(32 days)
The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.
The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K946336, K923953 and K943445 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy. Additional flat/ bare (no tips) fiber optic sizes of 230µ, 365µ, 400µ and 550u are included for clearance in this submission.
The provided text is a 510(k) summary for the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for a new, independent device evaluation.
Therefore, many of the requested sections about acceptance criteria, detailed study parameters, and ground truth establishment are not applicable or not present in this type of submission.
Here's a breakdown based on the provided text, indicating where information is present or absent:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: No specific quantifiable acceptance criteria are provided in the document.
- Reported Device Performance: The document states: "Since the performance of the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is well established and documented on soft tissue no performance testing is being specifically included in this submission."
Therefore, a table cannot be created as the submission explicitly states no new performance testing was conducted.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable, as no new performance testing was conducted or submitted.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable, as no new performance testing requiring ground truth establishment was conducted or submitted.
4. Adjudication Method for the Test Set
- Not applicable, as no new performance testing requiring adjudication was conducted or submitted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Was an MRMC study done?: No.
- Effect size of improvement with AI vs. without AI assistance: Not applicable, as this is a physical medical device (fiber optic delivery system), not an AI/software device, and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable, as this is a physical medical device, not an algorithm, and no standalone performance study was conducted.
7. The Type of Ground Truth Used
- Not applicable, as no new performance testing requiring ground truth establishment was conducted or submitted.
8. The Sample Size for the Training Set
- Not applicable, as this is a physical medical device, not a machine learning algorithm, and therefore no training set was used.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this is a physical medical device, not a machine learning algorithm, and therefore no training set with ground truth was established.
Summary of the Study that Proves the Device Meets Acceptance Criteria
The submission does not describe a study to prove the device meets acceptance criteria in the traditional sense of novel performance testing. Instead, the basis for approval is Substantial Equivalence (SE) to legally marketed predicate devices.
The key points of the argument for SE are:
- Predicate Devices: MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece (K946336, K923953, and K943445).
- Technological Characteristics: The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. contains "the identical same components and design" as the predicate device(s). The only difference mentioned is the inclusion of "Additional flat/bare (no tips) fiber optic sizes of 230µ, 365µ, 400µ and 550u for clearance."
- Safety and Efficacy: The submission explicitly states, "There are no differences in technology and as such does not raise any new questions on safety or efficacy."
- Intended Use: The intended use is identical: "to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared."
- Performance Data: The submission states, "Since the performance of the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is well established and documented on soft tissue no performance testing is being specifically included in this submission."
In essence, the "study" that proves the device meets (implicitly understood) acceptance criteria is the accumulated evidence and historical performance data of the predicate device, combined with the argument that the new device is technologically identical and shares the same intended use. The FDA agreed with this assessment by issuing a substantial equivalence determination.
§ 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.