(144 days)
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 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.
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.
§ 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.