(30 days)
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
The modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 180), and the delivery accessories that are used with it, is comprised of the following main components:
- Laser console with fiber port and RF ID bracket
- Operating software
- Detachable footswitch
- Delivery device accessories (fiber optic, handpieces and scanner)
The provided text describes a 510(k) summary for the modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180). This document is for a medical device that has been found substantially equivalent to predicate devices, rather than a diagnostic AI/ML device that would typically have the performance criteria and studies described in your request.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth adjudication, MRMC studies, standalone performance, or training set details.
The document focuses on:
- Device Name: Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180)
- Indications for Use: Surgical applications requiring vaporization, incision, ablation, cutting, and hemostasis/coagulation of soft tissue across numerous medical specialties (Urology, Thoracic Surgery, Plastic Surgery, Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT, Radiology, Endovascular coagulation, Oral Surgery, Dental procedures, Cardiac Surgery, Vascular Surgery).
- Predicate Devices: INTERmedic Diode Laser Family (K053540) and Biolitec, Inc. 180W Ceralas D 980nm Diode Laser (Model D180) (K083682).
- Rationale for Substantial Equivalence: The modified device shares the same indications for use, device operation, technical and functional capabilities with the predicate INTERmedic device, and similar functional capabilities as the Biolitec predicate device.
- Conclusion: The device was found substantially equivalent to predicate devices.
This type of submission primarily demonstrates that the new device is as safe and effective as a legally marketed device, and does not require complex performance studies against a ground truth as would be expected for a diagnostic AI/ML algorithm.
§ 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.