← Product Code FRO · K233111 # ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC (K233111) _Foshan United Medical Technologies, Ltd. · FRO · May 24, 2024 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K233111 ## Device Facts - **Applicant:** Foshan United Medical Technologies, Ltd. - **Product Code:** FRO - **Decision Date:** May 24, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Intended for prescription use in the management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, partial thickness burns. Also intended for over-the-counter use for minor abrasions, minor lacerations, minor cuts, minor scalds and minor burns. ## Device Story ALGS2 Ag Alginate Wound Dressing is a sterile, single-use, nonwoven pad or ribbon composed of calcium alginate and 0.95% ionic silver. Used in clinical settings or by patients (OTC) to manage various wound types. Upon contact with wound exudate, the dressing absorbs fluid and transforms into a soft, cohesive gel that conforms to the wound surface, maintaining a moist healing environment. The ionic silver inhibits bacterial growth within the dressing. The device is applied to the wound and secured with a secondary dressing; it can remain in place for up to 7 days. It benefits patients by providing a moist environment conducive to healing while managing exudate and preventing bacterial proliferation. ## Clinical Evidence Bench testing only. Evidence includes biocompatibility testing per ISO 10993 standards (cytotoxicity, sensitization, irritation, pyrogenicity, acute/subchronic systemic toxicity, implantation effects) and performance testing (weight, dimensions, absorbency, moisture content, acidity, silver content, heavy metal analysis, and antibacterial effectiveness showing >4 Log reduction). ## Technological Characteristics Materials: Calcium alginate and 0.95% ionic silver. Form factor: Nonwoven pad or ribbon. Mechanism: Hydrophilic gelling upon exudate contact. Sterilization: Gamma radiation (SAL 10^-6). Connectivity: None. Software: None. ## Predicate Devices - ALGS6 Ag Alginate Wound Dressing ([K172570](/device/K172570.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". May 24, 2024 Foshan United Medical Technologies, Ltd. Albert Rego Regulatory Consultant Southern Medical Devices Industrial Park 89 Taoyuan East Road, Shishan, Nanhai Guangdong Province, 528225 China Re: K233111 Trade/Device Name: ALGS2 Ag Alginate Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 9, 2024 Received: April 9, 2024 Dear Albert Rego: 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/cdrb/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. {1}------------------------------------------------ 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). Your device is also subject to, among other requirements, the Quality System (QS) 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. {2}------------------------------------------------ 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-regulatory- assistance/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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233111 Device Name ALGS2 Ag Alginate Wound Dressing Indications for Use (Describe) Rx Only Under the supervision of a healthcare professional, ALGS2 Ag Alginate Wound Dressing may be used for the management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, partial thickness burns. For Over-the-Counter use (Pad Configurations), ALGS2 Ag Alginate Wound Dressing may be used for: - * Minor Abrasions - * Minor Lacerations - * Minor cuts - * Minor scalds and burns | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {4}------------------------------------------------ #### 510(k) Summary (As required by 21 CFR 807.92) | I. SUBMITTER: | Foshan United Medical Technologies Ltd
Southern Medical Devices Industrial Park,89 Taoyuan East Road,
Shishan, Nanhai, Foshan,Guangdong Province,
528225, P.R. China | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person:
Phone: | Albert Rego, Ph.D Inc.
(949) 770-8710 | | Date Prepared: | May 10, 2024 | | II. DEVICE: | | | Trade Name: | ALGS2 Ag Alginate Wound Dressing | | Common Name: | Dressing, Wound Dressing | | Classification Nomer | Unclassified | | Classification Name: | Unclassified | |------------------------------|-----------------------------| | Regulatory Class: | Unclassified | | Classification Product Code: | FRO | | Device Class | Unclassified | | Classification Panel | General and Plastic Surgery | #### III. PREDICATE DEVICE: | | PREDICATE | |----------------|----------------------------------------| | 510(k) Number: | K172570 | | Product Name: | ALGS6 Ag Alginate Wound Dressing | | Manufacturer: | Foshan United Medical Technologies Ltd | #### IV. DEVICE DESCRIPTION: ALGS2 Ag Alginate Wound Dressing is a soft, highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad only) dressing composed of calcium alginate and 0.95% ionic silver which allows for a maximum of 18 mg of silver for a 4 inch x 4 inch dressing. The silver present in the dressing is to prevent or inhibit growth of bacteria within the dressing absorbs wound fluid and creates a soft and cohesive gel which conforms to the wound surface and assists in maintaining a moist environment. The ALGS2 Ag Alginate Wound Dressing helps maintain a moist wound environment which is conducive to wound healing. The ALGS2 Ag Alginate Wound Dressing is individually packaged in foil pouches and terminally sterilized by gamma radiation. {5}------------------------------------------------ ### V. INDICATIONS FOR USE ## Rx Only (Pad and Ribbon Configurations) Under the supervision of a healthcare professional, ALGS2 Ag Alginate Wound Dressing may be used for the management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, partial thickness burns. #### For Over-the-Counter use (Pad Configuration) ALGS2 Ag Alginate Wound Dressing may be used for - . Minor Abrasions - Minor Lacerations - . Minor cuts - . Minor scalds and burns #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE A comparison of the subject device to the predicate device is provided in the tables below. The information provided in this premarket notification demonstrates the subject device is substantially equivalent to the predicate device. | Comparison to Predicate Device | | | | | | |--------------------------------|----------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------|--|--| | Parameter | Subject Device
ALGS2 Ag Alginate Wound Dressing | Predicate Device
ALGS6 Ag Alginate Wound Dressing | Substantially
Equivalent or
Not
Substantially
Equivalent | | | | 510(k) Number | K233111 | K172570 | N/A | | | | Decision Date | | | | | | | Manufacturer | Foshan United Medical Technologies Ltd | Foshan United Medical Technologies
Ltd | N/A | | | | Product Code | FRO | FRO | N/A | | | {6}------------------------------------------------ | Comparison to Predicate Device | | | | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | Parameter | Subject Device
ALGS2 Ag Alginate Wound Dressing | Predicate Device
ALGS6 Ag Alginate Wound Dressing | Substantially
Equivalent or
Not
Substantially
Equivalent | | | Rx Only (Pad and Ribbon Configurations) | Rx Only (Pad and Ribbon Configurations) | Substantially
Equivalent | | Indications for Use | Under the supervision of a healthcare
professional, ALGS2 Ag Alginate Wound
Dressing may be used for the management
of acute and chronic, partial and full
thickness wounds including pressure ulcers,
leg ulcers, diabetic foot ulcers, surgical
wounds, traumatic wounds, partial
thickness burns. | Under the supervision of a healthcare
professional, ALGS6 Ag Alginate Wound
Dressing may be used for management
of acute and chronic, partial and full
thickness wounds including pressure
ulcers, leg ulcers, diabetic foot ulcers,
surgical wounds, traumatic wounds,
first and second degree burns. | | | | For Over-the-Counter use (Pad
Configuration)
ALGS2 Ag Alginate Wound Dressing may be
used for:
Minor AbrasionsMinor LacerationsMinor cutsMinor scalds and burns | For Over-the-Counter Use (Pad
Configuration):
ALGS6 Ag Alginate Wound Dressing
(K172570) may be used for:
Minor AbrasionsMinor LacerationsMinor cutsMinor scalds and burns | | | Intended Use | Intended for prescription use in the
management of acute and chronic, partial
and full thickness wounds including
pressure ulcers, leg ulcers, diabetic foot
ulcers, surgical wounds, traumatic wounds,
partial thickness burns. Also intended for
over-the-counter use for minor abrasions,
minor lacerations, minor cuts, minor scalds
and minor burns. | Intended for prescription use in the
management of acute and chronic,
partial and full thickness wounds
including pressure ulcers, leg ulcers,
diabetic foot ulcers, surgical wounds,
traumatic wounds, first and second
degree burns. Also intended for over-
the-counter use for minor abrasions,
lacerations cuts, scalds and burns. | Substantially
Equivalent | | Device Design | Highly absorbable, single layer, needle
punched non-woven pad or ribbon dressing
that can be cut or folded. | Highly absorbable, single layer, needle
punched non-woven pad or ribbon
dressing that can be cut or folded. | Substantially
Equivalent | | Mechanism of
Action | Conformable, absorbent hydrophilic
dressing that forms a soft, cohesive gel on
contact with wound exudate which
maintains a moist environment for optimal
wound healing; ionic silver provides an
antibacterial effect to prevent the growth of
bacteria within the dressing. | Same | Substantially
Equivalent | | Comparison to Predicate Device | | | | | Parameter | Subject Device
ALGS2 Ag Alginate Wound Dressing | Predicate Device
ALGS6 Ag Alginate Wound Dressing | Substantially
Equivalent or
Not
Substantially
Equivalent | | Antibacterial
Material | Ionic silver | Ionic Silver | Substantially
Equivalent | | Antibacterial
Activity | Greater than 4 Log Reduction | Greater than 4 Log Reduction | Substantially
Equivalent | | Hydrophilic
Material | Alginate | Alginate | Substantially
Equivalent | | Method of
Affixation | Covered and secured with an appropriate
secondary dressing | Same | Substantially
Equivalent | | Wear Time per
Dressing | Up to 7 days | Up to 7 days | Substantially
Equivalent | | Integral Removal | Yes | Same | Substantially
Equivalent | | Single Use | Yes | Same | Substantially
Equivalent | | Sterilization | Gamma radiation (SAL $10^{-6}$ ) | Same | Substantially
Equivalent | | Primary Packaging | Foil pouch | Same | Substantially
Equivalent | {7}------------------------------------------------ #### Summary As shown in the comparison table above and listed in the similarities table below, the Indications for Use, intended use, general design characteristics, mechanism of action, antibacterial activity are substantially equivalent to those of the designated previously marketed medical devices. In addition, both subject and predicate devices are single use, biocompatible, have the same packaging, provided sterile using gamma radiation, and have substantially equivalent absorbency and maximum silver release over 7 days within the dressing. Both subject and predicate devices have the same gelling properties in which the absorption of exudate forms a soft cool gel which maintains a moist environment for optimal wound healing. #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. {8}------------------------------------------------ ## Biocompatibility Testing | TEST | METHOD | |-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Cytotoxicity Test | ANSI/AAMI/ISO 10993-5
Tests for Cytotoxicity, In Vitro
Method | | ISO Guinea Pig
Maximization
Sensation Test
(Sensitization
Test) | ISO 10993-10
Test for Irritation and
Sensitization | | ISO
Intracutaneous
Reactivity
(Irritation Test) | ISO 10993-10
Test for Irritation and
Sensitization | | Material
Mediated
Pyrogenicity
(Pyrogen Test) | ISO 10993-11, per USP <151>
Test for Pyrogenicity Potential | | Acute Systemic
Toxicity
(Toxicity Test) | ISO 10993-11
Tests for Acute Exposure
Systemic Toxicity Potential | | Subchronic
[Subacute
Toxicity]
(Repeat Exposure
Test) | ISO 10993-11
Test to Discover The Effects a
Material With Repeat Exposure
Would Have On a Patient | | Implantation
Effects
(Wound Healing
Study) | ISO 10993-6
Test for local effects after
implantation (2016) | | Bacterial
Endotoxins Test | USP 43 <85>
Bacterial Endotoxins Test | ## SUMMARY OF BIOCOMPATIBILITY TESTS AND RESULTS {9}------------------------------------------------ ## Performance Testing - Bench | COMPONENT
(NAME AND PART
NUMBER/DRAWING
NUMBER) | MATERIAL
DESCRIPTION
(TRADE AND
GENERIC NAME) | MANUFACTURER
(NAME, CITY
AND STATE) | PATIENT
CONTACT? | TEST
RESULTS | |----------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Wound Dressing | Silver Alginate | Foshan United
Medical
Technologies
(China) | Direct | Weight/Dimensions
Absorbency
Moisture Content
Acidity
Silver Content
Heavy Metal Analysis
Evaluation of Antibacterial
Effectiveness | ## VIII. CONCLUSIONS Based on the comparison of intended use and technological characteristics with the predicate device, the subject device, the ALGS2 Ag Alginate Wound Dressing is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K233111](https://fda.innolitics.com/device/K233111) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com