(252 days)
The Tranberg 65 Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
The TRANBERGCSS|Thermal Therapy System consists of three parts:
- TRANBERGCSS|Mobile Laser
- TRANBERGCLS|Temperature Sensor ●
- Applicator Kit (The Applicator kit is not included)
The mobile laser unit is provided with a laser generator operating at the wavelength 1064 nm. The generated laser light is locally applied by means of a single use applicator kit through a less invasive surgical or percutaneous procedure. The energy within the laser light is absorbed by the tissue resulting in increased tissue temperature. Tissue heating and lesion formation is controlled by a tissue temperature feedback system integrated into the TRANBERGCS | Thermal Therapy System.
The document describes the TRANBERG® CLS Thermal Therapy System and its substantial equivalence to a predicate device, the PhoTex 30 Diode Laser Series (K092197). The device is a laser surgical instrument for soft tissue ablation, vaporization, excision, incision, and coagulation.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance & Equivalence:
The document doesn't present "acceptance criteria" in the typical format of a threshold to be met, but rather compares the technological characteristics of the TRANBERG® CLS Thermal Therapy System with its predicate device to demonstrate substantial equivalence. The "Acceptance Criteria" here are implicitly the predicate device's existing characteristics and performance, which the new device aims to match or exceed for safety and effectiveness.
| Parameter | Predicate Device (PhoTex 30 Diode Laser Series, K092197) | TRANBERG® CLS Thermal Therapy System (New Device) |
|---|---|---|
| Intended Use / Indications | "The PhoTex30 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery." | "The Tranberg CLS Thermal Therapy System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery." |
| Wavelength | 980nm, 810nm or 940 nm | 1064nm (Adapted to indication for use of the laser applicator/hand piece) |
| Output power | 3W – 30W at output port | 1W - 25W at output port |
| Output power accuracy | +/- 20% of selected value | +/- 10% of selected value |
| Mode of operation | Continuous wave (CW), pulsed, or external modulation modes. | Continuous wave or controlled by tissue temperature monitored by a temperature sensor |
| Output power increments | 0.5 W | 1W |
| Operating temperature | 10-35 °C | 15°C to 28°C |
| Weight | 20 lbs (9.1kg) | 18 Kg |
| Audio Warning Signal Level | HIGH, MEDIUM, LOW, and OFF | Fixed at HIGH |
| Temperature sensors | No | Yes |
| Performance | The BioTex device is verified and validated together with the Applicator kit cleared under K053087. | The CLS device is verified and validated to have the same performance when used together with the Applicator kit cleared under K053087. |
| Other Parameters | Mostly identical elements like Product Code (GEX), Device Class (2), Manufacturer (BioTex, US vs. Clinical LaserThermia Systems CLS, Sweden), Cooling (TEC), Channel(s) (1), Output port (SMA 905), Aiming wavelength (650 nm vs. 635 nm), Laser type IEC60825-1 (Class IV), Power source (100-240 V AC / 50-60 Hz), Foot switch operation (On/Off), Emergency switch (Yes), Key activation of laser output (Yes), Remote Interlock (Yes), Power ON/OFF Visual Indicator (Yes), Laser Emission Indicator (Yes), Internal Laser Power Monitor (Yes), Manual Reset (Yes), Fiber Insertion Interlock (Yes), Laser Emission Energy Monitoring (Yes), Safety classification FDA (Class II), Pump for cooling liquid for applicator (Yes), and Applicator kit interface. |
Study Proving Acceptance Criteria (Substantial Equivalence):
The study to prove the device meets the acceptance criteria is a non-clinical bench testing comparison to a legally marketed predicate device (K092197: BioTex, Inc.; PhoTex30 Diode Laser).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a numerical sample size. The "test set" for this type of submission typically refers to the testing conducted on the device itself against various standards and specifications. It does not involve a human patient data test set in the way a clinical study would.
- Data Provenance: The testing was non-clinical bench testing, meaning it was conducted in a lab environment. The document does not specify a country of origin for the data beyond "Non-clinical bench performance testing." It is implied to be from a controlled lab environment. The testing is prospective in the sense that it evaluates the new device's performance against predefined standards and the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of submission. Ground truth, in the context of expert consensus, pathology, or outcomes data, is relevant for AI/ML device evaluations or diagnostic devices where human interpretation or definitive medical findings are being compared. For this laser device, the "ground truth" is defined by established engineering and safety standards (e.g., ISO, IEC, FDA) and the functional characteristics of the predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions or interpretations, typically in clinical evaluations or ground truth establishment for diagnostic algorithms. Since no expert panel was used for ground truth for this non-clinical submission, no adjudication method was needed.
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 relevant for evaluating diagnostic or imaging devices where human readers interpret cases, and AI assistance is being assessed. This submission is for a surgical laser device based on substantial equivalence to an existing device through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in essence, standalone performance (non-clinical bench testing) was done. The device's performance characteristics (e.g., wavelength, output power accuracy, operating modes, safety features) were evaluated directly through engineering bench tests to ensure they meet applicable standards and are comparable to the predicate. There is no "algorithm" in the sense of AI/ML, but the device's operational parameters were tested without human intervention in the loop of the device's core function during these bench tests.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- Established engineering standards: Applicable ISO, IEC, and FDA safety and performance standards.
- Predicate device characteristics: The established and legally marketed characteristics and performance of the PhoTex 30 Diode Laser Series (K092197).
- Product Requirement Specifications: The device was tested against its own documented design and functional requirements.
8. The Sample Size for the Training Set:
This information is not applicable. This is a medical device clearance based on substantial equivalence, not an AI/ML algorithm requiring a training set. The device manufacturing processes and designs would undergo validation, but there isn't a "training set" in the machine learning context.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set for an AI/ML algorithm.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.