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 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.

AI/ML Overview

This document describes the FDA 510(k) clearance for the LT Antibacterial Alginate with Silver Dressing. Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) process for this device relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than explicit acceptance criteria and performance against those criteria in a typical clinical trial sense. The performance is assessed through non-clinical (bench and animal) testing and similarity to the predicate device.

Parameter	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Subject Device)
Biocompatibility	Biocompatible (per ISO standards)	Passed Cytotoxicity, Irritation, Sensitization, Implantation, Acute toxicity, Sub-acute toxicity, Pyrogenicity tests.
Antibacterial Activity	4-log reduction (as per AATCC 100)	Demonstrated 4-log antibacterial activity against gram-negative, gram-positive, and yeast for up to 7 days.
Moisture Exudate Capacity	Comparable to predicate	MEC results reported (actual value not specified, but implied to be acceptable for substantial equivalence).
Silver Content & Elution	Specified ranges/comparable to predicate	Silver content: 35 mg/g or 42mg/100cm2; Elution results reported (implied acceptable).
Absorption	Comparable to predicate	Absorption results reported (implied acceptable).
Moisture Vapor Transmission Rate (MVTR)	Comparable to predicate	MVTR results reported (implied acceptable).
Tensile Strength	Comparable to predicate	Tensile strength results reported (implied acceptable).
Stability	Stable over shelf life	Stability study performed (implied acceptable).
Sterilization	Sterility Assurance Level (SAL) of 10-6	Gamma Irradiation, SAL of 10-6.
Wound Healing	Evidence of promoting wound healing (animal model)	Porcine wound healing study performed (implied acceptable for substantial equivalence).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Non-Clinical Tests: Not specified in the document for individual tests (e.g., number of samples for AATCC 100, number of animals for the porcine study). The various configurations of the dressing (different sizes) would likely have been tested.
Data Provenance: Not explicitly stated, but based on the manufacturer's location (Zhejiang, China) and common industry practices, it's highly likely the non-clinical testing was conducted in laboratories, possibly in China or by contract research organizations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. For non-clinical studies (bench and animal), specific "experts" establishing ground truth in the sense of clinical adjudication are typically not involved. Results are measured objectively according to standard protocols (e.g., ISO, AATCC).

4. Adjudication Method for the Test Set

None as described in a clinical context. Non-clinical tests follow established protocols and measurement techniques for objective results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is a wound dressing, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a wound dressing, not a software algorithm.

7. The Type of Ground Truth Used

Objective Test Results and Animal Models:
- Bench Testing: Ground truth is established by standardized laboratory methods and measurements (e.g., bacterial count reduction for antibacterial activity, physical properties like tensile strength, chemical assays for silver content).
- Biocompatibility Testing: Ground truth is determined by standardized biological response assessments according to ISO 10993 series.
- Animal Testing: Ground truth is established by observational and histological assessments in a controlled animal model (porcine wound healing study).

8. The Sample Size for the Training Set

Not applicable. This device is a physical wound dressing; it does not involve machine learning or a "training set" in the computational sense.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for a machine learning model, there is no ground truth established for it.

Summary

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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

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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

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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 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)
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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, 2019Zhejiang Longterm Medical Technology Co., LTDNo. 493 North Huancheng Road, Mogan Mountain NationalHigh-Tech District, Deqing Zhejiang, CHINA 313200
Official Correspondent:	Claudia ZsangClaudia.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 can be cut and layered for various wound shapes and types.

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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.

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Substantial Equivalence 4

Parameter	Subject Device	Predicate Device #1	Predicate Device #2
510(k)#	K192478	K172570	K053590
Device name	LT Antibacterial Alginate with SilverDressing	ALGS6 Ag Alginate WoundDressing	Silverlon™ CA Calcium AlginateDressing-Antimicrobial Silver
ClassificationRegulation	Unclassified	Identical	Identical
Product Code	FRO	Identical	Identical
Composition	Calcium alginate with Silver salt	Calcium alginate with Silver salt	Calcium alginate, nylon contactlayer impregnated with metallicsilver
Intended Use	LT Antibacterial Alginate withSilver Dressing is used formanagement acute and chronicwounds, partial and full thicknesswounds, 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 withSilver Dressing is intended forexternal use only.	Under the supervision of ahealthcare professional, ALGS6 AgAlginate Wound Dressing may beused for management of acute andchronic, partial and full thicknesswounds including pressure ulcers,leg ulcers, diabetic foot ulcers,surgical wounds, traumatic wounds,first and second-degree burns.	Silverlon™ CA AdvancedAntimicrobial Alginate Dressing isan effective barrier to microbialpenetration for moderate to heavyexudating partial and full thicknesswounds, including pressure ulcers,venous ulcers, diabetic ulcers,donor and graft sites, traumatic andsurgical wounds and 1st and 2nddegree burns.Silverlon™ CA AdvancedAntimicrobial Dressing is indicatedfor external use only.
Device Category	Surface device, prolonged (>24hr to30d)), in contact with breached orcompromised skin	Identical	Identical
Device Design	Non-woven alginate with silver salt	Non-woven alginate with silver salt	Non-woven alginate with silvernylon contact layer
Antimicrobialagent	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
SterilityAssurance Level	SAL of 10-6	SAL of 10-6	SAL of 10-6

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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.

Regulation Number and Section

N/A