The SigmaPace 1000 External Pacemaker Analyzer is intended for use as regular preventative maintenance and quality assurance checks on external cardiac pacemakers in both the pre-hospital and hospital based environments.

The SigmaPace 1000 is limited to preventative maintenance checks for transcutaneous and transvenous types of temporary external cardiac pacemakers. The SigmaPace 1000 will perform a full range of specific testing procedures and protocols developed by the external cardiac pacemaker manufacturers. The SigmaPace 1000 will also provide ECG simulation capabilities for applications in clinical training and product demonstration.

The SigmaPace 1000 is intended to be used by biomedical technicians, OEM manufacturers, and third party service facilities to perform preventative maintenance and quality assurance checks on external cardiac pacemakers, to verify the operation of devices returned from repair, and to assist repair facilities in the diagnosis of intermittent performance problems. The SigmaPace 1000 is also intended to be used by training facilities to train medical personnel.

The SigmaPace 1000 is not used on patients and does not perform any diagnostic, therapeutic, or monitoring functions. Additionally, these devices are not used to test any programmable, implantable pacemakers or any related indwelling cardiovascular catheters or lead wires.

Device Description

The SigmaPace 1000 is a device used to verify the performance of various parameters of external cardiac pacemakers. This is done by connecting the external leads of the pacemaker to test inputs on the SigmaPace 1000 and selecting the pacemaker to test or by using the press buttons on the front panel display or via appropriate test cables by serial port (RS232). The SigmaPace 1000 can perform a variety of Transcutaneous and Transvenous (Atrial and Ventricular) Pacer tests.

Pulse current, rate, width, and energy
Qualitative demand and async mode tests
Amplitude sensitivity tests
Noise immunity tests
Paced and Sensed Refractory tests
Selectable model specific transcutaneous algorithms
Selectable test loads
DC leakage current (tranvenous)
Current drain test (transvenous)
Long term test for pacer output stability
ECG simulation for training activities

AI/ML Overview

Acceptance criteria and device performance information for the DNI NEVADA INC. SigmaPace 1000 External Pacemaker Analyzer:

This submission document primarily focuses on demonstrating substantial equivalence to predicate devices and does not detail specific quantitative acceptance criteria or a dedicated study report with performance metrics against those criteria. Instead, it describes a more general verification and validation process.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria and corresponding reported device performance values. It outlines the types of tests performed and attests that the device meets the requirements.

Acceptance Criteria Category	Reported Device Performance Summary (Qualitative)
General Functionality	Successfully completed for menu structure, test load selections, battery circuitry, baud rate, and serial port operation.
Pacer Parameter Testing	Transcutaneous test (ventricular channel) and transvenous tests (both atrial and ventricular channels) successfully completed. This implies accurate measurement of pulse current, rate, width, energy, amplitude sensitivity, noise immunity, paced and sensed refractory tests, DC leakage current, current drain, and long-term output stability.
Algorithms Testing	Algorithms for specific external cardiac pacemaker models successfully completed.
Microprocessor	Internal microprocessor clock frequency testing successfully completed.
Safety Standards	Designed to meet IEC 1010 safety standards; internal lithium battery charger meets UL/CSA safety requirements.
Hazard Analysis	Primary system function hazards were determined, reviewed, and addressed to identify and mitigate errors leading to incorrect results.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set.
The data provenance is not specified regarding country of origin or whether the testing was retrospective or prospective. It describes ongoing "verification and validation testing" which implies prospective testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The ground truth for a pacemaker analyzer would typically be established by comparing its measurements to a known, highly accurate reference standard or a golden standard pacemaker. The document does not specify who conducted this comparison or their qualifications.

4. Adjudication method for the test set:

An adjudication method is not mentioned. Given the nature of a test equipment device, performance would likely be validated against established electrical engineering standards and reference equipment, rather than expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The device is test equipment and is not directly involved in patient diagnosis or treatment by human readers. It analyzes external pacemakers, not medical images or patient data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, performance testing described is for the standalone device. The SigmaPace 1000 is an automated external pacemaker analyzer. Its "algorithms testing" and other parameter verifications are inherently standalone performance assessments.

7. The type of ground truth used:

The document implies the use of established engineering and functional specifications as the ground truth. The device "is tested to ensure it meets the requirements as defined in the product specification and advertising." This suggests the ground truth is derived from design specifications and established standards for pacemaker performance.

8. The sample size for the training set:

This information is not applicable and not provided. The SigmaPace 1000 is a measurement device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its "algorithms" refer to specific testing protocols for different pacemaker models, not learned models.

9. How the ground truth for the training set was established:

This information is not applicable and not provided for the reasons stated above (not an AI/ML algorithm requiring a training set). The "algorithms" are likely deterministic test sequences and calculation methods programmed into the device based on pacemaker manufacturer specifications and industry standards.

Summary

{0}------------------------------------------------

AUG 3 0 2001

K011729 p.1/3

DNI NEVADA INC. 510(k) SigmaPace 1000 External Pacemaker Analyzer

1 - 510(k) SUMMARY

Contact Person: 2-

Kristine G. Boggs, Quality Assurance Manager 775-883-3400 x265 (phone) 775-883-9541 (fax) boggsk@dninevada.com Establishment Registration Number: 2921581 Establishment will be both manufacturing and marketing SigmaPace 1000 Preparation Date: May 29, 2001

Classification Name: 3-

Common Name: Proprietary Name:

Analyzer, Pacemaker Generator Function, Product, DTC, Class II External Pacemaker Analyzer SigmaPace 1000

The device is substantially equivalent to the 4- Substantially Equivalent To: following two legally marketed predicate devices:

Netech, Model EXPMT 100 External Pacemaker Tester, -#K661582
Bio-Tek Inc, Model PMA-1 Pacemaker Analyzer, #K903966 ー

SigmaPace 1000 and the predicate External Pacemaker Analyzers have the identical intended use and there are no new technological features or issues that would raise concern of safety or effectiveness.

5 & 6 - Intended Use and Description of Device: This device is intended for use as an external pacemaker analyzer. It is intended to be used by biomedical technicians, third party service organizations, and manufacturers to perform regular preventative maintenance checks on external pacemakers, to verify operations of external pacemakers returned from repair, to assist repair technicians in isolating intermittent performance problems, and as a tool for training medical personnel in the use of external cardiac pacemakers. This device is not to be used as an external cardiac pacemaker calibrator or to make any adjustments based on SigmaPace 1000 test results. This device is not used on patients and does not perform any monitoring, diagnosing, or therapeutic functions.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "K011729 p.2/3" in a handwritten style. The text appears to be a document identifier or page number. The characters are written in black ink on a white background, and the handwriting is legible.

The SigmaPace 1000 is a device used to verify the performance of various parameters I he ciginal acc 1000 is a don'ts. This is done by connecting the external leads of the of external cardido pacematers: "Ital inputs on the SigmaPace 1000 and selecting the passemater to eas or by using the press buttons on the front panel display or via approprate test childr by same and port (RS232). The SigmaPace 1000 can perform a variety of Transcutaneous and Transvenous (Atrial and Ventricular) Pacer tests.

Pulse current, rate width , and energy ー

Qualitative demand and async mode tests -
Amplitude sensitivity tests -
Noise immunity tests
Paced and Sensed Refractory tests -
Selectable model specific transcutaneous algorithms 1
Selectable test loads -
DC leakage current (tranvenous) -
Current drain test (transvenous)
Long term test for pacer output stability
ECG simulation for training activities

7 ~ Summary of Technological Characteristics of Device Compared to Predicate: The SigmaPace 1000 is a dual channel device capable of testing external cardiac pacemakers. The predicate devices have the same intended use and perform most of the same functions as the SigmaPace 1000.

The SigmaPace 1000 is different in that is has dual channel input instead of single channel inputs to allow four pacemaker leads to be tested instead of two. The SigmaPace 1000 also has 5 lead and high level ECG output to allow it to be used with monitors and similar devices for training purposes. DNI has also included a number of manufacturer specific algorithms for improving testing of specific external cardiac pacemaker models. Last, the SigmaPace 1000 has increased test load selections over the predicate devices.

8 - Performance Testing: (Verification and Validation)

This device has undergone and continues to go through a variety of verification and validation testing. Each feature is tested to ensure it meets the requirements as defined in the product specification and advertising. To date, testing has been successfully completed for menu structure, test load selections, battery circuitry, transcutaneous test (ventricular channel), tranvenous tests (both atrial and ventricular channels), internal microprocessor clock frequency, algorithms testing, baud rate, and serial port operation. The data report for the first level validation as well as the full validation plan can be found in the Appendix of this submission.

{2}------------------------------------------------

K011729 p-3/3

9- Clinical Testing: Clinical testing was not required since the device is test equipment, and is never in contact with a patient nor do they have any diagnostic, therapeutic, or monitoring patient function. It is not intended to be used for calibrations and should not be used for clinical calls.

10 - Conclusions from testing: The testing conducted to date and that will be conducted prior to release will support all product claims for intended use including accuracy and full feature operation.

11 - Other Information of Interest to the FDA:

Potential System Hazards: The primary system function hazards were determined, reviewed, and addressed. The hazard analysis was aimed at identifying were error could occur which could cause believable but incorrect results. The hazard analysis detail can be found in the Appendix of this submission. In summary, the analysis looked at potential errors with keypad failures, display problems, serial port failures, LED indicator failure, failure of measurement circuitry or stimulus circuitry to be out of tolerance or improperly working, battery failure conditions, including shorts and low or no battery, short circuit of DN input node, and defibrillator discharge into Sigma Pace 1000.

User Safety Consideration: The SigmaPace 1000 is designed to meet IEC 1010 safety standards. The device itself uses an internal lithium battery with a battery charger that meets UL/CSA safety requirements for test equipment. IEC 1010 safety test leads are sent with each unit sold for further user protection.

The above information is certified to be truthful and accurate to the best of my knowledge.

1Lt. Lt. Bopp

Quality Assurance Manager

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2001

Ms. Kristine G. Boggs Quality Assurance Manager DNI Nevada, Inc. 2000 Arrowhead Drive Carson City, Nevada 89706-0403

Re: K011729

Trade Name: SigmaPace 1000 External Pacemaker Analyzer Regulation Number: 21 CFR 870.3630 Regulatory Class: II (two) Product Code: 74 DTC Dated: May 31, 2001 Received: June 4, 2001

Dear Ms. Boggs:

We have reviewed your Section 510(k) notification of intent to market the device referenced above we have determined the device is substantially equivalent (for the indications for use stated in and we acteenmally marketed predicate devices marketed in interstate commerce prior to the cholosure) to regally manifore of the Medical Device Amendments, or to devices that have been May 20, 1970, the enables with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The r ou may, are on on of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I spec rary, it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the

{4}------------------------------------------------

Page 2 – Ms. Kristine G. Boggs

Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication: "The FDF intaing of succement for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This Chaplestions on the promotion and advertising of your device, (201) 594-1015. Traditionally, 2011 proce at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornfacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html.

Sincerely yours,

K.G. Till

mes E. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): _ KO1 | 729

Device Name: SigmaPace 1000 External Pacemaker Analyzer

Indications for Use: The SigmaPace 1000 External Pacemaker Analyzer is intended for-Indications for USe. "The Digmatenance and quality assurance checks on external cardiac use as regular proventual oth the pre-hospital and hospital based environments.

The SigmaPace 1000 is limited to preventative maintenance checks for transcutancous The Urginal aod 1000 is temporary external cardiac pacemakers. The SigmaPace 1000 and transvenous types of temporary vecific testing procedures and protocols developed will perform a full fungo of anaker manufacturers. The SigmaPace 1000 will also by the external cardias pacemanes ulation capabilities for applications in clinical training and product demonstration.

The SigmaPace 1000 is intended to be used by biomedical technicians, OEM The Sigmal acc 1000 is metrosa vice facilities to perform preventative maintenance and manufacturers, and unra pary a cardiac pacemakers, to verify the operation of devices returned from repair, and to assist repair facilities in the diagnosis of intermittent devices routhed from repair as a sed by training facilities to train medical personnel.

The SigmaPace 1000 is not used on patients and does not perform any diagnostic, the orginial aos 1000 is ng functions. Additionally, these devices are not used to test any programmable, implantable pacemakers or any related indwelling cardiovascular catheters or lead wires.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number R011729

Prescription Use L (Per 21 CFR Part 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 870.3630 Pacemaker generator function analyzer.

(a)
Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.(b)
Classification. Class II (performance standards).