(69 days)
Not Found
No
The summary describes a simple temperature sensor probe and its testing, with no mention of AI, ML, or complex data processing beyond basic temperature monitoring.
No.
The device is intended for monitoring tissue temperature near the ablation site, which is a diagnostic or monitoring function, not a therapeutic intervention.
No
The device is intended for "monitoring tissue temperature near the ablation site," which is a measurement function rather than a diagnostic one. It provides data for monitoring but does not interpret that data to diagnose a condition or disease.
No
The device description explicitly lists physical components (Needle, Handle, Lead cable and connector) and the performance studies include testing on these physical components (biocompatibility, electrical safety, packaging integrity).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "monitoring tissue temperature near the ablation site." This is a measurement taken in vivo (within the living body), not in vitro (outside the body, typically on biological samples like blood, urine, or tissue).
- Device Description: The components (needle, handle, lead cable, connector) are consistent with a device used for direct tissue insertion and temperature measurement within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Temperature Sensor Probe is a medical device used for in vivo monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.
Product codes (comma separated list FDA assigned to the subject device)
NEY
Device Description
Temperature Sensor Probe is an optional accessory designed for use with compatible Varian ablation systems. Principal components of the temperature sensor probe include:
- Needle
- . Handle
- . Lead cable and connector
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tissue near ablation site
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)
1. Non-clinical Testing:
Temperature Sensor Probe underwent non-clinical testing to demonstrate the design and performance of the device meets the established design criteria. The subject device successfully completed functional intended use support and reliability testing. To support substantial equivalence in performance with the predicate device, the subject and predicate devices underwent side-by-side testing for performance i.e accuracy of temperature monitoring. The test results established that the subject device is substantially equivalent to the predicate device in performance and is as safe and effective as the predicate device.
2. Non-clinical Animal Testing:
Animal testing completed with Temperature Sensor Probe to validate usability and performance of the device on porcine soft tissue models complies with the United States Food and Drug Administration Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58.
3. Clinical Data/ Testing:
No clinical data/ testing is included within the submission.
4. Sterilization:
Temperature Sensor Probe is sterilized utilizing 100% ethylene oxide gas to ensure a minimum sterility assurance level of 106 in accordance with ISO 11135, ISO 10993-7, ISO 11138-1, ISO 11737-1 and ISO 11737-2.
5. Software, Cybersecurity, and Interoperability
Temperature Sensor Probe does not contain software. Software verification related to functionality of Temperature Sensor Probe with IntelliBlate Microwave Ablation System complies with IEC 62304 – "Medical device software – software life cycle processes "and FDA Guidance "Content of Premarket Submissions for Device Software Functions."
6. Temperature Monitoring:
Temperature monitoring testing completed in accordance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" demonstrates that the temperature sensing under simulated conditions meets design specification and performance requirements.
7. Biocompatibility:
Biocompatibility testing of the Temperature Sensor Probe in accordance with ISO 10993-1 demonstrates that the patient-contacting components are biocompatible.
8. Electrical Safety and Electromagnetic Compatibility:
Temperature Sensor Probe complies with applicable IEC 60601 series of standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-6, and IEC 60601-1-2.
9. Packaging Integrity and Shelf Life:
Packaging integrity and shelf-life testing complies with ISO 11607-1 and ISO 11607-2.
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.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 29, 2024
Varian Medical Systems, Inc. Lynn Allman Sr. Director Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304
Re: K240784
Trade/Device Name: Temperature Sensor Probe (ABL-18TP20) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: March 20, 2024 Received: March 21, 2024
Dear Lynn Allman:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm____identifies ___combination product submissions. 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long H. Chen -- S Digitally signed by Long H. Chen -S
Date: 2024.05.29 Date: 2024.05.29 13:06:28 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality
2
Enclosure
3
Indications for Use
510(k) Number (if known) K240784
Device Name Temperature Sensor Probe
Indications for Use (Describe)
The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image contains three blue circles arranged horizontally. The circles are evenly spaced and appear to be the same size. The background is plain white, which makes the blue circles stand out.
Image /page/4/Picture/2 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is in large, bold, black font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font size.
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
PREMARKET NOTIFICATION
510(k) Summary
Temperature Sensor Probe
The following information is provided as required by 21 CFR 807.92
Submitter's Information: l.
| Name and Address: | Varian Medical Systems Inc.
9825 Spectrum Drive, Building 2 Austin, TX 78717 |
|-------------------|---------------------------------------------------------------------------------|
| Contact Name: | Lynn Allman, Senior Director Regulatory Affairs |
| E-mail: | submissions.support@varian.com |
| Date Prepared: | May 29, 2024 |
Device Information: ll.
| Proprietary Name: | Temperature Sensor Probe |
|---|---|
| Common/ Usual Name: | System, Ablation, Microwave and Accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Panel: | General & Plastic Surgery |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code | NEY |
III. Predicate Device 510(k):
Emprint™ Ablation System with Thermosphere Technology: K200796
Predicate Device within K200796 identified to claim Substantial Equivalence: Ablation Remote Temperature Probe (RTP20).
IV. Subject Device Description:
Temperature Sensor Probe is an optional accessory designed for use with compatible Varian ablation systems. Principal components of the temperature sensor probe include:
- Needle ●
- . Handle
- . Lead cable and connector
5
Image /page/5/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K240784'. The characters are presented in a clear, sans-serif font, making them easily readable. The arrangement suggests a code, serial number, or identifier.
Image /page/5/Picture/1 description: The image shows three blue circles in a row. The circles are all the same size and color. The circles are evenly spaced apart from each other. The background is white.
Image /page/5/Picture/2 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white.
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
V. Intended Use/ Indications for Use Statement:
The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.
Substantial Equivalence Discussion: VI.
The following table compares the subject device to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence.
6
Image /page/6/Picture/0 description: The image shows three blue circles in a row. The circles are evenly spaced and of the same size. The background is white.
Image /page/6/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K240784'. The characters are rendered in a simple, sans-serif font, and they are all aligned horizontally. The image appears to be a close-up view of the characters, with a plain white background.
Image /page/6/Picture/2 description: The image shows the word "varian" in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The text is all black and the background is white.
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
Table 1: Summary of the comparison of technological characteristics between the predicate and subject devices
| Features/
Characteristics | Subject Device
Temperature Sensor Probe | Predicate Device (K200796)
Ablation Remote Temperature Probe | Differences |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
representative image | Image: Temperature Sensor Probe | Image: Ablation Remote Temperature Probe | |
| Intended Use/
Indications for Use | The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site. | The RTP20 remote temperature probe is for use with the Emprint Ablation System with Thermosphere Technology to monitor tissue temperature at or near the ablation site.
The remote temperature probe can be used with the Emprint Ablation Generator with Thermosphere Technology to automatically disable microwave | Both the subject and the predicate devices have the same intended use of monitoring tissue temperature in ablation procedures . The predicate's additional design feature mentioned in the indications of use statement has no impact on the overall intended use/ indications of use of the device. |
7
Image /page/7/Picture/0 description: The image shows the alphanumeric string "K240784" in a simple, sans-serif font. The characters are black against a white background. The string appears to be a code or identifier.
Image /page/7/Picture/1 description: The image shows three blue circles in a horizontal row. The circles are evenly spaced and appear to be the same size. The background is white, which makes the blue circles stand out. There are no other objects or elements in the image.
varian
A Siemens Healthineers Company
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
| Features/
| Characteristics | Subject Device | Predicate Device (K200796) | Differences |
|---|---|---|---|
| Temperature Sensor Probe | Ablation Remote Temperature Probe | ||
| energy when it measures a | |||
| temperature of 45° C (default | |||
| setting). Use of the RTP20 in an | |||
| ablation procedure is optional. | |||
| Compatible Systems | |||
| and their intended | |||
| use/ indications of | |||
| use | IntelliBlate Microwave Ablation | ||
| System under FDA review (K240480) | |||
| The IntelliBlate Microwave Ablation | |||
| System is intended for coagulation | |||
| (ablation) of soft tissue in | |||
| laparoscopic, intraoperative, and | |||
| percutaneous ablation procedures, | |||
| including partial or complete | |||
| ablation of non-resectable liver | |||
| tumors. | Emprint™ Ablation System with | ||
| Thermosphere Technology | |||
| The Emprint™ Ablation System is | |||
| intended for use in percutaneous, | |||
| laparoscopic, endoscopic, and | |||
| intraoperative coagulation (ablation) | |||
| of soft tissue, including partial or | |||
| complete ablation of nonresectable | |||
| liver tumors. | Same |
8
Image /page/8/Picture/1 description: The image shows three blue circles in a row. The circles are evenly spaced and of the same size. The background is white.
varian
A Siemens Healthineers Company
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
| Features/
Characteristics | Subject Device
Temperature Sensor Probe | Predicate Device (K200796)
Ablation Remote Temperature Probe | Differences |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures. | The Emprint™ Ablation System is not intended for use in cardiac procedures. | |
| Operating Principle | Measures the tissue temperature in real time via a thermocouple within the tip of the probe. | Measures the tissue temperature in real time via a thermocouple within the tip of the probe. | Same |
| Product code, FDA
regulation and device
class | NEY, 21 CFR 878.4400 and Class II | NEY, 21 CFR 878.4400 and Class II | Same |
| Manufacturer | Varian Medical Systems | Covidien | Different manufacturer |
| Prescription (Rx only) | Yes | Yes | Same |
| Optional Accessory | Yes | Yes | Same |
| Measuring Site | Tissue near ablation site | At or near ablation site | Similar |
| Temperature Range
(Temperature
Accuracy) | $10°C-60°C (±2°C)$ | $37°C-60°C (±1.5°C)$ | Similar performance
specifications.
Representation of the
reported temperature on
the User Interface of the
compatible ablation |
9
Image /page/9/Picture/0 description: The image shows the alphanumeric string "K240784" in a simple, sans-serif font. The characters are uniformly sized and spaced, creating a clear and legible sequence. The string appears to be a code or identifier, possibly a serial number or product key.
Image /page/9/Picture/1 description: The image shows three blue circles in a horizontal row. The circles are evenly spaced and of the same size. The background is white.
varian
A Siemens Healthineers Company
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
| Features/
Characteristics | Subject Device
Temperature Sensor Probe | Predicate Device (K200796)
Ablation Remote Temperature Probe | Differences |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | | | system used with the
subject device are rounded
to nearest integer to
enhance usability. |
| Thermocouple-based
temperature sensor
at the tip of the
needle | Yes | Yes | Same |
| Signal Processing and
Display on the
compatible ablation
system | Real time, continuous display of
tissue temperature | Real time, continuous display of
tissue temperature | Same |
| Tissue Contact per
ISO 10993-1 | External communicating device, in
contact with tissue/bone/dentin and
limited contact duration (A) (