Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a device for analyzing cardiac lead performance and displaying ECG data. It mentions a microprocessor and software components but does not include any terms or descriptions indicative of AI or ML, such as "AI," "ML," "DNN," "training set," or "performance metrics typically associated with AI/ML models (e.g., AUC, sensitivity/specificity in the context of an AI/ML algorithm's output)." The focus is on electrical analysis and data display.

Therapeutic

No
The device is described as an analyzer used by clinicians to analyze the electrical performance of cardiac leads and view/record live cardiac waveforms. It does not provide therapy itself.

Diagnostic

Yes
The device is used by clinicians to "analyze the electrical performance of cardiac leads" and to "view, measure, and record live cardiac waveforms," which are diagnostic activities.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system is comprised of a "Model 24970A Base" which includes "analyzer hardware and patient cable connections, ECG cable connections, and Bluetooth wireless technology." It also mentions a "microprocessor" and "two main integrated circuits (ICs)" within the Base. This indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. This is a direct assessment of the function of a medical device (cardiac leads) within the patient's body, not an analysis of a sample taken from the body.
Device Description: The device analyzes cardiac lead data and ECG data transmitted from the base. This is physiological data from the patient, not a sample.
Lack of Sample Analysis: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. This device does not mention analyzing any such samples.

The device is a medical device used for analyzing the performance of implanted cardiac leads and viewing physiological signals (ECG) in a clinical setting. It falls under the category of devices used for monitoring and assessing the function of other medical devices and the patient's cardiac electrical activity.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DTA, DTE

Device Description

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 Medtronic CareLink SmartSync Device Manager 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 to support electrical assessment of cardiac leads during implant, and ECG cable connections to collect live cardiac waveform data that can be viewed, measured, and recorded using the app running on your mobile device. It uses Bluetooth® wireless technology to communicate with the app running on your mobile device and contains a microprocessor that maintains the pacing engine logic function for the PSA. The App is the primary user interface for the device manager system, providing connectivity, lead analysis session initiation, sharing/printing of reports, and software updates. It displays and reports on cardiac lead and ECG data from the base, enabling clinicians to analyze electrical performance, assess proper placement of cardiac leads during implant, and view, measure, and document live cardiac waveforms. The system has dual and single chamber pacing modes, automatic P-wave and R-wave amplitude measurement, lead impedance measurement, real-time display of atrial and ventricular EGM and ECG waveforms, rapid atrial stimulation up to 850 min-1 (ppm), advanced pulse width versus amplitude pacing threshold tests, and measurement reports.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cardiovascular/Cardiac (implied, for cardiac leads)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare professionals only in operating environments under direct medical supervision.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data provided in support of substantial equivalence determination included:

Biocompatibility testing: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Justified by similarity to Medtronic Model 24967 patient connector (K163460). Tests included Cytotoxicity, Sensitization, and Irritation. The device is considered non-tissue or patient contacting.
Electrical safety and electromagnetic compatibility (EMC) testing: Complies with IEC 60601-1 (safety) and IEC 60601-1-2 third and fourth edition versions (EMC).
Software Verification and Validation Testing: Conducted and documented as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "major" level of concern.
Mechanical Testing: Included inspection of mechanical design features, workmanship, product labeling, forces to activate controls, chemical resistance, environmental and drop testing, reliability testing of components, and performance/robustness testing of the Articulated Lid.
Animal Study: No formalized animal studies performed.
Clinical Studies: No formalized clinical studies performed.

Conclusions state that non-clinical data, hardware and software verification support and demonstrate that the device should perform as intended and is substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics for the device include:

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 or Blanking: Atrial: 150 - 500 ms; Ventricular: 150 - 500 ms

Predicate Device(s)

Medtronic Model 2290 Lead Analyzer approved on 13MAR2002 P890003/S065, Medtronic Model 5311B A-V Pacing System Analyzer cleared on 07MAY1991 K910595

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

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.

1

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

Date Prepared:	January 13, 2017
510(k) Owner / Address:	Medtronic, Inc.
Cardiac Rhythm and Heart Failure
8200 Coral Sea Street
Mounds View, MN 55112
Contact:	Laura L. Danielson
Principal Regulatory Affairs Specialist
Telephone:	(763) 526-2385
Fax:	(651) 367-0603
E-mail:	laura.l.danielson@medtronic.com
Trade / Proprietary Name:	CareLink SmartSync™ Device Manager
Pacing System Analyzer
Common Name:	Pacing System Analyzer
Classification /
Classification Name:	Class II
Pacing 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 by
Medical Grade External Power
Supply. PSA Battery info in the
following 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 utilization
monitored by the Mobile Application on the
user mobile device.	2 years required replacement as
indicated by the Maintenance
schedule

Parameter	Description	Fixed Value
ECG Gain	Surface ECG User Interface display	1.0
Sampling
Rate	Rate at which the ECG signal is digitized	500 Hz
Sampling
Resolution	Number of bits per sample used in the digitization
of 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 the
digitization 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 Polycarbonate
White Resin per Medtronic color chip M954239A001
Elastomer Edge:
Eraprene A6060N-SP
Thermoplastic Elastomer
Blue per Pantone 301
Lid Base	Plastic:
SABIC LEXAN EXL-9330 Polycarbonate
White Resin per Medtronic color chip M954239A001
Graphics:
Pantone 301 Blue
Elastomer Edge:
Eraprene A6060N-SP
Thermoplastic Elastomer
Blue per Pantone 301
Bottom Enclosure Base	Plastic:
SABIC LEXAN EXL-9330 Polycarbonate
White Resin per Medtronic color chip M954239A001
Graphics:
Pantone 301 Blue
Membrane Keypad Base	Graphics:
Autotex-2(V200)
Polyester
Button:
Silicone Rubber
60 Shore A
Clear
Top Coat:
Polyurethane
Per color chip Pantone Cool Grey 8

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Component	Material
Battery Cover Base	SABIC LEXAN EXL-9330 Polycarbonate
White Resin per Medtronic color chip M954239A001
Foot Rear Base	Silicone Rubber 70 Shore A
Color: Pantone Cool Grey 8
Device Label Base	Lexan PC 8B35
Polycarbonate
Clear
QR Code Label Base	Lexan PC 8B35
Polycarbonate
Clear
PSA Connector Base	Hypertronics D02 Housing
Polyethermide
Black

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 60601-1-2
EN 300 328
EN 301 489
EN 302 195
EN 301 839
EN 55011 Class A
Radio	FCC CFR 47
Patient safety	UL/CUL 60601-1, Type BF applied part, Type CF applied parta
EN 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 rating
IP2X with regard to ingress of dust, other foreign objects, and
water 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 accessories
that come into direct contact with the patient. The base itself is not intended to come into contact with the patient during normal
use.
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 on
the 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 emissions
CISPR 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 to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11	Class A
Harmonic emissions
IEC 61000-3-2	Class A	The 24970A base is suitable for use in all establishments other
than domestic, and may be used in domestic establishments and
those directly connected to the public low-voltage power supply
network that supplied buildings used for domestic purposes,
provided the following warning is heeded:
Voltage fluctuations/flicker
emissions
IEC 61000-3-3	Complies	Warning: This equipment/system is intended for use by
healthcare professionals only. This equipment/system may cause
radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such
as re-orienting or relocating the 24970A base or shielding the
location.
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 | Electromagnetic
environment—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. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%. |
| Electrical fast transient/burst
IEC 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 be
that of a typical commercial or
hospital environment. |
| Surge
IEC 61000-4-5 | ±1 kV differential Mode
±2 kV common mode | ±1 kV differential Mode
±2 kV common mode | Mains power quality should be
that of a typical commercial or
hospital environment. |
| Voltage dips, short
interruptions, and voltage
variations on power supply
input lines
IEC 61000-4-11 | 95% dip in UT)
for 0.5 cycle
40% UT (60% dip in UT) for
5 cycles
70% UT (30% dip in UT) for
25 cycles
95% dip in UT)
for 5 s | 95% dip in UT)
for 0.5 cycle
40% UT (60% dip in UT) for
5 cycles
70% UT (30% dip in UT) for
25 cycles
95% dip in UT)
for 5 s | Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the 24970A base
requires continued operation
during power mains
interruptions, it is
recommended that the 24970A
base be powered from an
uninterruptible power supply or
a battery. Note: UT is the AC
mains voltage prior to
application of the test level. |
| Power frequency (50/60 Hz)
magnetic Field
IEC 61000-4-8 | 3 A/m | 3 A/m | Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment. |
| Conducted RF
IEC 61000-4-6 | 3 VRMS (volts root-
meansquare)
150 kHz to 80 MHz | 10 V | Portable and mobile RF
communications equipment
should be used no closer to any
part of the 24970A base,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
$d = 0.35 \sqrt{P}$ |
| 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: |
| | | | |
| | | | |
| | | | |

13

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 output

power 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.

14

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).

| Device
Parameter | CareLink SmartSync™
Device Manager (Model
24970A) and Applications
(D00U002, D00U001,
M01G02, M01A02, M01G01,
and M01A01)
KXXXXXXX | Medtronic Pacing System
Analyzer (Model 2290)
P890003/S065 | Medtronic A-V Pacing
System Analyzer
(Model 5311B)
K910595 07MAY1991 | Primary
Predicate | Difference |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------|
| Classification Name | Analyzer Lead Analysis Device
Image: [Medtronic CareLink SmartSync Device Manager]
Class II | Analyzer Lead Analysis Device
Image: [Medtronic Pacing System Analyzer]
Class III | AV pacing System Analyzer
Image: [Medtronic A-V Pacing System Analyzer]
Class III | Medtronic
Pacing System
Analyzer Model
2290 | Same |
| Device
Parameter | CareLink SmartSync™
Device Manager (Model
24970A) and Applications
(D00U002, D00U001,
M01G02, M01A02, M01G01,
and M01A01)
KXXXXXX | Medtronic Pacing System
Analyzer (Model 2290)
P890003/S065 | Medtronic A-V Pacing
System Analyzer
(Model 5311B)
K910595 07MAY1991 | Primary
Predicate | Difference |
| General Description | The CareLink SmartSync Device
Manager is a microprocessor-based
Device. The device is designed to
analyze the electrical
performance of a cardiac lead
system, using the mobile device
platform and associated
applications as a control and display
platform. | The Analyzer is a microprocessor-
based accessory that installs into
the programmer. The Analyzer is
designed to analyze the
electrical performance of a
cardiac lead system, and uses
the programmer as a control
and display platform. The
Analyzer can be operated
"concurrently" with the
Programmer desktop. That is, you
can switch to an analyzer session
from the Select Model screen on
the Programmer desktop, and you
can toggle back and forth between
an analyzer session and the Select
Model screen using icons on the
task bar. | The Medtronic Model 5311B
A-V Pacing System Analyzer
(PSA) is a hand-held
microprocessor based device
designed to test the
electrical performance of the
pulse generator and the
pacing lead system at the
time of pacemaker
implantation and during
invasive pacemaker
troubleshooting or
evaluation procedures. The
model 5311B A-V PSA
combines the functions for a
multimode external pulse
generator, a digital measuring
device, and a data processor
to provide the following
capabilities:
• External single and dual
chamber pacing in one of 10
selectable pacing modes to
support he patient during
pacemaker implantation and
pacing system test
procedures. The 5311B PSA
provides unipolar or bipolar
pacing for both single and
dual chamber applications.
• Measurement of cardiac
stimulation thresholds for
voltage and current or pulse
width.
• P-wave/R-wave analysis for
evaluation of the cardiac
signals detected by the
pacing lead system.
Information provided
includes the filtered and
unfiltered voltage amplitude
and the slew rate of the
detected depolarization
signal and an intracardiac
electrogram taken from the
pacing lead.
• A test for retrograde
conduction during evaluation
of a dual-chamber lead
system. This test is a feature
of the intracardiac
electrogram function.
• Automatic calculation of
pulse energy and lead
resistance from measured
pulse parameters.
• Implantable pulse generator
(IPG) tests include
determination of the pacing
mode and measurement of
the pacing mode and
measurement of up to 11
pacing parameters. | All | Same |
| Device
Parameter | CareLink SmartSync™
Device Manager (Model
24970A) and Applications
(D00U002, D00U001,
M01G02, M01A02, M01G01,
and M01A01)
KXXXXXX | Medtronic Pacing System
Analyzer (Model 2290)
P890003/S065 | Medtronic A-V Pacing
System Analyzer
(Model 5311B)
K910595 07MAY1991 | Primary
Predicate | Difference |
| General Description (Con't.) | | | Other capabilities of the Model
5311B A-C PSA include rapid
stimulation to 800 ppm in
VOOAOO, or Doo pacing
mode, total output inhibition in
any pacing mode, and an
emergency VVI pacing feature
that provides immediate
ventricular demand pacing at
preselected parameter values
by a single keystroke
command. | All | Same |
| | | | The PSA is a constant voltage
device. That is, the pulse
voltage is held constant at the
adjusted value, while the
resultant current flow is a
function of lead system
impedance (output load).
Constant voltage is the type of
output circuit used in most
implantable pulse generators. | | |
| | | | External features of the Model
5311B A-V PSA include a
membrane keyboard from
which all PSA functions are
controlled, a multifunction liquid
crystal display (LCD), and a 12-
charactoer thermal printer
(Figure 1). Two jacks on the
end of the PSA provide for
connection of cables that link
the PSA to the lead system for
pacing and lead system tests or
to the implantable pulse
generator for parameter
measurements. IPG tests may
be conducted without
interruption of the PSA pacing
function | | |
| | | | The PSA is powered by four,
9V, alkaline batteries located
under an access cover on the
back of the device. | | |
| Device
Parameter | CareLink SmartSync™™
Device Manager (Model
24970A) and Applications
(D00U002, D00U001,
M01G02, M01A02, M01G01,
and M01A01)
KXXXXXX | Medtronic Pacing System
Analyzer (Model 2290)
P890003/S065 | Medtronic A-V Pacing
System Analyzer
(Model 5311B)
K910595 07MAY1991 | Primary
Predicate | Difference |
| Indication for Use | 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 Analyzer is intended for use
by a clinician to analyze the
pacing and sensing
performance of the cardiac lead
system during the implant of a
cardiac arrhythmia management
device, or during invasive
troubleshooting of a cardiac
lead system. | The Medtronic Model 5311B
A-V Pacing System Analyzer
in intended for use by a
physician to measure
stimulation thresholds and
test the implantable pulse
generator and pacing lead
system during the surgical
procedures of pacemaker
implantation or during
invasive pacemaker
troubleshooting or
diagnostic procedures. The
Model 5311B A-V PSA is
designed to pace the patient
externally during pacing
system test and implantation
procedures. The pacing and
test functions of the Model
5311B A-V PSA are intended
for both single- and dual-
chamber pacemaker
applications. | Medtronic
Pacing System
Analyzer Model
2290 | Same |
| Product
Code | DTA, DTC
21 CFR 870.3720
21 CFR 870.3630
New
21 CFR 870.3605 | KRG and OSR | DTC
21 CFR 870.3630 | This medical
device has been
reclassified to
Class II
18APR2016
21CFR870 | Same |
| Device
Parameter | CareLink SmartSync™
Device Manager (Model
24970A) and Applications
(D00U002, D00U001,
M01G02, M01A02, M01G01,
and M01A01)
KXXXXXXX | Medtronic Pacing System
Analyzer (Model 2290)
P890003/S065 | Medtronic A-V Pacing
System Analyzer
(Model 5311B)
K910595 07MAY1991 | Primary
Predicate | Difference |
| Features | 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.
The PSA app includes these
features for the analysis of cardiac
leads:
• 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 base includes these features:
• Analyzer hardware and patient
cable connections to support
electrical assessment of cardiac
leads during implant.
• 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.
• A cradle to charge the Medtronic
24967 Patient Connector (The
24967 patient connector is not
the subject of this submission).
• Optional USB connectivity to
charge the patient connector.
(The 24967 patient connector is
not the subject of this
submission). | • Automatic measurement of P-
and R-wave amplitudes and
slew rates
• Automatic lead impedance
measurement
• Real-time display of atrial and
ventricular EGM
• Rapid atrial stimulation to 800
min-1 (ppm)
• Advanced analysis features,
including antegrade and
retrograde conduction tests,
and a pulse width versus
amplitude threshold analysis
• Measurement reports
Safety features
The Analyzer has the following
safety features:
• Backup battery in the event of a
power loss
• Electrical isolation from the
programmer
• Emergency VVI pacing | Below are the functions of the
PSA operating mode. For
pacing and lead system tests,
the Model 5410 Surgical Cable
is used to connect the PSA to
an indwelling lead system.
• Pacing Mode and Parameter
Adjustment
• Emergency VVI Pacing
• Stimulation Threshold
Measurement
• Lead System Resistance
• Filtered P-Wave / R-Wave
Amplitude
• Pulse Energy
• Slew Rate and Unfiltered
Signal Amplitude
• Intracardiac Electrogram
• Retrograde Conduction
Test Function
• Inhibit Function
• Rapid Stimulation | Medtronic
Pacing System
Analyzer Model
2290 | Same |
| Longevity | 5 year warranty | 10 years | 1 year warranty | NA | NA |
| Device
Parameter | CareLink SmartSync™
Device Manager (Model
24970A) and Applications
(D00U002, D00U001,
M01G02, M01A02, M01G01,
and M01A01)
KXXXXXX | Medtronic Pacing System
Analyzer (Model 2290)
P890003/S065 | Medtronic A-V Pacing
System Analyzer
(Model 5311B)
K910595 07MAY1991 | Primary
Predicate | Difference |
| Volume and
Footprint | The Base shall have the nominal
dimensions of approximately:
Length: 8.203" +/- 5% Width: 9.450"
+/- 5% Thickness: 1.810" +/- 5%.
The Base will have a maximum
footprint of:
548 cm². | The Analyzer will be installed into
the Model 2090 Expansion Bay.
When installed the Analyzer will
not change the physical size of the
Model 2090 Programmer. | H x W x D:
3.4" x 4.0" x 9.0" | All | Same |
| Mass | The Base Station shall have a
maximum weight of 0.91 kilograms
(2.0 lbs.). | 16 ounces (1 lbs.). | 1.5 kg (3.3 lbs.) | All | Same |
| MRI
Compatibility | No | No | No | All | Same |
| Basic
Rate | 30-200 ppm | 20-210 ppm | 30-180 ppm | Medtronic
Pacing System
Analyzer Model
2290 | Within the
range but |
| High Pacing
Rate | 200-850 ppm | 200-800 ppm | 100 - 180 ppm | Medtronic
Pacing System
Analyzer Model
2290 | Similar |
| Stimulation
Amplitude | 0.25 – 8.0 V | 0.1 – 10 V | 0.1 - 10 V | Medtronic
Pacing System
Analyzer Model
2290 | Similar |
| Pulse
Width | 0.03 - 1.50 ms | 0.02 - 1.5 ms | 0.05 - 2.0 ms | Medtronic
Pacing System
Analyzer Model
2290 | Same |
| Device
Parameter | CareLink SmartSync™™
Device Manager (Model
24970A) and Applications
(D00U002, D00U001,
M01G02, M01A02, M01G01,
and M01A01)
KXXXXXX | Medtronic Pacing System
Analyzer (Model 2290)
P890003/S065 | Medtronic A-V Pacing
System Analyzer
(Model 5311B)
K910595 07MAY1991 | Primary
Predicate | Difference |
| Sensitivity | 0.15 - 11.30 mV | 0.25 – 20 mV | 0.75 — 10mV | Medtronic
Pacing System
Analyzer Model
2290 | Similar |
| Refractory or
Blanking | Atrial: 150 - 500 ms
Ventricular: 150 - 500 ms | Atrial: 200-500 ms
Ventricular: 250 ms | Atrial: 235 or 400 ms
depending on mode
Ventricular: 233 or 325 ms
depending on mode | Medtronic
Pacing System
Analyzer Model
2290 | Similar |
| Slew
Rate | No | Yes | Yes | NA | NA |
| Pacing
Modes | 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 Surgical
Cable
Model 5103 Analyzer Adaptor
Model 5104 Analyzer Adaptor
Model 5114 Adaptor
Model 5833S/SL Disposable
Surgical Cables
Model 5436 Analyzer Patient Cable
Model 5410/5410S Surgical Cable
Model 5436 Patient Cable
Model 8190 Analyzer Software
Model 5832 Surgical cable
and additionally:
Model 5473 Ground cable
Model 5437 ECG Interface cable
Model 5437 A Adaptor
Model 2090 EC ECG cable
Model 2090 ECL ECG cable
Model 9790 LA ECG leads
Model 9790 XLA ECG leads
Two AA Batteries | Model 2292 Analyzer Surgical
Cable
Model 5103 Analyzer Adaptor
Model 5104 Analyzer Adaptor
Model 5114 Adaptor
Model 5833 Disposable Surgical
Cable
Model 5436 Analyzer Patient
Cable
Model 5410/5410S Surgical Cable
Model 5436 Patient Cable
Model 8190 Analyzer Software
Replacement Batteries (9V) | The Model 5311B A-V PSA is
supplied with batteries,
technical literature, and the
following accessory cables:
Model 5401B Test Cable
Model 5410 Surgical Cable
Model 5803A Indifferent Lead | Medtronic
Pacing System
Analyzer Model
2290 | Same |

15

16

17

18

19

20

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

21

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 ●

22

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.