(446 days)
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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K963969
Section K : Summary of Safety and Effectiveness
DEC 2 3 1997
Invitro and human clinical testing were conducted to establish the equivalence to predicate devices in terms of safety and efficacy and to characterize the performance of the laser system with different types of fiber optics.
When used as a general surgical instrument, the laser is able to provide power to cut or coagulate tissues. The table below shows the penetration depth in porcine tissues (invitro) as a function of time and exposure to diode laser power.
| ExposurePower/Time | Penetration Depth (mm) | ||
|---|---|---|---|
| Liver | Kidney | 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 |
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. Lesion sizes vary according to diffuser length and variation of tissue conditions.
The results of a prospective, randomized study shows that the Indigo procedure is safe and effective for the treatment of Benign Prostate Hyperplasia.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Starowicz Director of Regulatory, Clinical and Quality Systems Indigo Medical, Incorporated 10123 Alliance Road Cincinnati, Ohio 45242
DEC 2 3 1997
K963969 Re:
Trade Name: Indigo 830e LaserOptic Treatment System with Diffuser-Tip™ Fiberoptic Regulatory Class: II Product Code: GEX Dated: September 29, 1997 Received: September 30, 1997
Dear Ms. Starowicz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Ms. Starowicz
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number: | K963969 |
|---|---|
| Device Name: | Indigo 830e LaserOptic Treatment System with Diffuser-Tip™ Fiberoptic |
| Indications for Use: Note: | Indigo is requesting the expansion of the indications for use which have already been cleared under K955798 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 expanded Indications for Use will read as follows:
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K963969 |
| Prescription Use | OR | Over-the-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
00011
§ 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.