← Product Code FRO · K192478 # LT Antibacterial Alginate with Silver Dressing (K192478) _Zhejiang Longterm Medical Technology Co., Ltd. · FRO · Jun 17, 2020 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K192478 ## Device Facts - **Applicant:** Zhejiang Longterm Medical Technology Co., Ltd. - **Product Code:** FRO - **Decision Date:** Jun 17, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns. LT Antibacterial Alginate with Silver Dressing is intended for external use only. ## Device Story Advanced wound care dressing; composed of calcium alginate and 3.5% silver salt. Forms gel upon absorption of wound fluid; maintains moist environment; allows intact removal. Silver ions inhibit bacterial growth within dressing. Available in pad and ribbon configurations; cuttable and layerable for various wound shapes. Used in clinical settings for wound management; applied by healthcare professionals. Output is physical wound coverage and antimicrobial barrier; aids healing by protecting wound bed and managing exudate. ## Clinical Evidence No clinical testing was required. Evidence provided includes biocompatibility testing (ISO 10993-5, -6, -10, -11), bench testing (AATCC 100 antibacterial activity, silver elution, absorption, MVTR, tensile strength, stability, and transportation), and a porcine wound healing study. ## Technological Characteristics Non-woven calcium alginate dressing impregnated with 3.5% silver salt. Available in pad and ribbon configurations. Sterilized via gamma irradiation to a sterility assurance level (SAL) of 10^-6. Biocompatibility verified per ISO 10993 standards. Mechanical properties include absorption, MVTR, and tensile strength. ## Predicate Devices - ALGS6 Ag Alginate Wound Dressing ([K172570](/device/K172570.md)) - Silverlon CA Calcium Alginate Dressing-Antibacterial Silver ([K053590](/device/K053590.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 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. June 17, 2020 Zhejiang Longterm Medical Technology Co., Ltd. % Claudia Zsang Director if Regulatory Affairs Zhenjiang Longterm Medical Technology Co., Ltd. No. 493 North Huancheng Road, Morgan Mountain National High-Tech District Deqing, Zhejiang 313200 China Re: K192478 Trade/Device Name: LT Antibacterial Alginate with Silver Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 7, 2020 Received: May 19, 2020 Dear Claudia Zsang: 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 {1}------------------------------------------------ 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 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 (OS) 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, Anjana Jain, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192478 Device Name LT Antibacterial Alginate with Silver Dressing Indications for Use (Describe) LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns. LT Antibacterial Alginate with Silver Dressing is intended for external use only. 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) | |----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ ## 510(k) Summary - 1 The 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807. 92(c). | Date Prepared:
Applicant: | June 17, 2019
Zhejiang Longterm Medical Technology Co., LTD
No. 493 North Huancheng Road, Mogan Mountain National
High-Tech District, Deqing Zhejiang, CHINA 313200 | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent: | Claudia Zsang
Claudia.zsang@gmail.com | | Phone Number: | 416-276-9555 | | Device Name: | LT Antibacterial Alginate with Silver Dressing | | Common Name: | Dressing, Wound, Drug | | FDA Panel: | General and Plastic Surgery | | Product Code: | FRO | | Class: | Unclassified | | Predicate Devices: | | | K172570 | ALGS6 Ag Alginate Wound Dressing | | K053590 | (Foshan United Medical Technologies, Ltd.)
Silverlon CA Calcium Alginate Dressing-Antibacterial Silver
(Argentum LLC) | #### 2 Device Description: LT Antibacterial Alginate with Silver Dressing is an advanced wound care dressing composed of calcium alginate and silver salt (3.5%). The dressing forms a gel when absorbs wound fluid to provide a moist environment and allows intact removal. When in contact with wound fluid, silver ions within the dressing inhibit bacterial growth in the dressing. LT Antibacterial Alginate with Silver Dressing is available in pad and ribbon configurations and various sizes. The pad is used to cover and protect the wound bed and the ribbon is used to pack the wound with cavity. LT Antibacterial Alginate with Silver Dressing can be cut and layered for various wound shapes and types. {4}------------------------------------------------ | Product Code | Size(cm x cm) | |--------------|---------------| | SAD5301 | 5 x 5 | | SAD5304 | 10 x 10 | | SAD5306 | 10 x 20 | | SAD5312 | 15 x 20 | | SAD5315 | 20 x 20 | | SAD5405 | 2 x 30 | | SAD5407 | 2 x 40 | The device is available in the following configurations: #### Indications for Use: 3 LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, pressure ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns. LT Antibacterial Alginate with Silver Dressing is intended for external use only. {5}------------------------------------------------ ### Substantial Equivalence 4 | Parameter | Subject Device | Predicate Device #1 | Predicate Device #2 | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)# | K192478 | K172570 | K053590 | | Device name | LT Antibacterial Alginate with Silver
Dressing | ALGS6 Ag Alginate Wound
Dressing | Silverlon™ CA Calcium Alginate
Dressing-Antimicrobial Silver | | Classification
Regulation | Unclassified | Identical | Identical | | Product Code | FRO | Identical | Identical | | Composition | Calcium alginate with Silver salt | Calcium alginate with Silver salt | Calcium alginate, nylon contact
layer impregnated with metallic
silver | | Intended Use | LT Antibacterial Alginate with
Silver Dressing is used for
management acute and chronic
wounds, partial and full thickness
wounds, including pressure ulcers,
venous ulcers, diabetic ulcers,
pressure ulcers, donor and graft sites,
surgical wounds, traumatic wounds,
first and second-degree burns.
LT Antibacterial Alginate with
Silver Dressing is intended for
external use only. | 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. | Silverlon™ CA Advanced
Antimicrobial Alginate Dressing is
an effective barrier to microbial
penetration for moderate to heavy
exudating partial and full thickness
wounds, including pressure ulcers,
venous ulcers, diabetic ulcers,
donor and graft sites, traumatic and
surgical wounds and 1st and 2nd
degree burns.
Silverlon™ CA Advanced
Antimicrobial Dressing is indicated
for external use only. | | Device Category | Surface device, prolonged (>24hr to
30d)), in contact with breached or
compromised skin | Identical | Identical | | Device Design | Non-woven alginate with silver salt | Non-woven alginate with silver salt | Non-woven alginate with silver
nylon contact layer | | Antimicrobial
agent | Ionic silver | Ionic silver | Ionic silver | | Silver content | 35 mg/g or 42mg/100cm2 | 30.6mg/100cm2 | 546 mg/100cm2 | | Biocompatibility | Yes | Yes | Yes | | Sterilization | Gamma Irradiation | Gamma Irradiation | Irradiation | | Sterility
Assurance Level | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 | {6}------------------------------------------------ {7}------------------------------------------------ #### Non-clinical Testing Summary: 5 The following tests were performed to support the substantial equivalence of the subject device: ## Biocompatibility Testing: - Cytotoxicity ISO 10993-5:2009 ● - Irritation - ISO 10993-10:2010 - Sensitization - ISO 10093-10:2010 - . Implantation – ISO 10993-6:2016 - Acute toxicity ISO 10993-11:2017 ● - . Sub-acute toxicity - ISO-11:2017 - Pyrogenicity -ISO 10993-11:2006/USP39-NF34 <151> ## Bench testing: - 4-log Antibacterial activity test (AATCC 100) against gram-negative, gram-positive, and ● yeast for up to 7 days. - MEC - Silver content and elution ● - Absorption - MVTR ● - Tensile strength ● - Stability study ● - Simulated transportation test ### Animal testing: - Porcine wound healing study . #### Clinical Testing: 6 No clinical testing was required to support substantial equivalence. #### 7 Conclusion: The data provided demonstrates that there are no new questions of safety and effectiveness, and the subject device is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K192478](https://fda.innolitics.com/device/K192478) **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