(85 days)
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.
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.
The provided FDA 510(k) summary for the Medtronic Temporary External Pacemaker Model 53401 does not include acceptance criteria or a study that clearly demonstrates the device meets specific performance metrics in the way a clinical study would for an AI/ML device.
This document describes a medical device, specifically an external pacemaker, not an AI/ML powered diagnostic device. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and type of ground truth) is not applicable or present in this submission.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with various medical device standards.
Here's an analysis of the provided text in the context of the requested information, with specific notes on why certain categories are not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria with corresponding device performance metrics in the format typically seen for AI/ML performance. Instead, it states that "Design verification and validation was performed to demonstrate that the Medtronic 53401 SC EPG and its accessories meet established performance criteria." It refers to compliance with various standards.
Implicit Acceptance Criteria (based on standards compliance):
| Acceptance Criteria Category (Derived) | Stated Performance / Compliance |
|---|---|
| Safety (Electrical/Mechanical) | Complies with IEC 60601-1: 2012 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2: 2014; UL Test Reports, NW EMC Reports, and Product Verification |
| Basic Safety & Essential Performance (External Pacemakers) | Complies with IEC 60601-2-31: 2011 |
| Usability/Human Factors | Complies with IEC 60601-1-6:2013, EN 62366:2014, ANSI/AAMI HE75: 2013; Human Factors Evaluation |
| Biocompatibility | Complies with ISO 10993-1:2013; Biocompatibility Testing |
| Software Life-cycle Processes/Firmware | Complies with IEC EN 62304: 2006/AC:2008; Firmware (Embedded Software) Verification and Validation |
| Packaging Integrity | Complies with ASTM D4169: 2008; Packaging Testing |
| Intended Use & Technological Characteristics | Demonstrated to be "substantially equivalent" to predicate device (Medtronic Model 5392) |
2. Sample size 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 as the submission describes non-clinical bench testing and human factors evaluation of a physical device, not an AI/ML algorithm processing medical data. There is no "test set" in the sense of a dataset of medical cases.
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 is not applicable. Ground truth for medical data is not relevant to the testing described for this physical pacemaker device. Human factors evaluations would involve users, but they are assessing usability, not establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "test set" of medical cases requiring adjudication.
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 is not applicable. MRMC studies are used for diagnostic algorithms involving human readers interpreting outputs. This document is for a physical pacemaker device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device, not an algorithm. Performance testing (e.g., electrical output, battery life, physical durability) would be "standalone" in the sense that the device is tested by itself, but this is a different context than standalone AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The ground truth for device performance would be the specifications and requirements defined by the manufacturer and relevant medical device standards.
8. The sample size for the training set
This is not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
Summary of the Study:
The "study" presented here is a design verification and validation process for a traditional medical device (an external pacemaker). It primarily relies on non-clinical bench testing and human factors evaluation testing to demonstrate compliance with various international and national standards (e.g., IEC 60601 series, ISO 10993, ASTM D4169, ANSI/AAMI HE75). The key "proof" of meeting acceptance criteria is the documentation of compliance with these established safety, performance, usability, and manufacturing standards for medical devices. The ultimate goal of this submission is to establish substantial equivalence to an existing legally marketed predicate device (Medtronic Model 5392).
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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
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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 Management8200 Coral Sea Street NEMounds View, MN 55112 |
| Contact: | Syed Sumran MohiuddinPrincipal Regulatory Affairs Specialist |
| Telephone: | (763)526-2380 |
| Fax: | (651)367-0603 |
| E-mail: | syed.s.mohiuddin@medtronic.com |
| Proprietary Name: | Medtronic Temporary ExternalPacemaker Model 53401 |
| Common Name: | External pacemaker pulse generator |
| Device Classification | Class II (special controls), 21 CFR870.3600External 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
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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:
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| No. | Standard | Summary/Trace Report |
|---|---|---|
| 1 | IEC 60601-1: 2012 Medical electricalequipment - Part 1: General requirements forsafety | |
| 2 | IEC 60601-1-2: 2014 Medical electricalequipment - Part 1-2: General requirements forsafety - Collateral standard: Electromagneticcompatibility - Requirements and tests | UL Test Reports, NW EMC Reports, andProduct Verification |
| 3 | IEC 60601-2-31: 2011 1995 ParticularRequirements for the basic safety and essentialperformance of external cardiac pacemakerswith internal power source | |
| 4 | IEC 60601-1-6:2013 General requirements forbasic safety and essential performance –Collateral standard: Usability from theInternational Electrotechnical Commission | |
| 5 | EN 62366:2014 Medical devices -- Applicationof usability engineering to medical devices fromthe International Electrotechnical Commission | Human Factors Evaluation |
| 6 | ISO 10993-1:2013 Biological Evaluation ofMedical Devices | Biocompatibility Testing |
| 7 | IEC EN 62304: 2006/AC:2008 Medical devicesoftware - Software life-cycle processes | Firmware (Embedded Software)Verification and Validation |
| 8 | ASTM D4169: 2008 Practice for performancetesting of shipping containers and systems | Packaging Testing |
| 9 | ANSI/AAMI HE75: 2013 Human factors designprocess for medical devices from theAssociation for the Advancement of MedicalInstrumentation | 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.
§ 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.