(219 days)
The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD, Mega/OULE LDD and MoJO LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector or manufacturer specific connectors and adaptors.
VaporMAX LDD® family of fibers, which includes VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD, are fiber optic surgical laser energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905 or Trimedyne OmniPulse™ MAX, an anodized aluminum extension sleeve or polymer overnut for accommodating recessed laser ports, fiber/connector strain relief, and a transmitting optical fiber consisting of a low [OH-], fused silica core fiber with fluorine-doped, fused silica cladding, a fluoropolymer secondary cladding and an ethylene tetrafluorethylene copolymer (ETFE, e.g. DuPont Tefzel 210™) protective jacket. The distal tip is laser polished and is disposed within a fused quartz capsule (cap) containing a beam conditioning lens and a prism for redirecting the output at nearly right angles to the fiber longitudinal axis.
The dimensional difference between the optical fiber and the distal cap is equalized with a Udel tube covering the distal length of fiber that may be tasked to pass a cystoscope bridge working channel, sized to match the cap diameter and upon which is dispose a green visual indicator of the fiber rotational orientation. The proximal end of the diameter matching tube is terminated within a patent pending control knob for ergonomic rotational control (aiming). Some models of the VaporMAX LDD, those with subscripted "e", where e" indicates "ergonomic") exploit severing the connection between the redirection prism from the transmitting fiber by providing for free rotation of the cap about the fiber, vial the control knob, thereby aiming the fiber output without torquing the transmitting fiber.
VaporMAX LDD fibers are packaged as a coil upon a coated fiberboard or dense polymer carrier card that is intended to provide for ease of dispensing within the surgical field while immobilizing the product within the sterile pouch. The working end (distal section) of the fiber is maintained in a straight configuration to avoid "fiber jumping" when rotated in surgery (due to the device's "memory" of being stored in a coil). Carrier cards are sealed within non-woven/impermeable pouches, e.g., Tyvek/paper or Tyvek/Mylar, currently validated by IQ for a three-year shelf life. Sealed sterile pouches are protected by an outer, nonsterile fiberboard carton. Both the sterile pouch and carton are labeled with the product information per FDA labeling requirements. All tissue contacting VaporMAX LDD materials of construction, and any materials in fluidic communication with tissue, are USP Class VI biocompatible and are compatible with ethylene oxide (EO) sterilization.
The provided document does not contain acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the format typically used for medical device efficacy studies (e.g., clinical trials).
Instead, it's a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than direct proof of meeting defined acceptance criteria through a specific study. The "Performance Testing (Bench and User Evaluation)" section describes bench tests to compare performance with predicate devices.
However, based on the information provided, here's an attempt to extract and infer information relevant to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" (e.g., target accuracy, sensitivity, specificity, or specific performance metrics with defined thresholds) are not provided, I've inferred performance goals based on the comparison to predicate devices and the described testing.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| - Operate based on similar optical principles. | "All the predicate devices and VaporMAX LDD operate upon the same optical principles, although somewhat refined." |
| - Use similar materials of construction. | "The VaporMAX LDD uses similar materials of construction as the predicate devices..." |
| Durability/Lifetime: | |
| - Exceed predicate device lifetime (energy delivery). | Bench Test 1: Power tested under saline and in contact with tissue phantoms at 80 watts (4 joules, 20 Hz) with a CTH:YAG laser (2080nm) for 320,000 joules delivered. (This matches the minimum lifetime of the predicate VaporMAX™). |
| Bench Test 2: Similarly tested in contact with tissue phantoms at 200 watts with a thulium fiber laser (1940nm) for 600,000 joules and 1,000,000 joules (one megajoule). | |
| Performance: "The subject fibers maintained the original operating characteristics far further into testing than did predicate devices and none of the subject fibers failed even under the most abusive test conditions..." | |
| Output Characteristics: | |
| - Reproducible beam profiles and divergence. | "Beam profiles were obtained for the subject VaporMAX LDD and predicate VaporMAX... studies were performed to access the reproducibility of key performance variables (as measured by beam profiles and divergence as well as in simulated surgery with tissue phantoms)." |
| Reported Output Angle: 82° to 88° (Predicate VaporMAX: 78° to 82°). | |
| Reported Divergence: 12.7° max (Predicate VaporMAX: 12.7° max). | |
| Reported Output Area: >1.2 mm² (Predicate VaporMAX: >0.8 mm²). | |
| Mechanical Integrity: | |
| - Meet or exceed design specifications for | "The subject fibers' construction integrity was then tested with tensile strength measurements of cap retention on the fiber, orientation tube retention within the control knob, and fiber retention within the laser connector, all fibers surpassed design specifications." |
| cap retention, tube retention, and fiber | |
| retention within connector. | |
| Safety and Effectiveness: | |
| - "As safe and as effective as" predicate devices. | "The subject devices are determined to be as safe and as effective as the lower power capable predicate devices even when used at the maximum power output of modern surgical lasers." (This statement is a conclusion based on the bench testing and comparative analysis). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "subject fibers" (plural) meaning multiple units were tested, but no specific number is given.
- Data Provenance: The tests are described as "simulated surgery" and "bench tests" performed within the InnovaQuartz manufacturing facility in Phoenix, Arizona. This indicates these are prospective bench studies (laboratory-based testing). Country of origin is the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided. The document describes bench testing and performance comparisons, not studies involving expert evaluation of clinical data or images to establish a "ground truth."
4. Adjudication Method for the Test Set
- This information is not applicable/provided. The "tests" described are physical and mechanical performance tests, not those requiring expert adjudication of subjective outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing comparing the device's physical and optical performance to predicate devices, not human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device (laser fiber) is a physical medical device, not an algorithm or AI software. Therefore, an "algorithm only" performance study is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for the performance tests was based on physical measurements and defined operational characteristics (e.g., energy delivery, beam profiles, mechanical strength, output angle, divergence) in a controlled laboratory setting against known predicate device performance and design specifications. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for these specific tests.
8. The Sample Size for the Training Set
- This question is not applicable. The device is a physical laser fiber, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable as there is no training set for this type of device.
§ 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.