(446 days)
No
The document describes a laser treatment system for tissue ablation and coagulation, focusing on the physical interaction of the laser with tissue. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) and general surgical procedures, which are therapeutic interventions.
No
The device is indicated for the treatment of symptoms due to urinary outflow obstruction, as well as general surgical, general urological, and gastroenterological procedures involving incision, excision, ablation, coagulative necrosis, and interstitial laser coagulation of soft tissues. Its function is to cut or coagulate tissues by elevating tissue temperature. It does not mention any diagnostic capabilities.
No
The device description clearly describes a laser system with a fiberoptic, which are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for treating symptoms of BPH and performing surgical procedures on soft tissues. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details how the laser is used to cut, coagulate, and cause tissue necrosis. These are all actions performed on living tissue within the body.
- Anatomical Site: The anatomical sites mentioned (prostates, soft tissues) are within the human body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
The Indigo 830e LaserOptic Treatment System is a therapeutic device used for surgical procedures, not a diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
Device Description
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. Lesion sizes vary according to diffuser length and variation of tissue conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men with prostates
Indicated Patient Age Range
men over the age of 50
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The table below shows the penetration depth in porcine tissues (invitro) as a function of time and exposure to diode laser power.
| Exposure
| Power/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 |
The results of a prospective, randomized study shows that the Indigo procedure is safe and effective for the treatment of Benign Prostate Hyperplasia.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
| Exposure
| Power/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) |
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