The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for: - noninvasive blood pressure, - pulse rate, - noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and - body temperature in normal and axillary modes. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments. Monitoring can be accomplished on the VSM 6000 series bedside monitor itself and the VSM 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.g., at a central station). Secondary remote viewing and alarming features are intended to supplement and not replace patient bedside monitoring. The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities. The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities. The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring. Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input. The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting. This product is available for sale only upon the order of a physician or licensed health care professional.
Device Story
Modular vital signs monitor for spot-check and continuous monitoring; used by clinicians in hospitals/alternate care. Inputs: noninvasive blood pressure, pulse, SpO2, temperature, CO2, respiration rate, SpHb, and manual/electronic data (weight/height). Operates via touch screen interface; displays real-time vitals and IPI (1-10 scale). Data transmitted via USB, Ethernet, or wireless to remote viewing systems. Includes 'Applications Framework' for isolated software applications. Benefits: provides comprehensive patient status, alerts clinicians to changes in pulmonary/vital status, and supports clinical decision-making through integrated data display.
Clinical Evidence
No clinical studies were utilized; bench testing only. Verification and validation conducted per IEC 60601-1, 60601-1-2, 60601-1-4, 60601-1-8, 60601-2-30, 60601-2-49, ISO 9919, ISO 14971, ISO 21647, and IEC 62304.
Technological Characteristics
Enclosure: engineered plastics with internal steel members. Interface: touch screen, silicone light bar alarm. Connectivity: USB, wired Ethernet, wireless. Power: internal AC supply, Lithium Ion battery. Software: Applications Framework (isolated subsystem). Standards: IEC 60601 series, ISO 9919, ISO 14971, ISO 21647, IEC 62304.
Indications for Use
Indicated for neonatal, pediatric, and adult patients in hospitals and alternate care environments for monitoring noninvasive blood pressure, pulse rate, SpO2, body temperature, total hemoglobin (SpHb), respiration rate (RRa), and CO2. Includes Integrated Pulmonary Index (IPI) for ventilatory status assessment.
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
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### WelchAllyn
# 121013
JUL 26 2012 .
#### 510(k) Summary
[As described in 21 CFR 807.92]
Submitted by:
Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220
Contact Person:
Kevin Crossen Director of Regulatory Affairs Phone: (315) 685-2609 Fax: (315) 685-2532 E-mail: kevin.crossen(@welchallyn.com
June 26, 2012 Date Prepared:
Welch Allyn Connex® Vital Signs Monitor 6000 Series Trade Name:
Monitor, Physiological, Patient (without Arrhythmia Common Name: Detection or Alarms)
Class II, 870.2300, Cardiovascular Monitoring Devices Classification Reference: Product Code - MWI
Predicate Devices:
Welch Allyn Connex® Vital Signs Monitor - VSM 6000 Series (with Applications Framework) Vital Signs Monitor, CVSM 6000 Series, CVSM Welch Allyn, Inc. 510(k) Number K112687
Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and Accessories Pulse Oximeter and Sensor Masimo Corporation 510(k) Number K100428
Oridion Capnostream20® with MicromediCO2 Module Carbon Dioxide Gas Analyzer Oridion Capnography, Inc. 510(k) Number K094012
Welch Allyn VSM (vital signs monitor), Propaq LT Physiological Patient Monitor Welch Allyn, Inc. 510(k) Number K033378
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### Welch Allyn
## KI21013
#### Description of the Device:
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is designed to provide a scalable, modular system of components that can be configured to address the needs for vital signs spot check and continuous monitoring.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Patient monitors equiped with Masimo Rainbow SET® pulse Co-Oximeter modules are also capable of total hemoglobin measurements (SpHb, SpHbv) and acoustic respiration rate (RRa). Patient monitors equiped with Oridion capnography are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI). The CVSM can also display and transfer patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, IR temperature, and other patient or facility information. Data can be transferred electronically via USB, wired Ethernet, or wireless communications. Ethernet and wireless are intended for communication of vital signs parameters, patient data, and alarms (including continuous and episodic parameters and alarms) to secondary remote viewing and alarming systems. The Welch Allyn Application Framework (Framework) - has been included as a separate subsystem. The Framework is general purpose software that allows medical device and non-medical device software applications to run on the Framework independently of and isolated from the CVSM's vital signs monitoring functionality.
The monitor has an enclosure constructed of engineered plastics with internal steel members for strengthening. A silicone light bar is prominent in a carry handle on the top of the device and illuminates for different alarm conditions. A power button is located on the side of the device. A touch screen display is prominent on the front of the device and provides the primary interface for the user to interact with the device. Internal and external communications are primarily by USB. External host USB connections for accessories are tool accessible. A USB connection for data transfer is on the side of the device, as is a connection to an internal relay for use with nurse call systems. The device contains an internal AC power supply for operating the device and charging the internal Lithium Ion battery.
The monitor can be configured for use in different workflows including desktop, affixed to a mobile stand, or on a wall mount.
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{2}------------------------------------------------
### WelchAllyn
#### Indications for Use:
The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure, ー
- pulse rate, -
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), ー and
- body temperature in normal and axillary modes. -
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments. Monitoring can be accomplished on the VSM 6000 series bedside monitor itself and the VSM 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.g., at a central station). Secondary remote viewing and alarming features are intended to supplement and not replace patient bedside monitoring.
The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.
The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.
Page 3/5.
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## WelchAllyn
K121013
The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
This product is available for sale only upon the order of a physician or licensed health care professional.
#### Technological Characteristics:
The subject device has the same technological characteristics and indications for use as the predicate devices; minor modifications and additions to software and hardware were made to the CVSM to enable acquisition and display of acoustic respiration rate (RRa) utilizing the existing Masimo Rainbow SET® module and also the acquisition and display of carbon dioxide (CO2), respiration rate (RR), and a calculated integrated pulmonary index (IPI) utilizing the Oridion capnography module. The Welch Allyn Application Framework (Framework) has been included as a separate subsystem. The Framework is general purpose software that allows medical device and non-medical device software applications to run on the Framework independently of and isolated from the CVSM's vital signs monitoring functionality.
#### Non-Clinical Tests:
Verification and validation were conducted to ensure expected performance of the CVSM 6000 Series with enabled Masimo Rainbow SET® and the Oridion capnography module.
The Connex® Vital Signs Monitor 6000 Series was tested to evaluate its safety and effectiveness based on the following standards:
- IEC 60601-1:Ed. 2: 1988 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance (with A1:1991 +A2:1995)
- IEC 60601-1-2: Ed. 3: 2007 Medical electrical equipment Part 1-2: ● General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test
- IEC 60601-1-4: Consolidated Ed. 1.1: 2000 Medical electrical equipment -� Part 1-4: General requirement for safety: Collateral standard: Programmable electrical medical systems
- IEC 60601-1-8: Ed. 1: 2003 Medical electrical equipment Part 1-8: . General requirements for safety - Collateral standard: Alarm systems -
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{4}------------------------------------------------
**Welch Allyn**
K 121013
Requirements, tests and guidances - General requirements and guidelines for alarm systems in medical equipment (with A1:2006)
- IEC 60601-2-30: Ed. 2: 1999 Medical electrical equipment Part 2-30: . Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
- · IEC 60601-2-49: Ed. 1: 2001 Medical electrical equipment -- Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
- ISO 9919: Ed. 2: 2005 Medical electrical equipment -- Particular . requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
- ISO 14971: Ed. 2: 2007 Medical devices Application of risk management . to medical devices
- ISO 21647: Ed 1: 2004 Medical electrical equipment, Part 2: Particular . requirements for the basic safety and essential performance of respiratory gas monitors
- IEC 62304: Ed. 1: 2006 Medical Device Software Software Life-Cycle ● Processes
#### Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
#### Conclusion:
Based on the information presented in this 510(k) premarket notification. Welch Allyn's Connex® Vital Signs Monitor 6000 Series is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed devices cited in this submission.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 6 2012
Welch Allyn, Inc. c/o Mr. Kevin Crossen Director, Regulatory Affairs 4341 State Street Road Skaneateles Falls, NY 13153.
Re: K121013
Trade Name: Connex Vital Signs Monitor 6000 Series Regulation Number: 21 CFR 878.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: June 26, 2012 Received: June 29, 2012
Dear Mr. Crossen:
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.
{6}------------------------------------------------
#### Page 2 -- Mr. Kevin Crossen
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D/Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Device Name: Welch Allyn Connex® Vital Signs Monitor 6000 Series
#### Indications for Use:
The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure, 一
- pulse rate. -
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and -
- body temperature in normal and axillary modes. -
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments. Monitoring can be accomplished on the VSM 6000 series bedside monitor itself and the VSM 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.g., at a central station). Secondary remote viewing and alarming features are intended to supplement and not replace patient bedside monitoring.
The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.
The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <b>X</b> |
|-------------------------------------------------|------------------------------------------------|
| | AND/OR |
| | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|------------------------------------|--------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K21013 |
Page 1 of 2
{8}------------------------------------------------
### Indications for Use (continued)
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, and BMI input.
The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn The Weller Allyn Golmor "The Framework is general purpose software that allows Applications Framowork ( Prainonely) ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
This product is available for sale only upon the order of a physician or licensed health care professional.
Page 2 of 2
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.
