(25 days)
The MegaBeam Endo-ENT Probe is a fiber optic delivery system intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. It is indicated for ENT surgery for use with compatible lasers cleared for use in the desired application.
The MegaBeam Endo ENT Probe for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K952772 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.
This 510(k) summary states that the MegaBeam Endo-ENT Probe is substantially equivalent to a previously cleared device (MegaBeam Endo ENT Probe, K952772). Therefore, it relies on the predicate device's established performance without new studies.
Here's a breakdown of the requested information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "as safe... as the MegaBeam Endo-ENT Probe predicate device." |
| Effectiveness | "as effective ... as the MegaBeam Endo-ENT Probe predicate device." |
| Technological Characteristics | "contains the identical same components and design as the device cleared under K952772...no differences in technology." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new performance testing was conducted for this submission (K113858). The device is asserted to be identical to its predicate (K952772).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No new performance testing was conducted for this submission.
4. Adjudication Method for the Test Set
Not applicable. No new performance testing was conducted for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC study was not done for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical probe, not an algorithm.
7. The Type of Ground Truth Used
Not applicable for this submission as no new performance data was generated. The "ground truth" for demonstrating equivalence relies on the predicate device's historical clearance and established safe and effective use.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical probe, not an AI/ML algorithm that requires training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a physical medical probe, not an AI/ML algorithm that requires training.
§ 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.