(74 days)
532nm Applications:
The Cyber Surgical Laser Family and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
General Surgery:
Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft tissue as well as in Endoscopic (e.g. Iaparoscopic) or open surgeries.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Gynecology:
Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: Endometriosis; Cervical, vulvar, and vaginal intraepitheal neoplasia: Condyloma Acuminata; Uterine Septum; Intrauterine adhesions; Submucosal fibroids.
Head and Neck/Otorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis.
Neurosurgery:
Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.
Opthamology:
Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery:
Vaporizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
Spinal Surgery:
Percutaneous lumbar diskectomy. Thoracic Surgery: Vaporizing, Coagulating. Incising, Excising, Debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Urology:
Outting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of: Bladder; Urethral & Ureteral Tumors; Condylomas; Lesions of external genitalia; Urethral & penile Hemangioma; Urethral Strictures; Bladder Neck Obstructions; and, when used at 532nm it is intended to hemostatically vaporize prostate tissue of men suffering from benign prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer.
2.01 um Applications:
The Cyber Surgical Laser Family and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery, and Arthroscopy
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral Strictures
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral
- Tumors.
- Ablation of Benign Prostatic Hypertrophy (BHP),
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostrate (HoLRP)
- Laser Enuculeation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation vaporization, coagulation and hemostasis) including: - Appendectomy
- Polyps
- Biopsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- Gastric ulcers
- Duodenal ulcers
- Non Bleeding Ulcers
- Pancreatitas
- Hemorrhoids
- Cholecystectomy
- Benign and Malignant Neoplasm
- Angiodysplasia
- Colorectal cancer
- Telangiectasias
- Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric Erosions
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) - Intra-uterine treatment of submucous fibroids, benign endometrial polyps.
- and uterine septum by incision, excision, ablation and or vessel
- coagulation
- Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: - Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
- Tonsillectomy
- Adenoidectomy
General Surnqery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Cholecystectomy
- Lysis of adhesion
- Appendectomy
- Biopsy
- Skin incision
- Tissue dissection
- Excision of external tumors and lesions
- Complete or partial resection of internal organs, tumors and lesions
- Mastectomy
- Hepatectomy
- Pancreatectomy
- Splenectomy
- Thyroidectomy
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy
- Lymphadenectomy
- Partial Nephrectomy
- Pilonidal Cystectomy
- Resection of lipoma
- Debridement of Decubitus Ulcer
- Hemorrhoids
- Debridement of Statis Ulcer
- Biopsy
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) - Ablation of soft and cartilaginous tissue in Minimal Invasive -Spinal
- Surgery including
- Percutaneous Laser Disc Decompression/Discectomy
- Foraminoplasty
- Ablation and coagulation of soft vascular and non vascular tissue in
- minimally invasive spinal surgery.
The Cyber Surgical Laser Family is a surgical laser instrument for use in general surgery and dermatology. The Cyber Surgical Laser Family includes 3 models:
Model Cyber Green is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Opthamology, Plastic Surgery, Spinal Surgery and Urology.
Model Cyber Tm is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Gynecology, ENT, General Surgery and Arthroscopy
Model Cyber Green/Tm is a combination of Cyber Green and Cyber Tm. The indication for use is the same of Cyber Green and Cyber Tm.
The device consists of a rack that houses the cooling units (2 chillers), the laser source and the power supply. Above the rack, into a cover-proof light, the laser head and optical bench with the beam delivery optics and the power meter are housed.
The Cyber Green includes a Q-Switch Nd: YAG frequency doubled Laser Source (KTP) that emit a pulsed laser light at 532nm with power adjustable from 0.5 to 120W.
The Cyber Tm includes a Tm:YAG Laser Source that emit a Cw laser light at 2.01um wavelength with power adjustable from 5 to 120W.
The Cyber Green/Tm includes a Q-Switch Nd:YAG frequency doubled Laser Source (KTP) that emit a pulsed laser light at 532nm with power adjustable from 0.5 to 120W, and a Tm:YAG Laser Source that emit a Cw laser light at 2.0lum wavelength with power adjustable from 5 to 120W.
An SMA connector allows the connection of an optical fiber in which the main beam and the 650nm aiming beam are launched. Sidefire fibers (600um) and bare fibers (200, 400 and 600um) are available for both laser source.
The emergency red push button , the key-switch and the operation status led are housed in the front part of the system.
The footswitch connector is housed in the back side of the system. A metal door closes the lower rack.
On the back panel are housed the magneto-thermal switch (circuit braker), the line cable with IEC309 /32A plug and a safety interlock connector. The rear panel also contains the power supply and chillers outlet grids cooling .
The device is controlled by a touch-screen PC mounted on a oriental arm.
The provided document, K090962, is a 510(k) Summary for the Quanta System Cyber Surgical Laser Family. This type of submission to the FDA focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed clinical study data for new acceptance criteria.
Therefore, the document explicitly states "Performance Data: None." This means the submission does not contain a study designed to prove the device meets specific acceptance criteria through empirical testing. Instead, equivalence is asserted based on similar intended uses, indications, technological characteristics, and principles of operation to predicate devices (AllMed System Revolix 120 Laser System (K070476) and Laserscope GreenLight HPS Series Surgical Laser and System Accessories (K062719)).
Given this, I cannot extract most of the requested information, which pertains to clinical studies and performance metrics.
However, I can still provide the following based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no specific performance data or acceptance criteria are presented in this 510(k) summary, this table cannot be populated as requested. The device's "performance" in the context of this submission is its asserted substantial equivalence to predicate devices, implying it functions similarly and addresses the same clinical needs.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study was conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no performance study was conducted.
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 surgical laser, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance study was conducted.
8. The sample size for the training set: Not applicable, as this is a physical medical device (surgical laser), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable, as this is a physical medical device (surgical laser), not a machine learning algorithm.
§ 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.