(210 days)
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indication: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology: • Ablation ofBenign Prostatic Hyperplasia (Hypertrophy) [BPH] • Laser Resection of the Prostate (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 Gentalia ● Bladder Neck Incisions (BNI) ● Ablation and Resection of Bladder Tumors, and Ureteral Tumors . Endoscopic Fragmentation of Urethral, Ureteral, Bladder, and Renal Calculi ● Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Indications: ● Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones ● Endoscopic fragmentation of calculi ● Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology: Open and endoscopic gastroentery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) 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 . Pancreatits . Colitis . Hemorrhoids . Mallory-Weiss Tear . Cholecystectorny . Gastric Erosions . Benign and Malignant Neoplasm
Gynecology: Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories are portable thulium fiber lasers 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.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories generates non-ionizing radiation which is transferred to the relevant anatomical treatment site through surgical fibers that serve as the delivery vehicle from the laser energy generator to the treatment site.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories includes wireless (optional) and wired, three-pedal footswitches for hands-free control. The system can utilize an auxiliary video monitor to display operating parameters.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories front panel includes a surgical fiber connection port and a touchscreen with a user interface. The back panel includes electrical and interface cable ports. The Laser Console may be placed on an optional mobile cart.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories includes:
- Laser Console ●
- Footswitches, wired or wireless (optional) ●
- Surgical Fibers ●
- . Accessories:
- Power cord O
- O Video output cable
- Video adapter O
- Safety glasses O
- Fiber stripper O
- Fiber cleaver o
- Blast shield O
- O Interlock connector
- Mobile cart (optional) о
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories on emission wavelengths between 1920 and 1960 nm.
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories can operate at a maximum power output of 60 watts and a maximum frequency output of 2400 Hz with a maximum pulse energy of 6 Joules.
The IPG Medical Family of Thulium Fiber Lasers must be operated with the IPG Family of Surgical Fibers. The surgical fibers are flexible optical fibers that deliver the laser energy to the target tissue. The IPG Family of Surgical Fibers are offered in a range of core diameters from 150 microns - 940 microns and include single use, reusable and ball tip options. The surgical fibers are the only patient-contacting components of the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories.
The provided text is a 510(k) Summary for the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and design verification testing. It does not describe an AI/ML-driven medical device, and therefore the specific questions regarding acceptance criteria, study details, and ground truth for an AI device cannot be answered from the provided text.
Specifically, there is no information about:
- A table of acceptance criteria and reported device performance for an AI/ML component.
- Sample sizes for a test set or its provenance for an AI/ML component.
- Number of experts or their qualifications to establish ground truth for an AI/ML component.
- Adjudication method for an AI/ML component test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for AI assistance.
- Standalone (algorithm-only) performance of an AI/ML component.
- The type of ground truth used for an AI/ML component (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set of an AI/ML component.
- How the ground truth for an AI/ML component's training set was established.
The document describes performance testing for a laser system and its accessories, not an AI/ML algorithm. The listed tests include:
- Electrical Safety and EMC (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1)
- Biocompatibility (e.g., ISO 10993-1, -5, -10, -11, -12)
- Packaging and Sterile Barrier (e.g., ISO 11607-1, -2, ISO 14644-1, -2, ISO 14698-1, -2, ISO 15223-1, F1886/F1886M-16, F1980-16, F88/F88M-15, F2096-11, ASTM D4169-16, ASTM D4332-14, ISTA 3A, 3B)
- Sterilization (Surgical Fibers) (e.g., ISO 11135, ISO 10993-7, ISO 11138-1, ISO 11737-1, -2, ISO 17665)
- Human Factors (e.g., IEC 62366-1, IEC 60601-1-6)
- Risk Management (e.g., ISO 14971, ISO 22442-1)
- Software (e.g., IEC 62304)
- Measuring Systems (e.g., BS EN ISO 10012:2003)
- Design Verification Testing for the laser system and surgical fibers
- Shelf-Life testing for the Surgical Fibers
- Side-by-Side Comparison Testing (bench and animal tissue testing and analysis)
The conclusion states that "All testing demonstrated that the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories met its design requirements." and "Comparative testing (bench and animal tissue testing and analysis) between the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories and the primary predicate and additional predicate devices showed equivalent device performance and tissue response." This indicates that the acceptance criteria were met by passing these various non-clinical engineering and performance tests, rather than through a clinical study or AI/ML performance evaluation.
§ 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.