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The Luofucon Silver Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:

• · Ulcers (venous, arterial, diabetic)
• Pressure Sores
• · Donor Sites
• · Surgical Incisions
• · Surgical Excisions
• · Burns (1st and 2nd degree)

Luofucon Silver Foam Dressing is a sterile, single-use dressing composed of polyurethane and silver particles, which absorbs wound exudate and releases silver ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

The polyurethane material consists of metallic silver that provides effective protection of the dressing material (not wound) against bacterial contamination. The silver is a preservative that protects the dressing material (not wound) from a broad spectrum of bacteria over three days, based on in vitro laboratory testing.

All dressings are sterilized and sold directly to users after sterilization by EtO using conditions validated following ISO 11135-1: 2007.

The silver foam dressing in this submission consists of four variants:
The basic model, dressing without backing, is a sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth, elastic and breathable Polyurethane foam encapsulated with silver particles as an antimicrobial barrier. The product line is available in different sizes.

A second variant, non adhesive PU backing variant, has a two-layered structure: a thick layer of soft, smooth elastic and breathable Polyurethane foam encapsulated with silver particles, and a thin layer (0.025±0.005 mm thick) of non porous breathable Polyurethane film (backing film) laminated on the outer side (non-wound contacting side) of the thick layer. The thin backing has the same area as the thick soft Polyurethane layer and is for cosmetic purpose. The product line is available in different sizes.

A third adhesive variant, bordered PU adhesive backing variant, has a three-layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of Poly(ethylene terephthalate) (PET) (0.04±0.005 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The backing polyurethane layer and PET layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.

A fourth adhesive variant, bordered non-woven adhesive backing variant, is similar to the third variant and also has a three layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of non-woven material (0.28±0.02 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The non woven material is made from viscose rayon fiber and poly(ethylene terephthalate) fiber. The backing polyurethane layer and non woven layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.

The dressing has white appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size and backing.

This document is a 510(k) premarket notification for the "Luofucon Silver Foam Dressing." It describes the device, its intended use, and provides a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of acceptance criteria and the reported device performance

Note: The document explicitly states acceptance criteria for biocompatibility (conformance to specific ISO standards) and antibacterial activity (broad spectrum protection). For antibacterial duration, the acceptance criterion appears to be "at least 3 days" to show equivalence with the predicate for a "use case" of three days, even though the predicate performs for 5-7 days. The silver concentration is a specification, implying it was an acceptance criterion for manufacturing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • For biocompatibility testing, details on the number of samples (e.g., number of test specimens, animal subjects) are not explicitly stated in this summary. It mentions compliance with ISO standards, which would typically specify sample sizes for these tests.
  • For antibacterial activity, "a total of six (three Gram positive and three Gram negative) bacteria" were evaluated. This refers to the types of bacteria, not the number of physical dressing samples tested with each bacterium. The number of dressing samples per bacterial strain is not specified.
• Data Provenance: The studies were conducted for Huizhou Foryou Medical Devices Co., Ltd., which is located in Huizhou, Guangdong Province, China. The testing itself is indicated as "in vitro laboratory testing." The provenance of the actual lab where the tests were performed is not explicitly stated beyond the manufacturer's location. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document describes a medical device (wound dressing) and its performance in in vitro and biocompatibility testing. It does not involve a "test set" in the context of diagnostic or AI-driven devices that require expert-established ground truth on patient data (e.g., imaging reports). Therefore, this question is not applicable to the type of information provided. The "truth" for these tests (e.g., presence of toxicity, bacterial reduction) is determined by quantitative laboratory assays and adherence to international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this summary pertains to a medical device's in vitro and biocompatibility performance, not a diagnostic algorithm requiring human adjudication of 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

Not applicable. This is not an AI-driven diagnostic device; it's a wound dressing. Therefore, MRMC studies are irrelevant to this submission.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance claims in this submission is established through:

• Quantitative Laboratory Assays: For antibacterial activity (4 log reduction).
• Standardized Biocompatibility Protocols: Conformance to ISO 10993 series for cytotoxicity, skin irritation/sensitization, and systematic toxicity. These standards define the methods and criteria for evaluating biological responses to the device materials.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.

SUNTOUCH® Eye Spears are sterilized, single-use devices designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery. The Eye Spears include seven models which share same material. The models are different in size and configuration of plastic handle.

They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets them:

Note: The provided document describes a "Substantially Equivalent" (SE) determination, which focuses on comparing a new device to an existing legally marketed device (predicate device). This is different from a de novo premarket review where novel performance criteria might be established. Therefore, the "acceptance criteria" here largely refer to demonstrating comparable performance to the predicate device and compliance with relevant standards. The "study" is primarily a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many eye spears were tested for absorbency, or how many units for sterility). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

Data Provenance: The tests were conducted by the manufacturer, Huizhou Foryou Medical Devices Co., Ltd. located in China. The data would be considered prospective for the purpose of demonstrating the specified characteristics for this device submission.

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

This information is not applicable to this type of 510(k) submission. "Ground truth" established by experts is typically relevant for studies involving diagnosis, image interpretation, or clinical decision-making. This submission deals with the physical and biological properties of a medical device (eye spear). The acceptance criteria are based on established international and national standards (ISO, ASTM, USP, BS EN) and comparison to a predicate device, rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set

Not applicable. As the tests are non-clinical and objective (e.g., measuring absorbency, cytotoxicity), there is no "adjudication method" in the sense of resolving discrepancies between human interpretations of clinical data. The results would be objectively measured and compared against the defined standard or specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiology interpretation). This 510(k) pertains to a non-diagnostic, single-use medical device (an eye spear) and does not involve AI or human interpretation in its intended use.

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

No. This device is a physical medical instrument, not a software algorithm or an AI-powered system, so the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this device is the objective measurement against established industry and regulatory standards, and comparison to the characteristics of the predicate device.

• For biocompatibility: Adherence to ISO 10993 standards.
• For physical properties (absorbency, particulate release, etc.): Measurement against specific test methods (e.g., BS EN 13726-1, USP <789>) and demonstration of comparable performance to the predicate device.
• For sterility: Achieving a defined SAL and passing endotoxin tests.
• For packaging: Passing specified ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning model, so there is no "training set" in the context of data used for algorithm development.

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

Not applicable. As there is no training set for this device, this question is not relevant.

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Prescription: Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Luofucon Silver Alginate Dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and metallic silver particles, which absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The alginate material consists of metallic silver that provides effective protection against microbial contamination of the dressing material. Odour reduction results from the bacteria reduction effect in the dressing. The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 100 mm x 10 mm, 200 mm x 100 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.

The provided text describes two medical devices, the "Luofucon Silver Alginate Dressing (Prescription)" and the "Luofucon Antibacterial Alginate Dressing (OTC)". Both devices are essentially the same product but marketed for different intended uses (prescription vs. over-the-counter). The acceptance criteria and the study to prove the device meets these criteria are primarily focused on their antibacterial activity and biocompatibility.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for the test set regarding the antibacterial activity study (AATCC 100-2004). It mentions "six (three Gram positive and three Gram negative) bacteria" were tested, but not the number of dressing samples or replicates per bacteria.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the studies were conducted by Huizhou Foryou Medical Devices Co., Ltd. in China, so the data would likely originate from their internal testing facilities. The nature of these tests (antibacterial efficacy, biocompatibility) implies they are prospective bench studies conducted specifically for this submission, rather than retrospective clinical data.

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

This type of information is not applicable to the studies described. The "ground truth" for these tests (biocompatibility, antibacterial activity) is established through standardized laboratory assays (e.g., ISO, AATCC standards), not by expert consensus or clinical assessment of a test set in the way a diagnostic imaging device might require.

4. Adjudication Method for the Test Set

This is not applicable as the studies are laboratory-based and do not involve human interpretation or adjudication of results in the traditional sense of clinical trials. The results are quantitative measurements against established scientific benchmarks.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the device's impact on their performance is assessed. The submitted information is for a wound dressing, and the studies focus on its physical, chemical, and biological properties, not on human interpretive performance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done in the context of the antibacterial activity and biocompatibility testing. The "device" in this instance (Luofucon Silver Alginate Dressing) was tested directly and its performance was measured independently against established standards (AATCC 100-2004 for antibacterial activity, ISO 10993 series for biocompatibility). There is no "human-in-the-loop" component to these specific performance assessments.

7. Type of Ground Truth Used

The ground truth for the studies described is based on standardized laboratory test results and existing consensus standards.

• For antibacterial activity, the ground truth is defined by the AATCC 100-2004 standard, which dictates methods for quantitative bacterial reduction. The "truth" is the measured percentage reduction compared to controls.
• For biocompatibility, the ground truth is defined by the ISO 10993 series of standards, which specify acceptable levels for cytotoxicity, irritation, sensitization, and systemic toxicity. The "truth" is whether the device materials pass these established safety thresholds.

8. Sample Size for the Training Set

This information is not applicable. The device described is a physical medical dressing, not an AI/ML algorithm that requires a "training set" in the computational sense. The product's properties are inherent to its materials and manufacturing, not learned from data.

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

This question is not applicable for the same reason as #8.

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Prescription: Suntouch Topical Hemostatic Dressing is indicated for the management of topical wounds and to temporary control of external surface bleeding.
Over the Counter: Suntouch Topical Hemostatic Dressing is indicated for temporary external topical bleeding of minor cuts, minor lacerations, and it is contraindicated for internal use.

The Suntouch Topical Hemostatic Dressing is made from regenerated cotton cellulose, chemically treated to become water-soluble. When contacting blood and exudates, they expand into clear gel, thereby adhering and creating pressure to seal the wound. The gauzes are sold in the following forms: Sheet, rolls, and pack (four layers).

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text, specifically regarding the "Suntouch Topical Hemostatic Dressing":

This document outlines a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "study" described largely involves comparative performance testing against the predicate device and adherence to recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the performance of the "Suntouch Topical Hemostatic Dressing" to known performance metrics of a predicate device (Bloodstop Hemostatic Gauze, K072681/K071578). The key criteria relate to hemostatic performance and biocompatibility.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Hemostatic Performance Test (Swine Neck Artery Wound): The sample size is not explicitly stated in the provided text. It mentions "Stop bleeding tests were conducted on swine neck artery wound."
• In Vitro Procoagulant Test: Sample size not explicitly stated.
• Biocompatibility Tests: Sample size not explicitly stated for individual tests (Cytotoxicity, Skin Irritation, Systemic Toxicity, Pyrogenicity).
• Data Provenance: The hemostatic performance tests and biocompatibility tests appear to be prospective experiments conducted specifically for this submission. The origin of the data is implied to be from the manufacturer's testing facility or a contracted lab. The document does not specify a country of origin for the test data itself, beyond the manufacturer being in China.

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

This type of information is generally not required or provided in a 510(k) submission that relies on bench testing and comparison to predicates for performance. The "ground truth" for these tests (e.g., actual bleeding time, blood loss, presence of toxic effects) is established by the standardized protocols of the tests themselves, rather than expert consensus on individual cases. The tests are objective measurements.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective, quantitative measurements (e.g., time, mass, presence/absence of an effect), not subjective assessments requiring adjudication by human readers/experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical assessments where human interpretation plays a significant role. This submission focuses on a physical device for wound care with objective performance measures.

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

Yes, a standalone performance assessment was done for the device regarding its hemostatic and biocompatibility characteristics. The device's performance was evaluated independently against control dressings (for hemostasis) and against established standards (for biocompatibility). This is essentially an "algorithm only" equivalent, as it's the device's inherent property being measured, not its interaction with a human operator.

7. Type of Ground Truth Used:

• Hemostatic Performance: Objective measurements of physiological outcomes (stop bleeding time, blood loss) on an animal model (swine neck artery wound). The "control dressing" served as a baseline.
• In Vitro Procoagulant Test: Objective measurement of physiological outcome (blood clotting time) in an in-vitro setting.
• Biocompatibility: Established by adherence to international consensus standards (ISO 10993 series), which define acceptable biological responses. The ground truth here is the fulfillment of these predefined biological safety criteria.
• Chemical Structure: Established by analytical chemistry techniques (Infrared Spectroscopy), where an "identical" spectrum to a predicate device serves as confirmation of the basic chemical structure.

8. Sample Size for the Training Set:

This concept is not directly applicable to this type of device submission. The "training set" is a term typically used in machine learning or AI algorithm development. For a physical medical device, there isn't a "training set" in the same sense. The development of the device itself involves iterative design and testing, but not a formally defined "training set" from which an algorithm "learns."

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

As mentioned above, the concept of a formal "training set" with established ground truth is not relevant here. The development process for a physical device involves R&D, material science, engineering, and iterative testing, where "ground truth" for design decisions comes from scientific principles, material properties, and preliminary testing, not from a labeled dataset.

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