The Índigo OPTIMA Laser System with Diffuser-Tip Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic thyperplasia (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, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser coagulation of soft tissues such as tumors and fibroids.

The Indigo OPTIMA Laser System, when used in conjunction with the Bare-Tip Fiberoptic, is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures, including those involving urethral strictures, bladder neck contractures, and condylomata.

Device Description

The Indigo® OPTIMA Laser System consists of a treatment diode laser, fiberoptic energy delivery devices, a footswitch, and an optional cart with printer. The treatment laser allows delivery of controlled doses of laser energy in wavelengths between 800 and 850 nanometers (nm). When used with the OPTIMA Diffuser-Tip Fiberoptic, this laser energy is diffused radially at 360° to the affected tissue to provide interstitial thermotherapy (ITT), or interstitial laser coagulation (ILC). When used with the OPTIMA Bare-Tip or cutting fiber, the laser beam directly contacts the tissue to provide incision, excision, ablation, or coagulation of tissues with hemostasis. Both the OPTIMA Diffuser-Tip and Bare-Tip Fiberoptics are designed to deliver energy from the Índigo OPTIMA diode laser only and bear unique, proximal connectors to the OPTIMA laser. The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices. In addition, there are several accessories to the laser system including laser goggles, a traveling case, and fiberoptic instruments for servicing and demonstration (for sales representatives only and not for human use).

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Indigo OPTIMA Laser System, focusing on acceptance criteria and study details:

This 510(k) summary does not include a table of acceptance criteria or a detailed clinical study demonstrating the device's performance against specific clinical acceptance metrics. Instead, it relies on substantial equivalence to predicate devices and pre-clinical bench testing.

Here's a breakdown based on your requested information:

Acceptance Criteria and Device Performance (Not explicitly stated as clinical performance)

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety and Electromagnetic Compatibility	Demonstrated and certified by VDE Testing and Certification Institute.
Compliance with UL-2601-1, CSA 601.1, and IEC 60601-1	The Indigo OPTIMA System bears the CSA International label for these standards.
Compliance with U.S. Federal Safety and Performance Standards for light emitting products (21 CFR 1040.10/11).	The Indigo OPTIMA Laser System meets these standards.
Satisfactory performance for intended applications	Bench testing has indicated that the system demonstrates satisfactory performance for its intended applications.
Substantial equivalence to predicate device	The Indigo OPTIMA Laser System is a modification of the currently marketed Indigo LaserOptic Treatment System, with overall technology and intended use being the same. Design modifications (software, electronics, fiber size) are noted.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical test set involving human subjects is described in this 510(k) summary. The summary refers to "Preclinical testing" and "Bench testing."
- Data Provenance: Not applicable. The studies mentioned are pre-clinical bench tests and certifications, not clinical data from a specific country.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth was established by experts for a test set described in this summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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 device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is hardware (a laser system) and does not involve an algorithm with standalone performance in the context of AI. The device itself is "standalone" in that it performs its function when operated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Preclinical testing" and "Bench testing," the "ground truth" would be engineering specifications, performance metrics validated against physical standards, and compliance with known safety and performance standards (e.g., laser power output accuracy, beam profile, electrical safety parameters, electromagnetic compatibility). These are not medical ground truths like pathology or expert consensus on patient outcomes.
The sample size for the training set:
- Not applicable. This is a hardware device; the concept of a "training set" as it applies to AI/machine learning models is not relevant here.
How the ground truth for the training set was established:
- Not applicable. The concept of a training set and its ground truth does not apply to this type of device in the context of this 510(k) summary. The "training" for such devices typically involves iterative design, manufacturing, and testing against engineering specifications to ensure reliability and safety.

Summary of Approach in the 510(k):

The 510(k) summary for the Indigo OPTIMA Laser System primarily relies on demonstrating substantial equivalence to previously cleared predicate devices. The "Performance Data" section focuses on:

Pre-clinical bench testing to ensure the system performs as intended (details of these tests or specific metrics are not provided in this summary).
Compliance with electrical safety, electromagnetic compatibility, and various international and US federal safety standards (e.g., VDE, CSA, UL, IEC, 21 CFR 1040.10/11).

This approach is common for modifications to existing, well-understood medical devices, where the core technology and intended use remain the same, and the changes are primarily software, electronic, or minor mechanical upgrades. Clinical studies with explicit acceptance criteria for human data are typically required for novel devices or significant changes to existing device indications or technology.

Summary

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Índigo® OPTIMA Laser System DEC 1 3 2001 510(k) Summary of Safety & Effectiveness

Company

Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242

Contact

Linda G. Hill Regulatory Affairs Manager

Date Prepared

August 21, 2001

Device Name

Trade Name: Índigo® OPTIMA Laser System Classification Name: Laser powered surgical instrument

Predicate Device

The Índigo OPTIMA Laser System is substantially equivalent to the current Índigo LaserOptic® Treatment System cleared by FDA on December 23, 1997 (K963969), as well as the following submissions:

K954195, cleared January 25, 1996, Indigo Portable Laser System Model IDL 830 and ● Indigo Fiberoptics
K955758, cleared February 27, 1996, Índigo Portable Laser System with Temperature . Feedback Model 830e
K963081, cleared February 21, 1997, Índigo Models IDL 830 and IDL 830e Laser Systems ●
. K990851, cleared March 30, 1999, Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option
K003952, cleared March 16, 2001, Indigo LaserOptic Treatment System ●
K003953, cleared March 16, 2001, Indigo Diffuser-Tip Fiberoptic with Temperature . Sensing Option

Device Description

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energy from the Índigo OPTIMA diode laser only and bear unique, proximal connectors to the OPTIMA laser. The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices. In addition, there are several accessories to the laser system including laser goggles, a traveling case, and fiberoptic instruments for servicing and demonstration (for sales representatives only and not for human use).

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Intended Use

The Indigo OPTIMA Laser System,as a surgical instrument, is intended to be used in the noncontact mode to photocoagulate, vaporize/ablate soft tissue (muscle, connective tissue, organ), for cutting, excision, incision, and for coagulation of soft tissue in the contact mode (open/closed) surgical procedures. When used with bare fiberoptics, the Indigo diode laser can be used for the excision of external tumors and lesions, complete and partial resection of internal organs, treatment of tumors and lesions, skin incision and tissue dissection and ablation. The Diffuser-Tip Fiberoptic is intended for the safe and effective treatment of Benign Prostatic Hyperplasia (BPH).

Comparison of Technological Characteristics

The Índigo OPTIMA Laser System is a modification of the currently marketed Índigo LaserOptic Treatment System. While it represents a refinement to the predicate system, the overall technology and the intended use of the two systems are the same. Both the predicate and the modified systems are designed to treat Benign Prostatic Hyperplasia (BPH) when used with the Diffuser-Tip Fiber. and as a general surgical tool for cutting tissue when used with the Bare-Tip Fiber. The design modifications include upgrades to the software and electronic components, as well as modifications to the fibers to permit use with smaller cystoscopes, having a working channel of 5 FR. New accessories to the system include a laser cart, providing storage and mobility, and a printer to record procedure data for patient records.

The OPTIMA laser unit contains two, diode lasers that convert electrical energy to optical energy in narrow wavelength bands. The treatment laser produces red light in the near infra-red spectrum with a wavelength of 800-850 nm and is classified as a Class IV laser by the U.S. Center for Devices and Radiological Health (CDRH) and according to DIN VDE 0837. The marker laser produces light in the visible light range (approximately 633 nm) and is classified as a Class II laser by CDRH. This is identical to the predicate laser system.

Performance Data

Preclinical testing was performed to ensure that the laser system performs as intended when used according to the instructions for use. Bench testing has indicated that the system demonstrates satisfactory performance for its intended applications. Electrical safety and electromagnetic compatibility have been demonstrated and are certified by VDE Testing and Certification Institute. The Indigo OPTIMA System bears the CSA International label for UL-2601-1, CSA 601.1, and IEC 60601-1.

The Indigo OPTIMA Laser System meets U.S. Federal Safety and Performance Standards for light emitting products (21 CFR 1040.10/11).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2001

Ethicon Endo-Surgery c/o Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K013493

Trade/Device Name: Índigo® OPTIMA Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 4, 2001 Received: December 5, 2001

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The rou may a may a royisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, un

Image /page/3/Picture/5 description: The image shows a handwritten signature. The signature is in cursive and appears to be a stylized version of the letters 'sv'. The 's' is formed with a large loop at the top and a smaller loop at the bottom. The 'v' is connected to the 's' and has a sharp angle at the bottom. The signature is written in black ink on a white background.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): K013493

İndigo® OPTIMA Laser System Device Name :

Indications for Use :

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-off)
	Division of General Restorative Devices
510(k) number

Prescription Use
(Per 21 CFR 801.109)

OR
Over-the-Counter Use


	(Division Sign-Off)
	Division of General, Restorative
	and Neurological Devices

DEC 03 2001	510(k) Number K013493
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Regulation Number and Section

§ 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.