(437 days)
Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.
Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, moistening, debridement and removal of foreign material including debris from of skin abrasions, minor irritations, cuts and intact skin.
Spectricent Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).
Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.
This document is a 510(k) premarket notification for a medical device called "Spectricept Skin and Wound Cleanser." It seeks to demonstrate substantial equivalence to a legally marketed predicate device (Microcyn Plus Wound Care Solution). The information provided focuses on non-clinical testing and comparison to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria in a human population.
Therefore, many of the requested elements regarding clinical studies, human readers, and ground truth establishment in a clinical context are not applicable or extractable from this document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, human performance sense, as it's primarily a non-clinical submission for substantial equivalence. Instead, it details various bench tests and biocompatibility evaluations that the device passed to demonstrate safety and effectiveness, and to show similarity to the predicate device.
| Test Category | Test Name | Acceptance Criteria (Implied by "Passed") | Reported Device Performance (Implied by "Passed") |
|---|---|---|---|
| Biocompatibility Testing | ISO 10993-3 Genotoxicity, Carcinogenicity and Reproductive Toxicity | Acceptable performance | Passed |
| ISO 10993-5 - In Vitro Cytotoxicity | Acceptable performance | Passed | |
| ISO 10993-10 Irritation and Skin Sensitization. Direct Intracutaneous Injection Test | Acceptable performance | Passed | |
| ISO 10993-11 - Systemic Toxicity, Direct Systemic Injection Test | Acceptable performance | Passed | |
| ASTM F756 – Assessment of Hemolytic Properties | Acceptable performance | Passed | |
| USP<85> – Bacterial Endotoxins Test | Acceptable performance | Passed | |
| Bench Testing | Visual Inspection | Meets specification | Passed |
| Package Integrity | Meets specification | Passed | |
| Shelf-life Testing | Supports a 12-month shelf life | Passed (for 12 months) | |
| pH | Meets specification (pH range 3.0-4.3) | Passed | |
| Free Available Chlorine (FAC) | Meets specification | Passed | |
| Fill Volume | Meets specification | Passed | |
| Time to Kill Assay (ASTM E2315) | Meets specification | Passed | |
| Preservative Effectiveness Testing (USP <51>) | Acceptable performance | Passed | |
| Bioburden (USP<61>) | Meets specification | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical laboratory testing, not a clinical study involving human patient data. Therefore, the concept of a "test set" in the context of patient data, data provenance, or retrospective/prospective study design does not apply. The "samples" would refer to manufacturing lots or batches of the device product used for the various bench and biocompatibility tests. The document does not specify the number of samples used for each non-clinical test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as there was no clinical test set requiring expert ground truth establishment. The evaluations were based on standardized laboratory tests and their established evaluation criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical test set for human review or adjudication.
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 is a submission for a wound cleanser and does not involve AI or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a wound cleanser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the established scientific protocols, standards (e.g., ISO, ASTM, USP), and specifications for each test. For example:
- Biocompatibility: Standards like ISO 10993 define acceptable biological responses.
- Bench Testing: Specifications for pH range, FAC levels, fill volume, and performance criteria for preservative effectiveness or time to kill.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 13, 2023
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.) % Dana Dunn Principal Dunn Regulatory Associates, LLC 2709 Silkwood Court Oakton, Virginia 22124
Re: K213514 Trade/Device Name: Spectricept Skin and Wound Cleanser Regulatory Class: Not classified Product Code: FRO Dated: October 29, 2021 Received: November 2, 2021
Dear Dana Dunn:
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
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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 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,
Julie A. Morabito -S
Julie A. 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) K213514
Device Name Spectricept Skin and Wound Cleanser
Indications for Use (Describe)
Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.
Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, moistening, debridement and removal of foreign material including debris from of skin abrasions, minor irritations, cuts and intact skin.
Type of Use (Select one or both, as applicable)
| ☑ Production Use (Part 21 CFR 601 Subpart E) | ☑ One-Time Construction (21 CFR 601 Subpart C) |
|---|---|
| --------------------------------------------------------- | ----------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Spectricept Skin and Wound Cleanser
K213514
1. 510(k) Submitter & Submitter's Address
Spectrum Antimicrobials, Inc. 1770 Corporate Circle Petaluma, CA 94954 USA
2. Submitter's Contact Information
Hoji Alimi, CEO Phone: (707) 206-5326 Email: halimi@spectrumantimicrobials.com
3. Date and Type of 510(k) Submitted
April 27, 2022
4. Device Identification
| Trade/Proprietary Name: | Spectricept Skin and Wound Cleanser |
|---|---|
| Common/Usual Name: | Wound Cleanser |
| Classification Name: | Dressing, Wound |
| Regulation Number: | Unclassified |
| Product Code: | FRO - Solution, Saline |
| Wound Dressing Class: | Unclassified |
| Classification Panel: | Surgical and Infection Control Devices (OHT4)Infection Control and Plastic Surgery Devices (DHT4B) |
5. Legally Marketed Predicate Device(s)
| Device name: | Microcyn Plus Wound Care Solution |
|---|---|
| 510(k) number: | K161034 |
| Manufacturer: | Oculus Innovative Sciences, Petaluma, CA 94954 |
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6. Reference Device(s)
| Device Name: | Vashe Wound Solution |
|---|---|
| 510(k) number: | K131848 |
| Manufacturer: | PuriCore Inc., Malvern, PA 19355 |
| Device name: | NAWAlution Skin and Wound Cleanser |
| 510(k) number: | K141660 |
| Manufacturer: | NAWA Heilmittel GMBH, Washington, DC 20005 |
7. Indication for Use Statements
Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.
Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from of skin abrasions, lacerations, minor irritations, cuts and intact skin.
8. Device Description
Spectricent Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).
Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.
9. Substantial Equivalence Discussion
The following table compares the subject Spectricept Skin and Wound Cleanser to the selected predicated device and reference devices. The comparisons include the following attributes which forms the basis for determining substantial equivalence:
- Indications for use, ●
- . Technological characteristics
- . Device performance.
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| Table 1: Comparison of Characteristics | |||
|---|---|---|---|
| -- | ----------------------------------------- | -- | -- |
| Attribute | Spectricept Skin and Wound Cleanser | Microcyn Plus Wound Care Solution(K161034) | Comparison |
|---|---|---|---|
| Manufacturer | Spectrum Antimicrobials | Oculus Innovative Sciences | n/a |
| Product Code | FRO | FRO | Identical |
| Regulation Number | Unclassified | Unclassified | Identical |
| Device Description | Spectricept Skin and Wound Cleanser is a clearhypotonic solution that aids in the removal ofdebris and foreign material from the applicationsite with a pH range for 3.0-4.3.Foreign material and debris are mechanicallyremoved by the action of the wound cleansermoving across the wound bed with or withoutthe assistance of a suitable wound dressing(e.g., gauze).The solution will be supplied in sealed 8oz PETbottles. | The Oculus Microcyn Plus Wound CareSolution is a colorless, slightly chlorinatedodor, clear aqueous solution for moistening ofwound dressings, wound debridement, and usewith devices intended for wound irrigation witha pH range of 3.5 - 6.0.The solution will be supplied in 40mL glassvials with Teflon lined closures. | Essentially the same.Spectricept has aslightly lower pH limit(3.0) compared to thepredicate device (3.5) |
| Mechanism of Action | Mechanical removal of dirt, debris fromwounds by the action of fluid moving acrossthe wound. | Mechanical removal of dirt, debris fromwounds by the action of fluid moving acrossthe wound. | Identical |
| Sterile | No | No | Identical |
| Indications For Use | Under the supervision of a healthcareprofessional, Spectricept Skin and Wound | Under the supervision of a healthcareprofessional, Microcyn Plus Wound Care | Identical |
| Rx Label: | Cleanser is intended for cleansing, irrigating,moistening, debridement and removal offoreign material including debris from wounds,and dermal lesions including stage I-IVpressure ulcers, stasis ulcers, diabetic ulcers,post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of theskin, diabetic foot ulcers, ingrown toe nails,grafted/donor sites and exit sites. | Solution is intended for the cleansing,irrigation, moistening, debridement andremoval of foreign material includingmicroorganisms and debris from exudatingwounds, acute and chronic dermal lesionsincluding stage I-IV pressure ulcers, stasisulcers, diabetic ulcers, post-surgical wounds,first and second-degree burns, abrasions, minorirritations of the skin, diabetic foot ulcers,ingrown toenails, grafted/donor sites and exitsites. It is also intended for use to moisten and | |
| Attribute | Spectricept Skin and Wound Cleanser | Microcyn Plus Wound Care Solution(K161034) | Comparison |
| lubricate wound dressings and for use withdevices intended to irrigate wounds. | |||
| OTC Label | Spectricept Skin and Wound Cleanser isintended for OTC use for cleansing,irrigating, moistening, debridement andremoval of foreign material includingdebris from skin abrasions, lacerations, minorirritations, cuts and intact skin. | Microcyn Plus Wound Care Solution isintended for OTC use in the management ofskin abrasions, lacerations, minor irritations,cuts and intact skin. | Identical |
| Formulation | Water (99.94%),Hypochlorous Acid (0.036%),Copper Chloride (0.008%),Zinc Chloride (0.008%),Ferric Chloride (0.008%) | Water,Sodium Chloride, Hypochlorous acid andSodium Hypochlorite | Both use HOCl as theirmain preservative.Spectrum's salts andMicrocyn's hypochloritehave each passedBiocompatibilitytesting. |
| Single Use | No | No | Identical |
| Shelf Life | 12 months | 24 months | Not Equivalent |
| Container ClosureSystem | Aqueous Solution in 8 oz PET bottles | Aqueous Solution in 40 mL glass vials | Microcyn is alsoavailable in additionalsizes. Both devices areavailable in 8 oz.aqueous solution. |
| PreservativeEffectiveness Testing | USP<51> - Product demonstrated acceptableperformance. | USP <51> - Product demonstrated acceptableperformance. | Identical |
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10. Non-Clinical Performance Data
To demonstrate safety and effectiveness of Spectricept Skin and Wound Cleanser and to show substantial equivalence to the predicate devices, Spectrum Antimicrobials completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device have successfully been met.
Spectricept Skin and Wound Cleanser passed the tests conducted, supporting substantial equivalence to the predicate device with respect to safety and effectiveness.
Biocompatibility Testing
The biocompatibility evaluation for the Spectricept Skin and Wound Cleanser was conducted in accordance with the FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"' September 4, 2020, and International Standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The solution is considered a breached/compromised surface device with limited contact.
The following testing was completed:
- ISO 10993-3 Genotoxicity, Carcinogenicity and Reproductive Toxicity ●
- . ISO 10993-5 - In Vitro Cytotoxicity
- ISO 10993-10 Irritation and Skin Sensitization. Direct Intracutaneous Injection Test .
- ISO 10993-11 - Systemic Toxicity, Direct Systemic Injection Test
- . ASTM F756 – Assessment of Hemolytic Properties
- . USP<85> – Bacterial Endotoxins Test
Bench Testing
The following tests were performed to support the performance of Spectricept Skin and Wound Cleanser:
- Visual Inspection .
- . Package Integrity
- . Shelf-life Testing
- pH
- . Free Available Chlorine (FAC)
- . Fill Volume
- . Time to Kill Assav (ASTM E2315).
- . Preservative Effectiveness Testing (USP <51>)
- . Bioburden (USP<61>)
The Spectricept Skin and Wound Cleanser meets specification, biocompatibility and performance characteristics and is substantially equivalent to the predicate device, with the exception of shelflife testing which only supports a 12-month shelf life.
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11. Clinical Performance Data
No clinical testing was conducted on Spectricept Skin and Wound Cleanser, which is consistent with the predicate devices.
12. Conclusion and Statement of Substantial Equivalence
Spectrum Antimicrobials Spectricept Skin and Wound Cleanser has the same intended uses, similar indications for use, the same mechanism of action and similar technological characteristics, and does not raise any new questions of safety or effectiveness; therefore, Spectricept Skin and Wound Cleanser is substantially equivalent to the predicate device.
N/A