(162 days)
Not Found
Not Found
No
The summary describes a physical fiberoptic device for energy delivery and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device description and intended use focus on surgical procedures like incision, excision, and coagulation, which are interventional actions rather than therapeutic in the sense of treating a disease or condition directly through therapeutic action. It is a tool for surgical procedures.
No
This device is described as an "energy delivery device" used for procedures like "incision, excision, resection, ablation, vaporization, coagulation and hemostasis." These are therapeutic or surgical actions, not diagnostic ones. There is no mention of it being used to gather information about a patient's condition.
No
The device description clearly states it is a "reusable fiberoptic energy delivery device" consisting of an "optical fiber" and potentially other physical components like a catheter, cannula, needle, handpiece, or handle. This indicates a physical 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 describes surgical procedures performed directly on the body (incision, excision, resection, ablation, etc.). IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description: The device is a fiberoptic energy delivery device used for surgical procedures. This is consistent with a surgical tool, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Resposable Holmium Bare Fibers are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended for use with any pulsed Holmium: YAG 2.1 micrometer laser (with compatible connector) for incision, excision, resection, ablation, vaporization, coagulation and hemostasis.
Product codes
GEX
Device Description
The Resposable Holmium Bare Fibers are reusable fiberoptic energy delivery devices. These devices consist of an optical fiber which may or may not be contained in a catheter tube, cannula, needle, handpiece or handle. The fibers range from 50 to 1000 microns core diameter and will be offered with various distal tip configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
No nonclinical test data were submitted in this Premarket Notification.
No clinical tests were submitted in this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Trimedyne Disposable Holmium Bare Fibers
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
Image /page/0/Picture/0 description: The image shows the word "Trimedyne" in a bold, sans-serif font. Below the word is a graphic of three stacked arrowheads pointing downwards. Above the word "Trimedyne" is the alphanumeric string "K973172".
EB - 3 1998
Summary of 510(k) Safety and Effectiveness Information
Resposable Holmium Bare Fibers
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.
| 1. | Submitter Information: | Trimedyne, Inc.
P.O. Box 57001
Irvine, CA 92619-7001
714/559-5300
714/559-1330 |
|-----|------------------------|--------------------------------------------------------------------------------------------|
| | Contact Person: | Susan H. Gamble
Vice President, Regulatory Affairs & Quality Assurance |
| | Summary Date: | December 22, 1997 |
| 11. | Device Name | |
| | Proprietary: | Resposable Holmium Bare Fibers |
| | Common: | Laser Fiber |
| | Classification: | Accessories to Laser-Powered Instruments |
111. Predicate Device
The predicate devices are the Trimedyne Disposable Holmium Bare Fibers.
IV. Device Description
The Resposable Holmium Bare Fibers are reusable fiberoptic energy delivery devices. These devices consist of an optical fiber which may or may not be contained in a catheter tube, cannula, needle, handpiece or handle. The fibers range from 50 to 1000 microns core diameter and will be offered with various distal tip configurations.
V. Intended Use
These devices are intended for use with any pulsed Holmium: YAG 2.1 micrometer laser (with compatible connector) for incision, excision, resection, ablation, vaporization, coagulation and hemostasis.
Technological Characteristics VI.
The devices differ from their predicate devices due only to the incorporation of minor materials and configuration changes which allow for steam and EtO sterilization/reuse.
VII. Nonclinical Tests
No nonclinical test data were submitted in this Premarket Notification.
VIII. Clinical Tests
No clinical tests were submitted in this Premarket Notification.
Conclusions Drawn from Testing IX.
Not applicable.
TRIMEDYNE, INC. 2801 BARRANCA ROAD P.O. Box 57001, Irvine, CA 92619-7001 714 559-5300, FAX 714 559-1330, 800 733-5273
Image /page/0/Picture/21 description: The image contains the number "01" in a bold, sans-serif font. The number is positioned slightly to the right of the center of the image. The background is plain white.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan H. Gamble Vice President, Regulatory Affairs & Quality Assurance Trimedyne. Incorporated P.O. Box 57001 Irvine, California 92619-7001
FEB - 3 1998
K973172 Re:
Trade Name: Resposable Holmium Bare Fibers Regulatory Class: II Product Code: GEX Dated: December 22, 1997 Received: December 23, 1997 .....
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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
2
Page 2 - Ms. Gamble
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K973172
Device Name:
(
Resposable Holmium Bare Fibers
.
Indications for Use:
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (QDE)
A. Oleks
| Prescription Use | X |
|---|---|
| ------------------ | ----------------------------------------- |
OR
Over-the-Counter Use _