(422 days)
The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery.
Specific indications by wavelength include:
1064 & 532 nm (Q-Switched, nanosecond mode): Treatment of benign vascular lesions, benign pigmented lesions, hair and tattoo removal, incision, excision, ablation, vaporization of soft tissue for General dermatology.
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos.
- Treatment of benign vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, Cherry angioma, Spider nevi.
- Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, Ephalides, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus, Ota Nevus.
- Treatment of seborrheic keratosis.
- Treatment of post inflammatory hyperpigmentation.
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of dark ink (black, blue and brown) tattoos.
- Removal of benign pigmented lesions including: nevus of Ota, Café au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Nevus spilus.
- Treatment of common nevi.
- Removal or lightening of unwanted hair.
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (non Q-Switched – free running mode):
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.
- Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
- Coagulation and hemostasis of soft tissue.
- Treatment of wrinkles.
- Treatment of mild to moderate inflammatory acne vulgaris.
532 nm (picosecond mode), also with fractional and microbeam handpieces:
- Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
- Benign pigmented lesions removal for Fitzpatrick skin types I-IV.
- Only with fractional handpiece, treatment of wrinkles in Fitzpatrick Skin Types I-IV.
1064 nm (picosecond mode), also with fractional and microbeam handpieces:
- Removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
- Benign pigmented lesions removal for Fitzpatrick skin types I-IV.
- Only with fractional handpiece, treatment of wrinkles in Fitzpatrick Skin Types I-IV.
- Only with fractional handpiece, treatment of acne scars in Fitzpatrick Skin Types II-V.
694 nm (Q-Switched), including microbeam handpieces:
- Tattoo removal: Suggested for blue, sky blue, black, green and violet ink.
- Pigmented lesion removal (benign): Cafe au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Ota and Ito Nevus, Nevus spilus, Mongolian spot.
694 nm (non q-switch – free running mode):
- Remove benign dermal and epidermal pigmented lesions.
- Effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
IPL 590-1200nm; 625-1200nm; 650-1200nm:
- Permanent hair removal.
IPL 550-1200nm; 570-1200nm:
- Photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm:
- Inflammatory acne (mild to moderate acne vulgaris).
Integrated Skin Cooler:
- Provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments.
Type of Use: Prescription Use
The Discovery Pico Family includes medical laser devices for dermatology and aesthetic medicine used by healthcare professionals (dermatologists) in professional healthcare environments. The family comprises Discovery Pico, Discovery Pico Plus, and Discovery Pico Derm models, which differ based on installed laser sources and the presence of a Twain connector.
The device is equipped with a graphical user interface (GUI) displayed on a screen for user interaction, allowing for laser parameter settings. It can be used with Twain IPL and Twain 2940 devices (Twain 2940 is separately FDA cleared K173002).
The laser beam is delivered via an articulated arm with a handpiece and activated by a footswitch. Four types of handpieces are available:
- Round (diameter): 2 to 12 mm
- Square (side): 2, 3, 4, 5, 7 mm
- Microbeam/fractional handpieces: 8, 9 mm (9 mm microbeam handpiece is also called "High Coverage")
- Rosso handpiece (separately FDA cleared: K211228)
The device incorporates four main sections:
- Power electronics: Manages power supply to all device components.
- Control electronics: Primarily consists of a microcontroller board housing the device's main firmware (FW).
- Cooling system: Cools the laser source pumping chamber and, for Twain IPL, the IPL flashlamp.
- Optical bench.
Twain IPL is an optional accessory handpiece for intense pulsed light (IPL), intended for hair reduction and treatment of various skin lesions. Twain IPL can be cooled or uncooled and supports fixed or changeable guides with wavelength ranges of 650-1200 nm, 625-1200 nm, 590-1200 nm, 570-1200 nm, 550-1200 nm, and 400-1200 nm. Each guide is available in two sizes: small (25x13 mm²) and large (48x13 mm²).
In picosecond (PS) mode, the device offers "VarioPulse" technology, allowing the user to select three pulse levels corresponding to different pulse durations:
- Short (S): 450 ps (1064 nm), 370 ps (532 nm)
- Medium (M): 600 ps (1064 nm), 500 ps (532 nm)
- Long (L): 800 ps (1064 nm), 600 ps (532 nm)
The provided text is an FDA 510(k) clearance letter for the Discovery Pico Family of laser devices. While it outlines the device's indications for use, its technical specifications, and the non-clinical tests performed to demonstrate safety and effectiveness, it explicitly states "Clinical testing: N/A."
This means that the submission for this particular device did not include a clinical study (such as an MRMC study or a standalone algorithm performance study) to prove specific performance criteria against a ground truth in a human-in-the-loop or algorithm-only setting. The clearance relies on non-clinical bench testing and comparison to predicate devices, demonstrating substantial equivalence rather than a direct clinical performance study against quantified acceptance criteria for a specific AI-driven task.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because a clinical study with those elements was not conducted or presented for this 510(k) submission.
Below is a table summarizing the information that is available from the document and indicating where the requested information is "N/A" (Not Applicable) or "Not Provided" due to the nature of this 510(k) submission (bench testing and predicate comparison, not a clinical trial proving AI performance).
Acceptance Criteria and Device Performance (Based on available information)
| Acceptance Criteria | Reported Device Performance (as demonstrated by non-clinical tests and comparison to predicates) |
|---|---|
| Safety and Essential Performance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22) | All standards met, tests repeated/updated to current editions and minor electrical/firmware changes. Pulse duration accuracy verified. |
| Usability (IEC 60601-1-6, IEC 62366-1) | Usability engineering file updated and addressed. |
| Software Life Cycle Processes (IEC 62304) | SW verification and validation activities repeated and updated. |
| Laser Product Safety (IEC 60825-1) | Report updated to include new handpiece and formal updates. |
| Non-laser Light Source Safety (IEC 60601-2-57) | No changes to Twain IPL affecting test reports. |
| Biocompatibility (ISO 10993-1) | No changes affecting biocompatibility except for disinfection step; cytotoxicity test after reprocessing performed. |
| Reprocessing Validation (ISO 17664-1) | Disinfection step introduced, and reprocessing validation repeated. |
| Mechanical/Electrical Specifications (Comparison to Predicates) | Detailed comparison table (Table 3) shows similar or within range specifications for pulse width, energy, fluence, spot size, and repetition rate compared to predicate devices, with rationales for any differences. "Considered to be adequate for the safe and effective use of the device for its indications for use." |
| Indications for Use (Substantial Equivalence) | Indications for use are maintained as per the predicate device K191842, and the device is deemed substantially equivalent. |
Study Details (Based on available information)
| Information Category | Details from the Document |
|---|---|
| 1. Acceptance Criteria & Reported Performance | See table above. Critera are primarily related to safety, testing standards, and equivalence to predicates, not specific clinical performance metrics like sensitivity/specificity for an AI. |
| 2. Sample Size for Test Set & Data Provenance | N/A - Clinical testing was not performed. The submission primarily relies on non-clinical (bench) testing and comparison to predicate devices. |
| 3. Number of Experts and Qualifications for Ground Truth | N/A - Clinical testing was not performed. Ground truth in the context of AI performance was not established for this submission. |
| 4. Adjudication Method for Test Set | N/A - Clinical testing was not performed. |
| 5. MRMC Comparative Effectiveness Study & Effect Size | N/A - Clinical testing was not performed. The document states "Clinical testing: N/A." This type of study would fall under clinical testing. |
| 6. Standalone Algorithm Performance Study | N/A - This clearance is for a medical laser device, not an AI/software algorithm intended for standalone diagnostic or assistive performance requiring such a study. The software/firmware (SW/FW) was updated and verified (IEC 62304), but this pertains to the device's operational control, not an AI for image analysis or diagnosis. |
| 7. Type of Ground Truth Used | N/A - Clinical testing was not performed. For non-clinical tests, the "ground truth" is defined by the specifications and tolerances of the device's output parameters as measured by calibrated equipment. |
| 8. Sample Size for Training Set | N/A - Clinical testing/AI model training was not performed. The device is a physical laser, not an AI model requiring a training set in the typical sense. |
| 9. How Ground Truth for Training Set was Established | N/A - Clinical testing/AI model training was not performed. |
In summary: The FDA 510(k) clearance for the Discovery Pico Family is based on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical bench testing, adherence to recognized standards for safety and performance (electrical, software, biocompatibility, reprocessing), and comparison of technical specifications. It does not involve a clinical study to evaluate AI performance against specific clinical acceptance criteria or a ground truth derived from expert consensus or outcomes data. Therefore, the detailed questions related to such clinical studies are not applicable to this specific clearance document.
§ 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.