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The Cold Sore Device is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

The Cold Sore Device is a solid state opto-electronic device that emits a controlled quantity of 1072nm +/- 12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The tip of the device that contacts the patient is made out of Acrylonitrile Butadiene Styrene (ABS) + PC. Treatment with the device is commenced at the first symptoms of a cold sore 3 times a day with 4 hours in between each treatment for 2 consecutive days. The treatment area is approximately 3 cm². There are 2 light emitting diodes (LEDs) in the treatment area. The light within the device is activated by opening the cover of the device and automatically shut down after the pre-programmed treatment time (3 minutes). The device is designed for external, limited duration skin contact in an environment free from fluids and is provided non-sterile. The LEDs do not come in direct contact with the patient based upon the design of the device. The device is for OTC use and single patient use as described in the patient and box labeling.

The provided text is a 510(k) summary for the Cold Sore Device (QPZ-03) and does not contain the specific information requested about acceptance criteria and a study proving device performance in the context of clinical efficacy (shortening time to healing).

Instead, the summary focuses on demonstrating substantial equivalence to a predicate device (QPZ-01) based on non-clinical tests, physical characteristics, and intended use. The core argument for equivalence is that the subject device's technical parameters (wavelength, treatment time, etc.) are "highly consistent" with the predicate device, which presumably had clinical data supporting its efficacy.

Therefore, many of the requested fields cannot be filled directly from this document. I will highlight what information is available and what is explicitly stated as not performed or applicable.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance Study (as described in the document):

The document does not detail specific acceptance criteria for clinical effectiveness (e.g., a target reduction in healing time) that the new device directly met through a clinical study. Instead, it relies on demonstrating substantial equivalence to a predicate device which implies the predicate device had met such criteria. The reported "performance" for the subject device is largely in terms of its technical specifications aligning with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Usability Study:

  • Sample Size: 45 subjects for self-selection, reduced to 42 subjects for usability and label comprehension.
  • Data Provenance: Not explicitly stated, but implies a prospective study conducted by the manufacturer for regulatory submission. Country of origin not specified, but the manufacturer is based in China.

• For Clinical Efficacy (if a separate study existed): Not applicable, as the document explicitly states "So, there is no clinical test on our device" (referring to the subject device for clinical efficacy). Efficacy is established through substantial equivalence to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For Usability Study: The document mentions "researchers" and "investigator recorded the operation of the subject" but does not detail the number or qualifications of experts involved in objectively establishing "ground truth" (e.g., whether a correct operation was performed). It appears the researchers/investigators themselves made these judgments based on whether the instructions were followed.
• For Clinical Efficacy: Not applicable, as no clinical study was performed on the subject device.

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

• For Usability Study: No formal adjudication method like "2+1" or "3+1" is described. The "researchers" and "investigators" are implied to have made direct observations and judgments.
• For Clinical Efficacy: Not applicable, as no clinical study was performed on the subject device.

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 device is a light-based treatment device, not an AI-assisted diagnostic tool involving "human readers."

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

• Not applicable. This is a physical treatment device, not an algorithm. Its operation is standalone in the sense that once activated, it delivers light therapy for a set duration, but this does not equate to "algorithm only performance" in the context of diagnostic AI.

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

• For Usability Study: The "ground truth" was whether subjects could correctly follow instructions for self-selection, device operation, and label comprehension, as judged by the "researchers/investigators."
• For Clinical Efficacy: Not applicable for the subject device. For the predicate device, it is implied that the clinical ground truth for "shortening the time to healing of herpes simplex labialis lesions" would have been patient-described re-epithelialization or similar clinical outcomes data.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set in that sense.

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

• Not applicable. See point 8.

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The Cold Sore Device is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

The Cold Sore Device is a solid state opto-electronic device that emits a controlled quantity of 1072mm +/-12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The tip of the device that contacts the patient is made out of Acrylonitrile Butadiene Styrene (ABS) + PC. Treatment with the device is commenced at the first symptoms of a cold sore 3 times a day with 4 hours in between each treatment for 2 consecutive days. The treatment area is approximately 3 cm². There are 2 light emitting diodes (LEDs) in the treatment area. The light within the device is activated by opening the cover of the device and automatically shut down after the preprogrammed treatment time (3 minutes). The device is designed for external, limited duration skin contact in an environment free from fluids and is provided non-sterile. The LEDs do not come in direct contact with the patient based upon the design of the device. The device is for OTC use and single patient use as described in the patient and box labeling.

The provided text is a 510(k) summary for the Cold Sore Device (Model: QPZ-01). It outlines the device's characteristics, its comparison to a predicate device, and the testing conducted to support its substantial equivalence. However, the document explicitly states that "no clinical test on our device" was performed. This means the information requested about acceptance criteria and studies proving the device meets those criteria through clinical trials (e.g., sample size for test set/training set, expert involvement, adjudication, MRMC studies, standalone performance, ground truth establishment) cannot be extracted from this document because such studies were not conducted for this submission.

The FDA cleared this device based on its substantial equivalence to a predicate device (ViruLite Cold Sore Machine) and extensive non-clinical testing, including electrical safety, electromagnetic compatibility, photobiological safety, usability, and biocompatibility.

Here's a breakdown of what can be extracted and what cannot:

What can be extracted/inferred:

• Acceptance Criteria (Implied): The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with relevant safety and performance standards. The key performance measure for the intended use is "shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization." The submission argues that since the new device has the same wavelength, energy density, and treatment schedule as the predicate, it is expected to achieve similar efficacy.
• Device Performance (Reported): The device is reported to emit a controlled quantity of 1072nm +/-12nm peak wavelength near infrared light with a maximum peak light intensity of 20mW/cm² for approximately 3 minutes.
• Sample size used for the test set and the data provenance: No clinical test set was used to evaluate efficacy directly. Usability testing was conducted with 45 initial subjects (3 withdrew for not being suitable), and then 42 subjects participated in a usability study and label comprehension. The provenance of this usability data is not specified beyond "simulated user's home environment".
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for efficacy data, as no clinical study was performed. For usability, "researchers" made judgments, but their qualifications are not specified beyond their role in the study.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for efficacy data. For usability, "investigator will record the operation of the subject" and "investigators will record and analyze responses," implying a direct observation/analysis by the researchers. No formal adjudication process with multiple independent reviewers is described.
• 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, as this is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical light therapy device, not an algorithm.
• The type of ground truth used: Not applicable for efficacy data. For usability, the ground truth was the ability of subjects to correctly self-select, perform device operations, and comprehend labeling based on researcher observation/evaluation.
• The sample size for the training set: Not applicable, as no algorithm/AI training was performed.
• How the ground truth for the training set was established: Not applicable, as no algorithm/AI training was performed.

Summary Table of Applicable Information (based on the provided document):

In conclusion: The device was cleared based on its substantial equivalence to a legally marketed predicate device, along with extensive non-clinical and usability testing, as explicitly stated in the "Discussion of Clinical Tests Performed" section: "So there is no clinical test on our device." This type of submission relies on proving the new device is as safe and effective as a previously cleared device, rather than conducting new clinical trials to establish de novo efficacy.

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The ViruLite Cold Sore Machine is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.

The ViruLite is a solid state opto-electronic device that emits a controlled quantity of 1072nm +/- 12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The power source is a standard alkaline 9V battery. which is replaceable. The tip of the device that contacts the patient is made out of Acrylonitiile Butadiene Stvrene (ABS).

Here's an analysis of the provided text to extract the acceptance criteria and study details for the ViruLite Cold Sore Machine:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ViruLite Cold Sore Machine are primarily focused on demonstrating clinical benefit (shortening time to healing for herpes simplex labialis lesions) and safety. The clinical performance data provided supports these criteria.

| Trial | Healing Time in Days (Device) | Healing Time in Days (Placebo) | Difference (Placebo - Device) |
| Dougal and Kelly 2001 | 4.3 +/- 1.8 | 8.5 +/- 1.8 | 4.2 days |
| Dougal and Haslam 2004 | 5.1 +/- 3.1 | 6.8 +/- 2.8 | 1.7 days |
| Hargate 2006 | 6.3 +/- 3.0 | 9.4 +/- 4.6 | 3.1 days |
| Lee, Hargate and Dougal 2004 | 5.9 +/- 2.6 | 7.9 +/- 0.3 | 2.0 days |

The requester's own randomized clinical trial also indicated a trend towards effectiveness, though it had data collection and consistency concerns that prevented it from being standalone proof of effectiveness. |
| Clinical Safety | Assess risks of redness, discomfort, burns, and blisters. | Low risk profile demonstrated. The requester's randomized clinical trial reported no major long-lasting complications, only "mild blistering, burning or redness in some patients." This was consistent with what was observed in the four additional submitted datasets and with other light-based technologies. The overall risk was determined to be low. |
| Usability/Label Comprehension |

• Device can be used by the intended patient population without assistance.
• Labeling comprehension for OTC use.
• Appropriate for ages 16 and older. | Demonstrated through two usability studies.
• Combined, 47 out of 49 subjects correctly answered questions about appropriate actions in hypothetical scenarios, indicating good labeling comprehension and usability.
• The studies were conducted on subjects 16 years of age or older, and it was determined that 16-year-olds could comprehend and follow instructions, and there was little physiological difference between 16-19 and 20+ year-olds. |
  | Biocompatibility | Device must be demonstrated to be biocompatible. | Acceptable. The ABS material used for patient contact was evaluated per ISO 10993-1:2003 for cytotoxicity, irritation, and sensitization and found acceptable, as it's a widely used medical material. |
  | Cleaning & Disinfection | Cleaning and disinfection instructions for the device must be validated. | Validation Required pre-market. The text states that "Cleaning and disinfection validation data to verify the effectiveness of the cleaning and disinfection instructions are required prior to marketing the ViruLite, otherwise the device is considered to be misbranded and adulterated." This implies it was an outstanding requirement for full market acceptance, not necessarily a completed study at the time of this document, but critical for final acceptance. Labeling includes instructions. |
  | Ocular Safety | Performance testing must validate ocular safety. | Acceptable. ViruLite was tested according to IEC 64721:2008 (despite not being an FDA-recognized standard, accepted due to similar prior devices) operating at worst-case continuous LED operation for 8 hours. The measured exposure limit was below the standard's acceptable limit. |
  | Electrical Safety | Performance testing must validate electrical safety. | Accepted. The device was subjected to electrical safety testing performed in accordance with EN60601-1:1993. |
  | Electromagnetic Compatibility (EMC) | Performance testing must validate EMC. | Accepted. The device was subjected to EMC testing performed in accordance with EN60601-1-2:1993. |
  | Software | Software performs as intended and all software-related risks have been adequately mitigated. | Acceptable. The software was deemed to have a minor level of concern. The requester provided comprehensive documentation (requirements, design, traceability, V&V tests, risk analysis) that provided reasonable assurance the software performs as intended. |
  | Technical Parameters | The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized. | Characterized. The document describes: 1072nm +/- 12nm peak wavelength, ~3-minute treatment duration, 20mW/cm² maximum peak light intensity, ~7cm² treatment area, 2 LEDs. |
  | Labeling |
• Complies with 21 CFR 801 and FDA's Guidance on Medical Device Patient Labeling (2001).
• Direct users to contact manufacturer and MedWatch for adverse events.
• Includes specific information pertinent to use by intended patient population and treatment regimen. | Complies. The document explicitly states compliance with 21 CFR 801 and the guidance. The MedWatch adverse event reporting statement is directly quoted in the text. The various warnings, precautions, contraindications, and instructions for use (e.g., "Do not use except for cold sores...", "not to prevent cold sores...", "not studied in immunocompromised...") demonstrate specific patient information. |

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

The "test set" for clinical effectiveness and safety primarily refers to the patient data used in the clinical studies.

• Requester's Randomized Clinical Trial:

  • Sample Size: Total of 95 subjects (ages 20 years and above).
    • 48 subjects in the active (treatment) arm.
    • 47 subjects in the control (placebo) arm.
  • Data Provenance: Not explicitly stated but implied to be a prospective, double-blind, placebo-controlled, randomized clinical trial conducted by the requester. Location is not given, but likely the country where the company is based or a region allowing such trials.

• Four Additional Data Sets (Supporting Effectiveness):

  • Dougal and Kelly 2001: 56 subjects
  • Dougal and Haslam 2004: 54 subjects
  • Hargate 2006: 32 subjects
  • Lee, Hargate and Dougal 2004: 87 subjects
  • Data Provenance: These are listed as studies from 2001, 2004, and 2006. The exact country of origin is not explicitly mentioned but the authors' names (Dougal, Kelly, Haslam, Hargate, Lee) suggest a Western context (e.g., UK, USA, Australia). They are retrospective in the sense that they were submitted to support the De Novo request but were conducted prior to this specific submission. They are described as double-blind, placebo studies.

• Usability Studies:

  • Sample Size:
    • First study: 9 subjects.
    • Second study: 40 additional subjects (totaling 49, with 2 withdrawals).
    • Combined: 47 subjects (passed) out of 49.
  • Data Provenance: Not specified, but likely conducted by the requester in a relevant country for OTC use within the target population. Prospective.

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

The ground truth for the clinical effectiveness (time to healing) was primarily established by patient self-assessment. The primary endpoint was "time to healing" defined as "patient described re-epithelialization". Therefore, no external experts were explicitly mentioned for establishing this specific clinical ground truth.

4. Adjudication Method for the Test Set

Given that the primary endpoint was "patient described re-epithelialization," there was no formal external expert adjudication method (like 2+1 or 3+1 consensus) explicitly described for the clinical effectiveness data. The patients themselves provided the "ground truth" for healing time.

For internal study consistency and data integrity, there would have been study coordinators or investigators involved, but the ultimate "truth" for the primary endpoint came directly from the patient's report.

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

No obvious MRMC comparative effectiveness study was described. The studies compared the device to a placebo (or acyclovir in one instance for a specific arm), and the endpoint was patient-reported healing time, not an assessment by human readers. The concept of "human readers improving with/without AI assistance" does not apply here as it's a device for direct physical treatment, not an imaging or diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary clinical effectiveness studies are essentially "standalone" evaluations of the device. The ViruLite device is a physical light therapy device, not an algorithm. Its performance is measured directly by its effect on the patient (reduced healing time) without human intervention in its outcome assessment process beyond the patient's own reporting. The intervention itself (device use) is by the human (patient).

7. The Type of Ground Truth Used

• Clinical Effectiveness (Healing Time): Patient-described re-epithelialization. (Outcomes data - specifically patient-reported outcome).
• Clinical Safety: Patient self-reports of adverse events (redness, discomfort, blistering, burning), and overall absence of "major long-lasting complications."
• Usability: Subject responses to questions regarding labeling comprehension and appropriate actions in hypothetical scenarios.

8. The Sample Size for the Training Set

The provided document does not discuss a "training set" in the context of an AI/machine learning model. The ViruLite is a hardware device with "software" to monitor button presses, control LEDs, and manage the 3-minute treatment cycle. This software is not a machine learning algorithm that learns from data. Therefore, the concept of a training set as typically understood for AI models does not apply here. The software review was about demonstrating it performs as intended, not about training an AI.

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

As explained in point 8, there is no "training set" for an AI model. The software's "ground truth" in this context would be defined by the functional requirements in its software requirements specification (e.g., "ON button press correctly initiates treatment cycle," "LEDs activate at specified wavelength," "treatment duration is 3 minutes +/- tolerance"). These were established by the device's design specifications and verified through standard software and hardware testing (verification/validation tests), not through empirical data training.

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