(90 days)
The W.O.M. Laser U100 is intended for use in endoscopic surgical procedures . to fragment stones.
The W.O.M. Laser U100 is indicated for use to fragment urinary stones ● (kidney, ureter and bladder) and biliary stones in the contact mode during closed surgical procedures.
The W.O.M. Laser U100 is indicated for use in the contact mode to fragment urinary stones (kidney, ureter, bladder) and biliary stones in closed surgical procedures.
The W.O.M. Laser U100 has the same intended use, identical design features and principles of operation as the predicate device W.O.M. Laser U100 (K011175). Differently to the predicate device the W.O.M. Laser U100 described in this premarket notification is not only indicated for use to fragment urinary stones but also biliary stones. In addition, the W.O.M. Laser U100 has the same intended use and indication for use, similar design features and similar principles of operation as the Candela MDL 2000 LaserTripter (K901723).
All three devices are intended for use in endoscopic surgical procedures to fragment stones. Both the W.O.M. Laser U100 and the Candela MDL 2000 LaserTripter are indicated for use to fragment urinary and biliary stones in the contact mode during closed surgical procedures.
The W.O.M. Laser U100 and the predicate device W.O.M. Laser U100 (K011175) use identical physical processes to generate the laser beams and method of transmission to the stone. Although the W.O.M. Laser U100 and the Candela MDL 2000 LaserTripter (K901723) generate their respective laser beams through different physical processes, the characteristics of the treatment beams (wavelength, pulse energy, pulse duration and pulse frequency) are similar. Moreover, the method of transmission to the stone (laser fiber) is similar and both devices provide aiming beams to allow visual indication of the stone location.
All three devices incorporate an internal water cooling cycle with a water-air heat exchanger system. In addition, all three devices provide identical or similar safety features and identical or similar parameters are displayed on the operator panel of the devices.
Finally, the W.O.M. Laser U100 and the predicate devices transmit pulses of laser energy by a quartz fiber to the stone (contact mode). The laser pulses are transformed into an ultrasonic wave (acoustic impact waves) which mechanically crush the stone.
The provided text describes a 510(k) summary for the W.O.M. Laser U100, a medical device for fragmneting kidney, ureter, bladder and biliary stones. The document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML product. Therefore, many of the requested categories related to algorithm performance, training sets, and expert evaluations are not applicable or cannot be extracted from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or performance metrics in the way one would for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards.
| Criterion | Reported Performance/Evidence |
|---|---|
| Intended Use | - Same as predicate W.O.M. Laser U100 (K011175): endoscopic surgical procedures to fragment stones. |
| - Same as predicate Candela MDL-2000 (K901723): endoscopic surgical procedures to fragment stones. | |
| Indications for Use | - Extends predicate W.O.M. Laser U100 (K011175) indications to include biliary stones (in addition to urinary stones: kidney, ureter, bladder). |
| - Same as predicate Candela MDL-2000 (K901723): urinary and biliary stones in contact mode during closed surgical procedures. | |
| Design Features & Principles of Operation | - Identical to predicate W.O.M. Laser U100 (K011175) for generation of laser beams and method of transmission. |
| - Similar to predicate Candela MDL-2000 (K901723) in design features and principles of operation. Both use laser fiber for transmission and provide aiming beams. | |
| Treatment Beam Characteristics | - Identical to predicate W.O.M. Laser U100 (K011175). |
| - Similar to Candela MDL-2000 (K901723) in wavelength, pulse energy, pulse duration, and pulse frequency, despite different physical processes for laser generation. | |
| Cooling System | - Identical or similar to both predicate devices (internal water cooling cycle with water-air heat exchanger). |
| Safety Features & Parameters Displayed | - Identical or similar to both predicate devices. |
| Mechanism of Action | - All three devices transmit laser energy to mechanically crush stones via acoustic impact waves. |
| Safety and Effectiveness | - Complies with IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (EMC). |
| - Meets UL Standard 2601-1. | |
| - Bears CE mark (Medical Device Directive 93/42/EEC). | |
| - In vitro, in vivo and clinical data provided to demonstrate safety and effectiveness for fragmentation of biliary stones in closed surgical procedures. (Specific results not detailed in this summary). | |
| New Questions of Safety & Effectiveness | - "Differences of the W.O.M. Laser U100 to the predicate device W.O.M. Laser U100 (K011175) are minor and raise no new questions of safety and effectiveness." (Most modifications made for UL 2601 compliance). |
2. Sample Size Used for the Test Set and Data Provenance
- The summary states that "In vitro, in vivo and clinical data has been provided to demonstrate that the W.O.M. Laser U100 is safe and effective for the fragmentation of biliary stones in closed surgical procedures."
- Sample size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable as this is a medical device approval based on substantial equivalence and clinical data, not an AI/ML algorithm requiring expert-established ground truth for a test set. There's no mention of a human-in-the-loop diagnostic process being evaluated.
4. Adjudication Method
- Not applicable. This concept pertains to resolving discrepancies in expert interpretations for AI/ML algorithm evaluation, which is not described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not performed or reported in the provided text. This type of study is relevant for AI-assisted diagnostic tools, not for a laser lithotripter directly.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. The W.O.M. Laser U100 is a physical device, not a standalone algorithm. The "in vitro, in vivo and clinical data" refers to direct performance of the device.
7. Type of Ground Truth Used
- The document implies that clinical outcomes (fragmentation of biliary stones) and potentially pathology/imaging evidence of stone fragmentation served as the ultimate ground truth in the "in vitro, in vivo and clinical data." However, the exact nature of this "ground truth" (e.g., complete fragmentation, certain size reduction, clinical success rates) is not detailed in this summary.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is not 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.