(111 days)
This device is indicated for use in stimulation lead system analysis prior or during implantation of an electrical stimulator (pacemaker, pulse generator), for emergency stimulation and for high-rate (burst) stimulation limited to temporary diagnostic and therapeutic application.
PSA™ Series devices are portable pacing system analyzers, which are intended to be used for the evaluation of the integrity and most beneficial placement of stimulation leads. The integrity of a stimulation lead system is characterized by its electrical impedance, the measurement results of which shall meet the specifications of the manufacturer of the lead system. The most beneficial placement of a stimulation lead system is determined by the ability of the PSA Series device to capture the heart rhythm (successful stimulation) and to measure reasonable high amplitudes of P and/or R waves and corresponding slew rates. The PSA™ Series encompasses a single-channel device (PSA 100) and dual-channel device (PSA 200) with each channel employing a differential stimulation output and a differential sensing input. Stimulation leads or extension cables are connected to patented receptacles accommodating pins of 0.9 ... 2 mm or Hypertronics ™ style sockets. In addition to the aforementioned intra-cardiac channels, a PSA Series device offers an additional channel and corresponding terminal for a 5-lead surface ECG. The user interface is divided into a touch screen and an array of four keys dedicated to the functions: On / Off, Emergency, High-Rate, Home. The user monitors device measurements, heart activity and device status through the touch screen and LED indicators. Functions provided by PSA™ series pacing system analyzers are organized into so called applications such as (availability depending on PSA Series model): 1/A (Single-chamber stimulation (Channel 1/A)), 2/RV (Single-chamber stimulation (Channel 2/RV)), DDD (Atrioventricular (dual-chamber) stimulation), UHS (Burst stimulation (Universal Heart Stimulator)). By choosing one application, the (touch) screen displays all functions and information relevant to the specific application. The screen displays with minimal delay a marker signal and up to four signal waveforms all of which a user can select from the group of up to three IEGM signal waveforms (1/A, 2/RV; availability depending on PSA model) and seven surface ECG standard vectors (I, II, III, aVR, aVL, aVF, V). The device provides or facilitates the following measurements: Sensing of intrinsic events of the heart: P/R wave amplitudes and slew rate, Rates (PP, RR interval), Intrinsic AV delay (antegrade conduction time), Retrograde conduction time, Wenckebach point (2:1 conduction). Stimulation of the heart: Capture threshold in up to 2 chambers, Lead impedances, Burst stimulation. During an implantation procedure a PSA™ Series device can temporarily take over the functions of a cardiac pacemaker. Measurement results can be stored to a virtual print-out page, which upon completion of all measurements is transmitted wirelessly to a separate printer or computer. User-configurable settings for general use of the device and individual applications are stored in non-volatile memory. The HIGH-RATE function (dedicated key below the touch screen) provides bust stimulation at rates variable from 70 to 1,000 ppm for terminating atrial and ventricular tachycardia. The (optional) UHS application is special form of the high rate function. Within the UHS application, the user can program a train of burst prior to clinical application, which is also referred to as programmable electrical stimulation (PES). Pressing the EMERGENCY key (dedicated key below the touch screen) immediately initiates an emergency stimulation (VVI, 60 ppm, 7.5 V, 1.0 ms). Pressing the HOME key allows the user to return to the home screen (main menu). The device can operate from line power or the integrated rechargeable battery which provides up to 4 hours of continuous operation. A medical-grade AC power supply is part of the delivery unit. An integrated backup battery maintains stimulation in the unlikely event of a failure of the integrated rechargeable battery or AC power. The robust device enclosure is protected against accidental fluid spill.
1. Acceptance Criteria and Reported Device Performance
The provided document describes both bench testing and a clinical investigation for the Osypka Medical PSA™ Series Pacing System Analyzer (PSA 100™ and PSA 200™).
Bench Testing Acceptance Criteria (Implicitly, the device 'performs as intended' or 'verified for' the specified ranges):
| Parameter | Acceptance Criteria (Bench) | Reported Device Performance (Bench) |
|---|---|---|
| Stimulation Modes | AAI, VVI, DDD, VDD, DDI, VDI modes, high-rate pacing, emergency pacing | Performed as intended |
| Stimulation Parameters | ||
| Pulse Amplitude | 0.1 - 10 V | Verification for pulse amplitude of 0.1...10 V for each stimulation channel 1/A, 2/RV |
| Pulse Width | 0.1 - 2.5 ms | Verification for pulse widths of 0.1...2.5 ms for each stimulation channel 1/A, 2/RV |
| Pulse Rate | 30 - 220 ppm | Verification for pulse rates of 30...220 ppm for each stimulation channel 1/A, 2/RV |
| Sensing Parameters | ||
| Sensitivity | 0.2 - 20 mV | Verification for sensitivity threshold of 0.2...20 mV for each sensing channel 1/A, 2/RV |
| Timing Parameters | ||
| AV Delay | 10 - 400 ms | Verification for AV Delay settings of 10...400 ms measured between channel 1/A and 2/RV |
| Refractory Periods | 250 - 500 ms | Verification for refractory period settings of 250...500 ms for each channel 1/A, 2/RV |
| Fault Conditions | Device reacts as intended to specified faults | Device reacted as intended to: Start-up self-test failed, electrode impedance too low/high (short/open circuit), EGM signal noise, battery low/empty, attempt to switch device off during stimulation, High Rate pacing timeout atrium. |
| Comparison to Predicate | Substantial equivalence to predicate device (Biotronik ERA 300) | Demonstrated substantial equivalence with respect to Heart Rate/RR Interval, P/R Wave Amplitude, Lead Impedance, Retrograde Conduction Time, Wenckebach Point. Test results showed substantial equivalence. |
Clinical Investigation Acceptance Criteria and Reported Performance:
| Parameter | Acceptance Criteria (Clinical) | Reported Device Performance (Clinical) |
|---|---|---|
| Intrinsic Measurement Comparisons | PSA measurements (heart rate, amplitude, slew rate, impedance, anterograde/retrograde conduction time) are equivalent to predicate device (Biotronik ERA 300). Specific equivalence criteria for each parameter were established. | The PSA fulfilled the acceptance criteria for each parameter and thus can be considered equivalent to the ERA (Biotronik ERA 300). |
| Stimulation & Sensing Evaluation | - No adverse events occur when PSA is applied. - Effective sensing: Inhibition of atrial/ventricle pacemaker stimulus in the presence of P/R waves, respectively. - Effective pacing: Effective atrial/ventricle stimulation with their respective time domains. - Specific quantitative thresholds for effective sensing and pacing were likely part of the methodology, though not explicitly stated as "% of cycles". | - No adverse events occurred while PSA was applied to the patient. - PSA correctly recognized atrial and ventricular heart activity and inhibited in 364/364 (100%) cardiac cycles recorded. - PSA correctly caused atrial and/or ventricle capture in 1,621/1,621 (100%) of cardiac cycles recorded. - Conclusion: PSA is considered safe and effective. |
2. Sample Size and Data Provenance (for test set/clinical study)
- Sample Size: 17 patients were used for the clinical investigation comparing intrinsic measurements.
- Data Provenance: Prospective. The clinical investigations were conducted during routine pacemaker implantation procedures in the operating room at two clinical sites in Hamburg, Germany.
3. Number of Experts and Qualifications (for ground truth in clinical study)
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, it mentions:
- "ECG tracings and physician notes will be used to determine whether an adverse event occurred while the PSA was applied to the patient." This implies that qualified physicians (likely cardiologists or electrophysiologists) were involved in reviewing patient data and making clinical judgments.
4. Adjudication Method (for test set)
The document does not explicitly describe an adjudication method like 2+1 or 3+1 for consensus building. The clinical data appears to have been collected and analyzed by "physicians" at the clinical sites. For intrinsic measurements, the comparison was directly between the PSA, the predicate device (ERA 300), and a reference device (M2290); it's a comparison of device readings rather than expert consensus on a singular diagnosis. For stimulation and sensing, effective sensing/pacing and adverse events were determined using "ECG tracings and physician notes," suggesting a medical professional's direct observation and judgment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the device's performance against a predicate device and direct physiological measurements, not on the improvement of human reader performance with or without AI assistance.
6. Standalone Performance (Algorithm Only)
Yes, standalone performance was assessed through the "Bench Testing" and "Intrinsic measurement comparisons" portions of the clinical investigation.
- Bench Testing: The device was tested against an "Interstim II heart simulator" and a custom-built computer-assisted test system (Osypka SMS 1000) to verify various stimulation, sensing, and timing parameters. This represents the device's technical performance in a controlled environment.
- Clinical Intrinsic Measurement Comparisons: The PSA's intrinsic measurements were directly compared to those from two other pacing system analyzers (Biotronik ERA 300 and Medtronic Carelink 2290 Analyzer) on the same patients. This evaluates the device's direct measurement capabilities in a real-world setting without human interpretation as an intermediate step.
- Stimulation and Sensing Evaluation: The effectiveness of the PSA's pacing and sensing capabilities was directly observed based on ECG tracings and physician notes, indicating the device's direct performance.
7. Type of Ground Truth Used
The ground truth used was a combination of:
- Bench Test Standards/Known Values: For bench testing, the ground truth was the known or precisely controlled input signals from the test equipment (Interstim II heart simulator, Osypka SMS 1000).
- Predicate Device/Reference Device Measurements: For the intrinsic measurement comparisons in the clinical study, the measurements from the legally marketed predicate device (Biotronik ERA 300) and a reference device (Medtronic Carelink 2290 Analyzer) served as the reference or "ground truth" against which the PSA's measurements were compared for equivalence.
- Clinical Observation/Physician Notes: For determining effective stimulation and sensing, and the occurrence of adverse events, the ground truth was established through direct clinical observation, review of ECG tracings, and physician notes during the procedures. This represents a form of expert clinical judgment based on objective physiological data (ECG).
8. Sample Size for the Training Set
This document describes a premarket notification (510(k)) for a medical device that performs measurements and provides stimulation. It is not an AI/ML-based device that typically requires a "training set" in the machine learning sense. Therefore, there is no mention of a training set or its size. The device's functionality is based on established engineering principles for sensing and delivering electrical signals in cardiac pacing.
9. How Ground Truth for Training Set Was Established
As noted in point 8, this device does not appear to be an AI/ML-based system that uses a discrete "training set" with established ground truth in the context of machine learning. Its validation relies on engineering specifications, comparisons to established devices, and clinical observation.
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APR 0 9 2013
K123916 510(k) Summary
| Submitter: | Osypka Medical, Inc.7463 Draper Avenue, La Jolla, CA 92037 |
|---|---|
| ContactPerson: | Markus Osypka, Ph.D., PresidentOsypka Medical, Inc.7463 Draper Avenue, La Jolla, CA 92037 |
| DeviceTradeName: | PSA™ Series, PSA 200™ and PSA 100™ Pacing System Analyzer |
| PredicateDevice: | Biotronik ERA 300 Dual Chamber Pacing System Analyzer (K964190) |
| DeviceDescription: | PSA™ Series devices are portable pacing system analyzers, which are intendedto be used for the evaluation of the integrity and most beneficial placement ofstimulation leads. |
| The integrity of a stimulation lead system is characterized by its electricalimpedance, the measurement results of which shall meet the specifications of themanufacturer of the lead system. | |
| The most beneficial placement of a stimulation lead system is determined by theability of the PSA Series device to capture the heart rhythm (successfulstimulation) and to measure reasonable high amplitudes of P and/or R waves andcorresponding slew rates. | |
| The PSA™ Series encompasses a single-channel device (PSA 100) and dual-channel device (PSA 200) with each channel employing a differential stimulationoutput and a differential sensing input. Stimulation leads or extension cables areconnected to patented receptacles accommodating pins of 0.9 ... 2 mm orHypertronics ™ style sockets. In addition to the aforementioned intra-cardiacchannels, a PSA Series device offers an additional channel and correspondingterminal for a 5-lead surface ECG. |
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| DeviceDescription(continued): | The user interface is divided into a touch screen and an array of four keys dedicated to the functions | ||
|---|---|---|---|
| • On / Off | Turn device on or off | ||
| • Emergency | Switch to emergency stimulation mode | ||
| • High-Rate | Switch to High-Rate stimulation mode | ||
| • Home | Return to main menu | ||
| The user monitors device measurements, heart activity and device status through the touch screen and LED indicators. | |||
| Functions provided by PSA™ series pacing system analyzers are organized into so called applications such as (availability depending on PSA Series model): | |||
| • 1/A | Single-chamber stimulation (Channel 1/A) | ||
| • 2/RV | Single-chamber stimulation (Channel 2/RV) | ||
| • DDD | Atrioventricular (dual-chamber) stimulation | ||
| • UHS | Burst stimulation (Universal Heart Stimulator) | ||
| By choosing one application, the (touch) screen displays all functions and information relevant to the specific application. The screen displays with minimal delay a marker signal and up to four signal waveforms all of which a user can select from the group of up to three IEGM signal waveforms (1/A, 2/RV; availability depending on PSA model) and seven surface ECG standard vectors (I, II, III, aVR, aVL, aVF, V). | |||
| The device provides or facilitates the following measurements: | |||
| • Sensing of intrinsic events of the heart: | |||
| • P/R wave amplitudes and slew rate | |||
| • Rates (PP, RR interval) | |||
| • Intrinsic AV delay (antegrade conduction time) | |||
| • Retrograde conduction time | |||
| • Wenckebach point (2:1 conduction) | |||
| • Stimulation of the heart | |||
| • Capture threshold in up to 2 chambers | |||
| • Lead impedances | |||
| • Burst stimulation | |||
| During an implantation procedure a PSA™ Series device can temporarily take over the functions of a cardiac pacemaker. | |||
| Measurement results can be stored to a virtual print-out page, which upon completion of all measurements is transmitted wirelessly to a separate printer or computer. User-configurable settings for general use of the device and individual applications are stored in non-volatile memory. |
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| DeviceDescription(continued): | The HIGH-RATE function (dedicated key below the touch screen) provides buststimulation at rates variable from 70 to 1,000 ppm for terminating atrial andventricular tachycardia.The (optional) UHS application is special form of the high rate function. Within theUHS application, the user can program a train of burst prior to clinical application,which is also referred to as programmable electrical stimulation (PES).Pressing the EMERGENCY key (dedicated key below the touch screen)immediately initiates an emergency stimulation (VVI, 60 ppm, 7.5 V, 1.0 ms).Pressing the HOME key allows the user to return to the home screen (mainmenu).The device can operate from line power or the integrated rechargeable batterywhich provides up to 4 hours of continuous operation. A medical-grade AC powersupply is part of the delivery unit.An integrated backup battery maintains stimulation in the unlikely event of afailure of the integrated rechargeable battery or AC power.The robust device enclosure is protected against accidental fluid spill. | |
|---|---|---|
| IntendedUse: | This device is indicated for use in stimulation lead system analysis prior or duringimplantation of an electrical stimulator (pacemaker, pulse generator), foremergency stimulation and for high-rate (burst) stimulation limited to temporarydiagnostic and therapeutic application. | |
| PerformanceTest- Bench: | Purpose of bench testing is to verify the performance of the device under test withrespect to employing the intended stimulation (pacing) mode (including high-rateand emergency modes), stimulation (pacing), sensing and timing parameters, theability of the device to detect faulty conditions, and with respect to the predicatedevice. | |
| Stimulation Modes | ||
| Bench testing using an Interstim II heart simulator verified that the device undertest performed the following stimulation modes as intended: AAI, VVI, DDD, VDD,DDI and VDI. | ||
| Bench testing further verify that the functions high rate pacing and emergencypacing perform as intended. | ||
| Stimulation, Sensing and Timing Parameters | ||
| Parameters were measured with the Osypka SMS 1000, a custom-buildcomputer-assisted test system that consists of the PC card EKG2GEN (aspecialized and combined ADC/DAC card) and the PC program PACE. It is partof the supervised measuring equipment of the company and used for finalmeasurements of external pacemakers and pacing system analyzers. The testsystem fulfills the requirements of the applicable standards for measuringpacemaker parameters and is used otherwise in the production process ofpacemakers. | ||
| Parameter | Bench Testing | |
| StimulationParameters | Pulse Amplitude | Verification for pulse amplitude of 0.1...10 Vfor each stimulation channel 1/A, 2/RV |
| Pulse Width | Verification for pulse widths of 0.1...2.5 msfor each stimulation channel 1/A, 2/RV | |
| Pulse Rate | Verification for pulse rates of 30...220 ppmfor each stimulation channel 1/A, 2/RV | |
| Sensitivity | Verification for sensitivity threshold of0.2...20 mV for each sensing channel 1/A,2/RV | |
| Timing | AV Delay | Verification for AV Delay settings of 10...400ms measured between channel 1/A and2/RV |
| RefractoryPeriods | Verification for refractory period settings of250...500 ms for each channel 1/A, 2/RV | |
| Test of Device Behavior Under Fault Conditions | ||
| The device under test was exposed to the following device and application relatedfaults and reacted as intended: | ||
| • Start-up self-test failed | ||
| • Electrode impedance to low (short circuit) | ||
| • Electrode impedance to high (open lead) | ||
| • EGM signal noise | ||
| • Battery low | ||
| • Battery empty | ||
| • Attempt to switch device off during stimulation | ||
| • High Rate pacing timeout atrium | ||
| Essential Performance Comparison Testing | ||
| The device under test was compared to its predicate device with respect to thefollowing parameters: | ||
| • Heart Rate / RR Interval | ||
| • P/R Wave Amplitude | ||
| • Lead Impedance | ||
| • Retrograde Conduction Time | ||
| • Wenckebach Point | ||
| The test results demonstrated a substantial equivalence between the deviceunder test and the predicate device. |
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| PerformanceTest-Clinical | Performance Test - ClinicalThe objective of this clinical investigation is to determine whether OsypkaMedical's PSA pacing system analyzer (referred to hence forth as the "PSA") issafe and effective within the scope of its intended use. |
|---|---|
| This objective will be met by the following clinical investigations conducted at twoclinical sites in Hamburg, Germany. The clinical investigations were conductedduring routine pacemaker implantation procedure in the operating room: | |
| Intrinsic measurement comparisons | |
| Method | |
| PSA's measurements of the patient's intrinsic values will be compared to theBiotronik's ERA 300 dual chamber pacing system analyzer (referred to henceforth as the "ERA") and Medtronic Carelink 2290 Analyzer (referred to hence forthas the "M2290") performed on the same patient in consecutive order where thesemeasurements are appropriate. | |
| PSA, ERA, and M2290 parameters analyzed include heart rate (PP/RR intervals),amplitude, slew rate, impedance, anterograde conductance (AV time) andretrograde conductance (VA time). Data from 17 patients were used in thisanalysis. Although the M2290 is not used as a predicate device, it serves as areference when differences between the PSA and ERA need further explanation. | |
| Results | |
| Acceptance criteria were established for each parameter compared acrossdevices. Based on the data analyzed from 17 patients (15 atriums and 18ventricles), the PSA fulfilled the acceptance criteria for each parameter and thuscan be considered equivalent to the ERA. | |
| Stimulation and Sensing Evaluation | |
| Method | |
| ECG tracing are analyzed beat by beat while the PSA paces in order to determineeffective sensing and pacing. Effective sensing is defined here as inhibition of theatrial and/or ventricle pacemaker stimulus in the presence of P waves and Rwaves, respectively. Effective pacing is defined here as effective atrial and/orventricle stimulation with their respective time domains. ECG tracings andphysician notes will be used to determine whether an adverse event occurredwhile the PSA was applied to the patient. | |
| Results | |
| No adverse events occurred while PSA was applied to patient. PSA correctlyrecognized atrial and ventricular heart activity and inhibited in 364/364 (100%)cardiac cycles recorded. PSA correctly caused atrial and/or ventricle capture in1,621/1,621 (100%) of cardiac cycles recorded. PSA is considered safe andeffective. | |
| Conclusion: | Demonstration of substantial equivalence between the PSA™ Series devices(PSA 200™ and PSA 100™), and its predicate device established from clinicaland non-clinical performance data. |
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
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
April 9, 2013
Dr. Markus J. Osypka Osypka Medical, Inc 7855 Ivanhoe Avenue, Suite 226 La Jolla, California 92037
Re: K123916
Trade Name: PSATN Series Pacing System Analyzer (PSA 100TM and PSA 200™) Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class III Product Code: DTE, DTA Dated: March 1, 2013 Received: March 4, 2013
Dear Dr. Osypka:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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.
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Page 2 - Markus J. Osypka
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Owen PMEaris -S
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
K123916 510(k) Number (if known):
Device Names:
OSYPKA MEDICAL
PSA TM Series Pacing System Analyzer PSA 100™ and PSA 200™
CARDIOTRONIC PSA ™ Series
Pacing System Analyzer PSA 100™ and PSA 200™
Indications for Use:
This device is indicated for use in stimulation lead system analysis prior or during implantation of an electrical stimulator (pacemaker, pulse generator), for emergency stimulation and for high-rate (burst) stimulation limited to temporary diagnostic and therapeutic application.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter-Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
§ 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.