(142 days)
The laser is used to create laser energy for the destruction of calculi and/or for soft tissue treatments such as the cutting of tissue and the opening of stenosis and strictures during endoscopic urological applications.
The KARL STORZ Calculase II is a Ho-YAG desktop laser that emits a mid-infrared beam at the wavelength of 2080nm with pulse energy of 500-2000mJ and pulse frequency of 4 – 15Hz. The laser energy is transmitted into the tissue via an optical fiber, with the maximum limit of the laser energy set at 20W.
The laser energy generated by Calculase II enables the optimal lithotripsy of all calculus compositions in the human body and soft tissue treatment such as the ablation of strictures and stenosis, for example.
Calculase II is a desktop unit designed to be mobile so that it can be easily transported and placed on top of a desk or cart and positioned within the treatment room by using special, retractable handles located on the both sides of the desktop units. All controls and displays required for operating the unit (On/off switching key, fiber connection port, power setting. etc.) are located on the front of the device in a user-friendly control panel and easy-to-read LED displays, which make the unit safe and easy to operate by the users. The 1-pedal footswitch allows the users to release the laser to the intended area during use.
The Calculase II Holmium Laser system uses a flexible laser fiber, inserted into an endoscope (flexible, semi-rigid and rigid) through the urethra or percutaneously to fragment and vaporize the calculi stone located in the bladder, urethra, or kidney. With the proper energy level setting, it can also perform soft tissue treatments such as ablation of strictures and stenosis. For lithotripsy, proper energy level should be set depending on the fiber diameter, hardness of stone, and location of the stone.
The laser emission is activated by a footswitch pedal, which allows the operator to be "hands-free" for specific target fragmentation. With the fiber placed lightly against the stone or soft tissue in the contact procedure, pulses of energy are used to fragment and vaporize the stone or ablate strictures and stenosis.
As the laser beam is concentrated on the target area, the surrounding tissue can relax, cool and dissipate the heat in between the short bursts. This way the target tissue sustains cumulative thermal effect with maximum protection of the surrounding area.
This document describes the Karl Storz Calculase II, a powered laser surgical instrument (Ho-YAG desktop laser) used for the destruction of calculi and soft tissue treatments in endoscopic urological applications. The information provided is for regulatory submission (K140964) to the FDA to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Stated or Implied) | Reported Device Performance (Calculase II) |
|---|---|---|
| Laser Type | Ho-YAG desktop laser | Ho-YAG desktop laser |
| Wavelength | 2080nm | 2080nm |
| Max Energy Output | Not explicitly stated an "acceptance criteria" but compared to predicate 30W. | 20W |
| Pulse Energy Range | Not explicitly stated an "acceptance criteria" but compared to predicate 200-4000mJ. | 500 – 2000 mJ |
| Pulse Frequency Range | Not explicitly stated an "acceptance criteria" but compared to predicate 4 – 20Hz. | 4 – 15 Hz |
| Pulse Duration Range | Not explicitly stated an "acceptance criteria" but compared to predicate 200 – 500 μs. | 100 – 500 μs |
| Safety and Effectiveness | As safe and effective as legally marketed devices (predicate). | Bench testing demonstrates meeting design specifications and substantial equivalence. |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1 | Tested according to these standards. |
| Functional Performance | Enables optimal lithotripsy and soft tissue ablation | Demonstrated in bench tests, meeting design specifications. |
| Usability/Operation | User-friendly control panel, easy-to-read LED displays, 1-pedal footswitch. | Device described as having these features for safe and easy operation. |
Note on Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to a predicate device (AURIGA QI (K121570)). Therefore, the "acceptance criteria" are largely implied by the predicate device's characteristics and the Calculase II's design specifications. The key acceptance criterion is that the Calculase II meets its own stated specifications and is as safe and effective as the predicate, despite minor differences in technical parameters.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The primary testing described is non-clinical bench testing of the device's performance, not human clinical trials or analysis of patient data.
- Data Provenance: The data comes from the manufacturer's (Karl Storz Endoscopy-America, Inc.) internal bench testing. The country of origin for this testing is not explicitly stated but is implicitly associated with the manufacturer. The data is prospective in the sense that the tests were conducted specifically for this regulatory submission to evaluate the device's performance against its specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable as the study described is technical bench testing of device specifications, not a study involving expert assessment of medical data (like images or patient outcomes). Ground truth for device functionality is established through engineering and quality control procedures, adherence to technical specifications, and compliance with recognized standards.
4. Adjudication Method for the Test Set
- Ajudication Method: Not applicable. As this is non-clinical bench testing, there is no "adjudication" in the sense of reconciling multiple expert opinions on a medical diagnosis or outcome. The "adjudication" of performance is done by comparing achieved technical parameters to predefined design specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an active medical instrument operated by a human, not an algorithm. Performance is evaluated on the device's physical and functional capabilities, not on an algorithm's standalone accuracy.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical performance data is based on:
- Engineering Design Specifications: The predetermined technical parameters (e.g., maximum energy output, pulse energy range, frequency range, pulse duration range) the device was designed to achieve.
- International Standards: Compliance with electrical safety and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
- Functional Verification: The ability of the device to perform its stated functions (lithotripsy, soft tissue ablation) as intended.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware-based medical instrument and does not involve AI or machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.