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The Dornier Medilas H 20 Laser is intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coaqulation of soft tissue. The Dornier Medilas H 20 Laser is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy .
• Urology .
• Lithotripsy .
• Pulmonology .
• Gastroenterology .
• Gynecology
• ENT .
• General Surgery .

The Dornier Medilas H 20 Laser is a pulsed solid-state Holmium:YAG laser system. The Dornier Medilas H 20 Laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400pm (0.4mm). The Dornier Medilas H 20 Laser incorporates a graphic display panel with touch screen capabilities allowing the operator to control the functions and laser parameters of the laser pulse control panel regulates the pulse energy, pulse frequency, pulse mode (continuous mode, pedalcontrolled repetitive burst mode and control panel bursts mode), pilot brightness, and various Menu functions. The Dornier Medilas H 20 Laser light emission is transmitted to the application site by a sterile fiber optic delivery systems or fiber optic cables with a SMA 905 connector.

This document is a 510(k) summary for the Dornier Medilas H 20 Laser and describes its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through performance metrics.

Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.

The document focuses on comparing the new device's technological characteristics and intended use to existing, legally marketed predicate devices to establish substantial equivalence under the 510(k) pathway, which typically does not require new clinical performance studies with specific acceptance criteria in the same way a PMA or de novo submission might.

Here's what can be inferred from the document regarding the "study" for this submission:

• Type of "Study": This is a predicatibility study (comparison to predicate devices), not a performance study with acceptance criteria. The "study" here involves demonstrating that the Dornier Medilas H 20 Laser is "substantially equivalent" to already approved devices.
• Proof of Meeting "Acceptance Criteria": The "acceptance criteria" for a 510(k) submission are met when the FDA determines the new device is substantially equivalent to a predicate device. This is primarily done by showing it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Specific points from the document that relate to the comparison:

• Predicate Devices:
  • Dornier Medilas H Laser (K981718)
  • Trimedyne OmniPulse Mini, Model 2120 Holmium:YAG Laser System (K043012)
  • Lumenis VersaPulse PowerSuite Holmium Surgical Laser and Delivery Devices with Accessories (K011703)
• Comparative Technological Characteristics (used for showing equivalence, not acceptance criteria for performance):
  • Principles of Operation: Same basic operational features for Holmium YAG lasers with flash lamp emission.
  • Laser Type: Solid State Holmium HO:YAG lasers (equivalent).
  • Maximum Radiant Power: 20 Watts (equivalent to predicates).
  • Wavelength: 2080nm (new device) vs. 2100nm (predicates) - deemed equivalent.
  • Energy Output: 1.8J to 2.5J (equivalent to predicates).
  • Pulse Duration: 350us (new device) vs. 250us (predicates) - deemed equivalent.
  • Cooling Method: Integrated water cooling system with water/air exchangers (equivalent).
  • Operational Modes: Continuous and pulse modes (equivalent).
  • Delivery Systems: Ethylene oxide sterilized fiber optic delivery systems with SMA 905 connector (equivalent).
• Intended Use: The Dornier Medilas H 20 Laser has the same indications for use as the predicate device Dornier Medilas H Laser (K981718), and the same general indications for use as the other two predicates.
• Safety and Effectiveness Information: The document states that "Safety and effectiveness information was provided in the Premarket Notification to demonstrate that the Dornier Medilas H 20 Laser is safe and effective..." However, the nature of this information (e.g., specific test results, clinical data) is not detailed in this summary. It's typical for 510(k)s to rely on non-clinical (bench) testing and comparison to predicates rather than extensive human clinical trials to demonstrate safety and effectiveness for substantial equivalence.

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a research study with performance-based acceptance criteria.

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The Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparascopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas H/2 Laser is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

Not Found

I am sorry, but the provided text is a 510(k) summary for a medical device (Dornier Medilas H/2 Laser) and does not contain the kind of study information (acceptance criteria, sample sizes, expert qualifications, ground truth, etc.) that you are asking for.

The 510(k) summary focuses on establishing "substantial equivalence" of the new device to a predicate device already on the market, rather than presenting a performance study with detailed acceptance criteria and study data. It primarily discusses:

• Device Name, Submitter, and Contact Information: Basic identification details.
• Classification Name and Predicate Devices: How the device is categorized and which existing device(s) it is compared to for regulatory purposes.
• Intended Use and Indications for Use: What the device is designed to do and for which medical conditions/procedures. In this case, it's for cutting, vaporization, ablation, and coagulation of soft tissue in various surgical specialties.
• Technological Characteristics and Substantial Equivalence: The core of a 510(k), where the manufacturer argues that their new device is similar enough to an already legally marketed device (the predicate) that it does not raise new questions of safety or effectiveness. The key point here is that the only minor difference mentioned is the replacement of a contraindication with a precaution statement regarding kidney and bladder stone fragmentation.

Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a clinical study report or a pre-market approval (PMA) application summary, which typically include detailed performance data, acceptance criteria, and study methodologies.

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