(38 days)
The Uropulse is intended to be used for cutting, vaporization, 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 coagulation of soft tissue. The Uropulse is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy .
- Urology .
- Lithotripsv
- Pulmonology
- Gastroenterology
- Gynecology
- ENT
- General Surgery
The Dornier Medilas D Uropulse Laser is a solid-state Holmium YAG Laser. The 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 400μm (0.4mm). Due to the application-dependent optimization of the pulse time of 350 microseconds, the Uropulse can be used in various medical applications including breaking up stones, cutting tissue, tissue ablation, coagulation and vaporization.
The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. The bottom of the housing serves as a tank for cooling water and, at the same time, a base for the laser unit. A cooling circuit conducts away heat that is generated by the laser pump lamp. Water heated by the laser pump is conducted out of the cavity and into the stainless steel cooler. Following cooling, it is returned to the tanks.
A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the User. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser.
The laser light emission is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. Laser energy is transmitted through the fiber to the application site by depressing a foot pedal. The foot pedals, both the wired and wireless, are water- proof and explosion-proof. Various fiber sizes can be utilized depending on the application.
The laser pulse energy at the distal end of the fiber lies within the range of 200-3500mJ. The pulse frequency can be adjusted in 0.2Hz increments between 3 and 20 HZ. The Uropulse contains an aiming beam at a wavelength of 532nm at the maximum power aperture of 1mW. The device employs a Class IV (4) laser pursuant to 21 CFR 1040 and IEC/EN 60825-1.
The provided text is a 510(k) summary for a medical device called "Medilas H Uropulse," a Holmium: Yttrium Aluminum Garnet (HO:YAG) Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.
Therefore, many of the requested categories related to acceptance criteria and specific study results (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for training/test sets) are not applicable or available in this type of submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (implicit for substantial equivalence) | The submission argues that the Uropulse and its predicate devices are substantially equivalent and have the same intended use. The minor differences are stated to "not raise any concerns regarding the overall safety or effectiveness." |
| Technical Specifications (e.g., wavelength, power, pulse frequency) | Wavelength: 2080 nm (invisible) |
| Penetration Depth: ~400μm (0.4mm) | |
| Pulse Time: 350 microseconds | |
| Laser Pulse Energy (distal end): 200-3500mJ | |
| Pulse Frequency: 3-20 Hz (adjustable in 0.2Hz increments) | |
| Aiming Beam: 532nm at 1mW (Class IV (4) laser) |
2. Sample size used for the test set and the data provenance
- Not Applicable: This submission is for a Special 510(k) based on device modifications and substantial equivalence, not a clinical trial proving performance against a specific test set. The submission does not describe a test set or data provenance in the way clinical studies would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No test set or ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method for the test set
- Not Applicable: No test set or adjudication method is described.
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 device is a laser system, not an AI diagnostic tool. MRMC studies are irrelevant here.
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. Its performance is inherent in its physical operation, not an algorithmic output.
7. The type of ground truth used
- Not Applicable: For this type of device and submission, "ground truth" as it pertains to diagnostic accuracy (like pathology or outcomes data for AI) is not relevant. The "truth" being established is that the modified device performs safely and effectively similarly to its predicates. This is typically supported by engineering testing, bench testing, and comparison of specifications rather than
clinical ground truth derived from expert consensus or pathology on a patient cohort.
8. The sample size for the training set
- Not Applicable: This is a hardware laser system, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable: As above, this is not an AI device and does not have a "training set" with associated "ground truth" in that context.
§ 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.