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510(k) Data Aggregation
(446 days)
INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10
The Indigo 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 general surgery, general urological and for for gastroenterological procedures including the incision, excision, and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.
When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues. When used as a coagulating device, the Indigo laser in conjunction with a diffusing fiberoptic provides interstitial laser coagulation. The process of interstitial laser coagulation relies on quickly elevating tissue to a temperature range (Appox. 60 to 100°C) where tissue necrosis rapidly occurs, but below temperatures at which carbonization begins.
The provided text describes pre-market clearance for the "Indigo 830e LaserOptic Treatment System with Diffuser-Tip™ Fiberoptic" (K963969). The submission seeks to expand the indications for use, particularly for the treatment of Benign Prostate Hyperplasia (BPH).
Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The direct acceptance criteria are not explicitly stated as quantitative thresholds in the provided text. Instead, the submission relies on demonstrating equivalence to predicate devices in terms of safety and efficacy and characterizing performance.
Performance Characterization (Physical Parameters):
| Exposure Power/Time | Penetration Depth (mm) - Liver | Penetration Depth (mm) - Kidney | Penetration Depth (mm) - Heart |
|---|---|---|---|
| 5 Watts / 1 sec | 1.73 ± 0.20 | 1.75 ± 0.34 | 1.77 ± 0.37 |
| 5 Watts / 2 sec | 2.48 ± 0.73 | 2.29 ± 0.31 | 2.19 ± 0.62 |
| 5 Watts / 5 sec | 3.37 ± 0.64 | 3.31 ± 0.39 | 3.03 ± 0.72 |
| 10 Watts / 1 sec | 2.26 ± 0.47 | 1.90 ± 0.35 | 2.25 ± 0.62 |
| 10 Watts / 2 sec | 3.30 ± 0.59 | 2.36 ± 0.27 | 2.16 ± 0.35 |
| 10 Watts / 5 sec | 4.34 ± 0.78 | 3.65 ± 0.54 | 2.89 ± 0.34 |
| 15 Watts / 1 sec | 2.35 ± 0.45 | 2.60 ± 0.35 | 2.16 ± 0.32 |
| 15 Watts / 2 sec | 3.61 ± 0.50 | 3.17 ± 0.38 | 2.58 ± 0.34 |
| 20 Watts / 1 sec | 2.99 ± 0.48 | 2.64 ± 0.50 | 1.99 ± 0.36 |
| 20 Watts / 2 sec | 3.27 ± 1.34 | 2.98 ± 0.77 | 3.48 ± 0.79 |
| 25 Watts / 1 sec | 2.81 ± 1.13 | 2.24 ± 0.53 | 2.96 ± 0.83 |
| 25 Watts / 2 sec | 3.65 ± 0.72 | 3.17 ± 1.04 | 2.81 ± 0.44 |
Clinical Performance (BPH):
The text states: "The results of a prospective, randomized study shows that the Indigo procedure is safe and effective for the treatment of Benign Prostate Hyperplasia."
Details of the Study to Meet Acceptance Criteria:
The document combines "invitro" and "human clinical testing" to establish equivalence and characterize performance.
2. Sample Size Used for the Test Set and Data Provenance:
- "Invitro" testing: The text specifies penetration depth measurements in porcine tissues (invitro). The sample size for this invitro testing (number of tissue samples or repetitions per setting) is not provided.
- Human Clinical Testing (for BPH): A prospective, randomized study was conducted. The specific sample size for this human study is not provided.
- Data Provenance:
- Invitro: Porcine tissues, so likely laboratory-based data, origin not specified.
- Human Clinical: Prospective, randomized human study. The geographic origin of the study participants is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable for the reported studies.
- For the invitro study, the "ground truth" is direct physical measurement (penetration depth).
- For the clinical study, the "ground truth" would be clinical outcomes related to BPH treatment (e.g., symptom improvement, safety endpoints), which are observed by clinicians, but no specific "expert panel" for establishing ground truth is mentioned in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable. This device is a surgical treatment system, not a diagnostic imaging device requiring interpretation adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The studies described are:
- An invitro characterization of the device's physical cutting/coagulation properties.
- A prospective, randomized clinical study evaluating the device as a treatment for BPH. This clinical study is for treatment efficacy and safety, not for diagnostic performance comparison.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This question is not applicable to this physical medical device. The device is a laser system and a fiberoptic, which is operated by a human surgeon. It does not involve an "algorithm only" performance.
7. Type of Ground Truth Used:
- Invitro: Direct physical measurement of penetration depth in porcine tissues.
- Clinical (BPH): Clinical outcomes (safety and effectiveness) as measured in a prospective, randomized human study. These outcomes would typically be objective clinical endpoints.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical surgical tool, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for the device would be the design, engineering, and manufacturing process.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
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