(30 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 as follows.
Indications for use
1064 & 532 nm (Q-Switched, nanosecond mode)
The Discovery Pico Family is intended for treatment of vascular lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode)
Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
Treatment of vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angiomaa
- Cherry angioma
- Spider nevi
Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-Iait 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)
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 pigmented and 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 handpiece
Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
1064 nm (picosecond mode), also with fractional handpiece
Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
694 nm (Q-Switched)
Indicated for:
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)
Intended to remove benign dermal and epidermal pigmented lesions, and, to 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
Indicated for permanent hair removal.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime
IPL 550-1200nm; 570-1200nm
Indicated for photocoagulation of dermatological 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
Indicated for inflammatory acne (acne vulgaris).
Integrated Skin Cooler
The intended use of the integrated cooling system in the laser hand piece is to 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 vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.
The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser). The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths. All the models belonging to the Discovery Pico Family have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed. The Discovery Pico Family is controlled via a touch screen display housed in the front of the device. Emission is triggered by means of a footswitch.
The provided document is a 510(k) summary for the Discovery Pico Family laser system, which describes its modifications and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, specific device performance metrics, or a study design in the way typically expected for a clinical validation or AI-based device. Instead, it focuses on regulatory compliance and the safety/effectiveness of a modified laser device.
However, I can extract the relevant information that is present in the document which aligns with some of your requested categories, and indicate where the requested information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "There are no mandatory performance standards for this device." Instead of specific numerical acceptance criteria for clinical performance, the approval is based on compliance with electrical and safety standards, and equivalence to predicate devices.
| Acceptance Criterion (Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| IEC 60601-2-22: Surgical Laser Equipment | Complies |
| IEC 60825-1: Laser Product Safety | Complies |
| IEC 60601-1: Medical Electrical Equipment | Complies |
| IEC 60601-1-2: Electromagnetic Compatibility | Complies |
| Software Verification and Validation Testing | Conducted and documentation provided |
| Biocompatibility of materials | Established based on predicate devices |
| Thermal-histology performance (fractional handpieces) | Data provided (details not in summary) |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a medical device clearance based on substantial equivalence and compliance with engineering standards, not a clinical study involving a test set of data. The "test set" in this context refers to engineering and safety performance tests of the device itself, not a dataset for evaluating an algorithm's diagnostic or predictive performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. (See explanation for point 2).
4. Adjudication method for the test set
Not applicable. (See explanation for point 2).
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 is not an AI-based diagnostic or imaging device. It is a laser surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used
For the engineering and safety performance tests mentioned, the "ground truth" would be established by validated test methods and measurements against established engineering and safety standards. For example, laser power output would be measured with calibrated equipment, and electrical safety would be verified according to IEC standards.
8. The sample size for the training set
Not applicable. (See explanation for point 2).
9. How the ground truth for the training set was established
Not applicable. (See explanation for point 2).
Summary of Study (Based on the provided document):
The "study" described in this 510(k) summary is a regulatory submission demonstrating the substantial equivalence of the modified Discovery Pico Family laser system to previously cleared predicate devices. The primary focus is on proving that the modified device (with added fractional handpieces) maintains the same intended use, indications for use, and fundamental scientific technology as its unmodified predecessor (K163222), and that any differences do not raise new questions of safety or effectiveness.
The document highlights compliance with several recognized consensus standards (IEC 60601-2-22, IEC 60825-1, IEC 60601-1, IEC 60601-1-2) which cover general safety, laser safety, and electromagnetic compatibility for medical electrical equipment. It also mentions "Thermal-histology performance data for fractional handpieces" as being provided, which would involve laboratory/bench testing. Software verification and validation testing were also conducted.
There is no mention of clinical trials, human reader studies, or AI algorithm performance evaluations because the device is a laser system whose safety and effectiveness are established through compliance with existing standards and comparison to legally marketed predicate devices, rather than through novel diagnostic performance.
§ 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.