(139 days)
The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis; incision, excision, vaporization, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Photocoagulation of telangiectasia, venulectasia of the legs and face Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi
The DC International, LLC DC 7 is a medical grade, solidstate, infrared diode lasers (AlGaAs). The lasers are designed to deliver continuous or pulsed laser energy with a wavelength at 980 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.
The provided text is a 510(k) summary for the DC 7 Diode Laser Therapy System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Based on the document, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The DC 7 device is a diode laser therapy system. The acceptance criteria are based on substantial equivalence to predicate devices rather than meeting specific performance metrics in a clinical study. The device meets "acceptance criteria" by demonstrating that its technical and functional characteristics are either identical or sufficiently similar to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Table of Acceptance Criteria (based on comparison to predicate devices) and Reported Device Performance (DC 7):
| Characteristic | Predicate Device (DenLase 980/7 & Diolase 10S) Performance (Acpt. Criteria Implied by Equivalence) | DC 7 Reported Performance | Comparison Analysis (Acceptance Status) |
|---|---|---|---|
| Regulation | 21CFR878.4810 (Class II, Laser Surgical Instrument) | 21CFR878.4810 | Identical |
| Category of Device | Prescription Device | Prescription Device | Identical |
| Laser Medium | Diode Laser (GaAlAs) | Diode Laser (GaAlAs) | Identical |
| Wavelength | 980 nm (for DenLase 980/7), 940 +/- 15 nm (for Diolase 10S) | 980 nm | The DC 7 matches one predicate and is within a similar therapeutic range to the other. Not considered to affect safety/effectiveness. |
| Power to Tissue | Up to 7 Watts (DenLase 7), Up to 10 Watts (Diolase 10S) | Up to 7 Watts | Meets Acceptance: "The maximum power output of proposed device is between that of the two predicates devices, and all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not affect the safety and effectiveness of the proposed device." |
| Laser Class | Class IV | Class IV | Identical |
| Operating Modes | Continuous, Pulsed | Continuous, Pulsed | Identical |
| Pulse Width | 50us - 30s Up to 100 Hertz | 50us - 30s Up to 100 Hertz | Meets Acceptance: "The comparatively short pulse duration of DC7 will not introduce any problems regarding the safety and effectiveness of the device. In addition, the shorter pulse duration will decrease the injury which the laser beam bring to the normal tissue, at the same time the shorter pulse duration will reduce the smoke caused by treatment, then correspondingly optimize the vision during the treatment also. Considering the pulse duration range of the proposed product include the pulse duration range of the predicated product, the difference will not introduce any problems regarding the safety and effectiveness of the device." |
| Beam Delivery | Fibers, handpieces and tips | Fibers, handpieces and tips | Identical |
| Aiming Beam | 650 nm @ 1.0 mW Max adjustable | 650 nm @ 1.0 mW Max adjustable | Identical |
| Contacting Material | Stainless steel, polypropylene and quartz | Stainless steel, polypropylene and quartz | Identical |
| Contacting Components | Handpieces, tips and fiber | Handpieces, tips and fiber | Identical |
| Control System | Microprocessor | Microprocessor | Identical |
| Laser Operation | Footswitch | Footswitch | Identical |
| Electrical Supply | 100-230 VAC, 50-60 Hz | 100-230 VAC, 50-60 Hz | Identical |
| Cooling | Internal | Internal | Identical |
| Weight | 3 Pounds | 3 Pounds | Identical |
| Accessories | Fiber, disposable tips, handpieces | Fiber, disposable tips, handpieces | Identical |
| Software Validation | Comply with the FDA Guidance for traditional 510(k) | Comply with the FDA Guidance for traditional 510(k) | Identical |
| Electrical Safety | Comply with IEC60601-1 | Comply with IEC60601-1 | Identical |
| Electromagnetic Compatibility | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Identical |
| Labeling | Comply with related standards and refer to Labeling documentation of 510(k) submission | Comply with related standards and refer to Labeling documentation of 510(k) submission | Identical |
Study Details
The provided document (510(k) summary) explicitly states:
- Non clinical Performance Data: None
- Clinical Performance Data: None
This means that a traditional "study" to prove the device meets acceptance criteria in terms of performance was not performed in the context of this 510(k) submission. Instead, the "study" demonstrating that the device meets criteria is a comparative analysis proving substantial equivalence to predicate devices, which is sufficient for 510(k) clearance for this type of device.
Given the absence of clinical/non-clinical performance data, the following points cannot be addressed as no such studies were conducted or presented in this summary:
- Sample size used for the test set and the data provenance: Not applicable, as no test set data from performance studies were provided. The "test set" here would implicitly be the specifications of the predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance was not established via expert review in this submission.
- Adjudication method for the test set: Not applicable.
- 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 surgical laser, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical laser.
- The type of ground truth used: For the purpose of this 510(k), the "ground truth" for proving substantial equivalence comes from the established safety and effectiveness of the legally marketed predicate devices, against which the DC 7's technical specifications are compared.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
In summary, the clearance for the DC 7 is based on a demonstration of substantial equivalence to predicate devices through a detailed comparison of technical specifications, rather than new performance studies with specific acceptance criteria that would typically involve test sets, expert ground truth, or statistical analysis of clinical outcomes.
§ 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.