(90 days)
The Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is intended to ablate soft tissue during general surgery using radiofrequency energy.
The Medtronic® Cardioblate® Bipolar Radiofrequecy Ablation System is made of bipolar Surgical Ablation Device (Model 60821 & 60822) and a Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator & accessories (Model 60890) for the application of radiofrequency energy to tissue.
The Medtronic® Cardioblate® BP (Bipolar) Surgical Ablation Device, (Model 60821 & 60822) is a hand-held, bipolar, radiofrequency surgical ablation device.
The Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, (Model 60890) is capable of delivering the controlled radiofrequency energy for Bipolar or Monopolar surgical ablation. The Generator delivers in Bipolar mode up to 40 Watts, with a 20 - 350 Ohm range, and a Monopolar mode up to 50 Watts to the delivery device with a 20-500 Ohm range.
The provided text describes a 510(k) premarket submission for the Medtronic Cardioblate Bipolar Radiofrequency Ablation System. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report with specific performance metrics.
Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided document.
However, based on the available information, here's what can be inferred and what remains unknown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in safety and effectiveness for soft tissue ablation. | Performance characteristics were tested and compared to the performance specifications of listed predicate devices through bench testing and non-bench analyses. The differences were "minor and not raise any concern regarding the overall safety and effectiveness." |
| Effective ablation of soft tissue during general surgery using radiofrequency energy. | The device is intended to ablate soft tissue during general surgery using radiofrequency energy. (No specific ablation effectiveness metrics or success rates are reported in this summary.) |
| Safe operation with no undue risks. | The device is considered "substantially equivalent" in terms of safety and effectiveness to predicate devices. (No specific safety event rates or adverse effect data are reported.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "bench testing and non-bench analyses" for performance characteristic comparisons. These would typically involve test articles of the device but the number is not provided.
- Data Provenance: Not specified. The types of tests mentioned (bench testing) suggest laboratory-based data, but the country of origin or whether it's retrospective/prospective is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified. It is unlikely that an adjudication method in the context of human reader performance would be applicable to the "bench testing and non-bench analyses" described.
5. 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
- MRMC Study: No. This device is an electrosurgical ablation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: The document describes "bench testing and non-bench analyses" which would represent standalone performance of the device itself (not an algorithm). However, detailed results or specific metrics for this standalone performance are not provided beyond the general statement of comparison to predicate devices.
7. The type of ground truth used
- Type of Ground Truth: For the "bench testing and non-bench analyses," the ground truth would likely be established through engineering specifications, physical measurements, and comparison to the documented performance of the predicate devices. For instance, if testing ablation depth, the ground truth would be the measured depth in a controlled environment. The document is not specific on the methodology.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is an electrosurgical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for this type of device.
Summary of what the document does indicate:
- The device is intended to ablate soft tissue during general surgery using radiofrequency energy.
- The primary method for demonstrating its suitability for approval was non-clinical testing (bench testing and non-bench analyses) to show substantial equivalence to existing predicate devices (Medtronic Cardioblate Radiofrequency Ablation System K013392 and AtriCure Bipolar System K020919).
- The conclusion was that differences were "minor and not raise any concern regarding the overall safety and effectiveness."
- No human clinical trial data, AI performance metrics, or reader studies are mentioned in this 510(k) summary.
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510(k) Premarket Submission – Medtronic, Inc. - Cardioblate™ System
JUL 17 2003
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Application Information:
| 510(k) No.: | K031247 |
|---|---|
| Date Prepared:Submitter: | April 17, 2003Medtronic, Inc. |
| Address: | 710 Medtronic Parkway, NEMinneapolis, MN 55432-5604 |
| EstablishmentRegistration No. | 2135394 |
| Contact Person: | Scott CundyDirector Regulatory, Clinical & Quality |
| Telephone Number:Fax Number: | (763) 391-9941(763) 391-9279 |
Device Information:
| Trade Name: | Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System | |||||
|---|---|---|---|---|---|---|
| Common Names: | Medtronic® Cardioblate® Bipolar Surgical Ablation System, which consists of:• Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, model 60890• Medtronic® Cardioblate® Bipolar Surgical Ablation Device, models 60821 & 60822 | |||||
| Classification Name: | Electrosurgical Cutting, and Coagulation Device and Accessories | |||||
| Classification: | Class II, 21 CFR 878.4400 | |||||
| Predicate Devices: | Medtronic® Cardioblate® Radiofrequency Ablation System K013392AtriCure Bipolar System K020919 |
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- Device Description: The Medtronic® Cardioblate® Bipolar Radiofrequecy Ablation System is made of bipolar Surgical Ablation Device (Model 60821 & 60822) and a Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator & accessories (Model 60890) for the application of radiofrequency energy to tissue.
The Medtronic® Cardioblate® BP (Bipolar) Surgical Ablation Device, (Model 60821 & 60822) is a hand-held, bipolar, radiofrequency surgical ablation device.
The Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, (Model 60890) is capable of delivering the controlled radiofrequency energy for Bipolar or Monopolar surgical ablation. The Generator delivers in Bipolar mode up to 40 Watts, with a 20 - 350 Ohm range, and a Monopolar mode up to 50 Watts to the delivery device with a 20-500 Ohm range.
- Intended Uses: The Medtronic Cardioblate System is intended to ablate soft tissue during general surgery using radiofrequency energy.
- Contraindications: The Cardioblate® BP Surgical Ablation Device should not be used for patients that have:
Active endocarditis at time of surgery.
Ablation in a pool of blood (e.g., through a purse string suture on a beating heart). Effects of this type of ablation are unknown.
- Nonclinical The performance characteristics of the Medtronic Cardioblate Performance: System were tested and compared to the performance specifications of the listed predicate devices through both bench testing and non-bench analyses.
Substantial For the intended use listed above, the Medtronic Cardioblate Equivanlence System is considered substantially equivalent to the listed Conclusion: predicate devices. The differences that do exist are believed to be minor and not raise any concern regarding the overall safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2003
Mr. Scott Cundy Director Regulatory, Clinical & Quality Medtronic, Inc. 710 Medtronic Parkway, NE Minneapolis, Minnesota 55432-5604
Re: K031247
Trade/Device Name: Medtronic® Cardioblate® Bipolar Radiofrequency Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 17, 2003 Received: April 23, 2003
Dear Mr. Cundy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.'
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Scott Cundy
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: Cardioblate® Bipolar Radiofrequency Ablation System 510(k) Number (if known): KO31247
Indications for Use:
The Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is intended to ablate soft tissue during general surgery using radiofrequency energy.
(Please do not Write below this line - continue on another page if needed)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| Over the Counter Use: | |
|---|---|
| or | |
| Prescription Use: | |
| (Per 21 CFR 801.109) |
(optional format 1-2-96)
Miriam C. Provost
Division of General, Restorative and Neurological Devi
510(k) Number K031247
§ 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.