(147 days)
Not Found
No
The device description and performance studies focus on the chemical composition and mechanical action of a wound lavage solution, with no mention of AI or ML technologies.
Yes
The device is an aqueous solution used for irrigation and debridement of wounds, which is a therapeutic action aimed at wound cleansing and debris removal.
No
The device is a wound lavage solution used for cleansing and removal of debris, which is a treatment or therapeutic function, not a diagnostic one.
No
The device description clearly states it is an "aqueous solution" provided in a "polypropylene plastic container," indicating it is a physical product (a liquid and its packaging) and not solely software.
Based on the provided information, Bactisure Wound Lavage is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "cleansing and removal of debris, including micro-organisms, from wounds." This is a direct application to the wound for therapeutic or cleansing purposes, not for analyzing a sample taken from the body to provide diagnostic information.
- Mechanism of Action: The description states the mechanism of action is the "mechanical action of fluid moving across the wound." This is a physical process for cleaning, not a chemical or biological reaction used to detect or measure substances in a sample.
- Device Description: The description details an aqueous solution for irrigation and debridement, applied directly to the wound.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic results.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Bactisure Wound Lavage is applied to the body (the wound) for a cleansing purpose.
N/A
Intended Use / Indications for Use
Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus or Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.
Product codes
FQH, FRO
Device Description
Bactisure Wound Lavage is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds.
The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Bactisure Wound Lavage is provided in a 1000mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged. The formulation for Bactisure Wound Lavage is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride, and water.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wounds
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)
Biocompatibility testing meets the requirements of ISO 10993-1. Sterilization meets the requirements of ISO 11737-2, ISO 14937 and ISO 17665-1. The addition of the contraindication "Due to the ethanol content, do not use this product on neonates or infants (children under the age of 2)" and update to the warnings within the instructions for use are supported by literature and risk analyses. Biocompatibility concerns related to the change in composition were mitigated by a toxicological risk analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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January 23, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Next Science, LLC Jeanne Lee Regulatory Manager 10550 Deerwood Park Blvd., Ste. 300 Jacksonville. Florida 32256
Re: K192349
Trade/Device Name: Bactisure Wound Lavage Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FQH Dated: November 22, 2019 Received: November 26, 2019
Dear Jeanne Lee:
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,
For Kimberly Ferlin, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K192349
Device Name Bactisure Wound Lavage
Indications for Use (Describe)
Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.
| 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)
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K192349 510(k) Summary
Bactisure™ Wound Lavage
| Applicant: | Next Science™, LLC
10550 Deerwood Park
Suite 300
Jacksonville, FL 32256 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jeanne Lee
Next Science™, LLC
10550 Deerwood Park
Suite 300
Jacksonville, FL 32256
Regulatory Affairs Manager
1-855-564-2762 ext. 6003 |
| Date Prepared: | August 26, 2019 |
| Device Trade Name: | Bactisure™ Wound Lavage |
| Device Common Name: | Jet Lavage |
| Classification Name: | Lavage. Jet |
| Classification Name. | Lavage, Jet |
|---|---|
| Product Code: | FQH, FRO |
| Classification: | Class II, unclassified |
| CFR: | 21 CFR 880.5475 |
Predicate Device:
Next Science™ Irrigation Solution, K161165
Indications for Use:
Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus or Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.
Device Description:
Bactisure Wound Lavage is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds.
The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Bactisure Wound Lavage is provided in a 1000mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a
4
polyethylene overwrap and packaged. The formulation for Bactisure Wound Lavage is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride, and water.
Technoloqical Characteristics:
The table below summarizes any technological characteristics of Bactisure Wound Lavage as compared to the predicate device Next Science Irrigation Solution, K161165.
| | Bactisure™ Wound Lavage | Next Science™ Irrigation Solution
(Cleared Device K161165) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
use | Bactisure Wound Lavage is to
be used with the Zimmer
Pulsavac Plus or Pulsavac Plus
AC lavage systems and is
indicated for use in cleansing
and removal of debris, including
micro-organisms, from wounds. | Next Science Irrigation Solution is to
be used with a jet lavage system
and is indicated for use in cleansing
and removal of debris, including
microorganisms, from wounds. |
| Mechanism(s)
of Action | Mechanical removal of debris via hydrodynamic shear.
The mechanical action of moving across the wound aids in the removal
of foreign material such as dirt and debris. | |
| Description | Clear, colorless, low-odor solution containing ethanol, acetic acid,
sodium acetate and benzalkonium chloride. | |
| Composition | Ethanol, 100g/L
Acetic acid, 59g/L
Sodium acetate, 30g/L
Benzalkonium chloride, 1.3g/L
Purified water | Ethanol, 100g/L
Acetic acid, 50g/L
Sodium acetate, 30g/L
Benzalkonium chloride, 1.3g/L
Purified water |
Performance Testing:
Biocompatibility testing meets the requirements of ISO 10993-1.
Sterilization meets the requirements of ISO 11737-2, ISO 14937 and ISO 17665-1. The addition of the contraindication "Due to the ethanol content, do not use this product on neonates or infants (children under the age of 2)" and update to the warnings within the instructions for use are supported by literature and risk analyses. Biocompatibility concerns related to the change in composition were mitigated by a toxicological risk analysis.
Conclusion:
The conclusions drawn from the performance tests demonstrate that the device is as safe and effective as the legally marketed device Next Science Irrigation Solution (K161165).