(132 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 device 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 and 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, Dermatologv, 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 homeostasis 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 .
- Phototcoagulation 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 homeostasis 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 .
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- . Endometrial ablation
- Excision or vaporization of condylomata acuminata .
- Vaporization of cervical intraepithelial neoplasia .
- Cervical conization .
- Menorrhagia .
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: homeostasis 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.
The 100W Ceralas D 980 is identical to the previously cleared 50W Ceralas D 980 except for four modifications. The 100W Ceralas D 980 has a maximum wattage of 100W, while the cleared 50W Ceralas D890 has a maximum wattage of 50W. In addition, the 100W Ceralas D980 has a beam divergence of 12.79, rather than 20.50, and therefore can be used with delivery fibers of smaller diameter (0.22 NA or greater) than those recommended for use with the 50W Ceralas D 980 (0.37 NA or greater). Finally, the 100W Ceralas D 980 contains additional diodes.
The provided document is a 510(k) Summary for a medical device (Ceralas D 980 nm Diode Laser System, Model D100). This type of document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance metrics typically found in clinical trial reports for novel devices or AI/ML-enabled devices.
Therefore, many of the requested elements regarding acceptance criteria, study design, expert ground truth, and training data are not applicable (N/A) or not available (N/A) in this 510(k) summary. The document relies on comparing the technological characteristics and intended use to a predicate device.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| No explicit performance-based acceptance criteria are stated in this 510(k) summary. The basis for clearance is substantial equivalence to predicate devices. | The device (100W Ceralas D980) is identical to the cleared 50W Ceralas D980 except for four modifications: |
- Max wattage increased from 50W to 100W.
- Beam divergence changed from 20.5° to 12.7°.
- Can be used with smaller diameter delivery fibers (0.22 NA or greater vs 0.37 NA or greater for predicate).
- Contains additional diodes. | The argument is that these modifications do not raise new questions of safety or effectiveness. The performance is implied to be at least equivalent to, or improved from, the predicate device for the stated indications. |
| Compliance with voluntary consensus standards | Complies with: - 21 C.F.R. §§ 1040.10 & 1040.11 (Laser Product Performance Standards)
- ANSI/AAMI ES1 (Medical Electrical Equipment Safety)
- IEC 601-1 (Medical Electrical Equipment General Requirements for Safety)
- IEC 601-2-22 (Medical Electrical Equipment Particular requirements for the safety of surgical, therapeutic and diagnostic laser equipment)
- EN 60825-1 (Safety of laser products)
- ANSI/AAMI/ISO 10993-7 (Biological evaluation of medical devices - Ethylene oxide sterilization residuals) | This demonstrates compliance with relevant safety and performance standards for laser medical devices. |
2. Sample size used for the test set and the data provenance
- N/A. This 510(k) summary does not describe a clinical performance study with a test set. The submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, not on specific patient data or outcomes from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. There is no mention of a test set requiring expert-established ground truth in this submission.
4. Adjudication method for the test set
- N/A. No test set or related adjudication method is described.
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
- N/A. This device is a laser system, not an AI/ML-enabled diagnostic or assistance tool. Therefore, an MRMC study and AI-related effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a hardware laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. As no clinical study or test set is described for performance evaluation in this 510(k) summary, no "ground truth" was established in that context. The "ground truth" for the device's acceptable performance is implicitly established by its technological characteristics and compliance with standards, and by its substantial equivalence to already-cleared predicate devices.
8. The sample size for the training set
- N/A. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for this type of device.
§ 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.