K041892 · ZOLL Medical Corporation · MKJ · Feb 4, 2005 · Cardiovascular
Device Facts
Record ID
K041892
Device Name
ZOLL AED PRO EXTERNAL DEFIBRILLATOR
Applicant
ZOLL Medical Corporation
Product Code
MKJ · Cardiovascular
Decision Date
Feb 4, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.5310
Device Class
Class 3
Attributes
Therapeutic, Pediatric
Indications for Use
The ZOLL AED Pro External Defibrillator is a portable, ruggedized, automated external defibrillator intended for use by personnel who are trained in basic life support, advanced life support, or other physician-authorized emergency medical response who must respond to emergency situations, to deliver defibrillation therapy and to display ECG rhythms of patients during treatment.
Device Story
Portable, battery-powered AED for emergency cardiac arrest rescue. Inputs: ECG signals via defibrillation electrodes or ECG cable. Operation: Device analyzes ECG rhythm; if shockable, provides voice/visual prompts for defibrillation. Includes manual override and non-diagnostic ECG monitoring for trained providers. Features high-resolution LCD displaying ECG, shock count, and CPR compression performance (via CPR-D-padz). Used by BLS/ALS personnel in emergency settings. Output: Defibrillation shock and visual/audible feedback. Benefits: Facilitates rapid rhythm analysis and CPR quality improvement to increase survival chances.
Clinical Evidence
Bench testing only. Device subjected to extensive performance and safety testing to ensure compliance with functional requirements and recognized industry standards. No clinical data presented.
Technological Characteristics
Portable, battery-powered, ruggedized AED. Features high-resolution LCD. Uses proprietary defibrillation electrodes (pedi-padz II for pediatrics, CPR-D-padz for CPR feedback). Includes manual override and non-diagnostic ECG monitoring. Software-based interpretive algorithm for shock advisory. Connectivity via ECG cable for monitoring mode.
Indications for Use
Indicated for cardiac arrest victims exhibiting unconsciousness, absence of normal breathing, and absence of pulse/signs of circulation. Pediatric use (<8 years or <55 lbs) requires pedi-padz II electrodes. Monitoring mode indicated for non-diagnostic ECG display in breathing/responsive patients. Contraindicated for defibrillation if patient is conscious, breathing, or has a pulse. CPR monitoring contraindicated for patients under 8 years.
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.
Philips Medical Systems, Heartstart FR2+ (K013425)
Submission Summary (Full Text)
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K041892
FEB - 4 2005
## 510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Sean Reynolds (978) 421-9655, Ext. 9386
Date Summary Prepared:
June 28, 2004
#### Device:
ZOLL AED Pro External Defibrillator
Classification:
Defibrillator, Low-energy - DC: Class II (21 CFR 870.5300)
Automatic External Defibrillators; Class III (21 CFR 870.5310)
Cardiac Monitors (including Cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300
Substantial Equivalence:
The features and functions of the ZOLL AED Pro External Defibrillator are substantially equivalent to those of the ZOLL AED Plus with CPR Aid: 510(k) No. K011541, cleared 4/11/2002, the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004 and the Philips Medical Systems, Heartstart FR2+ (formerly Heartstream ForeRunner), 510(k) No. K013425, cleared 1/14/2002.
Description:
The ZOLL AED Pro External Defibrillator is a portable, battery powered, automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AED Pro acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts.
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#### 510(k) Summarv
Defibrillation therapy is provided by using defibrillation electrode products specifically designed to be attached to the ZOLL AED Pro. ZOLL pedirpadz™ II defibrillation electrodes enable users to provide therapy to children less than 8 years of age. When used in conjunction with ZOLL CPR-D-padz™, the AED Pro provides CPR compression performance feedback to the user through voice prompts.
The ZOLL AED Pro also provides a non-diagnostic ECG monitoring feature and manual override capabilities for physicians and appropriately trained healthcare providers. A high-resolution LCD Screen will display ECG Data, Visual Prompts, Shock Count and CPR compression performance.
#### Intended Use
The ZOLL AED Pro External Defibrillator is a portable, ruggedized, automated external defibrillator intended for use by personnel who are trained in basic life support, advanced life support, or other physician-authorized emergency medical response who must respond to emergency situations, to deliver defibrillation therapy and to display ECG rhythms of patients during treatment.
#### Comparison of Technological Characteristics:
The ZOLL AED Pro design characteristics are the same as those of the indicated predicate devices; the technology is very similar to that of the ZOLL AED Plus. The ZOLL AED Pro acquires and analyzes ECG signals and provides shock advisory determinations for adult and pediatric patients. The ZOLL AED Pro advises users to deliver a shock, perform CPR or conduct patient assessment through audible and visual prompts identical to those used by the ZOLL AED Plus. The AED Pro ECG monitoring feature and manual override capability are substantially equivalent to that of the Philips Heartstart FR2+ defibrillator.
#### Performance Testing:
The ZOLL AED Pro External Defibrillator has been subjected to extensive performance testing to ensure that the device meets all of its functional requirements and performance specifications. Safety testing was performed to assure the device complies with applicable sections of recognized industry and safety standards.
#### Conclusion
Based on the results of the performance and safety testing, the ZOLL AED Pro has demonstrated that its features, functions and incorporated interpretive algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
FEB - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sean Reynolds Regulatory Affairs Engineer Zoll Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105
K041892 Re:
Trade/Device Name: ZOLL AED Pro External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: III Product Code: MJK Dated: December 3, 2004 Received: December 6, 2004
Dear Mr. Reynolds:
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 ass ontale an 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register
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## Page 2 - Mr. Sean Reynolds
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 DX 3 issumost of our device complies with other requirements of the Act or that FDA nas mude a determilations administered by other Federal agencies. You must comply with all 1 Coords statutes and regendating, but not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements) incolares, none manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Connor provisions (Socure to begin marketing your device as described in your Section 510(k) This letter will and in yours Finding of substantial equivalence of your device to a legally prematics notification: "The PDF missing site and thus, permits 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), please in you attire Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Echeral 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimnica for
Bram D. Zuckerman, M.D. Division of Cardiovacsular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Section 4 - Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K041892
Device Name: ZOLL AED Pro External Defibrillator
### Indications for Use
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by:
- Unconsciousness, and .
- Absence of normal breathing, and .
- Absence of a pulse or signs of circulation. .
When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Pro unit should with the with ZOLL pedi-padz™ II defibiliation electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
At the discretion of the rescuer, the Monitoring Mode feature can be used with the AED Pro ECG Cable At the ulscretion of the resource and meathing or responsive patient's ECG rhythm, regardless of their to provide a not-olaghostic display of a broaking of Nosperiorms a background analysis of the patient's rhythm and disables its defibrillator feature.
### Contraindications for Use - Defibrillation
Do not use the AED Pro unit for defibrillation when the patient
- . ls conscious; or
- Is breathing; or .
- Has a detectable pulse or other signs of circulation. .
## Contraindications for Use - CPR Monitoring
The CPR monitoring function is not intended for use on patients under 8 years of age.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
ummuma Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number k 041892
Page 1 of 1 _
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.
