Who is the manufacturer of Spectricept Skin and Wound Cleanser?

Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. filed the 510(k) submission for Spectricept Skin and Wound Cleanser (K213514).

What is the FDA product code for Spectricept Skin and Wound Cleanser?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for Spectricept Skin and Wound Cleanser?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Spectricept Skin and Wound Cleanser?

Microcyn Plus Wound Care Solution (K161034).

Who can help prepare an FDA 510(k) submission like Spectricept Skin and Wound Cleanser?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Spectricept Skin and Wound Cleanser

K213514 · Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · FRO · Jan 13, 2023 · SU

Device Facts

Record ID	K213514
Device Name	Spectricept Skin and Wound Cleanser
Applicant	Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
Product Code	FRO · SU
Decision Date	Jan 13, 2023
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

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.

Device Story

Spectricept Skin and Wound Cleanser is a clear, hypotonic aqueous solution used for mechanical wound cleansing and debridement. It is applied to the wound bed, either directly or with a dressing (e.g., gauze), to facilitate the removal of debris and foreign material through fluid action. The device is intended for use by healthcare professionals in clinical settings or by patients for OTC applications. It contains water, hypochlorous acid (preservative), and chloride salts (copper, zinc, ferric) to stabilize the solution. The device is supplied in 8oz PET bottles. By mechanically flushing the wound site, the cleanser aids in maintaining a clean environment, which supports the management of various acute and chronic wounds and skin lesions.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by non-clinical bench testing and biocompatibility evaluations, including ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (systemic toxicity), ASTM F756 (hemolysis), and USP <85> (endotoxins). Bench performance testing included pH, free available chlorine, fill volume, ASTM E2315 (time-to-kill), USP <51> (preservative effectiveness), and USP <61> (bioburden).

Technological Characteristics

Hypotonic aqueous solution; pH 3.0-4.3. Composition: Water (99.94%), Hypochlorous acid (0.036%), Copper chloride (0.008%), Zinc chloride (0.008%), Ferric chloride (0.008%). Supplied in 8oz PET bottles. Mechanical action for debris removal. Non-sterile. Shelf life: 12 months.

Indications for Use

Indicated for cleansing, irrigating, moistening, debridement, and removal of foreign material/debris from wounds and dermal lesions (stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor skin irritations, ingrown toenails, grafted/donor sites, exit sites) in professional settings; also indicated for OTC use on skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Predicate Devices

Microcyn Plus Wound Care Solution (K161034)

Reference Devices

Vashe Wound Solution (K131848)
NAWAlution Skin and Wound Cleanser (K141660)

Related Devices

K243875 — Spectricept Skin and Wound Cleanser · Spectrum Antimicrobials, Inc. · Apr 21, 2025
K142592 — CleanSmart Wound Cleanser · Simple Science, LLC · Sep 2, 2015
K160095 — Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz · Simple Science, LLC · Jun 10, 2016
K172851 — Microcyn Plus Antimicrobial Wound Care Solution · Sonoma Pharmaceuticals, Inc. · Nov 15, 2017
K252023 — MiraChlor Antimicrobial Wound Solution · Letus Corporation · Mar 25, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <div>☑ Production Use (Part 21 CFR 601 Subpart E)</div> | <div>☑ One-Time Construction (21 CFR 601 Subpart C)</div> | |---------------------------------------------------------|-----------------------------------------------------------| |---------------------------------------------------------|-----------------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) |X | 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}------------------------------------------------ # 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 | {4}------------------------------------------------ ### 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. {5}------------------------------------------------ | | 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 clear hypotonic solution that aids in the removal of debris and foreign material from the application site with a pH range for 3.0-4.3. 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). The solution will be supplied in sealed 8oz PET bottles. | The Oculus Microcyn Plus Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and use with devices intended for wound irrigation with a pH range of 3.5 - 6.0. The solution will be supplied in 40mL glass vials with Teflon lined closures. | Essentially the same. Spectricept has a slightly lower pH limit (3.0) compared to the predicate device (3.5) | | Mechanism of Action | Mechanical removal of dirt, debris from wounds by the action of fluid moving across the wound. | Mechanical removal of dirt, debris from wounds by the action of fluid moving across the wound. | Identical | | Sterile | No | No | Identical | | Indications For Use | Under the supervision of a healthcare professional, Spectricept Skin and Wound | Under the supervision of a healthcare professional, Microcyn Plus Wound Care | Identical | | Rx Label: | 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. | Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toenails, grafted/donor sites and exit sites. 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 with devices intended to irrigate wounds. | | | OTC Label | Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from skin abrasions, lacerations, minor irritations, cuts and intact skin. | Microcyn Plus Wound Care Solution is intended for OTC use in the management of skin 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 and Sodium Hypochlorite | Both use HOCl as their main preservative. Spectrum's salts and Microcyn's hypochlorite have each passed Biocompatibility testing. | | Single Use | No | No | Identical | | Shelf Life | 12 months | 24 months | Not Equivalent | | Container Closure System | Aqueous Solution in 8 oz PET bottles | Aqueous Solution in 40 mL glass vials | Microcyn is also available in additional sizes. Both devices are available in 8 oz. aqueous solution. | | Preservative Effectiveness Testing | USP<51> - Product demonstrated acceptable performance. | USP <51> - Product demonstrated acceptable performance. | Identical | {6}------------------------------------------------ {7}------------------------------------------------ ### 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. {8}------------------------------------------------ # 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.