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510(k) Data Aggregation
(668 days)
NEW REGULATION NUMBER: 21 CFR 878.4880
CLASSIFICATION: Class II
PRODUCT CODE: OPE
BACKGROUND
Phototherapy device for reducing the appearance of acute post-surgical incisions Regulation Number: 21 CFR 878.4880
The Klox Biophotonic LumiHeal™ System is indicated to provide blue light and fluorescent light energy for use on post-surgical incisions for scar management. The System is intended to be used in FST I-IV female patients 22 years and over.
The Klox Biophotonic LumiHeal System is a device which consists of a blue light emitting Multi-LED Light device (KT-L Lamp) with emitted wavelengths of 440-460nm and a topical photoconverter gel (LumiHeal Gel). When the gel is illuminated by the LED device, it will emit fluorescence with blue, green, yellow, and orange wavelengths between 400mm to 625mm. The fluorescence mixed with the excitation blue light is used for scar management (i.e., reducing the appearance of acute post-surgical incisions).
The KT-L Lamp (Figure 1) has a timer and a distance sensor with which the system set the illumination time at 5 min and distance between the lamp and the wound area at 5cm. For the KT-L Lamp interface, press the Distance Verification Button to measure the distance. Display Screen should read approximately 50mm. Press the Time Display Button to return display to Timer Mode. During the illumination, it is possible to toggle between the Timer Mode or Measure Mode by pressing either the Time Display Button or the Distance Verification Button. Time remaining during illumination will be displayed in minutes (min). The lamp comes equipped with a power cable, 2 pairs of protective eyeglasses, and a user manual. The device specification is shown in the Table 1.
The LumiHeal Gel is provided as a two-component gel (Figure 2), specifically Jar A (25g) and Jar B (2.5g). The two components of the LumiHeal Gel are intended to be mixed immediately prior to use. Jar A is the carrier gel and Jar B is the chromophore gel. The LumiHeal Gel is applied just before use and is intended to remain in contact with the surface of wound for 5 minutes during the light exposure and application. After the 5-minute application period, exposure to the KT-L Lamp is discontinued and the LumiHeal Gel is removed.
The purpose of the LumiHeal Gel is to facilitate conversion of the non-coherent blue light wavelength from the KT-L Lamp into blue, green, yellow and orange wavelength light between 400nm to 625mm at the skin surface.
Acceptance Criteria and Device Performance for Klox Biophotonic LumiHeal System
This response synthesizes the acceptance criteria and study findings for the Klox Biophotonic LumiHeal System, as described in the provided regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for effectiveness in a quantitative manner (e.g., "device must achieve X% improvement in Y score"). Instead, it describes general expectations for safety and performance (mitigation of risks) and then reports the study's effectiveness findings. Thus, the acceptance criteria are inferred from the stated benefits and the demonstrated performance.
| Acceptance Criteria (Inferred from Risks & Benefits) | Reported Device Performance |
|---|---|
| Safety: | Safety: |
| 1. Biocompatibility: Patient-contacting components must be biocompatible (prevent adverse tissue reactions). | Biocompatibility assessment was adequate for both light-exposed and non-exposed photoconverter gel. Conclusion: "risk of a clinically significant biocompatibility concern is low." (Section: BIOCOMPATIBILITY/MATERIALS) |
| 2. Sterility: Patient-contacting components must be sterile to prevent infection. | LumiHeal Gel Jar B is terminally sterilized via autoclaving. Preservative effectiveness testing per USP for real-time aged Jar A and packaging integrity testing were performed. "The test gels met the acceptance criteria for each test." (Section: SHELF LIFE/STERILITY) |
| 3. Shelf Life: Photoconverter gel must maintain sterility and functional performance over its shelf life. | Shelf life testing performed (preservative effectiveness, packaging integrity); "The test gels met the acceptance criteria for each test." (Section: SHELF LIFE/STERILITY) Performance after simulated 5 years of service life met specifications. (Section: PERFORMANCE TESTING - BENCH, last bullet point) |
| 4. Electrical & Thermal Safety: Device must be electrically/thermally safe and electromagnetically compatible. | The KT-L lamp passed all relevant portions of IEC 60601-1 and IEC 60601-1-2 testing. (Section: ELECTROMAGNETIC CAPABILITY & ELECTROMAGNETIC SAFETY) Evaluation of heat dissipation showed skin temperatures remained "*within a safe temperature range ( |
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(59 days)
Name: Stapler, Surgical; Classification: II; Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4880
The PANTHER Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
The proposed device, PANTHER Cutter Stapler, is sterilized and disposable surgical instruments, which is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
It delivers four staggered rows of titanium staples with a knife that divides the tissue simultaneously between the second and third row of staples. The PANTHER Cutter Stapler may be reloaded and fire no more than 6 times in a single procedure.
This document is a 510(k) Premarket Notification from the FDA regarding the "PANTHER Cutter Stapler". It is a regulatory document and does not contain information about a study that proves the device meets specific acceptance criteria in the manner of an AI/algorithm-based medical device.
Instead, this document describes the device, its intended use, and states that no clinical or animal studies were included in the submission. The manufacturer relies on bench testing to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information in the format of an AI/algorithm study. However, I can provide the available information regarding the bench tests mentioned:
Acceptance Criteria and Device Performance (Bench Tests)
The document mentions that bench tests were conducted to confirm substantial equivalence to a predicate device, not to meet specific quantitative performance metrics against clinical ground truth. The acceptance criteria for these bench tests would typically be defined by engineering specifications and comparative performance to the predicate device. The document does not provide the specific numerical acceptance criteria or the reported performance values for each test.
| Acceptance Criteria Category (Implied by Test Name) | Reported Device Performance (No specific values provided in document) |
|---|---|
| Physical Specification | "perform as intended and are substantially equivalent" |
| Closed Staple Height Dimensions | "perform as intended and are substantially equivalent" |
| Pressure Resistance | "perform as intended and are substantially equivalent" |
| Maximum Tensile Strength | "perform as intended and are substantially equivalent" |
| Force Required to Fire Stapler | "perform as intended and are substantially equivalent" |
Since this is a submission for a surgical stapler and not an AI/algorithm device, the following points are not applicable or the information is not provided in the document:
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/algorithm study. For the bench tests, the sample sizes are not provided in this regulatory summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench test results are typically measured against engineering specifications or compared directly to a predicate device's performance, not expert consensus as ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical study is included in this submission."
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not an AI/algorithm device.
- The type of ground truth used: For the bench tests, the "ground truth" would be the engineering specifications and the performance of the predicate device.
- The sample size for the training set: Not applicable, as no AI model is being trained.
- How the ground truth for the training set was established: Not applicable.
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