(133 days)
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
| Criterion Type | Specific Criterion (if stated) | Reported Device Performance / Status |
|---|---|---|
| Clinical Efficacy | Shortening time to healing of herpes simplex labialis lesions (implied from predicate's performance) | "highly consistent with the predicate device (K22205)" in intended use and technical parameters. No direct clinical study on the subject device's efficacy is presented. |
| Non-Clinical Safety | Conformance to various IEC/ANSI/ISO standards (e.g., electrical safety, EMC, photobiological safety) | Non-clinical tests were performed to assure conformance. (Specific results not provided, but presumed to meet standards for clearance). |
| Biocompatibility | Conformance to ISO 10993 series (cytotoxicity, irritation, skin sensitization) | Biocompatibility tests performed and conformance stated. (Specific results not provided, but presumed to meet standards for clearance). |
| Software Validation | Conformance to FDA's 2023 Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." | Software verification and validation testing conducted. Documentation provided. Software documentation level considered "basic level" as failure could result in minor injury. (Specific results not provided). |
| Human Factors/Usability | Ability of users to make correct self-selection, operate the device, and comprehend labeling. | All 45 subjects made correct self-selection (3 found unsuitable). All 42 remaining subjects performed usability operation correctly. All 42 subjects correctly understood label information. |
| Technical Parameters (vs. Predicate) | Wavelength: 1072nm +/- 12nm, Energy Source: LED, Treatment Schedule: 3X/day, 4 hours between treatments, for 2 consecutive days, Auto-off feature: Yes, Treatment time: 3-minute, Treatment area: 3 cm², Energy density: 20 mw/cm² | Subject device matches all these parameters with the predicate device. |
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.
§ 878.4860 Light based energy source device for topical application.
(a)
Identification. The device emits light energy at near infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions on or around the lips.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, including wavelength, treatment time, treatment area, energy density, spot size, and power, must be characterized.
(2) The cleaning and disinfection instructions for the device must be validated.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must validate electromagnetic compatibility (EMC), ocular safety, and electrical safety of the device.
(5) Labeling must direct end-users to contact the device manufacturer and MedWatch if they experience any adverse events when using this device.
(6) Labeling must include specific information pertinent to use of the device by the intended patient population and the treatment regimen.
(7) Simulated use testing must include information from a usability, label comprehension and self-selection study to demonstrate that the device can be used by the intended patient population without any assistance.
(8) Clinical data must show adequate reduction in time to healing and assess risks of redness, discomfort, burns, and blisters.