(52 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 thyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral 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). When used with the OPTIMA Bare-Tip or cutting fiber, the laser beam directly contacts the tissue to provide incision, excision, ablation, or coagulation of tissues with hemostasis. Both the OPTIMA Diffuser-Tip and Bare-Tip Fiberoptics are designed to deliver energy from the Índigo OPTIMA diode laser only and bear unique, proximal connectors to the OPTIMA laser. The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices. In addition, there are several accessories to the laser system including laser goggles, a traveling case, and fiberoptic instruments for servicing and demonstration (for sales representatives only and not for human use).
Here's an analysis of the provided 510(k) summary regarding the Indigo OPTIMA Laser System, focusing on acceptance criteria and study details:
This 510(k) summary does not include a table of acceptance criteria or a detailed clinical study demonstrating the device's performance against specific clinical acceptance metrics. Instead, it relies on substantial equivalence to predicate devices and pre-clinical bench testing.
Here's a breakdown based on your requested information:
Acceptance Criteria and Device Performance (Not explicitly stated as clinical performance)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety and Electromagnetic Compatibility | Demonstrated and certified by VDE Testing and Certification Institute. |
| Compliance with UL-2601-1, CSA 601.1, and IEC 60601-1 | The Indigo OPTIMA System bears the CSA International label for these standards. |
| Compliance with U.S. Federal Safety and Performance Standards for light emitting products (21 CFR 1040.10/11). | The Indigo OPTIMA Laser System meets these standards. |
| Satisfactory performance for intended applications | Bench testing has indicated that the system demonstrates satisfactory performance for its intended applications. |
| Substantial equivalence to predicate device | The Indigo OPTIMA Laser System is a modification of the currently marketed Indigo LaserOptic Treatment System, with overall technology and intended use being the same. Design modifications (software, electronics, fiber size) are noted. |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical test set involving human subjects is described in this 510(k) summary. The summary refers to "Preclinical testing" and "Bench testing."
- Data Provenance: Not applicable. The studies mentioned are pre-clinical bench tests and certifications, not clinical data from a specific country.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth was established by experts for a test set described in this summary.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
-
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 device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool, and no MRMC study is mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is hardware (a laser system) and does not involve an algorithm with standalone performance in the context of AI. The device itself is "standalone" in that it performs its function when operated.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Preclinical testing" and "Bench testing," the "ground truth" would be engineering specifications, performance metrics validated against physical standards, and compliance with known safety and performance standards (e.g., laser power output accuracy, beam profile, electrical safety parameters, electromagnetic compatibility). These are not medical ground truths like pathology or expert consensus on patient outcomes.
-
The sample size for the training set:
- Not applicable. This is a hardware device; the concept of a "training set" as it applies to AI/machine learning models is not relevant here.
-
How the ground truth for the training set was established:
- Not applicable. The concept of a training set and its ground truth does not apply to this type of device in the context of this 510(k) summary. The "training" for such devices typically involves iterative design, manufacturing, and testing against engineering specifications to ensure reliability and safety.
Summary of Approach in the 510(k):
The 510(k) summary for the Indigo OPTIMA Laser System primarily relies on demonstrating substantial equivalence to previously cleared predicate devices. The "Performance Data" section focuses on:
- Pre-clinical bench testing to ensure the system performs as intended (details of these tests or specific metrics are not provided in this summary).
- Compliance with electrical safety, electromagnetic compatibility, and various international and US federal safety standards (e.g., VDE, CSA, UL, IEC, 21 CFR 1040.10/11).
This approach is common for modifications to existing, well-understood medical devices, where the core technology and intended use remain the same, and the changes are primarily software, electronic, or minor mechanical upgrades. Clinical studies with explicit acceptance criteria for human data are typically required for novel devices or significant changes to existing device indications or technology.
§ 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.