(476 days)
Not Found
No
The device description and performance studies focus on the chemical and mechanical properties of a wound irrigation solution, with no mention of AI or ML.
Yes
The device is intended for cleansing, moistening, and debriding acute and chronic dermal wounds, which constitutes a therapeutic action to aid healing.
No
This device is a wound irrigation solution used for cleansing, moistening, and debriding wounds, not for diagnosing them. It aids in the removal of debris and acts as a preservative, which are therapeutic and maintenance functions, not diagnostic ones.
No
The device description clearly states it is a "clear hypotonic solution topically applied to skin and wound areas" and is supplied in "food grade 4 oz. plastic PET bottles with spray inserts and caps." This indicates a physical product (liquid solution and packaging), not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cleansing, moistening and debriding to remove wound debris from acute and chronic dermal lesions." This is a topical application for wound management, not for testing samples taken from the body to diagnose a condition.
- Device Description: The device is a "wound management and cleansing solution topically applied to skin and wound areas." It describes a physical action (mechanical action of fluid) and a preservative function (iodine). This aligns with a wound care product, not an in vitro diagnostic test.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on aspects like pH, shelf life, antimicrobial effectiveness of the solution itself, cytotoxicity, and wound healing in a porcine model. These are relevant to a topical wound care product, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Rx: Clyra Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, moistening and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, stasis ulcers, abrasions and minor skin irritations, post surgical wounds, grafted and donor sites, in addition to moistening absorbent wound dressings.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Clyra Wound Irrigation Solution is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Clyra Wound Irrigation Solution will be supplied in food grade 4 oz. plastic PET bottles with spray inserts and caps. Clyra Wound Irrigation contains Potassium Iodide and Copper Sulphate, which release iodine when combined, resulting in a concentration within the product of 250 parts per million (ppm). The iodine acts as a preservative to inhibit contamination within the solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dermal lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
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 included:
- Cytotoxicity Assay (ISO 10993-5:2009)
- Porcine Wound Healing Study
- Sensitization Test (ISO 10993-10:2010)
- Irritation Test (ISO 10993-10:2010)
- Material medicated pyrogenicity
- Chemical characterization and toxicological risk assessment for systemic toxicity
- Antimicrobial Effectiveness Test (AET) (USP): Clyra Wound Irrigation Solution was evaluated for preservative activity in compliance with USP Antimicrobial Effectiveness Test , designed to test efficacy of preservatives. Exposure to Clyra Wound Irrigation Solution caused an inhibition in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus brasiliensis .
- Shelf Life Testing: A maximum shelf life of 2 years has been assigned to the Clyra Wound Irrigation Solution, when stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.
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.
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2019
Clyra Medical Technologies Inc. % Tanya Rhodes President Rhodes & Associates, Inc 211 Poinciana Lane Largo, Florida 33770
Re: K181428
Trade/Device Name: Clyra Wound Irrigation Solution Regulatory Class: Unclassified Product Code: FRO Dated: September 15, 2019 Received: September 17, 2019
Dear Tanya Rhodes:
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 mediation-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.
Cynthia Chang Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181428
Device Name Clyra™ Wound Irrigation Solution
Indications for Use (Describe)
Rx: Clyra Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, moistening and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, stasis ulcers, abrasions and minor skin irritations, post surgical wounds, grafted and donor sites, in addition to moistening absorbent wound dressings.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for "CLYRA Medical Technologies Inc." The logo consists of a circular emblem on the left and the company name on the right. The emblem is divided into two halves, with the top half being a dark blue color and containing a white plus sign, and the bottom half being a light green color with a leaf-like design. The company name is written in a modern, sans-serif font, with "CLYRA" in a larger, dark blue font and "Medical Technologies Inc" in a smaller, light green font.
Section 6
510(k) Summary
Clyra™ Wound Irrigation Solution
K181428
1. Submission Sponsor
Clyra Medical Technologies Inc.
14921 Chestnut St.
Westminster
California 92683
United States
Contact: Steven V. Harrison
Title: President
2. Submission Correspondent
Rhodes & Associates, Inc.
211 Poinciana Lane
Largo
FL 33770
Office Phone: 727-458-4291
Contact: Tanya Rhodes
Title: President
3. Date Prepared
9.20.2019
4. Device Identification
| Trade/Proprietary Name: | Clyra™ Wound Irrigation Solution |
|---|---|
| Common/Usual Name: | Wound Cleanser |
| Classification Name: | Dressing, Wound, Drug |
4
Image /page/4/Picture/0 description: The image is a logo for "CLYRA Medical Technologies Inc". The logo features a circular emblem on the left, divided into a blue upper half with a white plus sign and a green lower half with a leaf-like shape. To the right of the emblem is the word "CLYRA" in a stylized, sans-serif font, with the letters in a dark blue color. Below "CLYRA" is the text "Medical Technologies Inc" in a smaller, lighter green font.
| Regulation Number: | Unclassified |
|---|---|
| Product Code: | FRO |
| Device Class: | Unclassified (Pre-Amendment) |
| Classification Panel: | General & Plastic Surgery |
5. Legally Marketed Predicate Device(s)
K133452 - Puracyn Plus Skin and Wound Care - Innovacyn, Inc. Rialto, CA 92377
6. Indication for Use Statement
Clyra Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, irrigating, moistening and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.
7. Device Description
Clyra Wound Irrigation Solution is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Clyra Wound Irrigation Solution will be supplied in food grade 4 oz. plastic PET bottles with spray inserts and caps. Clyra Wound Irrigation contains Potassium Iodide and Copper Sulphate, which release iodine when combined, resulting in a concentration within the product of 250 parts per million (ppm). The iodine acts as a preservative to inhibit contamination within the solution.
8. Substantial Equivalence Discussion
The following table compares the Clyra Wound Irrigation to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
5
Image /page/5/Picture/0 description: The image is a logo for "CLYRA Medical Technologies Inc". The logo features a circular emblem on the left, divided into a blue upper half with a white plus sign and a green lower half with a leaf design. To the right of the emblem is the word "CLYRA" in a stylized, sans-serif font, with the words "Medical Technologies Inc" underneath in a smaller font.
| Manufacturer | Clyra Medical
Technologies Inc. | Innovacyn Inc. | Device Comparison |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Clyra Wound
Irrigation
Solution | Puracyn Plus Skin and
Wound Care | |
| 510(k) Number | K181428 | K133542 | Not applicable |
| Product Code | FRO | FRO | Same |
| Regulation Number | Unclassified | Unclassified | Same |
| Regulation Name | Dressing, Wound, Drug | Dressing, Wound, Drug | Same |
| Prescription Only
Indications for Use | Rx: Clyra Wound
Irrigation Solution is
intended for use by
healthcare professionals
for cleansing,
irrigating,moistening
and debriding to remove
wound debris from
acute and chronic
dermal lesions that are
partial or full thickness
wounds such as 1st and
2nd degree burns, stage
I - IV pressure ulcers,
diabetic ulcers, stasis
ulcers, abrasions and
minor skin irritations,
post surgical wounds,
grafted and donor sites,
in addition to
moistening and
lubricating absorbent
wound dressings. | Rx: Puracyn Plus™ Skin
and Wound Care is
intended for use by
healthcare professionals
for cleansing,
irrigating, moistening,
and debriding to remove
wound debris from
acute and chronic
dermal lesions that are
partial or full thickness
wounds such as 1st and
2nd degree burns, stage
I - IV pressure ulcers,
diabetic ulcers, stasis
ulcers, abrasions and
minor skin irritations,
post-surgical wounds,
grafted and donor sites,
in addition to
moistening and
lubricating absorbent
wound dressings. | Same
Each device is indicated
for topical wound care/
irrigation.
The Intended Use
Statement utilizes the
same indications as
previously cleared
under predicate
devices. |
| Manufacturer | Clyra Medical
Technologies Inc. | Inovacyn Inc | Device Comparison |
| Trade Name | Clyra Wound
Irrigation
Solution | Puracyn Plus
Skin and Wound
Care | |
| Device Description | Clyra Wound Irrigation
Solution is a clear
hypotonic solution
topically applied to skin
and wound areas. The
subject device is a
wound management and
cleansing solution that is
intended for cleansing,
irrigating, and debriding
dermal wounds in
addition to moistening
and lubricating
absorbent wound
dressings (e.g. gauze).
The mechanical action of
fluid moving across the
wound provides for the
mechanism of action and
aids in the removal of
foreign objects such as
dirt and debris.
Clyra Wound Irrigation
Solution will be supplied
in food grade 4 oz.
plastic PET bottles with
spray inserts and caps.
Clyra Wound Irrigation
Solution contains
Potassium lodide and
Copper Sulphate, which
release iodine when
combined, resulting in a
concentration within the
product of 250 parts per
million (ppm). The iodine
acts as a preservative to
inhibit contamination
within the solution. | Puracyn Plus Skin and
Wound Care is a clear
hypotonic solution
topically applied to skin
and wound areas. The
subject device is a
wound management
and cleansing solution
that is intended for
cleansing, irrigating, and
debriding dermal
wounds in addition to
moistening and
lubricating absorbent
wound dressings (e.g.
gauze). The mechanical
action of fluid moving
across the wound
provides for the
mechanism of action
and aids in the removal
of foreign objects such
as dirt and debris.
Puracyn Plus Skin and
Wound Care will be
supplied in food grade 4
oz. plastic PET bottles
with spray inserts and
caps. | Same.
Additional information
regarding Clyra Wound
Irrigation Solution
preservative system |
| Manufacturer | Clyra Medical
Technologies Inc. | Innovacyn Inc | Device Comparison |
| Trade Name | Clyra Wound Irrigation
Solution | Puracyn Plus Skin
and Wound Care | |
| Form | The device is supplied in
food grade 4 oz plastic
PET bottles with spray
inserts and caps. This
product is preserved and
provided non sterile | The device is supplied in
food grade 4 oz plastic
PET bottles with spray
inserts and caps. This
product is preserved and
provided non sterile. | Same |
| Ingredients | Copper Sulphate;
Potassium Iodide;
Sodium Chloride;
Water | Hypochlorous Acid;
Sodium Hypochlorite;
Phosphate;
Sodium Chloride;
Water | No significant difference.
Materials used in each
product are similar in
their properties to
provide a preserved
wound irrigation
solution |
| Pre-Clinical Testing | Pre-Clinical Testing
included pH, Shelf Life,
Chemical Stability,
Antimicrobial
Preservative
Effectiveness, | Pre-Clinical Testing
included pH, Shelf Life,
Chemical Stability,
Antimicrobial
Preservative
Effectiveness | No significant
difference. |
| Complies with
ISO 10993-1 | Yes | Yes | No significant difference |
| Complies with
Antimicrobial Test
USP | Non-sterile
Preserved/Conforming
to USP | Non-sterile
Preserved/Conforming
to USP | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Shelf-Life | Two (2) Years | Two (2) years | Same |
Table 6A – Comparison of Characteristics
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Image /page/6/Picture/0 description: The image contains the logo for "CLYRA Medical Technologies Inc". The logo features a circular emblem on the left, divided into a blue upper half and a green lower half, with a white medical cross symbol in the center. To the right of the emblem, the word "CLYRA" is written in a stylized, sans-serif font, with the words "Medical Technologies Inc" written in a smaller font below it.
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Image /page/7/Picture/0 description: The image shows the logo for "CLYRA Medical Technologies Inc". The logo consists of a circular emblem on the left and the company name on the right. The emblem is divided into two halves, with the top half being a dark blue color and the bottom half being a light green color. A white plus sign is in the center of the emblem. The company name is written in a sans-serif font, with "CLYRA" in a dark blue color and "Medical Technologies Inc" in a light green color.
9. Non-Clinical Performance Data
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Image /page/8/Picture/0 description: The image is a logo for "CLYRA Medical Technologies Inc". The logo consists of a circular emblem on the left and the company name on the right. The emblem is divided into two halves, with the top half being a dark blue color and containing a white plus sign, and the bottom half being a light green color with a leaf-like design. The company name is written in a simple, sans-serif font, with "CLYRA" in a larger font size than "Medical Technologies Inc".
As part of demonstrating safety and effectiveness of Clyra Wound Irrigation Solution and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Clyra Medical Technologies Inc. completed ISO 10993 biocompatibility testing to establish the safety of Clyra Wound Irrigation Solution for its intended use.
- Cytotoxicity Assay (ISO 10993-5:2009): ●
- Porcine Wound Healing Study
- . Sensitization Test (ISO 10993-10:2010):
- Irritation Test (ISO 10993-10:2010):
- Material medicated pyrogenicity
- Chemical characterization and toxicological risk assessment for systemic toxicity
- Antimicrobial Effectiveness Test (AET) (USP): Clyra Wound Irrigation Solution was evaluated for preservative activity in compliance with USP Antimicrobial Effectiveness Test , designed to test efficacy of preservatives. Exposure to Clyra Wound Irrigation Solution caused an inhibition in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus brasiliensis .
- Shelf Life Testing A maximum shelf life of 2 years has been assigned to the Clyra Wound ● Irrigation Solution, when stored unopened at ambient temperature, in accordance with the manufacturer's recommendations.
10. Clinical Performance Data
N/A
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Image /page/9/Picture/0 description: The image is a logo for "CLYRA Medical Technologies Inc." The logo features a green and blue circle with a white medical cross in the center. To the right of the circle is the company name, "CLYRA" in large, sans-serif font, with the words "Medical Technologies Inc" in a smaller font below.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise new questions regarding its safety and effectiveness as compared to the predicate device(s).
The Clyra Wound Irrigation Solution, as designed and manufactured, is determined to be substantially equivalent to the predicate device.