(160 days)
Not Found
No
The summary describes a laser fiber and laser system for surgical procedures, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for medical procedures such as incision, excision, and ablation for the treatment of benign prostatic hyperplasia (BPH) and other urological conditions, indicating a therapeutic purpose.
No
The device is described as a laser fiber and laser system used for treatment, including incision, excision, and ablation. It is used for therapeutic purposes, not for diagnosing conditions.
No
The device description explicitly details hardware components: a fiber optic cable, a tip for energy delivery, a fiber optic connector, and laser energy sources (Optilase systems) with aiming beams and adjustable power output. This is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures performed directly on the patient's prostate (incision, excision, resection, vaporization, ablation, coagulation). This is a therapeutic device used for treatment, not for examining specimens from the body to provide diagnostic information.
- Device Description: The device description details a laser energy delivery system and laser sources used for surgical intervention. This aligns with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is clearly used for direct surgical treatment.
N/A
Intended Use / Indications for Use
The Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of I no Right , trying incision, excision, resection, vaporization, validation, coagulation, Surglour asso moraumy of benign prostatic hyperplasia (BPH) and other urological conditions.
Product codes
Not Found
Device Description
The Right Angle Laser Fiber is a fiber optic Nd:YAG energy delivery system consisting of: r ne right kingth of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector.
The Optilase laser systems are continuous-wave Nd:YAG energy sources equipped with an aiming beam, adjustable power output, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A prospective, controlled and well-matched study was undertaken to compare visual laser ablation of the prostate (VLAP) to transurethral resection of the prostate (TURP).
The clinical data show that the Trimedyne Right Angle Laser Fibers and Optilase Nd:YAG Laser Systems are safe and effective for treatment of Benign Prostatic Hyperplasia (BPH).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
954j97
MAR 11 1990
Summary of 510(k) Safety and Effectiveness Information Trimedyne® Right Angle Laser Fibers and Optilase® Nd:YAG Laser System Models 1000, 4000, and 1000-100 (PL100)
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 92719-7001
714/559-5300
714/559-1330 (facsimile) |
|----|------------------------|--------------------------------------------------------------------------------------------------------|
| | Contact Person: | Susan H. Gamble
Director, Regulatory Affairs & Quality Assurance |
Summary Date: October 2, 1995
II. Device Name
Right Angle Laser Fibers:
| Proprietary: | Not yet selected |
|---|---|
| Common: | Laser fiber |
Classification: Accessory to Laser-powered Instrument (unclassified)
Optilase Lasers:
| Proprietary: |
|---|
| • Optilase® Model 1000 Nd:YAG Laser System |
| • Optilase® Model 4000 Nd:YAG Laser System |
| • Optilase® PL100 Model 1000-100 Nd:YAG Laser System |
| Common: |
| Neodymium Yttrium Aluminum Garnet (Nd:YAG) laser system |
Classification: Laser-powered Instrument
III. Predicate Device
The predicate devices for the intended use are various configurations of the Trimedyne Right Angle Laser Fiber cleared under 510(k) number K944204 and the Trimedyne Optilase Nd:YAG Laser Systems cleared under 510(k) numbers K922497 and K932883.
TRIMEDYNE, INC 2801 BARRANCA ROAD P.O. BOX 57001, IRVINE (CA 92619-7001 714 559-5300, FAX 714 559-1330 800 - 33-5273
1
IV. Device Description
The Right Angle Laser Fiber is a fiber optic Nd:YAG energy delivery system consisting of: r ne right kingth of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector.
The Optilase laser systems are continuous-wave Nd:YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector.
V. Intended Use
The Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of I no Right , trying incision, excision, resection, vaporization, ablation, coagulation, Surglour asso moraumy of benign prostatic hyperplasia (BPH) and other urological conditions.
Viewing scopes, which can be either flexible or rigid, may be used for visualization during laser procedures.
Technological Characteristics VI.
There are no technological characteristics differences between the devices cleared under this 510(k) and the predicate devices with regard to the intended use.
VII. Nonclinical Tests
No nonclinical tests were submitted in this Premarket Notification.
VIII. Clinical Tests
A prospective, controlled and well-matched study was undertaken to compare visual laser ablation of the prostate (VLAP) to transurethral resection of the prostate (TURP).
IX. Conclusions Drawn from Testing
The clinical data show that the Trimedyne Right Angle Laser Fibers and Optilase Nd:YAG Laser Systems are safe and effective for treatment of Benign Prostatic Hyperplasia (BPH).