K061627 · Versamed Medical Systems, Inc. · CBK · Jun 29, 2006 · Anesthesiology
Device Facts
Record ID
K061627
Device Name
MODIFICATION TO I VENT 201
Applicant
Versamed Medical Systems, Inc.
Product Code
CBK · Anesthesiology
Decision Date
Jun 29, 2006
Decision
SESE
Submission Type
Special
Regulation
21 CFR 868.5895
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The iVent™ 201 is a portable, computer controlled, electrically powered Intensive Care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require the following general modes of ventilatory support, as prescribed by an attending physician: Assist/Control (Pressure Controlled or Volume Controlled) . SIMV (Pressure Controlled or Volume Controlled) . CPAP/PSV . The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for use in hospitals and hospital-type facilities, inter and intra-hospital use, home and alternate-care site use, in transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate. The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician
Device Story
iVent 201 is a compact, microprocessor-controlled, turbine-powered portable ventilator; provides mechanical ventilation support (Assist/Control, SIMV, CPAP/PSV) for adult and pediatric patients. Features internal rechargeable battery; turbine air source; turn-and-click control knob; pushbuttons; screen for real-time monitoring. Includes optional pulse oximeter for SpO2 and pulse rate monitoring; remote alarm adapter for hospital central monitoring. Used in ICU, hospital wards, transport, emergency, and home settings by trained personnel. Clinicians use real-time waveform/loop/trend data to adjust ventilation settings; device provides continuous respiratory support and monitoring to improve patient outcomes.
Clinical Evidence
Bench testing only. Device complies with voluntary standards including ASTM F 1100-90, ASTM F 1246-91, MIL-STD-810E, ISO 10651-1/2/3, IEC 60601-1, IEC 60601-2-12, IEC 60601-1-2, CAN/CSA-C22.2 No.601.1, ISO 9919, and EN 865. Non-clinical testing confirmed device meets specifications for safety and effectiveness.
Technological Characteristics
Microprocessor-controlled, turbine-powered ventilator. Features internal rechargeable battery, serial digital interface for pulse oximetry, and remote alarm relay circuit. Dimensions/form factor: compact/portable. Connectivity: serial digital interface for sensors. Software: microprocessor-based control. Complies with IEC 60601-1, IEC 60601-2-12, and ISO 9919.
Indications for Use
Indicated for adult and pediatric patients requiring continuous or intermittent mechanical ventilatory support (Assist/Control, SIMV, CPAP/PSV modes) and non-invasive monitoring of oxygen saturation and pulse rate. Restricted to use by qualified personnel under physician direction.
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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K061627
JUN 2 9 2006
# VersaMed Medical Systems Inc.
### 2 Blue Hill Plaza Bldg. 2 Pearl River, NY 10965 USA
# Non-Confidential Summary of Safety and Effectiveness
## Summary of Safety and Effectiveness
Submitter's Name:
VersaMed Medical System Inc.
## Contact Person:
Mr. Jerry Korten Tel: 845 770 8240 Fax: 845 770 8250
## Trade Name:
iVent™ 201 Portable Ventilator
## Classification Name:
Anesthesiology
### Classification:
CBK, DQA, NOU.
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#### Predicate Devices:
The iVent™ 201 Portable Ventilator is substantially equivalent to:
- · iVent™ cleared under K053270
#### Performance Standards:
No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the iVent™ 201 portable ventilator complies with the following voluntary standards: ASTM F 1100-90 ASTM F 1246-91 MIL-STD-810E ISO 10651-112/3 IEC 60601-1 IEC 60601-2-12 IEC 60601-1-2 CAN/CSA-C22.2 No.601.1 ISO 9919 EN 865 (section 6)
The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use.
#### Device Description:
The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.
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The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.
Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.
#### Intended use:
The iVent™ 201 is a portable, computer controlled, electrically powered Intensive Care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require the following general modes of ventilatory support, as prescribed by an attending physician:
- Assist/Control (Pressure Controlled or Volume Controlled) .
- SIMV (Pressure Controlled or Volume Controlled) .
- CPAP/PSV .
The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for use in hospitals and hospital-type facilities, inter and intra-hospital use, home and alternate-care site use, in transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician
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### Substantial Equivalence:
The iVent™ 201 portable ventilator is viewed as substantially equivalent to the following predicate devices;
- · iVent™ cleared under K053270
The iVent 201 -portable ventilator in this submittal is the same device as the cleared device under K053270 except for the modification associated with this submittal:
clarification to the indications statement without changing the scope of the cleared device indications statement.
There are no significant differences between the iVent™ 201 portable ventilator in this submittal and the predicate device under K053270 that affect the safety or effectiveness of the intended device as compared to the predicate devices. The iVent 201 portable ventilator is viewed as substantially equivalent to the predicate device since they:
1. Have the same intended use:
1.1 The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support
for
the care of individuals who require mechanical ventilation.
2. Have the same environment for use:
2. in hospitals and hospital-type facilities, inter and intra-hospital use, home and alternate-care site use, in transport and emergency use.
3. Have the same patient populution :
3.1 this system can be used with adult and pediatric patients require Tidal Volume between 50-2000 ml.
- 4. Are similar in design
- 5. Employ the same technology
- 6. Are made of identical materials
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2006
Mr. Jerry Korten Official Correspondent Versamed Medical Systems, Incorporated 2 Blue Hill Plaza, Bldg. 2, 3td floor Pearl River, New York 10965
Re: K061627
Trade/Device Name: iVent™ 201 Portable Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 29, 2006 Received: June 12, 2006
Dear Ms. Korten:
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.
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. Korten
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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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#### INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
iVent™ 201 Portable Ventilator
#### Indications for Use:
The iVenf™ 201 is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require the following general modes of ventilatory support, as prescribed by an attending physician:
- Assist/Control (Pressure Controlled or Volume Controlled) .
- SIMV (Pressure Controlled or Volume Controlled) .
- . CPAP/PSV
The iVently 201 ventilator (with or without the non-invasive Pulse Oximeter option) is suitable for use in the ICU and all other hospital areas. in all hospital-type facilities. alternate-care sites, transport, emergency and in the home environment. The non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas.
The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
Cuningham
of Anesthesiology, Gene Jon Control. Denta : I :mber
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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.
