(146 days)
No
The device description and performance studies focus on the chemical composition and mechanical action of a wound cleansing solution. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The device mechanically cleanses wounds to remove debris and microorganisms, which is a supportive action rather than directly treating a disease or condition.
No
Explanation: The device is described as a solution for mechanical cleansing and removal of debris from wounds, and its mechanism of action is the physical movement of fluid. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly states it is a "clear, colorless solution" provided in a "soft polypropylene 1000mL container" and lists chemical components. This indicates 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 "mechanical cleansing and removal of debris, including microorganisms from wounds." This is a direct application to the wound for therapeutic or cleansing purposes, not for the diagnosis of a condition.
- Device Description: The description details a solution for cleansing wounds through mechanical action. It doesn't mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Language: The document focuses on wound cleansing, debris removal, and biocompatibility. There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic results.
- Predicate Device: The predicate device (Atteris Antimicrobial Skin & Wound Cleanser) is also a wound cleanser, not an IVD.
- Reference Devices: The reference devices (Bactisure, Irrisept, MIS Solution) also appear to be wound care products, not IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to clean wounds, which is a therapeutic or supportive action, not a diagnostic one.
N/A
Intended Use / Indications for Use
Biasurge Advanced Surgical Solution is indicated for use in mechanical cleansing and removal of debris, including microorganisms from wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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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
1
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
2
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 | DESCRIPTION | ||
| 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. | Description of Device | ||
| Atteris Antimicrobial Skin & | |||
| Wound Cleanser helps in the | |||
| mechanical removal of debris and | |||
| foreign material from the skin, | |||
| wound or application site. Atteris | |||
| Antimicrobial Skin & Wound | |||
| Cleanser is a pure, colorless, | |||
| isotonic cleanser that is safe. The | |||
| cleanser has a six month | |||
| expiration due to the preservative | |||
| that provides bactericidal and | |||
| fungicidal properties through the | |||
| action of the antimicrobial | |||
| (PHMB). | |||
| A preservative, PHMB, at a | |||
| concentration of 0.1% w/w is | |||
| added to the product to inhibit the | |||
| growth of microorganisms such | |||
| as, Staphylococcus aureus, | |||
| Staphylococcus epidermidis, | |||
| Pseudomonas aeruginosa, | |||
| Escherichia coli, antibiotic | |||
| resistant Methicillin Resistant | The proposed device's design is similar to the | ||
| predicate device and reference devices K192349. | |||
| Bactisure and K203835, MIS Solution. The | |||
| preservative is PHMB in both the subject and | |||
| predicate devices. | |||
| The mechanism of action for both devices is | |||
| mechanical removal of debris via hydrodynamic | |||
| shear. The mechanical action of moving across | |||
| the wound aids in the removal of foreign | |||
| material such as microorganisms, dirt and debris. | |||
| The mechanical action of the irrigation can be | |||
| provided by either a manual syringe or powered | |||
| irrigation device. | |||
| The design is substantially equivalent. | |||
| and fungus Candida albicans | |||
| within the product. | |||
| Indications for | |||
| Use | INDICATIONS | ||
| Biasurge Advanced Surgical | |||
| Solution is indicated for use in | |||
| mechanical cleansing and removal | |||
| of debris, including | |||
| microorganisms, from wounds. | |||
| Rx Only | Intended Use of Device | ||
| Atteris Antimicrobial Skin & | |||
| Wound Cleanser is intended for | |||
| over-the-counter (OTC) and | |||
| professional use as follows: | |||
| a. For Over-the-Counter Use:.... | |||
| b. Professional Use: (Rx Only) | |||
| Atteris Antimicrobial Skin & | |||
| Wound Cleanser is intended for | |||
| mechanical cleansing and removal | |||
| of debris, dirt and foreign | |||
| materials, including | |||
| microorganisms from wounds | |||
| such as stage I-IV pressure ulcers, | |||
| diabetic foot ulcers, post-surgical | |||
| wounds, first and second degree | |||
| burns, grafted and donor sites. | The description and indications for use are the | ||
| same as the reference device, K203835, MIS | |||
| Solution. The subject device is a single-patient- | |||
| multiple use product. | |||
| The Indications for Use are substantially | |||
| equivalent. | |||
| Rx Only and OTC | |||
| Materials | 1 L polypropylene bag with a | ||
| single twist-off port | HDPE bottle with Trigger Sprayer | Different. However, both are plastics commonly | |
| used in legally marketed medical device | |||
| irrigation solutions or wound cleansers. These | |||
| minor differences do not raise new questions of | |||
| safety or effectiveness. | |||
| The materials are substantially equivalent. | |||
| Other Features | Sterile - Moist Steam | Non-sterile | Provided sterile, but single-patient multi-use for |
| a period of 28-days. Predicate: non-sterile, | |||
| single patient multi-use for a period of 28-days. | |||
| Other features are substantially equivalent. | |||
| Biocompatibility | |||
| Testing | 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], EDTA | |||
| Disodium, EDTA Trisodium | Same. Chemcial safety is substantially | ||
| equivalent. | |||
| Packaging | 1 L polypropylene bag with a | ||
| single twist-off port | |||
| Overwrap | HDPE Trigger Sprayer | Different but allows for the same use, i.e., both | |
| allow for mechanical removal of debris from | |||
| wounds. Reference devices K192349, Bactisure | |||
| and K203835, MIS Solution were leveraged to | |||
| support the equivalence of the packaging. The | |||
| reference device MIS Solution shares the | |||
| same/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 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.