(240 days)
No
The device description and performance studies focus on the material properties and antibacterial effectiveness of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is a wound dressing used for the management of acute and chronic wounds, which is a therapeutic purpose.
No
The device description clearly states it is a wound dressing, used for managing acute and chronic wounds and maintaining a moist wound environment. Its function is to aid in healing, not to diagnose a condition.
No
The device description clearly indicates it is a physical wound dressing composed of calcium alginate and ionic silver. It is a tangible product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing used for the management of various types of wounds. This is a topical application for treating a physical condition, not a test performed on a sample taken from the body to diagnose a disease or condition.
- Device Description: The description details the composition and function of a wound dressing (absorbent material, silver for antibacterial properties, creating a moist environment). This aligns with the characteristics of a medical device used for wound care, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, antibodies, etc.)
- Providing diagnostic information about a patient's health status
Therefore, the ALGS2 Ag Alginate Wound Dressing is a medical device used for wound management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
FRO
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.
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
Healthcare professional (for Prescription Use only)
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)
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing:
- Cytotoxicity Test (ANSI/AAMI/ISO 10993-5)
- ISO Guinea Pig Maximization Sensation Test (ISO 10993-10)
- ISO Intracutaneous Reactivity (Irritation Test) (ISO 10993-10)
- Material Mediated Pyrogenicity (Pyrogen Test) (ISO 10993-11, per USP )
- Acute Systemic Toxicity (Toxicity Test) (ISO 10993-11)
- Subchronic [Subacute Toxicity] (Repeat Exposure Test) (ISO 10993-11)
- Implantation Effects (Wound Healing Study) (ISO 10993-6)
- Bacterial Endotoxins Test (USP 43 )
Performance Testing - Bench:
- Weight/Dimensions
- Absorbency
- Moisture Content
- Acidity
- Silver Content
- Heavy Metal Analysis
- Evaluation of Antibacterial Effectiveness
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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)
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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 |
| 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 |
| 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.