substantially equivalent to other pulsed Nd: YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures.

Device Description

The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd:YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. The DCL8 Enhanced Pulsed Nd: YAG laser system can be operated by either a footswitch or a fingerswitch.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device, specifically a Pulsed Nd:YAG Laser System. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device already legally marketed in the U.S., rather than to establish performance against specific acceptance criteria through a clinical study as would be required for a PMA (Premarket Approval) or De Novo submission.

Therefore, the sections requesting acceptance criteria and a study proving their fulfillment are not applicable in the context of this document. This submission does not provide the information requested in the prompt because it falls under a different regulatory pathway.

Here's a breakdown of why the requested information cannot be found in the provided text:

Acceptance Criteria & Reported Device Performance: This submission aims to prove the device is as safe and effective as existing devices, not to meet pre-defined performance thresholds demonstrated through new clinical data.
Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: All these points relate to specific clinical study designs and data collection strategies. A 510(k) typically relies on engineering comparisons, performance testing to recognized standards (like electrical safety), and a declaration of substantial equivalence based on the predicate device's established safety and effectiveness.

Instead, this document focuses on the following:

1. Device Description:
* Device Name: DCL8 Enhanced Pulsed Nd:YAG Laser System and Associated Fiberoptic Delivery Systems
* Common Name: Pulsed Nd:YAG Laser System
* Classification: Class II medical device for the laser system; accessory delivery systems expected to be Class II.

2. Compliance with Standards:
* The DCL8 system conforms with federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
* Product labels comply with 21 CFR 1040.10, 1040.11, and 801.

3. Equivalence Statement (the core of a 510(k)):
* Predicate Devices:
* SunLase Master Pulsed Nd:YAG laser system, Sunrise Technologies, Inc.
* SunLase Pulsed Nd:YAG laser system, Sunrise Technologies, Inc.
* PulseMaster 600 Pulsed Nd:YAG laser system, American Dental Technologies
* PulseMaster 1000 Pulsed Nd:YAG laser system, American Dental Technologies
* Basis for Equivalence:
* Intended Use: Substantially equivalent to other pulsed Nd:YAG laser systems for incision, excision, coagulation, or vaporization of soft tissues in open, endoscopic, and laparoscopic procedures.
* Operating Characteristics: Same average power to tissue, pulse rates, operating controls, indicators, red diode aiming beam, touch pad controls, and input power (110 VAC) as predicate devices.
* Delivery Systems: Uses industry standard SMA 905 fiberoptic connector system, identical to predicate devices. Many delivery systems to be used with DCL8 (NEOS Alloy Scalpels, Fiber Cap, Hybrid Surgical Device, Closed End, Closed End/Electrocautery, Bipolar Dissector, Super Scalpel, Fiber Contact Handpiece) have already received market clearance for use with other Nd:YAG laser systems. The interaction with tissue is considered independent of the laser source.
* User Interface: Can be operated by footswitch or fingerswitch, a technology offered on existing Nd:YAG laser systems since 1990.

In summary, this document is a regulatory submission for substantial equivalence, not a report on a study designed to meet specific performance acceptance criteria.

Summary

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JUN - 3 1996 9 mm

SUMMARY OF SAFETY & EFFECTIVENESS V.

SUMMARY OF 21 CFR 807.87

Device Name: A.
- Proprietary Name: DCL8 Enhanced Pulsed Nd:YAG 1. Laser System and Associated Fiberoptic Delivery Systems
- 1. Common Name: Pulsed Nd:YAG Laser System
B. Establishment Registration Number:

SLT-J has not yet registered as a medical device establishment with FDA. The company intends to complete all regulatory filings prior to introducing the DCL8 Enhanced Pulsed Nd: YAG laser system into interstate commerce.

Address all correspondence to: Michael D. Johnson johnson+associates 5848 Price Road Milford, OH 45150 513-248-8804

C. Device Classification:
ﻤﺴﺘﻌﻤﺎ

Pulsed surgical Nd: YAG laser systems are currently considered Class II medical devices subject to pre-market notification provisions for many surgical applications.

Although not formally classified, Nd: YAG surgical laser delivery systems typically have been regulated as Class II devices.

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Electrosurgery handpieces (pencils, electrodes) are considered Class II 79 GEI [21 CFR 878.4400]. SLT-J anticipates these accessory devices would receive the same classification if such delivery systems were officially classified.

Compliance With Standards D.

The DCL8 Enhanced Pulsed Nd:YAG laser system conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11, for medical laser systems. Certification reports will be submitted to CDRH certifying compliance with this standard are currently in preparation and will be submitted by SLT-J prior to commercial distribution of this product.

The sponsor is unaware of any specific standards solely for fiberoptic laser delivery systems.

E. Labeling

Product labels comply with 21 CFR 1040.10 and 1040.11 as applicable. A Operator's Manual for the DCL8 Enhanced Pulsed Nd: YAG laser system is currently in preparation. A draft Operator's Manual is included in this submission (see Section II, Device Description).

Product labels comply with 21 CFR 801 as applicable for accessory devices. Copies of the proposed text for these package labels are located in Section IV of this submission.

Promotional materials are not yet in preparation; therefore, they are not included with this submission.

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F. Equivalence Statement

In the opinion of SLT-J, the Pulsed Nd: YAG laser system is substantially equivalent to the following systems:

SunLase Master Pulsed Nd: YAG laser system, Sunrise Technologies, Inc., (Fremont, CA)

SunLase Pulsed Nd: Y AG laser system, Sunrise Technologies, Inc. (Fremont, CA)

PulseMaster 600 Pulsed Nd: YAG laser system, American Dental Technologies (Troy, MI)

PulseMaster 1000 Pulsed Nd:YAG laser system, American Dental Technologies (Troy, MI)

Summary of Safety and Effectiveness G.
The DCL8 Enhanced Pulsed Nd: YAG laser system is substantially equivalent to other pulsed Nd: YAG laser systems currently marketed by Sunrise Technologies (Fremont, CA) and American Dental Technologies (Trov, MI)

This belief is based upon the following facts:

The DCL8 Enhanced Pulsed Nd:YAG laser system is 1. substantially equivalent to other pulsed Nd: YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures. The delivery systems which can be used in conjunction with the DCL8 Enhanced Pulsed Nd: YAG laser system have previously been cleared for marketing by the FDA.

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1. The DCL8 Enhanced Pulsed Nd: YAG laser system has the same operating characteristics as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies.
1. The DCL8 Enhanced Pulsed Nd:YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. This is identical to the connector systems used by Sunrise Technologies and American Dental Technologies. The delivery systems which will be used with the DCL8 Enhanced Pulsed Nd: YAG laser system have previously received market clearance for use with Nd: YAG laser systems to which the delivery systems can be attached.
The DCL8 Enhanced Pulsed Nd: YAG laser system can be 4. operated by either a footswitch or a fingerswitch. This technology is equivalent to, and has been offered since 1990 on Nd:YAG laser systems offered by Surgical Laser Technologies (The Oaks, PA) and LCA (Cincinnati, OH), This allows the operator to select between either footswitch or fingerswitch control of the delivery system.
1. Many of the delivery systems (NEOS Alloy Scalpels, Fiber Cap, Hybrid Surgical Device, Closed End, Closed End/Electrocautery and Bipolar Dissector) which are to be used with the DCL8 Enhanced Pulsed Nd:YAG laser system have already received market clearance for use with other Nd: Y AG laser systems. Because of the configuration of these delivery systems, i.e., delivery of laser light to tissues, the source of laser energy is not important. The delivery systems still interact

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with tissue in a similar manner, regardless of the input (laser) source. The Super Scalpel behaves in a similar manner.

The Fiber Contact Handpiece is equivalent to those offered currently by Sunrise Technologies (Fremont, CA) and American Dental Technologies (Troy, MI) for their pulsed Nd: YAG laser systems. Additionally, Laserscope (San Jose, CA) offers an equivalent contact fiber handpiece assembly.

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.