(294 days)
Not Found
Not Found
No
The device description focuses on the laser technology and user-selectable parameters, with no mention of AI or ML. The performance studies rely on animal and human clinical data from published literature, not on training or testing of an AI/ML model.
Yes
The device is used for surgical procedures such as incision, excision, resection, and ablation to treat ruptured or herniated discs, which are therapeutic interventions.
No
The device is described as a Holmium Laser System used for surgical procedures like incision, excision, and ablation. Its intended uses are therapeutic (decompression/discectomy procedures), not for diagnosing conditions.
No
The device description explicitly states it is a "pulsed, solid state Holmium:YAG laser system," which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed directly on a patient's body (incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of disc tissue). IVDs are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health.
- Device Description: The device is a laser system designed to deliver energy for surgical procedures. This is consistent with a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
The device is a surgical laser system used for treating disc herniations, which falls under the category of a therapeutic medical device.
N/A
Intended Use / Indications for Use
The Trimedyne Holmium:YAG Laser System is intended for incision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications. The applications addressed in this premarket notification include percutaneous cervical, lumbar, and thoracic disc decompression/discectomy.
Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
- 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)
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 enerqy with a wavelength of 2.1 µm 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
Not Found
Anatomical Site
cervical, lumbar, thoracic discs
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)
Animal data and human clinical data from published literature were included in this premarket notification to demonstrate that the Trimedyne Holmium Laser Systems are safe and effective for the specified indications.
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.
Standard surgical instruments, such as knives and forceps.
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
SEP 23 2002
K 013974
510(k) Summary of Safety and Effectiveness Information Trimedyne Holmium Laser Systems
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 |
|---------------------------|--------------------------------------------------------------------------------------------------|
| Contact person: | Laurie Cartwright
Manager, Regulatory Affairs
Or
Glenn Yeik
Executive Vice President |
| Summary Date: | June 24, 2002 |
ll. Device Name
Proprietary: Trimedyne Holmium Laser System, including:
- Trimedyne OmniPulse™ Holmium Laser System (Model 1210) �
- Trimedyne OmniPulse MAX™ Holmium Laser System (Model 1210-� VHP)
- Trimedyne OmniPulse Jr. ™ Holmium Laser System (Model 1230-30) �
- Model 1500-A Holmium Laser System �
- Common: Holmium: Yttrium Aluminum Garnet (Holmium:YAG) Laser
Classification: Laser-Powered Instrument
III. Predicate Device
Standard surgical instruments, such as knives and forceps.
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 enerqy with a wavelength of 2.1 µm 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 intended for incision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications. The applications addressed in this premarket notification include percutaneous cervical. lumbar, and thoracic disc decompression/discectomy.
1
VI. Technological Characteristics
The laser system is a Holmium:YAG laser that emits light at a wavelength of 2.1 um (near infrared) and a pulsewidth of 350 microseconds. The laser has the capability of attaining a maximum output of 100 watts of power.
VII. Animal Data and Human Clinical Data
Animal data and human clinical data from published literature were included in this premarket notification to demonstrate that the Trimedyne Holmium Laser Systems are safe and effective for the specified indications.
VIII. Conclusion
The Trimedyne Holmium:YAG Laser System is substantially equivalent to the predicate device described in this premarket notification. Furthermore, the non-clinical and clinical data submitted demonstrated the safety and effectiveness of the device for the proposed applications. Therefore, upon clearance of this submission, the Trimedyne Holmium:YAG Laser System will be marketed for the proposed expanded indications.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central emblem. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2002
Ms. Laurie Cartwright Manager, Regulatory Affairs Trimedyne, Inc. 15091 Bake Parkway Irvine, CA 92618
Re: K013974
Trade/Device Name: Trimedyne Holmium Laser Systems: 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: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 24, 2002 Received: June 25, 2002
Dear Ms. Cartwright:
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
Page 2 - Ms. Laurie Cartwright
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.
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" (21CFR 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 vours.
Sincerely yours,
Mark N Millkerson
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
- This indications page includes only the indications statement affected by this premarket Note: notification submission.
510(k) Number (if known): K013974
Device Name:
Trimedyne Holmium Laser Systems, 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:
Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
- 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)
(PLEASE DO NOT WRITE BELOW THIS LINE –
CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K013974
Prescription Use _
OR Over-the-Counter Use _