(15 days)
The Indigo 830e LaserOptic ™ Treatment System is intended to be used in the contact mode to photocoagulate, vaporize/ablate soft tissue (muscle, connective tissue, organ), and in the contact or non-contact mode for cutting, excision, incision, and coagulation of soft tissue in both open or closed surgical procedures.
The Índigo 830e LaserOptic™ Treatment 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 lateral lobes ranging in total volume from 20-85 cc and for general surgery, general urological and gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.
The Índigo Diffuser- Tip™ Fiberoptic is a sterile, single-use, disposable fiberoptic which is 3 meters in length with a light-diffusing section at the distal tip. The device is designed to deliver energy from the Indigo Model 830e diode laser only and bears a unique connector for coupling to the 830e laser at the proximal end. Modifications have been made to increase the resistance to breakage of the fiberoptic and improve the manufacturability of the device. None of the changes affect the function, intended use, or overall design of the fiberoptic or of the Indigo LaserOpticTM Treatment System.
The Indigo Diffuser-Tip™ Fiberoptic with Temperature Sensing Option is a modified device, and its acceptance criteria and performance are established through equivalence testing against a previously cleared predicate device (K963969). The study focuses on demonstrating that the modified device performs equivalently to the predicate and shows improved resistance to breakage.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Equivalence to Predicate Device) | Reported Device Performance (Modified Diffuser-Tip™ Fiberoptic) |
|---|---|
| Equivalent Tissue Temperature Profile | Achieved |
| Equivalent Lesion Size | Achieved |
| Equivalent Internal Heating of the Fiber | Assumed equivalent based on other parameters |
| Equivalent Time to Reach Operating Temperature | Assumed equivalent based on other parameters |
| Equivalent Fiber Intensity Profile | Assumed equivalent based on other parameters |
| Equivalent Total Energy Delivered | Assumed equivalent based on other parameters |
| Improved Resistance to Breakage | Achieved (Significant improvement reported) |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the nonclinical tests. The tests were performed to compare the modified fiberoptic with the existing fiberoptic for equivalence. The data provenance is a non-clinical "testing" that was performed, implying laboratory or experimental settings rather than patient data. No country of origin for this data is specified, but it's part of a US FDA submission. The study is prospective in the sense of comparing a new modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device's performance is based on direct physical measurements and comparisons to a predicate device, not expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. The testing involves direct physical measurements and comparisons, not subjective interpretations requiring adjudication.
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 a diagnostic device involving human readers or AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (fiberoptic) for surgical procedures, not an algorithm.
7. The type of ground truth used
The ground truth used is based on direct physical measurements and comparisons to a legally marketed predicate device. This includes:
- Tissue temperature profiles
- Lesion size
- Internal heating of the fiber
- Time to reach operating temperature
- Fiber intensity profile
- Total energy delivered
- Resistance to breakage
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm or a diagnostic tool that learns from data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.