(82 days)
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Not Found
No
The document describes a laser system with user-selectable parameters and does not mention any AI or ML capabilities.
Yes
The device's intended uses clearly describe various surgical procedures across multiple medical specialties for "superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization," which are all therapeutic interventions.
No
This device is designed for therapeutic purposes, such as superficial incision, excision, resection, ablation, and coagulation, across various surgical specialties. It is not described as being used to provide diagnostic information about a patient's condition.
No
The device description clearly states it is a "medical grade, Class IV, pulsed, solid state Holmium: YAG laser system," which is a hardware device. The intended use also describes surgical procedures performed with this laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a laser system used for surgical procedures (incision, excision, ablation, etc.) on various tissues within the body. It directly interacts with the patient's tissues during surgery.
- Lack of Specimen Analysis: There is no mention of analyzing samples or specimens taken from the patient. The device's function is to perform surgical actions.
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 indicated for superficial incision. excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in multispecialty applications.
When used in conjunction with the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices, these laser systems may be used for interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications.
Product codes
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 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No non-clinical data were submitted in this Premarket Notification.
No clinical tests were submitted in this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Trimedyne Holmium Laser System
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, with a registered trademark symbol to the right of the word. Above the word "Trimedyne" is the text "k04 1660 1/2" in a handwritten font. Below the word "Trimedyne" is a graphic of three arrows stacked on top of each other.
SEP - 8 2004
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.
| Submitter Information: | Trimedyne, Inc.
15091 Bake Parkway
Irvine, CA 92618
949-951-3800 |
|------------------------|---------------------------------------------------------------------------|
| Contact Person: | Glenn Yeik
President and COO |
| Summary Date: | 20 August 2004 |
11. Device Name
Proprietary: Trimedyne Holmium Laser System, including:
- OmniPulse™ Holmium Laser System (Model 1210) ●
- OmniPulse MAX™ Holmium Laser System (Model 1210-VHP) .
- OmniPulse Jr. TM Holmium Laser System (Model 1230-30) .
- Model 1500-A Holmium Laser System .
Holmium: Yttrium Aluminum Garnet (Holmium: YAG) Laser Common:
Classification: Laser-Powered Instrument
!!!. Predicate Device
Trimedyne Holmium Laser System
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 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.
V. Intended Use
The Trimedyne Holmium:YAG Laser System is indicated for superficial incision. excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in multispecialty applications.
When used in conjunction with the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices, these laser systems may be used for interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications.
1
2/2
Technological Characteristics VI.
The laser system is a Holmium:YAG laser that emits light at a wavelength of 2.1 µm (near infrared) and a pulsewidth of 350 microseconds. The laser has the capability of attaining a maximum output of 100 watts of power.
VII. Nonclinical Data
No non-clinical data were submitted in this Premarket Notification.
VIII. Clinical Data
No clinical tests were submitted in this Premarket Notification.
IX. Conclusion
The Trimedyne Holmium:YAG Laser System is substantially equivalent to the predicate device described in this Premarket Notification. Therefore, upon clearance of this submission, the Trimedyne Holmium: YAG Laser System will be marketed with the proposed modified/clarified indications.
2
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 image of a stylized eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
Trimedyne, Inc. c/o Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891
Re: K041660 Trade/Device Name: Trimedyne Holmium Laser System, including: OmniPulse™ Holmium Laser System (Model 1210) OmniPulse MAX™ Holmium Laser System (Model 1210-VHP) OmniPulse Jr.TM Holmium Laser System (Model 1230-30) Model 1500-A Holmium Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 23, 2004 Received: August 24, 2004
Dear Ms. Danielson:
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.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be act noce 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 or uny I 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally promated predicated with 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), please if you desire of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ectorers, 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,
Mark A. Milkman
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 for Use
K041660 510(k) Number:
Device Name: Trimedyne Holmium Laser System, including:
- OmniPulse™ Holmium Laser System, Model 1210 .
- OmniPulse MAX™ Holmium Laser System, Model 1210-VHP .
- OmniPulse Jr.™ Holmium Laser System, Model 1230-30 .
- Model 1500-A Holmium Laser System .
Indications for Use:
Superficial 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, in l . therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including:
- scars .
- tattoo removal ﮩ
- vascular lesions (including port wine stains, ◆ hemangioma, telangiectasia [facial, leg], and rosacea)
- COLIS
- papillomas
- basal cell carcinomas
- lesions of skin and subcutaneous tissue
- plantar warts
- periungual and subungual warts
- debridement of decubitus ulcer
- skin tag vaporization
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ice of Device Eyaluation (ODE) Concurrence of CDRH, C
Mark A. Milleson
Division of General, Restorative, and Neurological Devices
510/k) Nu
Page 1 of 4
5
Indications - continued
2. Gastroenterological/Gastrointestinal Surgery, including:
- cholecystectomy +
- lysis of adhesions �
- appendectomy +
- biopsy +
- pylorostenotomy +
- benign and malignant lesions ◆
- rectal polyps of sigmoid colon ◆
- gall bladder 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
- telangiectasias of the Osler-Weber-Rendu disease
3. General Surgery of soft tissue, including:
- skin incision +
- tissue dissection �
- excision of external tumors and lesions +
- complete or partial resection of internal organs +
- tumors and lesions .
- tissue ablation
- mastectomy
- hepatectomy
- pancreatectomy
- splenectomy
- thyroidectomy
- parathyroidectomy
- hemiorrhaphy
- tonsillectomy
- lymphadenectomy
- partial nephrectomy
- pilonidal cystectomy
- resection of lipoma
- pelvic adhesiolysis
- debridement of decubitus ulcer
- hemorrhoids
- pilodidal cyst removal and repair
- debridement of statis ulcer
- biopsy
4. Genitourinary Surgery/Urology, including:
-
superficial urinary bladder tumors
-
invasive bladder carcinoma
-
urethral strictures
-
lesions of the external genitalia
-
bladder
-
urethral and ureteral tumors
-
condylomas
-
urethral and penile hemangioma
-
bladder neck obstructions
-
holmium laser incision, excision, resection, ablation, hemostasis, vaporization, and enucleation in the treatment of benign prostatic hyperplasia (BPH)
N Millican
Restorative
6
Indications - continued
-
- Gynecological Surgery during open and endoscopic procedures, including:
- condyloma acuminata
Lithotripsy and Percutaneous Urinary Lithotripsy, including: 6.
- fragmentation of urinary calculi �
- fragmentation of urethral calculi
- fragmentation of kidney calculi
- treatment of distal impacted fragment of steinstrasse when guide wires cannot be passed
- Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, 7. including:
- knee meniscectomy .
- knee synovectomy ◆
- chondromalacia and tears
- loose body debridement +
- lateral retinacular release .
- debridement of the degenerative knee
- plica removal
- ligament and tendon release
- contouring and sculpting of articular surfaces
- debridement of inflamed synovial tissue .
- capsulectomy in the knee .
- chondroplasty in the knee
- chondromalacia ablation
-
- Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including:
- endosinus surgery �
- functional endoscopic sinus surgery +
- turbinate procedures (e.g., turbinectorny) .
- dacryocystorhinostomy (DCR)
- ethmoidectomy
- polypectomy
- . maxillary antrostomy
- frontal sinusotomy
- sphenoidotomy
Mark N. Wilkerson
510(k) Number
10(k) Number.
7
Indications - continued
- Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: ರು. Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following:
- Percutaneous Lumbar Disc Decompression/Discectorny in soft, cartilaginous, and bony tissue, including: .
- foraminoplasty -
- Percutaneous Cervical Disc Decompression/Discectorny in soft tissue, in patients with:
- uncomplicated ruptured or herniated discs -
- neck pain with radiation down the arm .
- symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep tendon reflexes
- MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms
- positive electromyography and/or nerve conduction studies -
- no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)
- Percutaneous Thoracic Disc Decompression/Discectorny in soft tissue, in patients with:
- uncomplicated ruptured or herniated discs ー
- thoracic and intercostal intractable pain -
- paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myclography -
- MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms
- no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)
- Percutaneous Lumbar Disc Decompression/Discectorny in soft, cartilaginous, and bony tissue, including: .
Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstital applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.
Mark N. Mulkerson
al. Fortorative. ological Devices
510(k) Number K041660