(281 days)
Not Found
No
The device description and performance studies focus on the material properties and antibacterial activity of the wound dressing, with no mention of AI or ML.
Yes
The device, LT Antibacterial Alginate with Silver Dressing, is intended for the management of various acute and chronic wounds, including pressure ulcers, venous ulcers, diabetic ulcers, and burns, which indicates a therapeutic purpose. It also provides a moist environment for healing and inhibits bacterial growth, which are therapeutic actions.
No
The device, LT Antibacterial Alginate with Silver Dressing, is a wound care dressing used for management of wounds, not for diagnosis. Its function is to absorb wound fluid, provide a moist environment, and inhibit bacterial growth, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a wound care dressing composed of physical materials (calcium alginate and silver salt) and is available in pad and ribbon configurations, indicating it is a physical medical device, not software.
Based on the provided information, the LT Antibacterial Alginate with Silver Dressing is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "management of acute and chronic wounds." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound dressing that absorbs fluid, provides a moist environment, and inhibits bacterial growth in the dressing. This is a topical treatment applied directly to the wound, not a device that analyzes biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances from the patient's body for diagnostic purposes.
- Performance Studies: The performance studies focus on biocompatibility, antibacterial activity, physical properties of the dressing, and wound healing in an animal model. These are relevant to the safety and efficacy of a wound dressing, not the performance of a diagnostic test.
In summary, the LT Antibacterial Alginate with Silver Dressing is a therapeutic medical device intended for wound care, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing Summary: 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
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 .
No clinical testing was required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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)
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ |
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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, 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
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.