(14 days)
Nd:YAG 1064nm: Intended for general surgical applications; dermatology/plastic surgery; endoscopic/laparoscopic surgery; general surgery; gynecology; ENT; hemostasis; neurosurgery; oculoplastics; pulmonary surgery; thoracic surgery; urology; and orthopedics. General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/-otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery and urology. Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins and poikiloderma of Civatte and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis . It addition, the laser is 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, keratoses, tattoos (significant reduction in the intensity of blue and/or black tattoos), and plaques. 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. The laser is also indicated for the treatment of facial wrinkles. It is 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 of pseudofolliculitis barbae (PFB). It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. 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. Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obtructions. including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Incision, excision, coagulating and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectorny and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy). Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminate),
Nd:YAG 1320nm: Indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles, fine lines and wrinkles, and the treatment of back acne and atrophic acne scars.
Nd:YAG 532nm: For the coagulation and hemostasis of vascular lesions. Dermatology/Plastic Surgery: 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, blanching, flattening, reduction of lesion size. General Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft Tissue as well as in Endoscopic (e.g., laparoscopic) or open surgeries. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal homostasis (including Varices, Esophagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulccrs, Non-bleeding Ulcers, Gastric Erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids). Head and NecMOtorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis Hemostasis during Surgery: Adiunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery. Neurosurgery: Hemostasis for: Pituitary Tumor, Meningioma; hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma. Ophthalmology: Post-vitrectomy endophotocoagulation of the retina. Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including Squamous Cell Carcinoma, Adenocarcinoma; Carcinoid; Benign Tumors; Granulomas; Benign Strictures. Thoracic Surgery: Cutting (incision and excision), coagulating, and vaporizing of soft tissue Thoracic applications including, but not limited to: Isolation of vessels for endartecetomy and/or by-pass grafts, Wedge Resections, Thoractoniy, Formation of Pacemaker pockets. Vaporization, coagulation, incision and excision, debulking, and ablation oflung tissue (Thoracoscopy ) Urology: All applications including: Superficial urinary bladder tumors, invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).
Alexandrite 755nm: Intended for coagulation and hemostatis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin types. Also indicated for pigmented lesions and wrinkles.
IPL 590-1200nm ; 625-1200nm; 650-1200nm: Indicated for permanent hair reduction. 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. 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.
The Ultrawave III EX 1320 consists of two laser sources and an IPL. The laser sources emit wavelengths of 1064nm (long pulse and short pulse),1320nm and 532nm for the Nd:YAG source and 755nm for the Alexandrite source. The IPI. has several different spectral ranges to be utilized for different applications: 400-1200nm, 550-1200nm, 570-1200nm, 590-1200nm, 625-1200nm and 650-1200nm. In addition, the Ultrawave III EX 1320 includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; an integral skin cooler; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
This document is a 510(k) summary for the Quanta System Ultrawave III EX 1320, a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, the requested information cannot be fully provided in the format of a typical acceptance criteria table and study details for an AI/algorithm-based device. The document states that "Performance data was provided showing the Ultrawave III EX 1320 is capable of performing fractional photothermolysis, i.e., creation of pattern (lattice) of microscopic islets of damage at superficial skin layers." However, it does not specify what constitutes "capable" in terms of quantitative metrics or acceptance criteria.
The primary acceptance criterion for this 510(k) submission appears to be "Substantial Equivalence" to legally marketed predicate devices, meaning it has the same intended use, similar indications, technological characteristics, and principles of operation, and raises no new issues of safety or effectiveness.
Here's an attempt to structure the answer based on the provided text, acknowledging the limitations inherent in this type of regulatory submission for a physical medical device as opposed to an AI/software device:
Acceptance Criteria and Study for Quanta System Ultrawave III EX 1320
This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices rather than providing detailed, quantitative acceptance criteria for device performance with specific statistical outcomes from a dedicated clinical study for novel performance claims. For physical medical devices like lasers, performance is often assessed through bench testing and, where applicable, comparison to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device has the same intended uses and similar indications, technological characteristics, and principles of operation as predicate devices. | "The Quanta System Ultrawave III EX 1320 is as safe and effective as the predicate devices. The Ultrawave III EX 1320 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Ultrawave III EX 1320 and its predicate devices raise no new issues of safety or effectiveness. Thus, the Ultrawave III EX 1320 is substantially equivalent." |
| Performance Capability: Capable of performing fractional photothermolysis. | "Performance data was provided showing the Ultrawave III EX 1320 is capable of performing fractional photothermolysis, i.e., creation of pattern (lattice) of microscopic islets of damage at superficial skin layers." (No specific quantitative metric or threshold for "capable" is provided in this summary.) |
| Safety and Effectiveness: No new issues raised by technological differences. | Stated as part of the substantial equivalence claim. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not detail a "test set" in the context of a clinical performance study with human subjects or a dataset for evaluating an algorithm's performance. The "performance data" mentioned likely refers to bench testing or preclinical data demonstrating the physical capabilities of the laser, not a clinical trial with a defined sample size.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the 510(k) summary. The ground truth for a physical device's performance is typically established through engineering specifications, physical measurements, and, where relevant, histological analysis in preclinical studies, not expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is not an AI-assisted diagnostic or interpretive device for human readers.
6. Standalone (Algorithm Only) Performance
This is a physical laser device, not a standalone algorithm. Therefore, "algorithm only" performance is not applicable. The laser's performance is inherent to its physical properties and intended use.
7. Type of Ground Truth Used
For the "performance data showing the Ultrawave III EX 1320 is capable of performing fractional photothermolysis," the ground truth would likely involve histological examination of tissue samples (possibly ex vivo or in animal models) to confirm the creation of "microscopic islets of damage at superficial skin layers." However, the exact methodology is not detailed in this summary.
8. Sample Size for the Training Set
This is not an AI/machine learning device, so the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for an AI/machine learning model.
§ 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.