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510(k) Data Aggregation
(247 days)
Tranberg CLS Laser Fiber
The TRANBERG CLS Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology, at a wavelength of 1064nm.
The TRANBERG CLS Laser fiber is used to transfer laser energy from the laser unit to the location for the treatment. The laser fiber is an optical fiber with a core of 550 mic and radial diffusor. The length is 3m and it has a standard connector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The material in contact with human tissue is biocompatible. The TRANBERG CLS Laser fiber is delivered sterile and for single use only.
The provided document describes a 510(k) premarket notification for the TRANBERG CLS Laser Fiber, which is a medical device used for necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, the demonstration of substantial equivalence relies on comparing the device's technological characteristics and performance (as assessed through bench testing) to a legally marketed predicate device. The performance is assessed against general safety and performance standards rather than specific numerical criteria.
| Feature / Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (TRANBERG CLS Laser Fiber) |
|---|---|---|
| Intended Use | Necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in various surgical specialties at 800nm-1064nm wavelength. | Necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in various surgical specialties at 1064nm wavelength. (Matches predicate, but narrower wavelength range for the new device). |
| Regulatory Class | Class II, GEX Product Code | Class II, GEX Product Code |
| Fiber Core Diameter | 400 µm (range 200 – 1000 µm) | 550 µm |
| Numerical Aperture | 0.37 | 0.22 |
| Fiber Length | 3-12m standard | 3m |
| Proximal Connector | SMA 905 | SMA 905 |
| Wavelength | 532-1064nm | 1064 nm |
| Laser Operation Mode | Continuous Wave | Continuous Wave |
| Diffusing Region Length | 7.5-30mm | 1 mm |
| Diffusing Tip Assembly Diameter | 0.6-1.4mm | 1.55 mm |
| Lesion Shape | Ellipsoidal / Round | Round |
| Max Power | 8W for 400µm | 8W for 550µm (Indicated higher power capacity for larger fiber) |
| Lesion Volume | 0.8 cm³ | 0.8 cm³ (Refer to Report DV-2015-024) |
| Biocompatibility | Biocompatible materials | Meets biocompatibility standards |
| Safety and Performance | Meets applicable ISO, IEC, and FDA standards | Meets applicable ISO, IEC, and FDA safety and performance standards (demonstrated via engineering bench testing) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set with human subjects. The testing described is non-clinical bench testing.
- Data Provenance: The document does not specify the country of origin for the non-clinical bench testing data, but the manufacturer is Clinical Laserthermia Systems, AB, in Lund, Sweden. The testing appears to be retrospective in the sense that it was conducted before the 510(k) submission to demonstrate equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This was a non-clinical bench study. There was no "ground truth" derived from expert review of data in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process for clinical or image data is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There are no animal or clinical data submitted with this Notification." This type of study would involve human readers and AI assistance, neither of which is relevant to the data submitted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a conceptual sense, a "standalone" performance assessment of the device was done, but not in the context of an AI algorithm. The device itself (the laser fiber) was tested on a benchtop to ensure it met performance specifications and was substantially equivalent to its predicate. This is a standalone assessment of the physical device's functionality.
7. The Type of Ground Truth Used
For the non-clinical bench testing, the "ground truth" was established by engineering measurements and compliance with industry standards. For example, lesion volume was measured and compared to the predicate's reported lesion volume. Biocompatibility was assessed against established standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical laser fiber, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
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