(227 days)
The Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation and coagulation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following expanded Indications for Use:
Dermatology/Plastic Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking of benign tumors, decubitis ulcers, cysts, diagnostic biopsy and skin resurfacing and treatment of wrinkles.
Ear, Nose and Throat (ENT):
The following indications can be used with the Angled or Straight Handpieces:
ENT surgery in soft, mucosal, cartilaginous and bony tissue, including endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy) dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangiectasias, septoplasty, lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.
Gastroenterology:
The following indications can be used with the Angled or Straight Handpieces:
Gastroenterologic surgery of soft tissue, including cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Genitourinary/Urology:
The following indications are used with the Angled Handpieces:
Genitourinary surgery of soft tissue, including treatment of bladder, urethral and ureteral tumors, superficial urinary bladder tumors, invasive bladder carcinomas, urethral and penile hemangioma, urethral strictures, lesions of the external genitalia, urethra and anus, penis, scrotum, (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon, bladder neck obstructions.
The following indications are used with the Straight Handpieces:
Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynecology:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: General ophthalmic soft tissue surgical indications such as: Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.
Oral/Maxillofacial Surgery:
The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Oral/dental procedures for incision, excision, ablation, vaporization and hemostasis of soft tissue during gingivoplasties, gingivectomies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotomy.
Podiatry:
The following indications can be used with the Angled or Contra-Angled Handpieces: Warts, plantar verrucae, large mosaic verrucae and matrixectomy.
Pulmonary Surgery:
The following indications can be used with the Angled or Straight Handpieces: Open and endoscopic pulmonary surgery.
Thoracic Surgery:
The following indications can be used with the Angled or Straight Handpieces: Surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery.
The Waterlase iPlus S system is an erbium, chromium, yttrium, scandium, garnet (ER,CR:YSGG) solid state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2.78 µm (2780 nm). The laser consists of a cabinet which houses the power supply, the cooling system, micro-controller, laser, foot switch, and fiber optic for delivery of laser energy with the fiber optic handpiece. Various handpiece and tip types are available depending upon the clinician's preference for the different applications. The Waterlase iPlus S system utilizes direct laser energy either with or without water for cooling and hydration to perform soft tissue incision, resection, ablation, vaporization, coagulation and hemostasis.
The provided document is a 510(k) premarket notification for the "Waterlase iPlus S" laser surgical instrument. It details the device's intended use and provides a comparison to predicate devices, but it does not contain acceptance criteria or a study proving device performance in the way typically associated with clinical or standalone performance studies for AI/CAD devices.
The document states:
- "No other performance testing was conducted since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearances under 510(k) Nos.: K101658 and K122368."
- "Clinical testing was not conducted on this device."
- The conclusion of substantial equivalence is based on "comparison of the Waterlase iPlus S with the same device, Waterlase iPlus, Profile Multi-Platform System and Laserscope VELA previously cleared by the FDA".
Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence based on expanded indications for use and technical similarity to previously cleared predicate devices, rather than new performance data.
§ 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.