The Medtronic Cardioblate® Surgical Ablation System consists of a reusable radiofrequency generator which can be connected to hand-held monopolar or bipolar radiofrequency devices. The ablation devices are sterile, single-use devices operating in either monopolar or bipolar mode that deliver radiofrequency energy to the selected tissue.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) submission (K093203) is for a Special 510(k) BP2 Saline Line Modification for the Medtronic Cardioblate® Surgical Ablation System. Crucially, Special 510(k)s are filed for modifications to a manufacturer's own legally marketed device, where the modification does not affect the device's indications for use or its fundamental scientific technology. This typically means that clinical testing is not required to establish substantial equivalence because the changes are minor and do not raise new questions of safety or effectiveness.

Therefore, the information you're asking for, which is common for new device submissions or significant modifications requiring clinical trials, is largely not applicable in this context. The study performed is a justification that the modification itself is safe and effective, not a study of the overall device's clinical performance against acceptance criteria.

Summary of Acceptance Criteria and Device Performance (Not Applicable for Clinical Performance)

Acceptance Criteria (Related to Saline Line Modification)	Reported Device Performance (Related to Saline Line Modification)
Biocompatibility of new PVC formulation without DEHP	Met: Biocompatibility testing confirmed the new material is safe for patient contact.
Maintenance of device performance over time (shelf life)	Met: Accelerated aging study demonstrated continued performance over the expected shelf life.
Maintenance of identical indicated use	Met: Indicated use is unchanged.
Maintenance of identical operating principle	Met: Operating principle is unchanged.
Maintenance of identical radiofrequency generator and delivery system	Met: Generator and delivery system remain the same.
Maintenance of identical packaging and sterilization processes	Met: Packaging and sterilization processes remain the same.

Detailed Breakdown for K093203:

A table of acceptance criteria and the reported device performance:
(See table above). The acceptance criteria for this specific submission relate to demonstrating that the modification (change in PVC formulation for the saline line cable assembly) does not negatively impact the device's safety or fundamental performance, and that it maintains substantial equivalence to the predicate device.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
For Biocompatibility Testing and Accelerated Aging Study, the sample sizes would refer to the number of modified saline line cable assemblies or components tested. These are bench tests, not human studies. The document does not specify the exact sample sizes, but such tests are typically conducted in vitro (bench/lab-based). Data provenance would be related to the Medtronic's testing facilities (likely in the US, given the submission location). The studies are prospective in the sense that they are conducted specifically for this modification.
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. As clinical testing was not required, there was no "ground truth" to establish through expert consensus for a clinical assessment. The "experts" involved would be Medtronic's engineers and scientists conducting the biocompatibility and accelerated aging tests, evaluating the results against established standards (e.g., ISO standards for biocompatibility).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not Applicable. Adjudication methods are typically for subjective clinical endpoints or image interpretation. These were objective bench tests.
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:
Not Applicable. This device is a surgical ablation system, not an AI-powered diagnostic device. No MRMC studies were performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a hardware modification for a medical device; there is no "algorithm" in the sense of AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the biocompatibility testing, the "ground truth" is compliance with biocompatibility standards (e.g., ISO 10993 series), meaning no toxic or harmful reactions. For the accelerated aging study, the "ground truth" is the physical and functional integrity of the device components (e.g., material strength, electrical conductivity, seal integrity) after simulated aging, demonstrating it meets pre-defined engineering specifications.
The sample size for the training set:
Not Applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
Not Applicable. (As above, no training set).

Conclusion from the document:

The manufacturer concluded that the modifications to the saline line cable assembly result in a "substantially equivalent device because the fundamental scientific principle, labeling, and the intended use are unchanged as a result of these device modifications." The FDA concurred with this assessment, granting 510(k) clearance based on the provided bench test data.

Summary

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K093203 1/2

Special 510(k) BP2 Satine Line Modification

FEB 2 6 2010

510(k) Summary ·

Date Prepared	October 9, 2009
Submitter	Medtronic710 Medtronic Parkway NEMinneapolis, MN 55432-5604Establish Registration Number: 2135394
Contact Person	Mary E. DonlinSenior Regulatory Affairs SpecialistPhone: (763) 526-9172Fax: (763) 367-8147Email: mary.e.donlin@medtronic.com

and the control control of the control of the control of

Device Name and Classification

Trade Name:	Cardioblate® Surgical Ablation System
Common/Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number:	21 CFR 878.4400
Product Code:	GEI
Classification:	Class II

Predicate Device

Cardioblate® Surgical Ablation System (K080509)

Device Description

Indications for Use

The Medtronic Cardioblate® System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

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KU93203 2/2

Comparison to Predicate Device

A comparison of the modified product and the currently marketed surgical ablation device has the following similarities to the system which received 510(k) clearance:

· Same indicated use
· Same operating principle
· Same radiofrequency generator and delivery system
· Similar patient-contacting materials, with the exception of the change in PVC formulation to remove DEHP
· Same shelf life for disposables
· Patient-contacting devices are packaged and sterilized using identical materials and processes

Labeling and Intended Use

The labeling and intended use are unchanged as a result of the modification to the saline line cable assembly. The Instructions for Use and Labeling can be provided upon request.

Summary of Performance Data

Biocompatibility and performance bench test data were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. The following performance tests were condusted:

. Biocompatibility Testing
. Accelerated Aging Study

Conclusion

The modifications to the saline line cable assembly used with the Cardioblate® Surgical Ablation device described in this submission result in a substantially equivalent device beauxe the fundamental scientific principle, labeling, and the intended use are unchanged as a result of these device modifications.

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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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

FEB 2 6 2010

Medtronic Cardiovascular c/o Mary E. Donlin Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K093203

Trade/Device Name: Cardioblate Surgical 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: December 29, 2009 Received: January 29, 2010

Dear Ms. Donlin:

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, 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

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Paqe 2 ~ Ms. Mary E. Donlin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K093203 1/1

Special 510(k) BP2 Saline Line Modification

INDICATIONS FOR USE STATEMENT

5 10(k) Number:

Cardioblate Surgical Ablation System, consisting of the Cardioblate®68000 Generator (K060400) and the following ablation devices: Cardioblate®BP2 Surgical Ablation Device, Model 60831 and 68031 (K060400 & K080509) Cardioblate®LP Surgical Ablation Device, Model 60841 (K060400)

Indications for use:

The Medtronic Cardioblate® System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

These devices are already labeled with the proposed indication statement. .
OR

Prescription Use X (Part 21 CPR 801 Subpart D) Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.R.M.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K093203

Regulation Number and Section

§ 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.