OPUS S MODEL 4121 AND 4124 PACEMAKERS

K970072 · Ela Medical, Inc. · DXY · Aug 29, 1997 · Cardiovascular

Device Facts

• Record ID: K970072
• Device Name: OPUS S MODEL 4121 AND 4124 PACEMAKERS
• Applicant: Ela Medical, Inc.
• Product Code: DXY · Cardiovascular
• Decision Date: Aug 29, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3610
• Device Class: Class 3
• Attributes: Therapeutic

Indications for Use

Generally accepted indications for long-term single-chamber cardiac pacing include: - AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle), - Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

Device Story

Opus S Models 4121/4124 are single-chamber programmable pacemakers; provide cardiac pacing therapy. Device monitors intrinsic cardiac activity via implanted leads; delivers electrical pulses to heart based on programmed parameters (rate, amplitude, width, sensitivity). Operated by physicians using external programmer system (programming head, software, PC). Provides diagnostic data including event markers, intracardiac ECG, and lead measurements (impedance, current, voltage, energy). Output assists clinicians in managing patient pacing needs; improves patient comfort via smaller form factor compared to predicates. Used in clinical settings for long-term management of bradyarrhythmias.

Clinical Evidence

Bench testing only. Testing included sterilization validation, mechanical/environmental performance (thermal shock, vibration, drop tests), connector testing, feedthrough testing, hybrid component testing, and electromagnetic interference protection. Software validation for implant and programmer software was performed. No clinical data provided.

Technological Characteristics

Single-chamber pacemaker; titanium hermetic case; silicone elastomer connector. Hybrid circuit substrate with microprocessor and custom integrated circuits. Programmable SSI, SST, SOO modes. Unipolar (4121) or Unipolar/Bipolar (4124) sensing/pacing. Battery: WG 8426. Connectivity via external programmer system. Sterilization: ETO.

Indications for Use

Indicated for patients with AV conduction disorders, intraventricular conduction disorders with permanent atrial tachycardia (atrial fibrillation/flutter), sinus bradycardia, sinoatrial block, or brady-tachy syndrome without AV conduction disorder.

Regulatory Classification

Identification

An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.

Predicate Devices

• ELA Medical Opus Model 4021 (K900461, K952363)
• ELA Medical Opus Model 4024 (K882391, K952364)

Submission Summary (Full Text)

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k970073

AUG 29 1997

## Summary & Certification

### Summary of safety and effectiveness information

#### General Information

**Device Generic Name:** Single chamber, SSI pacemaker.

**Device Trade Name:** Opus S Model 4121 and 4124 pacemakers

**Applicant’s Name and Address:** ELA Medical, Inc., 2950 Xenium Lane N., Suite 120, Plymouth, MN 55441, Tel. [phone]

**Date of Summary Preparation:** October 21st, 1996

**Contact Person:** Catherine G. Goble

**510(k) Number:** K970072

**Date of Judgment of Substantial Equivalence Sent to Applicant:**

**Predicate Devices:** ELA Medical Opus Model 4021 (510(k) K900461 and K952363, ELA Medical Inc.) and 4024 pacemakers (510(k) K882391 and K952364, ELA Medical Inc.).

#### Description of Conditions for Which the Devices are Indicated

Generally accepted indications for long-term single-chamber cardiac pacing include:

- AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle),
- Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

#### Device Description

Opus S, Model 4121 and 4124 are single-chamber programmable pacemakers with the following specifications:

**Programmable parameters:**

**Basic parameters:**

Mode: SSI, SST, SOO

Basic rate (ppm): 30, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 89, 96

Maximum rate (ppm): 101, 110, 120, 132, 142, 154

Hysteresis (% of rate): 0, 5, 10, 20, 33

Absolute refractory period (ms): 172, 203, 234, 266, 297, 328, 359

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Pacing and sensing:

Pulse amplitude (V): 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0,

Pulse width (ms): 0.12, 0.24, 0.37, 0.49, 0.61, 0.73, 0.85, 98

Sensitivity (mV): 0.4, 0.6, 0.8, 1.0, 1.2, 1.5, 1.8, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5

Polarity:

| | Model 4121 | Model 4124 |
| --- | --- | --- |
| Pacing | Unipolar | Unipolar - Bipolar |
| Sensing | Unipolar | Unipolar - Bipolar |

Specific function:

Rate-smoothing (ms/8 cycles): 16, 31, 47, 63, 78, 94, OFF

Non-programmable parameters

Rate limit: 170 ppm

Magnet rate: 96 ppm at BOL, 80 ppm at ERI

Technical specifications

| | Model 4121 | Model 4124 |
| --- | --- | --- |
| Dimensions (mm) | 52.4 x 36.1 x 6.6 | 47.6 x 36.1 x 6.6 |
| Weight (g) | 25 | 25 |
| Volume (cc) | 9.9 | 9.4 |
| Connections | Unipolar, 5.0-6.0 mm | Unipolar/bipolar, IS-1 3.2 mm |
| Battery | WG 8426, 0.94 Ah | WG 8426, 0.94 Ah |
| Longevity | 6 years* | 6 years* |

* 100 % pacing, SSI, 70 ppm, 3.5 V, 0.49 ms, 500 Ω, 37 °C

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# Follow-up functions

## Statistics:

Number and percentage of: paced cycles, sensed cycles, extrasystoles

Number of: cardiac cycles, programmings

**Heart rate curve:** 45 minutes, 24 hours, **OFF**

**Event markers:** Identification of two event types: spontaneous and paced events

**Intracardiac ECG**

**Threshold test:** Programmable threshold test rate (ppm): 80, 89, **101**, 110, 120

**Lead measurement:** Impedance, current, voltage, and energy

**As shipped values shown in bold/italics**

## Physical characteristics

The electronic circuit and battery of Opus S Model 4121 and 4124 pacemakers are encapsulated in a hermetic titanium case. Pacing leads are connected through a medical grade silicone elastomer connector. The different functions of Opus S Model 4121 and 4124 pacemakers are assured by a hybrid circuit. The hybrid circuit is a substrate onto which different electronic components are mounted:

- passive components (resistors, capacitors, etc.) and
- integrated circuits (microprocessor and custom circuit).

## Programmer system

The programmer system consists of:

- Programming head
- Programmer software
- IBM-compatible PC

Opus S Model 4121 and 4124 pacemakers are similar in design and construction to other single-chamber pacemakers in commercial distribution.

## Comparison to predicate devices

ELA Medical Opus™ S Model 4121 and 4124 pacemakers are similar to the predicate Opus™ Model 4021 and 4024 pacemakers, respectively, except for these general differences. Physically, both Opus-S models are smaller to improve patient comfort. A smaller size was achieved by using a smaller (but widely used) battery, reducing the

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connector size (without substantially altering its design) and making the hybrid smaller. Functionally, a few programmable parameter values were changed to make Opus S more flexible for managing patient conditions. Pacing and sensing polarity were also made independently programmable for Opus-S Model 4124 pacemaker (versus fixed for Opus models) to offer more flexibility to manage patient needs. Otherwise, the two Opus-S models are substantially equivalent to the two respective predicate Opus models. The programmer parameter value changes and programmable polarity were achieved by modifying the custom integrated circuit on the hybrid. The programmer system is similar to that of Opus™ Model 4021 and 4024.

Similar designs and manufacturing processes, and the same materials, are used to make the ELA Medical Model 4121, 4124, 4021 and 4024 pacemakers.

## Alternatives

The alternatives for Opus S Model 4121 and 4124 pacemakers are other commercially available single-chamber, SSI pacemakers.

## Marketing History

Opus S Model 4121 and 4124 pacemakers are not in commercial distribution in the U.S. They were recently introduced into commercial distribution outside the U.S. No unanticipated adverse device effects have been reported for these pacemakers.

## Potential Adverse Effects

The potential adverse effects of Opus S Model 4121 and 4124 pacemakers are the same as those for single-chamber (SSI) pacemakers in commercial distribution. Pacemaker-related complications are described in the Opus S physician's manual.

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# Summary of Studies

The following in-vitro functional testing was performed on the Opus S Model 4121 and 4124 pacemakers:

| Test group | Tests |
| --- | --- |
| Sterilization Process Validation | • ETO sterilization process validation
• Mechanical qualification of sterilization process modification
• Sterilization indicator qualification |
| Laser Welding Process Validation | |
| Pacemaker Environmental Performance Testing | • Baseline Electrical Performance
• Thermal Shock
• Mechanical Shock
• Random Vibration
• Vibration: Italian Requirements
• Drop Tests (packaged and unpackaged devices) |
| Connector Testing (IS-1 and 5.0-6.0 mm) | • Electrical Isolation
• Pacing Lead Insertion/Withdrawal Forces
• Electrical Resistance
• Rotation of Inserts
• Perforation and Rupture Force |

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| Test group | Tests |
| --- | --- |
| Feedthrough Testing | - Electrical Isolation Resistance
- Hermeticity
- Tensile Strength
- Temperature Cycling
- Aging |
| Mechanical Qualification of Packaging | - Bioburden
- Visual Inspection
- Hermeticity |
| Hybrid Testing | - Environmental
- Temperature Cycling
- Constant Acceleration
- Vibration
- Mechanical Shock
- Seal Hermeticity
- Particle Impact Noise Detection (PIND)
- Final Electrical Test
- Life (Reliability) Test |
| Die Attach Qualification | |

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| Test group | Tests |
| --- | --- |
| Hybrid Component Testing | - Microprocessor
- Ceramic and Tantalum capacitors
- Resistor chip
- Zener diode
- Pacing chip |
| Pacemaker Interference Testing | - Protection Against Spurious Current Induced by Electromagnetic Interference
- Protection Against Sensing Electromagnetic Interference
- Protection Against Malfunction Due to Electromagnetic Interference
- Protection Against Electrosurgery Current
- Defibrillation Protection
- Electrostatic Discharge Protection
- Cellular Phone Interference |
| Software validation | - Implant software validation
- Programmer software validation |

Biocompatibility testing was not performed, due to the successful history with the same materials in other pacemakers. Sterilization testing and mechanical / environmental packaging validation were performed, because the pacemaker package design and sterilization method changed. All test results demonstrated that the established pass / fail criterion was met in all cases.

## Conclusion

The information presented in this submission provides reasonable assurance that the Opus S Model 4121 and 4124 pacemakers will perform in a safe and effective manner.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 29 1997

Ms. Catherine G. Goble
Regulatory Affairs Manger
Ela Medical
2950 Xenium Lane North
Plymouth, MN 55441

Re: K970072
Trade Name: Opus S Model 4121 and 4124 Single Chamber Pacemakers
Regulatory Class: III (3)
Product Code: DXY
Dated: August 20, 1997
Received: August 21, 1997

Dear Ms. Goble:

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 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 requirements, 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 GMP regulation may result in regulatory 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. Catherine G. Goble

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

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# Indications for Use Statement

510 (k) Number: K970072

Device Name: Opus S Model 4121 and 4124 pacemakers.

Indications for Use:

- AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle),
- Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐