(15 days)
Not Found
Not Found
No
The description focuses on the laser technology and its operational parameters, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly lists various therapeutic surgical procedures, such as "therapeutic plastic," "therapeutic dermatological," and "aesthetic surgical procedures," among others like tumor removal and lithotripsy, which are all therapeutic interventions.
No
Explanation: The device description and intended use clearly state that it is a surgical laser system designed for procedures like incision, excision, ablation, coagulation, hemostasis, and vaporization. These are therapeutic, not diagnostic, actions.
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:
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's body (incision, excision, ablation, coagulation, etc.) across various anatomical sites. This is a therapeutic device used for treatment.
- Device Description: The device is a laser system designed to deliver energy for surgical purposes. This is consistent with a surgical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used for direct surgical intervention.
N/A
Intended Use / Indications for Use
The OmniPulse™ Mini is designed for use in conjunction with Trimedyne's various arthroscopic handpieces and optical fiber delivery devices. As with the other cleared Trimedyne Ho:YAG laser systems, applications for this laser system include superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
. "
- General Surgery of Soft Tissues .
- . Genitourinary Surgery/Urology
- . Otorhinolanryngology (ENT) Surgery
- Gynecological Surgery .
- Lithotripsy and Percutaneous Urinary Lithotripsy ◆
- Orthopedic Surgery .
- Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression/Discectomy
- Therapeutic Dermatological, Therapeutic Plastic, and Aesthetic Surgical . Procedures
- Gastroenterological/Gastrointestinal Surgery .
When used in conjunction with the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices, this laser system may be used for interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The OmniPulse" Mini Laser System Model 2120 is a pulsed solid-state Holmium:YAG laser system is designed to deliver infrared laser energy with a wavelength of 2.1 um and a nominal pulse width of 350 microseconds. Menu driven control options allow the operator to select the pulse energy, the pulse repetition rate or frequency, and one of three exposure modes (continuous, single burst or repetitive burst).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Tissues, Genitourinary, Otorhinolanryngology (ENT), Gynecological, Cervical, Lumbar, Thoracic Disc, Dermatological, Plastic, Aesthetic, Gastroenterological/Gastrointestinal, urinary, urethral, kidney, joints, knee.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
No nonclinical data was submitted in this Premarket Notification.
Description of the test set, sample size, data source, and annotation protocol
No clinical data was submitted in this Premarket Notification.
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.
The predicate devices for the OmniPulse™ Mini are the Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems. (K number not provided)
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
Ko43012 11/2
1/2
NOV 17 2004 OmniPulse™ Mini, Model 2120
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
949-951-3800 |
|---------------------------|---------------------------------------------------------------------------|
| Contact Person: | Glenn Yeik
President and COO |
| Summary Date: | 27 September 2004 |
11. Device Name
| Proprietary: | OmniPulse™ Mini, Model 2120 |
|---|---|
| Common: | Holmium:Yttrium Aluminum Garnet (Ho:YAG) Laser System |
| Classification: | Various Medical Lasers |
lll. Predicate Device
The predicate devices for the OmniPulse™ Mini are the Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems.
IV. Device Description
The OmniPulse" Mini Laser System Model 2120 is a pulsed solid-state Holmium:YAG laser system is designed to deliver infrared laser energy with a wavelength of 2.1 um and a nominal pulse width of 350 microseconds. Menu driven control options allow the operator to select the pulse energy, the pulse repetition rate or frequency, and one of three exposure modes (continuous, single burst or repetitive burst).
V. Intended Use
The OmniPulse™ Mini is designed for use in conjunction with Trimedyne's various arthroscopic handpieces and optical fiber delivery devices. As with the other cleared Trimedyne Ho:YAG laser systems, applications for this laser system include superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
. "
- General Surgery of Soft Tissues .
- . Genitourinary Surgery/Urology
- . Otorhinolanryngology (ENT) Surgery
- Gynecological Surgery .
- Lithotripsy and Percutaneous Urinary Lithotripsy ◆
1
- Orthopedic Surgery .
- Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression/Discectomy
2/2
- Therapeutic Dermatological, Therapeutic Plastic, and Aesthetic Surgical . Procedures
- Gastroenterological/Gastrointestinal Surgery .
When used in conjunction with the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices, this laser system may be used for interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications.
VI. Technological Characteristics
The laser is driven by a flash lamp and emits one pulse of laser radiation each time the flash lamp is fired. The laser pulse refers to the pulse waveform - each laser pulse consists of large numbers of overlapping spikes that have a duration of about one microsecond. These spikes compose the pulse waveform with nominal pulse duration of 350 microseconds. Laser pulses are generated at the frequency chosen by the operator. Pulse frequencies of 7, 10, 15 and 20 Hz are available.
In general, the operator may request pulse energies from 0.2 to 2.0 Joules. The range of pulse energies available depends on the pulse frequency. Not all energies are available at all pulse frequencies. The number of pulses emitted from the laser system can be controlled by the operator through the choice of one of three exposure modes.
VII. Nonclinical Data
No nonclinical data was submitted in this Premarket Notification.
VIII. Clinical Data
No clinical data was submitted in this Premarket Notification.
. IX. Conclusions
All of the characteristics of the OmniPulse Mini fall with the previously cleared ranges for the predicate devices. Therefore, the OmniPulse Mini Model 2120 is substantially equivalent to the Trimedyne OmniPulse™-MAX and OmniPulse Jr. ™ laser systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three horizontal lines forming the body and stylized curves representing the head and tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 2004
Trimedyne, Inc. c/o Ms. Elizabeth Drew Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050-4169
Re: K043012 K043012
Trade/Device Name: Trimedyne OnmiPulse™ Mini 20 Watt Ho:YAG Laser System, Model 2120 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: October 20, 2004 Received: November 2, 2004
Dear Ms. Drew:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conime.co proc to may 20, 2017) 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). and Cosmeter for (100) and the device, subject to the general controls provisions of the Act. The r ou may, dicrerere, mains 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 rr your device 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 r reade o a . made a determination that your device complies with other requirements of the Act that I Dr Has Inters and regulations administered by other Federal agencies. You must or unly 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 - Ms. Elizabeth Drew
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo solvet notification. The FDA finding of substantial equivalence of your device to a legally premaince 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), please contact the Office of Compliance at (240) 276-0115. 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 Mass facturers, 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,
Miriam C. Provost
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
Koy3012 510(k) Number:
Device Name: Trimedyne OmniPulseTM Mini 20 watt Ho:YAG Laser System, Model 2120
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 】. therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including:
- scars
- tattoo removal
- vascular lesions (including port wine stains,
- hemangioma, telangiectasia [facial, leg], and rosacea) ー
- corns
- 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. -
Miriam C. Provost
eneral. Restorative. and Neurological Devices
510(k) Number_
Page 1 of 4
5
Indications - continued
Gastroenterological/Gastrointestinal Surgery, including: 2.
- cholecystectomy + lysis of adhesions �
- appendectomy
- biopsy
- pylorostenotomy ﻬ
- 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
Genitourinary Surgery/Urology, including: 4.
-
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)
6
Indications - continued
- Gynecological Surgery during open and endoscopic procedures, including: 5. .
- 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 ﺑ
-
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
-
- Qtorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including:
- endosinus surgery •
- functional endoscopic sinus surgery ◆
- turbinate procedures (e.g., turbinectomy) �
- dacryocystorhinostomy (DCR) +
- ethmoidectomy -�
-
polypectomy
-
maxillary antrostomy �
-
frontal sinusotomy 4
-
sphenoidotomy
7
Indications - continued
- Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: 9. Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following:
- Percutaneous Lumbar Disc Decompression/Discectomy in soft, cartilaginous, and bony tissue, including: .
- foraminoplasty -
- Percutaneous Cervical Disc Decompression/Discectomy 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/Discectomy in soft tissue, in patients with:
- uncomplicated ruptured or herniated discs -
- thoracic and intercostal intractable pain -
- paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myelography
- 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/Discectomy in soft, cartilaginous, and bony tissue, including: .
Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstitial applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.