(195 days)
The laser systems are intended for use in multispecialty applications, including dermatology and plastic surgery, discectorny, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology.
The fiber optic delivery systems are intended for use with any holmjum laser (with a compatible connector) for its cleared applications.
The OmniPulse and OmniPulse-MAX Holmium Lasers are medical grade, Class IV, pulsed, solidstate, Ho:YAG laser systems designed to deliver pulsed infrared laser energy with a wavelength of 2.1 micron and 350 microsecond pulse width. Menu-driven control options allow the user to select pulse repetition rate, output energy, and maximum lasing period.
The Proposed Laser System is a medical grade, Class IV, pulsed, solid-state Ho:YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 micron. The pulsewidth may either be 350 microseconds or variable up to a maximum of 350 microseconds, depending on the configuration of the laser. Menu-driven control options allow the user to select pulse repetition rate, output energy, pulsewidth (if variable), and lasing duration.
The proposed delivery systems are single use, contact or near-contact fiber optic energy delivery devices consisting of a flexible bundle of buffered optical fibers contained in a stainless steel shaft: the proximal end of the laser fiber optic incorporates either a custom or and SMA connector. These devices are shipping sterile/non-pyrogenic; from time-to-time they may be offered in nonsterile form in which case the user will be provided with sterilization instructions.
The provided text describes information about a medical device (laser system and fiber optic delivery devices) but it does not contain the specific details required to answer your request about acceptance criteria and a study proving those criteria are met, especially in the context of device performance metrics like sensitivity, specificity, accuracy, or a multi-reader, multi-case study.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: The document primarily focuses on the technical specifications of the laser system (e.g., wavelength, power output, pulse width) and the delivery systems. It states that "The proposed delivery systems were subjected to a series of tests; these tests included sterilization, efficiency, performance and mechanical studies" and that they "exhibit acceptable performance and mechanical properties." However, it does not quantify specific acceptance criteria (e.g., "device must achieve X accuracy" or "Y sensitivity") nor does it report numerical device performance against such criteria.
- Sample Size and Data Provenance: Since no clinical or performance study with quantified results is presented, there's no sample size for a test set or information on data provenance.
- Experts and Adjudication: These details are only relevant if a clinical study involving expert interpretation of data was conducted, which is not the case here.
- MRMC Study: The document explicitly states, "No clinical tests were submitted in this 510(k)." Therefore, an MRMC study was not performed.
- Standalone Performance: While the "efficiency, performance and mechanical studies" might imply some form of standalone testing, the results are not detailed, and no specific performance metrics are provided.
- Type of Ground Truth: Without a clinical study, there is no explicit ground truth generation discussed. The "acceptable performance and mechanical properties" are likely based on engineering and laboratory tests against predefined specifications.
- Training Set Sample Size and Ground Truth: This information would only be relevant for machine learning or AI-driven devices, which is not what this submission describes.
In summary, the provided text is a 510(k) summary for a medical device (laser system and fiber optic delivery devices) that establishes substantial equivalence based on technological characteristics and non-clinical bench testing, not on clinical performance studies involving a test set, human readers, or patient outcomes.
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JAN 16 1997
K9626632
Summary of 510(k) Safety and Effectiveness Information
Trimedyne® Holmium:YAG Laser Systems and Fiber Optic Delivery Devices for Multispecialty Applications
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 57001Irvine, CA 92619-7001714/559-5300714/559-1330 |
|---|---|---|
| Contact Person: | Susan H. GambleDirector, Regulatory Affairs & Quality Assurance | |
| Summary Date: | July 3, 1996 |
ll. Device Name
| Proprietary: | OmniPulse™ Holmium Laser (Model 1210) |
|---|---|
| OmniPulse-MAX™ Holmium Laser (Model 1210-VHP) | |
| Not yet determined for Proposed Holmium Laser | |
| Not yet determined for Proposed Delivery Systems | |
| Common: | Holmium: Yttrium Aluminum Garnet (Ho:YAG) laser system |
| Laser Fiber | |
| Classification: | Laser-powered instrument |
| Accessory to Laser-powered instrument |
III. Predicate Device
The predicate devices for the laser systems are the Tissue Technologies, Inc. TRU-PULSE™ Pulsed CO2 Surgical Laser System, Coherent® UltraPulse® 5000C Aesthetic Laser System, and the Trimedyne Optilase® 1000-100 Nd:YAG Laser.
The predicate devices for the fiber optic delivery systems are the Omni™ Switchtip System and the Tapertip™ Multiuse Holmium Arthroscopy Handpieces, both of which are currently marketed by Trimedyne.
IV. Device Description
The OmniPulse and OmniPulse-MAX Holmium Lasers are medical grade, Class IV, pulsed, solidstate, Ho:YAG laser systems designed to deliver pulsed infrared laser energy with a wavelength of 2.1 micron and 350 microsecond pulse width. Menu-driven control options allow the user to select pulse repetition rate, output energy, and maximum lasing period.
The Proposed Laser System is a medical grade, Class IV, pulsed, solid-state Ho:YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 micron. The pulsewidth may either be 350 microseconds or variable up to a maximum of 350 microseconds, depending on the configuration of the laser. Menu-driven control options allow the user to select pulse repetition rate, output energy, pulsewidth (if variable), and lasing duration.
TRIMEDYNE, INC. 2801 BARRANCA ROAD, IRVINE, CA 92714 F IUSERSILEIFDA1510KIDERMPLUS HO1510K_SUB DOC 3-Jul-904 559-5300, FAX 714 559-1330 800 733-5273
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The proposed delivery systems are single use, contact or near-contact fiber optic energy delivery devices consisting of a flexible bundle of buffered optical fibers contained in a stainless steel shaft: the proximal end of the laser fiber optic incorporates either a custom or and SMA connector. These devices are shipping sterile/non-pyrogenic; from time-to-time they may be offered in nonsterile form in which case the user will be provided with sterilization instructions.
V. Intended Use
The laser systems are intended for use in multispecialty applications, including dermatology and plastic surgery, discectorny, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology.
The fiber optic delivery systems are intended for use with any holmjum laser (with a compatible connector) for its cleared applications.
VI. Technological Characteristics
The Trimedyne laser systems included in this submission are Holmium: YAG lasers which emit light at a wavelength of 2.1 microns (near infrared) and a maximum pulse width of 350 microseconds.
The OmniPulse has the capability of attaining a maximum output of 40 watts of power (maximum 40 watts/3500 mJ and maximum frequency mode of 25 pps).
The OmniPulse-MAX has the capability of attaining a maximum output 80 watts of power (maximum 80 watts/3500 mJ and maximum frequency mode of 60 pps). This laser can operate in either single- or double-pulse mode and has an integrated power meter to enable the user to easily measure the output power
The Proposed Laser System has the capability of attaining a maximum output of 100 watts of power (maximum 100 watts/4200 mJ and maximum frequency mode of 100 pps).
The proposed delivery devices differ from their predicate devices in that they are designed with multiple fibers, as opposed to a single-fiber configuration .
VII. Nonclinical Tests
The proposed delivery systems were subjected to a series of tests; these tests included sterilization, efficiency, performance and mechanical studies. Biocompatibility data exhibiting the acceptability of materials used in the fiber optic delivery systems was also submitted.
VIII. Clinical Tests
No clinical tests were submitted in this 510(k).
IX. Conclusions Drawn from Testing
The proposed delivery systems are biocompatible and exhibit acceptable performance and mechanical properties when used according to their labeling.
§ 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.