(323 days)
Not Found
No
The device is a wound irrigation solution and the description focuses on its chemical composition and packaging, with no mention of AI or ML.
Yes.
The device is used to cleanse and remove debris from wounds, which directly contributes to the healing process and treatment of the wound.
No
The device is described as an irrigation solution used to cleanse and remove debris from wounds, not to diagnose a condition.
No
The device description clearly states it is a wound irrigation solution supplied in physical bags, indicating it is a liquid substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cleanse and remove debris from wounds" through irrigation. This is a direct application to the body for therapeutic or cleansing purposes, not for testing a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the chemical composition and packaging of a wound irrigation solution. It does not describe a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information. The purpose is purely for wound care.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation to cleanse and remove debris from wounds.
Product codes
FRO
Device Description
Puracyn® Plus Antimicrobial Irrigation Solution is a wound irrigation formula that contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of micro-organisms within the solution.
Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following studies have been performed to support the safety and effectiveness of the subject device:
- Stability Studies per ICH Q1A(R2)
- Biocompatibility studies in accordance with ISO10993-1
- Packaging Testing in accordance with ISO 11607-1 and ISO 11607-2
- Sterilization in accordance with ISO 11737-1 and 11737-2
- Endotoxin Testing per USP
- Preservative Antimicrobial Effectiveness Testing per USP
- Sterility Testing per USP
- Bioburden Testing per USP and USP
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, there is a circular seal with an abstract design. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
May 31, 2024
Innovacyn, Inc. Hungnan Lo Vice President, Technical Operations 3546 N. Riverside Ave. Rialto, California 92377
Re: K232080
Trade/Device Name: Puracyn® Plus Antimicrobial Irrigation Solution Regulatory Class: Unclassified Product Code: FRO Dated: April 26, 2024 Received: April 29, 2024
Dear Hungnan Lo:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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) K232080
Device Name
Puracyn® Plus Antimicrobial Irrigation Solution
Indications for Use (Describe)
Puracyn® Plus Antimicrobial Irrigation is applied with irrigation to cleanse and remove debris from wounds.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared: | 4/26/2024 |
|---|---|
| Applicant: | Innovacyn, Inc. |
| 3546 N. Riverside Avenue | |
| Rialto, CA 92377 | |
| Contact Person: | Hungnan Lo |
| Vice President, Technical Operations | |
| 866-787-2296 | |
| Device Trade Name: | Puracyn® Plus Antimicrobial Irrigation Solution |
| Device Code: | FRO |
| Regulatory Class: | Unclassified |
Predicate Device: K133542, Puracyn Plus Skin and Wound Care, Innovacyn, Inc.
Device Description:
Puracyn® Plus Antimicrobial Irrigation Solution is a wound irrigation formula that contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of micro-organisms within the solution.
Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.
Indications For Use:
Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation to cleanse and remove debris from wounds.
Comparison of Technological Characteristics:
A comparison of technological characteristics between Puracyn® Plus Antimicrobial Irrigation Solution and the predicate device Puracyn Plus™ Skin and Wound Care (K133542) is provided in the following Table 1:
| | SUBJECT DEVICE:
Puracyn® Plus Antimicrobial
Irrigation Solution
(K232080) | PRIMARY PREDICATE:
Puracyn Plus™ Skin and Wound Care
(K133542) |
|-------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Composition | Purified water, Hypochlorous acid,
phosphates | Purified water, Hypochlorous acid,
phosphates |
| Description | Clear, colorless solution packaged in
flexible plastic bags | Clear, colorless, non-sterile solution
packaged in plastic PET bottles |
| Volume | 1000 mL, 3000 mL | 1000 ml to 55 ml |
| Indications | Puracyn® Plus Antimicrobial
Irrigation Solution is applied with | |
Table 1. Comparison of Puracyn Antimicrobial Irrigation Solution to Predicate Device
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| | SUBJECT DEVICE:
Puracyn® Plus Antimicrobial
Irrigation Solution
(K232080) | PRIMARY PREDICATE:
Puracyn Plus™ Skin and Wound Care
(K133542) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | irrigation to cleanse and remove
debris from wounds. | Professional Use: 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 Is' 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. |
| Mechanism(s) of
Action | The mechanical action of fluid
moving across the wound provides
for the mechanism of action and aids
in the removal of foreign objects. | 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. |
| Antimicrobial
Preservative | Preservative: Hypochlorous acid | Preservative: Hypochlorous acid |
| Microbial Control
and Sterility | Meets USP and USP | Meets USP |
| Biocompatibility | Meets ISO 10993-1 requirements | Meets ISO 10993-1 requirements |
| Use | Multiple use within
a single patient | Multiple use for
multiple patients |
Discussion:
The Puracyn Plus Antimicrobial Irrigation Solution is substantially equivalent to the primary predicate, Puracyn Plus Skin and Wound Care (K133542), with respect to intended use and technological characteristics such as chemical composition, mechanism of action, preservative, and biocompatibility. While there are slight differences in packaging/volume, use, and wording for the indications for use, these do not raise new questions of safety and effectiveness when compared to the primary predicate device.
Performance Testing:
The following studies have been performed to support the safety and effectiveness of the subject device:
- . Stability Studies per ICH Q1A(R2)
- Biocompatibility studies in accordance with ISO10993-1
- Packaging Testing in accordance with ISO 11607-1 and ISO 11607-2
- Sterilization in accordance with ISO 11737-1 and 11737-2
- Endotoxin Testing per USP
- Preservative Antimicrobial Effectiveness Testing per USP ●
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- Sterility Testing per USP ●
- Bioburden Testing per USP and USP .
Conclusion:
In summary, the Puracyn Plus Antimicrobial Irrigation Solution is substantially equivalent to the primary predicate in essential aspects critical to its clinical use. The noted differences in packaging/volume, use, and wording for the indications for use align with the subject device's specific application and operational requirements. These differences do not raise new questions of safety and effectiveness, thereby supporting its substantial equivalence to the primary predicate device.