(178 days)
The family of Modified Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
1064nm:
Dermatology:
The Altus Medical Aesthetic Modified CoolGlide laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the lasers are 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.
The Modified CoolGlide lasers are also indicated for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Modified CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the Altus Modified CoolGlide laser handpiece 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 lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications ::
The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endosopy/laproscopy. gastroenterology, general surgery, a head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
Indications for use (532nm):
For coagulation 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 extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
Family of Altus Medical Modified CoolGlide Aesthetic Lasers are comprised of the following main components:
- · a laser system console (including software and control electronics);
- · a control and display panel;
- · a permanently attached fiberoptic-coupled handpiece;
- · a skin cooling device integrated into the handpiece;
- · a footswitch (or finger-operated exposure switch (handswitch) option integrated into the handpiece)
- · a remote interlock connector (disables laser when treatment room door is opened).
The provided text is a 510(k) summary for a medical device (Altus Medical Modified CoolGlide Aesthetic Lasers) and does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving those criteria.
The document focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting primary clinical study data with specific acceptance criteria, sample sizes, and ground truth methodologies.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness based on their established indications for use and technological similarity.
- Reported Device Performance: No specific performance metrics (e.g., success rates, accuracy, precision, duration of effect) are reported for the new device based on a dedicated study. The document states: "Technologically, the modified CoolGlide family of aesthetic lasers is identical to the previous predicate CoolGlide family (K003202). Therefore the risks and benefits for the modified CoolGlide laser family are comparable to the predicate devices." This implies performance is assumed to be similar to the predicates.
2. Sample size used for the test set and the data provenance:
- Not Applicable. The submission does not describe a new clinical "test set" for performance evaluation in the way a an AI algorithm would have. It relies on the prior approval and established use of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No new ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No new test set and adjudication process are described.
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 a laser device, not an AI or diagnostic imaging device involving human readers or comparative effectiveness in that sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a laser device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the multiple predicate laser devices for their specific indications.
8. The sample size for the training set:
- Not Applicable. This document does not describe a training set for an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. This document does not describe a training set for an algorithm.
Summary of Information from the Provided Text:
The "study" that proves the device meets (implicit) acceptance criteria is the submission's argument for substantial equivalence to existing predicate devices. The core argument is based on:
- Similar Indications for Use: The modified device has largely the same general indications as numerous predicate laser systems.
- Technological Identity: "...the modified CoolGlide family of aesthetic lasers is identical to the previous predicate CoolGlide family (K003202)." This is the primary "proof."
- Comparable Risks and Benefits: Because of technological identity, the risks and benefits are considered comparable to the predicate devices, which have already been deemed safe and effective.
Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device is fundamentally the same as devices already on the market and proven safe and effective for the stated indications. There is no discrete clinical performance study described in this 510(k) summary with specific quantitative acceptance criteria or performance numbers for the new device itself.
§ 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.