(102 days)
No
The description focuses on standard feedback control mechanisms (monitoring impedance and temperature to adjust RF output) and does not mention AI or ML.
Yes
The device is used for 'coagulation and ablation of tissue', which is a therapeutic intervention aimed at treating medical conditions by modifying or destroying tissue.
No
The device is described as an ablation system used for tissue coagulation and ablation, not for diagnosing a condition or disease. It monitors parameters internally for energy delivery, not for diagnostic purposes.
No
The device description explicitly lists hardware components such as an RF generator, active electrode, grounding pad, and peristaltic pump, indicating it is not a software-only device.
Based on the provided information, the CRF Radiofrequency Ablation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue." This describes a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The description details a system that delivers radiofrequency energy directly to tissue within the patient. It involves an electrode, grounding pad, and cooling system, all designed for direct interaction with the patient's internal tissues.
- Mechanism of Action: The device works by causing "tissue heating at the tip of the electrode causing coagulation and ablation of tissue." This is a physical process applied directly to the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device is therapeutic, not diagnostic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CRF Radiofrequency Ablation System does not fit this definition.
N/A
Intended Use / Indications for Use
The CRF Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue.
Product codes
GEI
Device Description
The CRF Radiofrequency Ablation System consists of an RF generator, active electrode, grounding pad, and peristaltic pump for electrode cooling. This device is designed to cause tissue heating at the tip of the electrode causing coagulation and ablation of tissue. The CRF Generator supplies radiofrequency energy at 480 kHz while monitoring both the tissue temperature at the CRF electrode tip. The CRF Generator monitors the power, resistance, current and temperature during energy delivery to the patient.
The CRF Electrodes are sterile, single-use, hand-held for use in radiofrequency ablation procedures. The electrodes are surgically invasive, transient devices in patient contact typically for less than one hour. Cooling of the electrodes is provided by chilled sterile saline or water that is pumped through the electrode and out via outflow tubing. This is an enclosed system within the electrode and the saline does not contact. The CRF Generator automatically monitors impedance and temperature and adjusts RF output accordingly. The CRF Radiofrequency Ablation System is used in a healthcare facility or hospital setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility or hospital setting
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)
Performance testing of the device was completed to demonstrate substantial equivalence of the CRF Radiofrequency Ablation System to the identified predicate device. Non-clinical animal testing of the device was not required to establish substantial equivalence. The device components were subjected to the following verification and validation testing, as required:
- Mechanical testing: Mechanical verification testing was performed on subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 standards and the Company's internal test requirements.
- Electrical testing: Electrical verification testing was conducted for the subject device to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 electrical requirements.
- Electromagnetic compatibility: Electromagnetic compatibility testing was completed for the subject device to ensure compliance with the current IEC 60601-1-2 standard.
- Benchtop ablation testing. Comparative ablation verification testing was performed using an ex vivo tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate devices.
- Usability testing: Testing was performed to verify and validate the usability requirements of the subject devices as a system in compliance with IEC 62366 and IEC 60601-1-6. Elements captured included normal use errors, and testable requirements for primary operating functions and frequent use scenarios.
- Biocompatibility testing: Biocompatibility testing of patient contacting CRF devices was performed in accordance with the FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" including cytotoxicity, systemic toxicity and irritation testing. All CRF devices demonstrated compliance with listed requirements.
- Sterilization validation testing: ETO sterilization validation for CRF devices was carried out using the overkill method and halfcycles in accordance with the current ISO 11135 standard to provide a SAL of 10-6.
- Packaging and shelf life testing: Sterile packaging performance testing was conducted for the subject devices in their final packaging. Shelf life testing for sterile subject devices and packaging was conducted based on an accelerated aging protocol in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Real-time age testing will be performed to add to and support the results of the accelerated age testing.
- Software validation testing: The CRF radiofrequency generator includes software developed according to the Company's software development process in compliance with the current IEC 62304 standard. Software verification testing was conducted in accordance with the FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG" and "ADMINISTRATION".
January 7, 2020
Cambridge Interventional LLC Michael Arnold President 78 Cambridge Street Burlington, Massachusetts 01803
Re: K192715
Trade/Device Name: CRF Radiofrequency Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 12, 2019 Received: November 19, 2019
Dear Michael Arnold:
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. 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 located 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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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 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 Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192715
Device Name
CRF Radiofrequency Ablation System
Indications for Use (Describe)
The CRF Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
CRF Radiofrequency Ablation System
Submitter:
Cambridge Interventional LLC 78 Cambridge Street Burlington MA 01803
Telephone: 617-365-6899 Contact Name: Michael Arnold Email: marnold@cambint.com Date prepared: November 12, 2019
Device Name and Classification
Model Name: CRF Radiofrequency Ablation System Common Name: Electrosurgical Cutting and Coagulation Device and Accessories Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Device Class: II
Name of Predicate Device
Valleylab Cool-tip™ Switching Controller (K070446) - Product Code GEI, Class II
Name of Reference Device
Valleylab Cool-tip™ Radiofrequency Ablation System (K052796) - Product Code GEI, Class II
Description of Device
The CRF Radiofrequency Ablation System consists of an RF generator, active electrode, grounding pad, and peristallic punp for electrode cooling. This device is designed to cal tissue heating at the tip of the electrode causing coagulation and ablation of tissue. The CRF Generator supplies radiofrequency energy at 480 kHz while monitoring both the tissue imperature at the CRF electrode tip. The CRF Generator monitors the power, resistance, current and temperature during energy delivery to the paient.
The CRF Electrodes are sterile, single-use, hand-held for use in radiofrequency ablation procedures. The electrodes are surgically invasive, transient devices in patient contact typically for less than one hour. Cooling of the electrodes is provided by chilled sterile saline or water that is pumped through the electrode and out via outflow tubing. This is an enclosed system within the electrode and the saline does not contact. The CRF Generator automatically monitors impedance and temperature and adjusts RF output accordingly. The CRF Radiofrequency Ablation System is used in a healthcare facility or hospital setting. The table below lists components for the CRF Radiofrequency Ablation System.
| Catalog No. | Description of Component | Provided Sterile? |
|---|---|---|
| CRF | CRF Radiofrequency Generator | No |
| CRF-C1020 | RF Cannula, 10 cm, 2 cm Tip | Yes |
| CRF-C1030 | RF Cannula, 10 cm, 3 cm Tip | Yes |
| CRF-C1510 | RF Cannula, 15 cm, 1 cm Tip | Yes |
| CRF-C1520 | RF Cannula, 15 cm, 2 cm Tip | Yes |
| CRF-C1530 | RF Cannula, 15 cm, 3 cm Tip | Yes |
| CRF-C2020 | RF Cannula, 20 cm, 2 cm Tip | Yes |
| CRF-C2030 | RF Cannula, 20 cm, 3 cm Tip | Yes |
| CRF-C2040 | RF Cannula, 20 cm, 4 cm Tip | Yes |
| CRF-C2050 | RF Cannula, 20 cm, 5 cm Tip | Yes |
4
| Catalog No. | Description of Component | Provided Sterile? |
|---|---|---|
| CRF-C2520 | RF Cannula, 25 cm, 2 cm Tip | Yes |
| CRF-C2530 | RF Cannula, 25 cm, 3 cm Tip | Yes |
| CRF-E10 | RF Electrode, Cooled, Blunt Tip, 10 cm | Yes |
| CRF-E15 | RF Electrode, Cooled, Blunt Tip, 15 cm | Yes |
| CRF-E20 | RF Electrode, Cooled, Blunt Tip, 20 cm | Yes |
| CRF-E25 | RF Electrode, Cooled, Blunt Tip, 25 cm | Yes |
| CRF-N1005 | RF Electrode, Non-Cooled, Sharp Tip, 10cm, 0.5cm Tip | Yes |
| CRF-N1510 | RF Electrode, Non-Cooled, Sharp Tip, 15cm, 1cm Tip | Yes |
| CRF-N2020 | RF Electrode, Non-Cooled, Sharp Tip, 20cm, 2cm Tip | Yes |
| CRF-N2520 | RF Electrode, Non-Cooled, Sharp Tip, 25cm, 2cm Tip | Yes |
| CRF-TN | Temperature Probe, Cannula | Yes |
| CRF-TP | Temperature Probe, Blunt Probe | Yes |
| CRF-U1020 | RF Electrode, Cooled, Sharp Tip, 10cm, 2cm Tip | Yes |
| CRF-U1030 | RF Electrode, Cooled, Sharp Tip, 10cm, 3cm Tip | Yes |
| CRF-U1507 | RF Electrode, Cooled, Sharp Tip, 15cm, 0.7cm Tip | Yes |
| CRF-U1510 | RF Electrode, Cooled, Sharp Tip, 15cm, 1cm Tip | Yes |
| CRF-U1520 | RF Electrode, Cooled, Sharp Tip, 15cm, 2cm Tip | Yes |
| CRF-U1530 | RF Electrode, Cooled, Sharp Tip, 15cm, 3cm Tip | Yes |
| CRF-U2020 | RF Electrode, Cooled, Sharp Tip, 20cm, 2cm Tip | Yes |
| CRF-U2030 | RF Electrode, Cooled, Sharp Tip, 20cm, 3cm Tip | Yes |
| CRF-U2050 | RF Electrode, Cooled, Sharp Tip, 20cm, 5cm Tip | Yes |
| CRF-U2525 | RF Electrode, Cooled, Sharp Tip, 25cm, 2.5cm Tip | Yes |
| CRF-U2535 | RF Electrode, Cooled, Sharp Tip, 25cm, 3.5cm Tip | Yes |
| CRF-FS | Footswitch | No |
| CRF-PUMP | Pump | No |
| CRF-A3E | Cable, CRF electrodes to CRF generator | No |
| CRF-AME | Cable, CRF electrode to Cool-tip generator | No |
| CRF-AMG | Cable, CRF-GP to Cool-tip generator | No |
| CRF-SCG | Storage Case for CRF Generator | No |
| CRF-SCP | Storage Case for Pump | No |
| CRF-TUBE | Tubing Set for Pump | Yes |
| CRF-GBC | Introducer for CRF-C | Yes |
| CRF-GBU | Introducer for CRF-U | Yes |
| CRF-GP | Ground Pad, Disposable | No |
Indications for Use
The CRF Radiofrequency Ablation System is intended for use in percutaneous, intraoperative coagulation and ablation of tissue.
The Indications for Use statement is consistent with the predicate Cool-tip™ device, but without specific indications.
Comparison to Predicate Device
Compared to the predicate Cool-tip™ device, the CRF Radiofrequency Ablation System has similar technological characteristics and operating principle. There are no significant design or performance specifications that affect safety of the subject device. There is substantial equivalence between the subject device and the predicate with respect to indications and intended use. The CRF Radiofrequency Ablation System is substantially equivalent to the legally marketed predicate device with respect to indications for use and technology characteristics. The table below presents side-by-side comparisons for each major component for the subject and predicate device.
5
| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device | CRF Radiofrequency Ablation System | Valleylab Cool-tip™ Switching | |
| Controller (K070446) | N/A | ||
| Indication | The CRF Radiofrequency Ablation | ||
| System is indicated for use in | |||
| percutaneous, laparoscopic and | |||
| intraoperative coagulation and ablation | |||
| of tissue. | The Cool-tip™ RF Switching Controller | ||
| is to be used with the Cool-tip™ RF | |||
| System and is intended for use in | |||
| percutaneous, laparoscopic and | |||
| intraoperative coagulation and ablation | |||
| of tissue, such as partial or complete | |||
| ablation of nonresectable liver tumors, | |||
| and osteoid osteoma tumors within | |||
| bone. | Different | ||
| Principle of Operation | Provide RF energy to patient-contacting | ||
| TC Electrode for tissue ablation. | Provide RF energy to patient-contacting | ||
| TC Electrode for tissue ablation. | Identical | ||
| Classification | 878.4400 | 878.4400 | Identical |
| Device Class | GEI | GEI | Identical |
| Generator Electrical | |||
| Classification | Class 1, IPX0, Type BF | Class 1, IPX0, Type BF | Identical |
| Generator Output Frequency | 480 kHz | 480 kHz | Identical |
| Generator waveform | Sine wave | Sine wave | Identical |
| Generator waveform crest factor | 1.4 | 1.4 | Identical |
| Generator Rated Power | Up to 370w | Up to 200w | Different |
| Generator Impedance | Up to 1000 ohms | Up to 1000 ohms | Identical |
| Generator Timer | Up to 15:00 min | Up to 30:00 min | Different |
| Generator Temperature Monitor | Thermocouple | Thermocouple | Identical |
| Generator Footswitch control | Available | Available | Identical |
| TC Electrode length | 10, 15, 20, 25cm | 10, 14.4, 15, 20, 25cm | Different |
| TC Electrode tip exposure | 0.5, 0.7, 1, 2, 2.5, 3, 3.5, 4, 5cm | 0.7, 1, 2, 2.5, 3, 4cm | Different |
| TC Electrode tip diameter | 0.9, 1.5, 1.8mm | 1.5mm | Different |
| TC Electrode Cooling | |||
| Mechanism | Electrode cooling is provided by sterile | ||
| water, which is pumped through the | |||
| inflow tubing into the Electrode shaft, | |||
| and out through the outflow tubing. | Electrode cooling is provided by sterile | ||
| water, which is pumped through the | |||
| inflow tubing into the Electrode shaft, | |||
| and out through the outflow tubing. | Identical | ||
| Maximum number of Electrodes | |||
| connected simultaneously | Up to 3 | Up to 3 | Identical |
| Temp probe sensor | Type T Thermocouple | Type T Thermocouple | Identical |
| Temp Probe & Introducer length | 20cm | 20cm | Identical |
| Temp Probe & Introducer | |||
| diameter | 0.9, 1.3mm | 0.9, 1.3mm | Identical |
| Active electrode material | Stainless Steel | Stainless Steel | Identical |
| Electrode insulation material | Polyester | Polyester | Identical |
| Electrode sterilization | ETO Sterilization | ETO Sterilization | Identical |
| Electrode shelf life | 4 years | 4 years | Identical |
| Electrode usage | Single Use | Single Use | Identical |
| Pump type | Peristaltic pump | Peristaltic pump | Identical |
| Pump specification | 80-120 ml/min | 80-140 ml/min | Different |
| Tubing Set Configuration | Two-piece set (inflow and outflow | ||
| components) | Two-piece set (inflow and outflow | ||
| components) | Identical | ||
| Tubing Set Material | PVC tubing | PVC tubing | Identical |
| Tubing Set sterilization | ETO Sterilization | ETO Sterilization | Identical |
| Tubing Set shelf life | 4 years | 4 years | Identical |
| Tubing Set usage | Single Use | Single Use | Identical |
| Ground Pad material | Conductive hydrogel | Conductive hydrogel | Identical |
| Ground Pad usage | Single Use | Single Use | Identical |
| Ground Pad shelf life | 2 years | 2 years | Identical |
| Ground Pad regulatory clearance | 510(k) clearance (K000079) | 510(k) clearance (K030697) | Identical |
6
K192715
Summary of Non-Clinical Data
Performance testing of the device was completed to demonstrate substantial equivalence of the CRF Radiofrequency Ablation System to the identified predicate device. Non-clinical animal testing of the device was not required to establish substantial equivalence. The device components were subjected to the following verification and validation testing, as required:
• Mechanical testing: Mechanical verification testing was performed on subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 standards and the Company's internal test requirements.
· Electrical testing: Electrical verification testing was conducted for the subject device to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 electrical requirements.
· Electromagnetic compatibility: Electromagnetic compatibility testing was completed for the subject device to ensure compliance with the current IEC 60601-1-2 standard.
· Benchtop ablation testing. Comparative ablation verification testing was performed using an ex vivo tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate devices.
• Usability testing: Testing was performed to verify and validate the usability requirements of the subject devices as a system in compliance with IEC 62366 and IEC 60601-1-6. Elements captured included normal use errors, and testable requirements for primary operating functions and frequent use scenarios.
· Biocompatibility testing: Biocompatibility testing of patient contacting CRF devices was performed in accordance with the FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" including cytotoxicity, systemic toxicity and irritation testing. All CRF devices demonstrated compliance with listed requirements.
· Sterilization validation testing: ETO sterilization validation for CRF devices was carred out using the overkill method and halfcycles in accordance with the current ISO 11135 standard to provide a SAL of 10-6.
• Packaging and shelf life testing: Sterile packaging performance testing was conducted for the subject devices in their final packaging. Shelf life testing for sterile subject devices and packaging was conducted based on an accelerated aging protocol in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Real-time age testing will be performed to add to and support the results of the accelerated age testing.
· Software validation testing:
The CRF radiofrequency generator includes software developed according to the Company's software development process in compliance with the current IEC 62304 standard. Software verification testing was conducted in accordance with the FDA Gudance for Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304.
Summary of Clinical Data
Clinical testing of the device was not required to establish substantial equivalence.
Conclusion
The CRF Radiofrequency Ablation System is substantially equivalent to the predicate device cleared in K070446. The subject and predicate devices share the same fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics between the subject device do not raise any new questions of safety and effectiveness. The intended use of the subject device has not changed. The comparison of technological characteristics, non-clinical performance data, electrical safety and electromagnetic compatibility testing demonstrates that the CRP Radiofrequency Ablation System is substantially equivalent to the previously cleared predicate device.