The Medtronic Cardioblate® 68000 Generator is a reusable, non-sterile radiofrequency generator. In bipolar mode, the generator is attached to a bipolar Surgical Ablation Device (e.g. Model 60831 or 60841), which is the hand-held, sterile, single-use device that applies radiofrequency energy to the selected tissue. The Cardioblate® 68000 Generator is capable of delivering a controlled amount of radiofrequency energy for both Monopolar and Bipolar surgical ablation techniques. The generator delivers up to 50 Watts energy in either the bipolar or monopolar mode.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Cardioblate® 68000 Generator. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report with specific performance metrics typically found in clinical efficacy or standalone performance studies for new technologies.

Therefore, much of the requested information regarding acceptance criteria, specific performance statistics, sample sizes for test and training sets, expert qualifications, and adjudication methods is not explicitly available in this summary. The summary focuses on the comparison to a predicate device and the verification and validation (V&V) of the new generator.

Here's an attempt to extract and infer information based on the provided text, while also explicitly stating what is not available:

Acceptance Criteria and Study for Medtronic Cardioblate® 68000 Generator

The Medtronic Cardioblate® 68000 Generator is presented as substantially equivalent to its predicate device, the Cardioblate® Bipolar Radiofrequency Ablation System (K031247). The primary "acceptance criteria" presented here revolve around demonstrating this substantial equivalence through verification and validation testing, ensuring the new generator performs comparably to the predicate and meets general safety and performance standards for electrosurgical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary)
Functional Equivalence: The Cardioblate® 68000 Generator delivers the same amount of radiofrequency energy and uses the same algorithms as the predicate device. Ensures comparable energy output for ablation.	"The Generator uses the same energy source to deliver the same amount of radiofrequency energy to ablate tissues, and uses the same surgical ablation devices." "Although both generators use the same algorithms to operate, the Model 68000 Generator is updated to include a touchscreen interface, an updated microprocessor and a molded, ergonomic case."
Lesion Equivalence: The device, when used with specified ablation devices, produces equivalent lesions to the predicate system in tissue.	"lesion equivalence...tests on tissue with the entire system." (Implies successful demonstration but no specific metrics are provided.)
Transmurality Equivalence: The device achieves equivalent transmurality (penetration through tissue layers) compared to the predicate system.	"transmurality equivalence tests on tissue with the entire system." (Implies successful demonstration but no specific metrics are provided.)
Software Validation: The updated software for the touchscreen interface and microprocessor functions correctly and safely.	"software validation"
Hardware Qualification: The updated hardware components (microprocessor, molded case) meet design specifications and safety requirements.	"hardware qualification"
Electromagnetic Compatibility (EMC): The device operates without causing or being susceptible to electromagnetic interference.	"electromagnetic compatibility"
Safety Testing: The device meets all relevant electrical and patient safety standards.	"safety testing on the generator"
Intended Use: The device is suitable for its intended use of ablating soft tissue during general surgery using radiofrequency energy.	The "Intended Use" statement is identical to the predicate device.

Missing Information: Specific quantitative thresholds or statistical metrics for "equivalence" (e.g., within X% of predicate) are not provided in this summary. The summary confirms that testing was done and confirmed equivalence, but not the detailed results.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "lesion equivalence and transmurality equivalence tests on tissue," implying an in vitro or ex vivo test environment.
Data Provenance: The tests were conducted as "Verification and validation testing" by the manufacturer (Medtronic). There's no mention of country of origin for data beyond the implied in-house testing. The nature of these tests (lesion and transmurality equivalence) suggests in vitro or ex vivo lab studies rather than clinical trials. Therefore, it is retrospective as it refers to performance specifications to be met rather than clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For lesion and transmurality equivalence in tissue, "ground truth" would likely be established through histological analysis by pathologists or specialized technicians, or by direct physical measurement by engineering or medical staff. However, no details are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified. This type of performance testing (lesion size, transmurality) usually involves direct physical measurement or objective histological assessment rather than subjective expert review requiring adjudication in the way clinical image interpretation studies do.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, where human readers interpret medical images with and without AI assistance. This device is an electrosurgical generator, and its performance is evaluated through physical characteristics (power output, lesion size) and safety parameters, not through human interpretation of cases.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Standalone Study: Yes, in a sense. The "Verification and validation testing" on the generator and "lesion equivalence and transmurality equivalence tests on tissue with the entire system" constitute a standalone evaluation of the device's functional performance against established parameters (likely derived from the predicate device). The performance discussed relates to the device's physical output and effect on tissue, not an AI algorithm's interpretive ability.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the "lesion equivalence and transmurality equivalence tests on tissue" would likely be:
- Direct Measurement: Physical dimensions (length, width, depth) of the lesions created in tissue.
- Histopathology: Microscopic examination of tissue samples to confirm lesion characteristics, cellular damage, and transmurality.
- Known Electrical Output: Verification of the generator's energy delivery based on established electrical engineering principles.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This device is an electrosurgical generator, not an AI algorithm that "learns" from a training set. The "algorithms" mentioned refer to the control logic within the generator for delivering radiofrequency energy, which are programmed, not trained with data in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. As noted above, this device does not use a training set in the context of machine learning. The algorithms are programmed based on engineering principles and knowledge of radiofrequency energy delivery in biological tissue, reflecting established medical device design practices.

Summary

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FEB 2 8 2006 KD60400

Page 1 of 2

510(k) SUMMARY of Safety and Effectiveness

(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)

I. Applicant Information:

Date Prepared:Submitter:	February 3, 2006Medtronic, Inc.
Address:	710 Medtronic Parkway, NEMinneapolis, MN 55432-5604
EstablishmentRegistration No.	2135394
Contact Person:	David D. Cox, Ph.D.Senior Principal Regulatory Affairs Specialist
Telephone Number:	(763) 391-9251
Fax Number:	(763) 391-9279

II. Device Information:

Trade Name:	Cardioblate® 68000 Generator
Common Name:	Cardioblate® Surgical Ablation System, which consists of:• Cardioblate® 68000 Generator
	Which can be used with:• Cardioblate® BP2 Surgical Ablation Device, model 60831• Cardioblate® LP Surgical Ablation Device, model 60841• Cardioblate® Monopolar Pens (K013392)
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Classification:	Class II, 21 CFR 878.4400
Product Code:	GEI
Predicate Device:	Cardioblate® Bipolar Radiofrequency Ablation System510(k) No. K031247, Reg. No. 878.4400; Product Code: GEI
	Predicate Device Intended Use: The Medtronic CardioblateSystem is intended to ablate soft tissue during general surgeryusing radiofrequency energy.

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K060 400

Page 2 of 2

The Medtronic Cardioblate® 68000 Generator is a reusable, non-Device Description: sterile radiofrequency generator. In bipolar mode, the generator is attached to a bipolar Surgical Ablation Device (e.g. Model 60831 or 60841), which is the hand-held, sterile, single-use device that applies radiofrequency energy to the selected tissue.
The Cardioblate® 68000 Generator is capable of delivering a controlled amount of radiofrequency energy for both Monopolar and Bipolar surgical ablation techniques. The generator delivers up to 50 Watts energy in either the bipolar or monopolar mode.
The Cardioblate® Surgical Ablation System is intended to ablate Intended Use: soft tissue during general surgery using radiofrequency energy.
The Cardioblate® Surgical Ablation System is contraindicated for Contraindications: patients that have active endocarditis at the time of surgery.
The Cardioblate® Surgical Ablation System with the model 68000 Predicate Device: Generator is substantially equivalent to the Cardioblate" Surgical Ablation System with the Model 60890 Generator cleared by K031247. The Generator uses the same energy source to deliver the same amount of radiofrequency energy to ablate tissues, and uses the same surgical ablation devices. Although both generators use the same algorithms to operate, the Model 68000 Generator is updated to include a touchscreen interface, an updated microprocessor and a molded, ergonomic case.
Verification and validation testing confirms that the functional Test Data: characteristics of the Cardioblate Surgical Ablation System with the Cardioblate® 68000 Generator are substantially equivalent to the predicate devices cited. This included software validation, hardware qualification, electromagnetic compatibility and safety testing on the generator, and lesion equivalence and transmurality equivalence tests on tissue with the entire system.
Based on the technical information, intended use, laboratory Summary: verification tests and in vitro performance information provided, the system which includes the Cardioblate® 68000 in substantially equivalent to the currently marketed predicate device.

Comparison to

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2006

Medtronic, Inc. c/o Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062

Re: K060400

Trade/Device Name: Medtronic Cardioblate® 68000 Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 10, 2006 Received: February 15, 2006

Dear Ms. Ankova:

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.

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 - Ms. Ankova

This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle will anow you to begin manieting of substantial equivalence of your device to a legally premarket nonifeddom "Te 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 If you desire specific at no 10-10-10-115. Also, please note the regulation entitled, Comation of Ornec of Compilance and Ert notification" (21 CFR Part 807.97). You may obtain Whisoranding of Torerence to promesponsibilities under the Act from the Division of Small other general mionnational and Consumer Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and ddress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

fa Mark N. Melkerson, M.S.
Acting Director
Division of General, Restorative and
Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number:

K 060400

Device Name: Medtronic Cardioblate® 68000 Generator

Indications for use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) OR 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)

Q.MDL

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

长060400 510(k) Number_

Medtronic Cardioblate® 68000 Generator 510(k) Premarket Notification

Section 4 - Page 1

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.