(26 days)
LITHO 60 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, Discectomy, 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 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
- · Cholecvstectomy
- · 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, excision, resection, ablation, vaporization 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 60 is submitted due to Device Modifications of the already cleared device Cyber Ho (K170331) due to some technical changes. 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. Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards.
The provided text describes a Special 510(k) submission for the Litho 60 laser system, highlighting modifications to an already cleared device, the Cyber Ho (K170331). The submission claims substantial equivalence based on the same intended use and fundamental scientific technology (Holmium laser sources).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from the perspective of device safety and performance) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-22:2007+A1:2012 (Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) | Passed all required testing. |
| Compliance with IEC 60825-1 Ed. 3.0 (2014) (Safety of laser products – Part 1: Equipment classification and requirements) | Passed all required testing. |
| Software verifications and validation. | Successfully passed software verifications and validation. |
| Device modifications do not change intended use. | The modified device has the same intended use as the unmodified device. Labels also reflect no change in intended use. |
| Device modifications do not compromise fundamental scientific technology (Holmium laser sources). | The modified and unmodified devices have the same fundamental scientific technology, based on Holmium laser sources. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing" and "software verifications and validation." However, it does not specify the sample size for these tests. It also does not provide information on the data provenance in terms of country of origin or whether the tests were retrospective or prospective. These tests are typically conducted in a laboratory or controlled environment rather than with patient 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)
This section is not applicable as the provided document pertains to regulatory compliance and technical performance testing of a laser surgical instrument, not a diagnostic device that requires expert ground truth for interpretation of medical images or data. The "ground truth" here is the adherence to established safety and performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3. Adjudication methods are relevant for cases where human interpretation is involved in establishing a ground truth or evaluating performance, which is not the case for the compliance testing described here.
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
This section is not applicable. The Litho 60 is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The Litho 60 is a physical medical device (a laser system) and not an algorithm or software that operates in a standalone capacity for diagnosis or interpretation. Its performance is evaluated based on its physical and electrical characteristics, and its ability to perform its intended surgical functions, not as a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the Litho 60 device's performance is established by its compliance with internationally recognized consensus standards for medical electrical equipment and laser product safety (IEC 60601-2-22 and IEC 60825-1, respectively), as well as successful software verifications and validations. These standards define the expected performance and safety characteristics.
8. The sample size for the training set
This section is not applicable. The Litho 60 is a laser surgical instrument and does not involve machine learning or artificial intelligence, thus it does not have a "training set." Its design and performance are based on engineering principles and regulatory standards.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 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.