(233 days)
- 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).
Opus S, Model 4121 and 4124 are single-chamber programmable pacemakers. The electronic circuit and battery are encapsulated in a hermetic titanium case. Pacing leads are connected through a medical grade silicone elastomer connector. The different functions are assured by a hybrid circuit with passive components and integrated circuits (microprocessor and custom circuit). The programmer system consists of a programming head, programmer software, and an IBM-compatible PC.
The provided text describes the safety and effectiveness information for the ELA Medical Opus S Model 4121 and 4124 pacemakers, which are single-chamber SSI pacemakers. The document details the device description, comparison to predicate devices, potential adverse effects, and a summary of studies conducted to ensure its performance.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in the way one might expect for a quantitative clinical study. Instead, it describes various "Tests" conducted under different "Test groups." The general statement, "All test results demonstrated that the established pass / fail criterion was met in all cases," indicates that the devices successfully passed the acceptance criteria for each test.
Below is a table summarizing the test groups and the types of tests performed. The "Acceptance Criteria" for these are implied to be success in passing the specific validation or performance standards relevant to each test type (e.g., proper mechanical function, electrical isolation, sterility). The "Reported Device Performance" is the overarching statement that all criteria were met.
| Test Group | Tests Performed | Implied Acceptance Criteria (Pass/Fail) | Reported Device Performance |
|---|---|---|---|
| Sterilization Process Validation | ETO sterilization process validation, Mechanical qualification of sterilization process modification, Sterilization indicator qualification | Successful sterilization, mechanical integrity after sterilization, indicator efficacy | Met in all cases |
| Laser Welding Process Validation | (No specific tests listed, but implies validation of the welding process) | Proper and reliable laser welds | Met in all cases |
| Pacemaker Environmental Performance Testing | Baseline Electrical Performance, Thermal Shock, Mechanical Shock, Random Vibration, Vibration: Italian Requirements, Drop Tests (packaged and unpackaged devices) | Electrical functionality within specifications, structural integrity and performance under various environmental and mechanical stresses | Met in all cases |
| 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 | Electrical isolation maintained, appropriate force for lead insertion/withdrawal, low electrical resistance, secure insertion, resistance to perforation/rupture | Met in all cases |
| Feedthrough Testing | Electrical Isolation, Resistance, Hermeticity, Tensile Strength, Temperature Cycling, Aging | Electrical isolation maintained, resistance within limits, hermetic seal integrity, mechanical strength, performance stability over temperature changes and time | Met in all cases |
| Mechanical Qualification of Packaging | Bioburden, Visual Inspection, Hermeticity | Packaging maintains sterility (low bioburden), free from visual defects, hermetic seal integrity | Met in all cases |
| Hybrid Testing | Environmental Temperature Cycling, Constant Acceleration, Vibration, Mechanical Shock, Seal Hermeticity, Particle Impact Noise Detection (PIND), Final Electrical Test, Life (Reliability) Test | Reliable electrical function and structural integrity of the hybrid circuit under various environmental and mechanical stresses, hermeticity of the seal, absence of loose particles, long-term reliability | Met in all cases |
| Die Attach Qualification | (No specific tests listed, but implies validation of the die attach process) | Secure and reliable die attachment | Met in all cases |
| Hybrid Component Testing | Microprocessor, Ceramic and Tantalum capacitors, Resistor chip, Zener diode, Pacing chip | Individual components meet their specifications and perform reliably | Met in all cases |
| 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 | Device remains functional and safe under electromagnetic interference, electrosurgery, defibrillation, electrostatic discharge, and cellular phone interference | Met in all cases |
| Software Validation | Implant software validation, Programmer software validation | Software functions correctly and reliably, adhering to design specifications | Met in all cases |
| Biocompatibility Testing | Not performed, due to successful history with same materials in other pacemakers. | (N/A - relied on predicate device data) | (Data from predicate devices) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document comprehensively lists various in-vitro functional testing performed on the Opus S Model 4121 and 4124 pacemakers. However, it does not specify the sample sizes used for these in-vitro tests (e.g., how many units were subjected to thermal shock, how many connectors were tested). It also does not mention the country of origin of the data or whether the tests were prospective or retrospective. Given that these are in-vitro functional tests, they would inherently be prospective.
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 type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving human interpretation or clinical endpoints (e.g., image analysis, disease diagnosis). The studies described here are primarily in-vitro functional and environmental tests for a medical device (pacemaker). Such tests rely on engineering specifications, standardized protocols, and instrument measurements rather than expert human interpretation for "ground truth." Therefore, this information is not applicable to the described verification and validation activities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similar to point 3, adjudication methods (like 2+1 or 3+1 consensus) are typically used in studies where there's subjectivity in determining ground truth (e.g., reviewing medical images). For the in-vitro functional and environmental tests described, the 'truth' is determined by whether the device's performance meets pre-defined engineering specifications and standards. There is no mention of an adjudication method as it would not be relevant for these types of objective functional tests.
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
The document describes the verification and validation of a pacemaker, which is an implantable electronic device, not an AI-powered diagnostic tool requiring human reader assistance. Therefore, no MRMC comparative effectiveness study was performed or is applicable to this device. This information is irrelevant in the context of pacemaker approval.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is also generally related to AI algorithms. While the pacemaker itself functions in a "standalone" manner within the patient, and its software (implant and programmer) underwent validation, the concept of "standalone performance" in the context of an "algorithm only without human-in-the-loop performance" typical for AI diagnostics does not directly apply here. The device's performance is its intrinsic function, which was verified through extensive testing as detailed. There isn't an "algorithm" in the sense of a predictive model being assessed for its diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in-vitro functional and environmental tests conducted on the pacemaker, the "ground truth" is established by engineering specifications, international standards (e.g., for EMI, ESD, vibration), and predefined pass/fail criteria derived from the device's design requirements. For example, for "Electrical Isolation," the ground truth is a measurement confirming that certain leakage currents or resistance levels are not exceeded. For "Sterilization Process Validation," the ground truth is evidence of sterility (e.g., via biological indicators) after the process. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these specific tests. Biocompatibility was handled by relying on predicate device history, which implicitly references previous outcomes data and regulatory acceptance.
8. The sample size for the training set
The document describes the verification and validation of manufactured devices, not the development of an AI model that requires a "training set." Therefore, this information is not applicable. The "training" for such a device effectively happens during its design and manufacturing process, using engineering principles and established requirements.
9. How the ground truth for the training set was established
As there is no training set in the context of AI/machine learning for this device, the question of how its ground truth was established is not applicable.
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970072
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. (612) 519-9400
Date of Summary Preparation: October 2155 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 ℃
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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 ProcessValidation | ETO sterilization process validation Mechanical qualification of sterilization process modification Sterilization indicator qualification |
| Laser Welding ProcessValidation | |
| Pacemaker EnvironmentalPerformance Testing | Baseline Electrical Performance Thermal Shock Mechanical Shock Random Vibration Vibration: Italian Requirements Drop Tests (packaged and unpackaged devices) |
| Connector Testing (IS-1 and5.0-6.0 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 |
Biocompatiblity 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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Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 1997
Ms. Catherine G. Goble Requlatory Affairs Manger Ela Medical 2950 Xenium Lane North Plymouth, MN 55441
K970072 Re: 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 aqainst misbranding and adulteration.
If vour 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
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
Opus S Model 4121 and 4124 pacemakers. Device Name:
Indications for Use:
- · AV conduction diserders 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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K970072 |
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
§ 870.3610 Implantable pacemaker pulse generator.
(a)
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.(b)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 20, 2012, for any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976, or that has, on or before September 20, 2012, been found to be substantially equivalent to any implantable pacemaker pulse generator device that was in commercial distribution before May 28, 1976. Any other implantable pacemaker pulse generator device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.