(8 days)
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 100W Ceralas D980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- Removal of benign lesions from the ear, nose and throat .
- Excision and vaporization of vocal cord nodules and polyps ●
- Incision and excision of carcinoma in situ .
- . Ablation and vaporization of hyperkeratosis
- Excision of carcinoma of the larynx .
- Laryngeal papillomectomy .
- Excision and vaporization of herpes simplex I and II .
- Neck dissection
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy .
- Synovectomy .
- Chondromalacia .
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
- Hemostasis of upper and lower GI bleeding .
- Excision and vaporization of colorectal carcinoma .
- Excision of polyps .
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy ●
- Excision of neuromas ●
- Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids ◆
- Liver resection .
- Excision of cutaneous lesions .
- Hemorrhoidectomy .
- Appendectomy .
- Debridement of decubitus ulcers .
- Hepatobiliary tumors .
- Mastectomy .
- Dermabrasion .
- Vaporization and hemostasis of capillary hemangioma .
- Excision, vaporization and hemostasis of abdominal tumors ●
- Excision, vaporization and hemostasis of rectal pathology .
- Pilonidal cystectomy ●
- Herniorapphy .
- Adhesiolysis .
- Parathyroidectomy .
- Laparoscopic cholecystectomy .
- Thyroidectomy
- Resection of organs
- Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities .
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
- Vaporization of urethral tumors .
- Release of urethral stricture .
- Removal of bladder neck obstruction .
- Excision and vaporization of condyloma .
- Lesions of external genitalia .
- Vaporization of the prostate to treat benign prostatic . hyperplasia (BPH)
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation .
- Excision or vaporization of condylomata acuminate .
- Vaporization of cervical intraepithelial neoplasia .
- Cervical conization ●
- Menorrhagia ●
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture .
- Benign and malignant pulmonary obstruction .
- Endoscopic pulmonary applications .
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
Not Found
The provided text describes a 510(k) premarket notification for a medical device, the Biolitec Inc.'s 100W Ceralas Diode 980nm Laser System (Model D100). This submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of, for example, a new diagnostic algorithm.
Here's an analysis of the provided information, noting what can and cannot be extracted based on the nature of a 510(k) submission for a laser device:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a laser surgical system, the "acceptance criteria" are not in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) against a ground truth, but rather relate to safety and effectiveness compared to predicate devices. The performance reported is in terms of substantial equivalence.
| Acceptance Criteria (Implied for 510(k) equivalence) | Reported Device Performance (Ceralas D100) |
|---|---|
| Safety and Effectiveness is equivalent to predicate devices. | "Performance testing of the Ceralas D100 demonstrates no significant difference as compared to the cleared Ceralas D100 device (K050824)." |
| Technological Characteristics are substantially similar to predicate devices. | "The Ceralas D100 ... has the same technological characteristics as the cleared Ceralas D100 and substantially similar technological characteristics as compared to the INTERmedic Diode Laser." |
| Intended Uses and Indications for Use are the same or similar to predicate devices. | "The Ceralas D100 has the same intended uses and similar indications... as its predicate devices." |
| No New Issues of Safety or Effectiveness are raised by minor technological differences. | "The minor technological differences between the Ceralas D100 and its predicate devices raise no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of a dataset for evaluating an algorithm. Instead, it refers to "performance testing." This testing is likely related to engineering specifications, electrical safety, EMC, and optical output characteristics of the laser system. The document does not specify:
- Sample size for any human or animal studies, if they were conducted for performance validation.
- Data provenance (e.g., country of origin, retrospective/prospective).
The statement "The performance and safety testing obtained for the cleared Ceralas D100 is fully applicable to the Ceralas D100" implies that the device is a re-submission or a minor modification of an already cleared device (K050824), and leverages previous testing data. Without access to K050824, specifics are unavailable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device submission. The Ceralas D100 is a surgical laser, not a diagnostic device requiring expert interpretation of results to establish a clinical ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
This information is not applicable. An MRMC study is relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance. This document describes a surgical laser, not a diagnostic AI tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no "algorithm" in the sense of AI or diagnostic software for this device. It is a physical laser system.
7. The Type of Ground Truth Used
The "ground truth" for a surgical laser system isn't pathology, outcomes data, or expert consensus in the same way it would be for a diagnostic tool. Instead, the "ground truth" for a surgical laser's performance relates to its ability to perform its intended surgical functions (e.g., incision, excision, coagulation) safely and effectively, typically measured by engineering specifications, in-vitro testing, and potentially pre-clinical (animal) or limited clinical studies demonstrating the laser's physical effects on tissue. The document states "Performance data demonstrate that the Ceralas D100 is as safe and effective as the predicate devices," implying that the ground truth used was the established safety and effectiveness of the existing predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no AI algorithm being "trained" for this device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
In summary:
This 510(k) submission for the Biolitec Inc.'s 100W Ceralas Diode 980nm Laser System (Model D100) demonstrates substantial equivalence to previously cleared predicate devices (K050824 and K053540). The "study" proving it meets "acceptance criteria" is the demonstration that its technological characteristics, intended uses, and safety/effectiveness profiles are comparable to these existing devices, without raising new questions of safety or effectiveness. The detailed elements requested in your prompt (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are typically required for AI/ML-enabled diagnostic devices or complex new technologies, and are largely not relevant or provided for a surgical laser system 510(k) submission.
§ 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.