(64 days)
The intended use of the AcuPulse 30/40 ST CO2 Laser Systems and AcuPulse 40WG CO2 Laser series is for the vaporization, incision, excision, ablation or photocoagulation 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 AcuPulse series 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 AcuPulse laser is indicated for use in dermatology and plastic surgery for the following applications:
- Ablation, vaporization, excision, incision and coagulation of soft tissue in the performance of:
- Laser skin resurfacing
- Laser dermabrasion
- 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:
- Keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheci wart and verruUT seborrheica.
- Vermillionectomy of the lip
- Cutaneous horns
- Solar/actinic elastosis
- Cheilitis, 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 pyogenic granulomas/granuloma pyogenicum/granuloma telangiectaticum)
- 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 sqamous cell carcinoma, 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/avascular skin lesions
- Moh's surgery
- Lipectomy
- Verrucae and seborrhoecae vulgares, including paronychial, periungal 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 recipient sites for hair transplantation
Podiatry
The AcuPulse laser 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, periungal 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 (ENT)
The AcuPulse laser 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, pharynx 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 Diverticulum/pharyngoesophageal diverticulum (endoscopic laser-assisted esophagodiverticulostomy (ELAED))
- Stenosis, including subglottic 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, pharynx, 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 chondrodermatitis nondularis chroniUT helices/Winkler's disease
- Telangiectasia/hemangioma of Iarynx, pharynx and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue)
- Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea
- Myringotomy/tympanostomy (tympanic membrane fenestration)
- Uvulopalatoplasty (LAUP, laser UPPP)
- Turbinectomy and turbinate reduction/ablation
- Septal spur ablation/reduction and septoplasty
- Partial glossectomy
- Tumor resection of oral, subfacial and neck tissues
- Rhinophyma
- Verrucae vulgares (warts)
- Gingivoplasty/gingivectomy
Gynecology and GYN Laparoscopy Indications
The AcuPulse laser is indicated for use in gynecology for the followig 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) of Bartholin's and nabothian cysts
- Herpes vaporization
- Urethral caruncle vaporization
- Cervical dysplasia
- Benign and malignant tumors
- Hemangiomas
- Vaporization, incision, excision, ablation or photocoagulation of soft tissue in endoscopic and laparoscopic 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 AcuPulse laser is indicated for laser incision, excision, ablation and/or vaporization 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 AcuPulse Laser is indication for incision, 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 AcuPulse Laser is indication for the incision, excision 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 AcuPulse Laser is indication for the incision, excision and vaporization of soft tissue in dentistry 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
- Preprosthetic gum preparation
- Leukoplakia
- Partial glossectomy
- Periodental gum resection
The AcuPulse 30/40 (ST and WG) CO2 Laser systems provide up to 30 or 40 Watts (model dependent) on tissue. The systems incorporate the following components:
- The CO2 laser tube within the main cabinet,
- An articulated arm beam delivery system (AcuPulse 30/40 ST) or a new short arm that may be used with a WaveGuide beam delivery system (AcuPulse 40WG).
- A footswitch for laser activation;
- A laser beam wavelength of 10.6 µm.
The AcuPulse CO2 40WG Laser system contains a short arm, WaveGuide port which connects to the Fiberlase CO2 Laser WaveGuide beam delivery system. The WaveGuide port is a rigid, fixed position arm with an internal adjustable folding mirror. The tip of the WaveGuide port has a 905 SMA connect to the WaveGuide. The WaveGuide port contains a small WaveGuide support arm to support the WaveGuide during use. Additionally, the AcuPulse CO2 40WG Laser system may be used with an articulating WaveGuide Support Arm to support the WaveGuide when not in use. The WaveGuide Support Arm is clamped at one end to the rear handle of the laser system and contains a receptacle at the other end, into which the WaveGuide hand piece may be placed when not in use.
The AcuPulse CO2 Laser system series are offered with the following three basic modes of laser energy:
- Continuous Wave (CW) Mode
The continuous wave mode is optimal for incision or ablation where homeostasis is desirable as it delivers a continuous, steady beam of energy. - Pulser Mode
The pulser mode high-frequency delivers pulses in a contract present pulse frequency for enhanced tissue incision capability as controlled by varying the ON time. Thermal damage to surrounding tissue is usually reduced with shorter laser activation durations, whereby the adjacent healthy tissue has more time to cool between pulses. - SuperPulse Mode
The superpulse mode is optimal for incision or ablation where char-free performance is desirable. This includes many dermal applications. SuperPulse is a continuous series of short duration, peak power pulses whose average power is the set power. The SuperPulse laser rapidly vaporizes the target tissue so only a negligible amount of heat is transferred (by conduction) to adjacent tissue.
The provided document describes a 510(k) premarket notification for a CO2 laser system, focusing on its substantial equivalence to a predicate device. However, it does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of diagnostic accuracy or clinical effectiveness.
The "Performance Testing" section (Section 7) is primarily about compliance with electrical, laser safety, and software validation standards, rather than clinical performance or accuracy in a diagnostic sense.
Therefore, I cannot directly answer your request based on the provided text for certain points. Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with clinical acceptance criteria (e.g., accuracy, sensitivity, specificity for a diagnostic device) or device performance in that context. The "performance" discussed relates to compliance with safety and electrical engineering standards, not clinical outcomes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety) | Complied with standard |
| IEC 60825-1 (Safety of laser products, Part 1: Equipment classification and requirements) | Complied with standard |
| IEC 60601-2-22 (Medical Electrical Equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) | Complied with standard |
| IEC 60601-1-2 (Medical Electrical Equipment, Part 1-2: Collateral Standard: Electromagnetic Compatibility – Requirements and Tests) | Complied with standard |
| Software requirements specifications | New software version met the specifications (Software Validation) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance tests mentioned are technical compliance tests, not clinical studies with patients or data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there were no clinical studies described that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there were no clinical studies described that would require adjudication.
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
There was no MRMC comparative effectiveness study done or described. This device is a CO2 laser system, which is a surgical tool, not a diagnostic imaging device with an AI component for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as there were no clinical studies described. The "ground truth" for the performance testing mentioned was compliance with established technical and safety standards.
8. The sample size for the training set
This information is not provided as there's no mention of a "training set" in the context of machine learning or diagnostic algorithm development. The software validation mentioned would refer to testing the software meets its specified functional requirements, not training a model.
9. How the ground truth for the training set was established
This information is not provided as there's no mention of a "training set" or its ground truth.
§ 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.