The Model 6495 bipolar temporary myocardial pacing lead is designed for temporary atrial and ventricular pacing and sensing, for a maximum of 7 days, during and after cardiac surgery. The Model 6495 bipolar temporary myocardial pacing lead is intended for SINGLE USE ONLY.

Device Description

The bipolar temporary myocardial pacing wire, Model 6495 consists of a distal electrode, and a coaxial conductor which are crimped together. A blue polypropylene fiber proximally coiled (flattered coil) for fixation of the lead is attached to the distal electrode and terminated in an atraumatic curved needle. An atraumatic breakaway chest needle at the other end of the conductor wire permits running the lead through the chest wall. Proximal to the chest needle is a connector ring crimped to the conductor wire. After removal of the pacing wire, which is performed by gentle traction, no part of the wire remains in the body.

AI/ML Overview

The provided text describes a 510(k) submission for the Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Wire. This submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove performance as would be seen for novel devices or software.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly define numerical acceptance criteria for "device performance" in terms of clinical outcomes or specific thresholds for functionality. Instead, it relies on demonstrating that the device meets "specified requirements" through integrity testing and is substantially equivalent to existing, legally marketed predicate devices.

Acceptance Criteria Category	Reported Device Performance (Summary)
Visual Verification	Met specified requirements
X-ray & Dimensional Verification	Met specified requirements
Electrical Verification	Met specified requirements
Pull Strength Verification	Met specified requirements
Flex Life Verification	Met specified requirements
Connector Compatibility	Met specified requirements
Break Moment of Thorax Needle	Met specified requirements
Substantial Equivalence	Demonstrated to predicate devices (Model 6500, TME 65 C) based on technological characteristics and integrity testing.

Note: The specific "specified requirements" (e.g., exact pull strength values, dimensional tolerances) are not detailed in this summary document.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size used for the device integrity testing (e.g., how many units were subjected to pull strength or flex life tests). It also does not provide information on the data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are engineering tests on the device itself, not clinical data.

Summary:

Sample Size for Test Set: Not specified.
Data Provenance: Not applicable in the context of device integrity tests; these are laboratory engineering tests.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to this type of 510(k) submission. The "ground truth" here is the device's adherence to engineering specifications and comparison to predicate device characteristics. Experts typically establish ground truth in clinical studies involving interpretation (e.g., radiologists for imaging, pathologists for tissue samples), which is not the nature of the presented device integrity testing.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert disagreement on ground truth needs to be resolved. This is not relevant for the device integrity testing described, as the tests (e.g., pull strength, electrical verification) have objective pass/fail criteria based on engineering specifications.

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

No MRMC study was conducted or mentioned. This is a medical device (pacing wire), not an AI/software device that assists human readers.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device integrity testing was based on engineering specifications and established test methodologies to ensure the device met its design requirements and was comparable to predicate devices. For substantial equivalence, the "ground truth" was a comparison of technological characteristics to existing devices (Medtronic Model 6500 and Oscor Model TME 65 C).

8. Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train machine learning models. This document describes a physical medical device undergoing engineering integrity tests, not an AI/ML product.

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

Not applicable, as there is no training set for a physical medical device.

Summary

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MEDTRONIC CONFIDENTIAL

G: 510(K) SUMMARY

1. SUBMITTER'S NAME, ADDRESS

Susan M. Noddin Associate Product Regulation Manager Medtronic, Inc. 7000 Central Avenue NE Minneapolis, MN 55432 Phone: (612) 574-6191 Fax: (612) 574-6424

JUL 22 1997

2. TRADE NAME:	Bipolar temporary myocardial pacing wire, Model 6495
Common Name:	Temporary Pacing Lead
Classification Name:	Temporary Pacemaker Electrode
Classification	This device has been classified by the Circulatory SystemsDevice Panel into Class II, (21 CFR 870.3680(a)).
3. SUBSTANTIALLYEQUIVALENT DEVICE(S)	Temporary Myocardial Pacing Wire, Medtronic Model6500, marketed via K944957Bipolar temporary Myocardial Heart Wire, Oscor ModelTME 65 C, marketed via K850622

4. DEVICE DESCRIPTION

After removal of the pacing wire, which is performed by gentle traction, no part of the wire remains in the body.

5. INDICATIONS FOR USE

The bipolar temporary myocardial pacing wire, Model 6495 is designed for temporary atrial and ventricular pacing and sensing, for a maximum of the days, during and after cardiac surgery. The Model 6495 is intended for single use only.

6. TECHNOLOGICAL CHARACTERISTIC COMPARISONS

The bipolar temporary myocardial pacing wire, Model 6495 is substantially equivalent to the following products:

Unipolar temporary myocardial pacing wire, Medtronic Model 6500, marketed via K944957 .
Bipolar temporary myocardial heart wire, Oscor Medical Corporation Model TME 65 C, marketed via ● K850622

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MEDTRONIC CONFIDENTIAL

The table below contains a comparison of the similarities and differences of the Model 6495 to the predicate devices to which it is substantially equivalent. Similarities between the Model 6495 and the comparison devices are noted.

The bipolar temporary myocardial pacing wire, Model 6495 contains technologies comparable to Medtronic, Inc. temporary myocardial pacing lead, Model 6500. The proximal end of the Model 6495 ends in a straight chest needle, similar to the Model 6500. The conductor wire material is stainless steel, identical to that of the Model 6500 and the Oscor Model TME 65 C. The insulation materials for the Model 6495 are identical to the Model 6500 and the Model TME 65 C. The distal end is identical to the Model 6500, and similar to the Model TME 65 C. The Model 6495 utilizes the double pouch package configuration, identical to that utilized by the Model 6500. The Model 6495 uses the same 100% EtO sterilization process as the Model 6500. The Model 6495 is a bipolar heartwire, as is the Model TME 65 C myocardial heartwire.

Manufacturer	Medtronic	Oscor Medical	Medtronic
Model No.	6495	TME 65 C	6500
510(k) Number		K850622	K944957
Intended Use	TemporaryMyocardial Pacingand Sensing	Same	Same
	Bipolar	Bipolar	Unipolar
Electrode	Two discreteelectrodes	Ring electrode andwire	Tip
Electrode andConductor Material	Stainless Steel	Same	Same
Fixation Mode	"Pigtail" Coil	Zigzag and suturing	"Pigtail" Coil
Outer InsulationMaterial	Polyethylene	Same	Same
Insulated WireDiameter (nominal)	0.7mm	0.45 mm	0.7mm
Proximal NeedleShape and
Breakaway FeatureSize (nominal)	StraightBreakawayL = 88mmD = 1.0mm	Slightly curvedL= 80mmD = 1.12 mm	StraightBreakawayL = 90 mmD = 1.0 mm

Distal NeedleShapeSize (nominal)	3/8CurvedL = 32mmD = 0.38mm	1/2CurvedL=16mmD = 0.52 mm	3/8CurvedL = 25mmD = 0.66mm
Sterile Package
Configuration	Blister/Pouch	Pouch/Pouch	Blister/Pouch
Sterile PackagingMaterials	spunboundedolefin-PE/Polyester	not known	spunbounded olefin-PE/Polyester
Sterilization &Aeration Process	100% EtO	not known	100% EtO

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MEDTRONIC CONFIDENTIAL

7. SUMMARY OF STUDIES

Medtronic, Inc. performed device integrity testing to support the bipolar temporary myocardial pacing wire, Model 6495 is substantially equivalent to the predicate devices.

Device integrity testing included:

Visual verification ●
X-ray & Dimensional verification .
Electrical verification .
Pull strength verification .
Flex life verification
Connector compatibility
Break moment of thorax needle .

All device integrity test results for the bipolar temporary myocardial pacing wire, Model 6495 met specified requirements.

8. CONCLUSION (STATEMENT OF EQUIVALENCE)

Through the data and information provided in this submission, numerous similarities support a substantial equivalence determination, and, therefore, clearance of the 510(k) notification for the bipolar temporary myocardial pacing wire, Model 6495.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Ms. Susan Noddin Product Regulation Manager Medtronic, Inc. Mediconic, The .
7000 Central Avenue, N.E. . . . . . JUL 2 2 1997 Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minn

Re: K963898 Model 6495 Bipolar Temporary Pacing Lead Regulatory Class: III (three) Product Code: LDF Dated: April 24, 1997 Received: April 25, 1997

Dear Ms. Noddin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval) , it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Medtronic Confidential

K963898

Indications For Use

INDICATIONS FOR USE

Tu-A-Ryp

(Division Sign-Off) Division of Cardiovascular, Respirato and Neurological Devices 4963898 510(k) Number_

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Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.