(56 days)
The Litho EVO laser system and its fiber optic delivery system are intended for use 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, Discectory, 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 (BPH).
· 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 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/Discectomy
Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, 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
Biopsv
Litho Evo is based on Holmium laser cavity emitting at 2100nm. Laser emission is triggered by mean of a footswitch and is delivered to the tissue through fiber optics. The main parts (subsystems) of the subject device are the Holmium laser source, the optical delivery system, the power electronics, the control electronics and the cooling system. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
The provided text describes a 510(k) premarket notification for a medical device called Litho Evo, a Holmium laser system. This submission is a "Special 510(k)" due to modifications of an already cleared device, Olympus Empower H35 (K180426). The document states that performance testing and software verification and validation were conducted according to relevant standards. However, it does not provide a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance or effectiveness.
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria for device performance in a clinical or measurable outcomes sense, nor does it report specific performance metrics (e.g., success rates, fragmentation efficiency, treatment times) for the Litho Evo device. Instead, it focuses on compliance with general safety and performance standards for medical electrical equipment and laser products.
| Acceptance Criteria (Stated as Compliance with Standards) | Reported Device Performance (Stated as Compliance) |
|---|---|
| IEC 60601-1:2012, ed 3.1 (Basic Safety & Essential Performance) | Passed all required testing and is in compliance |
| IEC 60601-1-2 Ed 4: 2014 (EMC Requirements) | Passed all required testing and is in compliance |
| IEC 60601-2-22: 2012-10 ed 3.1 (Surgical Laser Equipment) | Passed all required testing and is in compliance |
| IEC 60825-1 Ed. 3.0 (2014) (Safety of Laser Products) | Passed all required testing and is in compliance |
| Software Verification and Validation Testing | Conducted and documentation provided as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe any specific human-subject or clinical "test set" for evaluating the performance of the Litho Evo device against acceptance criteria. The performance testing mentioned refers to technical compliance with engineering and safety standards, not clinical data.
3. 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. The performance testing described is related to engineering and safety standards, not medical interpretation or clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.
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
Not applicable. The Litho Evo is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser surgical instrument requiring human operation, not an autonomous algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the performance testing mentioned appears to be defined by the technical specifications and requirements outlined in the cited IEC and FDA standards for safety, electromagnetic compatibility, and laser product safety.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. Software verification and validation were conducted, but this doesn't equate to an AI training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
§ 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.