The Chandler Transluminal V-Pacing Probe is indicated for temporary ventricular pacing when used with a Swan-Ganz Paceport or A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraventricular ECG detection (during placement).

The Flex-Tip Transluminal A-Pacing Probe is indicated for temporary emergency atrial pacing or sequential A-V pacing when used with a Swan-Ganz A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraatrial ECG detection (during placement).

Device Description

The Chandler Transluminal V-Pacing Probe and the Flex-Tip Transluminal A-Pacing Probe are 2.4F probes indicated for temporary emergency pacing of either the ventricle or atrium.

The Chandler Transluminal V-Pacing probe is a 2.4F pacing probe with a straight distal electrode tip for emergency temporary ventricular pacing when connected to an external pulse generator.

The Flex-Tip Transluminal A-Pacing probe is a 2.4F pacing probe with a 'J' tip distal electrode for emergency temporary atrial or A-V sequential pacing when connected to an external pulse generator.

AI/ML Overview

The provided document describes the Chandler Transluminal V-Pacing Probe and the Flex-Tip Transluminal A-Pacing Probe. It outlines a comparison to a predicate device and states that the new devices successfully passed functional-performance and biocompatibility testing. However, it does not provide specific acceptance criteria or detailed results of a study as typically performed for diagnostic or AI-based devices.

Therefore, many of the requested elements cannot be extracted from this document, as it focuses on the substantial equivalence of pacing probes rather than the performance of a diagnostic algorithm or device with measurable performance metrics against a defined ground truth.

Here's a breakdown of what can and cannot be answered:

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

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for the pacing probes. Instead, the "acceptance criteria" are implied by successful completion of various tests showing "substantial equivalence" to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Material biocompatibility in compliance with ISO 10993 standards	Successfully passed
Functional-performance testing	Successfully passed
Safety testing	Successfully passed
Substantial equivalence to predicate device (K813521)	Shown to be substantially equivalent for intended use

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

This information is not provided in the document. The document refers to "material biocompatibility testing" and "functional-performance testing" but does not specify sample sizes or data provenance for these tests. For a pacing probe, this usually involves lab testing or animal studies, not a "test set" in the context of diagnostic data.

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)

This information is not applicable/provided. The ground truth for a pacing probe's performance would be established by engineering and physiological standards, not expert consensus on diagnostic images or data.

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

This information is not applicable/provided. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving interpretation, which is not the nature of the testing described 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

This information is not applicable/provided. This type of study relates to AI-assisted diagnostic tools, not pacing probes.

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

This information is not applicable/provided. This device is a pacing probe, not an algorithm.

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

The ground truth for the testing of these pacing probes would be established by engineering specifications, physiological compatibility, and material science standards. This is inferred from the mention of "applicable ISO 10993 requirements" and "functional-performance testing."

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" for a physical device like a pacing probe.

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

This information is not applicable/provided. As above, there is no "training set."

Summary of the Study:

The study described is a comparative analysis to demonstrate substantial equivalence of the Chandler Transluminal V-Pacing Probe and the Flex-Tip Transluminal A-Pacing Probe to the predicate device K813521 Transluminal™ BiPolar Pacing Probe. This was achieved through:

Material biocompatibility testing: In compliance with applicable ISO 10993 requirements.
Functional-performance testing: To assess the device's operational capabilities.
Safety testing: To ensure the device is safe for its intended use.

The document states that these tests were successfully passed, indicating that the fundamental scientific technology remains unchanged and the devices are safe, effective, and substantially equivalent to the predicate device. The nature of this submission is not for a diagnostic device, particularly one involving AI or interpretation of data, but rather for a physical medical device.

Summary

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Public Health Service

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

October 15, 2015

Edwards Lifesciences, LLC Deana Boushell Sr. Principal Project Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K152633

Trade/Device Name:	Chandler Transluminal Bipolar Pacing Probe, Flextip TransluminalBipolar Pacing Probe
Regulation Number:	21 CFR 870.3680
Regulation Name:	Cardiovascular Permanent or Temporary Pacemaker Electrode
Regulatory Class:	Class II
Product Code:	LDF
Dated:	September 14, 2015
Received:	September 15, 2015

Dear Deana Boushell:

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 device

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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 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 yours.

Mitchell Stein

for 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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Indications for Use

510(k) Number (if known) K152633

Device Name Bipolar Transluminal Pacing Probes

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)

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SECTION 5 - 510(k) SUMMARY

	Chandler™ Transluminal V-Pacing Probe and
Flex-Tip™ Transluminal A-Pacing Probe
510(k) Submitter	Edwards Lifesciences, LLC
EstablishmentRegistrationNumber	2015691
Address	One Edwards WayIrvine, CA 92614Phone: 949-250-2500
Contact Person	Deana M. Boushell RACSenior Principal Project Manager, Regulatory AffairsDirect Line: 949-250-4472email: deana_boushell@edwards.comFAX: 949-809-2967
Date Prepared	September 14, 2015
Trade Names	Chandler Transluminal V-Pacing ProbeFlex-Tip Transluminal A-Pacing Probe
Common Name	Pacing Probe
ClassificationName	Electrode, Pacemaker, Temporary21 CFR 870.3680(a), Product Code LDF
RegulationClass/ProductCode	Class IILDF
Predicate Device(s)	K813521 Transluminal™ BiPolar Pacing Probe (cleared March 15, 1982)
Device Description	The Chandler Transluminal V-Pacing Probe and the Flex-TipTransluminal A-Pacing Probe are 2.4F probes indicated for temporaryemergency pacing of either the ventricle or atrium.
Models	Chandler Transluminal V-Pacing Probe Model: D98100Flex-Tip Transluminal A-Pacing Probe Model: D98500
Device Characteristics
Indications forUse/Intended Use	The Chandler Transluminal V-Pacing Probe is indicated for temporaryemergency ventricular pacing when used with a Swan-Ganz Paceport orA-V Paceport catheter, and can be inserted with or without the aid offluoroscopy. The probe can also be used for intraventricular ECGdetection (during placement).The Flex-Tip Transluminal A-Pacing Probe is indicated for temporaryemergency atrial pacing or sequential A-V pacing when used with aSwan-Ganz A-V Paceport catheter, and can be inserted with or withoutthe aid of fluoroscopy. The probe can also be used for intraatrial ECGdetection (during placement).
Environment ofUse	The system is intended for use by a trained clinician in a hospital orother appropriate clinical setting.
Device Description	The Chandler Transluminal V-Pacing probe is a 2.4F pacing probe witha straight distal electrode tip for emergency temporary ventricular pacingwhen connected to an external pulse generator.The Flex-Tip Transluminal A-Pacing probe is a 2.4F pacing probe with a'J' tip distal electrode for emergency temporary atrial or A-V sequentialpacing when connected to an external pulse generator.
Key PerformanceSpecifications/Characteristics ofthe Device	The Chandler Transluminal V-Pacing probe and the Flex-TipTransluminal A-Pacing probe have a total usable length of 135 cm and ausable length of 15 cm in either the ventricle or atrium. The devicesincorporate an electrode pair that is comprised of stainless steel withadequate surface area to depolarize the cardiac tissue.
ComparativeAnalysis	Material biocompatibility testing in compliance with applicable ISO 10993requirements, and performance testing was conducted to compare thesubject devices to the predicate device. The results of the testingindicate that the fundamental scientific technology of the proposeddevices remain unchanged from the legally marketed predicate device.The proposed change to the Chandler Transluminal V-Pacing probe andthe Flex-Tip Transluminal A-Pacing probe has been shown to be safe,effective, and substantially equivalent to the predicate device (K813521Transluminal BiPolar Pacing Probe) for its intended use.
Functional/ SafetyTesting	The Chandler Transluminal V-Pacing probe and the Flex-TipTransluminal A-Pacing probe have successfully passed functional-performance testing and biocompatibility testing, in accordance withapplicable consensus standards.
Conclusion	The Chandler Transluminal V-Pacing Probe and the Flex-TipTransluminal A-Pacing Probe have been shown to be substantiallyequivalent to the predicate Transluminal BiPolar Pacing Probe and safeand effective for their intended use.

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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.