(146 days)
Biasurge Advanced Surgical Solution is indicated for use in mechanical cleansing and removal of debris, including microorganisms from wounds.
BIASURGE Advanced Surgical Solution is a clear, colorless solution intended for cleansing and removal of 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 microorganism, from wounds. BIASURGE Solution is provided in a soft polypropylene 1000mL container with a spikeable port. BIASURGE Solution is composed of Purified Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Hypromellose, Octane-1,2-diol, Polyaminopropyl Biguanide [PHMB; a preservative], EDTA Disodium, EDTA Trisodium.
The provided text describes the 510(k) premarket notification for the BIASURGE Advanced Surgical Solution. However, it does not contain the detailed information necessary to fully address all aspects of the request, especially regarding specific acceptance criteria for performance, test set sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies of an AI-powered device.
This document describes a medical device that is a wound cleanser/irrigation solution, not an AI-powered diagnostic or assistive device that would typically have the kind of performance data (e.g., sensitivity, specificity, reader studies) requested in the prompt. The performance testing mentioned is related to biocompatibility, preservative effectiveness, and shelf-life, which are chemical and physical properties, not diagnostic accuracy.
Therefore, many sections of your request cannot be fulfilled from the provided text. I will address what information is available and explicitly state when information is missing.
This document describes the 510(k) submission for the BIASURGE Advanced Surgical Solution, a wound cleanser. The submission focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, product form, function, and safety evaluations. The device's performance testing primarily pertains to its chemical and physical properties, not diagnostic accuracy or AI-driven tasks.
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" as typically applied to AI/diagnostic devices (e.g., sensitivity, specificity, AUC) is not directly applicable to this wound cleanser. The performance testing detailed here is for safety and stability.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met for Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 Requirements | Demonstrated ISO 10993 biocompatibility. |
| Preservation Effectiveness | Preservative (PHMB) is appropriate for formulation and inhibits microbial growth. | USP <51> testing demonstrates chosen preservative is appropriate for product formulation. |
| Stability/Shelf-Life | Product is stable and effective for proposed shelf life. | Results of aging study indicate product is stable and effective for proposed shelf life. |
| Packaging Suitability | Packaging allows for the intended use (mechanical removal of debris from wounds). | Leveraged reference devices (K192349, K203835) to support equivalence; similar to K203835. |
| Chemical Safety | Chemical composition is safe and substantially equivalent to predicate. | Same chemical composition as the predicate device (implied and stated as "Same. Chemical safety is substantially equivalent."). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The performance testing described (biocompatibility, USP <51>, aging study) would involve specific sample sizes relevant to those types of chemical/material tests, but these are not disclosed. The data provenance (e.g., country of origin, retrospective/prospective) is also not stated as it's not relevant for this type of device and submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided. This device is a wound cleanser, not an imaging or diagnostic device where expert ground truth establishment for a test set would be required. The "ground truth" here relates to chemical/physical properties and safety validated by standard laboratory methods and ISO guidelines, not clinical expert consensus on images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving expert readers for diagnostic accuracy assessments, which is not the case for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of an AI system on human reader performance, which is irrelevant for a wound cleansing solution.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical solution, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on:
- Standardized laboratory testing results (e.g., ISO 10993 for biocompatibility, USP <51> for preservative effectiveness, aging studies for stability).
- Chemical composition analysis comparing it to the predicate device.
- The fundamental mechanism of action: mechanical cleansing and removal of debris via hydrodynamic shear, which is a known physical principle.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of diagnostic accuracy for this device.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a chemical solution, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no training set for this type of medical device.
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Image /page/0/Picture/0 description: The image shows 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
March 30, 2023
Rochal Technologies LLC William Coulston Director, Quality & Regulatory Affairs 1200 Network Boulevard San Antonio, Texas 78249
Re: K223377
Trade/Device Name: BIASURGE Advanced Surgical Solution Regulatory Class: Unclassified Product Code: FRO Dated: February 27, 2023 Received: February 28, 2023
Dear William Coulston:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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).
Sincerelv.
Julie A. Morabito -S
Julie Morabito, 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
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Indications for Use
510(k) Number (if known) K223377
Device Name BIASURGE Advanced Surgical Solution
Indications for Use (Describe)
Biasurge Advanced Surgical Solution is indicated for use in mechanical cleansing and removal of debris, including microorganisms from wounds.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Rochal Technologies. The logo features a blue globe-like icon on the left, followed by the text "Rochal" in a bold, dark blue font. To the right of "Rochal" is the word "Technologies" in a lighter blue color. Below the text is the phrase "A Sanara MedTech Inc. Company" in a smaller font.
510(k) Summary
1. Submitter's Name and Address
Rochal Technologies LLC. 12000 Network Blvd, Ste B200 San Antonio, Texas, 78249
2. Submitter's Contact Person
William J. Coulston Director of Quality & Regulatory Affairs (210) 375-9349 ext 110 wcoulston@rochaltech.com
3. Date of 510(k) Summary Preparation:
29 March 2023
4. Device Name (Proprietary)
Biasurge Advanced Surgical Solution
5. Common Name
Wound Cleanser, Irrigation Solution, Wound Lavage
6. Classification Name
Dressing, Wound, Drug
7. Device Class
Unclassified
8. Device Code
FRO
9. Reference Devices
K192349, Bactisure K222804, Irrisept K203835. MIS Solution
10. Description of Device
BIASURGE Advanced Surgical Solution is a clear, colorless solution intended for cleansing and removal of 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 microorganism, from wounds. BIASURGE Solution is provided in a soft polypropylene 1000mL container with a spikeable port. BIASURGE Solution is composed of Purified Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Hypromellose, Octane-1,2-diol, Polyaminopropyl Biguanide [PHMB; a preservative], EDTA Disodium, EDTA Trisodium.
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Image /page/4/Picture/0 description: The image shows the logo for Rochal Technologies. The word "Rochal" is in a bold, dark blue font, while "Technologies" is in a lighter blue. Below the company name is the text "A Sanara MedTech, Inc. Company" in a smaller, gray font.
11. Intended Use of Device
Biasurge Advanced Surgical Solution is indicated for use in mechanical cleansing and removal of debris, including microorganisms, from wounds.
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Image /page/5/Picture/0 description: The image shows the logo for Rochal Technologies. The logo features a blue globe-like icon on the left, followed by the text "Rochal" in a bold, dark blue font. To the right of "Rochal" is the word "Technologies" in a lighter blue font. Below the main text, in a smaller font, it reads "A Sanara MedTech Inc. Company."
12. Legally Marketed Device for substantial equivalence comparison:
| Feature Being | PROPOSED DEVICE | PREDICATE DEVICE | Discussion of characteristics |
|---|---|---|---|
| Compared | BIASURGE | K160192 (BIAKŌS) | |
| Design | DESCRIPTIONBIASURGE Advanced SurgicalSolution is a clear, colorlesssolution intended for cleansingand removal of debris, includingmicroorganisms, from wounds.The mechanical action of fluidmoving across the woundprovides the mechanism of actionand aids in the removal of debris,including microorganism, fromwounds. BIASURGE Solution isprovided in a soft polypropylene1000mL container with aspikeable port. BIASURGESolution is composed of PurifiedWater, Poloxamer 407, SodiumChloride, Ethylhexylglycerin,Hypromellose, Octane-1,2-diol,Polyaminopropyl Biguanide[PHMB; a preservative], EDTADisodium, EDTA Trisodium. | Description of DeviceAtteris Antimicrobial Skin &Wound Cleanser helps in themechanical removal of debris andforeign material from the skin,wound or application site. AtterisAntimicrobial Skin & WoundCleanser is a pure, colorless,isotonic cleanser that is safe. Thecleanser has a six monthexpiration due to the preservativethat provides bactericidal andfungicidal properties through theaction of the antimicrobial(PHMB).A preservative, PHMB, at aconcentration of 0.1% w/w isadded to the product to inhibit thegrowth of microorganisms suchas, Staphylococcus aureus,Staphylococcus epidermidis,Pseudomonas aeruginosa,Escherichia coli, antibioticresistant Methicillin Resistant | The proposed device's design is similar to thepredicate device and reference devices K192349.Bactisure and K203835, MIS Solution. Thepreservative is PHMB in both the subject andpredicate devices.The mechanism of action for both devices ismechanical removal of debris via hydrodynamicshear. The mechanical action of moving acrossthe wound aids in the removal of foreignmaterial such as microorganisms, dirt and debris.The mechanical action of the irrigation can beprovided by either a manual syringe or poweredirrigation device.The design is substantially equivalent. |
| and fungus Candida albicanswithin the product. | |||
| Indications forUse | INDICATIONSBiasurge Advanced SurgicalSolution is indicated for use inmechanical cleansing and removalof debris, includingmicroorganisms, from wounds.Rx Only | Intended Use of DeviceAtteris Antimicrobial Skin &Wound Cleanser is intended forover-the-counter (OTC) andprofessional use as follows:a. For Over-the-Counter Use:....b. Professional Use: (Rx Only)Atteris Antimicrobial Skin &Wound Cleanser is intended formechanical cleansing and removalof debris, dirt and foreignmaterials, includingmicroorganisms from woundssuch as stage I-IV pressure ulcers,diabetic foot ulcers, post-surgicalwounds, first and second degreeburns, grafted and donor sites. | The description and indications for use are thesame as the reference device, K203835, MISSolution. The subject device is a single-patient-multiple use product.The Indications for Use are substantiallyequivalent. |
| Rx Only and OTC | |||
| Materials | 1 L polypropylene bag with asingle twist-off port | HDPE bottle with Trigger Sprayer | Different. However, both are plastics commonlyused in legally marketed medical deviceirrigation solutions or wound cleansers. Theseminor differences do not raise new questions ofsafety or effectiveness.The materials are substantially equivalent. |
| Other Features | Sterile - Moist Steam | Non-sterile | Provided sterile, but single-patient multi-use fora period of 28-days. Predicate: non-sterile,single patient multi-use for a period of 28-days. |
| Other features are substantially equivalent. | |||
| BiocompatibilityTesting | ISO 10993-1 Requirements | ISO 10993-1 Requirements | Biocompatibility is substantially equivalent |
| Chemical Safety | Same as the predicate device | Purified Water, Poloxamer 407,Sodium Chloride,Ethylhexylglycerin,Hypromellose, Octane-1,2-diol,Polyaminopropyl Biguanide[PHMB; a preservative], EDTADisodium, EDTA Trisodium | Same. Chemcial safety is substantiallyequivalent. |
| Packaging | 1 L polypropylene bag with asingle twist-off portOverwrap | HDPE Trigger Sprayer | Different but allows for the same use, i.e., bothallow for mechanical removal of debris fromwounds. Reference devices K192349, Bactisureand K203835, MIS Solution were leveraged tosupport the equivalence of the packaging. Thereference device MIS Solution shares thesame/similar packaging.The packaging is substantially equivalent. |
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Image /page/6/Picture/0 description: The image shows the logo for Rochal Technologies. The logo consists of a blue globe-like image on the left, followed by the company name in blue text. The words "Rochal" are in a darker blue, while "Technologies" is in a lighter blue. Below the company name, in smaller, light gray text, is the phrase "A Sanara MedTech Inc. Company".
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Image /page/7/Picture/0 description: The image shows the logo for Rochal Technologies. The logo consists of a blue globe-like icon on the left, followed by the company name in blue text. The word "Rochal" is in a darker shade of blue, while "Technologies" is in a lighter shade. Below the company name, there is a tagline that reads "A Sanara MedTech Inc. Company" in a smaller font size.
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Image /page/8/Picture/0 description: The image shows the logo for Rochal Technologies, a Sanara MedTech Inc. company. The logo features a blue, stylized globe on the left, followed by the word "Rochal" in a bold, dark blue font. To the right of "Rochal" is the word "Technologies" in a lighter blue font. Below "Rochal Technologies" is the text "A Sanara MedTech Inc. Company" in a smaller, gray font.
13. Performance Testing
Biasurge Advanced Surgical Solution has been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe and as effective as its predicate device. USP <51> testing demonstrates the chosen preservative is appropriate for the product formulation. The results of the aging study indicate the product is stable and effective for the proposed shelf life. Reference devices K192349, Bactisure and K203835, MIS Solution were leveraged to support the equivalence of the packaging.
14. Substantial Equivalence Conclusion
As discussed in the 510(k) submission, Biasurge Advanced Surgical Solution has similar indications for use, product form and function, as the predicate device, Atteris Antimicrobial Skin & Wound Cleanser (K160192). The safety evaluation meets the requirements as detailed by ISO 10993.
On the basis of the information presented in this 510(k) submission, Rochal Technologies LLC, concludes (a) Biasurge Advanced Surgical Solution is substantially equivalent to the predicate device, as it has the similar intended uses, the same technology, packaging, and sterilization as the predicate and reference devices; and (b) demonstrates the device is at least as safe and effective as the legally marketed predicate device.
N/A