K071328 · Biotex, Inc. · GEX · Aug 31, 2007 · General, Plastic Surgery
Device Facts
Record ID
K071328
Device Name
VISUALASE THERMAL THERAPY SYSTEM
Applicant
Biotex, Inc.
Product Code
GEX · General, Plastic Surgery
Decision Date
Aug 31, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4810
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device 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 Visualase analysis.
Device Story
System integrates laser energy source, cooled laser applicator, coolant pump, and workstation with MRI analysis software into a portable cart. Used for MR-guided laser thermal therapy. Applicator inserted into target tissue; connected to laser and pump for ablation. During procedure, system processes real/imaginary image data from MRI gradient recalled echo sequences. Software uses proton resonance-frequency (PRF) shift analysis and image subtraction to calculate complex phase angle changes, relating them to relative tissue temperature changes. Physician monitors thermal data on workstation; output provides passive monitoring to assist in assessment of thermal therapy. Does not automate clinical decisions; physician interprets data to guide ablation. Benefits include real-time thermal visualization during minimally invasive procedures.
Clinical Evidence
Bench testing only. No clinical data provided. Performance and technical data for individual components remain unchanged from original submissions.
Technological Characteristics
System includes laser energy source (800-1064nm), cooled laser applicator, coolant pump, and workstation. MRI-compatible components allow use within MRI magnet. Software performs image processing of MRI sequences. Connectivity involves integration of components into a portable cart.
Indications for Use
Indicated for patients requiring soft tissue necrosis or coagulation via interstitial irradiation/thermal therapy in various surgical specialties (cardiovascular thoracic, dermatology, ENT, gastroenterology, general, gynecology, head/neck, neurosurgery, plastic, orthopedics, pulmonology, radiology, urology). Contraindicated for heart and vessels in the pericardial sac.
Regulatory Classification
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.
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K071328
# 510(k) Summary
In accordance with the Safe Medical Devices Act of 1990 and in compliance with 21CFR 807, the following serves as the 510(k) Summary information upon which the substantial equivalence determination is based.
# Contact Information
| Submitter: | BioTex, Inc.<br>8058 El Rio St.<br>Houston, TX 77054 |
|-----------------|----------------------------------------------------------------------------------------------------------------|
| | AUG 31 2007 |
| Phone: | 713-741-0111 |
| Contact Person: | Matthew Fox |
| Date Prepared: | 5/11/2007 |
| Device Names | |
| Trade Name/s: | Visualase® Thermal Therapy System. |
| Common Name: | Magnetic Resonance Image Guided Laser Thermal Therapy System |
| Classification: | Picture Archiving and Communications System,<br>Powered Surgical Laser Instrument/Applicator,<br>Infusion Pump |
| Product Code: | LLZ (Image Processing System),<br>GEX (Surgical Laser, Laser Applicator),<br>FRN (Infusion Pump) |
| Reg. Class: | Class II |
| Reg. Number: | 21CFR892.2050 (LLZ)<br>21CFR878.4810 (GEX)<br>21CFR880.5725 (FRN) |
## Predicate Devices
Visualase ENVISION MRI Analysis Software by BioTex, Inc. K063505 PhoTex15 Surgical Diode Laser System by BioTex, Inc. K060304 Visualase Cooled Laser Applicator System by BioTex, Inc. K053087 K-pump by Kolster Methods, Inc. K991203
## Description of Device
The Visualase Thermal Therapy System comprises four devices: a laser energy source, a cooled laser applicator, a pump for circulating coolant through the applicator, and a computer workstation with magnetic resonance imaging (MRI) analysis software for determination and visualization of relative changes in tissue temperature during therapy.
The four components have themselves been previously cleared for marketing via 510(k) notifications with the new device bringing these four components into a single portable cart for use in MR-guided laser thermal therapy procedures. In practice, all of the devices are used according to their approved indications for use. That is, the laser applicator is introduced into the tissue to be destroyed and connected to both the laser energy source and the cooling pump. The
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cooling pump and laser are operated as normal to deliver energy and cause tissue ablation. Since the laser applicator is MR-compatible, the laser ablation procedure may be carried out inside of an MRI magnet. In this case, appropriate MR imaging can be performed during the treatment, and the MR analysis software can be used to evaluate the thermal changes in the target tissue. For example, the Visualase system can process real and imaginary image data from gradient recalled echo sequences using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. Thus, the laser thermal therapy procedure can be performed under MR image guidance.
It is important to note that the functions and uses of the constituent components of the Visualase Thermal Therapy System remain unchanged from their currently approved labeling and indications statements. In particular, the operation of the ENVISION analysis software provides passive monitoring of the laser treatment, and the operation of the laser, applicator, and pump are independent of the MR imaging. The combination of these devices into a single system, however, provides a convenience to the user who will perform laser thermal therapy treatments under MR image guidance. Thus, the indications for use statement for the combined system now describes that the system may be used for laser thermal therapy treatments under magnetic resonance imaging guidance.
# Indications for Use
The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
When interpreted by a trained physician, this device 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 Visualase analysis.
# Comparison to Predicate Devices
The Visualase Thermal Therapy System indications for use are the same as those of the individual components except that, when used together as a system, the laser thermal treatment may be performed under MRI guidance.
#### Non-clinical Performance Tests
Performance and technical data for each of the components of the Visualase Thermal Therapy System are unchanged from those listed in the original submissions and are therefore not included here.
## Conclusion
The Visualase Thermal Therapy System is substantially equivalent to predicate devices. The combination of the devices into a system does not affect the specifications, functions, or performance of any of the individual devices.
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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 stylized caduceus symbol, which features three parallel lines that curve and resemble a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2007
Bio Tex, Inc. 8058 El Rio Street % Mr. Matthew Fox Engineering Manager Houston, TX 77054
Re: K071328
Trade/Device Name: Visualase® Thermal Therapy 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 28, 2007 Received: August 29, 2007
Dear Mr. Fox:
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.
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
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Page 2 – Mr. Matthew Fox
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), 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 Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milburn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indication for Use
K071328 510(k) Number (if known):
Device Name:
Visualase Thermal Therapy System
Indication For Use:
The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
When interpreted by a trained physician, this device 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 Visualase analysis.
Prescription Use ____ X And/Or (21 CFR Part 801 Subpart D)
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) =
Mark A. Millerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
વડિ
KO 7 1328
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
