(77 days)
Not Found
No
The device description focuses on laser energy delivery and does not mention any computational or algorithmic components indicative of AI/ML. The performance study is a clinical comparison, not an evaluation of an AI/ML algorithm.
Yes
The device is described as being used for surgical procedures like incision, excision, and ablation, and specifically for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH), which are all therapeutic interventions.
No
The device is described for surgical uses such as incision, excision, resection, vaporization, ablation, coagulation, and hemostasis, which are therapeutic actions, not diagnostic.
No
The device description explicitly details hardware components: "Optilase laser systems are continuous wave Nd: YAG energy sources" and "Right Angle Laser Fibers are fiber optic Nd:YAG energy delivery systems consisting of: a three meter length of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector." This indicates a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed on the patient (incision, excision, resection, vaporization, ablation, coagulation, hemostasis, prostatectomy). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The device is a laser system and fiber optic delivery system designed to deliver energy to tissue, not to analyze biological samples.
- Anatomical Site: The anatomical site mentioned (prostate) is where the surgical procedure is performed, not where a sample is taken for analysis.
- Performance Studies: The performance study described is a clinical study comparing different laser power levels for a surgical procedure (VLAP), not a study evaluating the performance of a diagnostic test on biological samples.
Therefore, the device is a surgical laser system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Right Angle Laser Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH).
Product codes
Not Found
Device Description
The Optilase laser systems are continuous wave Nd: YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector.
The Right Angle Laser Fibers are fiber optic Nd:YAG energy delivery systems consisting of : a three meter length of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A limited clinical study was undertaken to provide information related to Visual Laser Ablation of the Prostate (VLAP) with 60 watts of laser power. These data were compared to data obtained from an earlier study in which VLAP at 40 watts of laser power was compared to TURP.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
APR 21 1997
Image /page/0/Picture/1 description: The image shows the word "Trimedyne" in a bold, sans-serif font. Below the word is a logo consisting of three stacked, stylized arrow shapes. The arrows are pointing to the right and are arranged in a descending order of size from top to bottom.
Summary of 510(k) Safety and Effectiveness Information
Trimedyne® Right Angle Laser Fibers and Optilase® Lasers for the Treatment of BPH at 60 watts of Laser Power
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| I. | Submitter Information: | Trimedyne, Inc.
P.O. Box 57001
Irvine, CA 92619-7001
714/559-5300
714/559-1330 |
|----|------------------------|--------------------------------------------------------------------------------------------|
| | Contact Person: | Susan H. Gamble
Director, Regulatory Affairs & Quality Assurance |
| | Summary Date: | February 3, 1997 |
ll. Device Name
Optilase® Model 1000 Nd:YAG Laser System Proprietary:
Optilase® Model 4000 Nd:YAG Laser System
Optilase® PL100 Model 1000-100 Nd:YAG Laser System
UroGold™ Right Angle Laser Fibers
UroMax™ Right Angle Laser Fibers
Additional proprietary names may be used for other Right Angle Laser Fiber configurations.
Common: Laser-powered Instrument
Laser Fiber
Classification: Nd:YAG Laser System
Accessory to Laser-powered Instrument - Not Classified
III. Predicate Device
The predicate devices are those cleared under 510(k) K954597.
IV. Device Description
The Optilase laser systems are continuous wave Nd: YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector.
The Right Anale Laser Fibers are fiber optic Nd:YAG energy delivery systems consisting of : a three meter length of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector.
TRIMEDYNE, INC. 2801 BARRANCA ROAD, IRVINE, CA 92714 714 559-5300, FAX 714 559-1330 800 733-5273
1
V. Intended Use
The Right Angle Laser Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH).
VI. Technological Characteristics
There are no technological differences between these devices and those cleared under K954597.
VII. Nonclinical Tests
No nonclinical tests were submitted in this Premarket Notification.
VIII. Clinical Tests
A limited clinical study was undertaken to provide information related to Visual Laser Ablation of the Prostate (VLAP) with 60 watts of laser power. These data were compared to data obtained from an earlier study in which VLAP at 40 watts of laser power was compared to TURP.
IX. Conclusions Drawn from Testing
The results of the comparative data submitted in this Premarket Notification demonstrate that VLAP, whether it be performed at 40 watt treatment parameters, is a viable alternative to TURP.