(86 days)
The BeaMed Laser Surgery Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue, it is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The BeaMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
The BeaMed Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibilty of the target tissue.
This document is a 510(k) Premarket Notification from the FDA for the BeaMed Laser Surgery Fibers. It details the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.
Based on the provided text, the device in question (BeaMed Laser Surgery Fibers) is a physical medical device, not an AI/software-based medical device. Therefore, the requested information regarding acceptance criteria, ground truth, sample sizes for training and testing, expert adjudication, and MRMC studies, which are typical for AI/ML medical devices, is largely not applicable to this submission.
The "studies" mentioned in this document are primarily bench testing to demonstrate the physical and performance characteristics of the laser fibers, and to show that they are substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way one would for an AI/ML model's diagnostic accuracy. Instead, it relies on demonstrating that the BeaMed Laser Surgery Fibers meet the same specifications and performance characteristics as the predicate device (Adler MicroMed Laser Surgery Fibers, K152417). The acceptance criteria are implicitly that the subject device performs equivalently to the predicate across various physical and functional parameters.
Bench Test Summary (Implicit Acceptance Criteria and Performance):
| Test/Specification | Implicit Acceptance Criteria | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Indications for Use | Same as predicate device | The Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. Wavelength range of 450 nm to 2100 nm, contact/non-contact mode, multiple surgical specialties, SMA 905 connector. (Identical to predicate) |
| Fiber core material | Silica quartz glass | Silica quartz glass (Identical to predicate) |
| Fiber cladding material | Silica quartz glass cladding and/or Hardclad | Silica quartz glass cladding and/or Hardclad (Identical to predicate) |
| Buffer | Silicone buffer | Silicone buffer (Identical to predicate) |
| Jacket material | Silicone / ETFE / polymide / nylon / acrylate / PVDF/ PU; Color additives possible | Silicone / ETFE / polymide / nylon / acrylate / PVDF/ PU; Color additives possible (Identical to predicate) |
| Maximal temperature | 176°F (80°C) for nylon jacket, 302°F (150°C) for ETFE jacket | 176°F (80°C) for nylon jacket, 302°F (150°C) for ETFE jacket (Identical to predicate) |
| Minimal bend radius | 51 x core diameter (short term) 121 x core diameter (long term) | 51 x core diameter (short term) 121 x core diameter (long term) (Identical to predicate) |
| Maximal laser power | Suitable for laser power up to 100W | Suitable for laser power up to 100W (Identical to predicate) |
| Shelf life | 5 years | 5 years (Identical to predicate) |
| Numerical aperture range | 0.37 (quartz/hardclad), 0.22 (quartz/quartz) | 0.37 (for quartz/ hardclad fibers), 0.22 (for quartz/quartz) (Identical to predicate) |
| Core diameter range | 200 µm to 1000 μm | 200 µm to 1000 μm (Identical to predicate) |
| Outer diameter range | 240 µm to 1800 µm typically | 240 µm to 1800 µm typically (Identical to predicate) |
| Distal fiber tip types | Flat, conical, ball, spherical or bended bare fibers, round or conical caps | Flat, conical, ball, spherical or bended bare fibers, round or conical caps (Identical to predicate) |
| Fiber tip outer diameter range | 1.0mm to 1.8mm | 1.0mm to 1.8mm (Identical to predicate) |
| Wavelength range | 450nm to 2100 nm | 450nm to 2100 nm (Identical to predicate) |
| Length range | 6.5 feet (2 meters) to 9.9 feet (3 meters) | 6.5 feet (2 meters) to 9.9 feet (3 meters) (Identical to predicate) |
| Emission angle range | Straight, forward directed cone or 60° cone angle from fiber axis, diffuse emission, and radial 360° | Straight, forward directed cone or 60° cone angle from fiber axis, diffuse emission, and radial 360° (Slight difference noted in description between subject and predicate - predicate says "fibe axis and radial emission of 360°" while subject says "fiber axis, diffuse emission, and radial 360°". The FDA found this difference acceptable for substantial equivalence). |
| Single/multiple use | Single use | Single use (Identical to predicate) |
| Sterility | Sterile by EO | Sterile by EO (Identical to predicate) |
| Packaging | Sterile, double pouched | Sterile, double pouched (Identical to predicate) |
| Proximal end | SMA 905 connector | SMA 905 connector (Identical to predicate) |
| Bench Tests | Meet established standards for each test | Transmission validation of fibers; Packaging seal strength; Dye penetration test; Packaging microbial barrier; Sterilization re-validation; Bioburden tests; Shelf-life validation; EO residuals report; Sterility Assurance Level (SAL); Biocompatibility tests. All these tests were performed and presumably met the required standards to demonstrate safety and effectiveness equivalent to the predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set: For the bench testing, the "sample size" would refer to the number of fibers or samples of materials tested for each specific bench test (e.g., how many fibers were tested for transmission validation, how many packages for seal strength). This specific number is not provided in the summary.
- Data Provenance: Not specified, but generally, bench testing data would be generated within the manufacturer's facility or a contracted testing lab. No patient data or geographical provenance is mentioned, as this is a physical device submission relying on bench tests. The testing would be "prospective" in the sense that the tests are conducted intentionally to demonstrate performance for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a physical device like a laser fiber, "ground truth" isn't established by medical experts in the diagnostic sense (e.g., radiologists interpreting images). The "truth" is based on objective physical measurements and engineering specifications, and compliance with recognized standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus ground truth in subjective medical interpretation, typically for AI/ML diagnostic devices. This device relies on objective engineering and performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting medical cases. No MRMC study was performed or is relevant to this device's substantial equivalence determination.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on:
- Engineering Specifications: The design specifications of the fiber (e.g., dimensions, materials).
- Objective Bench Testing: Measurable physical and functional properties validated through laboratory tests (e.g., power transmission, bend radius, sterility, biocompatibility).
- Comparison to Predicate Device: The performance and safety profile of the legally marketed predicate device (K152417) serves as the benchmark against which the new device demonstrates substantial equivalence. The predicate device's established safety and effectiveness are the "ground truth" for the new device's acceptable performance.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.
Summary Conclusion from the Document:
The FDA determined that the BeaMed Laser Surgery Fibers are substantially equivalent to the predicate device (Adler MicroMed Laser Surgery Fibers, K152417) based on shared indications for use, technical characteristics, and performance data from internal bench testing. The submission confirms "Animal or clinical studies: None," indicating that the equivalence was demonstrated entirely through physical and performance testing against the predicate.
§ 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.