(10 days)
Trimedyne OmniTip™ Switchable Tips, Tapertip™ Holmium Arthroscopic Handpieces
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No
The document describes a mechanical and optical energy delivery device with suction/irrigation capabilities. There is no mention of AI, ML, image processing, or any software-driven analytical functions that would typically indicate the presence of AI/ML. The performance studies focus on mechanical, biological, and simulated clinical testing of the physical device.
Yes
The device is intended for medical procedures such as incision, excision, ablation, vaporization, and coagulation using a laser to treat tissues. These are therapeutic actions.
No
The device is described as an "energy delivery device" for "incision, excision, ablation, vaporization, and coagulation," which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components like a fiber optic energy delivery device, needle assembly, capillary tube, stainless steel shaft, handpiece, and luer connector assembly, indicating it is a hardware 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 states the device is for surgical procedures (incision, excision, ablation, vaporization, and coagulation) using a laser. This is a therapeutic and surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a fiber optic energy delivery device used for surgical intervention. It involves a laser fiber and suction/irrigation, all components of a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
IVD devices are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium: YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation.
Product codes
GEX, GCX, GBX
Device Description
The OmniTip Side Firing Switchable Tip with Suction/Irrigation is a fiber optic energy delivery device consisting of a near-contact laser fiber enclosed in a needle assembly of a capillary tube and an external stainless steel shaft. The device is attached to the Omni Multiuse Handpiece through a quick-connect mechanism. A luer connector assembly installed at the proximal end of the device connects the suction/irrigation channel to a pump via an external line.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The device was subjected to a series of tests, including mechanical, biological, and performance studies. The device was subjected to a simulated clinical testing using heart tissue. A physician's feedback is also used to validate the use of the device in a clinical setting.
Key Metrics
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Predicate Device(s)
Trimedyne OmniTip™ Switchable Tips, Tapertip™ Holmium Arthroscopic Handpieces
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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K992230 Attachment 4
510(k) Summary of Safety and Effectiveness Information
Trimedyne® OmniTip™ Side Firing Switchable Tips with Suction/Irrigation
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.
| Submitter Information: | Trimedyne, Inc.
P.O. Box 57001
Irvine, CA 92619-7001
(949) 559-5300
(949) 559-1330 |
|------------------------|------------------------------------------------------------------------------------------------|
| Contact person: | Susan H. Gamble
Vice President, Regulatory Affairs and Quality |
| Summary Date: | July 1, 1999 |
II. Device Name
OmniTip™ Side Firing Switchable Tip with Suction/Irrigation Proprietary:
Common: Laser Fiber
Classification: Accessories to Laser-Powered Instrument (unclassified)
Predicate Device III.
The predicate devices are the Trimedyne OmniTip™ Switchable Tips and Tapertip™ Holmium Arthroscopic Handpieces.
IV. Device Description
The OmniTip Side Firing Switchable Tip with Suction/Irrigation is a fiber optic energy delivery device consisting of a near-contact laser fiber enclosed in a needle assembly of a capillary tube and an external stainless steel shaft. The device is attached to the Omni Multiuse Handpiece through a quick-connect mechanism. A luer connector assembly installed at the proximal end of the device connects the suction/irrigation channel to a pump via an external line.
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V. Intended Use
This device is intended for use with any Holmium laser (with a compatible connector) for its cleared applications.
VI. Technological Characteristics
The device differs from the predicate devices due mainly only to the incorporation of suction/irrigation channel and minor configuration changes.
VII. Nonclinical Tests
The device was subjected to a series of tests, including mechanical, biological, and performance studies.
VIII. Clinical Tests
The device was subjected to a simulated clinical testing using heart tissue. A physician's feedback is also used to validate the use of the device in a clinical setting.
IX. Conclusions Drawn from Testing
The device is biocompatible, performs as intended, and has acceptable mechanical properties when used according to its labeling.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 12 1999
Ms. Susan H. Gamble Vice President, Regulatory Affairs and Quality Trimedyne, Inc. 2801 Barranca Road P.O. Box 57001 Irvine, California 92619
K992230 Re:
Trade Name: OmniTip™ Side Firing Switchable Tip with Suction/Irrigation Regulatory Class: II Product Code: GEX, GCX, and GBX Dated: July 1, 1999 Received: July 2, 1999
Dear Ms. Gamble:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Susan H. Gamble
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Indications for Use Statement
| 510(k) Number | K992230 |
|---|---|
| Device Name | OmniTip™ Side Firing Switchable Tip with Suction/Irrigation |
| Indications for Use | The OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium: YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | --------------------------------------------------- | ---- | ---------------------- | -------------------------------------------------- |
(Per 21 CFR 801.109)
Signature
Title of General Representative
| (Ax) Number | K992230 | Page 28 of 32 |
|---|---|---|
| ------------- | --------- | --------------- |