(233 days)
No
The document describes a standard programmable pacemaker with a microprocessor and custom circuit, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as a "programmable pacemaker" and its "Intended Use / Indications for Use" clearly state its purpose in treating various cardiac conduction disorders, which directly indicates a therapeutic function.
No
The device description clearly states that Opus S, Model 4121 and 4124 are "single-chamber programmable pacemakers," which are therapeutic devices designed to deliver electrical impulses to the heart, not to diagnose conditions.
No
The device description explicitly states it is a single-chamber programmable pacemaker with an electronic circuit, battery, titanium case, and pacing leads. It also mentions a programmer system consisting of a programming head, programmer software, and a PC, indicating hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this device is a pacemaker. Pacemakers are implanted devices that regulate the heart's rhythm by delivering electrical impulses directly to the heart muscle. This is an in vivo (within the living body) procedure, not an in vitro test.
- Anatomical Site: The device is implanted in the heart (ventricle, atrium), which is an internal anatomical site.
The information provided describes a medical device used for treatment and management of heart rhythm disorders, not for diagnostic testing of bodily specimens.
N/A
Intended Use / 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).
Product codes
DXY
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
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:
Pacing: Model 4121: Unipolar, Model 4124: Unipolar - Bipolar
Sensing: Model 4121: Unipolar, Model 4124: 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
Dimensions (mm): Model 4121: 52.4 x 36.1 x 6.6, Model 4124: 47.6 x 36.1 x 6.6
Weight (g): 25 for both models
Volume (cc): Model 4121: 9.9, Model 4124: 9.4
Connections: Model 4121: Unipolar, 5.0-6.0 mm, Model 4124: Unipolar/bipolar, IS-1 3.2 mm
Battery: WG 8426, 0.94 Ah for both models
Longevity: 6 years* (* 100 % pacing, SSI, 70 ppm, 3.5 V, 0.49 ms, 500 Omega, 37 degrees C)
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
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance 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 / Not specified
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
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 / Not specified
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 previous success with the same materials. Sterilization and mechanical/environmental packaging validation were performed due to changes in package design and sterilization method. All test results met the established pass/fail criteria.
Key Metrics
Not Found
Predicate Device(s)
ELA Medical Opus Model 4021 (510(k) K900461 and K952363, ELA Medical Inc.), 4024 pacemakers (510(k) K882391 and K952364, ELA Medical Inc.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 ℃
2
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
3
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.
4
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 |
5
| 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 |
(
(
6
| 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.
7
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.
8
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
9
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) |