(28 days)
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology:
· Ablation of Benign Prostatic Hypertrophy) [BPH]• Laser Resection of the Prostrate (LRP)• Laser Enucleation of the Prostate (LEP) · Laser Ablation of the Prostate (LAP) · Transurethral Incision of the Prostate (TUIP) · Condylomas · Urethral strictures · Lesions of external genitalia · Bladder neck incisions (BN) · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors Endoscopic fragmentation of ureteral, bladder, and renal calculi• Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy Indications:
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones • Endoscopic fragmentation of calculi • Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology:
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
· Appendectomy · Angiodysplasia · Polyps · Colorectal cancer · Biopsy · Telangiectasias
• Gall Bladder calculi • Telangiectasias of the Osler-Weber-Renu disease • Biliary/Bile duct calculi • Vascular Malformation . Ulcers . Gastric ulcers . Esophagitis . Duodenal ulcers . Esophageal ulcers . Non Bleeding Ulcers · Varices · Pancreatitis · Colitis · Haemorrhoids · Mallory-Weiss tear · Cholecystectomy · Gastric Erosions • Benign and Malignant Neoplasm
Gynecology:
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue
The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser, producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam.
The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns.
The system includes:
- Laser console ●
- Laser fibers sterile single use and reusable ●
- Foot pedal, wireless or wired ●
- Accessories power cord, HDMI cable, safety goggles/glasses, fiber cutter, .
- fiber cleaver, fiber gripper, sterilization trav, cart .
The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.
The provided text is a summary of a 510(k) premarket notification for a medical device, the SOLTIVE Laser System. It focuses on demonstrating substantial equivalence to a predicate device, primarily due to a software update. While it discusses the device's technical characteristics, intended use, and compliance with standards, it does not contain information about studies conducted to prove that the device meets specific acceptance criteria related to its performance in surgical procedures, nor does it detail clinical performance metrics like accuracy, sensitivity, or specificity.
Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and the study that proves the device meets them, specifically:
- A table of acceptance criteria and the reported device performance: This document does not list specific performance acceptance criteria for surgical outcomes or diagnostic accuracy, nor does it provide reported performance data for such criteria. The "Software verification tests" mentioned only confirm that "all performance requirements met the prescribed acceptance criteria" for the software itself, not for the device's clinical efficacy.
- Sample sizes used for the test set and the data provenance: No clinical test set or patient data is mentioned. The "testing" referred to is software verification.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-read test set or ground truth establishment relevant to clinical performance is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 system for surgical procedures, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as no machine learning/AI training data is mentioned.
- How the ground truth for the training set was established: Not applicable.
In essence, this document is a regulatory submission demonstrating technical equivalence and safety aspects (like sterilization, biocompatibility, and compliance with electrical/laser safety standards) of a laser surgical device after a software update. It is not a clinical study report describing the performance of the device in patient procedures using specific outcome measures and statistical analysis.
§ 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.