(123 days)
The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.
The CareLink SmartSync Device Manager system is comprised of the Model 24970A Base and CareLink SmartSync Device Manager app installed and running on your mobile device. The Base pairs with the app on your mobile device to analyze the cardiac lead system for an implantable Medtronic device. The base includes analyzer hardware and patient cable connections, ECG cable connections, and Bluetooth wireless technology. The Base contains a microprocessor that maintains the pacing engine logic function. The PSA hardware within the Base consists of two main integrated circuits (ICs): a Micro Controller Unit and a Mixed Signal Integrated Circuit. The App is the primary user interface and includes a Host Application, a Platform Application, a Common Application, and a PSA Application component. The Analyzer tools in the App display and report on the cardiac lead and ECG data transmitted from the base.
The provided text describes a 510(k) premarket notification for the Medtronic CareLink SmartSync Device Manager Pacing System Analyzer (K163008). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with a test set, ground truth experts, and MRMC analysis as typically understood for an AI/ML medical device.
Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) based on the provided document.
The document outlines performance data collected to support the substantial equivalence claim, which includes: Biocompatibility testing, Electrical safety and electromagnetic compatibility (EMC) testing, Software Verification and Validation Testing, and Mechanical Testing.
Here's a breakdown of the information that is available in the document, mapped against your request:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with corresponding "reported device performance" in the typical sense of a clinical validation study for an AI/ML device. Instead, it demonstrates compliance with relevant standards and functionality of a medical device (a Pacing System Analyzer). The "performance" is primarily shown through a comparison to predicate devices and adherence to regulatory standards.
Here's an interpretation based on the provided "Key Performance Specifications/Characteristics of the Device" table, which functions like a set of performance criteria, and the statement of compliance:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | N/A (implicit: device materials must not cause adverse biological reactions, justified by similarity to predicate) | "The biocompatibility evaluation... was conducted in accordance with the FDA Blue Book Memorandum #G95-1... and International Standard ISO 10993-1... The device was justified by similarity to the Medtronic Model 24967 patient connector (K163460). The battery of testing for materials used in the Model 24970A included the following tests: Cytotoxicity, Sensitization, Irritation. The Model 24970A is considered non-tissue or patient contacting." |
| Electrical Safety and EMC | Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Specific test levels for ESD, Fast Transient/burst, Surge, Voltage dips, Power frequency magnetic field, Conducted RF, Radiated RF. | "The system complies with the IEC 60601-1, standards for safety and the IEC 60601-1-2 third and fourth edition versions of the standard for EMC." (Detailed compliance levels provided in tables on pages 11-13, showing "Compliance level" meets or exceeds "IEC 60601 Test level" for immunity tests). |
| Software Verification & Validation | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software level of concern: "major" (failure could result in serious injury or death). | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'major' level of concern..." |
| Mechanical Testing | Inspection of mechanical design features, workmanship, labeling. Forces for controls, chemical resistance, environmental/drop testing, reliability of buttons/electrical contacts, performance/robustness of articulated lid. | "The following is a list of testing performed: Inspection of the required mechanical design features and function; Workmanship inspection concerning all external surfaces...; Product labeling inspection; Forces required to activate controls; Chemical resistance testing for effects of repeat cleaning cycles; Environmental and drop testing; Reliability testing of buttons, electrical contacts, user connector insertions, and replaceable or moving mechanical components; Performance and robustness testing of the Articulated Lid." (Implicitly, these tests were passed to support the substantial equivalence claim). |
| Technical Specifications (e.g., ECG/EGM) | ECG Signal Characteristics: Gain (1.0), Sampling Rate (500 Hz), Sampling Resolution (16 bits/sample). EGM Signal Characteristics: Atrial Gain (75X), Ventricular Gain (18.75X), High Pass Pole (2.0Hz to 3.0Hz), Low Pass Pole (80Hz to 110Hz), Sampling Rate (256 Hz), Sampling Resolution (8 bits/sample). Pacing Parameters: Basic Rate (30-200 ppm), High Pacing Rate (200-850 ppm), Stimulation Amplitude (0.25–8.0 V), Pulse Width (0.03-1.50 ms), Sensitivity (0.15-11.30 mV), Refractory/Blanking (Atrial: 150-500 ms, Ventricular: 150-500 ms), Pacing Modes (VOO, VVI, AOO, AAI, DOO, DDD, DDI, ODO, OOO) | Values are listed as "Fixed Value" or "Range" in Tables 3 & 4 and the "Comparison of Technological Characteristics" section. For example, "ECG Gain: 1.0", "Sampling Rate: 500 Hz", etc. The comparison table states "Same" or "Similar" for these parameters when compared to the predicate device, implying they meet the functional requirements for a Pacing System Analyzer. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission is for a hardware/software medical device (Pacing System Analyzer), not an AI/ML algorithm requiring a specific patient test set for performance evaluation in the clinical sense you described. Performance is demonstrated through engineering verification and validation, and comparison to a predicate device.
- Data Provenance: Not applicable for an AI/ML algorithm test set. The testing conducted is primarily laboratory-based engineering and software verification.
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)
- N/A. Ground truth establishment by experts for a test set is not relevant to this type of device submission. The device's function is to objectively measure electrical performance of cardiac leads and display waveforms, not to interpret medical images or signals in a way that requires human expert adjudication for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are not applicable for this device submission.
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
- N/A. This device is a Pacing System Analyzer, not an AI-assisted diagnostic tool that would typically undergo an MRMC study to assess human reader performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. The device itself is a "standalone" system in that it performs its measurements according to its specifications. There isn't an "algorithm only" component that generates a decision or output that would then be compared to human performance in the context of an AI/ML device. Its function is to provide objective electrical measurements to a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. The "ground truth" for this device's performance relates to its ability to accurately measure electrical parameters (e.g., amplitude, impedance, rates) and display waveforms as per engineering specifications and comparison to predicate devices, rather than a clinical ground truth like disease presence or absence. Measurements are validated against known inputs and established engineering principles.
8. The sample size for the training set
- N/A. This document does not describe the development or validation of an AI/ML algorithm that requires a "training set" in the machine learning sense. The software described is traditional deterministic software.
9. How the ground truth for the training set was established
- N/A. As no AI/ML training set is mentioned or implied, this question is not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Medtronic, Inc. Laura Danielson Principal Regulatory Affairs Specialist 8200 Coral Sea Street Ne Mounds View, Minnesota 55112
Re: K163008
Trade/Device Name: Carelink SmartSync Device Manager Pacing System Analyzer Regulation Number: 21 CFR 870.3605 Regulation Name: Pacing System Analyzer Regulatory Class: Class II Product Code: DTA, DTE Dated: January 25, 2017 Received: January 26, 2017
Dear Laura Danielson:
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 (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Sincerely,
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
510(k) Number (if known) K163008
Device Name
Carelink SmartSync Device Manager Pacing System Analyzer
Indications for Use (Describe)
The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared: | January 13, 2017 |
|---|---|
| 510(k) Owner / Address: | Medtronic, Inc.Cardiac Rhythm and Heart Failure8200 Coral Sea StreetMounds View, MN 55112 |
| Contact: | Laura L. DanielsonPrincipal Regulatory Affairs Specialist |
| Telephone: | (763) 526-2385 |
| Fax: | (651) 367-0603 |
| E-mail: | laura.l.danielson@medtronic.com |
| Trade / Proprietary Name: | CareLink SmartSync™ Device ManagerPacing System Analyzer |
| Common Name: | Pacing System Analyzer |
| Classification /Classification Name: | Class IIPacing System Analyzer(21 CFR 870.3605) |
| Product Code: | DTA, DTE |
Predicate Devices
The intended use, design, materials and performance of the CareLink SmartSync™ Device Manager Pacing System Analyzer with associated Applications (Models: D00U001, D00U002, M01G02, M01A02, M01G01, and M01A01), cables (previously approved) and accessories are substantially equivalent to the following predicate device:
- Medtronic Model 2290 Lead Analyzer approved on 13MAR2002 P890003/S065. ●
- . Medtronic Model 5311B A-V Pacing System Analyzer cleared on 07MAY1991 K910595.
Device Description
Device Identification:
The following is a list all key device components included in the submission:
- . CareLink SmartSync Device Manager base (PSA hardware), Model 24970A
- . CareLink SmartSync PSA App, Model D00U002
- CareLink SmartSync Host, Model D00U001
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- . CareLink SmartSync Common Application, Model M01G02 (Android) and Model M01A02 ( iOS )
- . CareLink SmartSync Platform, Model M01G01 (Android) and Model M01A01 (iOS)
- . Non-Medical Mobile Platform (i.e. Tablet)
The following compatible accessories are available for the CareLink SmartSync Device Manager base (PSA hardware) that Medtronic is seeking clearance for in this 510(k) submission:
- . ME20A054F03 power supply (Medtronic re-order number: 249701), 1.8 m (approximately 6 ft.): a floor mount that connects through the 249705 AC power cord to the wall on one end, and through a DC power cord to the base station on the other end with a right angle barrel plug
- . 249705 AC power cord, 1.8 m (approximately 6 ft.): Connects the power supply to AC power
- 249702 USB cable, approximately 3 m (10 ft.): connects to the Model 24967 patient . connector (not the subject of this submission. but in another 510(k) but only upon approval of both models)
- . 249672 Tether Kit: Secures the USB cable 249702 and Power supply 24951 to the Model 24967 patient connector (Not the subject of this 510(k) submission). Contains an Allen wrench, screw, and cable retainer
- . 249703 Wall mount: mounts the base to the wall when table space is a concern
The above listed accessories are considered off the shelf and non-medical.
The following compatible cables and adaptors are available for the base. These are the same adaptors and cables used with the current market approved and released Model 2290 PSA predicate and are considered medical devices.
Surgical and patient cables connect the base to cardiac leads for lead analysis. Adaptors allow surgical and patient cables to be connected to the base when their plugs are not compatible with the Type CF connection port on the base. Ground cables connect to the base (via alligator clip connecting to a cable) and complete the electrical circuit when connected to unipolar implantable cardiac device leads.
- 2292 Surgical cable, 3.66 m (12 ft.) – Approved: P890003/S065, 13MAR2002
- 5103 A/V adaptor Approved: P890003/S054, 24SEPT1998 ●
- 5104 Analyzer Adaptor - Approved: P890003/S054, 24SEPT1998
- 5114 Adaptor - Approved P890003 (initial submission), 24AUG1989
- 5832 Surgical cable, approximately 3.5 m (12 ft.) P890003/S070, 31OCT1995 ●
- 5833S Surgical cable, 1.83 m (6 ft.) Cleared: K923407, 190CT1992 ●
- 5833SL Surgical cable, 3.66 m (12 ft.) Cleared: K923407, 19OCT1992 .
- 5473 Ground cable Cleared: K961520, 13NOV1996 ●
- 5436 Analyzer patient cable, 3.66 m (12 ft.) - Approved: P890003/S054, 24SEPT1998
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The following compatible ECG interface cables, and adaptors are available for the base. These are the same Adaptors and Cables used with the current market approved and released Model 2290 PSA predicate and are considered medical devices.
ECG cables and leads connect the base to surface electrodes on the patient for the display of live waveforms. Adaptors allow ECG monitors with phono connectors to be connected to the base.
- 5437 ECG Interface cable, 6.4 m (20 ft.) Approved: P890003/S065, 13MAR2002 ●
- 5437A Adaptor Approved: P890003/S065, 13MAR2002 .
- . 2090EC ECG cable, approximately 2.6 m (103 in.) - Approved: P890003/S065. 13MAR2002
- 2090ECL ECG cable, approximately 5.5 m (215 in.) - Approved: P890003/S065, 13MAR2002
- 9790LA ECG leads, approximately 1 m (40 in.) Approved: P890003/S027, ● 29NOV1994
- . 9790XLA ECG leads, approximately 1 m (40 in.) = Approved: P890003/S027, 29NOV1994
Medtronic recommends the use of Medtronic-supplied components only. Use of unapproved components may reduce device effectiveness or impact user or patient safety.
Device Characteristics:
The CareLink SmartSync PSA is comprised of Base, software applications, associated cables and power cords. The software applications reside on a mobile platform or tablet and pair via Bluetooth® with the base hardware. The mobile platform is considered non-medical. The Operating System is also non-medical software that is delivered with and resides on the Mobile Platform.
The CareLink SmartSync Device Manager base (Model 24970A) is not considered a single-use device.
The CareLink SmartSync Device Manager base (Model 24970A) is not provided sterile.
Environment of Use:
The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.
Brief Written Description of the Device:
The CareLink SmartSync Device Manager system (referred to from now on as the device manager system) is comprised of the Model 24970A Base and CareLink SmartSync Device Manager app installed and running on your mobile device.
The CareLink SmartSync Device Manager Base (referred to from now on as the base) pairs with the Medtronic CareLink SmartSync Device Manager app on your mobile device to analyze the cardiac lead system for an implantable Medtronic device. The base includes these features:
- Analyzer hardware and patient cable connections to support electrical assessment of ● cardiac leads during implant.
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- . ECG cable connections to collect live cardiac waveform data that can be viewed, measured, and recorded using the app running on your mobile device.
- Bluetooth® wireless technology to communicate with the app running on your mobile . device.1
The Model 24970A Base contains a microprocessor that maintains the pacing engine logic function for the PSA.
The PSA hardware within the Base consists of two main integrated circuits (ICs) which provide a variety of functions as listed below:
- . Micro Controller Unit: the microprocessor is used to provide timing support and also onboard memory for the device.
- Mixed Signal Integrated Circuit: the mixed signal IC chip takes the input signals from the . cables (connected to a lead) and digitizes it for use by the device. This IC is also responsible for the electrogram (EGM) waveform and power management.
The App is the primary user interface for the device manager system. The App for the CareLink SmartSync PSA is comprised of four main components:
- . A Host Application component that provides the system user interface necessary to initialize, and set-up the CareLink SmartSync Device Manager and launch the PSA Clinician Application
- . a Platform Application component for the transfer/exchange, storage/retrieval, electronic conversion, and electronic display of medical device data
- a Common Application component that is a collection of software components that are . utilized by the PSA or Device Applications
- . a PSA Application component that is a Mobile Platform Application that allows user to use the PSA device
The App includes these features:
- Bluetooth® connectivity to pair with the base. .
- Integration with the base to start a lead analysis session.
- . Mobile device connectivity tools for sharing and printing Analyzer reports.
- . Updates to app software using an Internet connection.
The Analyzer tools in the App form the primary user interface to the Base). These tools display and report on the cardiac lead and ECG data transmitted from the base. Clinicians use this data to perform these tasks:
- Analyze electrical performance of cardiac leads during implant. ●
- . Assess proper placement of cardiac leads during implant.
- . View, measure, and document live cardiac waveforms.
CareLink SmartSync Application Models installed on a clinician's off-the-shelf non-medical mobile device. The Operating System is also non-medical software that is delivered with and resides on the non-medical Mobile Platform.
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The Analyzer has the following features:
- Dual and single chamber pacing modes.
- . Automatic measurement of P-wave and R-wave amplitudes.
- Lead impedance measurement. ●
- Real-time display of atrial and ventricular EGM and ECG waveforms.
- Rapid atrial stimulation to 850 min-1 (ppm).
- Advanced pulse width versus amplitude pacing threshold tests.
- Measurement reports.
The CareLink SmartSync Device Manager provides the essential capabilities for analysis of and the electrical performance of cardiac leads during device implant in a hospital environment (See Tables 1 through Table 4).
Table 1: PSA Base Physical Characteristics
| Parameter | Value |
|---|---|
| Footprint | 548 cm² |
| Mass | 0.91 kg (2.0 lbs.) |
| Dimensions H x W x D | 1.8 in x 9.45 in x 8.2 in |
| Device identification code | Device serial number prefix"SPM" |
| Power Source | 5V Direct Current provided byMedical Grade External PowerSupply. PSA Battery info in thefollowing table. |
Table 2: PSA Base (off the shelf) AA Battery Characteristics
| Parameter | Value |
|---|---|
| Manufacturer | Panasonic |
| Model/type | IEC LR6 Alkaline Battery (AA)(n=2) per Base |
| Chemistry | Alkaline |
| Battery Life dependence upon utilizationmonitored by the Mobile Application on theuser mobile device. | 2 years required replacement asindicated by the Maintenanceschedule |
| Parameter | Description | Fixed Value |
|---|---|---|
| ECG Gain | Surface ECG User Interface display | 1.0 |
| SamplingRate | Rate at which the ECG signal is digitized | 500 Hz |
| SamplingResolution | Number of bits per sample used in the digitizationof the ECG signal | 16 bits /sample |
Table 3: PSA Base ECG Signal Characteristics
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| Parameter | Description | Fixed Value |
|---|---|---|
| EGM Gain, Atrial | Amplification of the atrial EGM signal | 75X |
| EGM Gain, Ventricular | Amplification of the ventricular EGM signal | 18.75X |
| High Pass Pole | -3dB high pass filter frequency | 2.0Hz to 3.0Hz |
| Low Pass Pole | -3dB low pass filter frequency | 80Hz to 110Hz |
| Sampling Rate | Rate at which the EGM signal is digitized | 256 Hz |
| Sampling Resolution | Number of bits per sample used in thedigitization of the EGM signal | 8 bits / sample |
Table 4: PSA Base EGM Signal Characteristics
Materials of Use
The following is a list of exposed materials included in the manufacture of the Model 24970A:
| Component | Material |
|---|---|
| Top Enclosure Base | Plastic:SABIC LEXAN EXL-9330 PolycarbonateWhite Resin per Medtronic color chip M954239A001Elastomer Edge:Eraprene A6060N-SPThermoplastic ElastomerBlue per Pantone 301 |
| Lid Base | Plastic:SABIC LEXAN EXL-9330 PolycarbonateWhite Resin per Medtronic color chip M954239A001Graphics:Pantone 301 BlueElastomer Edge:Eraprene A6060N-SPThermoplastic ElastomerBlue per Pantone 301 |
| Bottom Enclosure Base | Plastic:SABIC LEXAN EXL-9330 PolycarbonateWhite Resin per Medtronic color chip M954239A001Graphics:Pantone 301 Blue |
| Membrane Keypad Base | Graphics:Autotex-2(V200)PolyesterButton:Silicone Rubber60 Shore AClearTop Coat:PolyurethanePer color chip Pantone Cool Grey 8 |
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| Component | Material |
|---|---|
| Battery Cover Base | SABIC LEXAN EXL-9330 PolycarbonateWhite Resin per Medtronic color chip M954239A001 |
| Foot Rear Base | Silicone Rubber 70 Shore AColor: Pantone Cool Grey 8 |
| Device Label Base | Lexan PC 8B35PolycarbonateClear |
| QR Code Label Base | Lexan PC 8B35PolycarbonateClear |
| PSA Connector Base | Hypertronics D02 HousingPolyethermideBlack |
The device does not include biologics, drugs, or coating additives. The pacing system analyzer is not intended for patient contact.
Key Performance Specifications/Characteristics of the Device
Base Specifications
| Standards (The base complies with the following:) | |
|---|---|
| Radio frequency wireless specifications and applicable standards | |
| EMC | EN / IEC 60601-1-2EN 300 328EN 301 489EN 302 195EN 301 839EN 55011 Class A |
| Radio | FCC CFR 47 |
| Patient safety | UL/CUL 60601-1, Type BF applied part, Type CF applied partaEN 60601-1, Class 2, continuous operation, Type BF, Type CFa |
| AC power requirement | |
| Voltage | 100-240 VAC nominal |
| Frequency | 50/60 Hz nominal |
| Battery | |
| Type | AA Alkaline (LR6) or Lithium-ion, non-rechargeable (quantity of 2) |
| Voltage | 1.5 V each |
| Base Electrical Specifications | |
| Power Supply | |
| Model | ME20A0540F03 power supply (Medtronic re-order number 249701) |
| Voltage in | 100-240 VAC 0.5A at 50-60 Hz |
| Voltage out | 5 VDC 3 A |
| USB Cable | |
| Model | 249702 USB cable |
| Voltage | 5 V 0.8 A |
| Power | 4 W |
| Charge cradle | |
| Model | 24970A |
| Voltage | 5 V 0.8 A |
| Power | 4 W |
| IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) | |
| Ingress | This product complies with international electrical safety ratingIP2X with regard to ingress of dust, other foreign objects, andwater as required by IEC 60601-1. |
| Physical dimension and weight | |
| Height | 4.6 cm (1.8in) |
| Width | 24 cm (9.5 in) |
| Depth | 20.8 cm (8.2 in) |
| Weight | 0.91 kg (2 lbs) |
| Temperature Limits | |
| Operating | 10°C to 35°C (50°F to 95°F) |
| Storage | 15°C to 30°C (59°F to 86°F) |
| Transport | - 30°C to 55°C (-22°F to 131°F) |
| Humidity Limits | |
| Operating | 8%-80% |
| Storage | 15%-93% at 35°C (95°F) |
| Transport | 15%-93% at 35°C (95°F) |
| Altitude | |
| Maximum | 3000 m |
| Connectivity | |
| Conexus wireless telemetry | |
| Frequency range | 402-405 MHz |
| Modulation frequency | Frequency shift key |
| Output power | 25 µW EIRP max |
| Bluetooth 2.1 and 4.0 | |
| Frequency range | 2.4-2.483 GHz |
| Modulation frequency | Gaussian frequency shift key |
| Output power | Less than 10 mW EIRP |
| * The ECG cable (Type BF), 24967 Patient Connector (Type BF) and patient or surgical cable (Type CF) are the only accessoriesthat come into direct contact with the patient. The base itself is not intended to come into contact with the patient during normaluse. | |
| Expected Service Life: | 5 years |
| Disposal of the base: Return the base to Medtronic for proper disposal. Contact Medtronic at the address or telephone number onthe back cover for information on returning the base. | |
| Electromagnetic compatibility declaration | |
| The following list of accessories is compliant with the requirements of IEC 60601-1-2. | |
| Accessory | Maximum length |
| ME20A0540F03 Power supply | 1.8 m (6 ft) |
| 249705 AC power cord | 1.8 m (6 ft) |
| 249702 USB cable | 3 m (10 ft) |
| 24967 Patient Connector | N/A |
| 2292 Surgical cable | 3.66 m (12 ft) |
| 5832 Surgical cable | 3.5 m (12 ft) |
| 5833S Surgical cable | 1.83 m (6 ft) |
| 5833SL Surgical cable | 3.66 m (12 ft) |
| 5346 Analyzer patient cable | 3.66 m (12 ft) |
| 5437 ECG Interface cable | 6.4 m (20 ft) |
| 2090EC EKG cable | 2.6 m (103 in) |
| 2090ECL EKG cable | 5.5 m (215 in) |
| 9790LA EKG leads | 1 m (40 in) |
| 9790XLA EKG leads | 1 m (40 in) |
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Use of accessories other than what is specifically listed may result in increased immunity of the 24970A base.
The 24970A base needs special precautions regarding electromagnetic compatibility (EMC) and used according to the EMC information provided in the accompanying documents.
The 24970A base should not be used adjacent to or stacked with other equipment that is not part of the device manager system (base, mobile device, and accompanying accessories). If adjacent or stacked use is necessary, the 24970A base should be observed to verify normal operation in the configuration in which it will be used.
The 24970A base contains RF transmission and receiving capabilities. Consequently, it is possible that other equipment may interfere with the 24970A base even if that other equipment complies with CISPR emission requirements. The following is a technical summary of the RF communication properties:
Transmitting and receiving:
- Technology type: Conexus wireless telemetry, Bluetooth wireless technology
- Frequency of operation: 402 MHz to 405 MHz, 2.4 GHz to 2.483 GHz
- Modulation characteristics: Frequency shift key, Gaussian frequency shift key
- Field strength: 25 µW EIRP max, less than 10 mW EIRP ●
Guidance and manufacturer's declaration-electromagnetic emissions
The 24970A base is intended for use in the electromagnetic environment specified below. The user of the 24970A base should assure that it is used in such an environment.
| Emissions test | Compliance | Electromagnetic environment-guidance |
|---|---|---|
| RF emissionsCISPR 11 | Group 1 | The 24970A base uses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely tocause any interference in nearby electronic equipment. |
| RF emissionsCISPR 11 | Class A | |
| Harmonic emissionsIEC 61000-3-2 | Class A | The 24970A base is suitable for use in all establishments otherthan domestic, and may be used in domestic establishments andthose directly connected to the public low-voltage power supplynetwork that supplied buildings used for domestic purposes,provided the following warning is heeded: |
| Voltage fluctuations/flickeremissionsIEC 61000-3-3 | Complies | Warning: This equipment/system is intended for use byhealthcare professionals only. This equipment/system may causeradio interference or may disrupt the operation of nearbyequipment. It may be necessary to take mitigation measures, suchas re-orienting or relocating the 24970A base or shielding thelocation. |
| Guidance and manufacturer's declaration-electromagnetic immunity |
The 24970A base is intended for use in the electromagnetic environment specified below. The user of the 24970A base should assure that it is used in such an environment.
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| Immunity test | IEC 60601 Test level | Compliance level | Electromagneticenvironment—guidance |
|---|---|---|---|
| Electrostatic discharge(ESD)IEC 61000-4-2 | ±6 kV contact±8 kV air | ±8 kV contact±15 kV air | Floors should be wood,concrete, or ceramic tile. Iffloors are covered withsynthetic material, the relativehumidity should be at least30%. |
| Electrical fast transient/burstIEC 61000-4-4 | ±2 kV for power supply lines±1 kV for input/ output lines | ±2 kV for power supply lines±1 kV for input/ output lines | Mains power quality should bethat of a typical commercial orhospital environment. |
| SurgeIEC 61000-4-5 | ±1 kV differential Mode±2 kV common mode | ±1 kV differential Mode±2 kV common mode | Mains power quality should bethat of a typical commercial orhospital environment. |
| Voltage dips, shortinterruptions, and voltagevariations on power supplyinput linesIEC 61000-4-11 | <5% UT (>95% dip in UT)for 0.5 cycle40% UT (60% dip in UT) for5 cycles70% UT (30% dip in UT) for25 cycles<5% UT (>95% dip in UT)for 5 s | <5% UT (>95% dip in UT)for 0.5 cycle40% UT (60% dip in UT) for5 cycles70% UT (30% dip in UT) for25 cycles<5% UT (>95% dip in UT)for 5 s | Mains power quality should bethat of a typical commercial orhospital environment. If theuser of the 24970A baserequires continued operationduring power mainsinterruptions, it isrecommended that the 24970Abase be powered from anuninterruptible power supply ora battery. Note: UT is the ACmains voltage prior toapplication of the test level. |
| Power frequency (50/60 Hz)magnetic FieldIEC 61000-4-8 | 3 A/m | 3 A/m | Power frequency magneticfields should be at levelscharacteristic of a typicallocation in a typicalcommercial or hospitalenvironment. |
| Conducted RFIEC 61000-4-6 | 3 VRMS (volts root-meansquare)150 kHz to 80 MHz | 10 V | Portable and mobile RFcommunications equipmentshould be used no closer to anypart of the 24970A base,including cables, than therecommended separationdistance calculated from theequation applicable to thefrequency of the transmitter.Recommended separationdistance$d = 0.35 \sqrt{P}$ |
| Radiated RF | 3 V/m | 10 V/m | d = 0.35 VP for 80 MHz to 800 |
| IEC 61000-4-3 | 80 MHz to 2.5 GHz | MHz | |
| d = 0.70VP for 800 MHz to 2.5 | |||
| GHz | |||
| where P is the maximum | |||
| output power rating of the | |||
| transmitter in watts (W) | |||
| according to the transmitter | |||
| manufacturer and d is the | |||
| recommended separation | |||
| distance in meters (m). | |||
| Field strengths from fixed RF | |||
| transmitters, as determined by | |||
| an electromagnetic site survey,4 | |||
| should be less than the | |||
| compliance level in each | |||
| frequency range.0 | |||
| Interference may occur in the | |||
| vicinity of equipment marked | |||
| with the following symbol: | |||
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Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affection from structures, objects, and people.
4 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, consider an electromagnetic site survey. If the measured field strength in the location in which the 24970A base is used exceeds the applicable RF compliance level above, observe the 24970A base to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the 24970A base.
b Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the 24970A base
The 24970A base is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 24970A base can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 24970A base as recommended below, according to the maximum output power of the communications equipment.
| Rated maximum outputpower of transmitter | Separation distance according to frequency of transmitter | ||
|---|---|---|---|
| 150 kHz to 80 MHz$d = 0.35\sqrt{P}$ | 80 MHz to 800 MHz$d = 0.35\sqrt{P}$ | 800 MHz to 2.5 GHz$d = 0.70\sqrt{P}$ | |
| 0.01 W | 0.035 m | 0.035 m | 0.070 m |
| 0.1 W | 0.11 m | 0.11 m | 0.22 m |
| 1 W | 0.35 m | 0.35 m | 0.70 m |
| 10 W | 1.1 m | 1.1 m | 2.0 m |
| 100 W | 3.5 m | 3.5 m | 7.0 m |
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affection from structures, objects, and people.
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Indications for Use
The following is the Indications for Use Statement:
The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base's ECG connections along with the app display to view, measure, and record live cardiac waveforms.
The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.
Comparison of Technological Characteristics with the Predicate Device
The following table contains a comparison of the CareLink SmartSync Device Manager Pacing System Analyzer to the predicate devices (Models 2290 and 5311B).
| DeviceParameter | CareLink SmartSync™Device Manager (Model24970A) and Applications(D00U002, D00U001,M01G02, M01A02, M01G01,and M01A01)KXXXXXXX | Medtronic Pacing SystemAnalyzer (Model 2290)P890003/S065 | Medtronic A-V PacingSystem Analyzer(Model 5311B)K910595 07MAY1991 | PrimaryPredicate | Difference |
|---|---|---|---|---|---|
| Classification Name | Analyzer Lead Analysis DeviceImage: [Medtronic CareLink SmartSync Device Manager]Class II | Analyzer Lead Analysis DeviceImage: [Medtronic Pacing System Analyzer]Class III | AV pacing System AnalyzerImage: [Medtronic A-V Pacing System Analyzer]Class III | MedtronicPacing SystemAnalyzer Model2290 | Same |
| DeviceParameter | CareLink SmartSync™Device Manager (Model24970A) and Applications(D00U002, D00U001,M01G02, M01A02, M01G01,and M01A01)KXXXXXX | Medtronic Pacing SystemAnalyzer (Model 2290)P890003/S065 | Medtronic A-V PacingSystem Analyzer(Model 5311B)K910595 07MAY1991 | PrimaryPredicate | Difference |
| General Description | The CareLink SmartSync DeviceManager is a microprocessor-basedDevice. The device is designed toanalyze the electricalperformance of a cardiac leadsystem, using the mobile deviceplatform and associatedapplications as a control and displayplatform. | The Analyzer is a microprocessor-based accessory that installs intothe programmer. The Analyzer isdesigned to analyze theelectrical performance of acardiac lead system, and usesthe programmer as a controland display platform. TheAnalyzer can be operated"concurrently" with theProgrammer desktop. That is, youcan switch to an analyzer sessionfrom the Select Model screen onthe Programmer desktop, and youcan toggle back and forth betweenan analyzer session and the SelectModel screen using icons on thetask bar. | The Medtronic Model 5311BA-V Pacing System Analyzer(PSA) is a hand-heldmicroprocessor based devicedesigned to test theelectrical performance of thepulse generator and thepacing lead system at thetime of pacemakerimplantation and duringinvasive pacemakertroubleshooting orevaluation procedures. Themodel 5311B A-V PSAcombines the functions for amultimode external pulsegenerator, a digital measuringdevice, and a data processorto provide the followingcapabilities:• External single and dualchamber pacing in one of 10selectable pacing modes tosupport he patient duringpacemaker implantation andpacing system testprocedures. The 5311B PSAprovides unipolar or bipolarpacing for both single anddual chamber applications.• Measurement of cardiacstimulation thresholds forvoltage and current or pulsewidth.• P-wave/R-wave analysis forevaluation of the cardiacsignals detected by thepacing lead system.Information providedincludes the filtered andunfiltered voltage amplitudeand the slew rate of thedetected depolarizationsignal and an intracardiacelectrogram taken from thepacing lead.• A test for retrogradeconduction during evaluationof a dual-chamber leadsystem. This test is a featureof the intracardiacelectrogram function.• Automatic calculation ofpulse energy and leadresistance from measuredpulse parameters.• Implantable pulse generator(IPG) tests includedetermination of the pacingmode and measurement ofthe pacing mode andmeasurement of up to 11pacing parameters. | All | Same |
| DeviceParameter | CareLink SmartSync™Device Manager (Model24970A) and Applications(D00U002, D00U001,M01G02, M01A02, M01G01,and M01A01)KXXXXXX | Medtronic Pacing SystemAnalyzer (Model 2290)P890003/S065 | Medtronic A-V PacingSystem Analyzer(Model 5311B)K910595 07MAY1991 | PrimaryPredicate | Difference |
| General Description (Con't.) | Other capabilities of the Model5311B A-C PSA include rapidstimulation to 800 ppm inVOOAOO, or Doo pacingmode, total output inhibition inany pacing mode, and anemergency VVI pacing featurethat provides immediateventricular demand pacing atpreselected parameter valuesby a single keystrokecommand. | All | Same | ||
| The PSA is a constant voltagedevice. That is, the pulsevoltage is held constant at theadjusted value, while theresultant current flow is afunction of lead systemimpedance (output load).Constant voltage is the type ofoutput circuit used in mostimplantable pulse generators. | |||||
| External features of the Model5311B A-V PSA include amembrane keyboard fromwhich all PSA functions arecontrolled, a multifunction liquidcrystal display (LCD), and a 12-charactoer thermal printer(Figure 1). Two jacks on theend of the PSA provide forconnection of cables that linkthe PSA to the lead system forpacing and lead system tests orto the implantable pulsegenerator for parametermeasurements. IPG tests maybe conducted withoutinterruption of the PSA pacingfunction | |||||
| The PSA is powered by four,9V, alkaline batteries locatedunder an access cover on theback of the device. | |||||
| DeviceParameter | CareLink SmartSync™™Device Manager (Model24970A) and Applications(D00U002, D00U001,M01G02, M01A02, M01G01,and M01A01)KXXXXXX | Medtronic Pacing SystemAnalyzer (Model 2290)P890003/S065 | Medtronic A-V PacingSystem Analyzer(Model 5311B)K910595 07MAY1991 | PrimaryPredicate | Difference |
| Indication for Use | The base is intended to be used aspart of the CareLink SmartSyncdevice manager system. Cliniciansuse the base to analyze theelectrical performance of cardiacleads during device implant orinvasive troubleshooting.Clinicians use the base's ECGconnections along with the appdisplay to view, measure, andrecord live cardiac waveforms.The base is intended to be used byhealthcare professionals only inoperating environments under directmedical supervision. | The Analyzer is intended for useby a clinician to analyze thepacing and sensingperformance of the cardiac leadsystem during the implant of acardiac arrhythmia managementdevice, or during invasivetroubleshooting of a cardiaclead system. | The Medtronic Model 5311BA-V Pacing System Analyzerin intended for use by aphysician to measurestimulation thresholds andtest the implantable pulsegenerator and pacing leadsystem during the surgicalprocedures of pacemakerimplantation or duringinvasive pacemakertroubleshooting ordiagnostic procedures. TheModel 5311B A-V PSA isdesigned to pace the patientexternally during pacingsystem test and implantationprocedures. The pacing andtest functions of the Model5311B A-V PSA are intendedfor both single- and dual-chamber pacemakerapplications. | MedtronicPacing SystemAnalyzer Model2290 | Same |
| ProductCode | DTA, DTC21 CFR 870.372021 CFR 870.3630New21 CFR 870.3605 | KRG and OSR | DTC21 CFR 870.3630 | This medicaldevice has beenreclassified toClass II18APR201621CFR870 | Same |
| DeviceParameter | CareLink SmartSync™Device Manager (Model24970A) and Applications(D00U002, D00U001,M01G02, M01A02, M01G01,and M01A01)KXXXXXXX | Medtronic Pacing SystemAnalyzer (Model 2290)P890003/S065 | Medtronic A-V PacingSystem Analyzer(Model 5311B)K910595 07MAY1991 | PrimaryPredicate | Difference |
| Features | Clinicians use this data to performthese tasks:• Analyze electrical performance ofcardiac leads during implant.• Assess proper placement ofcardiac leads during implant.• View, measure, and documentlive cardiac waveforms.The PSA app includes thesefeatures for the analysis of cardiacleads:• Dual and single chamber pacingmodes.• Automatic measurement of P-wave and R-wave amplitudes.• Lead impedance measurement.• Real-time display of atrial andventricular EGM and ECGwaveforms.• Rapid atrial stimulation to 850min-1 (ppm).• Advanced pulse width versusamplitude pacing thresholdtests.• Measurement reports.The base includes these features:• Analyzer hardware and patientcable connections to supportelectrical assessment of cardiacleads during implant.• ECG cable connections to collectlive cardiac waveform data thatcan be viewed, measured, andrecorded using the app runningon your mobile device.• Bluetooth® wireless technologyto communicate with the apprunning on your mobile device.• A cradle to charge the Medtronic24967 Patient Connector (The24967 patient connector is notthe subject of this submission).• Optional USB connectivity tocharge the patient connector.(The 24967 patient connector isnot the subject of thissubmission). | • Automatic measurement of P-and R-wave amplitudes andslew rates• Automatic lead impedancemeasurement• Real-time display of atrial andventricular EGM• Rapid atrial stimulation to 800min-1 (ppm)• Advanced analysis features,including antegrade andretrograde conduction tests,and a pulse width versusamplitude threshold analysis• Measurement reportsSafety featuresThe Analyzer has the followingsafety features:• Backup battery in the event of apower loss• Electrical isolation from theprogrammer• Emergency VVI pacing | Below are the functions of thePSA operating mode. Forpacing and lead system tests,the Model 5410 Surgical Cableis used to connect the PSA toan indwelling lead system.• Pacing Mode and ParameterAdjustment• Emergency VVI Pacing• Stimulation ThresholdMeasurement• Lead System Resistance• Filtered P-Wave / R-WaveAmplitude• Pulse Energy• Slew Rate and UnfilteredSignal Amplitude• Intracardiac Electrogram• Retrograde ConductionTest Function• Inhibit Function• Rapid Stimulation | MedtronicPacing SystemAnalyzer Model2290 | Same |
| Longevity | 5 year warranty | 10 years | 1 year warranty | NA | NA |
| DeviceParameter | CareLink SmartSync™Device Manager (Model24970A) and Applications(D00U002, D00U001,M01G02, M01A02, M01G01,and M01A01)KXXXXXX | Medtronic Pacing SystemAnalyzer (Model 2290)P890003/S065 | Medtronic A-V PacingSystem Analyzer(Model 5311B)K910595 07MAY1991 | PrimaryPredicate | Difference |
| Volume andFootprint | The Base shall have the nominaldimensions of approximately:Length: 8.203" +/- 5% Width: 9.450"+/- 5% Thickness: 1.810" +/- 5%.The Base will have a maximumfootprint of:548 cm². | The Analyzer will be installed intothe Model 2090 Expansion Bay.When installed the Analyzer willnot change the physical size of theModel 2090 Programmer. | H x W x D:3.4" x 4.0" x 9.0" | All | Same |
| Mass | The Base Station shall have amaximum weight of 0.91 kilograms(2.0 lbs.). | 16 ounces (1 lbs.). | 1.5 kg (3.3 lbs.) | All | Same |
| MRICompatibility | No | No | No | All | Same |
| BasicRate | 30-200 ppm | 20-210 ppm | 30-180 ppm | MedtronicPacing SystemAnalyzer Model2290 | Within therange but |
| High PacingRate | 200-850 ppm | 200-800 ppm | 100 - 180 ppm | MedtronicPacing SystemAnalyzer Model2290 | Similar |
| StimulationAmplitude | 0.25 – 8.0 V | 0.1 – 10 V | 0.1 - 10 V | MedtronicPacing SystemAnalyzer Model2290 | Similar |
| PulseWidth | 0.03 - 1.50 ms | 0.02 - 1.5 ms | 0.05 - 2.0 ms | MedtronicPacing SystemAnalyzer Model2290 | Same |
| DeviceParameter | CareLink SmartSync™™Device Manager (Model24970A) and Applications(D00U002, D00U001,M01G02, M01A02, M01G01,and M01A01)KXXXXXX | Medtronic Pacing SystemAnalyzer (Model 2290)P890003/S065 | Medtronic A-V PacingSystem Analyzer(Model 5311B)K910595 07MAY1991 | PrimaryPredicate | Difference |
| Sensitivity | 0.15 - 11.30 mV | 0.25 – 20 mV | 0.75 — 10mV | MedtronicPacing SystemAnalyzer Model2290 | Similar |
| Refractory orBlanking | Atrial: 150 - 500 msVentricular: 150 - 500 ms | Atrial: 200-500 msVentricular: 250 ms | Atrial: 235 or 400 msdepending on modeVentricular: 233 or 325 msdepending on mode | MedtronicPacing SystemAnalyzer Model2290 | Similar |
| SlewRate | No | Yes | Yes | NA | NA |
| PacingModes | VOO; VVI; AOO; AAI; DOO; DDD;DDI; ODO; OOO | VOO, VVI,AOO, AAI, DOO, DDD,VDD, ODO | VVI, VVT, VOO, AAI, AAT,AOO, DDD, DVI, DOO, VDD | All | Same(excluding VVV) |
| Accessories | Model 2292 Analyzer SurgicalCableModel 5103 Analyzer AdaptorModel 5104 Analyzer AdaptorModel 5114 AdaptorModel 5833S/SL DisposableSurgical CablesModel 5436 Analyzer Patient CableModel 5410/5410S Surgical CableModel 5436 Patient CableModel 8190 Analyzer SoftwareModel 5832 Surgical cableand additionally:Model 5473 Ground cableModel 5437 ECG Interface cableModel 5437 A AdaptorModel 2090 EC ECG cableModel 2090 ECL ECG cableModel 9790 LA ECG leadsModel 9790 XLA ECG leadsTwo AA Batteries | Model 2292 Analyzer SurgicalCableModel 5103 Analyzer AdaptorModel 5104 Analyzer AdaptorModel 5114 AdaptorModel 5833 Disposable SurgicalCableModel 5436 Analyzer PatientCableModel 5410/5410S Surgical CableModel 5436 Patient CableModel 8190 Analyzer SoftwareReplacement Batteries (9V) | The Model 5311B A-V PSA issupplied with batteries,technical literature, and thefollowing accessory cables:Model 5401B Test CableModel 5410 Surgical CableModel 5803A Indifferent Lead | MedtronicPacing SystemAnalyzer Model2290 | Same |
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Performance Data
The following performance data were provided in support of the substantial equivalence determination.
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Biocompatibility testing
The biocompatibility evaluation for the CareLink SmartSync Device Manager, Pacing System Analyzer Base, Model 24970A was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The device was justified by similarity to the Medtronic Model 24967 patient connector (K163460). The battery of testing for materials used in the Model 24970A included the following tests:
- Cytotoxicity ●
- Sensitization
- Irritation
The Model 24970A is considered non-tissue or patient contacting.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the CareLink SmartSync Device Manager. Pacing System Analyzer Base, Model 24970A, associated applications and non-medical mobile platform (i.e. Tablet) with associated cables as necessary for test. The system complies with the IEC 60601-1, standards for safety and the IEC 60601-1-2 third and fourth edition versions of the standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Mechanical Testing
The following is a list of testing performed:
- Inspection of the required mechanical design features and function
- Workmanship inspection concerning all external surfaces that can cause injury such as sharp edges or pinch points
- Product labeling inspection
- Forces required to activate controls
- Chemical resistance testing for effects of repeat cleaning cycles ●
- Environmental and drop testing
- Reliability testing of buttons, electrical contacts, user connector insertions, and replaceable or moving mechanical components
- Performance and robustness testing of the Articulated Lid ●
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Animal Study
There were no formalized animal studies performed for this 510(k) submission.
Clinical Studies
There were no formalized clinical studies performed for this 510(k) submission.
Conclusions
The non-clinical data, the hardware and software verification support and demonstrate that the CareLink SmartSync Device Manager, Pacing System Analyzer Base, Model 24970A should perform as intended in the specified use conditions and is substantially equivalent to the predicate device.
§ 870.3720 Pacemaker electrode function tester.
(a)
Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.(b)
Classification. Class II (performance standards).