(87 days)
The Profile 2000 Laser System, and Delivery Devices and Accessories, is indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications: Dermatology and Plastic Surgery, Gastroenterological/Gastrointestinal Surgery, General Surgery, Genitourinary Surgery/Urology, Gynecological Surgery, Lithotripsy and Percutaneous Urinary Lithotripsy, Lumbar Discectomy, Orthopedic Surgery, Otorhinolaryrigological (ENT) Surgery, Pulmonary Surgery.
The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Aesthetic Surgery, Dermatology & Plastic Surgery, Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial, Otorhinolaryrigological (ENT) Surgery, Podiatry, Pulmonary Surgery, Thoracic Surgery.
The Profile 2000 and Profile 3000 emits laser energy with wavelength of 2.01 µm and 2.94 µm respectively. The laser consists of a system console, internal computer, control panel and display, and a fiber optic delivery system and footswitch.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical "acceptance criteria" or specific "reported device performance" in the way one might find for a diagnostic algorithm. Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices.
2. Sample Size and Data Provenance for Test Set:
Not applicable. This device is a laser system, not a diagnostic algorithm that would typically use a test set of data for performance evaluation in the context of the requested questions. The equivalence is based on design features, intended use, and functional features.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. Ground truth for a test set of data is not relevant for this type of device submission.
4. Adjudication Method:
Not applicable. Adjudication methods are typically used in studies involving expert review of diagnostic outputs, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study assesses how AI might improve human reader performance, which is not relevant for a laser surgical instrument.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical laser system, not a standalone algorithm.
7. Type of Ground Truth Used:
Not applicable. The ground truth concept, as it pertains to AI/algorithm development, is not applicable to the substantial equivalence determination for this laser system. The "truth" in this context is the safety and effectiveness profile of the predicate devices.
8. Sample Size for Training Set:
Not applicable. This device does not involve a training set for an AI algorithm.
9. How Ground Truth for Training Set Was Established:
Not applicable. This device does not involve a training set for an AI algorithm.
Summary of the Study for Device Acceptance:
The acceptance of the Profile 2000 and Profile 3000 Laser Systems, and Delivery Devices and Accessories, is based on a substantial equivalence determination to legally marketed predicate devices. This is a common pathway for medical device clearance (510(k)) in the U.S.
The study, or rather, the justification for acceptance, presented in the 510(k) summary (sections {0}-{4} of the provided text) highlights the following:
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Rationale for Substantial Equivalence: The key argument is that the Profile 2000 and Profile 3000 Laser Systems share:
- Intended Use: They are both laser surgical instruments.
- Indications for Use: The current devices are indicated for a broad range of surgical applications, which are outlined in detail for both Profile 2000 and Profile 3000 systems. These indications are explicitly stated to be "based upon the indications for use for predicate systems."
- Similar Design Features: This includes wavelength (2.01 µm for Profile 2000 and 2.94 µm for Profile 3000), power supply, cooling system, and control system.
- Functional Features: This includes power output, repetition rate, and pulse duration.
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Predicate Devices: A comprehensive list of legally marketed predicate devices (both for Profile 2000 and Profile 3000 equivalents) is provided. These predicate devices serve as the benchmark against which the new device is compared.
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Safety and Effectiveness Information: The document states that because the new devices are "technologically substantially equivalent to the listed predicate devices," their "risks and benefits... are comparable to the predicate devices." This implies that the safety and effectiveness of the predicate devices, established through their marketing history, implicitly serve as the "acceptance criteria" which the new device meets by virtue of its equivalence.
In essence, the "study" proving the device met acceptance criteria was a regulatory comparison demonstrating that the new laser systems are sufficiently similar in design, function, and intended use to already cleared devices, and therefore share a comparable safety and effectiveness profile. There are no explicit performance metrics in this document because the regulatory pathway is based on equivalence rather than de novo performance benchmarks against a "ground truth" data set in the way an AI algorithm might be evaluated.
§ 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.