(29 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 document is a 510(k) premarket notification for a medical device called "Litho 150, Cyber Ho 150" (Multicavity Holmium laser). It describes device modifications and asserts substantial equivalence to a predicate device (Litho 100/60, K192600).
However, this document does not contain the detailed information necessary to complete the requested table and answer questions 2-9.
Here's why and what information is missing:
- Acceptance Criteria and Reported Performance: The document states that the device "underwent and successfully passed electrical safety, EMC and performance testing" according to specific standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and "Software Verification and Validation Testing". However, it does not provide specific numerical acceptance criteria (e.g., "power output must be within +/- 5%") or the actual numerical performance results of these tests (e.g., "power output was 150W +/- 2W"). It only confirms successful passing of these tests.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These questions are typically relevant for studies evaluating the clinical effectiveness or diagnostic accuracy of a device, especially those involving AI/ML models, image analysis, or outcomes assessment. This 510(k) is for a surgical laser, and the "performance testing" mentioned refers to engineering and safety standards, not a clinical study to establish diagnostic or treatment efficacy performance metrics in terms of sensitivity, specificity, accuracy, or similar measures against a clinical ground truth.
Therefore, I cannot populate the table or answer questions 2-9 based on the provided text.
However, I can extract the available information regarding the device's technical specifications and the standards it met:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Parameter/Test Type | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Technical Specifications | ||
| Wavelength | Not explicitly stated as a criterion, but predicate device (Litho 100) has 2100nm. Subject device has same. | 2100nm (Subject device, unchanged from predicate) |
| Max Energy | Not explicitly stated as a criterion, but predicate device (Litho 100) has 5J. Subject device has same. | 5J (Subject device, unchanged from predicate). Reference device (MultiPulse HoPlus) has up to 6.0 J. |
| Max Power | Not explicitly stated as a criterion. Predicate device (Litho 100) has 100W/105W. Subject device is modified to higher power. | 152W (Subject device, increased from predicate). Reference device (MultiPulse HoPlus) has 140 W. |
| Max Frequency | Not explicitly stated as a criterion. Predicate device (Litho 100) has 80Hz. Subject device is modified to higher frequency. | 100Hz (Subject device, increased from predicate). Reference device (MultiPulse HoPlus) has from 5 to 100 Hz. |
| Pulse Duration | Not explicitly stated as a criterion. Predicate device has up to 1100 µs. Subject device has same. | Up to 1100 µs (Subject device, unchanged from predicate). Reference device (MultiPulse HoPlus) has up to 1700 µs. |
| Performance Testing (Compliance) | ||
| Electrical Safety | Compliance with IEC 60601-1:2012, ed 3.1 and IEC 60601-2-22: 2012-10 ed 3.1. | "Successfully passed electrical safety... testing" according to specified standards. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 4: 2014. | "Successfully passed... EMC... testing" according to specified standard. |
| Laser Safety | Compliance with IEC 60825-1 Ed. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements. | "Successfully passed electrical safety... testing" according to specified standard. (Implied, as laser safety is part of this type.) |
| Performance Testing (General) | Not explicitly defined beyond compliance with specified IEC standards for general performance in the context of electrical/laser medical equipment. | "Successfully passed... performance testing." |
| Software Verification & Validation | As recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." |
Regarding the other questions (2-9):
The document provides no information on these points because the submission is a "Special 510(k)" for device modifications based on hardware changes (increased power and frequency) to an already cleared device (K192600). The basis for this type of submission relies on demonstrating that the modified device remains substantially equivalent to the predicate through engineering and safety testing, not typically through new clinical studies involving human subjects or extensive ground truth establishment in the manner described by these questions. Such detailed clinical study methodology would be expected for novel devices or significant changes impacting clinical performance but is not provided for this specific submission type.
§ 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.