(90 days)
Not Found
No
The description focuses on the mechanical and optical components of a laser fiber delivery system and does not mention any computational or algorithmic features indicative of AI/ML.
Yes
The device is described as an "energy delivery device" used for "incision, excision, ablation, vaporization, and coagulation," which are therapeutic procedures. It also mentions "tissue affect studies" in its performance summary.
No
The device is described as an energy delivery device for superficial and interstitial incision, excision, ablation, vaporization, and coagulation, all of which are treatment-oriented actions rather than diagnostic ones.
No
The device description clearly details a physical, disposable fiberoptic energy delivery device with a needle assembly, luer connector, and vent sheath. It is a hardware component used with a handpiece and fiber assembly.
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 on the body (incision, excision, ablation, vaporization, and coagulation). IVDs are used to examine specimens from the body (like blood, urine, or tissue samples) to diagnose or monitor conditions.
- Device Description: The description details a laser fiber delivery device used for surgical intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or diagnostic tests.
The device is clearly intended for therapeutic surgical use, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Side Firing Needle with Vent Sheath is intended for superficial or interstitial incision. excision, resection, ablation, vaporization, coagulation and hemostasis and may be used with any cleared Holmium laser that has a compatible connector.
Superficial and interstitial incision, excision, ablation, vaporization, and coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Side Firing Needle with Vent Sheath is a single use, disposable fiberoptic energy delivery device for use with the Omni™ Multiuse Handpiece and Fiber Assembly. The device consists of a near-contact laser fiber enclosed in a stainless steel pointed needle assembly. The device includes a luer connector assembly that connects the irrigation channel to an irrigation fluid source via an external line, as well as a vent sheath with proximal exhaust ports that terminates just proximal to the beam exit point. The Side Firing Needle with Vent Sheath is attached to the Omni Multiuse Handpiece through a quick-connect mechanism.
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)
The Side Firing Needle with Vent Sheath was subjected to a series of verification and validation tests, including performance and tissue affect studies.
No clinical tests were submitted in this Premarket Notification.
The Side Firing Needle with Vent Sheath is biocompatible, performs as intended, and has acceptable mechanical properties when used in accordance with its labeling.
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
Side Firing Needle with Vent Sheath
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.
15091 Bake Parkway
Irvine, CA 92618
949-559-5300 |
|----|------------------------|---------------------------------------------------------------------------|
| | Contact Person: | Glenn Yeik
Executive Vice President |
August 8, 2002 Summary Date:
ll. Device Name
| Proprietary: | To be determined |
|---|---|
| Common: | Laser Fiber |
| Classification: | Accessory to Laser-Powered Instrument |
III. Predicate Device
The predicate devices for the Side Firing Needle with Vent Sheath are:
- Trimedyne Side Firing Switchable Tip with Suction/Irrigation cleared under K992230; .
- SLT Diffuser™ Fiber cleared under K010041; and .
- . Índigo Diffuser-Tip™ Fiberoptic cleared under K990851.
IV. Device Description
The Side Firing Needle with Vent Sheath is a single use, disposable fiberoptic energy delivery device for use with the Omni™ Multiuse Handpiece and Fiber Assembly. The device consists of a near-contact laser fiber enclosed in a stainless steel pointed needle assembly. The device includes a luer connector assembly that connects the irrigation channel to an irrigation fluid source via an external line, as well as a vent sheath with proximal exhaust ports that terminates just proximal to the beam exit point. The Side Firing Needle with Vent Sheath is attached to the Omni Multiuse Handpiece through a quick-connect mechanism.
V. Intended Use
The Side Firing Needle with Vent Sheath is intended for superficial or interstitial incision. excision, resection, ablation, vaporization, coagulation and hemostasis and may be used with any cleared Holmium laser that has a compatible connector.
1
Technological Characteristics VI.
The Side Firing Needle with Vent Sheath differs from the Side Firing Switchable Tip with Suction/Irrigation in the addition of a pointed tip, a silver reflector to minimize energy emission in other than the main beam direction, and a vent sheath to provide an exhaust path for fluid and vapor.
VII. Nonclinical Data
The Side Firing Needle with Vent Sheath was subjected to a series of verification and validation tests, including performance and tissue affect studies.
VIII. Clinical Data
No clinical tests were submitted in this Premarket Notification.
IX. Conclusions Drawn From Testing
The Side Firing Needle with Vent Sheath is biocompatible, performs as intended, and has acceptable mechanical properties when used in accordance with its labeling.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Human Services USA. The logo is a circular emblem with the words "HUMAN SERVICES * USA" arranged around the top half of the circle. The bottom half of the circle contains the word "DEPARTMENT". In the center of the circle is a stylized image of three overlapping human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2002 NOV
Trimedyne, Inc. Glenn D. Yeik Executive Vice President 15091 Bake Parkway Irvine, California 92618
Re: K022655
Trade/Device Name: Trimedyne Side Firing Needle with Vent Sheath Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 8, 2002 Received: August 9, 2002
Dear Mr. Yeik:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act. or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Glenn D. Yeik
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
. . . . .
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications Page
Page 1 of 1
510(k) Number: 12022655
Device Name:
Trimedyne Side Firing Needle with Vent Sheath
Indications for Use:
Superficial and interstitial 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)
My Signature Of
(Division Sign Division of General, Restorative and Neurological Devices
L
510(k) Number K022455
Prescription Use _
OR
Over-the-Counter Use