(259 days)
Not Found
No
The device description and performance studies focus on the chemical composition and delivery mechanism of a saline solution, with no mention of AI or ML technologies.
No
A therapeutic device is one that treats or heals an ailment. This device simply cleans wounds, which is a preparatory step, not a treatment in itself.
No
The "Intended Use / Indications for Use" states the device is "To cleanse minor wounds, scrapes and minor burns," which describes a therapeutic or cleansing action, not a diagnostic one. The device description further elaborates on its function of removing foreign material and exudate from wounds.
No
The device description clearly states it is a physical product, a sterile saline solution packaged in an aerosol system, and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To cleanse minor wounds, scrapes and minor burns." This is a topical application for wound care, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a sterile saline solution for cleaning wounds. It does not involve analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, this device falls under the category of a wound care product, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To cleanse minor wounds, scrapes and minor burns
It may also be used to moisten dressings to ease removal from the wound area.
Product codes
FRO
Device Description
Saline Wound Wash is an isotonic sterile saline solution packaged in a bag-in-can (also known as bag-on-valve, BOV) aerosol system. Actuation of the valve device delivers a consistent flow of sterile isotonic saline solution at the wound site. The flow of isotonic saline solution at the wound or abrasion site 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 ANSI/AAMI/ISO 11137-1:2006/(R) 2015 & A1:2013 requirements [Sterilization of Health Care Products -Requirements for development, validation and routine control of a sterilization process for medical devices]. Saline Wound Wash passes the USP Sterility Test.
Saline Wound Wash is intended to be used for cleansing dermal wounds. The mechanical action of sterile isotonic saline solution irrigating the wound assists in the cleansing and removal of foreign material. Saline Wound Wash will also help remove tissue debris, wound exudate, and other extraneous matter allowing for a cleansed wound and any necessary subsequent wound dressing. It may also be used to moisten dressings to ease removal from the wound area.
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
Over-The-Counter Use
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
The device was tested and conforms to the currently official (May 1, 2018) USP monograph, Sodium Chloride Irrigation.
Laboratory testing of the componentry and formulation of the Predicate Device was carried out and all technological characteristics including can pressure, pH, and saline concentration are used in Saline Wound Wash. The data so obtained support technical equivalence of Saline Wound Wash and the Predicate Device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 12, 2019
Ascent Consumer Products, Inc. Carey Bottom Consulting Associate 105 Baylis Road Melville, New York 11747
Re: K183662
Trade/Device Name: Saline Wound Wash; SteriCleanse™ Regulatory Class: Unclassified Product Code: FRO Dated: August 5, 2019 Received: August 12, 2019
Dear Carey 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cynthia J. Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183662
Device Name SALINE WOUND WASH, SteriCleanse(TM)
Indications for Use (Describe) To cleanse minor wounds, scrapes and minor burns
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY (in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)
SALINE WOUND WASH
1. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared/Revised
ASCENT CONSUMER PRODUCTS, INC. 105 BAYLIS RD MELVILLE NY 11747-3833
| Phone: | (631) 755-1155 |
|---|---|
| Facsimile: | (631) 755-1195 |
| Contact Person: | Carey Bottom | |
|---|---|---|
| cbottom@gmail.com |
September 12, 2019 Date Revised:
2. Name of Device and Name/Address of Sponsor
Saline Wound Wash
ASCENT CONSUMER PRODUCTS, INC. 105 BAYLIS RD MELVILLE NY 11747-3833
3. Common or Usual Name
Wound Cleanser; SteriCleanse TM
4. Classification Name
| Common or usual name: | Dressing, Wound, Drug |
|---|---|
| Classification name: | Unclassified |
| Product code: | FRO |
5. Device Description
Saline Wound Wash is an isotonic sterile saline solution packaged in a bag-in-can (also known as bag-on-valve, BOV) aerosol system. Actuation of the valve device delivers a consistent flow of sterile isotonic saline solution at the wound site. The flow of isotonic saline solution at the wound or abrasion site aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudate and other extraneous
4
matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ANSI/AAMI/ISO 11137-1:2006/(R) 2015 & A1:2013 requirements [Sterilization of Health Care Products -Requirements for development, validation and routine control of a sterilization process for medical devices]. Saline Wound Wash passes the USP Sterility Test.
Saline Wound Wash is intended to be used for cleansing dermal wounds. The mechanical action of sterile isotonic saline solution irrigating the wound assists in the cleansing and removal of foreign material. Saline Wound Wash will also help remove tissue debris, wound exudate, and other extraneous matter allowing for a cleansed wound and any necessary subsequent wound dressing. It may also be used to moisten dressings to ease removal from the wound area.
6. Predicate Device
Wound Wash Saline ® [K083355]; (Currently labeled as Simply Saline™ Wound Wash)
7. Intended Use / Indications for Use
Saline Wound Wash is an over-the counter device/product and is labeled for use in cleansing wounds as follows: "To cleanse minor wounds, scrapes and minor burns".
It may also be used to moisten dressings to ease removal from the wound area.
8. Technological Characteristics
Saline Wound Wash is an aerosol bag-in-can system, otherwise also known as a bag-onvalve (BOV). The propellant, compressed air, is charged into the container between the bag and the can creating internal pressure and a means to dispense the contents (isotonic sterile saline solution) of the bag by pressing on the actuator. The bag is a 4-layer laminate system including a sandwiched aluminum layer establishing an impermeable barrier between the propellant (compressed air) and the bag contents (sterile isotonic saline). The device formulation, isotonic saline solution, is in contact with a polyethylene liner/layer. New or other suppliers of BOV systems may use polypropylene. Saline Wound Wash is a clear, colorless 0.9% sodium chloride solution prepared from Sodium Chloride, USP and Purified Water, USP. After filling and pressurizing, the device is sterilized by gamma irradiation at a contract gamma irradiation sterilizer. The validation of sterilization and subsequent testing has been carried out. The product is tested against established manufacturing specifications and meets current USP sterility requirements.
The device has been tested and conforms to the currently official (May 1, 2018) USP monograph, Sodium Chloride Irrigation.
The content volume of the Predicate Device as marketed is 7.1 FL OZ (210 mL) compared to the Ascent Device at 7.4 Fl OZ (211 g).
5
| | Saline Wound Wash
[DEVICE] | Wound Wash Saline, 210 mL, Model
B8552 [K083355]
(Now known as Simply Saline™
Wound Wash [K083355] |
|--------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| OTC or Rx | OTC | OTC |
| Indications for Use | To cleanse minor wounds, scrapes and
minor burns | To cleanse wounds, scrapes and minor
burns |
| Ingredients /Composition | Isotonic saline solution
[0.9% Sodium Chloride Solution] | Isotonic saline solution
[0.9% Sodium Chloride Solution] |
| Drug Component | No | No |
| Antibacterial claims | No | No |
| Sterile | Yes | Yes |
| Packaging | 7.4 oz (211g) | 7.1 oz (210 mL)
(originally marketed at 90 & 210 cc) |
| Delivery System | Bag-on-valve | Bag-on-valve |
Comparison of Device and Predicate Device
9. Substantial Equivalence
Saline Wound Wash is as safe and effective as the Predicate Device. It is very similar in all physical and performance characteristics as the Predicate Device. Saline Wound Wash has the same intended uses. It has very similar technical characteristics as well as the same basic principles of operation as the Predicate Device.
Laboratory testing of the componentry and formulation of the Predicate Device was carried out and all technological characteristics including can pressure, pH, and saline concentration are used in Saline Wound Wash. The data so obtained support technical equivalence of Saline Wound Wash and the Predicate Device. Therefore, the new device raises no issues of safety and effectiveness.
Saline Wound Wash is substantially equivalent to the Predicate Device.
This concludes the 510(k) Summary