product that physically cleanses the wound area. It does not perform any diagnostic testing.
N/A
Intended Use / Indications for Use
Wound Wash Saline® is intended to be used for cleansing dermal wounds. The label declared indications are: " To cleanse wounds, scrapes and minor burns." The mechanical action of sterile isotonic saline solution irrigating the wound provides for the removal of foreign material such as, but not exclusively, dirt and debris. Wound Wash Saline® can be used to remove tissue debris, wound exudate, and other extraneous matter. Bacteria and tissue metabolic products may also be removed or reduced in level allowing for the natural healing process to take place unimpeded. It may also be used to moisten wound dressings to ease removal from the wound area.
Wound Wash Saline® is indicated for use in cleansing wounds, scrapes, and minor burns
To cleanse wounds, scrapes, and minor burns.
Product codes
FRO
Device Description
Wound Wash Saline® is a multi-use, isotonic sterile saline solution packaged in a bag-incan aerosol system. Actuation of the device (product can) delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to15 psi [Clinical Practice Guideline Number 15, AHCPR, U.S. Department of Health and Human Services]. The mechanical action of isotonic saline solution moving across the wound aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudate and other extraneous matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements [Sterilization of health care products - Requirements for validation and routine control- Radiation sterilization]. Wound Wash Saline® passes the USP Sterility Test. Wound Wash Saline® is an OTC device and will only be labeled for use in cleansing wounds, including the removal of foreign material such as dirt and debris.
Wound Wash Saline® is an aerosol bag-in-can system. The propellant, compressed air, is charged into the container between the bag and the can creating a means to dispense the contents of the bag, isotonic sterile saline solution. The bag is a 4-layer laminate system including sandwiched aluminum layer establishing an impermeable barrier between the propellant (compressed air) and the bag contents (sterile isotonic saline). The isotonic saline solution is in contact with either a polypropylene or polyethylene layer. Wound Wash Saline® is a clear, colorless 0.9% sodium chloride solution prepared from sodium choride, USP and purified water, USP. After filling and pressurizing, the device is sterilized by gamma irradiation. The product is tested against established specifications and meets USP sterility requirements.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073610, K040683, K063063, K063069, K070463, K040779
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
KD83355
page 1/3
510(k) SUMMARY (in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)
WOUND WASH SALINE®
1. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
DEC 2 9 2008
BLAIREX LABORATORIES, INC. 1600 W BRIAN DR COLUMBUS, IN 47201-4047
| Phone: | (812) 378-1864 |
|---|---|
| Facsimile: | (812) 378-1033 |
Contact Person: Carey Bottom cbottom@blairex.com
Date Prepared: November 10, 2008
2. Name of Device and Name/Address of Sponsor
Wound Wash Saline®
BLAIREX LABORATORIES, INC. 1600 W BRIAN DR COLUMBUS, IN 47201-4047
3. Common or Usual Name
Wound Cleanser and Irrigant
4. Classification Name
Dressing, Wound, Drug
5. Description
Wound Wash Saline® is a multi-use, isotonic sterile saline solution packaged in a bag-incan aerosol system. Actuation of the device (product can) delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to15 psi [Clinical Practice Guideline Number 15, AHCPR, U.S. Department of Health and Human Services]. The mechanical action of isotonic saline solution moving across
CONFIDENTIAL
1
K063355
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the wound aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudate and other extraneous matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements [Sterilization of health care products - Requirements for validation and routine control- Radiation sterilization]. Wound Wash Saline® passes the USP Sterility Test. Wound Wash Saline® is an OTC device and will only be labeled for use in cleansing wounds, including the removal of foreign material such as dirt and debris.
6. Predicate Devices
Elta Advanced Wound Wash; Medical Molecular Therapeutics LLC [K073610]
BioDerm Wound Solution; BioDerm Wound Sciences, Inc. [K040683]
Silvion Antibacterial Silver Skin & Wound Moisturizing Solution; Medical Molecular Therapeutics LLC [K063063]
Silvaklenz Antibacterial Silver Skin & Wound Cleanser; Medical Molecular Therapeutics LLC [K063069]
Revera Wound Care; Revalesio Corporation [K070463]
Restore Wound Cleanser; Hollister Incorporated [K040779]
7. Intended Use / Indications for Use
Wound Wash Saline® is intended to be used for cleansing dermal wounds. The label declared indications are: " To cleanse wounds, scrapes and minor burns." The mechanical action of sterile isotonic saline solution irrigating the wound provides for the removal of foreign material such as, but not exclusively, dirt and debris. Wound Wash Saline® can be used to remove tissue debris, wound exudate, and other extraneous matter. Bacteria and tissue metabolic products may also be removed or reduced in level allowing for the natural healing process to take place unimpeded. It may also be used to moisten wound dressings to ease removal from the wound area.
Wound Wash Saline® is indicated for use in cleansing wounds, scrapes, and minor burns
8. Technological Characteristics
Wound Wash Saline® is an aerosol bag-in-can system. The propellant, compressed air, is charged into the container between the bag and the can creating a means to dispense the contents of the bag, isotonic sterile saline solution. The bag is a 4-layer laminate
2
K0833555
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system including sandwiched aluminum layer establishing an impermeable barrier between the propellant (compressed air) and the bag contents (sterile isotonic saline). The isotonic saline solution is in contact with either a polypropylene or polyethylene layer. Wound Wash Saline® is a clear, colorless 0.9% sodium chloride solution prepared from sodium choride, USP and purified water, USP. After filling and pressurizing, the device is sterilized by gamma irradiation. The product is tested against established specifications and meets USP sterility requirements.
9. Substantial Equivalence
Wound Wash Saline is as safe and effective as the predicate devices. Wound Wash Saline has the same intended uses, technological characteristics, and basic principles of operation as its predicate devices. The minor technological differences between Wound Wash Saline® and its predicate devices raise no new issues of safety or effectiveness. Thus, Wound Wash Saline® is substantially equivalent to the predicate devices.
This concludes the 510(k) Summary.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Blairex Laboratories, Inc. % Carey B. Bottom, Ph.D. Director, Regulatory Affairs 1600 Brian Drive Columbus, Indiana 47202-2127
DEC 2 9 2008
Re: K083355
Trade/Device Name: WOUND WASH SALINE® Regulatory Class: Unclassified Product Code: FRO Dated: November 10, 2008 Received: November 13, 2008
Dear Dr. Bottom:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Carey B. Bottom, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KOB3355
Device Name: WOUND WASH SALINE®
Indications for Use:
To cleanse wounds, scrapes, and minor burns.
Prescription Use (Part 21 CFR 801 Subpart D)
(
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ K083358
CONFIDENTIAL