The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Device Description

The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead which contains a distal, discrete, ring electrode (1), a discrete, tip electrode (2); and a coaxial conductor lead body (3). Each discrete electrode is crimped onto a conductor and terminates in an atraumatic, myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins (6). To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device: the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead. This document is focused on establishing "substantial equivalence" to a predicate device, specifically due to a material change in a component (shrink band).

The information requested in the prompt, particularly regarding acceptance criteria and studies proving device performance in the context of AI/machine learning (e.g., ground truth, expert consensus, MRMC studies, training/test set sample sizes), is not present in this document. This document pertains to a traditional medical device (a pacing lead), not an AI-enabled one. Therefore, the questions related to AI-specific performance metrics, ground truth establishment, and training/test sets are not applicable to the content provided.

The document primarily focuses on:

Device Description: What the pacing lead is and how it functions.
Intended Use: Temporary post-surgical pacing for 7 days or less.
Comparison to Predicate Device: Emphasizing similarity in intended use, performance (claimed as substantially equivalent), principles of operation, technology, design, and materials.
Description of Change: The specific change being submitted – a material change to the shrink band.
Summary of Testing: Only lists "Biocompatibility" and "Manufacturability" tests for the new shrink band material, both of which "Passed." These are standard tests for material changes in medical devices, not performance studies of an AI algorithm.
Conclusion: States that the device is substantially equivalent to the legally marketed predicate device based on the data submitted.

To directly answer your prompt based only on the provided text, many fields will be "Not Applicable" or "Not Provided" because the document describes a physical medical device, not an AI/ML algorithm.

Here's how the provided information maps to your questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility (for new shrink band material)	Passed
Manufacturability (for new shrink band material)	Passed
Substantial Equivalence to Predicate Device	Concluded as Substantially Equivalent
Safety and Effectiveness (implied by 510(k) process)	Concluded as having reasonable assurance of safety and effectiveness

Note: The document doesn't explicitly state quantitative acceptance criteria beyond "passed" for the listed tests. The overarching "acceptance criterion" for a 510(k) is demonstrating substantial equivalence.

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

Sample Size: Not specified for any testing. The testing summary is very high-level ("Tests conducted").
Data Provenance: Not specified.
Retrospective or Prospective: Not applicable, as this refers to clinical study design which is not detailed here for this device.

3. 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. This document describes a physical pacing lead, not an AI/ML device requiring expert-established ground truth for image/data interpretation.

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

Not Applicable. This refers to expert consensus in AI/ML performance evaluation, which is not relevant here.

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

No. An MRMC study is not relevant for this type of device.

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

Not Applicable. This refers to AI/ML algorithm performance.

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

Not Applicable. Ground truth, in the context of AI/ML, is not relevant for the testing described for this physical device. The "ground truth" for the device's function would be its demonstrated physical and electrical properties, and biocompatibility, as tested in labs, not human interpretation or outcomes analysis as in an AI study.

8. The sample size for the training set

Not Applicable. There is no AI training set for this device.

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

Not Applicable. There is no AI training set or ground truth establishment relevant to AI for this device.

Summary

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

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2016

Medtronic Debra Taitague Regulatory Affairs Specialist 1801 East Deere Ave Santa Ana, California 92705

Re: K161249

Trade/Device Name: Streamline 6495 Bipolar Temporary Myocardial Pacing Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: July 20, 2016 Received: July 21, 2016

Dear Debra Taitague:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M.G. Willemann

for

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

Enclosure

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

Indications for Use

510(k) Number (if known) K161249

Device Name

Streamline 6495 Bipolar Temporary Myocardial Pacing Lead

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

7.0 510(k) Summary

Date Prepared:	May 02, 2016
Applicant:	MedtronicMedtronic Heart Valve Division1851 East Deere AveSanta Ana, CA 92705
Contact Person:	Debra TaitagueRegulatory Affairs SpecialistMedtronicPhone: (234) 248 4186Fax: (949) 553 8983Email: debra.a.taitague@medtronic.comAlternate ContactDonna SaitoSr. Regulatory Affairs ManagerMedtronicPhone: (949) 399 1675Fax: (949) 553 8983Email: donna.y.saito@medtronic.com
Trade Name:	Streamline 6495 Bipolar Temporary Myocardial PacingLead Electrode
Classification Name:	Temporary Pacing Lead
Regulation Number:	21 CFR 870.3680(a)
Product Classification:	Class II
Product Code:	LDF
Name of PredicateDevice	Streamline 6495 Bipolar Temporary Myocardial Pacing Lead

Device Description

The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead (see Figure 1) which contains a distal, discrete, ring electrode (1), a discrete, tip electrode (2); and a coaxial conductor lead body (3). Each discrete electrode is crimped onto a conductor and terminates in an atraumatic, myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall.

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

Terminated on the back of the chest needle are two breakaway connector pins (6). To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

Image /page/4/Figure/1 description: The image shows a medical device with several labeled components. The components include a ring electrode labeled as 1, a tip electrode labeled as 2, and a coaxial conductor lead body labeled as 3. Additionally, there is a curved needle labeled as 4, a chest needle labeled as 5, and breakaway connector pins labeled as 6.

Figure 1: Model 6465

Indication for Use

Contraindications

There are no known general contraindications to temporary postsurgical pacing. The particular medical condition and anatomy of the patient, however, may dictate the lead system and implantation procedure to be used.

Comparison to Predicate Device

A comparison of the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is being made to the current marketed predicate device: the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead and listed below indicates the following similarities:

Intended Use: The intended use is the same as the predicate
Performance: The performance is substantially equivalent to the predicate device.
Principles of Operation and Technology: The principles of operation are the same as the o predicate device.
. Design: The overall design is the same as the predicate features

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

o Materials: The material types used are the same as the predicate

Description of Change

The purpose of this Premarket notification submission is to notify FDA of the proposed material change made to the formulation of the shrink band material. The current supplier, Vesta Thermoplastic Division informed Medtronic that their raw material supplier will no longer provide them with the raw material resins.

Summary of Testing

Testing has demonstrated that the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is substantially equivalent to the predicate. Presented in Table 7-1 are the tests conducted:

Table 7-1: Tests conducted

Component	Base Material Change	Verification Validation	Results
Shrink Band	Current: Polyolefin	Biocompatibility	Passed
	Proposed: Polyolefin	Manufacturability	Passed

Conclusion

The data included in this submission is sufficient in providing reasonable assurance of the safety and effectiveness of the device and the Streamline 6495 Bipolar Temporary Myocardial Pacing lead is substantially equivalent to the legally marketed predicate device, the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead.

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.