(34 days)
The Litho laser system and its fiber optic delivery system are in surgical procedures using open. laparoscopic and endoscopic incision. resection. ablation. vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectonly, Gynaecology. ENT and General Surgery.
Urology
Open and endoscopic surgery (incision, excision, resection, ablation.
vaporization, coagulation and haemostasis) including:
- · Urethral Strictures
- · Bladder Neck Incisions (BNI)
- · Ablation and resection of Bladder Tumors. Uretheral Tumors and Ureteral · Tumors,
- · Ablation of Benign Prostatic Hypertrophy (BHP),
- · Transurethral incision of the prostate (TUIP)
- · Holmium Laser Resection of the Prostrate (HoLRP)
- · Holmium Laser Enucleation of the Prostate (HoLEP)
- · Holmium laser Ablation of the Prostate (HoLAP)
- · Condylomas
- Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of urethral. ureteral. bladder and renal calculi including cystine, calcium oxalate.
monohydrate and calcium oxalate
· dehydrate stones.
- · Endoscopic fragmentation of kidney calculi
- · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
Gastroenterology
Open and endoscopic Gastroenterology surgery (incision, excision. resection. ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- Polyps
- · Biopsy
- Gall Bladder calculi
- · Biliary/Bile duct calculi
- Ulcers
- Gastric ulcers
- · Duodenal ulcers
- · Non Bleeding Ulcers
- Pancreatitas
- Haemorrhoids
- 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
Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
- · Ligament and tendon Release
- Contouring and sculpting of articular surfaces
- · Capsulectomy in the Knee
- Chondreplasty in the Knee
- Debridement of inflamed synovial tissue
- Chondromalacia Ablation
- · Chondromalacia and tears
- Plica Removal
- Meniscectomy
- Loose Body Debridement
- Lateral retinecular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
- · Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
- Percutaneous Thoracic Disc Decompression/Discectorny
Gynaecology
Open and laparoscopic gynaecological surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue
ENT
Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:
- Endonasal/sinus Surgery
- · Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy
- · Frontal Sinusotomy
- · Ethmoidectomy
- Maxillary antrostomy
- · Functional endoscopic sinus surgery
General Surgery
Open. laparoscopic and endoscopic surgery (incision. resection. ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- Skin incision
- Excision of external and internal lesions
- · Complete of partial resection of internal organs, tumors and lesions
- · Biopsy
This Special 510(k) of the modified device Litho is submitted due to Device Modifications of the already cleared device (K141101) due to the broadening of the range of some laser emission parameters such as power, energy and frequency. The modified device has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications. The modified and unmodified devices are exactly the same except for the available range of emission parameters. A change to the software determined the differences between the modified and unmodified versions.
The provided text describes a 510(k) premarket notification for a medical device called "Litho," which is a laser system for various surgical procedures. The submission is for modifications to an already cleared device, primarily broadening the range of some laser emission parameters.
However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The performance testing mentioned (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) pertains to electrical safety, electromagnetic compatibility, and general performance of the laser equipment, not to the efficacy or analytical performance of an AI or algorithm.
Therefore, I cannot extract the requested information regarding AI/algorithm acceptance criteria and performance study details from the provided text. The document is about a hardware modification (broadening laser parameters) to an existing laser surgical instrument, and its compliance with safety and electrical performance standards.
§ 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.