SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
K011729 · Dni Nevada, Inc. · DTC · Aug 30, 2001 · Cardiovascular
Device Facts
Record ID
K011729
Device Name
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
Applicant
Dni Nevada, Inc.
Product Code
DTC · Cardiovascular
Decision Date
Aug 30, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.3630
Device Class
Class 2
Indications for Use
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 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. It is also 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 Story
SigmaPace 1000 is a dual-channel external pacemaker analyzer; tests transcutaneous and transvenous temporary pacemakers. Inputs: pacemaker leads connected to device ports; user interface via front panel buttons or RS232 serial port. Device performs pulse current, rate, width, energy, demand/async mode, amplitude sensitivity, noise immunity, refractory period, DC leakage, current drain, and output stability tests. Includes manufacturer-specific algorithms for testing specific pacemaker models; provides ECG simulation for training. Used in clinical/hospital settings by biomedical technicians and service personnel. Output: test results displayed on front panel; used by technicians to verify performance, isolate intermittent problems, and perform preventative maintenance. Benefits: ensures reliability of external pacemakers before clinical use.
Clinical Evidence
No clinical data. Device is test equipment not used on patients; does not perform diagnostic, therapeutic, or monitoring functions. Verification and validation performed via bench testing of features including menu structure, test loads, battery circuitry, transcutaneous/transvenous channel tests, microprocessor clock, and algorithms.
Technological Characteristics
Dual-channel analyzer; internal lithium battery; RS232 connectivity. Meets IEC 1010 safety standards. Features include 5-lead and high-level ECG output, selectable test loads, and manufacturer-specific algorithms for pacemaker testing. Dimensions/form factor not specified.
Indications for Use
Indicated for use by biomedical technicians, manufacturers, and service facilities to perform preventative maintenance, quality assurance, and performance verification of temporary transcutaneous and transvenous external cardiac pacemakers. Not for use on patients; not for diagnostic, therapeutic, or monitoring functions; not for testing implantable pacemakers or indwelling catheters.
Regulatory Classification
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.
Predicate Devices
Netech, Model EXPMT 100 External Pacemaker Tester (K661582)
Bio-Tek Inc, Model PMA-1 Pacemaker Analyzer (K903966)
Submission Summary (Full Text)
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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.
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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.
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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
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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
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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
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# 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)
OR
Over-The-Counter Use
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
