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Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization, and ablation of joint tissues during arthroscopic surgery. Gastroenterology: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Orthopedics: Dissect and coagulate. General Surgery, Dematology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion. GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Gynecology: Ablation, excision, incision, coagulation, hemostasis, and vaporization of tissue. Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue. Ophthalmology: Dacryocystorhinostomy transcanalicular, Open DCR, Tumor Excision, Blepharoplasty. Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, ablation, and excision of tissue. Cardiac Surgery: Coagulation and hemostasis of cardiac tissue. Thoracic Surgery: Thoracotomy, Pulmonary resection, Hemostasis, Pericardiectomy, Adhesiolysis, Coagulation of blebs and bullae. Urology: Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues. Dermatology/Aesthetics: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities, Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas, Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi, Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas, Bowe, Kaposi sarcoma. Warty leucoplasty and ulcers debridement, Seborrheic keratosis, Mixoid cyst, Papillary varix, Acne treatment. Vascular Surgery: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities.

The Diolase™ 10S system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The Diolase™ 10S laser consists of two permanently connected components: Console, and Delivery System. The Console has a Control Panel (Touch Screen and Keypad) in front and a detachable base attached at the bottom rear of the Console. The Diolase™10S Laser Delivery System consists of the following: Fiber Optic Assembly and Surgical Handpiece.

The provided document is a 510(k) summary for the Diolase™ 10S laser system, seeking expanded indications for use. This document asserts substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria and results for the device itself.

Therefore, most of the requested information cannot be extracted from this document as it does not contain a study evaluating the device against specific acceptance criteria. Specifically, the document states: "Non-clinical performance data is not presented. Comparison with previously cleared devices is included in the body of the 510(k) submission for the demonstration of safety and effectiveness of the new indication of this device and to support substantial equivalence to legally marketed devices."

However, I can provide what can be inferred or directly stated from the document regarding the basis of its clearance for expanded indications.

Acceptance Criteria and Device Performance (Inferred/Stated Basis for Substantial Equivalence)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No specific performance study with a test set was conducted for this 510(k) submission. The submission relies on substantial equivalence to predicate devices that already have these indications, implying that any required testing was done on the predicate devices.

2. 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. No specific performance study with a test set was conducted.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No specific performance study with a test set was conducted.

4. 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 laser surgical instrument, not an AI/imaging device requiring MRMC studies.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a laser surgical instrument, not an algorithm. The 510(k) is for the physical device itself and its expanded indications for use.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No specific performance study with a ground truth was conducted for this submission. The "ground truth" for the expanded indications effectively comes from the regulatory clearance of the predicate devices based on their established safety and effectiveness.

7. The sample size for the training set

• Not applicable. No new training set or performance study was involved in this 510(k) submission.

8. How the ground truth for the training set was established

• Not applicable. No new training set or performance study was involved in this 510(k) submission.

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The ezlase™ diode system emits energy in the near- infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

The ezlase™ diode laser system, was cleared for dental soft tissue indications under KQ61898 and K083069. The system uses a Gallium Aluminum Arsenide (GaAlA) and/or an Indium Gallium Arsenide Phosphorus (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiberoptic cable to a handpiece that emits the energy to the targeted site. A visible light is emitted at the same time to visually identify the treatment location.

This document, K083595, describes a Special 510(k) Summary Statement for the Biolase Technology, Inc. ezlase™ diode laser system. The purpose of this 510(k) is to expand the current indications for use to include therapeutic indications.

Acceptance Criteria and Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative performance metric table as might be found for a diagnostic device. Instead, the justification for the expanded indications relies on substantial equivalence to already cleared predicate devices. The "performance" being demonstrated is that the ezlase™ meets the same therapeutic claims as these predicates.

Study Details:

This submission is a Special 510(k) for expanding indications based on substantial equivalence to existing cleared devices, not a clinical trial demonstrating novel performance against new, specific acceptance criteria through a newly conducted study. Therefore, many of the typical elements of a standalone clinical study are not applicable or explicitly provided in this document.

1. Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a new clinical test set. The basis for approval is substantial equivalence to previously cleared devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no new clinical test set described in this document. The "ground truth" for the predicate devices would have been established during their respective clearances, but details are not provided here.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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 laser system for therapeutic use, not an AI-assisted diagnostic tool involving human readers.

5. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. The "performance" assessment is based on the functional and claims equivalence to predicate devices, not a standalone algorithm's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the purpose of this 510(k) submission, the "ground truth" or evidence of effectiveness for the therapeutic indications is derived from the prior FDA clearance of the predicate devices with identical (or very similar) Indications for Use. This implicitly relies on the data and "ground truth" (likely clinical study outcomes or established physiological effects) that supported the original clearances of those predicate devices.

7. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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808 nm, 940 nm, 980nm Wavelengths
The Quanta System Diode Medical Lasers Family, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The Quanta System Diode Medical Lasers Family are indicated for use in the performance of specific surgical applications in gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics. ophthalmology, pulmonology, and thoracic surgery as follows:

Gastroenterology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy.

Neurosurgery (Medical 30, 6)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex.

General Surgery (Medical 30)
Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy; cholecystectomy; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma; thyroidectomy; thoracotomy; cavernous hemangioma.

Genitourinary (Urology) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia

Thoracic Surgery (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectomy; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection: hemostasis; thoracotomy.

Gvnecology (GYN) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum.

Pulmonology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.

Ophthalmology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endo-nasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty.

Orthopedics (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: Open: Dissect and coagulate.

Otolaryngology (ENT) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy; Laryngotracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy.

In addition, at 808 nm and 940 nm wavelengths, the Quanta system Diode Medical Laser Family is intended for the following use:

Urology (Medical 30):
Lesions of external genitalia; Circumcision; Condyloma; Bladder tumors; Bladder neck incisions; Vaporization of the prostate

Neurosurgery (Medical 30):
Percutaneous Disc Decompression; Discectomy; Hemostasis in conjunction with meningiomas

Arthroscopy (Medical 30): Chondromalacia; Synovectomy; Menisectomy

Pulmonary Surgery (Medical 30);
Endoscopic pulmonary applications; Tracheal bronchial lesions; Benign and malignant pulmonary or stricture

Cardiac Surgery (Medical 30): Coagulation and haemostasis of cardiac tissue

Dermatology/Aesthetics (Medical 30):
Photocoagulation of vascular & dermatological lesions of the face and extremities; Photocoagulation of telangiectasia, veinulectasias of the legs and face; Treatment of reticular veins and branch varicosities; Pyogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas; Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Chery angioma, Hemangioma, Port wine stains, angiokeratoma, and benign ipidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.; Dermatology surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment; Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne treatment; Hair removal of unwanted hair from skin type I-V;

Plastic Surgery (Medical 30):
Cut, coagulation & vaporization; Blepharoplasy

Vascular Surgery (Medical 30):
Endoluminal or endovenus laser surgery for saphenous incompetent veins.

Dental applications (Medical 30, 6, 4):
Frenectomy; Frenotomy; Biopsy; Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening

808 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Quanta System Diode Medical Laser Family are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

940 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85cc and for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non contact open surgery (with or without a handpiece).

It (Medical 30) is also intended for use in the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.

It (Medical 30) is also indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.

The Quanta System Diode Laser Family (Medical 30, 6, 4) is also indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:Excisional and incisional biopsiesExposure of unerupted teeth; Fibroma removal; Frenectomy; Frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingivoplasty; Gingival incision and excision; Haemostasis and coagulation; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomy; Pulpotomy as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty

The Quanta System Diode Laser Family (Medical 30, 6, 4) is also indicated for Laser Periodontal procedures, including: Laser soft tissue curettage; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Model 30 is indicated for Surgical, Dermatological, Dental and Endovascular applications.

Model 6 and Model 4 are indicated for Dental and Surgical applications.

The 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 external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the Diode Laser Family incorporates several safety features, including a remote interlock and a key switch.

This 510(k) summary for the Quanta System Diode Medical Laser Family (Models 4, 6, and 30) does NOT contain information about specific acceptance criteria or an explicit study proving performance against such criteria in the way typically expected for an AI/ML device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means that instead of presenting novel performance data, the manufacturer asserts that their device is as safe and effective as pre-existing, legally marketed devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text because these types of studies are not typically required for a substantial equivalence claim when the technology is well-established.

However, I can extract the general acceptance criteria inferred from the substantial equivalence claim and what is stated about meeting this criterion.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size Used for the Test Set and Data Provenance:

• Not Applicable / Not Provided. This submission relies on substantial equivalence to predicate devices, not on a new clinical performance study with a dedicated test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable / Not Provided. Ground truth establishment for a test set is not detailed because a new performance study is not presented. The basis for safety and effectiveness is the established history and regulatory clearances of the predicate devices.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided. No new test set data is presented.

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:

• No. This is not an AI/ML device, and no MRMC study or comparative effectiveness study involving human readers is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a laser surgical instrument, not an algorithm, so standalone performance in the context of AI is irrelevant. The performance of the laser itself would be assessed through engineering and other non-clinical testing, which are not detailed in this 510(k) summary but would have been part of the full submission.

7. The Type of Ground Truth Used:

• Substantial Equivalence to Predicate Devices: The "ground truth" for acceptance is the established safety and effectiveness of the identified predicate devices in their respective clinical applications. The submission asserts that the new device performs equivalently to these legally marketed devices.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. This is not an AI/ML device, so there is no concept of a training set in this context.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable / Not Provided. As above, no training set for an AI/ML model.

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