(34 days)
Litho laser system and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectorny, 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 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, 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-S1 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 or partial resection of internal organs, tumors and lesions
- • Biopsy
Litho family includes surgical laser devices that are used by health care professionals in professional healthcare environments. Litho family includes the following models: Litho 60, Litho 100 and Litho 150. They differ only for the maximum power: 60, 105 and 152, respectively.
Litho devices are connected to optical fibers accessories (separately FDA cleared: K131473, K160513, K200234).
The device is equipped with a graphical user interface through which the user can set energy, frequency and pulse duration level. Different pre-sets are available among which the so called "special effects": Virtual Basket and Magneto. Virtual basket and Magneto are optional configurations.
Virtual basket had been introduced with K192600 (for Litho 100) and already included in Litho 150 510K (K201455). While, Magneto is the object of the present 510K.
Virtual basket consists of two sub-pulses separated by a certain delay. The first pulse generates a cavitation bubble and the second one is emitted when the first bubble reaches its maximum expansion. This allows the stone to be "caught" to be fragmentated. The set energy is the sum of the two sub-pulses. While Magneto consists of a pulse with a duration higher than standard one (2000 μs vs 1100 μs). Devices with Magneto configuration installed are characterized by black covers and Magneto logos.
The device can be divided into four main sections:
- . Power electronics: they manage power supplied to all device compartments;
- . Control electronics: they mainly consist of a microcontroller board where device main firmware (FW) is resident and a PC embedded with graphical user interface where device software (SW) runs;
- Cooling system: it cools the laser source pumping chamber;
- . Optical bench.
Here's an analysis of the provided text to extract information about acceptance criteria and the study proving device performance.
It's important to note that the provided text is an FDA 510(k) clearance letter and an accompanying 510(k) summary for a medical laser device. This type of document primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than outlining a detailed clinical or performance study with acceptance criteria in the way one might for a novel AI/ML device.
Therefore, many of the typical questions asked about acceptance criteria and proving device performance for AI/ML devices (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies) are not directly applicable or explicitly detailed in this type of submission.
The "performance" described here is primarily in terms of technical specifications and demonstrating that the device's optical and safety characteristics are similar to or within acceptable limits compared to predicates.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Overview: The submission describes the "Litho 60; Litho 100; Litho 150" laser systems. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Litho 60, Litho 100 (K192600), Litho 150 (K201455)) and a reference device (MultiPulse HoPlus (K161257)). The change addressed in this submission is the introduction of a new "Magneto" configuration, which alters the pulse duration.
The "acceptance criteria" in this context are not performance metrics for an AI/ML algorithm (like sensitivity/specificity), but rather the demonstration that the modified device's technical specifications (e.g., laser wavelength, power, pulse width) and safety profiles remain substantially equivalent to, or are a sub-set of, the predicate/reference devices, and that it continues to meet relevant medical device safety standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria/Parameter (Implied) | Reported Device Performance (Subject Device) | Rationale for Acceptance (from document) |
|---|---|---|
| Product Code Equivalence (GEX) | Subject device shares the same product code (GEX) as predicates and reference. | "The same" as predicate/reference devices. |
| Laser Source & Wavelength Equivalence (CTH:YAG, 2100 nm) | Subject device uses CTH:YAG laser source with 2100 nm wavelength. | "The same" as predicate/reference devices. |
| Indications for Use Equivalence | Litho laser system for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue in Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynecology, ENT, and General Surgery. | Subject device's indications are a sub-set of the reference device indications (MultiPulse HoPlus). No changes to the intended use have been implemented. |
| Maximum Pulse Width (Standard) (1100 µs) | 1100 µs | "The same" as predicate device. |
| Maximum Pulse Width (with Magneto) | 2000 µs (Litho 100, Litho 150) | "very similar to the reference device (they differ less than 20%)" compared to reference device's 1700 µs. This difference is deemed acceptable. |
| Maximum Repetition Rate | Litho 60: 60 Hz; Litho 100: 80 Hz; Litho 150: 100 Hz | "The same" as predicate devices and matching the reference device's 100 Hz (for Litho 150). |
| Maximum Energy (5 J) | 5 J | "The same of unmodified device and lower than the reference device (20% of difference)" (reference is 6 J). This difference is deemed acceptable/favorable. |
| Maximum Power | Litho 60: 60 W; Litho 100: 105 W; Litho 150: 152 W | "The same of unmodified device and very similar to the reference (less than 20% of difference)" (reference is 140 W). This difference is deemed acceptable. |
| Safety and Performance Standards Compliance (e.g., IEC 60601-1, IEC 60601-2-22) | Verified through non-clinical bench testing. Specific tests repeated for pulse duration accuracy (IEC 60601-2-22:2019) and SW verification/validation due to SW/FW update (IEC 62304:2006/AMD1:2015). Other standards not affected by the change. | "The results of the non-clinical performance standards testing support that the subject device can be used safely and effectively." "Non-clinical tests conducted support that the used safely and effectively. The differences in technological characteristics between the subject and predicate/reference devices do not raise regarding safety and effectiveness..." |
2. Sample size used for the test set and data provenance:
- This document does not describe a "test set" in the context of an AI/ML model's performance on patient data.
- The "testing" mentioned refers to non-clinical bench testing to confirm the device's technical specifications and compliance with safety standards (e.g., electrical safety, electromagnetic compatibility, laser safety).
- Data provenance for such bench tests is typically internal laboratory data, not patient data from specific countries or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" derived from expert review in this type of submission. Performance is measured against engineering specifications and international standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process foreseen for this type of device and submission.
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. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. The "ground truth" here is the adherence to engineering specifications, validated physical measurements (e.g., laser power, pulse width), and compliance with the requirements of recognized safety and performance standards (e.g., IEC 60601 series).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
In summary, this 510(k) demonstrates substantial equivalence for a medical laser device based on engineering specifications, compliance with international safety standards, and comparison of its performance characteristics (like laser parameters) and indications for use to previously cleared devices. It does not involve AI/ML performance testing or studies with human readers/cases.
§ 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.