(437 days)
No
The device description and performance studies focus on the chemical composition and mechanical action of the cleanser, with no mention of AI or ML.
Yes.
The device is intended for the "cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions" and contains active chemical components which are functions of a therapeutic device.
No
Explanation: The device is described as a skin and wound cleanser intended for mechanical removal of debris and foreign material, and contains components that function as preservatives and stabilizers. Its primary purpose is cleansing and debridement, not to diagnose a condition or disease.
No
The device description clearly states that Spectricept Skin and Wound Cleanser is a "combination device that contains water, hypochlorous acid, copper chloride, zinc chloride and ferric chloride." This indicates it is a physical product (a solution) and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a cleanser for wounds and skin. It focuses on the physical action of cleaning, debridement, and removal of foreign material from the application site. This is a topical application for treating the wound itself.
- Device Description: The description details a solution applied externally to the skin and wounds. It explains the mechanical action of cleaning and the function of the ingredients as a preservative and stabilizers.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, collect a sample for analysis, or provide information about a patient's health status based on in vitro testing.
- Anatomical Site: The anatomical sites are external wounds and skin. IVDs typically involve testing bodily fluids or tissues in vitro (outside the body).
- Performance Studies: The performance studies focus on biocompatibility and bench testing related to the physical and chemical properties of the solution and its ability to clean and preserve. There are no studies related to diagnostic accuracy or performance in detecting specific analytes or conditions.
In summary, Spectricept Skin and Wound Cleanser is a topical medical device intended for the treatment and management of wounds and skin, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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; skin abrasions, minor irritations, cuts and intact skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use: Under the supervision of a healthcare professional
OTC Use: Not specified, implies self-use
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)
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 – 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 Assay (ASTM E2315)
- Preservative Effectiveness Testing (USP )
- Bioburden (USP)
Key results:
The Spectricept Skin and Wound Cleanser meets specification, biocompatibility and performance characteristics and is substantially equivalent to the predicate device, with the exception of shelf-life testing which only supports a 12-month shelf life.
Clinical Performance Data:
No clinical testing was conducted on Spectricept Skin and Wound Cleanser, which is consistent with the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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)
| ☑ 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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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 - Product demonstrated acceptable
performance. | USP - 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 – 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 )
- . Bioburden (USP)
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.