(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.
{0}------------------------------------------------
990851
APPENDIX IX
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the modified Indigo Diffuser-Tip™ Fiberoptic with Temperature Sensing Option.
Submitter:
Índigo Medical, Inc. 10123 Alliance Road Cincinnati, Oh 45242 Telephone : 513-786-7987 Fax : 513- 483-3410
Contact Person :
Jacquelyn A. Hughes, RAC
Device Name :
| Trade Name: | Índigo Diffuser-Tip™ Fiberoptic with Temperature Sensing Option |
|---|---|
| Common Name: | Diode laser fiberoptic delivery system |
| Proprietary Name: | Índigo LaserOptic™ Treatment System |
| Classification Name: | Accessory to laser-powered surgical instrument |
Date Prepared:
March 2, 1999
Predicate Device: The modified Índigo Diffuser-Tip™ Fiberoptic with Temperature Sensing Option is substantially equivalent to the current Indigo Diffuser-Tip™ Fiberoptic with Temperature Sensing Option cleared by FDA on December 23, 1997 (K963969).
Device Description: 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.
{1}------------------------------------------------
APPENDIX IX
Intended Use: 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.
Indications
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.
Comparison of Technological Characteristics: The technical and functional characteristics of the modified Diffuser-Tip™ Fiberoptic are essentially identical to the existing Diffuser-Tip™ Fiberoptic. The modifications to the components incorporated in the design are refinements to the manufacturing process and to the design which do not represent technological changes. The laser source is the Model 830e diode laser in both cases and the output and resulting lesion size have not changed.
Nonclinical Tests: Testing was performed in order to compare the modified Diffuser-Tip™ Fiberoptic with the existing fiberoptic for equivalence of the tissue temperature profiles and the resulting lesion size. The lesion size, temperature accuracy, internal heating of the fiber, time to reach operating temperature, fiber intensity profile, and total energy delivered were measured and compared. The results indicated that the modified Diffuser-Tip™ Fiberoptic had an equivalent tissue temperature profile, and that the lesion size created by the modified fiberoptic is equivalent to the lesion size created by the current Diffuser-Tip™ Fiberoptic. A reliability assessment was conducted to evaluate the robustness and resistance to breakage of the modified fiberoptic as compared to the current Diffuser-Tip™ Fiberoptic. Results indicated a significant improvement.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with two snakes entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 1999
Ms. Jacquelyn A. Hughes, RAC Manager, Regulatory Affairs Indigo Medical, Inc. 10123 Alliance Road Cincinnati, Ohio 45242
K990851 Re:
Trade Name: Indigo Diffuser-Tip "Fiberoptic with Temperature Sensing Option Regulatory Class: II Product Code: GEX
Dated: March 12, 1999 Received: March 15, 1999
Dear Ms. Hughes:
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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Ms. Jacquelyn A. Hughes, RAC
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 vour 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
SECTION 1
NDICATIONS FOR US
510 (k) Number (if known): K990811
Índigo Diffuser-Tip™ Fiberoptic , accessory to the Indigo Device Name : LaserOptic™ Treatment System
The Indigo LaserOptic™ Treatment System with Indications for Use : 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 20-85cc 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off)
Division of General Restorative Devices
510(k) number K990851
Prescription Use _/
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
§ 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.