(266 days)
Dornier MedTech America, Inc. is requesting the expansion of the indications for use for the Dornier Diode Laser family previously cleared under K982629, K000072, K003993 and K021724. The Dornier Diode Laser family, Medilas™ D Fibertom Laser ("Medilas D"), Medilas™ D Skinulse™ ("SkinPulse") and Medilas™ S ("SkinPulse™ S ("SkinPulse S"), are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for cutting, vaporization, ablation, and coagulation of soft tissue in coniunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without a handpiece). The SkinPulse™ and SkinPulse™ S lasers are also for the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.
The Dornier Diode Family Lasers are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology,
This premarket notification requests clearance for the additional indication as stated:
The Dornier diode family lasers, Medilas D Fibertom Laser ("Medilas D"), Medilas D SkinPulse ("SkinPulse") and Medilas D SkinPulse S ("SkinPulse S") are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Dornier's Diode Laser Family, including:
- Medilas D Laser System ("Medilas D") .
- Medilas D SkinPulse Laser System ("SkinPulse") ●
- Medilas D SkinPulse S Laser System ("SkinPulse S") .
This is a 510(k) summary for a medical device (Dornier Diode Laser Family), which focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in the provided document.
Here's an breakdown of what can be extracted and what is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated. The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance targets.
- Reported Device Performance: Not explicitly stated in numerical terms against acceptance criteria. The document asserts "no significant differences exist between the Dornier diode lasers and the predicate device" based on "technological characteristics and overall performance."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Substantially equivalent to predicate devices (Diomed 810 nm Surgical Lasers, Dornier Medilas D Laser System, Dornier Medilas D SkinPulse Laser System, Dornier Medilas D SkinPulse S Laser System) in technological characteristics and overall performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not mentioned. This document does not describe a clinical study with a "test set" in the context of algorithm performance or diagnostic accuracy. It's a submission for laser device clearance based on substantial equivalence.
- Data Provenance: Not applicable / Not mentioned. No specific patient data or study data is detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable / Not mentioned. No ground truth establishment processes for a test set are described as this is not a study assessing diagnostic performance.
- Qualifications of Experts: Not applicable / Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable / Not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No. This document does not describe such a study.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a laser system, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. The "ground truth" in this context is the safety and effectiveness of the predicate devices, to which the new device is compared. There's no clinical "ground truth" being established by experts for a specific diagnostic task.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable / Not mentioned. This is a medical device 510(k) submission, not an AI/algorithm development document.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable / Not mentioned.
§ 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.