(337 days)
Not Found
No
The summary describes a system for laser thermal therapy with MRI guidance and thermographic analysis, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for use to necrotize or coagulate soft tissue, which are direct therapeutic actions.
No
The device is primarily intended for planning, monitoring, and performing thermal therapies, specifically necrotizing or coagulating soft tissue using lasers, rather than diagnosing conditions. While it provides "information that may be useful in the determination or assessment of thermal therapy," this information supports the interventional procedure rather than establishing a diagnosis.
No
The device description explicitly states that the system is a combination of three major components, including a Laser Probe and a Probe Driver, which are hardware components.
Based on the provided information, the Monteris Medical AutoLITT System 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.
- AutoLITT System Function: The AutoLITT System is a therapeutic device used for necrotizing or coagulating soft tissue through interstitial irradiation or thermal therapy. It is used directly on the patient's tissue during a surgical procedure, guided by MRI.
- Lack of Sample Analysis: The system does not analyze samples taken from the body. Its function is to deliver energy to tissue for therapeutic purposes.
- Intended Use: The intended use clearly states its purpose is for "necrotize or coagulate soft tissue" and "planning and monitoring thermal therapies under MRI visualization." This is a therapeutic and procedural guidance function, not a diagnostic one based on analyzing biological samples.
Therefore, the AutoLITT System falls under the category of a therapeutic device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Monteris Medical AutoLITT System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
The Monteris Medical AutoLITT System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) AutoLITT Laser Delivery Probe. It also provides real-time thermographic analysis of selected MRI images.
When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the AutoLITT analysis.
Product codes
GEX
Device Description
The Monteris AutoLITT™ System is a combination of three major components:
Monteris AutoLITT™ Laser Probe
Monteris AutoLITT™ Probe Driver
Monteris AutoLITT™ VizApp Software
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Soft tissue (specifically brain tissue as implied by animal testing for neurosurgery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Discipline of neurosurgery
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)
Biocompatibility data demonstrates that the Laser Probe is in compliance with ISO 10993.
Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling.
Animal testing demonstrated that the System, can be used to coagulate brain tissue under MRI guidance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
MONTERIS
MEDICAL
1081509
AutoLITT™ System Combined Premarket Notification (K0815(19)
Section 5: 510(k) Summary
| a. Device Information: | |
|---|---|
| Category | Comments |
| Sponsor: | Monteris Medical, Inc. |
| 100 – 78 Innovation Drive | |
| Winnipeg, Manitoba | |
| CANADA R3T 6C2 | |
| Tel: 204-272-2220 | |
| Fax: 204-272-2219 | |
| www.monteris.com | |
| Correspondent Contact | |
| Information: | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| Device Common Name: | Magnetic Resonance Image Guided Laser |
| Thermal Therapy System | |
| Device Classification & | |
| Code: | Class II |
| GEX | |
| Device Classification | |
| Name: | 21CFR878.4810 |
| Laser surgical instrument for use in general | |
| and plastic surgery and in dermatology | |
| Device Proprietary | |
| Name: | Monteris Medical AutoLITT™ System |
Predicate Device Information:
| Predicate Devices: | Visualase Thermal
Therapy System | GreenLight HPS Series
Surgical Laser System
& Accessories | NaviVision |
|-----------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------|------------------------|
| Predicate Device
Manufacturers: | BioTex | LaserScope | BrainLab |
| Predicate Device
Common Name: | Magnetic Resonance
Image Guided Laser
Thermal Therapy
System | Laser Probe & Laser | Stereotaxic instrument |
| Premarket
Notification # | K071328 | K062719 | K062086 |
| Predicate Device
Classification: | 21CFR 878.4810 | 21CFR 878.4810 | 21 CFR 882.4560 |
| Predicate Device
Classification &
Code: | Class II, GEX | Class II, GEX | Class II, HAW |
b. Date Summary Preparcd
28 April 2009
1
c. Description of Device
The Monteris AutoLITT™ System is a combination of three major components: Monteris AutoLITT™ Laser Probe
Monteris AutoLITT™ Probe Driver Monteris AutoLITT™ VizApp Software
d. Intended Use
The Monteris Medical AutoLITT System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
The Monteris Medical AutoLITT System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRIbased trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) AutoLITT Laser Delivery Probe. It also provides real-time thermographic analysis of selected MRI images.
When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the AutoLITT analysis.
e. Comparison to Predicate Device
The Monteris Medical AutoLITT™ System is substantially equivalent to the above described predicate devices in intended use, technology, design and physician use.
f. Summary of Supporting Data
Biocompatibility data demonstrates that the Laser Probe is in compliance with ISO 10993.
Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling.
Animal testing demonstrated that the System, can be used to coagulate brain tissue under MRI guidance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
MAY - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Monteris Medical % Coombs Medical Device Consulting, Inc. Mr. Craig Coombs President 1193 Sherman Street Alameda, California 94501
Re: K081509
Trade/Device Name: Monteris Mcdical AutoLITT™ 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: March 6, 2009
•
Dear Mr. Coombs:
Received: March 9, 2009
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as sct 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. Craig Coombs
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the · Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Monteris Medical AutoLITT™ System
Indications For Use:
The Monteris Medical AutoLITT System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
The Monteris Medical AutoLITT System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) AutoLITT Laser Delivery Probe. It also provides real-time thermographic analysis of selected MRI images.
When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the AutoLITT analysis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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 | K081509 |
|---|---|
| --------------- | --------- |
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