MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL

K971474 · Medtronic Vascular · DTE · Jul 14, 1997 · Cardiovascular

Device Facts

• Record ID: K971474
• Device Name: MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
• Applicant: Medtronic Vascular
• Product Code: DTE · Cardiovascular
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3600
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is intended to be used in conjunction with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment. The Model 5318 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: Sick sinus syndrome; Sinus bradycardia; Atrial and/or ventricular arrhythmias; Complete heart block; Cardiac arrest; Bradycardia with congestive heart failure; Support, management, and evaluation of a patient before implantable pacemaker implantation; Support during implantable pacemaker replacement; Cardiac complications during invasive or surgical procedures; Support following cardiac surgery; Acute myocardial infarction complicated by heart block. The Model 5318 is also intended to be used by or on the order of a physician to determine sensing and stimulation thresholds and measure lead impedance of implantable lead systems during implantable pacemaker implantation.

Device Story

Hand-held, battery-powered, microprocessor-based external single-chamber pacemaker; used in clinical environments by physicians or under physician order. Inputs: electrical signals from transvenous or myocardial pacing leads. Device performs pacing therapy (synchronous/demand or asynchronous) and diagnostic testing (sensing/stimulation thresholds, lead impedance). Outputs: electrical pacing pulses to the heart; visual data on LCD screens (rate, output, sensitivity, impedance, status). Features include manual dials for parameter adjustment, membrane keys for mode selection, emergency pacing, and self-test. Benefits: provides temporary hemodynamic support and facilitates accurate lead placement/evaluation during permanent pacemaker implantation. Healthcare providers use output to adjust pacing parameters and confirm lead integrity, directly informing clinical management of bradycardia and cardiac complications.

Clinical Evidence

Bench testing only. No clinical data. Testing included user interface verification, electrical performance (waveform integrity, sensitivity, impedance, pacing modes), environmental testing (EMC, defibrillation, electrocautery, ESD, thermal/mechanical shock), and software verification. Reliability assessed per MIL Standard 217.

Technological Characteristics

Hand-held, battery-operated, microprocessor-based device. Single-chamber pacing (atrial or ventricular). Connectivity: patient cables for lead connection. Features: LCD screens, membrane keys, dials for parameter control. Safety: defibrillation/ESD protection, runaway rate protection, self-test, emergency mode. Software: formal development process including requirements, hazard analysis, and verification testing.

Indications for Use

Indicated for patients requiring short-term, single-chamber, synchronous or asynchronous cardiac pacing for therapeutic, prophylactic, or diagnostic purposes, including sick sinus syndrome, sinus bradycardia, arrhythmias, heart block, cardiac arrest, and post-surgical support. Also indicated for use during permanent pacemaker implantation or replacement to determine sensing/stimulation thresholds and measure lead impedance. Contraindicated for atrial pacing in atrial fibrillation/flutter, AV conduction disorders, or asynchronous pacing in the presence of intrinsic cardiac rhythms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 5311B Pacing System Analyzer (K884331, K910595)

Submission Summary (Full Text)

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MEDTRONIC CONFIDENTIAL

# JUL | 4 1:97

#### 2. 510(k) SUMMARY

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#### General Information A.

| Submitter's Name | Lorna J. Harmuth | |
|------------------|----------------------------|--|
| | Product Regulation Manager | |

| Company Name and Address | Medtronic, Inc.<br>7000 Central Avenue N.E.<br>Minneapolis, MN 55432 |
|--------------------------|----------------------------------------------------------------------|
|--------------------------|----------------------------------------------------------------------|

Submission Date

April 22, 1997

#### Device Name and Classification B.

| Device Generic Name | Pacing System Analyzer |
|----------------------------|---------------------------------------------------------------------------------------------|
| Device Trade Name | Medtronic Model 5318 Temporary<br>Pacemaker / Implant Tool |
| Classification Name/Number | Pacemaker Generator Function<br>Analyzer<br>21 CFR 870.3630, Class III<br>Product Code: DTC |

#### Predicate Devices C.

| Model Number | Document Control<br>Number | Approval Date |
|------------------------------|----------------------------|------------------|
| 5311B Pacing System Analyzer | K884331 | January 10, 1989 |
| | K910595 | May 7, 1991 |

#### Device Description D.

The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is a hand-held, temporary, battery-powered, external, single chamber pacemaker designed for antibradycardia pacing therapy in asynchronous or synchronous (demand) pacing modes and to test the electrical performance of implanted lead systems. The Model 5318 Temporary Pacemaker / Implant Tool can be used with transvenous or myocardial lead systems in either a bipolar or unipolar lead configuration. In

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addition, the Model 5318 Temporary Pacemaker/ Implant Tool can be used to determine stimulation and sensing thresholds for temporary pacing. The device is connected to commercially available temporary or permanent pacing leads with patient cables.

14:40 12 11:20

The device incorporates the following features:

- Output Rate, Amplitude and Sensitivity control and display on base level . screen
- Lead impedance measurement and display capability .
- Adjustable Pulse Width from .06 2.0 ms (0.06-0.6 ms in 0.06 ms . increments; 0.6-2.0 in 0.1 ms increments)
- Ouput Range: 0.1 V 10.0 V .
- Base Rate: 30 to 200 ppm (30-50 ppm in 5 ppm increments; 50-100 ppm . in 2 ppm increments; 100-200 ppm in 5 ppm increments)
- . Sensitivity Range: 0.5 mV - 20 mV in synchronous pacing modes
- Pacing mode determined by manual adjustments to output amplitude and ● sensitivity parameter settings
- Battery polarity reversal capability .
- 10 second continuous operation at nominal values during battery . replacement
- Self-test capability .
- Pin-protected cables (no exposed pins) ●
- Pace and Sense indicators .
- On-Screen messages .
- Screen backlighting for adjustment in low-light level situations ●
- . Control lock function which prevents the dials from being changed inadvertently
- . Low battery indicator
- EMERGENCY key ●
- . Reversion circuitry
- . Pause capability

The Model 5318 Temporary Pacemaker / Implant Tool allows pacing parameter adjustments and pacing mode selections to be made with four dials and seven membrane keys located on the front side of the device. The dials are for RATE, OUTPUT, SENSITIVITY, and PULSE WIDTH. The seven membrane keys are: LOCK/UNLOCK, MEASURE, PULSE WIDTH, PAUSE, OFF, ON and EMERGENCY.

Device parameter setting information is provided to the user with two liquid crystal display (LCD) screens on the front of the device. The upper screen displays the parameters for basic pacing (rate, output and sensitivity) and device status. The lower screen displays: warnings and instructions to the user; pulse

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width setting; and impedance measurements. A light source aids visibility for the LCD display under low-light conditions. Bails on the case allow the device to be hung from an IV pole or strapped to the mounting position of choice.

#### Intended Use E.

The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is intended to be used in conjunction with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment. The Model 5318 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:

- Sick sinus syndrome ●
- Sinus bradycardia ●
- Atrial and/or ventricular arrhythmias ●

and the comments of the comments of the comments of the

- Complete heart block ●
- Cardiac arrest ●
- Bradycardia with congestive heart failure .
- Support, management, and evaluation of a patient before implantable ● pacemaker implantation
- Support during implantable pacemaker replacement .
- Cardiac complications during invasive or surgical procedures ●
- Support following cardiac surgery .
- Acute myocardial infarction complicated by heart block ●

The Model 5318 is also intended to be used by or on the order of a physician to determine sensing and stimulation thresholds and measure lead impedance of implantable lead systems during implantable pacemaker implantation.

## Contraindications

There are no known contraindications to the use of temporary pacing as a means to control the heart rate. The patient's age and medical condition, however, may dictate the type of temporary pacemaker and lead system used by the physician.

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## Atrial Pacing

Atrial pacing is ineffective in the presence of atrial fibrillation or atrial flutter.

Single chamber atrial pacing is contraindicated in the presence of AV conduction disorders.

## Asynchronous Pacing

Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms.

#### Comparison of Required Technological F. Characteristics

The Model 5318 Temporary Pacemaker / Implant Tool is substantially equivalent in design, intended use, function and performance to the Model 5311B Pacing System Analyzer. The Medtronic Model 5311B A-V Pacing System Analyzer is a hand-held microprocessor based device designed to provide temporary external stimulation and to test the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation. The devices are substantially equivalent in device design, function, materials and intended use. The comparison of required characteristics is provided below.

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MEDTRONIC CONFIDENTIAL

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| Characteristics | Medtronic 5318 Temporary<br>Pacemaker/Implant Tool | Medtronic 5311B Pacing System Analyzer |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| a. Product Labeling | Combined Technical and Operating<br>Manual | Separate Technical and Operator's Manuals -<br>Substantially equivalent indications,<br>contraindications, warnings, precautions,<br>adverse effects. See Attachment 3 for Model<br>5311B labeling. |
| b. Intended Use | Intended to be used in conjunction with a<br>cardiac pacing lead system for temporary<br>single chamber pacing in a clinical<br>environment. The 5318 can be used<br>where short-term synchronous or<br>asynchronous pacing is indicated for<br>therapeutic, prophylactic, or diagnostic<br>purposes. The Model 5318 is also used<br>to determine sensing and stimulation<br>thresholds and measure lead impedance<br>of implantable lead systems during<br>implantable pacemaker implantation. | Intended for use by a physician to measure<br>stimulation thresholds and test the IPG and<br>pacing lead system during permanent<br>pacemaker implantation or during invasive<br>pacemaker troubleshooting or diagnostic<br>procedures. The 5311B is designed to pace<br>the patient externally during pacing pacing<br>system test and implantation procedures. The<br>pacing and test functions are intended for<br>both single- and dual-chamber pacemaker<br>applications. |
| c. Physical<br>Characteristics | Hand held, battery operated,<br>microprocessor based device. | SAME |
| d. Anatomical Sites | Single chamber of the heart, either atrial<br>or ventricular. | Single or dual chambers of the heart, either<br>atrial or ventricular. |
| e. Target<br>Population | The 5318 can be used during permanent<br>pacemaker implantation for testing or<br>pacing in patients who require short-term,<br>single chamber, synchronous or<br>asynchronous pacing. | The 5311B can be used during permanent<br>pacemaker implantation for testing or pacing<br>in patients who require short-term, single or<br>dual chamber, synchronous or asynchronous<br>pacing. |
| f. Performance<br>Testing | Fully tested for user interface,<br>electrical,environmental and product<br>integrity requirements. | SAME |
| g. Safety<br>Characteristics | Two step operation required to turn off<br>device.<br>Low battery indicator.<br>Emergency Pacing available.<br>Reversible battery polarity.<br>Continuous pacing operation during<br>battery replacement.<br>Keyboard lock feature.<br>Pin-protected cable connections.<br>Self-test function and runaway rate<br>protection.<br>Protection from defibrillation shock and<br>electrostatic discharge.<br>Minimized susceptibility to<br>electromagnetic and magnetic<br>interference. | Low battery indicator. |

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#### Summary of Studies G.

Medtronic has thoroughly evaluated the Model 5318 Temporary Pacemaker / Implant Tool and/or test assemblies through in-vitro testing to assure suitability and reliability for its intended use. All testing conducted on the Model 5318 Temporary Pacemaker / Implant Tool demonstrated that all design and manufacturing process requirements were met, and that the new device raises no new questions of safety or efficacy.

and the model of the Research and the comments of

The following section provides a summary of the non-clinical testing performed on the Model 5318 Temporary Pacemaker / Implant Tool to ensure safety, reliability and performance according to Medtronic specifications. Electrical, mechanical, environmental and software testing and verification was all performed on the Model 5318 Temporary Pacemaker / Implant Tool.

## User Interface Requirements

The Model 5318 Temporary Pacemaker / Implant Tool devices were tested to verify that the device meets the user interface requirements including proper mechanical operation of the device, control dials and keys, function of the indicators and physical requirements of the device. The following user interfaces were examined to ensure conformance to specifications:

- . Dials
- . Liquid-Crystal-Display (LCD)
- . Membrane Keys
- Pace LED Indicator
- Sense LED Indicator .
- Backlight
- Battery Compartment
- Attachment Mechanisms ●
- Weight
- . Size

All of these tests showed that the device operated to Medtronic specification as shown by proper operation of all above characteristics under labeled usage conditions.

### Electrical Conformance

The Model 5318 Temporary Pacemaker / Implant Tool devices were tested to verify that the device meets the electrical requirements. This testing consisted of examination of the function of the device under conditions similar to those found in normal usage. The following electrical requirements were examined to ensure conformance to specifications:

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## MEDTRONIC CONFIDENTIAL

Barrell Bank Band Bank

- Base Rate .
- Rate Runaway Protection .
- Waveform Integrity ●
- Sensitivity ●
- . Pulse Width
- Impedance Measurement ●
- Output .
- Frequency Response .
- Refractory .
- . Blanking
- . Pacing Modes
- Pacing Mode Transition Rules .
- Emergency Mode .
- Direct Current (DC) Rejection .
- Alternating Current (AC) Rejection .
- Common Mode Rejection .
- Reversion .
- Battery Life .
- Performance Under Low Battery Conditions .
- Operation After Battery Removal .
- Power-On Self Test .
- Serial Link .

All of these tests showed that the device operated to Medtronic specification as shown by proper operation of all above characteristics under labeled usage conditions.

## Environmental Requirements

The Model 5318 Temporary Pacemaker / Implant Tool devices were tested to verify that the device meets the environmental requirements. The following environmental requirements were examined to ensure conformance to specifications:

- Electromagnetic Compatibility (EMC) .
- Defibrillation ●
- Electrocautery .
- Electrostatic Discharge (ESD) .
- Vibration .
- Thermal Shock .
- Mechanical Shock .
- Spill Resistance ●
- Operating Temperature ●
- Storage Temperature .

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- Humidity Testing .
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- . Safety Testing
- Chemical Resistance ●
- Sterilization .
- Packaging and Handling .

All of these tests showed that the device operated to Medtronic specification as shown by proper operation of all above characteristics under labeled usage conditions.

## Predicted Reliability

A reliability assessment was performed according to MIL Standard 217 (Reliability Predictions of Electrical Equipment).

## Software Development and Testing

Software Development and testing was conducted in accordance with formal procedures for the development and testing of software. These procedures include development of a Software Requirements Specification, a Software Description, a System Hazard Analysis, and a Verification Test Specification and Verification Test Plan. The software was tested per the Verification Test Specification and Verification Test Plan. Errors, anomalies, or inconsistencies were noted in Engineering Report Forms (ERFs), and all corrections were made and verified. A final configuration audit was performed by Quality Assurance to ensure that all documents and code were properly coded and released.

#### H. Conclusion

The bench testing presented herein provides reasonable assurance that the Medtronic Model 5318 Temporary Pacemaker / Implant Tool will perform as intended when used in accordance with its labeling. Additionally, based on similarities in design, materials, intended use and in-vitro test data, the 5318 Temporary Pacemaker / Implant Tool is considered substantially equivalent to the 5311B AV Pacing System Analyzer.

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Image /page/8/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, stacked on top of each other, with a stylized wing extending from the top profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lorna J. Harmuth Product Regulation Manager Medtronic, Inc. 7000 Central Avenue, N.E. … Minneapolis, Minnesota 55432-3576

JUL 1 4 1997

Re: K971474 Trade Name: Model 5318 Temporary Pacemaker/Implant Tool Regulatory Class: III Product Code: 74DTE Dated: April 22, 1997 Received: April 23, 1997

Dear Ms. Harmuth:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMF regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lorna J. Harmuth

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

・

| Device Name: | Model 5318 Temporary Pacemaker / Implant Tool |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The Medtronic Model 5318 Temporary Pacemaker / Implant Tool is intended to be used in conjunction with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment. The Model 5318 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: |
| | <ul><li>Sick sinus syndrome</li><li>Sinus bradycardia</li><li>Atrial and/or ventricular arrhythmias</li><li>Complete heart block</li><li>Cardiac arrest</li><li>Bradycardia with congestive heart failure</li><li>Support, management, and evaluation of a patient before implantable pacemaker implantation</li><li>Support during implantable pacemaker replacement</li><li>Cardiac complications during invasive or surgical procedures</li><li>Support following cardiac surgery</li><li>Acute myocardial infarction complicated by heart block</li></ul> |
| | The Model 5318 is also intended to be used by or on the order of a physician to determine sensing and stimulation thresholds and measure lead impedance of implantable lead systems during implantable pacemaker implantation. |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR |
| | (Optional Format 1-2-96) |
| | Division Sign-Off)<br>Division of Cardiovascular, Respiratory, and Neurological Devices<br>510(k) Number: K971474 |

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