(99 days)
The intended use for the Dual Switch Adapter is for the vaporization, ablation, or photocaogulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.
The intended use of the Dual Switch Adapter is for the performance of specific surgical applications in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows:
Dermatology:
The Dual Switch Adapter is indicated for use in dermatology and plastic surgery for the following applications: -Ablation, vaporization, excision, and coagulation of soft tissue in the performance of: laser skin resurfacing, laser dermabrasion, and laser burn debridement -Laser skin resurfacing) ablation and/or vaporization) for the treatment of: wrinkles, rhytids and furrows (including fine lines and texture irregularities). -Laser skin resurfacing (ablation, and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of. Keratosis, including actinic and sebortheic keratosis, seborrheci wart and verruUT sebortheica. Vermillionectomy of the lip Cutaneous horns Solar/actinic elastosis Cheilis, including actinic cheilitis Lentigines, including lentigo maligna or Hutchinson's malignant freckle Uneven pigmentation/dyschromia Acne scars Surgical scars Keloids including acne keloidalis nuchae Hemangiomas (including Buccal, port wine and pygenic granuloma pyogenicum/granuloma telangiectatioum) Tatoos Telangiectasia Removal of small skin tumors, including periungual (Koenen) and subungual fibromas Superficial pigmented lesions Adenosebaceous hypertrophy or sebaceous hyperplasia Rhinophyma reduction Cutaneous papilloma (skin tags) Milia Debridement of eczematous or infected skin Bramous and squamous cell carminoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions Nevi, including spider, epidermal, and protruding Neurofibromas Laser de-epitheliazation Tricoepitheliomas Xanthelasma palpebrarum Syringoma -Laser ablation, vaporization, and/or excision for complete and partial nail matrixecomy - Vaporization/coagulation of: benign/malignant vascular skin lesions, Moh's surgery, Lipectomy, Verrucae and seborrhoecae vulgares, including paronychial, periungual and subungual warts -Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty -Laser incision and/or excision of soft tissue for the creation of receipt sites for hair transplantation
Podiatry
The Dual Switch Adapter is indicated for use in podiatry for the following applications: -Laser ablation, vaporization, and/or excision of soft tissue for the reduction, removal, and/or treatment of: Verrucae vulgares/plantar (warts), including paronychial, periungual and subungual warts - Fungal nail treatment Porokeratoma ablation Ingrown nail treatment Neuromas/fibromas, including Morton's neuroma Debridement of ulcers Other soft tissue lesions -Laser ablation, vaporization, and/or excision for complete and partial (nail) matrixectomy
Otolaryngology
The Dual Switch Adapter is indicated for laser incision, ablation and/or vaporization of soft tissue in otolaryngology for the treatment of: -Choanal atresia -Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue -Nasal obstruction -Adult and juvenile papillomatosis polyps -Polypectomy of nose and nasal passages -Lymphangioma removal - -Removal of vocal cord/fold nodules, polyps and cysts -Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx and trachea, including the uvula, palatal. upper lateral pharyngeal tissue, tongue and vocal cords. -Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue -Zenker's Deverticulum/pharyngoesophageal diverticulum) endoscopic laser-assisted esophagodiverticulostomy (ELAED) -Stenosis, including subgottic stenosis Tonsillectomy (including tonsilar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy -Pulmonary bronchial and tracheal lesion removal -Benign and malignant nodules, tumors and fibromas (larynx, trachea, tracheobronchial/endobronchial) -Benign and malignant lesions and fibromas (nose and nasal passages) -Benign and malignant tumors and fibromas (oral) -Stapedotomy/Stapedectomy -Acoustic neuroma in the ear -Superficial lesions of the ear, including chondrodermatatis nondularis chroniUT helices/Winkler's disease -Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue) -Cordectomy, cordotomy (for the treatment of vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea -Myringotomy/tympanostomy (tympanic membrane fenestration) -Uvulopalatoplasty and turbinate reduction/ablation -Septal spur ablation/reduction and septoplasty -Partial glossectomy - -Tumor resection of oral, subfacial and neck tissue -Rhinophyma -Verrucae vulgares (warts) -Gingivoplasty/gingivectomy
Gynecology and GYN Laparoscopy Indication
The Dual Switch Adapter is indicated for use in gynecology for the following applications: -Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of: Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN) Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowenoid papulosa (BP lesions) Leukoplakia (vulvar dystrophies) Incision and drainage (I&D) or Bartholin's and nabothian cysts Herpes vaporizaton Urethral caruncle vaporization Cervical dysplasia Benign and malignant tumors Hemangiomas - Vaporization, incision, excision, ablation or photocoagulation of soft tissue in endoscopic surgery, including gynecological laparoscopy, for the treatment of: Endometrial lesions, including ablation of endometriosis Excision/lysis adhesions Salpingostomy Oophorectomy Fimbrioplasty Metroplasty Microsurgery (tubal) Uterine myomas and fibroids Ovarian fibromas and follicle cysts Uterosacral ligament ablation Hysterectomy
Neurosurgery Indications
The Dual Switch Adapter is indicated for laser incision, ablation and/or vaporizaton of soft tissue in neurosurgery for the treatment of: -Cranial Posterior fossa tumors Peripheral neurectomy Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors Arteriovenous malformation Pituitary gland tumors (transphenoidal approach) -Spinal Cord Incision/excision and vaporization of benign and malignant tumors and cysts Intra and extradural lesions Laminectomy/laminotomy/microdiscectomy
Orthopedic Indication
The Dual Switch Adapter is indication, excision, and vaporization of soft tissue in orthopedic surgery, including the following applications: -Arthroscopy Meniscectomy Chondromalacia Chondroplasty Ligament release (lateral and other) Excision of plica Partial synovectomy -General Debridement of traumatic wounds Debridement of decubitus and diabetic ulcers Microsurgery Artificial joint revision PMMA removal
General and Thoracic Surgery
The Dual Switch Adapter is indication for the incision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures. Applications include: -Debridement of decubitus ulcers stasis, diabetic, and other ulcers -Mastectomy - -Debridement of burns - -Rectal and anal hemorrhoidectomy - -Breast biopsy - -Reduction mammoplasty - -Cytoreduction for metastatic disease - -Laparotomy and laparoscopic applications - -Mediastinal and thoracic lesions and abnormalities - -Skin tag vaporization - -Atheroma - -Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips - -Pilondial cyst removal and repair - -Abscesses - -Other soft tissue applications
Dental and Oral Surgery
The Dual Switch Adapter is indication for the incision, excision of soft tissue in dentisty and oral surgery. Applications include: - -Gingivectomy/removal of hyperplasias - -Gingivoplasty - -Incisional and excisional biopsy - -Treatment of ulcerous lesions, including aphthous ulcers - -Incision of infection when used with antibiotic therapy - -Frenectomy (frenum release) - -Excision and ablation of benign and malignant lesions - -Homeostasis - -Operculectomy - -Crown lengthening - -Removal of soft tissue, cysts and tumors - -Oral cavity tumors and hemangiomas - -Abscesses - -Extraction site hemostasis - -Salivary gland pathologies - -Preproshetic gum preperation - -Leukoplakia
The Dual Switch Adaptor is indicated for use with the Ultra MD CO2 Laser Systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surgery, oto-rhinolaryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues.
The Dual Switch Adaptor can be used in open surgical procedures and endoscopic procedures.
The use of the Dual Switch Adaptor does not change the indications for use of the Ultra MD CO2 laser system.
The Dual Switch Adaptor is an accessory that can be mounted onto the Ultra MD CO2 Laser System currently manufactured by Laser Engineering, Inc. under the existing 510K numbers: K881580, K881581, K881582, K881583, K881584, K881585, K881587, K881588, and K905676.
The Dual Switch Adaptor allows the laser beam to exit the laser vertically through the articulating arm or horizontally through a flexible laser waveguide. The Dual Switch Adaptor provides an alternate delivery system for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue. The Dual Switch Adaptor consists of a protective housing that is mounted into the path of the laser beam to divert the energy to the fiber coupler.
The Dual Switch Adaptor is designed to operate at 10.6um and has a broad enough transmission band to accommodate any laser operating in this region.
The laser energy can be supplied traditionally through the articulating arm or into a focusing lens that is coupled into the flexible waveguide, exiting to the tissue at the distal end.
The provided text is a 510(k) premarket notification for a medical device called the "Dual Switch Adapter." This type of document is for regulatory approval and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against acceptance criteria in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested categories about acceptance criteria, study design, expert involvement, and ground truth are not applicable in this context. The document describes engineering-focused performance testing rather than clinical or AI-driven performance.
Here's a breakdown of what information is available and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing | Established percent transmission, optical alignment, and alignment stability. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified beyond "the Dual Switch Adaptor." It implies testing of the device itself, not a dataset of patient cases.
- Data Provenance: Not applicable. The testing is on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. The testing is technical/engineering, not requiring expert clinical ground truth.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. The testing is technical/engineering.
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
- MRMC study: No. This is not an AI-assisted device.
- Effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- Ground Truth Type: Not applicable. The "ground truth" for this device's performance would be engineering specifications and measurements (e.g., actual transmission values, physical alignment measurements).
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.