(77 days)
The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dermatology: For hair removal (destruction of hair follicles) in all skin types and for coagulation and hemostasis of vascular lesions and soft tissue applications. In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles.
Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.
Gastroenterology: Tissue ablation and hemostasis in the Gl tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids.
General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation.
Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intrauterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum.
Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue.
Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures).
Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma.
Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents.
Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications.
Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue.
Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.
Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets.
Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).
Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neromas.
The CoolTouch Varia Laser System is an Nd:YAG laser producing laser emission at 1064 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with fiber optic handpiece setup.
The provided text is a 510(k) Premarket Notification for the CoolTouch Varia Nd:YAG Surgical Laser system. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials to prove efficacy against specific acceptance criteria. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of a new, independent clinical study are not applicable here.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices, meaning it has the same intended use and technological characteristics as one or more legally marketed devices.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in the traditional sense for a new clinical study. The "acceptance criteria" for a 510(k) submission is that the device is "substantially equivalent" to predicate devices. This is achieved by demonstrating the same intended use and similar technological characteristics.
- Reported Device Performance: The primary "performance" reported is that "The CoolTouch Varia has the same principle of operation, the same wavelength and essentially the same pulse energy rate as the predicate devices." This is a statement of technological similarity to the predicates, not a measured performance against pre-defined clinical thresholds.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Has the same principle of operation, same wavelength, and essentially the same pulse energy rate as predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "Clinical Performance Data: None requested at this time." This indicates that no clinical test set was used for this 510(k) submission.
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)
- Since no clinical test set was used, no experts were used to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Since no clinical test set was used, no adjudication method was applicable.
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
- This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a surgical laser, not an algorithm. Therefore, no standalone algorithm performance study was done, and this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Since no clinical test set was used, no ground truth was established for the purpose of evaluating device performance in a clinical study. The ground for "substantial equivalence" is the regulatory approval of predicate devices.
8. The sample size for the training set
- Since no machine learning algorithm or AI component is mentioned, there is no training set in the context of this 510(k) submission.
9. How the ground truth for the training set was established
- As there is no training set, this question is not applicable.
In summary, this 510(k) submission relies on demonstrating substantial equivalence to already approved predicate devices based on technological characteristics and intended use, rather than presenting new clinical study data with predefined 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.