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510(k) Data Aggregation
(149 days)
The device FlexSys is a multi-modality skin surface treatment . Depending on the chosen modules the intended use and the mode of operation varies.
Module MultiLite:
The intended use of the device FlexSys with MultiLite module is:
· Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
· Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
· Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions.
Module Green 532:
The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Module Yellow 577:
The GME FlexSys with module Yellow 577 (wavelength: 577mm) is intended for treatment of benign vascular and benign pigmented lesions.
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, and the door plug are connected to the base unit. The touch-screen serves as the main control panel.
The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.
The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
The provided text is a 510(k) summary for the GME FlexSys device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it explicitly states:
"Clinical Performance Data: None"
This means that no clinical study was conducted to prove the device's performance against specific acceptance criteria. The acceptance criteria and the study proving the device meets them are therefore not available in this document.
The document primarily focuses on demonstrating substantial equivalence based on:
- Technological similarity: Comparing the FlexSys's technology (laser and LED light sources) to predicate devices.
- Physical output characteristics: Assessing that the physical output of the FlexSys is similar to predicates.
- Indications for Use: Comparing the intended uses of the FlexSys modules to those of predicate devices.
- Design, materials, and performance: General comparisons to predicate devices without specific quantitative clinical data.
- Nonclinical tests: Conformance with standards for safety (electrical, EMC, laser safety), software validation, and biocompatibility.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided document.
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(143 days)
The Quanta System QUANTA Diode Laser Family, including the QUANTA532, QUANTA808, QUANTA940, QUANTA980, QUANTA1064, QUANTA1320, QUANTA1470, and QUANTA1950 (and all their double wavelength combination and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery(PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures. The QUANTA980 and QUANTA1470 Diode Laser are further indicated for laser assisted lipolysis.
The QUANTA Diode Laser Family is designed with 4 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics, which controls the power electronics, the user interface and the laser source temperature via a thermostat board: and (4) the laser system with an opto-mechanical block composed of the laser source, the Peltier cooling system with dissipater and fans, the fiber launching system, the red diode aiming beam, and the power calibration system. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the QUANTA Diode Laser Family incorporates several safety features, including a remote interlock, an emergency red push button and a key switch. The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications and laser assisted lipolysis.
The Quanta System QUANTA Diode Laser Family for surgical applications has been recognized as substantially equivalent to various predicate devices (K072034, K083613, K091534, K053604, K090164) and does not have specific acceptance criteria or an analytical study presented in the provided text to demonstrate its performance. Instead, the FDA's 510(k) clearance is based on its substantial equivalence to already marketed devices.
However, based on the provided text, we can describe the intended uses for each laser model, which implicitly sets the performance expectations for these devices.
Acceptance Criteria and Reported Device Performance
Since no specific quantitative acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) were provided in the document, the "performance" here refers to the extensive list of intended uses and indications for which the device is cleared. The device "meets the acceptance criteria" by being substantially equivalent to existing devices and being cleared for the broad range of surgical applications outlined.
| Laser Model | Acceptance Criteria (Intended Use/Indications) | Reported Device Performance (Implicitly Meets Indications) |
|---|---|---|
| QUANTA532 | Ophthalmology (Retinal Photocoagulation, Pan Retinal Photocoagulation, Endophotocoagulation, Macular Treatments, Laser Trabeculoplasty), Otolaryngology (Stapedectomy, Stapedotomy, Myringotomy, Lysis of adhesions, Control of bleeding, Removal of acoustic neuromas, Soft tissue adhesion in micro/macro otologic procedures), Dermatology (Vascular lesion, Pigmented lesion). | Cleared for all listed indications. |
| QUANTA808 | Urology (BPH), Genitourinary, Thoracic Surgery, Plastic Surgery and Dermatology (vascular lesions, hair removal), General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT, Radiology, Endovascular coagulation, Oral Surgery, Dental procedures. Specific indications include lesions of external genitalia, circumcision, condyloma, bladder tumors, bladder neck incisions, vaporization of prostate, rectal/anal hemorrhoidectomy, mastectomy, dermabrasion, appendectomy, bowel resection, colectomy, liver resection, resection of organs, thyroidectomy, adhesiolysis, hepatobiliary tumors, thoracotomy, cholecystectomy, breast biopsy, PLDD, discectomy, hemostasis (meningiomas), cervical conization, myomectomy, endometrial ablation, ovarian cystectomy, appendectomy, dacryocystorhinostomy, open DCR, tumor excision, blepharoplasty, dissect/coagulate, hemostasis (colonoscopy, esophageal varices), excision of polyps, chondromalacia, synovectomy, menisectomy, pulmonary resection, pericardiectomy, coagulation of blebs/bullae, endoscopic pulmonary applications, tracheal bronchial lesions, benign/malignant pulmonary obstruction, removal of benign lesions (ear, nose, throat), excision of carcinoma (larynx), incision/excision of carcinoma in situ, neck dissection, laryngeal papillomectomy, removal of vocal cord/fold nodules/polyps/cyst, frenectomy, frenotomy, biopsy, pulpotomy, cardiac tissue coagulation/hemostasis, photocoagulation of vascular/dermatological lesions, telangiectasia/veinulectasia, reticular veins/branch varicosities, pyrogenic granuloma, lymphangioma, angiofibromas, superficial benign vascular lesions (telangiectasias, rosacea, angioma, venous lakes, couperosis, cherry angioma, hemangioma, port wine stains, angiokeratoma), benign epidermal pigment lesions (lentigines, epidermal nevi, spider nevi), dermatological surgery (condyloma acuminata, warts, small non-malignant skin tumors, small semi-malignant tumors, warty leucoplasty, ulcers debridment), seborrheic keratosis, mixoid cyst, papillary varix, acne treatment, hair removal (skin type I-V), cut/coagulation/vaporization, resurfacing (non), blepharoplasty, endoluminal/endovenous laser saphenous incompetent vein surgery. | Cleared for all listed indications. |
| QUANTA940 | Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology, Endovascular Surgery, Dental Procedures. Intended for cutting, vaporization, ablation and coagulation of soft tissue (with endoscopic equipment, contact/non-contact open surgery), treatment/removal of vascular lesions/tumors, removal of unwanted hair, endovascular coagulation of greater saphenous vein (superficial vein reflux), treatment of BPH symptoms (28-85cc prostates), incision/excision/vaporization/ablation/coagulation of oral soft tissue (biopsies, exposure of unerupted teeth, fibroma removal, frenectomy, frenotomy, gingival troughing, gingivectomy, gingivoplasty, gingival incision/excision, haemostasis/coagulation, implant recovery, incision/drainage of abscess, leukoplakia, operculectomy, oral papillectomies, pulpotomy, pulpotomy adjunct to root canal therapy, reduction of gingival hypertrophy, soft tissue crown lengthening, treatment of canker sores/herpetic/aphthous ulcers, vestibuloplasty), Laser Periodontal procedures (soft tissue curettage, removal of diseased/infected/inflamed/necrosed soft tissue, sulcular debridement). | Cleared for all listed indications. |
| QUANTA980 | Incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, endovenous occlusion of greater saphenous vein. Further indicated for laser assisted lipolysis. Specific indications are the same as 808nm for most categories, with additional specific surgical tasks listed for ENT/Oral Surgery, Arthroscopy, Gastroenterology, General Surgery/Dermatology/Plastic Surgery/Podiatry, Urology, Gynecology, Neurosurgery, Cardiac Surgery, Pulmonary Surgery, Dental Applications, and Endovenous Occlusion. | Cleared for all listed indications. |
| QUANTA1064 | Dermatology/Plastic Surgery (Photocoagulation of Colored Vascular Lesions of Skin if Argon Laser unsuccessful), Discectomy (Percutaneous Lumbar Discectomy), Gastrointestinal (Tissue Ablation for Benign/Malignant Neoplasm, Polyps, Colitis, Ulcers, Aniodysplasia, Hemorrhoids; Hemostasis for Varices, Esophagitis, Esophageal Ulcer, Mallory-Weiss Tear, Gastric Ulcers, Duodenal Ulcers, Non-bleeding Ulcers, Gastric Erosions), General Surgery (Skin Incision, Tissue Dissection, Excision (external tumors/lesions), Resection of Internal Organs, Tumors/Lesions, Tissue Ablation, Vessel Coagulation), Genitourinary Surgery (Ablation/Hemostasis for Superficial Urinary Bladder Tumors, Invasive Bladder Carcinoma, Urethral Strictures, Lesions of External Genitalia), Gynecological Tissue Ablation (Endometrial Ablation (menorrhagia), Soft Tissue Excisional Conization, Submuccous Fibroids, Polyps, Septa), Neurosurgery (Hemostasis), Orthopedic Surgery (Soft Tissue incision/excision in Knee, Shoulder), Otorhinolaryngology Surgery (Soft Tissue: Skin Incision, Tissue Dissection, Excision (external tumors/lesions), Resection of Internal Organs, Tumors/Lesions, Tissue Ablation, Vessel Coagulation), Prostatectomy (Soft Tissue Coagulation for BPH), Pulmonary Surgery (Palliative Treatment for Benign/Malignant Pulmonary Airway Obstructions). | Cleared for all listed indications. |
| QUANTA1320 | Dermatology (incision, excision, ablation, vaporization with hemostasis of soft tissue, treatment of fine lines/wrinkles, back acne, atrophic acne scars), Endovascular surgery (treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities). | Cleared for all listed indications. |
| QUANTA1470 | Endovenous occlusion of the greater saphenous vein. Further indicated for laser assisted lipolysis. Specifically for endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux. | Cleared for all listed indications. |
| QUANTA1950 | Urology (Open/endoscopic surgery for urethral strictures, bladder neck incisions, ablation/resection of bladder/urethral/ureteral tumors, BPH, TUIP, HoLRP, HoLEP, HoLAP, condylomas, lesions of external genitalia), Gastroenterology (Open/endoscopic surgery for appendectomy, polyps, biopsy, gall bladder/biliary/bile duct calculi, ulcers, pancreatitis, hemorrhoids, cholecystectomy, benign/malignant neoplasm, angiodysplasia, colorectal cancer, telangiectasias, vascular malformation, gastritis, esophagitis, esophageal ulcers, varices, colitis, Mallory-Weiss tear, gastric erosions), Thoracic/Pulmonary Surgery (Open/endoscopic surgery for laryngeal lesions, airway obstruction, polyps/granulomas, palliation of obstructing carcinomas), Gynecology (Open/endoscopic surgery for intra-uterine treatment of submucous fibroids, benign endometrial polyps, uterine septum; soft tissue excision procedures like excisional conization of cervix), Ear, Nose & Throat (Endoscopic endonasal surgery for endonasal/sinus surgery, partial turbinectomy, polypectomy, dacryocystorhinostomy, frontal sinusotomy, ethmoidectomy, maxillary antrostomy, functional endoscopic sinus surgery, lesions/tumors of oral/nasal/glossal/pharyngeal/laryngeal, tonsillectomy, adenoidectomy), Dermatology/Plastic Surgery (Incision/excision/resection/ablation/vaporization/coagulation/hemostasis of soft/mucosal/fatty/cartilaginous tissue for basal cell carcinomas, lesions of skin/subcutaneous tissue, skin tags, plantar warts), Arthroscopy (excision/ablation/coagulation of soft/cartilaginous tissue in minimally invasive spinal surgery, PLDD, foraminoplasty, ablation/coagulation of soft vascular/non-vascular tissue), General Surgery (Open/laparoscopic/endoscopic surgery for cholecystectomy, lysis of adhesions, appendectomy, biopsy, skin incision, tissue dissection, excision of external tumors/lesions, complete/partial resection of internal organs/tumors/lesions, mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, herniorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, debridement of decubitus/stasis ulcers, hemorrhoids). | Cleared for all listed indications. |
Regarding the study that proves the device meets the acceptance criteria:
The provided 510(k) Premarket Notification document does not describe a specific clinical study for the Quanta System QUANTA Diode Laser Family to prove its performance against acceptance criteria in the traditional sense of a new device. Instead, the basis for its market clearance is "Substantial Equivalence" to predicate devices already on the market.
The document explicitly states under "Performance Data": "None".
This means that a new clinical study was not conducted or presented to demonstrate the device's efficacy or safety. The FDA's determination of substantial equivalence (K100558) implies that the new device is as safe and effective as the predicate devices based on similarities in intended use, indications for use, technological characteristics, and principles of operation, and that minor technological differences raise no new issues of safety or effectiveness.
Therefore, the following points cannot be answered from the provided text, as the underlying regulatory pathway for this device did not require such studies or data submission:
- Sample size used for the test set and the data provenance: Not applicable, as no performance testing using a test set against ground truth was described in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 surgical device, not an AI-based diagnostic tool relying on human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as no machine learning or AI component with a training set was mentioned.
- How the ground truth for the training set was established: Not applicable.
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