(337 days)
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.
The Monteris AutoLITT™ System is a combination of three major components: Monteris AutoLITT™ Laser Probe, Monteris AutoLITT™ Probe Driver, Monteris AutoLITT™ VizApp Software
The provided text describes a 510(k) premarket notification for the Monteris Medical AutoLITT™ System. However, it does not contain specific information regarding acceptance criteria, a detailed study proving the device meets said criteria, or most of the requested fields such as sample sizes, ground truth establishment, or expert qualifications for a test set.
The document primarily focuses on establishing substantial equivalence to predicate devices, providing a device description, intended use, and general summary of supporting data.
Here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the format of a table. It only generally states: "Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (Explicitly Stated) |
|---|---|
| Not explicitly stated in quantitative terms. | "Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling." |
| Compliance with ISO 10993 (Biocompatibility) | "Biocompatibility data demonstrates that the Laser Probe is in compliance with ISO 10993." |
| Ability to coagulate brain tissue under MRI guidance | "Animal testing demonstrated that the System, can be used to coagulate brain tissue under MRI guidance." |
Study Details
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "Bench testing" and "Animal testing" but does not specify sample sizes or data provenance for a test set in the context of performance metrics for the software components (e.g., thermographic analysis).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not provided. The document states, "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." This suggests human interpretation is critical, but details about ground truth establishment are missing.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not provided. The document does not mention an MRMC study. The device provides "planning assistance" and "real-time thermographic analysis," implying human-in-the-loop use, but no comparative effectiveness study details are given.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated in terms of specific performance metrics. The device provides "thermographic analysis" and "planning assistance," but its intended use is "when interpreted by a trained physician," suggesting it's not designed for standalone diagnostic or therapeutic decisions.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly provided. For biocompatibility, lab testing based on ISO standards is the ground truth. For animal testing, the observation of "coagulated brain tissue" under MRI guidance serves as the ground truth. For the software components (planning assistance, thermographic analysis), the method for establishing ground truth for performance evaluation is not detailed.
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The sample size for the training set:
- Not provided. The document does not discuss a training set, which is typical for AI/ML device submissions, but this document predates widespread AI/ML regulatory guidance.
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How the ground truth for the training set was established:
- Not provided.
In summary, the provided 510(k) submission is for a device involving image guidance and thermal therapy, but it precedes the era of detailed performance studies for AI/ML components as requested in your prompt. The "Summary of Supporting Data" mainly covers biocompatibility, general bench testing, and animal testing to broadly assure safety and effectiveness, rather than specific performance metrics for the software-driven analysis components.
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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 DriveWinnipeg, ManitobaCANADA R3T 6C2Tel: 204-272-2220Fax: 204-272-2219www.monteris.com |
| Correspondent ContactInformation: | Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416 |
| Device Common Name: | Magnetic Resonance Image Guided LaserThermal Therapy System |
| Device Classification &Code: | Class IIGEX |
| Device ClassificationName: | 21CFR878.4810Laser surgical instrument for use in generaland plastic surgery and in dermatology |
| Device ProprietaryName: | Monteris Medical AutoLITT™ System |
Predicate Device Information:
| Predicate Devices: | Visualase ThermalTherapy System | GreenLight HPS SeriesSurgical Laser System& Accessories | NaviVision |
|---|---|---|---|
| Predicate DeviceManufacturers: | BioTex | LaserScope | BrainLab |
| Predicate DeviceCommon Name: | Magnetic ResonanceImage Guided LaserThermal TherapySystem | Laser Probe & Laser | Stereotaxic instrument |
| PremarketNotification # | K071328 | K062719 | K062086 |
| Predicate DeviceClassification: | 21CFR 878.4810 | 21CFR 878.4810 | 21 CFR 882.4560 |
| Predicate DeviceClassification &Code: | Class II, GEX | Class II, GEX | Class II, HAW |
b. Date Summary Preparcd
28 April 2009
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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.
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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.
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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
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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 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 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.