(72 days)
General intended use: Suprema 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 nm (pulsed): Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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. It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.
532 nm (pulsed): Intended for the coagulation and hemostasis of vascular lesions. For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).
755 nm (pulsed): Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
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 Suprema Family 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 fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.
Suprema family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal. Suprema models differ for the installed laser sources only according to Table 1. Suprema devices are transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction. Laser radiation is delivered through optical fibers connected to handpieces having fix or variable spot dimension. The device can be optionally equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling the laser handpiece at the same time. Configurations without optional integrated skin cooler, can be used in conjunction with Cryo 6 skin cooler manufactured by Zimmer GmbH (K060395). In this case, an optional housing is provided which is called Skin Cryo handpiece. Laser handpieces cannot be used alone but only in conjunction to Skin Cooler and Skin Cryo handpieces. Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler and Skin Cryo handpieces. The device can be divided into four main sections: Power electronics, Control electronics, Cooling system, Optical bench. Suprema devices can be used in conjunction with Twain 2940 devices. Twain IPL and Twain 2940 are already FDA cleared (K202503, K173002, respectively).
This document describes a 510(k) premarket notification for a family of laser surgical instruments (Duetto Suprema, Domino Suprema, Suprema VT, Suprema VT+, Suprema 4V) for use in general and plastic surgery and in dermatology. The submission demonstrates substantial equivalence to predicate devices (Evo Platform K192160 and Chrome K202503).
Here's an analysis of the provided text in terms of acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device) and then report performance against these criteria. Instead, it relies on demonstrating that the subject device's technical specifications and intended uses are comparable to those of already cleared predicate devices. The "acceptance criteria" here are implicitly that the new device's performance, as measured by its specifications and safety/efficacy profile, is substantially equivalent to the predicate devices.
The comparison table provided (Table 3 on pages 6-8) is the closest equivalent to reporting device performance relative to a benchmark.
| Specification | Predicate (Evo Platform K192160) | Subject Device (Suprema Family) | Discussion regarding equivalence/impact |
|---|---|---|---|
| Device Name | Evo Platform | Suprema Family | - |
| K number | K192160 | (Not applicable for subject device) | - |
| Manufacturer | Quanta System S.p.A. | Quanta System S.p.A. | Same manufacturer, implies similar quality systems. |
| Product Code | GEX | GEX | Same product code. |
| Laser Sources | Nd:YAG and Alexandrite | Nd:YAG and Alexandrite | Same type of laser sources. |
| Laser Wavelengths | 1064nm, 532nm, 755nm (pulsed) | 1064nm, 532nm, 755nm (pulsed) | Same wavelengths for laser components. |
| Pulse width (max) | @1064 nm: 300 ms | ||
| @532 nm: 50 ms | |||
| @755 nm: 300 ms | The same | Identical pulse widths. | |
| Fluence (max) | @1064 nm: 300 J/cm² | ||
| @532 nm: 95 J/cm² | |||
| @755 nm: 60 J/cm² | The same | Identical maximum fluences. | |
| Spot Size | @1064 nm: 2÷5, 6, 8, 10, 12, 14, 16 mm | ||
| @532 nm: 2÷5, 6, 7 mm | |||
| @755 nm: 6, 8, 10, 12, 14, 16 mm | Variable: 2÷6 mm (1 mm step), 8÷20 mm (2 mm step) | ||
| Fixed: 14, 16, 18, 20, 22 mm | Differences noted, with justification for no new concerns: |
- 1064nm & 755nm: Subject device max spot area 7% larger. Justified by lower energy/fluence for larger spots and no new thermal concerns.
- 532nm: Subject device max spot area 12x larger. Justified by 28x lower fluence for largest spots and equivalence of maximum fluence in small spots. |
| Repetition Rate (max) | @1064 nm: 10 Hz
@532 nm: 5 Hz
@755 nm: 10 Hz | The same | Identical repetition rates. |
| Skin Cooling | Three cooling levels | The same | Identical skin cooling capabilities. |
| Twain IPL (Predicate: Chrome K202503) | (Specific IPL wavelengths for Chrome) | Same IPL wavelengths as Chrome | The Twain IPL accessory is identical to the Chrome family's. |
| Twain IPL Pulse width (max) | 40 ms | The same | Identical pulse width for IPL. |
| Twain IPL Spot size | 48mm x 13mm, 25mm x 13mm | The same | Identical spot sizes for IPL. |
| Twain IPL Fluence (max) | 25 J/cm² | The same | Identical maximum fluence for IPL. |
| Twain IPL Repetition rate | 3 Hz | The same | Identical repetition rate for IPL. |
| Twain IPL Cooled waveguides | Three cooling levels | The same | Identical cooling for IPL waveguides. |
| Indications for Use | Broad range of dermatological and surgical applications (vascular, pigmented lesions, hair reduction, wrinkles, acne for IPL) | The same | Indications for use are identical to the predicate device, across all wavelengths and IPL. |
| Non-clinical testing | Compliance with various IEC/ISO standards | Compliance with various IEC/ISO standards | Tests (electrical safety, EMC, usability, software, laser safety, biocompatibility) were repeated for the subject device due to minor hardware/software changes or specific component differences. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission is for a laser surgical instrument, and the provided text does not mention any clinical study involving patient data or a test set of clinical cases. The evaluation is based entirely on non-clinical testing (engineering verification and validation, performance testing against standards, and comparison of specifications to predicate devices). Therefore, there is no sample size for a test set or data provenance in the context of clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there was no clinical test set or ground truth established by experts in a clinical context. The evaluation relies on engineering standards and comparison to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical test set requiring expert adjudication.
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 surgical instrument, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. Its performance is related to its physical parameters (wavelength, fluence, spot size, etc.) and its electrical/mechanical safety and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" is defined by the technical specifications outlined in the predicate device's clearance and by compliance with recognized international standards (e.g., IEC 60601 series, IEC 60825-1, ISO 10993-1). The device's performance is measured against these engineering and safety standards, rather than clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.