(80 days)
Cardioblate 49313 Surgical Ablation Pen: The Cardioblate surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Cardioblate 49314 XL Surgical Ablation Pen: The Cardioblate XL surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Cardioblate Surgical Ablation devices (Pen and XL Pen, Model 49313 and 49314 respectively) are hand held, single use, monopolar, RF ablation devices for use in cardiac surgery. Each device has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode tip to cool the tissue during RF energy delivery. The devices are intended for intermittent operation. The proposed Cardioblate Pen and XL Pen devices are intended for use with the Valleylab™ FT10 Energy Platform (VLFT10GEN) with software version 3.0.0 or higher. These devices are sterile, nonpyrogenic, disposable, and single use only. They are sterilized using ethylene oxide.
The document you provided is a 510(k) Pre-Market Notification from the FDA for a medical device (Cardioblate Surgical Ablation Pen). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for novel performance claims.
Therefore, the information typically requested in your prompt (acceptance criteria, specific study details with sample sizes, expert ground truth, MRMC, standalone performance, training set details) is not present in this document because it describes a different type of regulatory submission.
Here's why and what information can be extracted:
Why the requested information is not present:
- Acceptance Criteria & Device Performance Table, Study Details, Ground Truth, MRMC, Standalone Performance, Training Set: The 510(k) pathway focuses on showing that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness and that data demonstrates it is as safe and effective as the predicate. Clinical efficacy or performance studies with detailed statistical acceptance criteria for novel claims, as might be found in a De Novo or PMA submission, are generally not required for 510(k) clearances unless substantial equivalence cannot be established through other means (e.g., bench testing, non-clinical data).
- Expert Ground Truth & Adjudication: These are typical for studies assessing diagnostic accuracy, often with human interpretation. The Cardioblate Pen is a surgical ablation device, not a diagnostic or imaging device, so these concepts are not applicable in the context described.
What is present in the document:
- Device Description: The Cardioblate Surgical Ablation devices (Pen and XL Pen) are hand-held, single-use, monopolar, RF ablation devices for cardiac surgery, designed to be used with the Valleylab™ FT10 Energy Platform. They use a saline irrigation system to cool tissue during RF energy delivery.
- Indications for Use: To ablate cardiac tissue during cardiac surgery using radiofrequency energy.
- Comparison to Predicate Devices (K080509): The new devices have the same intended use, contraindications, technological characteristics, operating principle, design features, performance specifications, patient-contacting components, materials, and shelf life. Differences include a new plug connector for compatibility with the Valleylab™ FT10 Energy Platform, updated IFU and labeling (including eIFU), and packaging changes for the standard pen.
- Performance Testing (Non-Clinical): To demonstrate substantial equivalence, the following verification testing was performed:
- Mechanical: To ensure compliance with IEC 60601-1 and IEC 60601-2-2 standards and Medtronic internal requirements.
- Electrical: To ensure compliance with IEC 60601-1 and IEC 60601-2-2 electrical requirements.
- Electromagnetic compatibility: To ensure compliance with IEC 60601-1-2 standard requirements.
- Benchtop Lesion Verification: Comparative lesion verification testing using a soft tissue model to demonstrate "substantially equivalent ablation performance" of the subject and predicate systems. No specific metrics or acceptance criteria for this "substantially equivalent performance" are provided in this summary.
- Usability: To verify and validate usability requirements, including normal use cases, foreseeable worst-case scenarios, and primary operating functions.
- Packaging: Sterile barrier system performance testing in accordance with ISO 11607-1.
- Conclusion: The verification and validation test results demonstrate substantial equivalence to the predicate, with differences not raising new questions of safety and effectiveness.
In summary, based only on the provided document, I cannot fulfill the detailed request regarding acceptance criteria and study particulars because the document is a 510(k) summary, which focuses on substantial equivalence through non-clinical testing rather than detailed clinical performance studies with the specific metrics you've asked for.
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May 30, 2019
Medtronic Rahul Shah Sr. Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428
Re: K190623
Trade/Device Name: Cardioblate 49313 Surgical Ablation Pen, Cardioblate 49314 Surgical Ablation Pen Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: April 2, 2019 Received: April 3, 2019
Dear Rahul Shah:
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.
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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 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.
Bram D. Zuckerman, M.D. Director OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190623
Device Name
Cardioblate 49313 Surgical Ablation Pen Cardioblate 49314 XL Surgical Ablation Pen
Indications for Use (Describe)
Cardioblate 49313 Surgical Ablation Pen
The Cardioblate surgical ablation pen is intended to ablate cardiac surgery using radiofrequency energy.
Cardioblate 49314 XL Surgical Ablation Pen
The Cardioblate XL surgical ablation pen is intended to ablate cardiac surgery using radiofrequency energy.
| 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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510(k) Summary
| Date Prepared: | March 8, 2019 |
|---|---|
| Submitter: | Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009 |
| Contact Person: | Rahul ShahSenior Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 763.514.9846Email: rahul.m.shah@medtronic.com |
| Alternate Contact: | Mike GreenSenior Regulatory Affairs Manager MedtronicPerfusion SystemsPhone: 763.514.9774Email: mike.green@medtronic.com |
| Device Name and Classification | |
| Trade Name: | Cardioblate 49313 Surgical Ablation PenCardioblate 49314 XL Surgical Ablation Pen |
| Common Name: | Electrosurgical device |
| Classification name | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | OCL |
| Name of Predicate Device | |
| K080509 | Cardioblate Monopolar Pens, Models 60813 and 60814 |
| Name of Reference Device |
K182610 Valleylab™ FT10 Energy Platform, Model VLFT10GEN
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Device Description
The Cardioblate Surgical Ablation devices (Pen and XL Pen, Model 49313 and 49314 respectively) are hand held, single use, monopolar, RF ablation devices for use in cardiac surgery. Each device has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode tip to cool the tissue during RF energy delivery. The devices are intended for intermittent operation.
The proposed Cardioblate Pen and XL Pen devices are intended for use with the Valleylab™ FT10 Energy Platform (VLFT10GEN) with software version 3.0.0 or higher.
These devices are sterile, nonpyrogenic, disposable, and single use only. They are sterilized using ethylene oxide
Indications for Use
Cardioblate Pen (49313)
The Cardioblate surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Cardioblate XL Pen (49314)
The Cardioblate XL surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Comparison to Predicate Devices
When compared to predicate devices (K080509), the Cardioblate Surgical Ablation Devices (Pen and XL Pen) presented in this submission have the same:
- . Intended Use and Contraindications
- Technological characteristics and operating principle
- . Design features
- Performance specifications ●
- Patient contacting components and materials
- Shelf life
When compared to predicate devices (K080509), the Cardioblate Surgical Ablation Devices (Pen and XL Pen) presented in this submission have the following differences:
- . Cardioblate Monopolar (Pen and XL Pen) Devices
- New plug connector for VLFT10GEN compatibility
- IFU and Labeling updates ●
- . eIFU rather than paper IFU
- Cardioblate Monopolar (standard) Pen only .
- Packaging
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Performance Testing
Performance testing was completed to demonstrate substantial equivalence of the system (the proposed Cardioblate surgical ablation devices (Pen and XL Pen), used with the Valleylab FT10 Energy Platform, software version 3.0 or higher) to the identified predicate system. Clinical and non-clinical animal testing was not required to establish substantial equivalence. The system components were subjected to the following verification testing, as applicable:
Mechanical: Mechanical verification testing was conducted for components of the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 standard requirements and Medtronic self-enforced requirements.
Electrical: Electrical verification testing was conducted for the subject devices 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 devices to ensure compliance with current IEC 60601-1-2 standard requirements.
Benchtop Lesion Verification: Comparative lesion verification testing was performed using a soft tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate systems.
Usability: Testing was performed to verify and validate the usability requirements of the subject devices as a system. Elements captured included normal use cases, a foreseeable worst-case use scenario, and testable requirements for primary operating functions.
Packaging: Packaging sterile barrier system performance testing was conducted for the proposed devices in their final packaging in accordance with ISO 11607-1.
Conclusion
Verification and validation test results demonstrate that the proposed devices are substantially equivalent to the predicates cleared in K080509. Differences between the proposed and predicate devices do not raise different questions of safety and effectiveness. The intended use of the devices has not changed. Moreover, the fundamental scientific technology, operating principle, and design features are unchanged from that of the predicate.
1 The term 'substantially equivalent' as used herein is intended to be a determination of substantial equivalency under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be market approval or reclassification. Such a determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits or other patent matters." (Federal Register, Vol. 42, No. 163, Aug. 23, 1977, page 42525 and 42529).
§ 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.