K093094 · Cardinal Health 207, Inc. · CBK · May 11, 2010 · Anesthesiology
Device Facts
Record ID
K093094
Device Name
VELA VENTILATOR
Applicant
Cardinal Health 207, Inc.
Product Code
CBK · Anesthesiology
Decision Date
May 11, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.5895
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric patients weighting at least 5 kg (11lb), who require the following types of ventilation support, as prescribed by an attending physician. Positive pressure ventilation Assist / control, SIMV, or CPAP modes of ventilation The ventilator is suitable for use in institutional and transport settings. It is not intended of use in an emergency medical transport ventilator or for home care applications.
Device Story
VELA Ventilator is a self-contained, servo-controlled, software-driven ventilator for adult and pediatric patients (≥5 kg). Device provides positive pressure ventilation (Assist/Control, SIMV, CPAP) in institutional and transport settings. Features include a flat-panel color LCD, touch screen, membrane keys, and dial for parameter adjustment. Precision gas delivery turbine with active inhalation/exhalation control. Optional mainstream CO2 monitoring via external CAPNOSTAT 5 sensor. Software performs real-time charting, digital monitoring, and automated calculations including f/Vt (rapid shallow breathing index) and circuit resistance. Operated by qualified personnel under physician direction. Output allows clinicians to monitor ventilation effectiveness and adjust therapy settings. Benefits include flexible, easy-to-use respiratory support with integrated monitoring capabilities.
Clinical Evidence
Bench testing only. Performance testing verified that the VELA Ventilator meets its performance requirements and is substantially equivalent to legally marketed predicate devices.
Technological Characteristics
Servo-controlled, software-driven ventilator. Features precision gas delivery turbine, flat-panel color LCD, touch screen interface. Connectivity includes LEMO connector for external CO2 sensor (SELV). Software-based monitoring of f/Vt and circuit resistance. Designed for institutional use with liquid-resistant casing.
Indications for Use
Indicated for adult and pediatric patients weighing at least 5 kg (11 lb) requiring continuous or intermittent mechanical ventilatory support (Positive pressure, Assist/Control, SIMV, or CPAP) in institutional or transport settings. Contraindicated for emergency medical transport or homecare use.
Regulatory Classification
Identification
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
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K093094
MAY 1 1 2010
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Manufacturing<br>Site: | Cardinal Health 211<br>1100 Bird Center Drive<br>Palm Springs, CA 92262 |
|-------------------------------------------|-------------------------------------------------------------------------|
| Contact: | Farokh Etemadieh (714) 919-3249 (phone); (714) 283-8420 (fax) |
| Summary Date | June 5,-2009 |
| Device Trade<br>Name: | VELA Ventilator |
| Device<br>Common/Classific<br>ation Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| Establishment<br>Registration<br>Number | 202171 |
| Device Class: | Class II |
| Classification<br>Panel: | Anesthesiology |
| Predicate Device: | The predicate devices are: |
| | • Maquet Servo-I K022132<br>• LTV 1200: K060647 |
- Cardinal Health AVEA Ventilator: K073069 .
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Device Description:
A VELA with the CO2 monitoring option is intended to monitor the effectiveness of ventilation. It may be used on adult and pediatric patients. It is suitable for use in a hospital critical care environment, and is a restricted medical device intend for use by qualified trained personnel under the direction of a physician.
The VELA Series Ventilator is a modified Tbird Ventilator and like its predecessor, is an easy to use, self-contained, servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for pediatric through adult patients. Its revolutionary user interface module provides maximum flexibility with simple operator interaction. It has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery turbine with servo controlled active inhalation and exhalation improves performance over previous generations.
The VELA Series Ventilator may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It is easy to clean and its design does not allow liquids to pool on the casing, reducing the likelihood of fluid leakage into the body of the ventilator.
The VELA Series Ventilator base model comes with comprehensive features for the critical care environment. Optional features can be added at time of purchase or at a later date.
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The Vela ventilator is intended to provide continuous or intermittent Intended Use: ventilatory support for the care of individuals who require mechanical verification. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11lb), who require the following general types of ventilation support, as prescribed by attending physician:
> Positive pressure ventilation Assist/Control, SIMV, or CPAP modes of ventilation
The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator or for homecare applications.
Substantial Equivalence: Predicate Device Information
The predicate device(s) are:
- Maquet Servo-I: K022132 .
- LTV 1200: K060647 .
- Cardinal Health AVEA: K073069 .
- The modifications to VELA associated with this submittal as follows:
- An End Tidal CO2 monitoring option consisting of an external mainstream CO2 ● sensor module, the CAPNOSTAT 5, OEMed from Respironics and for added safety connected to the device using a LEMO connector at extra safety low voltage (SELV).
- The ventilator will be applicable for adult and pediatric patients weighing at least 5 kg . (11 Ib), who require continuous respiratory support, as prescribed by an attending physician.
- Monitoring of f/Vt and Circuit Resistance. . F/Vt monitoring by definition is the rapid shallow breathing index calculated by the ratio of the monitored spontaneous breath rate and monitored tidal volume. F/Vt is described at page 118 and Circuit Resistance at page 75 of the Vela operator manual L2854-101 Rev. B. and exhibit A.
- The setting range of the PSV Cycle changed from 5 30% to 5 70%. .
Summary of Testing and Validation:
In Summary Performance testing verified that the VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to predicate medical devices currently legally marketed in the United States.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
### MAY 1 1 2010
Mr. Farokh Etemadieh Regulatory Affairs Consultant Cardinal Health 207, Incorporated 22745 Savi Ranch Parkway Yorba Linda, California 92887
Re: K093094
Trade/Device Name: Vela Ventilator Regulation Number: 21 CFR 868,5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 22, 2010 Received: April 27, 2010
Dear Mr. Etemadieh:
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.
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#### Page 2- Mr. Farokh Etemadieh
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 53) -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/CentersOtfices/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,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indication for Use
510(k) number (if known): K093094
Device Name: VELA Ventilator Indications for Use:
> The VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric patients weighting at least 5 kg (11lb), who require the following types of ventilation support, as prescribed by an attending physician.
- Positive pressure ventilation
- Assist / control, SIMV, or CPAP modes of ventilation
The ventilator is suitable for use in institutional and transport settings. It is not intended of use in an emergency medical transport ventilator or for home care applications.
#### WARNING
The Vela ventilator is approved for institutional use only and should not be used to transport patients outside of the institutional setting.
Prescription Use V AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)
> Concurrence of CDRH Office of Device Evaluation ODE) Sheltons and
L. Schulten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices . 510(k) Number: K093094 Page of (Posted
November 13, 2003)
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.
