(147 days)
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.
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.
This document describes K192349, a 510(k) premarket notification for the "Bactisure Wound Lavage" device. The acceptance criteria described here refer to the performance testing used to demonstrate substantial equivalence to a predicate device, rather than specific performance metrics for the device itself.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Meets the requirements of ISO 10993-1. |
| Sterilization | Meets the requirements of ISO 11737-2, ISO 14937, and ISO 17665-1. |
| Safety related to composition change | Toxicological risk analysis mitigated biocompatibility concerns related to the change in composition. |
| Safety related to ethanol content | Addition of contraindication ("Due to the ethanol content, do not use this product on neonates or infants (children under the age of 2)") and updated warnings in the Instructions for Use supported by literature and risk analyses. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of a clinical study with patients or data points. The performance testing appears to be primarily laboratory-based (biocompatibility, sterilization, toxicological analysis, literature review) rather than a direct evaluation of device performance on a biological test set with a specific sample size. Therefore, sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the typical sense for this submission type.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This submission relies on established international standards (ISO) for biocompatibility and sterilization, and internal risk analyses and literature reviews for safety related to product composition and use. There is no mention of external experts establishing a "ground truth" for a specific test set of cases.
4. Adjudication Method for the Test Set:
Not applicable, as there is no specific test set requiring adjudication in the context of clinical or diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance:
Not applicable. This device is a medical lavage solution, not an AI-assisted diagnostic or assistive technology. Therefore, an MRMC study and effects on human reader performance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a medical solution and does not involve an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- International Standards: For biocompatibility (ISO 10993-1) and sterilization (ISO 11737-2, ISO 14937, ISO 17665-1).
- Toxicological Risk Analysis: For assessing the safety implications of changes in solution composition.
- Literature Reviews and Risk Analyses: For supporting contraindications and warnings related to specific ingredients (e.g., ethanol content).
8. The Sample Size for the Training Set:
Not applicable. This device does not use machine learning or AI models, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
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
{2}------------------------------------------------
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)
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}------------------------------------------------
K192349 510(k) Summary
Bactisure™ Wound Lavage
| Applicant: | Next Science™, LLC10550 Deerwood ParkSuite 300Jacksonville, FL 32256 |
|---|---|
| Contact Person: | Jeanne LeeNext Science™, LLC10550 Deerwood ParkSuite 300Jacksonville, FL 32256Regulatory Affairs Manager1-855-564-2762 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 foruse | Bactisure Wound Lavage is tobe used with the ZimmerPulsavac Plus or Pulsavac PlusAC lavage systems and isindicated for use in cleansingand removal of debris, includingmicro-organisms, from wounds. | Next Science Irrigation Solution is tobe used with a jet lavage systemand is indicated for use in cleansingand removal of debris, includingmicroorganisms, from wounds. |
| Mechanism(s)of Action | Mechanical removal of debris via hydrodynamic shear.The mechanical action of moving across the wound aids in the removalof 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/LAcetic acid, 59g/LSodium acetate, 30g/LBenzalkonium chloride, 1.3g/LPurified water | Ethanol, 100g/LAcetic acid, 50g/LSodium acetate, 30g/LBenzalkonium chloride, 1.3g/LPurified 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).
§ 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.