(30 days)
K813521 Transluminal BiPolar Pacing Probe
Not Found
No
The summary describes a simple pacing probe and does not mention any AI or ML capabilities.
Yes
The device is indicated for temporary ventricular and atrial pacing, which is a therapeutic intervention to regulate heart rhythm.
No
The device is primarily intended for temporary pacing (therapeutic intervention) and uses ECG detection only during placement, which is part of the placement procedure, not for ongoing diagnosis.
No
The device description clearly describes physical probes (2.4F pacing probes with electrode tips) which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that these probes are used for temporary ventricular and atrial pacing and intraventricular/intraatrial ECG detection. These are procedures performed inside the body to directly interact with and monitor the heart.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens. The device is used for direct electrical stimulation and signal detection within the patient's body.
Therefore, based on the provided information, the Chandler Transluminal V-Pacing Probe and the Flex-Tip Transluminal A-Pacing Probe are not IVD devices. They are invasive medical devices used for therapeutic and diagnostic purposes within the body.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
LDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricle, atrium, intraventricular, intraatrial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: The system is intended for use by a trained clinician in a hospital or other appropriate clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Analysis: Material biocompatibility testing in compliance with applicable ISO 10993 requirements, and performance testing was conducted to compare the subject devices to the predicate device. The results of the testing indicate that the fundamental scientific technology of the proposed devices remain unchanged from the legally marketed predicate device. The proposed change to the Chandler Transluminal V-Pacing probe and the Flex-Tip Transluminal A-Pacing probe has been shown to be safe, effective, and substantially equivalent to the predicate device (K813521 Transluminal BiPolar Pacing Probe) for its intended use.
Functional/ Safety Testing: The Chandler Transluminal V-Pacing probe and the Flex-Tip Transluminal A-Pacing probe have successfully passed functional-performance testing and biocompatibility testing, in accordance with applicable consensus standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K813521 Transluminal BiPolar Pacing Probe
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 Transluminal
Bipolar 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)
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).
| 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 |
| Establishment | |
| Registration | |
| Number | 2015691 |
| Address | One Edwards Way |
| Irvine, CA 92614 | |
| Phone: 949-250-2500 | |
| Contact Person | Deana M. Boushell RAC |
| Senior Principal Project Manager, Regulatory Affairs | |
| Direct Line: 949-250-4472 | |
| email: deana_boushell@edwards.com | |
| FAX: 949-809-2967 | |
| Date Prepared | September 14, 2015 |
| Trade Names | Chandler Transluminal V-Pacing Probe |
| Flex-Tip Transluminal A-Pacing Probe | |
| Common Name | Pacing Probe |
| Classification | |
| Name | Electrode, Pacemaker, Temporary |
| 21 CFR 870.3680(a), Product Code LDF | |
| Regulation | |
| Class/Product | |
| Code | Class II |
| LDF | |
| Predicate Device(s) | K813521 Transluminal™ BiPolar Pacing Probe (cleared March 15, 1982) |
| 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. | |
| Models | Chandler Transluminal V-Pacing Probe Model: D98100 |
| Flex-Tip Transluminal A-Pacing Probe Model: D98500 | |
| Device Characteristics | |
| Indications for | |
| Use/Intended Use | The Chandler Transluminal V-Pacing Probe is indicated for temporary |
| emergency 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). |
| Environment of
Use | The system is intended for use by a trained clinician in a hospital or
other appropriate clinical setting. |
| Device Description | 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. |
| Key Performance
Specifications/
Characteristics of
the Device | The Chandler Transluminal V-Pacing probe and the Flex-Tip
Transluminal A-Pacing probe have a total usable length of 135 cm and a
usable length of 15 cm in either the ventricle or atrium. The devices
incorporate an electrode pair that is comprised of stainless steel with
adequate surface area to depolarize the cardiac tissue. |
| Comparative
Analysis | Material biocompatibility testing in compliance with applicable ISO 10993
requirements, and performance testing was conducted to compare the
subject devices to the predicate device. The results of the testing
indicate that the fundamental scientific technology of the proposed
devices remain unchanged from the legally marketed predicate device.
The proposed change to the Chandler Transluminal V-Pacing probe and
the Flex-Tip Transluminal A-Pacing probe has been shown to be safe,
effective, and substantially equivalent to the predicate device (K813521
Transluminal BiPolar Pacing Probe) for its intended use. |
| Functional/ Safety
Testing | The Chandler Transluminal V-Pacing probe and the Flex-Tip
Transluminal A-Pacing probe have successfully passed functional-
performance testing and biocompatibility testing, in accordance with
applicable consensus standards. |
| Conclusion | The Chandler Transluminal V-Pacing Probe and the Flex-Tip
Transluminal A-Pacing Probe have been shown to be substantially
equivalent to the predicate Transluminal BiPolar Pacing Probe and safe
and effective for their intended use. |
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