(159 days)
The Incisive Family of InPulse Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including:
Oropharangeal / Dental Surgery
Indicated for:
- Abscess incision and drainage
- Aphthous ulcers treatment
- Biopsies, excisional and incisional
- Crown lengthening
- Exposure of unerupted / partially erupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival incision and excision
- Gingivectomy
- Gingivoplasty
- Hemostatis
- Implant recovery
- Lesion (tumor) removal
- Leukoplakia
- Operculectomy
- Oral papillectomy
- Pulpotomy
- Pulpotomy as adjunct to root canal therapy
- Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
- Selective ablation of enamel (first degree) caries removal
- Sulcular debridement (removal of diseased or inflamed soft tissue in the periodonta pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth; attachment loss, and tooth mobility
- Tissue retraction for impressions
- Vestibuloplasty
General Surgery
Indicated for:
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Cholecystectomy
- Lymphadenectomy
- Mastectomy
- Partial nephrectomy
- Hepatectomy
- Pilonidal cystectomy
- Pancreatectomy
- Resection of lipoma
- Splenectomy
- Pelvic adhesiolysis Hemorrhoidectomy
- Removal of lesions
- Thyroidectomy
- Removal of polyps
- Parathyroidectomy
- Removal of tumors Herniorrhaphy
- Tumor biopsy
- Tonsillectomy
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery
Endonasal surgery (ablation; vaporization; incision, and coagulation of soft tissue) including:
- Besions or turnors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
- Tonsillectomy
- Adenoidectomy
Podiatry (ablation, vaporization, incision, and coagulation of soft tissue) including:
- Matrixectomy
- Periungual and subungual warts
- Plantar warts
- Radical nail excision
- Neuromas
Dermatology and Plastic Surgery
Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Lesions of skin and subcutaneous tissue
- Telangiectasia
- Port wine lesions
- Spider veins
- Hemangiomas
- Plantar warts
- Periungual and subungual warts
- Removal of tattoos
- Debridement of decubitus ulcer
- Treatment of keloids
The Incisive Family of InPulse Nd:YAG Lasers are comprised of the following main components:
Main console containing the major electrical components, including:
- Control/ Display Panel with the:
- Keyswitch (that controls authorized acess to the laser sytem);
- emergency Laser Stop button:
- Displays (laser emission indicator, average power, pulse energy, repetition rate)
- Standby button (default mode when laser system turned on places system into the Standby mode preventing laser emission).
- Ready button (places system into the Ready mode allowing laser emission when the footswitch is depressed and a fiber optic is properly attached);
- A 1064 nm treatment laser (solid state Nd:YAG laser rod) with flashlamp and associaged light regulation components and electronics;
- A 630 -680 nm (red) aiming beam diode laser;
- Delivery device fiber-optic connector port;
- A Remote interlock connector (External door interlock connector);
- Connector ports for the footswitch and power cord:
- A Accessory holder (attached to the rear of the main console);
- Footswitch:
- Medical grade power cord;
- Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue:
- Guide Tip -No Standoff: Reusable, cleanable, tip is provided for noncontact use to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tip attaches to the end of the handpiece (previously cleared in K011423, see below). The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
- Guide Tip -With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beamat the treatment location. The Guide tip attaches to the end of the handpiece (previously cleared in K011423, see below). The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
- Delivery Devices for Contact with Breached Surfaces (Previously Cleared in K011423):
- Optical Fibers - Reusable, cleanable, sterilizable optical fibers (range of 200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
- Handpieces - Reusable, cleanable, sterilizable handpieces (large and small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap;
- Handpiece Tips -Disposable single-use tips are provided in straight and curved configurations and are used to direct and control the placement of the optical fiber tip at the treatment location. The handpiece tips attach to the end of the handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip;
- Accessories:
- A Safety Glasses
- Tools:
- A Optical Fiber Striper:
- A Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).
This document is a 510(k) premarket notification for the Incisive Family of InPulse Nd:YAG Lasers. It is a submission to the FDA seeking clearance to market a medical device, demonstrating substantial equivalence to previously cleared devices, rather than a study proving the device meets specific acceptance criteria through clinical trials and performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not applicable to this type of regulatory submission.
The document focuses on:
- Device Description: What the device is and its components.
- Predicate Devices: Identifying similar, legally marketed devices to establish a basis for comparison.
- Rationale for Substantial Equivalence: Arguing that the new device is as safe and effective as the predicate devices, sharing similar indications for use, device operation, and technical/functional capabilities.
- Indications for Use: Listing the specific medical procedures and specialties for which the laser is intended.
The FDA's review and approval (as indicated by the letter from Mark M. Melkerson) means they have determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls, and can be marketed. This is a regulatory clearance based on equivalence, not a performance study against specific 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.