PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

K070594 · Pulmonetic Systems, Inc. · CBK · Aug 1, 2007 · Anesthesiology

Device Facts

• Record ID: K070594
• Device Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Applicant: Pulmonetic Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations. Federal law (USA) restricts the sale of this device except by or on the order of a physician.

Device Story

PALMTop PTV Models 8/10 are portable ventilators providing invasive or non-invasive positive pressure support. Device uses internal flow generator, eliminating need for external compressed gas. Inputs include patient circuit pressure and optional FIO2/oximetry data. System supports multiple modes: CPAP, Pressure Support, SIMV, Control, Assist/Control, and PRVC. Features include leak compensation, apnea backup, and synchronized nebulization. Operated by trained personnel in home, hospital, or transport environments. Output includes real-time waveforms, loops, trending histograms, and monitored parameters (PIP, PEEP, tidal volume, minute volume). Clinicians use data to adjust ventilation settings, optimizing patient respiratory support and gas exchange. Benefits include high-performance ventilation in a lightweight, mobile form factor.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing verified that the PALMTop Models PTV 8/10 meet specified performance requirements and are substantially equivalent to the predicate devices.

Technological Characteristics

Portable ventilator with internal flow generator. Supports invasive/non-invasive ventilation. Features: touch screen, lockable controls, optional FIO2 sensor, optional oximetry module. Power: AC, battery, or external DC. Connectivity: real-time waveform/loop display, trending histograms. Software-controlled ventilation modes (CPAP, SIMV, Control, Assist/Control, PRVC).

Indications for Use

Indicated for patients requiring respiratory support or mechanical ventilation weighing at least 5 kg (11 lbs). Suitable for invasive or non-invasive continuous or intermittent positive pressure ventilation in home, hospital, and transport settings. Restricted to use by trained 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.

Predicate Devices

• LTV 1200 Ventilator (K060647)
• LTV 1000 Ventilator (K981371, K984056)
• iVent 201 Portable Ventilator with Pulse Oximeter (K021981)
• TBird VELA Ventilator (K032451)

Submission Summary (Full Text)

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# 510(K) SUMMARY

#### SUBMITTER

Pulmonetic Systems, Inc. 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341

AUG - I 2007

| Contact Person: | Robert C. Samec | Telephone |
|-----------------|-----------------|-----------|
| | [phone] | |
| | [phone] | Facsimile |

#### DEVICE / TRADE NAME

| Trade Name: | PALMTop PTV Models 8/10 |
|----------------------|----------------------------------------------|
| Common Name: | Ventilator |
| Classification Name: | Ventilator, Continuous (Respirator) 868.5895 |

#### SUBMISSION DATE

Submission Date: August 1, 2007

#### DESCRIPTION

The PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.

The PTV platform provides for the following features:

- . High performance ventilation in a small lightweight package
- A range of maneuvers including Inspiratory and Expiratory hold . and synchronized Nebulization (touch screen models only)
- . Internal flow generator, allowing the PTV to operate without an external compressed gas source
- . Four distinct breath types offering a range of treatment options. CPAP with optional Pressure Support 1, SIMV2, Control, Assist /

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Control

- Configurable Apnea back-up ventilation .
- NPPV3 ventilation, providing an alarm package suitable for . mask ventilation of patients whose needs do not extend to life support
- Volume Control, Pressure Control and PRVC4 ventilation modes t
- Adjustable alarm settings including High Peak Pressure. Low . Peak Pressure, Low Minute Volume, and Apnea
- Oxygen blending from a high-pressure oxygen source (optional) . or low-pressure oxygen bleed-in
- Lockable front panel controls .
- A wide range of monitors including Breath Rate (f), I:E Ratio . (Measured), MAP, Exhaled Minute Volume (VE), PEEP, PIP and Tidal Volume (Vte)
- Dynamic waveform and loop displays .
- . Graphic trending histogram display
- Real-time patient circuit pressure display .
- . Variable termination options for Pressure Support breaths, including maximum inspiratory time and percentage of peak flow
- . Selectable Percentage of Peak Flow termination for Pressure Control breaths
- Leak Compensation to improve patient triggering when a circuit . leak is present
- . Operation from a variety of power sources including AC power. removable battery and external DC power sources
- . Optional FIO2 sensor package.
- . Optional Oximetry module

### INTENDED USE

PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.

¹ Continuous Positive Pressure Ventilation

² Synchronized Intermittent Mandatory Ventilation

³ Non-invasive Positive Pressure Ventilation

⁴ Pressure Regulated, Volume Controlled

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PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

## Federal law (USA) restricts the sale of this device except by or on the order of a physician.

#### Summary of Testing and Validation

Performance testing (Bench testing) verified that the Palmtop Models PTV 8/10 meet specified performance requirements and that the devices are substantially equivalent to the predicate devices listed below.

| Predicate Device | 510(k) Clearance | Manufacturer |
|------------------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------|
| LTV 1200<br>Ventilator | K060647 | VIASYS<br>Healthcare/Pulmonetic<br>Systems, Inc.<br>17400 Medina Road.<br>Suite 100<br>Minneapolis, MN 55447 |
| LTV 1000<br>Ventilator | K981371<br>K984056 | VIASYS<br>Healthcare/Pulmonetic<br>Systems, Inc.<br>17400 Medina Road,<br>Suite 100<br>Minneapolis, MN 55447 |
| iVent 201<br>Portable<br>Ventilator with<br>Pulse Oximeter | K021981 | Versamed Corporation<br>2 Blue Hill Plaza<br>Pearl River, NY 10965 |
| TBird VELA<br>Ventilator | K032451 | VIASYS Healthcare/Bird<br>Products Corporation<br>1100 Bird Center Drive<br>Palm Springs, CA 92262 |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. 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

AUG - 1 2007

Pulmonetic Systems, Incorporated C/O Mr. Robert C. Samec Vice President- Quality Assurance/Regulatory Affairs Division of VIASYS Healthcare 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341

Re: K070594

Trade/Device Name: PALMTop PTV Models 8/10 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 26, 2007 Received: July 27, 2007

Dear Mr. Samec:

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. Samec

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clues

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

K070594 510(k) Number (if known):

Device Name: PALMTop PTV Models 8/10

Indications For Use:

Indications for Use

PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.

PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

Federal law (USA) restricts the sale of this device except by or on the order of a physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Ch (Division Sign-Off)

(acting B.C.) Division of Anesthesinlogy, General Hospital Infection Control, Dental Devices

510(k) Number: K070594

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