(154 days)
The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.
The devices belonging to Multicavity Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.
The provided text describes a 510(k) premarket notification for a medical device (Quanta System Spa's Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60) which involves a modification to existing cleared devices. The modification is the addition of a new emission mode called "Virtual Basket" based on pulse modulation.
Critically, this document does not contain acceptance criteria or study data that proves the device meets specific performance metrics.
The submission is a Special 510(k) for device modifications, which means it evaluates whether the modified device remains substantially equivalent to its predicate devices, rather than establishing new performance benchmarks through de novo studies. Due to this, the level of detailed performance study data, acceptance criteria, and clinical trial information typically associated with complex AI/ML device submissions is not present.
Here's what can be extracted, and what information is explicitly not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical acceptance criteria for a new clinical performance claim. The primary "acceptance" is substantial equivalence to the predicate device, implying no adverse change in safety or effectiveness with the software modification. | Bench testing comparing the Virtual Basket emission mode to the standard emission mode of the original device was performed. |
| Software Verification and Validation Testing was conducted according to FDA guidance for software in medical devices. |
Explanation: The document states, "Based on the nature of the changes implemented, the device underwent and successfully passed software verifications and validation according to the relevant standards." This implies the "acceptance criteria" were successful completion of these tests. However, no specific numerical or qualitative performance criteria are listed for the "Virtual Basket" mode.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a clinical test set with patients/data. The testing involved bench testing (presumably on materials relevant to laser-tissue interaction or stone fragmentation) and software verification and validation. No patient-specific test set is described.
- Data Provenance: Not applicable. The tests are technical/engineering in nature (bench testing, software V&V) rather than clinical studies using patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. There is no mention of human experts establishing a "ground truth" for a test set, as this submission is not about an AI/ML diagnostic or prognostic device requiring expert annotation. It's about a laser surgical instrument and a new emission mode.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set requiring adjudication by experts is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study was not done. The device is a surgical laser, not an imaging analysis or diagnostic AI/ML device that assists readers. The document only mentions "Bench testing comparing the Virtual Basket emission mode to the standard emission mode of the original device".
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable in the typical sense of AI/ML. The "Virtual Basket" mode is an emission mode of a laser; it's always used by a human surgeon. The "software verification and validation testing" would assess the software's standalone functionality.
7. The Type of Ground Truth Used:
- For Bench Testing: Likely physical measurements, observations, and objective assessment against engineering specifications related to laser power, pulse characteristics, and effects on target materials (e.g., stone fragmentation efficiency, tissue ablation depth).
- For Software Verification and Validation: Software requirements specifications, design specifications, and coding standards. The "ground truth" would be whether the software performs as designed and intended, free of critical defects.
8. The Sample Size for the Training Set:
- Not applicable. This submission doesn't describe an AI/ML model that requires a training set of data. The "Virtual Basket" mode is a predefined pulse modulation algorithm, not a machine learning model trained on data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8.)
Summary of what the document does tell us about the device and its assessment:
- Device: Holmium laser surgical system (Cyber Ho 60/100, Litho 60/100).
- Modification: Addition of a "Virtual Basket" emission mode via software update.
- Basis for Submission: Device modifications (Special 510(k)).
- Predicate Devices: Litho 60 (K172025) and Litho 100 (K180922).
- Testing Performed:
- Bench testing comparing the new "Virtual Basket" mode to the standard emission mode.
- Software Verification and Validation testing (according to FDA guidance).
- Tests Not Repeated (as there was no hardware or architecture change that could affect them): Electromagnetic compatibility, electrical safety, and general performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
- Conclusion: The device is considered substantially equivalent to its predicate devices, indicating the modifications (including the new Virtual Basket mode) do not raise new questions of safety or effectiveness.
§ 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.