(304 days)
TorrentX Wound Wash is indicated for use in cleansing and removal of debris, including microorganisms from wounds.
TorrentX Wound Wash is a non-sterile, clear, colorless, 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 foreign material such as debris and bacteria via hydrodynamic shear.
TorrentX Wound Wash will be provided in a 20mL low density polyethylene ampoule with a twist-off seal. Ten (10) ampoules and applicator tips will be provided together in a shelf carton.
The formulation for TorrentX Wound Wash is composed of ethanol, water, sodium citrate, citric acid and benzalkonium chloride.
The provided text is a 510(k) summary for a medical device called "TorrentX Wound Wash." It describes the device, its indications for use, and a summary of nonclinical studies performed to demonstrate its substantial equivalence to a predicate device.
Regarding your request for acceptance criteria and study details, it's important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving a device meets specific, quantitative "acceptance criteria" in the way a novel therapeutic might.
For the TorrentX Wound Wash, the "acceptance criteria" are implied by demonstrating that it is "as safe, as effective, and performs as well as the legally marketed device Next Science® Irrigation Solution (K161165)." The studies listed are designed to show that the new device does not raise new questions of safety or effectiveness compared to the predicate.
Given this context, I will provide the information based on the available text, understanding that it's framed within a 510(k) submission for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantitative "acceptance criteria" for performance metrics are not typically presented in a 510(k) summary for a wound wash in the same way they would be for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are demonstrating similarity or equivalence to the predicate device in terms of safety and effectiveness, across various nonclinical tests.
| Acceptance Criterion (Implied by Substantial Equivalence Goal) | Reported Device Performance (Summary from Text) |
|---|---|
| Mechanical Action / Cleansing Efficacy equivalence (hydrodynamic shear, debris removal) | Both TorrentX Wound Wash and the predicate (Next Science® Irrigation Solution) share the same mechanism of action: mechanical removal of debris via hydrodynamic shear, aiding in the removal of foreign material such as microorganisms, dirt, and debris. Performance Bench Testing: - Application Pressure Test: Performed to support safety, effectiveness, and substantial equivalence. (Specific results not detailed, but implied to be acceptable/comparable). |
| Antimicrobial/Preservation Effectiveness | Performance Bench Testing: - Antimicrobial Effectiveness Test (Preservation) (USP <51>): Performed. (Specific results not detailed, but implied to be acceptable/comparable for the preservation properties of the formulation). |
| Biocompatibility / Safety (no new safety concerns) | Biocompatibility Testing: - Sensitization: Performed. - Material-mediated Pyrogenicity: Performed. - Toxicological Risk Assessment: Performed. Endotoxin Test: - Endotoxin LAL Test: Performed. Animal Testing: - Porcine Wound Healing Study: Performed to support safety, effectiveness, and substantial equivalence. (Specific results not detailed, but implied to show no adverse effects or comparable healing to expectation). Conclusion: "The difference in ingredients do not raise different questions of safety or effectiveness." and "The conclusions drawn from the performance tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device Next Science® Irrigation Solution (K161165)." |
| Chemical Composition Compatibility | "All the components of TorrentX Wound Wash are consistent with known ingredients for cleared wound dressings under the FRO product code." "The proposed and predicate devices contain the same surfactant to assist in the solubilization of debris and the same vehicle to carry away any debris..." |
Detailed Information on Studies:
The text describes nonclinical studies, not clinical trials with human subjects or AI performance evaluations, therefore, many of your specific questions (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this type of submission or the information provided.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes nonclinical studies (bench, animal, biocompatibility) rather than a test set for an algorithm with human data. Details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for the nonclinical studies summarized here.
4. Adjudication method for the test set:
- Not Applicable. No test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a wound wash, not an AI diagnostic or assistance tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical wound wash product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Bench Testing: Likely based on established physical/chemical standards (e.g., USP <51> for Antimicrobial Effectiveness Test, standard test methods for pressure, LAL test for endotoxin).
- For Animal Testing (Porcine Wound Healing Study): Ground truth would be based on macroscopic and/or microscopic assessment of wound healing parameters, typically by veterinary pathologists or trained researchers against controls, following established protocols.
- For Biocompatibility Testing: Ground truth is against established ISO standards for biocompatibility (e.g., for sensitization, pyrogenicity, toxicology).
8. The sample size for the training set:
- Not Applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. (See #8)
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September 23, 2021
Next Science, LLC Courtney Narain Regulatory Affairs Specialist 10550 Deerwood Park Blvd Ste 300 Jacksonville, Florida 32256
Re: K203446
Trade/Device Name: TorrentX Wound Wash Regulatory Class: Unclassified Product Code: FRO Dated: August 19, 2021 Received: August 20, 2021
Dear Courtney Narain:
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).
Sincerely,
Lixin Liu, 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)
Device Name TorrentX Wound Wash
Indications for Use (Describe)
TorrentX Wound Wash is indicated for use in cleansing and removal of debris, including microorganisms 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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510(k) Summary
TorrentX Wound Wash
| Submitter: | Next Science®, LLC10550 Deerwood ParkSuite 300Jacksonville, Florida 32256 |
|---|---|
| Contact Person: | Courtney NarainRegulatory Affairs Specialist855-564-2762 ext. 6004855-564-2460 (fax) |
| Date Prepared: | September 21, 2021 |
| Device Common Name: | Wound Wash |
| Device Trade Name: | TorrentX Wound Wash |
| Classification Name: | Dressing, Wound, Drug |
| Product Code: | FRO |
| Classification: | Unclassified |
| Predicate Device: | Next Science® Irrigation Solution (K161165) |
| Indications For Use: | TorrentX Wound Wash is indicated for use in cleansing andremoval of debris, including microorganisms from wounds. |
Device Description:
TorrentX Wound Wash is a non-sterile, clear, colorless, 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 foreign material such as debris and bacteria via hydrodynamic shear.
TorrentX Wound Wash will be provided in a 20mL low density polyethylene ampoule with a twist-off seal. Ten (10) ampoules and applicator tips will be provided together in a shelf carton.
The formulation for TorrentX Wound Wash is composed of ethanol, water, sodium citrate, citric acid and benzalkonium chloride.
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Technological Characteristics:
TorrentX Wound Wash contains ethanol, water, citric acid, sodium citrate and benzalkonium chloride. All the components of TorrentX Wound Wash are consistent with known ingredients for cleared wound dressings under the FRO product code.
TorrentX Wound Wash and Next Science® Irrigation Solution are both clear, colorless solutions used for cleansing wounds. Both devices share the same mechanism of action and use in a clinical setting. The proposed and predicate devices contain the same surfactant to assist in the solubilization of debris and the same vehicle to carry away any debris that is washed from the wound during the irrigation process. As shown by the bench, animal and biocompatibility testing, the difference in ingredients do not raise different questions of safety or effectiveness. The following table compares TorrentX Wound Wash to the predicate device.
| Product | Torrent X Wound Wash(Proposed) | Next Science® Irrigation Solution(Predicate) |
|---|---|---|
| Company | Next Science, LLC | Next Science, LLC |
| 510(k) Number | K203446 | K161165 |
| Indications | Indicated for use in cleansing andremoval of debris, includingmicroorganisms, from wounds. | Next Science® Irrigation Solution is tobe used with a jet lavage system and isindicated for use in cleansing andremoval of debris, including micro-organisms, from wounds. |
| Composition | Benzalkonium ChlorideEthanolCitric AcidSodium CitrateWater | Benzalkonium chlorideEthanolAcetic acidSodium acetateWater |
| TargetPopulation | Single patient use | Single patient use |
| Mechanism(s)of Action | Mechanical removal of debris viahydrodynamic shear. The mechanicalaction of moving across the wound aidsin the removal of foreign material suchas, microorganisms, dirt and debris. | Mechanical removal of debris viahydrodynamic shear. The mechanicalaction of moving across the wound aidsin the removal of foreign material suchas dirt and debris.The mechanical action of the irrigationis provided by the Pulsavac Plus AClavage system. |
| Sterility | Non-sterile | Sterile |
| Instructions | Not for repeated useOne ampoule per procedure | Not for repeated use |
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Summary of Nonclinical Studies
The following tests were performed to support the safety, effectiveness and substantial equivalency of TorrentX Wound Wash:
Performance Bench Testing
- Application Pressure Test
- Antimicrobial Effectiveness Test (Preservation) (USP <51>)
- Endotoxin LAL Test ●
Animal Testing
- Porcine Wound Healing Study ●
Biocompatibility Testing
- Sensitization
- Material-mediated Pyrogenicity ●
- Toxicological Risk Assessment ●
Conclusion:
The conclusions drawn from the performance tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device Next Science® Irrigation Solution (K161165).
N/A