(76 days)
The Cyber Tm Family (that Includes Cyber Tm 150, Cyber Tm 180 and Cyber Tm 200) and its accessories are intended for use in surgical procedures using open, laparoscopic incision, resection, abletton, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urclogy, Gastroentarology, Thoracio Gynecslogy, ENT, Demainly, Plastic Surgery, General Surgary and Arthroscopy.
Note; The Cyber Tm 180 and Cyber Tm 200 are only approved for the treatment of BPH when used at power levels greater than 150V.
The Cyber Tm Family is laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). In the Cyber Tm Family is installed a single Tm:YAG Laser Source with CW emission at 2.01um with adjustable power from 5 W to the maximum output power (as given below). The laser radiation is delivered to the tissue to be treated through fiber optics. The Cyber Tm Family (that includes Cyber Tm 150, Cyber Tm 150, Cyber Tm 180 and Cyber Tm 200) and its accessories are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.
The acceptance criteria and study proving device performance are described below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Basic Safety and Effectiveness | The Cyber Tm Family devices (including Cyber Tm 120, Cyber Tm 150, Cyber Tm 180, and Cyber Tm 200) and their accessories must comply with all applicable safety and performance standards for medical electrical equipment and laser products. This includes: | The Cyber Tm Family (including Cyber Tm 120, Cyber Tm 150, Cyber Tm 180, and Cyber Tm 200) and its accessories were tested and found to comply with: |
| • IEC 60601-1:2005 | ||
| • IEC 60601-1-2:2005 | ||
| • IEC 60601-1-4: 1996 (First Ed.) -+ Am.l: 1999 (Consolidated 1.1 Ed.) - for use with IEO 60601-1 (1988), Amts 1 (1991) and 2 (1995) | ||
| • IEC 60601-2-22:2005 | ||
| • IEC 60825-1:2007 | ||
| They also comply with European Medical Device 93/42/EEC. | ||
| Substantial Equivalence - Tissue Effects (for modified devices vs. predicate) | The modified devices (Cyber Tm 180 and Cyber Tm 200) must demonstrate comparable tissue effects (depth of thermal injury, coagulation, ablation depth, carbonization) to the predicate devices (Cyber Tm 120 and Cyber Tm 150) under equivalent operating conditions (when accounting for power density through fiber diameter). | A specific bench testing was conducted on the Cyber Tm Family devices. The depth of thermal injury and coagulation were measured and compared to the unmodified predicate devices and "did not show significant differences." The ablation depth was also measured and "found to be of comparable depth, keeping the same power density through the use of different fiber diameter." Other tissue effects such as carbonization were also "found to be comparable." This suggests the modified devices meet the criteria for comparable tissue effects to the predicate devices. |
| Intended Use Equivalence | The modified devices (Cyber Tm 180 and Cyber Tm 200) must have the same intended use as the predicate devices (Cyber Tm 120 and Cyber Tm 150). (Note: Specific power levels for BPH treatment are a conditional part of the intended use for the higher power models). | The "intended use of the predicate devices (Legally Marketed Devices) are the same as the modified devices." This indicates the modified devices fulfill the intended use equivalence. The document explicitly states for the Cyber Tm 180 and Cyber Tm 200 that they "are only approved for the treatment of BPH when used at power levels greater than 150W," which is a specific condition within the broader stated intended use. |
| Technological Characteristics Equivalence | The modified devices (Cyber Tm 180 and Cyber Tm 200) must share the same structure, components, software, and technological characteristics as the unmodified predicate devices, with the primary differentiation being the factory-set maximum output power. | "All models of the Cyber Tm Family share the same structure, the same components and the same software." The "differentiation of the models derives only from the factory set of the maximum output power of the laser resonator." This demonstrates that the technological characteristics, apart from the maximum output power, are equivalent. |
Study Proving Device Meets Acceptance Criteria:
The device's acceptance criteria are met through performance and basic safety testing, and a specific bench testing that supports the determination of substantial equivalence to the predicate devices.
- Study Type: This appears to be a bench testing/laboratory study combined with compliance assessments to established international safety and performance standards. It is not a clinical study involving human or animal subjects, nor is it a multi-reader multi-case (MRMC) study.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional sense. The bench testing involved measuring tissue effects on the proposed Cyber Tm Family devices (Cyber Tm 180 and Cyber Tm 200) and comparing them to unmodified predicate devices (Cyber Tm 120 and Cyber Tm 150). The number of actual tissue samples or laser firing instances used for these measurements is not specified.
- Data Provenance: The testing was conducted by Quanta System SpA, the manufacturer, based in Italy. The data is retrospective in the sense that it's a submission of bench test results, not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This study does not involve human expert interpretation or labeling of data for ground truth establishment. The "ground truth" for the bench testing would be the physical measurements of tissue effects, conducted by technical personnel/engineers, and direct comparison to the predicate device's performance.
4. Adjudication Method for the Test Set:
- Not applicable. As there are no human readers or interpretations of complex data requiring consensus, no adjudication method was used. The comparison was based on direct measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC comparative effectiveness study was not done. This submission focuses on engineering and performance changes of a laser surgical instrument, primarily demonstrating safety and substantial equivalence through bench testing, not diagnostic effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Partially Applicable (in a different context): While not an "algorithm" in the typical AI sense, the performance evaluation in this submission focuses on the standalone performance of the laser device itself (i.e., its ability to produce specific tissue effects) without human intervention in the measurement of those effects. There is no AI algorithm being evaluated here.
7. The Type of Ground Truth Used:
- The ground truth used for the bench testing was direct physical measurement of tissue effects (e.g., depth of thermal injury, coagulation, ablation depth, carbonization). This is a form of objective, quantitative data derived from the interaction of the device with tissue.
8. The Sample Size for the Training Set:
- Not applicable. This submission does not describe an AI/machine learning model, and therefore, there is no "training set." The predicate devices represent established performance benchmarks rather than a training set for an algorithm.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for an AI model, this question is not relevant to this submission.
§ 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.