(271 days)
(1) The Medical Diode Laser Systems, model: GBOX-6H, VELAS II-6H is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coaqulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-6H and VELAS II -6H is 1940nm.
(2) The Medical Diode Laser Systems, model: GBOX-10D, GBOX-12D is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endloscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The output wavelength of model GBOX-10D and GBOX-12D is 1470nm.
(3) The Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The GBOX-15D, VELAS II - 15D is further indicated for laser assisted lipolysis. The output wavelength of model GBOX-15D and VELAS II -15D is 1470nm.
(4) The Medical Diode Laser Systems, model: VELAS Pro-30B15D is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. Medical Diode Laser Systems, model: VELAS Pro-30B15D is further indicated for laser assisted lipolysis. The output wavelength of model VELAS Pro-30B15D is 980nm or 1470nm.
The "Medical Diode Laser Systems", include model: GBOX-6H, VELAS II -6H, GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D, VELAS Pro-30B15D which consist of three main components: Main device; Foot switch; Accessories. Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1940nm for GBOX-6H, VELAS II -6H; 1470nm for GBOX-10D, GBOX-12D, GBOX-15D, VELAS III-15D; 980nm or 1470nm for VELAS Pro-30B15D. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.
The provided document is a 510(k) summary for Medical Diode Laser Systems. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in terms of clinical performance. The document primarily discusses the similarity of the proposed device to predicate devices. Therefore, much of the requested information cannot be extracted directly from this type of regulatory submission.
Here's a breakdown of what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria for clinical performance (e.g., specific efficacy rates or safety profiles) for the proposed device, nor does it report its performance against such criteria. Instead, it compares the technological characteristics of the proposed device to predicate devices. The "acceptance criteria" here are implicitly meeting the performance characteristics of the predicate devices to prove substantial equivalence.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (as compared to Predicate) |
|---|---|
| Indications for Use (GBOX-6H, VELAS II-6H): Surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialists. | Substantially Equivalent (Same indications as K222701, covered by K193656) |
| Indications for Use (GBOX-10D, GBOX-12D): Surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialists. | Substantially Equivalent (Same indications as K222701, covered by K160952) |
| Indications for Use (GBOX-15D, VELAS II-15D): Endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux; laser assisted lipolysis. | Substantially Equivalent (Same indications as K160952, covered by K222701) |
| Indications for Use (VELAS Pro-30B15D): Surgical applications requiring vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialists; endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux; laser assisted lipolysis. | Identical to K240747 |
| Laser Type: Diode laser | Identical (Diode laser) |
| Wavelength (GBOX-6H, VELAS II-6H): 1940nm | Identical (1940nm) |
| Wavelength (GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D): 1470nm | Identical (1470nm) |
| Wavelength (VELAS Pro-30B15D): 980nm or 1470nm | Identical (980nm or 1470nm) |
| Output Power (GBOX-6H, VELAS II-6H): 1-6W | Similar (Predicate K222701 at 5W, Predicate K193656 up to 7.5W) |
| Output Power (GBOX-10D, GBOX-12D, GBOX-15D): GBOX-10D: 1-10W; GBOX-12D: 1-12W; GBOX-15D: 1-15W | Similar (Within scope of Predicate K222701: Max. 12W and Predicate K160952: Max. 15W) |
| Output Power (VELAS Pro-30B15D): 980nm: 30W; 1470nm: 15W | Identical (Same as K240747) |
| Pulse Width (GBOX-6H, VELAS II-6H): 10ms-10s | Similar (Predicate K222701: 10ms-30s; Predicate K193656: 10ms-10s) |
| Pulse Width (GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D): 10ms-10s | Similar (Predicate K222701: 10ms-30s; Predicate K160952: 10-990ms) |
| Pulse Width (VELAS Pro-30B15D): 10ms-1s | Identical (Same as K240747) |
| Operation Mode: CW, single pulse, repeat pulse | Identical (CW, pulsed, single pulse; Continuous wave, single pulse, pulsed) |
| Operation Interface: Color LCD touch screen | Identical (Color touch screen; Touch screen control; LCD touch screen) |
| Repetition Rate (GBOX-6H, VELAS II-6H): 0.05Hz-50Hz | Similar (Predicate K222701: 0.02-50Hz; Predicate K193656: CW or up to 100Hz) |
| Repetition Rate (GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D): 0.05Hz-50Hz | Similar (Predicate K222701: 0.02-50Hz; Predicate K160952: CW or up to 100Hz) |
| Aiming Beam: Specifications varying by model | Substantially Equivalent |
| Laser Class: 4 | Identical |
| Electrical Safety and EMC: Conformity to IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-6 | Verified. |
| Software Verification and Validation: Conformity to FDA Guidance, "moderate" level of concern. | Documentation provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Animal Study - It is not applicable." and "Clinical Studies - It is not applicable." This indicates that no clinical "test set" (i.e., patient data for direct performance evaluation) was used for this 510(k) submission. The data provenance is therefore not relevant in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical studies or test sets with patient data were conducted for this submission, there were no experts used to establish ground truth for such a test set. The submission relies on establishing equivalence to legally marketed predicate devices, implying their established safety and efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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-powered diagnostic tool, and no MRMC studies were mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies requiring a ground truth for performance evaluation were conducted. The "ground truth" in this context is the safety and efficacy profiles of the predicate devices as legally marketed.
8. The sample size for the training set
Not applicable, as this is a hardware medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a hardware medical device.
§ 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.