(76 days)
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Multi-Application Platform for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), general neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, podiatry, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
Indications for Use:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Periungual and subungual warts
- Plantar warts
- Radical nail excision
- Neuromas
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) are intended for use with the Harmony XL™ Multi-Application Platform for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of:
- Benign vascular lesions such as, but not limited to treatment of: Port wine stains, Hemangiomas, Warts, Superficial and deep telangiectasias (venulectasias), Reticular veins (0.1-4.0 mm dia.) of the leg, Rosacea, Venus lake, Leg veins, Spider veins, Poikiloderma of Civatte, Angiomas
- Benign cutaneous lesions, such as, but not limited to: Warts, Scars, Striae, Psoriasis
- Benign pigmented lesions such as, but not limited to: Lentigos (age spots), Solar lentigos (sun spots), Cafe-au-lait macules, Seborrheic keratoses, Nevi and nevus of Ota, Chloasma, Verrucae, Skin tags, Keratoses, The removal of black, blue or green tattoos (significant reduction in the intensity of black and for blue/black tattoos), Plaques
- 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.
- The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles, Perioral wrinkles
- Laser skin resurfacing procedures for the treatment of: Acne scars, Wrinkles
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The 1064 nm Nd: YAG lasers (Long Pulsed only, with and without contact-cooling) is indicated for:
- Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
- Removal or lightening of unwanted hair (with and without adjuvant preparation)
- Treatment of pseudofolliculitis barbae (PFB)
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for use in podiatry and for the temporary increase in clear nail in patients with onychomycosis is a laser handpiece that contains the optical bench that emits the high power Nd: YAG laser beam. The Modified Alma Lasers Harmony 1064nm (Nd: YAG) Modules are designed to be used with the Harmony XL™ Muli-Application Platform [Accent, Accent XL, Accent Beauty] for the delivery of long-pulse or O-switched laser energy. The patient contact portion of the Modified Alma Lasers Harmony 1064nm (Nd. YAG) Modules is a removable, cleanable, sterilizable stand-off tip.
The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are comprised of the following main components:
- Handpiece Housing
- Incorporates the optical head (laser)
- Handpiece trigger.
- Standoff-Tip (cleanable/ sterilizable)
- Laser emission indicator illuminates prior to- and during laser energy emission
- Umbilical cable houses the wiring to the Harmony XLTM Muli-Application Platform
- Module (handpiece) connector - connects the handpiece umbilical cable to its port on the Harmony XLTM Muli-Application Platform.
This document is a 510(k) Premarket Notification for the "Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules". This type of submission to the FDA focuses on establishing substantial equivalence to existing legally marketed devices (predicates), rather than proving safety and efficacy through clinical trial data with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical performance evaluation against predefined endpoints. Instead, it asserts substantial equivalence based on technological characteristics and intended use.
Here's a breakdown of why the requested information isn't present in this type of submission and what the document does provide:
-
A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or specific device performance metrics from a clinical study. The tables in the document (pages 3-4) compare the technological characteristics of the subject device (Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules) to those of predicate devices, not clinical performance. The "acceptance criteria" here is implicitly reaching substantial equivalence in technological characteristics and intended use to the predicates.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. No "test set" in a clinical performance sense is referenced. The submission relies on a comparison of device specifications to predicates.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable/Not provided. There is no clinical "test set" requiring ground truth established by experts.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. No clinical "test set" requiring adjudication is detailed.
-
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/Not provided. This device is a laser system, not an AI diagnostic tool. MRMC studies are not relevant to this type of submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is a hardware laser device, not a software algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. There is no clinical ground truth established or used for performance evaluation in this 510(k). The clinical experience of the predicate devices is implied validation for the similar new device.
-
The sample size for the training set: Not applicable/Not provided. This is a hardware device; machine learning "training sets" are not part of its development or submission.
-
How the ground truth for the training set was established: Not applicable/Not provided. As above, no training set for machine learning is involved.
Summary of what the document does provide regarding "acceptance criteria" for substantial equivalence:
The "acceptance criteria" in a 510(k) context are that the new device has the same intended use and technological characteristics as a predicate device, or that any differences in technological characteristics do not raise new questions of safety and effectiveness.
-
Intended Use & Indications for Use: Pages 1, 2, 8, 9, 10 clearly list the intended use and extensive indications for use in various medical specialties, including podiatry for temporary increase in clear nail in onychomycosis, benign vascular lesions, benign cutaneous lesions, benign pigmented lesions, non-ablative treatment of facial wrinkles, laser skin resurfacing, reduction of red pigmentation in scars, and hair removal. This is compared to the indications for use of the predicate devices implicitly.
-
Technological Characteristics Comparison (Tables on pages 3-4): The document provides detailed tables comparing the key technical specifications of the Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) to those of the predicate devices. These characteristics include:
- Treatment wavelength (1064 nm Nd:YAG)
- Spot Size
- Pulse Energy
- Pulse Duration
- Laser Power
- Energy Density
- Repetition Rate
- Patient Contact Materials
- How provided (Reusable, non-sterile, cleanable, sterilizable tip)
- Electrical Requirements
- System Dimensions and Weight
-
Rationale for Substantial Equivalence (Page 5): The submission explicitly states: "The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (used with the Harmony XL™ Muli-Application Platform) share the same indications for use, device operation, overall technical and functional capabilities, and therefore are substantially equivalent to the predicate devices."
In conclusion, this 510(k) submission does not present a clinical study with acceptance criteria and performance data as requested in the prompt. Instead, it demonstrates substantial equivalence to predicate devices based on a comparison of intended uses and technological characteristics.
§ 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.