Defibrillation therapy is used as a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating supraventricular tachycardia, atrial fibrillation, atrial flutter, and, in relatively stable patients, ventricular tachycardia. The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole. The 3 and 4 wire ECG allows for identification or interpetation of cardiac rhythms or dysrhythmias and calculation of heart rate. The 12-lead electrocardiogram (ECG) is used to identify, diagnose, and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction. A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO2). It is used for monitoring patients who are at risk of developing hypoxemia.
Device Story
LIFEPAK 12 is a portable, battery/auxiliary-powered acute cardiac response system. Inputs include ECG signals (3, 4, or 12-lead) and pulse oximetry (SpO2) data. The device functions as a manual/AED defibrillator, monitor, and noninvasive pacemaker. It processes cardiac rhythms to provide diagnostic ECG interpretation and heart rate calculation. Used in prehospital (EMS) and hospital settings (ED, ICU, OR) by ALS/BLS providers, paramedics, and EMTs. Output is displayed on-screen and can be transmitted via landline or cellular phone to external systems (fax, printer, computer). Enables rapid clinical decision-making for cardiac emergencies; provides life-saving defibrillation and pacing therapy.
Clinical Evidence
Bench testing only. Compliance with ANSI/AAMI standards (EC11, EC13, DF2, DF39) provided to demonstrate safety, effectiveness, and performance equivalence to predicate devices.
Technological Characteristics
Multiparameter system including defibrillator, monitor, pacemaker, and pulse oximeter. Features 3, 4, and 12-lead ECG monitoring. Connectivity via landline or cellular phone for data transmission. Complies with ANSI/AAMI EC11, EC13, DF2, and DF39 standards. Optimized form factor for transport and prehospital use.
Indications for Use
Indicated for patients in cardiopulmonary arrest (AED mode), patients with fatal arrhythmias (ventricular fibrillation, symptomatic ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter), patients with symptomatic bradycardia or asystole, and patients at risk of hypoxemia requiring SpO2 monitoring.
Regulatory Classification
Identification
An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.
Marquette Electronics Eagle 4000 monitor with 12SL (K964750)
Submission Summary (Full Text)
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K973486
Jan 9, 1998
#### 510(k) Summary
Submitter's Name and Address: Physio-Control Corporation 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073
Sherri L. Pocock Contact Person: (206) 867-4332
September 12, 1997 Date Summary Prepared:
Device:
Physio-Control Corporation LIFEPAK® 12 defibrillator / monitor / pacemaker system
Classification:
Low-Energy DC - Defibrillators (including Paddles): Class II (21 CFR 870.5300)
Cardiac Monitors (including cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300)
External Transcutaneous Cardiac Pacemakers (noninvasive): Class III (870.5550)
Oximeter: Class II (21 CFR 870.2700)
Automated External Defibrillator: Class III
Interpretive 12 lead ECG: Class III
Substantial Equivalence:
The intended use and function of the LIFEPAK 12 system are substantially equivalent to those of the
> Physio-Control LIFEPAK 11 defibrillator / pacemaker, 510(k) no. K951593.
Physio-Control LIFEPAK 11 monitor, 510(k) no. K912189
WAB
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Hewlett Packard CodeMaster 100 defibrillator/monitor, 510(k) no. K950483
Marquette Electronics Responder 1500 Defibrillator/Monitor, 510(k) no. K903644
Marquette Electronics Eagle 4000 monitor with 12SL, 510(k) no. K964750
#### Description:
The LIFEPAK 12 defibrillator/monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system
The users will be Advanced Life Support and Basic Life Support providers in a variety of hospital and prehospital settings. Emergency Medical Services users will include Paramedics and Emergency Medical Technicians trained and authorized to respond to medical emergencies. This device will be used in the prehospital setting and in the hospital, in critical areas (emergency departments, critical care, operating rooms etc.) and on general duty floors (e.g. medical/surgical.) It will also be used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
Indications for Use:
Defibrillation is a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. The AED mode is for use on patients in cardiopulmonary arrest. Pacing is used to treat symptomatic bradycardia and asystole. ECG monitoring is used for identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate. Pulse oximetery is used to check the saturation of in the arterial blood of patients who are at risk of developing hypoxemia.
DADAM
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Technological characteristics of new and predicate devices:
The features and functions of the LIFEPAK 12 system are very similar to those of currently marketed Physio-Control devices. The LIFEPAK 12 is smaller than our currently marketed multiparameter devices and the design has been optimized for both prehospital, hospital, and transport use.
Summary of Performance Information:
Information is provided in the 510(k) regarding compliance to applicable sections of the following voluntary industry standards and FDA guidance documents:
- ANSI / AAMI EC11 1991, Diagnostic Electrocardiographic Devices . Standard
- ANSI/AAMI EC13 1992, Cardiac Monitors Standard ●
- ANSI / AAMI DF2 1989, Cardiac Defibrillator Devices Standard ●
- ANSI / AAMI DF39 1993, Automatic External Defibrillator . Standard
This information demonstrates that the LIFEPAK 12 is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.
3-31225
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 1998
Mr. Michael D. Willingham Vice President Quality and Regulatory Affairs Physio-Control Corporation 11811 Willows Road Northeast Post Office Box 97006 98073-9706 Redmond, WA
Re: K973486 LIFEPAK® 12 Defibrillator/Monitor System Regulatory Class: III (three) Product Code: 74 MKJ Dated: December 17, 1997 Received: December 18, 1997
Dear Mr. Willingham:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2 - Mr. Michael D. Willingham
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows The specific requirements of the the patients who receive them. regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Please be advised that, in the future, FDA may require postmarket surveillance of this device under the authorities granted under section 522 of the Federal Food, Drug and Cosmetic Act. This issue is currently undergoing consideration by FDA and you will be notified of our decision in writing.
Sincerely yours,
Thoma f. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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# LIFEPAK 12 defibrillator/monitor series - Indications for use
# Automated External Defibrillator feature
The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.
#### Defibrillator Therapy
Defibrillation therapy is used as a means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating supraventricular tachycardia, atrial fibrillation, atrial flutter, and, in relatively stable patients, ventricular tachycardia.
### Noninvasive Pacemaker
Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole.
## Electrocardiograph
### 3-Lead (3 wire) and 6-Lead (4 wire) ECG Monitoring:
The 3 and 4 wire ECG allows for identification or interpetation of cardiac rhythms or dysrhythmias and calculation of heart rate.
#### 12-lead electrocardiogram (ECG)
The 12-lead electrocardiogram (ECG) is used to identify, diagnose, and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
# Pulse Oximetery
A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO2). It is used for monitoring patients who are at risk of developing hypoxemia.
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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.
