(163 days)
The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).
CO2 Handpieces
The Helix CO2 handpieces with wavelength of 10600 nm are indicated for use for the particular indications as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- laser skin resurfacing
- laser derm-abrasion
- laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.
Scanning unit
The Helix Scanning unit, with wavelength of 10600 nm is indicated for:
·Laser skin resurfacing (ablation and/or vaporization) of soft tissue
The Helix Scanning unit, with wavelength of 1570 nm, is indicated for:
· Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
The Helix Scanning unit, with wavelengths of 10600 nm & 1570mm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
The Helix system consists of:
• Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
• LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system.
- Two wavelengths CO2 and 1570 nm
- Articulated arm
- Footswitch
- Delivery devices (CO₂ non-fractional applicators, Scanner CO₂/1570nm fractional applicator)
Electrical specifications are:
100-230V ~ single phase, 50/60 Hz, Absorbed electric power 1500 VA (max)
The DEKA HELIX is a laser surgical instrument for use in general, plastic surgery, and dermatology. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below, based on the provided FDA 510(k) summary (K222221).
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) submission primarily demonstrates substantial equivalence to a predicate device (Alma Hybrid Laser System, K203441) rather than explicitly defining and meeting specific analytical or clinical performance acceptance criteria in the format of a separate study. Instead, the "acceptance criteria" are implied through the comparison of the proposed device's characteristics and performance to those of the legally marketed predicate device, and through compliance with recognized electrical safety and laser safety standards.
The table below summarizes the comparison between the DEKA HELIX and its predicate device, highlighting where the proposed device is considered to be "as safe, as effective, and performs as well." Differences are noted as not affecting safety and effectiveness, implying performance within acceptable limits.
| Acceptance Criteria (Implied by Predicate Equivalence & Standards Compliance) | Reported Device Performance (DEKA HELIX) | Comment |
|---|---|---|
| Indications for Use (General) | Intended for surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue in aesthetic surgery (dermatology and plastic surgery). Specific indications for CO2 handpieces and scanning unit are listed, including laser skin resurfacing for warts, acne scars, nevi epidermal, syringoma, and fractional skin resurfacing/coagulation with 1570 nm. | Identical to predicate device in overall scope. |
| Regulation Number | 21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology | Identical |
| Product Code | GEX, ONG | Identical |
| System Control | Fully computerized | Identical |
| Emission Control | Footswitch, Interlock | Identical |
| User Interface | Touch-screen display, Emergency button, Key switch | Identical |
| Cooling System | Closed loop, heat exchanger | Identical |
| Emission Indicator | Visual, Audible | Identical |
| Electrical Requirements | 100-230 V, 16A 50/60 Hz, single phase | Differences do not affect safety and effectiveness. |
| Physical Dimensions and Weight | 62 cm x 63 cm x 138/202 cm (erected), ~ 70 Kg | Differences do not affect safety and effectiveness. |
| Laser Type | RF-excited CO2 laser, Class 4; Fiber Laser, Class 4 | Identical |
| CO2 Handpieces Wavelength | 10600 nm | Identical |
| CO2 Handpieces Pilot Beam | 635nm, 4mW | Differences do not affect safety and effectiveness. |
| CO2 Handpieces Spot Size (mm) | 0.125 – 2.0 mm | Differences do not affect safety and effectiveness. |
| CO2 Handpieces Pulse Duration | 10 - 900ms | Differences do not affect safety and effectiveness. |
| CO2 Handpieces Pulse Repetition Frequency | 0.2 — 200 Hz | Differences do not affect safety and effectiveness. |
| CO2 Handpieces Min Output Energy | 5 mJ | Identical |
| CO2 Handpieces Output Power | 70W | Differences do not affect safety and effectiveness (Predicate has 30W, 70W; Proposed has 70W). |
| Scanning Unit Wavelength | 10600 nm and/or 1570 nm | Identical |
| Scanning Unit Pilot Beam | 635nm, 4mW | Differences do not affect safety and effectiveness. |
| Scanning Unit Scanner | Dual axis scanner | Identical |
| Scanning Unit Tip | Cooled | Identical |
| Scanning Unit Spot Size @ 10600 nm | 0.374mm | Differences do not affect safety and effectiveness. |
| Scanning Unit Scan Size @ 1570 nm | 20x20 mm | Differences do not affect safety and effectiveness. |
| Scanning Unit Spot Size @ 1570 nm | 0.75mm | Identical |
| Scanning Unit Output Energy @ 10600 nm | Max 251mJ | Differences do not affect safety and effectiveness. |
| Scanning Unit Output Energy @ 1570 nm | Max 144mJ | Identical |
| Scanning Unit Beam Density @ 10600 nm | 61% - 98% untreated tissue between spots | Differences do not affect safety and effectiveness. |
| Scanning Unit Beam Density @ 1570 nm | Up to 400 pixels/cm2 | Differences do not affect safety and effectiveness. |
| Electrical Safety & EMC | Compliance with ANSI AAMI ES60601-1 and IEC 60601-1-2. | Testing conducted and documented. |
| Software Validation & Verification | Conducted and documented as recommended by FDA guidance. | Testing conducted and documented. |
| Laser Safety | Compliance with IEC 60601-2-22 and IEC 60825-1. | Testing conducted and documented. |
2. Sample Size Used for the Test Set and Data Provenance
No clinical performance data (human subject studies) were conducted for this 510(k) submission. Therefore, there is no "test set" in the context of clinical data for which a sample size or data provenance would be specified. The submission relies solely on non-clinical performance data and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Since no clinical performance data was used, there was no need for experts to establish ground truth for a test set.
4. Adjudication Method
Not applicable. No test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Performance Data: None."
6. Standalone Algorithm Performance Study
Not applicable. This device is a hardware laser system, not an AI algorithm, so there is no standalone algorithm performance to evaluate.
7. Type of Ground Truth Used
Not applicable. No clinical performance data was presented, so no ground truth from pathology, outcomes data, or expert consensus was required for direct device evaluation in this submission. The ground truth for proving safety and effectiveness relies on established engineering principles, international safety standards compliance, and the equivalence to a legally marketed predicate device.
8. Sample Size for the Training Set
Not applicable. As a hardware device with no AI algorithm, there is no "training set" in the machine learning sense. The development of the device likely involved engineering design, prototyping, and iterative testing, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set in the context of machine learning.
§ 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.