(210 days)
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral strictures .
- Bladder neck incisions .
- Ablation and resection of bladder tumors, urethral tumors and . ureteral tumors
- Ablation of Benign Prostatic hypertrophy (BPH)
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostate (HoLRP)
- Laser Enucleation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of the external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy ●
- Polyps
- Biopsv ●
- Gall Bladder calculi
- Biliary/bile duct calculi t
- Ulcers .
- Gastric ulcers .
- Duodenal ulcers .
- . Non-bleeding ulcers
- . Pancreatitis
- Hemorrhoids .
- Cholecystectomy .
- Benign and malignant neoplasm .
- . Angiodysplasia
- Colorectal cancer .
- Telangiectasias .
- Telangiectasias of the Osler-Weber-Renu disease .
- Vascular malformation .
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric erosions ●
Thoracic/Pulmonary Surgery
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including
- Laryngeal lesions .
- Airway obstruction including carcinoma .
- Polyps and granulomas .
- Palliation of obstructing carcinomas of the tracheobronchial tree .
Gynecology
Open and endoscopic surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) including
- Intra uterine treatment of submucous fibroids, benign . endometrial polyps and uterine septum by incision, excision, ablation and or vessel coagulation
- Soft tissue excision procedures such as excisional conization of . the cervix
Ear, Nose and Throat (Otolaryngology)
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Endonasal/sinus surgery .
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy ●
- Frontal sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
- Tonsillectomy
- Adenoidectomy
Dermatology/Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic procedures including:
- Basal Cell carcinomas .
- Lesions of the skin and subcutaneous tissue ●
- Skin tags .
- Plantar warts
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
- Ablation of soft and cartilaginous tissue in minimally invasive . spinal surgery including:
- Percutaneous laser disc decompression/discectomy ♥
- Foraminoplasty .
- Ablation and coagulation of soft vascular and non . vascular tissue
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystecomy
- Lysis of adhesions
- Appendectomy
- Biopsv
- Skin incision
- Tissue dissection
- Excision of external tumors and lesions
- Complete or partial resection of internal organs, tumors and lesions
- Mastectomy
- Hepatectomy
- Pancreatectomy
- Splenectomy
- Thyroidectomy
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy
- Lymphadenectomy
- Partial nephrectomy
- Pilonidal Cystectomy
- Resection of lipoma
- Debridement of decubitus ulcers
- Hemorrhoids
- Debridement of statis ulcers
- Biopsy
The Ceralas D1950 is a diode laser operating at 1950nm with a maximum power output of 50W.
This 510(k) summary describes a medical device, the Biolitec Inc.'s 50W Ceralas Diode 1950nm Laser System (Model D1950), which is a surgical diode laser. The provided document details its intended uses and compares its performance to a predicate device for substantial equivalence.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the typical quantitative sense (e.g., a specific numerical threshold for accuracy or a statistical measure). Instead, the acceptance criterion for regulatory clearance appears to be "substantially equivalent performance" to a legally marketed predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantially equivalent vaporization rates to predicate 2010nm laser | Bench testing demonstrated substantially equivalent performance on potato slices and porcine muscle tissue. |
| Substantially equivalent cutting rates to predicate 2010nm laser | Bench testing demonstrated substantially equivalent performance on porcine liver, skin, and muscle tissue. |
| Substantially equivalent coagulation rates to predicate 2010nm laser | Bench testing demonstrated substantially equivalent performance on porcine liver, skin, and muscle tissue. |
| Similar tissue effects to predicate 2010nm laser | Testing demonstrated similar tissue effects between the Ceralas D1950 and the 2010nm laser. |
| Same intended uses and indications as predicate devices | Stated in the "Substantial Equivalence" section. |
| Similar technological characteristics as predicate devices | Stated in the "Substantial Equivalence" section. |
| Similar principles of operation as predicate devices | Stated in the "Substantial Equivalence" section. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size (e.g., number of potato slices, porcine muscle tissue samples, or individual tests). It states "potato slices and porcine muscle tissue" and "porcine liver, skin, and muscle tissue." This suggests an experimental setup but lacks quantification of samples.
- Data Provenance: The data provenance is generally "bench testing." There is no mention of country of origin for the data or whether it was retrospective or prospective. Given it is bench testing, it would inherently be prospective for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is not applicable to the provided document. The study involved bench testing on inanimate and animal tissue to assess physical effects (vaporization, cutting, coagulation), not a clinical assessment requiring expert interpretation of ground truth in the human diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable. As a bench test comparing physical effects, there is no "adjudication method" in the sense of resolving discrepancies between human readers or experts. The comparison was based on performance and observed tissue effects, presumably by the researchers conducting the bench tests.
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
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is an engineering bench test comparing a new laser system to a predicate laser system based on their physical interaction with tissue, not on diagnostic accuracy with human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This question is not applicable. The device is a surgical laser, not an AI algorithm. The performance evaluation was for the laser's physical capabilities (vaporization, cutting, coagulation) in a standalone manner (without a human in the loop for the performance measurement itself), but it's not an "algorithm" in the typical sense this question implies for AI/diagnostic devices.
7. The Type of Ground Truth Used
The "ground truth" for this study was the directly observed physical effects (vaporization, cutting, coagulation rates, and overall tissue effects) of the laser on standardized biological and non-biological materials (potato slices, porcine muscle, liver, and skin). The predicate device's performance served as the benchmark for "substantially equivalent" ground truth.
8. The Sample Size for the Training Set
Not applicable. This product is a physical laser device, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of device, no ground truth was established for a training set.
§ 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.