SLT CL MD CONTACT LASER SYSTEM by SURGICAL LASER TECHNOLOGIES, INC.

The SLT CL MD Laser Systems are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. This device is specifically intended for use in prostate procedures which treat the clinical condition of Benign Prostatic Hyperplasia. This device is currently cleared for market for multiple surgical indications.

The specific indication for use of the SLT® Contact Laser™ Fiber Delivery System is for the Incision, Excision, Coagulation and Vaporization of soft tissue for prostatectomy in treatment of Benign Prostatic Hyperplasia (BPH).

Vaporization of Prostatic Tissue - The Contact Laser Vaporization of the Prostate (CLVP) procedure vaporizes prostate lobe tissue as well as tissue obstructing the urinary channel. This procedure is indicated for prostates up to 45 grams in size.

Coagulation and Vaporization of Prostatic Tissue - The Coagulation and Hemostatic Resection of the Prostate (CHRP)™ coagulates the prostate lobe tissue and vaporizes tissue obstructing the urinary channel. This procedure is indicated for prostates up to 75 grams.

Device Description

AI/ML Overview

The provided text describes a 510(k) submission for the SLT CL MD Laser System. The submission aims to establish substantial equivalence for the use of this laser system in prostate procedures for Benign Prostatic Hyperplasia (BPH) by demonstrating its safety and effectiveness are equivalent to the traditional electrosurgical procedure (TURP).

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or device performance in the typical format of metrics like sensitivity, specificity, or accuracy. Instead, the acceptance is based on demonstrating substantial equivalence in safety and effectiveness to existing legally marketed predicate devices, specifically the "current Gold Standard Electrosurgical Procedure (TURP)" for BPH.

Acceptance Criteria	Reported Device Performance
Safety: Device compliance with relevant safety standards (UL 2601, IEC 601-1, IEC 601-2-22, etc.). Safety verified by Hazard analysis, software validation, and performance testing.	The safety of the laser system was assessed and cleared for market under prior 510(k)s (K854669, K884815, K912793, and K930490). This submission further establishes safety equivalence to TURP through clinical data.
Effectiveness: Achieve precise tissue effects of incision, excision, vaporization, and coagulation of tissue in general surgery and specific surgical specialties.	The device achieves the stated tissue effects. This submission specifically focuses on demonstrating effectiveness for BPH treatment (CLVP and CHRP procedures) equivalent to TURP.
Intended Use Equivalence: SLT CL MD Laser Systems intended use is as defined in prior clearances and is equivalent to other legally marketed predicate devices.	The device's intended use in general surgery and various specialties is already cleared. This submission focuses on demonstrating equivalence for BPH treatment.
Substantial Equivalence for BPH treatment: Clinical data demonstrates that the laser procedure for BPH is equivalent in safety and effectiveness to the traditional electrosurgical procedure (TURP).	CLVP Procedure: Vaporizes prostate lobe tissue and tissue obstructing the urinary channel for prostates up to 45 grams. CHRP Procedure: Coagulates prostate lobe tissue and vaporizes tissue obstructing the urinary channel for prostates up to 75 grams. These are presented as equivalent in safety and effectiveness to TURP.

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "This submission will establish, based on clinical data, that the laser procedure for treatment of BPH is equivalent in safety and effectiveness to the traditional electrosurgical procedure."
However, the sample size for the clinical data (test set) is not specified in this summary.
The provenance of the data (country of origin, retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the given text.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. The study describes a comparison to an established procedure (TURP), implying clinical outcomes would be the primary measure, rather than an expert consensus on individual cases in a traditional AI model evaluation.

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:

The document describes a clinical study comparing a laser procedure to an electrosurgical procedure (TURP). This is a comparative effectiveness study, but it's not an MRMC study comparing human readers with and without AI assistance. The device is a surgical tool, not an AI diagnostic aid.
Therefore, an MRMC study and effect size in human reader improvement with AI are not applicable in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is a surgical laser system, intended for use by a surgeon. It is not an algorithm that performs autonomously.
Therefore, a standalone algorithm-only performance assessment is not applicable.

7. The Type of Ground Truth Used:

The ground truth in this context would be clinical outcomes data from patients treated with the laser procedure for BPH, compared against clinical outcomes data from patients treated with the traditional electrosurgical procedure (TURP).
The effectiveness is assessed by the ability of the laser to achieve the intended tissue effects and clinical improvements in BPH patients, equivalent to TURP.

8. The Sample Size for the Training Set:

This device is a surgical tool, not an AI model that relies on a "training set" in the machine learning sense. The concept of a training set is not applicable.
The device's design, safety, and initial effectiveness were developed and tested through engineering principles, performance testing, and prior 510(k) clearances.

9. How the Ground Truth for the Training Set was Established:

As the device is a surgical tool and not an AI model, the concept of "ground truth for the training set" is not applicable.
The "ground truth" for the device's development and validation would stem from established medical and engineering principles, preclinical testing, and clinical experience/literature forming the basis for the predicate devices.

Summary

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APR 21 1998

K972548

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used as well. The comparison of intended use and technological features of this device to other legally marketed devices taken together with validation results indicate that this device is substantially equivalent to legally marketed predicate devices with regards to safety effectiveness and intended use. This information was provided in 510(k) K902241 which cleared the device for Genitourinary surgical procedures and K955813 which extended the Urology claims to include catheter removal within 24 hours. This submission will establish, based on clinical data, that the laser procedure for treatment of BPH is equivalent in safety and effectivness to the traditional electrosurgical procedure.

The safety of this device is shown by compliance to relevant safety standards for Laser systems devices such as UL 2601, IEC 601-1, IEC 601-2-22, etc. Product safety is also verified by Hazard analysis, software validation and performance testing to ensure the product performs as intended. The safety of the laser system was assessed and cleared for market under 510(k) K854669, K884815, K912793, and K930490.

The intended use of this device is the same as the intended use of many other products currently on the market. Specifically, there are SLT Products as well as competitors products which are intended to provide the identical tissue effects. Therefore, all aspect of this device have predicates which are well accepted in the clinical community. This product simply provides the clinical data to show that laser prostate procedures are substantially equivalent in safety and efficacy to the current Gold Standard Electrosurgical Procedure (TURP).

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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 21 1998

Ms. Monica Ferrante ·Regulatory Affairs Surgical Laser Technologies 147 Keystone Drive Montgomeryville, Pennsylvania 18936-9638

K972548 Re: Trade Name: SLT CL MD Contact Laser System and Delivery Fibers Regulatory Class: II Product Code: GEX Dated: February 16, 1998 Received: February 17, 1998

Dear Ms. Ferrante:

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 reqistration, 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. ದ 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 In addition, FDA may publish further announcements action. 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.

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Page 2 - Ms. Ferrante

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.qov/cdrh/dsmamain.html".

Sincerely yours,

E. Celia M. Witton, Ph. D., M.

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

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INDICATIONS FOR USE

Prescription Use
(Per 21 CFR 801.109)

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

510(k) Number K972548 -

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.