(275 days)
Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization, and ablation of joint tissues during arthroscopic surgery. Gastroenterology: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Orthopedics: Dissect and coagulate. General Surgery, Dematology & 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. GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Gynecology: Ablation, excision, incision, coagulation, hemostasis, and vaporization of tissue. Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue. Ophthalmology: Dacryocystorhinostomy transcanalicular, Open DCR, Tumor Excision, Blepharoplasty. Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, ablation, and excision of tissue. Cardiac Surgery: Coagulation and hemostasis of cardiac tissue. Thoracic Surgery: Thoracotomy, Pulmonary resection, Hemostasis, Pericardiectomy, Adhesiolysis, Coagulation of blebs and bullae. Urology: Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues. Dermatology/Aesthetics: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities, Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas, Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi, Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas, Bowe, Kaposi sarcoma. Warty leucoplasty and ulcers debridement, Seborrheic keratosis, Mixoid cyst, Papillary varix, Acne treatment. Vascular Surgery: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities.
The Diolase™ 10S system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The Diolase™ 10S laser consists of two permanently connected components: Console, and Delivery System. The Console has a Control Panel (Touch Screen and Keypad) in front and a detachable base attached at the bottom rear of the Console. The Diolase™10S Laser Delivery System consists of the following: Fiber Optic Assembly and Surgical Handpiece.
The provided document is a 510(k) summary for the Diolase™ 10S laser system, seeking expanded indications for use. This document asserts substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria and results for the device itself.
Therefore, most of the requested information cannot be extracted from this document as it does not contain a study evaluating the device against specific acceptance criteria. Specifically, the document states: "Non-clinical performance data is not presented. Comparison with previously cleared devices is included in the body of the 510(k) submission for the demonstration of safety and effectiveness of the new indication of this device and to support substantial equivalence to legally marketed devices."
However, I can provide what can be inferred or directly stated from the document regarding the basis of its clearance for expanded indications.
Acceptance Criteria and Device Performance (Inferred/Stated Basis for Substantial Equivalence)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for new indications | Demonstrated through comparison to legally marketed predicate devices that already hold the requested indications. The Diolase™ 10S system is claimed to be "as safe, as effective, and will perform as well as the predicate devices." |
| Technological Characteristics Equivalence | The Diolase™ 10S system has the same technological characteristics (design, material, chemical composition, energy source) as the predicate devices. This equivalence underpins the assertion of similar safety and effectiveness. |
| Expanded Indications for Use (Specific Medical Procedures) | The requested additional indications (listed extensively in the "Indications for Use" section from page 2-4 and confirmed in the FDA letter and attached Indications for Use document from page 8-12) have been previously cleared by FDA for several equivalent medical devices, specifically K100558 (Quanta System QUANTA Diode Laser Family by Quanta System SpA) and K110375 (Blueshine GOLD Series by Blueshine srl), and the reference device K061898 (ezlase™ by Biolase Technology, Inc.) and K083069 (ezlase™ 10W by Biolase Technology, Inc.). The Diolase™ 10S is considered "substantially equivalent" to these predicates. |
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No specific performance study with a test set was conducted for this 510(k) submission. The submission relies on substantial equivalence to predicate devices that already have these indications, implying that any required testing was done on the predicate devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No specific performance study with a test set was conducted.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No specific performance study with a test set was conducted.
4. 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
- Not applicable. This device is a laser surgical instrument, not an AI/imaging device requiring MRMC studies.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a laser surgical instrument, not an algorithm. The 510(k) is for the physical device itself and its expanded indications for use.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No specific performance study with a ground truth was conducted for this submission. The "ground truth" for the expanded indications effectively comes from the regulatory clearance of the predicate devices based on their established safety and effectiveness.
7. The sample size for the training set
- Not applicable. No new training set or performance study was involved in this 510(k) submission.
8. How the ground truth for the training set was established
- Not applicable. No new training set or performance study was involved in this 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.