(301 days)
Not Found
No
The device description and performance studies focus on the physical properties, antimicrobial efficacy, and biocompatibility of a standard bandage with an antiseptic. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is an anti-bacterial bandage used for minor cuts and scrapes, which is generally considered a wound dressing and not a therapeutic device in the sense of actively treating or curing a disease beyond basic wound care and infection prevention.
No
The device is an anti-bacterial bandage primarily used for wound management and preventing bacterial colonization, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (elastic cloth, absorbent pad, release liner, adhesive) and a chemical component (Benzalkonium chloride), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be applied topically to the skin for the management of minor cuts, minor scrapes." This is a topical application for wound care, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical bandage with an absorbent pad containing an antibacterial agent. This is a physical barrier and treatment for a wound, not a diagnostic test.
- Performance Studies: The performance studies focus on physical properties (absorbency, adhesion), biocompatibility, and antimicrobial efficacy. These are relevant to a wound dressing, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the device is a topical wound dressing with antibacterial properties, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes.
Product codes
FRO
Device Description
The Anti-bacterial bandage is EO sterilized and is for single use only. The bandage is made of three layers: Elastic Cloth (Fabric) type (Polyethylene terephthalate) or plastic type (Polyethylene), regenerated cellulose absorbent pad, and release liner (Glassine Release Paper). The absorbent pad contains 0.8% Benzalkonium chloride. Center non-woven absorbent pad is to absorb liquid, Benzalkonium chloride present in the pad is to reduce bacterial colonization within the dressing and backing adhesive (Liquid styrene polymer with 2-methyl-1,3-butadiene, White Mineral Oil, Petroleum Resins) layer is to keep the bandage in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
For use on minor cuts, minor scrapes.
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
Non-clinical Performance Test Conclusion:
Biocompatibility: Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with breached or compromised surface with limited duration (.
Performance Bench Tests: Performance testing were conducted to verify that the proposed device met all design specifications were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Anti-bacterial bandage complies with the following standards: Liquid absorbency: EN 13726-1-2002, Peel adhesion: ASTMD 3330/D3330M, Antimicrobial Efficacy: AATCC 100-2019, Minimum Bacteriostatic Concentration Test: AATCC 100-2019.
Animal Study: No animal study is included in this submission.
Clinical Test Conclusion: No clinical study is included in this submission.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 31, 2024
Jinhua Jingdi Medical Supplies Co., Ltd. % Julie Chen Consultant Shanghai Puang Technology Consulting Co., Ltd. Building 5, No. 525 Yuanjiang Road, Minhang District Shanghai, 201109 China
Re: K232333
Trade/Device Name: Anti-bacterial bandage Regulatory Class: Unclassified Product Code: FRO Dated: April 3, 2024 Received: April 22, 2024
Dear Julie Chen:
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"
1
(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 OS 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 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
3
Indications for Use
510(k) Number (if known) K232333
Device Name Anti-bacterial bandage
Indications for Use (Describe)
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes.
Type of Use (Select one or both, as applicable)
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 K232333
This 510(K) Summary information is being submitted in accordance with 21 CFR 807.92
I. SUBMITTER [21 CFR 807.92(a)(1)]
Company Name: Jinhua Jingdi Medical Supplies Co., Ltd. Company Address: Building,2ditian Function,Xiaoshun Town Jingdong Zone, Jinhua, 321000 Zhejiang, P.R. China Contact Person: Xiaojiang Hu Position: Quality Manager Phone Number: 0579-89116761 Email: hxj@jingdimed.com
Submission Correspondent: Julie Chen Email: c1.julie702@gmail.com Phone Number: +86 139 1804 5781
Summary prepared: July 31st, 2023
II. SUBJECT DEVICE [807.92(a)(2)]
Name of Device: Anti-bacterial bandage Device Type: PE Type and Elastic Cloth Type Classification Name: Dressing, Wound, Drug FDA Panel: General and Plastic Surgery Product Code: FRO Device Class: Unclassified
III. IDENTIFICATION of PREDICATE DEVICE [807.92(a)(3)]
Company Name: Medline Industries, Inc. Device Trade Name: CuradAntibacterial Bandage 5 IO(k) Number: K1 13583 Classification Name: Dressing, Wound, Drug FDA Panel: General and Plastic Surgery Product Code: FRO Device Class: Unclassified
5
IV. DEVICE DESCRIPTION [807.92(a)(4)]
The Anti-bacterial bandage is EO sterilized and is for single use only. The bandage is made of three layers: Elastic Cloth (Fabric) type (Polyethylene terephthalate) or plastic type (Polyethylene), regenerated cellulose absorbent pad, and release liner (Glassine Release Paper). The absorbent pad contains 0.8% Benzalkonium chloride. Center non-woven absorbent pad is to absorb liquid, Benzalkonium chloride present in the pad is to reduce bacterial colonization within the dressing and backing adhesive (Liquid styrene polymer with 2-methyl-1,3-butadiene, White Mineral Oil, Petroleum Resins) layer is to keep the bandage in place.
V. AVAILABEL MODELS
The proposed device is available in two types with different sizes, as shown in the below.
Type: Elastic Cloth (Fabric) type (Polyethylene terephthalate)/plastic type (Polyethylene)
Size: 25mm, 22mm, 98mm x38mm, 95mm x65mm, 90mm x20mm, 89mm x27mm, 85mm x55mm, 76mm x51mm, 76mm x45mm, 76mm x38mm, 76mm x25mm, 76mm x19mm, 75mm x50mm, 75mm x25mm, 75mm x22mm, 74mm x25mm, 74mm x24mm, 74mm x19mm, 72mm x38mm, 72mm x30mm, 72mm x25mm, 72mm x24mm, 72mm x22mm, 72mmx20mm, 72mm x19mm, 70mm x22mm, 70mm x18mm, 70mm x17mm, 6mm x75mm, 65mm x40mm, 65mm x25mm, 65mm x20mm, 56mm x19mm, 55mm x25mm, 52mm x52mm, 50mm x60mm, 50mm x50mm, 50mm x45mm, 49mm x10mm, 48mm x10mm, 46mm x10mm, 45mm x45mm, 45mm x10mm, 40mm x20mm, 40mm x10mm, 38mm x38mm, 100mm x50mm, 100mm x12.5mm, 100mm x6mm
VI. INTENDED USE [Form FDA3881]
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes.
VII. Indications for Use [21 CFR 807.92(a)(5)]
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes.
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VIII. Contraindications [21 CFR 807.92(a)(5)]
The dressing should not be used on patients who are allergic to benzalkonium chloride.
IX. Substantial Equivalence [21 CFR 807.92(b)(l) and 807.92(b)(2)]
The Anti-bacterial bandage is compared with the predicate device, Curad Antibacterial Bandage (K113583), manufactured by Medline Industries, Inc. The results are shown below in the Technological Characteristics Comparison Table:
| Predicate Device | |||
|---|---|---|---|
| Device Item | Proposed Device: (K232333) | ||
| Anti-bacterial bandage | Predicate Device(K113583) | ||
| Curad Antibacterial | |||
| Bandage | SE Discussion | ||
| Device | |||
| Classification | |||
| Name | Dressing, Wound, Drug | Dressing, Wound, Drug | Same |
| Device Class | Unclassified | Unclassified | Same |
| Classification | |||
| Panel | General and Plastic | ||
| Surgery | General and Plastic | ||
| Surgery | Same | ||
| Product Code | FRO | FRO | Same |
| Intended Use | Anti-bacterial bandages are to | ||
| be applied topically to the skin | |||
| for the management of minor | |||
| cuts, minor scrapes. | Antibacterial bandages are to be | ||
| applied topically to the skin to | |||
| help prevent infection in | |||
| minor cuts, scrapes and bums | Same | ||
| Indications for | |||
| Use | Anti-bacterial bandages are to | ||
| be applied topically to the skin | |||
| for the management of minor | |||
| cuts, minor scrapes. | Anti-bacterial bandages are to | ||
| be applied topically to the skin | |||
| for the management of minor | |||
| cuts, minor scrapes. | Same | ||
| Mechanism of | |||
| Action | Center non-woven pad for | ||
| absorbing liquid, | |||
| Benzalkonium chloride present | |||
| in the pad for reducing | |||
| bacterial colonization within | |||
| dressing, | |||
| Backing adhesive layer | |||
| for self-adhesive and | |||
| keep the bandage in | |||
| place. | Center non-woven pad for | ||
| absorbing liquid, | |||
| Benzalkonium chloride present | |||
| in the pad for reducing | |||
| bacterial colonization within | |||
| dressing, | |||
| Backing adhesive layer | |||
| for self-adhesive and | |||
| keep the bandage in | |||
| place. | Same | ||
| Antimicrobial | |||
| agent | 0.8% (w/w) | ||
| benzalkonium chloride | 0.8% (w/w) | ||
| benzalkonium chloride | Same |
Table 1 Technological Characteristics Comparison Table Between Subject Device and Predicate Device
7
| | layer (fabric or plastic);
(2) Antibacterial nonstick
absorbent pad layer
(3) Release liner; | layer
(2) Antibacterial nonstick
absorbent pad layer
(3) Release liner; | Same |
|--------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------|
| Antibacterial
Effectiveness | ≥4 Log reduction | ≥4 Log | Same |
| Anatomical
Location | For use on minor cuts, minor
scrapes. | For use on minor cuts, minor
scrapes. | Same |
| Use time | No more than 24 hours | No more than one week | Different |
| Sterilization
Method | Ethylene oxide sterilization | Ethylene oxide sterilization | Same |
| Sterilization | Ethylene Oxide
Sterilization
SAL:10-6 | Ethylene Oxide
Sterilization
SAL:10-6 | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Complies with ISO
10993-1 for limited
contact duration on
breached/compromised
skin | Complies with ISO
10993-1 for limited
contact duration on
breached/compromised
skin | Same |
X. SUBSTANTIAL EQUIVALENCE DISCUSSION per 21 CFR 807.92(b)
Anti-bacterial bandage has been conducted biocompatibility studies in accordance with ISO 10993 to demonstrate the device is as safe as its predicate device. The performance bench testing was conducted to demonstrate that the subject device is as effective as its predicate device.
XI. PERFORMANCE DATA
Non-clinical Performance Test Conclusion
Biocompatibilitv
Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with breached or compromised surface with limited duration (
Performance Bench Tests
Performance testing were conducted to verify that the proposed device met all design specifications were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Anti-bacterial bandage complies with the following standards:
Liquid absorbency: EN 13726-1-2002 Peel adhesion: ASTMD 3330/D3330M Antimicrobial Efficacy: AATCC 100-2019 Minimum Bacteriostatic Concentration Test: AATCC 100-2019
Animal Studv
No animal study is included in this submission.
Clinical Test Conclusion
No clinical study is included in this submission.
XII. CONCLISION per 21 CFR 807.92(c)
The conclusions drawn from the nonclinical tests demonstrate that the proposed device, the Anti-bacterial bandage is as safe, as effective, and performs as well as the legally marketed predicate device Curad Antibacterial Bandage (K1 13583).