(8 days)
The VAPORMAX II is intended for surgical use including: incision, vaporization, vaporization, in ablation, and coagulation of soft tissue.
The VAPORMAX II is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.
The VAPORMAX II is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
The provided document K053457 describes a 510(k) premarket notification for the VAPORMAX™ II Side Firing Fiber. It explicitly states that no nonclinical data and no clinical tests were submitted. Instead, the device's substantial equivalence was established by comparing its technological characteristics to a predicate device. Therefore, a study demonstrating the device meets acceptance criteria as typically understood in a clinical or performance study context was not performed or submitted.
Here's a breakdown based on your requested information, highlighting what is not applicable due to the nature of this 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (No specific performance criteria tied to a clinical or non-clinical study were provided for this submission. The submission relies on substantial equivalence to predicate devices.) | Not Applicable (No specific performance metrics from a study were reported.) |
| Intended use: Incision, excision, ablation, vaporization, and coagulation of soft tissue with cleared Holmium:YAG lasers. | The VAPORMAX™ II performs as intended and has acceptable mechanical properties when used in accordance with its labeling, as concluded from substantial equivalence to predicate devices. |
| Mechanical properties (e.g., ability to withstand up to 100 watts of laser power). | The VAPORMAX™ II shares most of its design characteristics and all materials with its VAPORMAX predicate and can therefore be used with up to 100 watts of laser power. |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: Not applicable. No test set was used for a performance study.
- Data Provenance: Not applicable. No clinical or non-clinical study data were provided.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- Not applicable. No test set was used, and therefore no ground truth was established by experts in the context of a performance study.
4. Adjudication method for the test set
- Not applicable. No test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human improvement with vs. without AI assistance
- Not applicable. This device is a laser fiber and does not involve AI or human-in-the-loop performance measurement.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This device is a laser fiber and does not involve an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth in the context of a performance study was established. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. This device is a physical medical device (laser fiber) and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
Summary of the Study (as presented in the 510(k)):
The "study" in this context is a substantial equivalence comparison to predicate devices, not a performance study with clinical or non-clinical data generation.
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Predicate Devices:
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Methodology: The submission relies on demonstrating that the VAPORMAX™ II Side Firing Fiber has the "same technological characteristics" and "intended use" as the predicate devices.
- Technological Characteristics: The VAPORMAX™ II shares most of its design characteristics and all materials with its VAPORMAX™ predicate. It emits laser energy at an approximately 90-degree angle by way of direct reflection, like the UROLASE® predicate. This allows it to be used with up to 100 watts of laser power, consistent with its predicate.
- Intended Use: The intended use for incision, excision, ablation, vaporization, and coagulation of soft tissue with cleared Holmium:YAG lasers is the same as for its predicates.
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Conclusion: Based on this comparison, it was concluded that the VAPORMAX™ II performs as intended and has acceptable mechanical properties when used in accordance with its labeling, implying that it is as safe and effective as the legally marketed predicate devices. No new performance data was generated to prove specific acceptance criteria for the new device itself.
§ 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.