The 800 Series Surgical Laser System (KTP Upgrade) and Accessories is intended to be used for all currently cleared Laserscope indications. These indications include applications in the following specialities:

KTP/532 nm Applications: Dermatology. Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Spinal Surgery, Plastic Surgery, Thoracic Surgery and Urology.

Nd:YAG/1064 Applications: Dermatology, Gastroenterology, General Surgery, Genecology, Head and Neck/Otorhinolaryngology (ENT), Hemostasis During Surgery, Neurosurgery, Oculoplastics, Orthopedics, Plastic Surgery, Pulmonary Surgery, Thoracic Surgery, Urology.

Device Description

The Laserscope 800 Series Surgical Laser System is currently available in 8 configurations, 7 which have a KTP laser emitting light at 532 nm. This is achieved by passing the infrared beam produced by the Nd: Y A G source through a second crystal made from potassium titanyl phosphate (KTP). The process that converts the infrared light to the visible green light requires two photons of infrared light to produce one photon of ereen light. This conversion process halves the wavelength, or doubles the frequency, so the wavelength of the KTP beam is exactly half that of the Nd: Y AG beam.

The Laserscope 800 Series Surgical Laser Sytem (KTP Upgrade) is achieved by an upgraded, higher quality q-switch and driver; increasing the power supply; adding a water to water heat exchanger and utilizing silicone based titanium dioxide lamp reflectors. Four new configurations are available:

Model 833, 2XP: 50 watts KTP/532, 100 watts Nd:YAG/1064, Dual Port
Model 834, 2XP: 50 watts KTP/532, 100 watts Nd:YAG/1064, Single Port
Model 843, 3XP: 60 watts KTP/532, 100 watts Nd: YAG/1064, Dual Port
Model 843, 3XP: 60 watts KTP/532, 100 watts Nd:YAG/1064, Single Port

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "800 Series Surgical Laser System (KTP Upgrade) and Accessories." This document is a regulatory submission to the FDA for market clearance, not a study report. Therefore, it does not contain the detailed information typically found in a clinical study used to "prove" a device meets acceptance criteria.

Instead, the document asserts substantial equivalence to a predicate device, which is the primary mechanism for 510(k) clearance. This means the manufacturer is claiming the new device is as safe and effective as a device already legally marketed, rather than providing new clinical data to prove a specific set of performance criteria.

Therefore, many of the requested details related to clinical study design, sample sizes, ground truth establishment, and multi-reader studies are not available in this type of regulatory submission.

However, I can extract the relevant information implied by a 510(k) submission regarding acceptance criteria generally and the comparison with the predicate device.

Description of Acceptance Criteria and the "Study" (Substantial Equivalence Claim)

The "acceptance criteria" for a 510(k) upgraded device relying on substantial equivalence are primarily centered around demonstrating that the modified device performs as safely and effectively as, and does not raise new questions of safety or effectiveness compared to, the predicate device. This is achieved by showing comparable indications for use, materials, method of operation, physical construction, and performance.

The "study" that proves the device meets these acceptance criteria, in this context, is the Premarket Notification (510(k)) submission itself. It details the device's characteristics and compares them explicitly to a legally marketed predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) on an upgrade to an existing system, the "acceptance criteria" are implied by the requirements for substantial equivalence. The "reported device performance" is the assertion of equivalence to the predicate.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate device.	The risks and benefits for the 800 Series Surgical Laser System (KTP Upgrade) and Accessories are comparable to the predicate device when used for similar clinical applications. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
Indications for Use: The upgraded device is intended for the same indications as the predicate.	"The 800 Series Surgical Laser System (KTP Upgrade) and Accessories is intended to be used for all currently cleared Laserscope indications." (Specific KTP/532 nm and Nd:YAG/1064 applications across Dermatology, Gastroenterology, General Surgery, Gynecology, ENT, Neurosurgery, Ophthalmology, Plastic Surgery, Spinal Surgery, Thoracic Surgery, and Urology are listed explicitly and are identical to the predicate.)
Technological Characteristics: Materials, method of operation, and physical construction are substantially equivalent to the predicate device.	"The 800 Series Surgical Laser System (KTP Upgrade) and Accessories is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device..." (Upgrade details: higher quality q-switch and driver, increased power supply, water to water heat exchanger, silicone-based titanium dioxide lamp reflectors and new configurations with higher KTP wattages).
Performance Standards: Conformance to relevant federal regulations and performance standards.	"The 800 Series Surgical Laser System (KTP Upgrade) and Accessories conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems."

The remainder of the requested information pertains to clinical study design, which is not provided in this 510(k) summary. These types of submissions typically leverage existing data and the established safety and efficacy of a predicate device, rather than generating new, extensive clinical evidence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not provided. A formal "test set" from a clinical study is not described. The submission relies on establishing equivalence to a predicate device, which implies that the predicate's performance history and existing data (which are not detailed here) serve as the basis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not provided. No specific "ground truth" establishment by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not provided. No clinical test set requiring adjudication is described.

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 device is a surgical laser system, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a hardware surgical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Implied by Predicate Device: The "ground truth" for demonstrating safety and effectiveness of the upgraded device is the established safety and effectiveness of the predicate device for its approved indications for use. No new ground truth data type is specified for the upgrade.

8. The sample size for the training set

Not Applicable / Not provided. No training set for an algorithm is described.

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

Not Applicable / Not provided. No training set for an algorithm is described.

Summary

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970948

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE 800 SERIES SURGICAL LASER SYSTEM (KTP UPGRADE) AND ACCESSORIES

REGULATORY AUTHORITY

Safe Medical Device Act of 1990, 21 CFR 807.92

MAY 2 | 1997

COMPANY NAME/CONTACT:

Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134 Phone: 408 943-0636 FAX: 408-943-1454

DEVICE TRADE NAME:

800 Series Surgical Laser System and Accessories

DEVICE COMMON NAME:

Laser Instrument, Surgical, Powered

DEVICE DESCRIPTION:

Model 833, 2XP:	50 watts KTP/532, 100 watts Nd:YAG/1064, Dual Port
Model 834, 2XP:	50 watts KTP/532, 100 watts Nd:YAG/1064, Single Port
Model 843, 3XP:	60 watts KTP/532, 100 watts Nd: YAG/1064, Dual Port
Model 843, 3XP:	60 watts KTP/532, 100 watts Nd:YAG/1064, Single Port

Laserscope Premarket Notification For 800 Series Surgical Laser Systems

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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2

DEVICE CLASSIFICATION:

The 800 Series Surgical Laser System (KTP Upgrade) and Accessories has been classified as a Class II medical device by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.

PERFORMANCE STANDARDS:

The 800 Series Surgical Laser System (KTP Upgrade) and Accessories conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.

INDICATIONS FOR USE STATEMENT:

COMPARISON WITH PREDICATE DEVICE:

The 800 Series Surgical Laser System (KTP Upgrade) and Accessories is substantially equivalent to the Laserscope 800 Series Surgical Laser System and Accessories.

The risks and benefits for the 800 Series Surgical Laser System (KTP Upgrade) and Accessories are comparable to the predicate device when used for similar clinical applications.

Since the 800 Series Surgical Laser System (KTP Upgrade) and Accessories is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.

Laserscope Premarket Notification For 800 Series Surgical Laser Systems

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized eagle-like symbol with three wavy lines beneath it, representing water or waves. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 1997

Ms. Lisa McGrath Senior Regulatory Affairs Specialist Laserscope 3052 Orchard Drive San Jose, California 95134-2011

K970948 Re: Trade Name: 800 Series Surgical Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: March 13, 1997 Received: March 14, 1997

Dear Ms. McGrath:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 mav 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.

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Page 2 - Ms. Lisa McGrath

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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INDICATIONS FOR USE STATEMENT

Q ot

510(K) Number:	970948
Device Name:	800 Series Surgical Laser System (KTP/532, KTP/532 andNd:YAG/1064 and Nd:YAG/1064 Configurations) andAccessories
Indications for Use:	The 800 Series Surgical Laser System and Accessories isintended to be used for the following indications:

KTP/532 nm Applications:

Dermatology - Indications include photocoagulation, hemostasis, color lightening, blanching flattening and reduction of lesion size for the following categories of lesions: vascular lesions including angiomas, hemangiomas, telangiectasia; benign pigmented lesions including nevi, lentigines, chloasma, cafe-au-lait, tattoos; culaneous lesions including verrucae, skin tags, keratoses and plaques.

Gasteroenterology - indications for hemostasis in the gastrointestinal tract including varices, esophagitis, esophageal uicer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers and gastric erostons. Indications for tissue ablation in the gastrointestinal tract including benign and malignant neoplasms, anglodysplassia, polyps, uicers, collitis and hemormoids. Indications for esophageal neoplastic obstructions including squarnous cell carcinoma and adenocarcinoma.

General Surgery - indications include vaporization, coagulation, incision, excision, debulking and ablation of soft tissue in endoscopic or open procedures.

Gynecology - indications include vaporization, incision and coagulation of tissue associated with treatments for conditions such as endometriosis; carvical, vulvar and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions and submucosal fibroids.

Head and Neck/Otorhinolaryngology (ENT) - indications include tissue incision, excision ablation and vessel hemostasis.

Neurosurgery - indications include incision, excision, coagulation and vaportzation, of neurosurgical turnors of the firm, textured type.

Ophthalmology - indications include post-vitrectorny endophotocoagulation of the retina.

Plastic Surgery - indications include vaporization, coagulation, incision, excision, debutking and ablation of soft tissue in endoscopic and open procedures. ----------

Spinal Surgery - indications include percutaneous lumbar discectorny.

Thoracic Surgery - indications include vaporization, coagulation, incision, excision, debulking and ablation of soft tissue, including lung tissue in thoracoscopic or open procedures.

Urology - indications include cutting, coagulation or vaporization of soft tissue dunk urologic procedures.

Division Sign-Off
Division of General Restorative Devices
510(k) Number K970448

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Indications for Use Statement, Page 2

Nd:YAG/1064 Applications:

Dermatology - indications include photocoagulation of pigmented vascular lesions to reduce lesion size: for patients with lesions that would potentially benefit from aggressive treatment; and for patients with lesions that have not responded to other laser treatments.

Gasteroenterology - indications for hemostasis in the gastrointestinal tract, including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric uicer, anoiodysplasia, stomal ulcers, non-bleeding ulcers and gastric erosions. Indications for tissue ablation in the gastrointestinal tract including benign and mallgnant neoplasms, angiodysplasia, polyps, ulcers, colitis and hemorrhoids. Indications for esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma.

General Surgery - indications include cutting, ablation and/or hemostasis of soft tissue in endoscopic/laparoscopic and open general surgical applications, including cholecystectorny. appendectorny, vagotomy and pyloromyotomy. Soft tissue general surgical indications include skin incision, tissue dissection, excision of external turnors and lessions, tissue ablation, vessel coaculation and complete or partial resection of internal organs, turnors and lesions.

Genecology - indications include treatment of menormagia by photocoagulation of the endometrial lining of the uterus; ablation of endometrial implants and/or peritoneal adhesions: soft tissue excisional procedures, such as excision of the cervix; intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated, including submucous fibroids, benign endometrial polyps and uterine septum.

Head and Neck/Otorhinolaryngology (ENT) - indications include tissue incision, exclision, ablation and vessel hemostasis.

Hemostasis During Surgery - indications include adjunctive coaculation and hemostasis (bleeding control) during surgery in endoscopic and epen procedures.

Neurosurgery - indications include hemostasis for pituitary turnor. meningloma. hemoglioblastoma. AVMs. diloblastoma. astrocytoma and oligodendroglioma.

Oculoplastics - indications include incision, excision and/or coagulation of tissue in oculoplastic procedures such as operations on the lacrimal system, operations on the evelids, removal or biopsy of orbital turnors, enucleation of eyeball, exemeration of orbital contents.

Orthopedics - indications include cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.

Plastic Surgery - indications include cutting, incision, coagulation and vaporization of ... ... soft tissue.

Pulmonary Surgery - indications include palliative procedures for benign and mallignant pulmonary airway obstructions, including squarnous cell carcinoma, carcinoma, carcinoid. benign turnors, granulomas, tracheal stenosis and benion strictures.

Thoracic Surgery - indications incision, excision, excision, coagulation and vaportzation of soft tissue. Thoracic applications, including isolation of vessels for endarterectorny and/or bypass grafts, wedge resections, thoracotomy, formation of pacemaker pockets, vaporization, coagulation, incision, excision debulking and aprilion of lung tissue (thoracoscopy).

scosley e

(Division Sign-Off)
Division of General Restorative Devices K970448
510(k) Number

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Indications for Use Statement, Page 3

Urology - Indications include superficial urinary bladder turnors, invasive bladder carcinoma. urethreal strictures, bladder neck contracture, diverticulum and lesions of the external genitalia (including condyloma acuminata).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices/920948
510(k) Number

Prescription Use
(per 21 CFR 801.109)
or
Over-The-Counter Use

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.