(69 days)
The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.
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
The provided text describes the regulatory clearance of a Temperature Sensor Probe (ABL-18TP20) for use with Varian ablation systems for monitoring tissue temperature. The submission focuses on demonstrating substantial equivalence to a predicate device, the Emprint™ Ablation System with Thermosphere Technology: K200796, specifically the Ablation Remote Temperature Probe (RTP20).
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Predicate Device K200796, RTP20) | Reported Device Performance (Subject Device: Temperature Sensor Probe) |
|---|---|---|
| Intended Use/Indications for Use | Monitoring tissue temperature at or near the ablation site. | Monitoring tissue temperature near the ablation site. |
| Operating Principle | Measures tissue temperature in real time via a thermocouple within the tip of the probe. | Measures tissue temperature in real time via a thermocouple within the tip of the probe. |
| Product code, FDA regulation, class | NEY, 21 CFR 878.4400, Class II | NEY, 21 CFR 878.4400, Class II |
| Prescription (Rx only) | Yes | Yes |
| Optional Accessory | Yes | Yes |
| Measuring Site | At or near ablation site | Tissue near ablation site |
| Temperature Range (Accuracy) | 37°C - 60°C (±1.5°C) | 10°C - 60°C (±2°C) |
| Thermocouple-based sensor at tip | Yes | Yes |
| Signal Processing & Display | Real-time, continuous display of tissue temperature. | Real-time, continuous display of tissue temperature. |
| Tissue Contact per ISO 10993-1 | External communicating device, in contact with tissue/bone/dentin and limited contact duration (A) (<24 hours). | External communicating device, in contact with tissue/bone/dentin and limited contact duration (A) (<24 hours). |
| Rigid Construction | Yes | Yes |
| Needle Shaft length | 20cm | 20cm |
| Needle Gauge (inserted in tissue) | 18G Cannula with 20.5G needle. | 18G |
| Needle Thermocouple | Soldered at the tip | Soldered at the tip |
| Patient Contacting Materials | Stainless Steel (needle), TPV (lead cable), ABS (handle). | Stainless Steel (needle), PVC (lead cable), ABS (handle). |
| Thermocouple Type | T-Type | T-Type |
| Safety Standard Compliance | IEC 60601-1, 60601-1-6, 60601-2-6, 60601-1-2 | IEC 60601-1, 60601-1-6, IEC 60601-2-6, IEC 60601-1-2 |
| Biocompatibility | Evaluated by ISO 10993-1 | Evaluated by ISO 10993-1 |
| Software | No | No |
| Device Usage | Single-use, disposable, optional accessory | Single-use, disposable, optional accessory |
| Sterilization | ETO | ETO |
| Packaging integrity and shelf-life | Complies with ISO 11607-1 and ISO 11607-2 | Complies with ISO 11607-1 and ISO 11607-2 |
Explanation of "Differences" for key criteria:
- Temperature Range (Accuracy): The subject device has a wider temperature range (10-60°C vs 37-60°C) and a slightly lower accuracy (±2°C vs ±1.5°C). The document states this is "Similar performance specifications" and notes that the compatible ablation system rounds reported temperature to the nearest integer for usability, implying this difference is acceptable.
- Needle Gauge (inserted in tissue): While both effectively result in an 18G insertion, the subject device uses a thicker-wall 18G needle directly, eliminating the need for a separate cannula and stylet, which the predicate device uses with a thinner 20.5G needle inside an 18G cannula. This is deemed "Similar" in overall gauge size.
- Probe handle with PCBA: The subject device has a PCBA in the handle for analog-to-digital signal conversion, whereas the predicate performs this in the console. This is a "Different design" but ultimately serves the same function of displaying real-time temperature.
- Lead Cable Outer Jacket: Different polymers (PVC vs TPV), but stated as "thermoplastic elastomer similar to the predicate device."
- Packaging: Different configurations (Tyvek pouch in cardboard box vs thermoform tray and Tyvek lid in SBS carton), noted as "Different packaging (less footprint)."
Study Information
-
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document implies that testing for "accuracy of temperature monitoring" involved side-by-side testing of the subject and predicate devices. However, specific numerical sample sizes for these tests are not provided.
- Data Provenance: The studies are described as "non-clinical testing" and "non-clinical animal testing." No country of origin is specified for these tests. The animal testing was conducted on "porcine soft tissue models." These are likely prospective studies as they involve testing the new device.
-
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 applicable/Not provided. The testing described is primarily focused on physical and electrical device performance, temperature accuracy, and biocompatibility, not on expert interpretation of medical images or diagnostic outcomes. Therefore, no experts were explicitly used to establish "ground truth" in the manner relevant to image-based diagnostic AI.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to studies where multiple readers interpret cases and their discrepancies need to be resolved for ground truth. The studies for this device are technical performance tests, not reader studies.
-
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:
- No, an MRMC comparative effectiveness study was not done. This device is a temperature sensor probe, an accessory for ablation systems. It does not involve AI or human interpretation of data in a diagnostic context that would warrant an MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device "does not contain software" that performs analytical functions. The testing focused on the physical device's performance, such as temperature accuracy. Therefore, "standalone" algorithm performance in the typical AI sense is not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing of temperature monitoring, the ground truth would be established by calibrated reference standards or laboratory-controlled conditions (e.g., precise temperature baths with highly accurate reference thermometers).
- For biocompatibility, the ISO 10993-1 standard provides the framework for establishing ground truth regarding material safety.
- For animal testing, the ground truth would be directly measured tissue temperature in the porcine model using reference temperature measurement methods.
-
The sample size for the training set:
- Not applicable/Not provided. This device does not use AI/machine learning algorithms that require a training set.
-
How the ground truth for the training set was established:
- Not applicable. As the device does not use AI/machine learning, no training set or ground truth for such a set was established.
In summary, the FDA clearance for the Varian Temperature Sensor Probe is based on a demonstration of substantial equivalence through non-clinical performance testing, including accuracy of temperature monitoring, biocompatibility, electrical safety, sterilization, and packaging integrity. The nature of this device (a physical accessory for temperature measurement) means that many of the typical AI/ML study components (like expert ground truth, MRMC studies, or training sets) are not relevant or applicable.
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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"
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(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
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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
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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.
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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 DeviceTemperature Sensor Probe | Predicate Device (K200796)Ablation Remote Temperature Probe | Differences |
|---|---|---|---|
| Devicerepresentative 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. |
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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 Probeenergy when it measures atemperature of 45° C (defaultsetting). Use of the RTP20 in anablation procedure is optional. | ||
| Compatible Systemsand their intendeduse/ indications ofuse | IntelliBlate Microwave AblationSystem under FDA review (K240480)The IntelliBlate Microwave AblationSystem is intended for coagulation(ablation) of soft tissue inlaparoscopic, intraoperative, andpercutaneous ablation procedures,including partial or completeablation of non-resectable livertumors. | Emprint™ Ablation System withThermosphere TechnologyThe Emprint™ Ablation System isintended for use in percutaneous,laparoscopic, endoscopic, andintraoperative coagulation (ablation)of soft tissue, including partial orcomplete ablation of nonresectableliver tumors. | Same |
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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 DeviceTemperature 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, FDAregulation and deviceclass | 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(TemperatureAccuracy) | $10°C-60°C (±2°C)$ | $37°C-60°C (±1.5°C)$ | Similar performancespecifications.Representation of thereported temperature onthe User Interface of thecompatible ablation |
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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 DeviceTemperature Sensor Probe | Predicate Device (K200796)Ablation Remote Temperature Probe | Differences |
|---|---|---|---|
| system used with thesubject device are roundedto nearest integer toenhance usability. | |||
| Thermocouple-basedtemperature sensorat the tip of theneedle | Yes | Yes | Same |
| Signal Processing andDisplay on thecompatible ablationsystem | Real time, continuous display oftissue temperature | Real time, continuous display oftissue temperature | Same |
| Tissue Contact perISO 10993-1 | External communicating device, incontact with tissue/bone/dentin andlimited contact duration (A) (<24hours) | External communicating device, incontact with tissue/bone/dentin andlimited contact duration (A) (<24hours) | Same |
| Design and Construction | |||
| PrincipleComponents | Needle, handle and lead cable | Needle, handle, lead cable andcannula with stylet | Thicker needle shaft of thesubject device eliminatesthe use of a cannula |
| Rigid Construction | Yes | Yes | Same |
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Image /page/10/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.
varian
A Siemens Healthineers Company
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
| Features/Characteristics | Subject DeviceTemperature Sensor Probe | Predicate Device (K200796)Ablation Remote Temperature Probe | Differences |
|---|---|---|---|
| Distal Tipconfiguration | Trocar Tip | Rounded non-sharp tip onTemperature Probe used togetherwith a sharp cannula | Sharp Trocar Tip replacesthe use of a cannula |
| Right Angle Probe | Yes | Yes | Same |
| Needle Shaft length | 20cm | 20 cm | Same |
| Needle Gaugeinserted in the tissue | 18G | 18GCannula (18G) with stylet insertedwith 20.5G needle. | Similar.Overall gauge size is thesame, however thepredicate uses a cannulawith a stylet and thinnerprobe needle.Thicker wall of the subjectdevice's needle shaftprovides mechanicalstiffness that eliminatesthe use of a cannula andstylet. |
| Cannula and Stylet | No | Yes | Thicker wall of the needleshaft of the subject deviceprovides mechanicalstiffness that eliminatesthe use of a cannula andstylet. |
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Image /page/11/Picture/0 description: The image shows the alphanumeric string "K240784" in a clear, sans-serif font. The characters are uniformly sized and spaced, making the entire string easily readable. The string appears to be a code or identifier, possibly a serial number or part number.
Image /page/11/Picture/1 description: The image contains three blue circles in a horizontal row. The circles are evenly spaced and appear to be the same size. The background is plain white, which makes the blue circles stand out. The image is simple and minimalist in design.
varian
A Siemens Healthineers Company
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
| Features/Characteristics | Subject DeviceTemperature Sensor Probe | Predicate Device (K200796)Ablation Remote Temperature Probe | Differences |
|---|---|---|---|
| NeedleThermocouple | Soldered at the tip | Soldered at the tip | Same |
| Patient ContactingComponents | Needle Shaft and needle tip | Needle: Needle Shaft and needle tipCannula: Cannula tipStylet: Stylet tip | Same.Thicker wall of the needleshaft of the subject deviceprovides mechanicalstiffness that eliminatesthe use of a cannula andstylet |
| Probe handle withPrinted Circuit BoardAssembly (PCBA) | Yes | No | Different design.The predicate deviceconverts the probe analogtemperature to digitalsignal inside the consoleand sends the informationto the display.The subject deviceconverts the probe analogtemperature to digitalsignal in the handle (PCBA)and sends the informationto the console display. |
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Image /page/12/Picture/1 description: The image contains three blue circles arranged horizontally. 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 DeviceTemperature Sensor Probe | Predicate Device (K200796)Ablation Remote Temperature Probe | Differences |
|---|---|---|---|
| Patient ContactingMaterials | Stainless Steel | Stainless Steel | Same |
| Lead Cable OuterJacket | PVC | TPV | Different polymer;thermoplastic elastomersimilar to the predicatedevice. |
| Handle Plastic | ABS | ABS | Same |
| Thermocouple | T-Type | T-Type | Same |
| Safety StandardCompliance | IEC 60601-1, 60601-1-6, 60601-2-6,60601-1-2 | IEC 60601-1, 60601-1-6, 60601-2-6,60601-1-2 | Same |
| Biocompatibility | All the patient-contacting materialsare evaluated by thebiocompatibilitystandard ISO 10993-1. | All the patient-contacting materialsare evaluated by thebiocompatibilitystandard ISO 10993-1. | Same |
| Software | No | No | Same |
| Device Usage | Single-use, disposable, optionalaccessory | Single-use, disposable, optionalaccessory | Same |
| Sterilization | ETO | ETO | Same |
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Image /page/13/Picture/0 description: The image shows three blue circles in a horizontal line. The circles are evenly spaced and appear to be 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/ | Subject Device | Predicate Device (K200796) | Differences |
|---|---|---|---|
| Characteristics | Temperature Sensor Probe | Ablation Remote Temperature Probe | |
| Packagingconfiguration andmaterials | Tyvek sterile barrier pouch within acardboard shelf carton box sealedwith a tamper tape. | Thermoform tray and single Tyveksterile barrier lid within a SBS (solidbleached sulfate) shelf carton boxsealed with a tamper paper tape. | Different packaging (lessfootprint) |
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Image /page/14/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.
Image /page/14/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 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
Performance Data: VII.
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.
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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
9. Packaging Integrity and Shelf Life:
Packaging integrity and shelf-life testing complies with ISO 11607-1 and ISO 11607-2.
VIII. Conclusion:
The performance data for the Temperature Sensor Probe support the safety of the device and the verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Varian considers Temperature Sensor Probe to be as safe and effective as the predicate device and therefore, substantially equivalent to the predicate device, Ablation Remote Temperature Probe cleared along with Emprint Ablation System in K200796.
§ 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.