SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS by SURGICAL LASER TECHNOLOGIES, INC.

The SLT Select Fiber Delivery Systems and Contact Tips are indicated for use 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. The universal SMA-905 connector allows this family of fiber delivery systems and tips to be used with any laser system meeting the following requirements:

Laser must operate at a wavelength between 532 and 1064 nanometers. Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. Laser must have a numerical apertures of 0.39 or less Laser must accept the universal SMA-905 connector.

Fiber Delivery Systems are cleared for use for the particular indications of the laser system to which they are attached.

This device is a prescription device.

Device Description

The SLT Select Fiber Delivery Systems and Contact Tips 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 and tips achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905 connector.

AI/ML Overview

This document, K980156, is a 510(k) summary for the SLT Select Fiber Delivery Systems and Contact Tips, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance criteria or clinical study results as would be expected for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for AI models is not applicable or cannot be extracted from this particular document.

Here's an analysis based on the provided text, addressing the points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or detailed performance metrics in the way a modern AI/software device submission would. The basis for approval is "substantial equivalence" to existing devices. The document states:

"Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used. 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 implies that some form of validation was conducted to show the device performed comparably to predicate devices in achieving specific "tissue effects of incision, excision, vaporization and coagulation of tissue." However, the specific criteria for these effects (e.g., depth of incision, degree of coagulation, rate of vaporization) and the results of this validation are not provided in this summary.

The "acceptance criteria" can be inferred as the device successfully demonstrating the intended tissue effects when used with compatible laser systems, comparable to how predicate devices perform these actions.

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Ability to achieve precise tissue effects: incision, excision, vaporization, and coagulation.	"The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue." (The document states this as a capability rather than a measured performance against a quantitative target, implying it was demonstrated to be functionally equivalent to predicate devices.)
Compatibility with laser systems meeting specified requirements (wavelength, mode, numerical aperture, SMA-905 connector).	"The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905 connector." And further, "Laser must operate at a wavelength between 532 and 1064 nanometers. Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. Laser must have a numerical apertures of 0.39 or less Laser must accept the universal SMA-905 connector." (This is a design feature enabling compatibility, implicitly demonstrating it met this criterion).
Safety and effectiveness comparable to legally marketed predicate devices.	"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 is the overarching conclusion of the 510(k) process, not a specific reported performance metric.)

2. Sample size used for the test set and the data provenance

Not applicable. This is a medical device for surgical procedures, not an AI/software device that uses test sets of data for algorithm evaluation. The "validation results" mentioned are likely related to engineering testing, material compatibility, and demonstration of functional performance in controlled environments or potentially animal/benchtop models, not human data sets. The document does not provide details on the specific validation tests or the sample sizes used in them.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of "ground truth" or expert review in the context of a test set, as this is not an AI/software device being evaluated for diagnostic or predictive accuracy.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication process described for this type of medical device submission.

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 an AI-assisted device.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

Not applicable. As this is not an AI/software device, the concept of "ground truth" in terms of clinical outcomes or expert consensus on data is not relevant to this submission. The "validation results" would likely be based on physical measurements and observations of the fiber's ability to transmit laser energy and create the desired tissue effects.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning model, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set or associated ground truth for this medical device.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

FEB 2 7 1998

Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used. 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.

The intended use of this device is the same as the intended use of other laser fiber delivery systems and identical to the proprietary SLT Products currently marketed to provide the same tissue effects. Therefore, all aspect of this device have predicates which are well accepted in the clinical community. This product simply provides the ability to use the SLT fiber delivery systems with any 532 to 1064 nm wavelength laser system which accepts the SMA-905 connector.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 1998

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

Re : K980156 Trade Name: SLT Select Fiber Delivery System and Contact Tips Requlatory Class: II Product Code: GEX Dated: January 1998 Received: January 16, 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 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. ਸ 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 requlatory 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.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

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K980156

INDICATIONS FOR USE

Fiber Delivery Systems are cleared for use for the particular indications of the laser system to which they are attached.

This device is a prescription device.

Signature

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

510(k) Number __ K980156

Prescription Use
(Per 21 CFR 801.109)

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.