(30 days)
The Índigo OPTIMA Laser System with Diffuser-Tip Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or Jateral lobes ranging in total volume from 20-85 cc; and for general surgery, general urological, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser coagulation of soft tissues such as tumors and fibroids.
The Indigo OPTIMA Laser System, when used in conjunction with the Bare-Tip Fiberoptic, is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures, including those involving urethral strictures, bladder neck contractures, and condylomata.
The Indigo® OPTIMA Laser System consists of a treatment diode laser, fiberoptic energy delivery devices, a footswitch, and an optional cart with printer. The treatment laser allows delivery of controlled doses of laser energy in wavelengths between 800 and 850 nanometers (nm). When used with the OPTIMA Diffuser-Tip Fiberoptic, this laser energy is diffused radially at 360° to the affected tissue to provide interstitial thermotherapy (ITT), or interstitial laser coagulation (ILC). The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices.
Modifications to design of the Diffuser-Tip Fiberoptic have been made to improve manufacturability. Changes include removal of the inner sleeve, use of a new non patient-contacting adhesive, and a software modification.
The provided text describes a Special 510(k) Premarket Notification for the Índigo® OPTIMA Laser System. This type of submission is for modifications to a previously cleared device, asserting substantial equivalence to the predicate device. Therefore, the focus of the performance data is on demonstrating that the modifications do not raise new questions of safety or effectiveness and that the modified device performs as intended and is equivalent to the predicate.
Based on the provided text, a detailed study with specific acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness with human readers (as would be typical for an AI/ML device) is not applicable here. This document is for a medical device that delivers laser energy, not an AI or imaging diagnostic device.
Here's a breakdown of the information as requested, tailored to the context of this device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Modified Diffuser-Tip Fiberoptic performs as intended and is equivalent to the predicate. | "Design verification and validation testing confirms the modified Diffuser-Tip Fiberoptic performs as intended and is equivalent to the predicate." |
| Safety | Modifications do not raise new issues of safety. | "No new issues of safety and effectiveness have been raised by these modifications." |
| Effectiveness | Modifications do not raise new issues of effectiveness. | "No new issues of safety and effectiveness have been raised by these modifications." |
| Operating Parameters | Adjusted laser operating parameters accommodate design changes with no loss in performance. | "The operating parameters of the laser have been adjusted slightly to accommodate the design changes with no loss in performance." |
| Intended Use | Device maintains its intended use for treating BPH symptoms. | The intended use statement remains the same as the predicate: "The Indigo OPTIMA Laser System when used with the Diffuser-Tip Fiberoptic is intended for the safe and effective treatment of symptoms of benign prostatic hyperplasia (BPH)." |
| Technological Characteristics | Technological features remain the same as the predicate, with minor design changes aimed at manufacturability. | "The technological features of the modified Diffuser-Tip Fiberoptic are the same as the predicate with exception of the above design changes." (Changes include removal of inner sleeve, new non-patient contacting adhesive, software modification). |
Explanation: In a Special 510(k), the primary "acceptance criterion" is often demonstrating that the modified device is substantially equivalent to the predicate and that the changes do not adversely affect safety or effectiveness. Specific quantitative metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML or diagnostic devices are not provided because the device's function is energy delivery for treatment, not diagnostic interpretation.
2. Sample size used for the test set and the data provenance:
- Information Not Provided: The submission does not detail specific "test sets" or data provenance in the way an AI/ML device might. The "performance data" refers to "design verification and validation testing." This likely involved engineering bench testing, simulated use, and potentially some animal or cadaver studies, but specifics are not outlined in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Information Not Provided: This concept of "expert ground truth" is not applicable to a laser energy delivery system submission. The "truth" is established through engineering and biological performance verification, not expert interpretation of outputs.
4. Adjudication method for the test set:
- Information Not Provided: Not applicable for this type of device.
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:
- No, not done: This is a laser energy delivery system, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: The Indigo® OPTIMA Laser System is a physical medical device operated by a human, not a standalone algorithm.
7. The type of ground truth used:
- Engineering Specifications and Biological Performance: The implicit "ground truth" for this device would be its ability to consistently and reliably deliver specific laser energy parameters, achieve the intended thermal effects in tissue, and maintain its sterility and structural integrity as per its design specifications and prior clinical understanding of the predicate device's performance.
8. The sample size for the training set:
- Information Not Provided: The concept of a "training set" is not relevant for this hardware device. Design and manufacturing processes are iterative and involve testing, but not in the "training set" context of AI/ML.
9. How the ground truth for the training set was established:
- N/A: Not applicable for this device.
Summary of Device Context:
The Índigo® OPTIMA Laser System is a therapeutic device, specifically a laser system for interstitial thermotherapy. The 510(k) submission is for minor modifications to the Diffuser-Tip Fiberoptic (removal of inner sleeve, new adhesive, software modification) aimed at improving manufacturability. The core message is that these changes do not alter the technological features or performance in a way that raises new safety or effectiveness concerns, and the modified device remains substantially equivalent to its predicate. The "performance data" refers to design verification and validation testing demonstrating this equivalence and intended performance.
§ 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.