The Cardioblate® Monopolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate® generator or for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker.

Device Description

The Medtronic Cardioblate® Monopolar Pen is a hand-held, electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy when connected to the Cardioblate 68000 generator along with a return electrode when the operator presses the footswitch. In addition, the Cardioblate Pen can be used with the Medtronic Model 2090/2290 Programmer/Analyzer, and the Medtronic Model 5348/5388 External Temporary Pacemaker. When connected to a ground source, the monopolar pen can sense depolarization's of the ventricle and stimulate (pace) either the atrium or ventricle. The Cardioblate Pen is intended for intermittent operation, is sterile, non-pvrogenic, disposable, and single use only.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Cardioblate Monopolar Pen. It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, it is not possible to fully populate the table and answer all questions directly from the provided document. The document primarily states that the devices were "tested and compared to the performance specification of the Detect Surgical Pacing and Mapping Tool" and "are considered safe and effective per the following standards for Medical Electrical Equipment: Part 1:General Requirements, IEC 60601-1 and, IEC 60601-2-27." However, it does not provide the specifics of these performance specifications or test results.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from text)	Reported Device Performance (from text)
Safe and effective per IEC 60601-1 and IEC 60601-2-27	Passed, considered safe and effective per IEC 60601-1 and IEC 60601-2-27
Equivalent to predicate products in indications for use, basic overall function, and materials.	Performance characteristics were tested and compared to the performance specification of the Detect Surgical Pacing and Mapping Tool; no changes to expand indication for use.
(Specific quantitative criteria for ablation efficacy, pacing, sensing, recording, stimulation are NOT provided)	(Specific quantitative performance metrics are NOT provided)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document states "The performance characteristics of the Cardioblate Monopolar Pen and XL Pen were tested," but does not provide any details about the number of units tested, the types of tests (e.g., bench, animal, clinical), or the sample size of any data collected from these tests.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. This type of information is typically found in human factors or clinical studies, which are not described here. The study described focuses on device performance against standards and predicate specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Adjudication methods are usually relevant for human-read interpretations or clinical endpoints, which are not detailed in this document.

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

Not applicable. This is not an AI-assisted device. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical electrosurgery pen, not an algorithm. The performance described is "standalone" in the sense that the device itself was tested, but "human-in-the-loop" is fundamental to its operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" or reference for performance was based on performance specifications of the predicate device (Medtronic Detect™ Surgical Pacing and Mapping Tool) and adherence to international standards (IEC 60601-1 and IEC 60601-2-27). There is no mention of clinical outcomes, pathology, or expert consensus as ground truth for this type of device performance evaluation.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary

{0}------------------------------------------------

JUN 1 8 2007

510(k) SUMMARY of Safety and Effectiveness K070288

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

I. Applicant Information:

Date Prepared:Submitter:	January 29, 2007Medtronic, Inc.
Address:	710 Medtronic Parkway, NEMinneapolis, MN 55432-5604
EstablishmentRegistration No.	2135394
Contact Person:	Debbie Kidder.Senior Regulatory Affairs Specialist
Telephone Number:Fax Number:	(763) 391-9251(763) 391-9279

II. Device Information:

Trade Name:	Cardioblate® Monopolar Pen, Model 60813 andXL Pen Model 60814
Common Name:	Cardioblate® Surgical Ablation System, which consists of theCardioblate® Surgical Ablation Generator (K060400) andMonopolar Pen (K013392 and K031247)

Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Classification: Class II, 21 CFR 878.4400 Product Code: GEI

The Medtronic Cardioblate® Monopolar Pen is a hand-held, Device Description: electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy when connected to the Cardioblate 68000 generator along with a return electrode when the operator presses the footswitch. In addition, the Cardioblate Pen can be used with the Medtronic Model 2090/2290 Programmer/Analyzer, and the Medtronic Model 5348/5388 External Temporary Pacemaker. When connected to a ground

{1}------------------------------------------------

source, the monopolar pen can sense depolarization's of the ventricle and stimulate (pace) either the atrium or ventricle. The Cardioblate Pen is intended for intermittent operation, is sterile, non-pvrogenic, disposable, and single use only.

The Cardioblate® Monopolar Pen is a sterile, single use Intended Use: electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate generator or for temporary cardiac pacing, sensing, recording and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker.

The Medtronic Cardioblate® System is contraindicated for patients Contraindications: that have active endocarditis at the time of surgery.

Medtronic Detect™ Surgical Pacing and Mapping Tool Predicate Device 1: 510(k) No. K040812, Reg. No. 870.3680; Product Code: LDF

Predicate Device Intended Use: The Medtronic Detect™ Surgical Pacing and Mapping Tool is a handheld, single use device designed to provide temporary cardiac pacing or monitoring.

Atricure Isolator™ Transpolar Pen System Predicate Device 2: 510(k) No. K061593, Reg. No. 878.4400; Product Code: GEI

Predicate Device Intended Use: The Isolator™ Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

Medtronic Cardioblate® Monopolar Pen Predicate Device 3: 510(k) No. K013392 and K031247, Reg. No. 878.4400; Product Code: GEI

The Cardioblate® device is Predicate Device Intended Use: currently indicated to ablate cardiac tissue during general surgery using radiofrequency energy.

{2}------------------------------------------------

III.SUBSTANTIAL EQUIVALENCE SUMMARY

The Cardioblate Monopolar Pen Model 60813 and XL Pen Model 60814 are equivalent to the predicate products in their indications for use, basic overall function and materials. The performance characteristics of the Cardioblate Monopolar Pen and XL Pen were tested and compared to the performance specification of the Detect Surgical Pacing and Mapping Tool. There have been no changes to the Cardioblate Monopolar Pen that is currently marketed today in order to expand the indication for use. The Cardioblate® Monopolar Pens, Model 60813 and XL Pen Model 60814 have been tested and are considered safe and effective per the following standards for Medical Electrical Equipment: Part 1:General Requirements, IEC 60601-1 and, IEC 60601-2-27

Medtronic Cardioblate® Monopolar Pen and XL Pen 510(k) Premarket Notification

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird-like figure with three human profiles incorporated into its design. The profiles appear to be facing towards the right.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic, Inc. c/o Mr. Scott Cundy Senior Director Regulatory and Clinical Medtronic Cardiac Surgery 7601 Northland Drive Minneapolis, MN 55428

Re: K070288

Trade/Device Name: Cardioblate Monopolar Pen model 60813 and Cardioblate XL Monopolar Pen model 60814 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL Dated: May 30, 2007

Dear Mr. Cundy:

This letter corrects our substantially equivalent letter of June 18, 2007.

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 (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 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.

{4}------------------------------------------------

Page 2 - Mr. Scott Cundy

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.

This letter will allow you to continue 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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

{5}------------------------------------------------

Statement of Indications for Use

510(k) Number: Ko"70288

Device Name: Medtronic Cardioblate Surgical Ablation Pen and XL Pen (Models 60813 and 60814)

Indications for use:

Prescription Use (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)

Bhumlamon

Medtronic Cardioblate® Monopola 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.