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The General Surgery Indications for Use for the Athos laser are modified as follow: 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, and treatment of leg veins. The Athoscan and Constans Cooling System are indicated for use with the Athos laser for indications for which the laser has been cleared.

Device Description

The Athos laser emits a beam of coherent light at 1064 microns which is delivered to the Athos handpieces, the Athoscan, or the Constans Cooling System through fiber optics. The Athoscan increases the efficiency of treating large areas of skin (during hair removal) and the Constans Cooling System reduces reduce pain and the risk of thermal damage by cooling the skin during laser treatment.

AI/ML Overview

The provided text is a 510(k) summary for the Athos laser and its accessories. It states explicitly:

"Performance Data: None required."

This indicates that the submission did not include any studies or performance data to establish acceptance criteria or demonstrate device performance against such criteria. The basis for substantial equivalence was primarily through comparison with predicate devices and a modification of indications for use.

Therefore, I cannot provide the requested information as it is not present in the provided document. Many of the questions in your prompt (e.g., sample size, ground truth, expert qualifications, MRMC study, standalone performance) relate to performance studies, which were explicitly stated as "None required" for this 510(k) submission.

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K Number

K020072

Device Name

ATHOS LASER

Manufacturer

QUANTEL MEDICAL

Date Cleared

2002-04-09

(90 days)

Product Code

GEX

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K001704

Predicate For

N/A

Intended Use

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).

Device Description

The Athos laser emits a beam of coherent light at 1064 microns.

AI/ML Overview

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: