(72 days)
| Source selection
| and wavelength | Indications for Use |
|---|---|
| Nd:YAG laser | |
| (1064nm) | |
| Nd:YAG laser | |
| (532nm) | These wavelengths are absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. They are indicated for: |
| Tattoo removal: | |
| 1064nm: suggested for dark blue and black ink | |
| 532nm: suggested for red, orange, yellow, and purple ink | |
| Pigmented lesion removal (benign): | |
| Café au lait spot | |
| Ephalides, solar lentigo (lentigines) | |
| Becker Nevus | |
| Ota Nevus | |
| Nevus spilus | |
| Ruby laser | |
| (694nm) | This wavelength is absorbed by natural chromophores, like melanin, hemoglobin and water and by exogen pigments like tattoo ink. It is indicated for: |
| Tattoo removal: | |
| Suggested for blue, sky blue, black, green and violet ink | |
| Pigmented lesion removal (benign): | |
| Café au lait spot | |
| Ephalides, solar lentigo (lentigines) | |
| Becker Nevus | |
| Ota and Ito Nevus | |
| Nevus spilus | |
| Mongolian spot | |
| IPL 650-1200nm | |
| IPL 625-1200nm | Indicated for hair removal |
| IPL 590-1200m | |
| IPL 550-1200nm | |
| IPL 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 550-1200nm | Indicated for face vascular lesions and solar lentigines (benign pigmented lesions) |
| IPL 400-1200nm | Indicated for inflammatory acne (acne vulgaris) |
The Q-Plus T + IPL Laser System is intended for the incision, ablation and vaporization of soft tissue for general dermatology. The device includes a Q-Switched Nd:YAG laser source with a max energy of 1000mJ at 1064nm and a max energy of 500mJ at 532nm, a Q-Switched Ruby laser source with a max energy of 1000mJ at 694nm, and an intense pulse light (IPL) hand piece. The Q-Switched lasers are intended for treatment of pigmented lesions and tattoo removal. The optical delivery system for the three laser wavelengths is an articulated arm with replaceable hand pieces with 2, 3, 4, and 6 mm spot sizes. The IPL hand piece, depending on the particular wavelength filter used, is intended for hair removal, treatment of dermatological vascular lesions, benign pigmented lesions and inflammatory acne (acne vulgaris). The IPL hand pieces are provided in a fixed or a replaceable configuration. The Q-Plus T + IPL laser system incorporates several safety features, including a remote interlock, a key switch and an emergency stop button.
The Quanta System SPA Q-Plus T + IPL Laser System is a laser surgical instrument designed for use in general and plastic surgery and in dermatology. It's intended for the incision, ablation, and vaporization of soft tissue, as well as for the treatment of vascular and pigmented lesions, tattoo removal, and inflammatory acne (acne vulgaris).
The device's performance is demonstrated through substantial equivalence to two predicate devices: K073549 Q-Plus T and K083207 Ultrawave III EX 1320. The submission states that "The Quanta System Q-Plus T + IPL laser system is as safe and effective as the predicate devices. The Q-Plus T + IPL laser system has the same intended use and similar technological characteristics and principles of operation as its predicate devices. The minor technological differences between the Q-Plus T + IPL laser system and its predicate devices raise no new issues of substantial equivalence or safety and effectiveness."
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission based on technological characteristics and intended use, formal "acceptance criteria" with specific performance metrics (like sensitivity, specificity, or accuracy) derived from a clinical study are not provided in the document. Instead, the "acceptance criteria" can be inferred as demonstrating that the technological characteristics and indications for use of the Q-Plus T + IPL Laser System are substantially equivalent to the cleared predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Laser Source: Nd:YAG (1064nm & 532nm) and Ruby (694nm) performance substantially equivalent to K073549 (Q-Plus T). | The Q-Switched Nd:YAG laser source and Q-Switched Ruby laser source are identical to those utilized in the Q-Plus T device. |
| IPL Hand Piece: Performance substantially equivalent to K083207 (Ultrawave III EX 1320). | The IPL hand piece portion is the same as the IPL hand piece portion of the Ultrawave III EX 1320. |
| Optical Delivery System: Substantially equivalent to predicate devices. | The optical delivery system for the three laser wavelengths (articulated arm) is also used in the Q-Plus T device. |
| Other Components: (Power supply, cooling system, microprocessor controller, safety features) substantially equivalent to predicate devices. | These components are "either similar or identical to those in the Ultrawave III EX 1320 and Q-Plus T devices." |
| Laser Specifications: (wavelengths, max energy, spot size, fluence, pulse width, repetition rate, beam delivery, power monitor, actuator, aiming beam) substantially equivalent to predicate devices. | Laser specifications are "substantially equivalent" to the identified predicate device (Q-Plus T) with respect to these parameters. |
| Intended Use: The intended use of the combined system is substantially equivalent to the intended uses of the predicate devices. | The intended use of the laser portion is the "same as the intended use of the previously cleared Q-Plus T." The intended use of the IPL hand piece is "substantially equivalent to the intended use of the IPL hand piece used with the Ultrawave III EX 1320." |
| Safety and Effectiveness: No new issues of safety and effectiveness compared to predicate devices. | The device is deemed "as safe and effective as the predicate devices." |
Study that Proves the Device Meets Acceptance Criteria:
The current submission for the Q-Plus T + IPL Laser System does not provide details of specific clinical or performance studies with acceptance criteria in the traditional sense (e.g., sensitivity, specificity, or controlled patient trials). Instead, the "study" proving the device meets the acceptance criteria is a benchmarking and comparison study against two legally marketed and cleared predicate devices (K073549 Q-Plus T and K083207 Ultrawave III EX 1320).
The argument for substantial equivalence is based on:
- Identical/Similar Technological Characteristics: The laser sources (Q-Switched Nd:YAG and Ruby) are identical to the Q-Plus T. The IPL hand piece is the same as the IPL hand piece of the Ultrawave III EX 1320. Other components are similar or identical.
- Equivalent Intended Use: The intended uses align with the combined indications of the predicate devices.
This means the "study" is effectively a literature review and technical comparison of the device's specifications and indications for use against those of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. The submission relies on technical comparison and the established safety and effectiveness of the predicate devices. There is no mention of a separate "test set" of patients or data for this specific submission to prove clinical efficacy.
- Data Provenance: Not applicable for a new clinical test set. The provenance relies on the regulatory clearances and underlying data (which are not detailed here) for the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No new test set requiring expert ground truth establishment for this 510(k) submission.
4. Adjudication Method for the Test Set:
- Not applicable. No new test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is not mentioned or required for this 510(k) submission, which focuses on substantial equivalence to existing devices based on technological characteristics and intended use.
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, and its performance inherently involves human operation.
7. The Type of Ground Truth Used:
- Indirect Ground Truth: The "ground truth" for the Q-Plus T + IPL Laser System is established indirectly through the proven safety and efficacy of the predicate devices for their respective indications. The FDA's clearance of the predicate devices implies that sufficient evidence (including, for example, clinical data, performance testing, and expert consensus from those prior submissions) was provided to support their safety and effectiveness.
8. The Sample Size for the Training Set:
- Not applicable. As this is not an AI/algorithm device that requires a training set. The submission is based on demonstrating substantial equivalence to pre-existing, cleared devices.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
§ 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.