(85 days)
Not Found
No
The document describes a standard temporary external pacemaker and does not mention any AI or ML capabilities. The performance studies are nonclinical bench testing and human factors evaluation, not studies typically associated with validating AI/ML algorithms.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device can be used for "therapeutic, prophylactic, or diagnostic purposes" and lists several conditions for which temporary cardiac pacing is indicated, such as "Complete heart block" and "Sinus bradycardia," which are therapeutic interventions. Additionally, the "Device Description" mentions it is "designed primarily for temporary antibradycardia pacing therapy."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device can be used for "diagnostic purposes."
No
The device description explicitly states it is a "battery-powered, single chamber, temporary pacemaker" and mentions an optional "disposable protective cover," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary atrial or ventricular pacing in a clinical environment" and describes its use for therapeutic, prophylactic, or diagnostic purposes related to cardiac rhythm. This involves directly interacting with the patient's body to regulate heart function.
- Device Description: The description confirms it's a "battery-powered, single chamber, temporary pacemaker" designed for "temporary antibradycardia pacing therapy." This is a device that delivers electrical pulses to the heart.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
Therefore, the Model 53401 SC EPG is a therapeutic medical device used for cardiac pacing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylatic, or diagnostic purposes.
Specification indications for temporary cardiac pacing include, but are not limited to, the following indications:
- · Complete heart block
- · Sinus bradycardia
- · Sick Sinus Syndrome
- · Bradycardia with congestive heart failure
- · Atrial and/or ventricular arrhythmias
- · Cardiac arrest
- · Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
- · Support during permanent pacemaker replacement
- · Cardiac complications during invasive or surgical procedures
- · Temporary support of a patient following cardiac surgery
- · Acute myocardial infarction complicated by heart block
- · High-rate burst pacing for the treatment of supraventricular tachyarrhythmias.
Product codes
DTE
Device Description
The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical environment
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)
Design verification and validation was performed to demonstrate that the Medtronic 53401 SC EPG and its accessories meet established performance criteria to support equivalency to the referenced predicate device. Draft Guidance – Class II Special Controls Guidance Document: External Pacemaker Pulse Generator was followed. All performance testing conducted was nonclinical, and consisted of bench testing and human factors evaluation testing. The testing results indicate that the 53401 SC EPG performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3600 External pacemaker pulse generator.
(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
i.e., battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
e.g., overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
Medtronic, Inc. Syed Mohiuddin Principal Regulatory Affairs Specialist 8200 Coral Sea Street Ne Mounds View, Minnesota 55112
Re: K162054
Trade/Device Name: Medtronic Temporary External Pacemaker 53401 Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class II Product Code: DTE Dated: July 22, 2016 Received: July 25, 2016
Dear Syed Mohiuddin:
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.
Sincerelv.
M.A. Hillebrenner
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) K162054
Device Name
Medtronic Temporary External Pacemaker 53401
Indications for Use (Describe)
The Model 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylatic, or diagnostic purposes.
Specification indications for temporary cardiac pacing include, but are not limited to, the following indications:
- · Complete heart block
- · Sinus bradycardia
- · Sick Sinus Syndrome
- · Bradycardia with congestive heart failure
- · Atrial and/or ventricular arrhythmias
- · Cardiac arrest
- · Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
- · Support during permanent pacemaker replacement
- · Cardiac complications during invasive or surgical procedures
- · Temporary support of a patient following cardiac surgery
- · Acute myocardial infarction complicated by heart block
- · High-rate burst pacing for the treatment of supraventricular tachyarrhythmias.
| 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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510(k) Summary
Introduction
Medtronic is submitting this Traditional 510(k) to establish substantial equivalence of the Temporary External Pacemaker Model 53401 to its legally marketed predicate device. The Table 3 below lists the administrative information related to this 510(k) submission.
| 510(k) Administrative Information | |
|---|---|
| Date Prepared: | 20 July 2016 |
| Submitter: | Medtronic, Inc. |
| Cardiac Rhythm Disease Management | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Contact: | Syed Sumran Mohiuddin |
| Principal Regulatory Affairs Specialist | |
| Telephone: | (763)526-2380 |
| Fax: | (651)367-0603 |
| E-mail: | syed.s.mohiuddin@medtronic.com |
| Proprietary Name: | Medtronic Temporary External |
| Pacemaker Model 53401 | |
| Common Name: | External pacemaker pulse generator |
| Device Classification | Class II (special controls), 21 CFR |
| 870.3600 | |
| External pacemaker pulse generator | |
| Product Code: | DTE |
| Table 3: 510(k) Summary | ||
|---|---|---|
Substantial Equivalence Statement
The intended use, design, materials and performance of the Medtronic Temporary External Pacemaker Model 53401 is substantially equivalent to the following predicate device:
- Medtronic Model 5392 Dual Chamber Temporary External Pacemaker, initially cleared ● via 510(k) application, reference number K132924 on October 31, 2013.
Brief Device Description
The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for
4
temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.
Indications for Use
The 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The 53401can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes.
Specific indications for temporary cardiac pacing include, but are not limited to, the following indications:
- Complete heart block
- Sinus bradycardia
- Sick Sinus Syndrome
- Bradycardia with congestive heart failure ●
- Atrial and/or ventricular arrhythmias ●
- Cardiac arrest
- Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
- Support during permanent pacemaker replacement
- Cardiac complications during invasive or surgical procedures
- Temporary support of a patient following cardiac surgery
- Acute myocardial infarction complicated by heart block
- High-rate burst pacing for the treatment of supraventricular tachyarrhythmias .
Technological Characteristics
Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate device referenced.
Overview of Testing
Design verification and validation was performed to demonstrate that the Medtronic 53401 SC EPG and its accessories meet established performance criteria to support equivalency to the referenced predicate device. Draft Guidance – Class II Special Controls Guidance Document: External Pacemaker Pulse Generator was followed. All performance testing conducted was nonclinical, and consisted of bench testing and human factors evaluation testing. The testing results indicate that the 53401 SC EPG performs as intended.
The Table 4 below lists the performance standards that were used during testing:
5
| No. | Standard | Summary/Trace Report |
|---|---|---|
| 1 | IEC 60601-1: 2012 Medical electrical | |
| equipment - Part 1: General requirements for | ||
| safety | ||
| 2 | IEC 60601-1-2: 2014 Medical electrical | |
| equipment - Part 1-2: General requirements for | ||
| safety - Collateral standard: Electromagnetic | ||
| compatibility - Requirements and tests | UL Test Reports, NW EMC Reports, and | |
| Product Verification | ||
| 3 | IEC 60601-2-31: 2011 1995 Particular | |
| Requirements for the basic safety and essential | ||
| performance of external cardiac pacemakers | ||
| with internal power source | ||
| 4 | IEC 60601-1-6:2013 General requirements for | |
| basic safety and essential performance – | ||
| Collateral standard: Usability from the | ||
| International Electrotechnical Commission | ||
| 5 | EN 62366:2014 Medical devices -- Application | |
| of usability engineering to medical devices from | ||
| the International Electrotechnical Commission | Human Factors Evaluation | |
| 6 | ISO 10993-1:2013 Biological Evaluation of | |
| Medical Devices | Biocompatibility Testing | |
| 7 | IEC EN 62304: 2006/AC:2008 Medical device | |
| software - Software life-cycle processes | Firmware (Embedded Software) | |
| Verification and Validation | ||
| 8 | ASTM D4169: 2008 Practice for performance | |
| testing of shipping containers and systems | Packaging Testing | |
| 9 | ANSI/AAMI HE75: 2013 Human factors design | |
| process for medical devices from the | ||
| Association for the Advancement of Medical | ||
| Instrumentation | Human Factors Evaluation |
Table 4: Standards & Testing
Conclusion
Medtronic demonstrates in this submission that the 53401 SC EPG is substantially equivalent to its predicate device (the Model 5392 Dual Chamber Temporary External Pacemaker) because the fundamental scientific principle, operating principle, design features and intended use are substantially equivalent to the predicate device.