(88 days)
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Not Found
No
The device description and intended use focus on the physical properties and surgical applications of a laser system, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The device is described as a "medical grade" system intended for various surgical procedures, including incision, excision, and coagulation, all of which are considered therapeutic interventions.
No
The device description and intended use clearly state that it is a surgical laser system used for various procedures like incision, excision, and ablation. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states it is a "pulsed, solid state Holmium: YAG laser system," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Trimedyne Holmium Laser System clearly indicate it is a surgical laser system used for various procedures directly on the body (incision, excision, ablation, etc.) in multiple surgical specialties. It delivers energy to tissue for therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Trimedyne Holmium Laser System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Trimedyne Holmium:YAG Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications, including dermatology and plastic surgery, discectomy, gastroenterological/ gastrointestinal surgery, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology surgery.
Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/ Gastrointestinal Surgery, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), corns, papillomas, and basal cell carcinomas.
General Surgery of soft tissues, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablation.
Genitourinary Surgery, including: superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.
Gynecological Surgery during open and endoscopic procedures.
Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi.
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectorny, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, and debridement of the degenerative knee.
Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocystorhinostomy (DCR).
Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium: YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 um and up to 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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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)
Not Found
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.
Not Found
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
OCT 2 9 1999
510(k) Summary of Safety and Effectiveness Information
Trimedyne® Holmium Laser System
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 92619-7001 |
|----|------------------------|-------------------------------------------------------------------|
| | Contact person: | Susan H. Gamble
Vice President, Regulatory Affairs and Quality |
| | Summary Date: | July 29, 1999 |
II. Device Name
Trimedyne Holmium Laser System, including: Proprietary:
- Trimedyne OmniPulse™ Holmium Laser System (Model 1210) +
- Trimedyne OmniPulseTM-MAX Holmium Laser System (Model 1210-VHP) ◆
- Model 1500-A Holmium Laser System �
Holmium: Yttrium Aluminum Garnet (Holmium: YAG) Laser Common:
Classification: Laser-Powered Instrument
III. Predicate Device
The predicate devices are:
- Coherent VersaPulse Select Dual Wavelength Surgical Laser. 1.
- Trimedyne Optilase® Model 1000-100 Nd: YAG Laser System. 2.
- Nortech Autolith Lithotriptor Electro-Hydraulic System. 3.
IV. Device Description
The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium: YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 um and up to 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.
1
V. Intended Use
The Trimedyne Holmium:YAG Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications, including dermatology and plastic surgery, discectomy, gastroenterological/ gastrointestinal surgery, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology surgery.
VI. Technological Characteristics
The laser system is a Holmium: YAG laser which emits light at a wavelength of 2.1 um (near infrared) and a maximum pulsewidth of 350 microseconds. The laser has the capability of attaining a maximum output of 100 watts of power.
VII. Conclusions Drawn from Testing
The Trimedyne Holmium: YAG Laser System can be used for the proposed indications.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Ms. Susan H. Gamble Vice President, Regulatory Affairs and Quality Trimedyne, Inc. 2801 Barranca Road P.O. Box 57001 Irvine, California 92619
Re: K992574
Trade Name: Omni Pulse™ Holmium Laser System, Model 1210 Omni Pulse™ MAX Holmium Laser System, Model 1210-VHP Model 1500-A Holmium Laser System
Regulatory Class: II Product Code: GEX Dated: July 29, 1999 Received: August 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
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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 vours.
Munell H. Sager
Sur 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
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9925'74
Page 1 of 2 (revised)
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Trimedyne Holmium Laser System, including: |
| OmniPulse™ Holmium Laser System, Model 1210 | |
| OmniPulse™-MAX Holmium Laser System, Model 1210-VHP | |
| Model 1500-A Holmium Laser System | |
| Indications for Use: | Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/ Gastrointestinal Surgery, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease. |
| Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications: | |
| Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), corns, papillomas, and basal cell carcinomas. | |
| General Surgery of soft tissues, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablation. | |
| (Continued on page 2) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-the-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number ____________________________________________________________________________________________________
. .
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Indications - continued
Genitourinary Surgery, including: superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.
Gynecological Surgery during open and endoscopic procedures.
Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi.
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectorny, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, and debridement of the degenerative knee.
Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocystorhinostomy (DCR).
Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.