(90 days)
The Athos laser is intended for hair removal (destruction of hair follicles) in all skin types and for soft tissue applications. 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: 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.
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.
Tissue ablation and hemostasis in the GI tract; Gastroenterology: 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.
Treatment of menorrhagia by photocoagulation of thee Gynecology: endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine septum.
Head and Neck/Otorhinolaryngology (ENT): For the 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 turnors, enucleation of the eyeball, exteneration of orbital contents.
Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intraarticular tissue in orthopedic surgical and arthroscopic applications.
Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization 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 turnors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).
The Athos laser emits a beam of coherent light at 1064 microns.
The provided document is a 510(k) summary for the Athos Long Pulsed Nd:YAG laser. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data from clinical trials.
Therefore, the document explicitly states: "Performance Data: None required."
This means that a formal study proving the device meets acceptance criteria, complete with detailed performance metrics, sample sizes, expert involvement, and ground truth establishment, was not conducted or required for this particular 510(k) clearance. The clearance was based on demonstrating equivalence to an already legally marketed device (K001704).
Given this, I cannot provide the requested information. The sections below are included for completeness, but they reflect the absence of such data in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified/not required for 510(k) submission. | Not applicable/not reported. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable; no performance study reported.
- Data Provenance: Not applicable; no performance study reported.
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; no performance study reported.
- Qualifications of Experts: Not applicable; no performance study reported.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable; no performance study reported.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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, and no such comparative effectiveness study was reported.
- 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 laser device, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable; no performance study reported.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable; no performance study involving a training set was reported.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable; no performance study involving a training set was reported.
§ 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.