(16 days)
Not Found
No
The summary describes a traditional external pacemaker with no mention of AI or ML capabilities. The performance studies focus on firmware and system verification, not AI/ML model validation.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "therapeutic" purposes and lists multiple medical conditions for which it provides temporary pacing support. Additionally, the "Device Description" states 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 a "disposable protective cover," indicating it is a physical hardware device, not software only. The performance studies also mention "firmware design verification and system verification," which are related to the software component but the overall device is clearly hardware.
Based on the provided information, the Medtronic Temporary External Pacemaker 53401 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "temporary atrial or ventricular pacing in a clinical environment" and for "temporary cardiac pacing." This involves directly interacting with the patient's heart to regulate its rhythm.
- Device Description: It's described as a "battery-powered, single chamber, temporary pacemaker." This is a device that delivers electrical pulses to the heart.
- Lack of IVD Characteristics: IVD devices are 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.
The device is a therapeutic and diagnostic tool used in vivo (within the living body) for managing cardiac rhythm, not for in vitro (in glass/outside the body) analysis of biological samples.
N/A
Intended Use / Indications for Use
The Medtronic Temporary External Pacemaker 53401 is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. It can 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
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
Not Found
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)
Technological differences between the subject and predicate devices have been evaluated with firmware design verification and system verification. The data from the newly verified firmware show that the devices could be manufactured with a new firmware version to mitigate rebooting of the device caused by interrupts in the firmware system.
The modified Medtronic Model 53401 External Pulse Generator is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design and materials have been verified through the following:
- Firmware Verification
- System Verification
The results of the above verification testing met the specified acceptance criteria and did not raise new safety or performance issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Model 53401 External Pulse Generator (EPG) K162054
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2018
Medtronic, Inc. Brenna Loufek Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K180873
Trade/Device Name: Medtronic Model 53401 External Pulse Generator (EPG) Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class II Product Code: DTE Dated: April 2, 2018 Received: April 3, 2018
Dear Brenna Loufek:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willenmen
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)
K180873
Device Name Medtronic Model 53401 External Pulse Generator (EPG)
Indications for Use (Describe)
The Medtronic Temporary External Pacemaker 53401 is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. It can 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
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
[As required by 21 CFR 807.92]
| Date Prepared: | March 16, 2018 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Cardiac Rhythm Heart Failure | |
| 8200 Coral Sea Street N.E. | |
| Mounds View, MN 55112 | |
| Establishment Registration Number: 2182208 | |
| Contact Person: | Brenna Loufek |
| Regulatory Affairs Specialist | |
| Medtronic Cardiac Rhythm Heart Failure | |
| Phone: 763.526.7829 | |
| Fax: 651.367.0603 | |
| Email: brenna.loufek@medtronic.com | |
| Alternate Contact: | Rachel Libi |
| Senior Regulatory Affairs Manager | |
| Medtronic Cardiac Rhythm Heart Failure | |
| Phone: 763.526.1668 | |
| Fax: 651.367.0603 | |
| Email: rachel.libi@medtronic.com |
General Information
| Trade Name: | Medtronic Model 53401 External Pulse Generator (EPG) |
|---|---|
| Common Name: | External pacemaker pulse generator |
| Regulation Number: | 21 CFR 870.3600 |
| Product Code: | DTE |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Special Controls: | Not applicable |
| Predicate Devices: | Medtronic Model 53401 External Pulse Generator (EPG) K162054 |
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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.
Indications for Use
The Medtronic Temporary External Pacemaker 53401 is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. It can 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
- o 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 ●
- o 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 devices referenced.
When compared to the predicate device (K162054), the modified Medtronic Model 53401 External Pulse Generator presented in this submission has the same:
- Intended use/indications for use
- Operating principle ●
- Design features
- Device functionality
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- Biological safety
- Packaging materials
- Shelf life ●
The modified Model 53401 EPG and the predicate device differ in the following:
- The modified 53401 EPG has updated firmware, Firmware Version 1.03
Substantial Equivalence and Summary of Studies:
Technological differences between the subject and predicate devices have been evaluated with firmware design verification and system verification. The data from the newly verified firmware show that the devices could be manufactured with a new firmware version to mitigate rebooting of the device caused by interrupts in the firmware system.
The modified Medtronic Model 53401 External Pulse Generator is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design and materials have been verified through the following:
- Firmware Verification ●
- System Verification
Conclusion:
The results of the above verification testing met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the modifications made to the Medtronic Model 53401 External Pulse Generator described in this submission result in a device that is substantially equivalent to the predicate.