MODIFICATION TO LTV 1000 VENTILATOR

K040540 · Pulmonetic Systems, Inc. · CBK · Apr 29, 2004 · Anesthesiology

Device Facts

• Record ID: K040540
• Device Name: MODIFICATION TO LTV 1000 VENTILATOR
• Applicant: Pulmonetic Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Apr 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The LTV ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. 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 (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control, SIMV, or CPAP modes of ventilation. - Breath types including Volume, Pressure Control and Pressure Support. The ventilator is suitable for use in institutional, home and transport settings.

Device Story

LTV 1000 is a portable, continuous ventilator for adult/pediatric patients (>= 5 kg). Device provides positive pressure ventilation (invasive/non-invasive) via Assist/Control, SIMV, or CPAP modes. Modifications include: high breath rate alarm; O2 cylinder duration monitoring (based on operator input); 100% O2 flush feature; automatic high O2 switchover (alerts operator to high-pressure source, defaults to 21% O2); increased max O2 input pressure (up to 70 psig). Operated by trained personnel in institutional, home, or transport settings. Output provides respiratory support; alarms/indicators assist clinicians in monitoring patient status and gas supply. Benefits include enhanced safety, monitoring, and compatibility with diverse oxygen sources.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing of modified features.

Technological Characteristics

Continuous ventilator; supports invasive/non-invasive positive pressure ventilation. Features: high breath rate alarm, O2 cylinder duration monitoring, 100% O2 flush, automatic high O2 switchover. Max O2 input pressure 70 psig. Suitable for institutional, home, transport. Software-controlled monitoring and alarm logic.

Indications for Use

Indicated for adult and pediatric patients weighing >= 5 kg requiring continuous or intermittent mechanical ventilatory support (invasive or non-invasive) in institutional, home, or transport settings. Modes include Assist/Control, SIMV, or CPAP.

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 1000 Ventilator (K981371, K984056, K002881, K010608, K032226)
• T-Bird AVS (K981971)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the text "K040540" written in black ink. The text is slightly tilted, with the numbers appearing to be handwritten. Below the text, there is a number "1." which is also written in black ink.

## 510(K) SUMMARY

#### 1.1 SUBMITTER

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

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

#### DEVICE / TRADE NAME 1.2

LTV 1000 Ventilator Trade Name:

Ventilator Common Name:

Classification Name: Ventilator, Continuous (Respirator) 868.5895

#### SUBMISSION DATE 1.3

Submission Date: April 1. 2004

#### 1,4 DESCRIPTION

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

- . Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
- Assist/Control, SIMV, or CPAP modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. ●

The modifications intended to be cleared by this submission are:

- . The addition of a High Breath Rate Alarm to alert operators to a patient's high breath rate condition.
- . The addition of O2 cylinder duration monitoring to provide a reference indicator of the approximate remaining usable time of an external O2 cylinder based on operator entered input parameters.

{1}------------------------------------------------

- The addition of a 100% O₂ flush feature allowing the operator to elevate delivered FIO₂ . for a preset time period.
- The addition of Automatic High O₂ Switchover to alert operators that a high O₂ pressure . source is attached to the ventilator when a low O2 pressure source has been selected. In this condition, the ventilator will switch to a high O2 pressure source mode and set O2 delivery to 21% or room air.
- A change in maximum allowable oxygen input pressure from 70 psig to allow . broader compatibility with institutional oxygen sources.

#### INTENDED USE 1.5

The LTV ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. 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 (11 lbs.), who require the following types of ventilatory support:

- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively . (via mask).
- Assist/Control, SIMV, or CPAP modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. .

The ventilator is suitable for use in institutional, home and transport settings.

### EQUIVALENCE TO PREDICATE DEVICE(S) 1.6

The LTV 1000 Ventilator listed modifications are substantially equivalent to the following listed devices:

| Predicate Device | 510(k) Clearance | Manufacturer |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| LTV 1000 Ventilator | K981371 - Initial clearance for<br>Institutional and Transport<br>settings.<br>K984056 - Homecare settings.<br>K002881 - Enhancements.<br>K010608 - Lap Top Monitor.<br>K032226 - 5 kg Patient Application. | Pulmonetic Systems, Inc.<br>Colton, CA/Mpls., MN |
| T-Bird AVS | K981971 | Bird Products, Palm<br>Springs, CA |

{2}------------------------------------------------

The LTV 1000 ventilator, previously cleared for homecare use and for institutional and transport settings, is now being submitted for clearance with the listed modifications.

The table on the following pages compares the modifications/features of the LTV to the previously cleared LTV 1000 ventilator and the T-Bird AVS ventilator.

The LTV 1000 ventilator with the modifications listed is substantially equivalent to the predicate LTV 1000 (K032226) and the T-Bird AVS Ventilator (K981971) manufactured by Bird Products.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of three thick, curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2004

Mr. Robert C. Samec Vice President-Regulatory Affairs Pulmonetic System, Incorporated 17400 Medina Road Suite 100 Minneapolis, Minnesota 55447

Re: K040540

Trade/Device Name: LTV 1000 Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 1, 2004 Received: April 2, 2004

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 apper (a) sprovisions 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 (1 will ), it hay ob of of the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Lederal Register.

{4}------------------------------------------------

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. or the receir any 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 and inning (s 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) rins leter 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

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

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): K040540

Device Name: Ventilator, Continuous (Respirator)

Indications For Use:

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. 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 (11lbs.), who require the following types of ventilatory support:

- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
- Assist Control, SIMV, or CPAP modes of ventilation. -

The ventilator is suitable for use in institutional, home, or transport settings.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sthmil

on of Anesthesiology, General Hospital, Infection Control Dental Device

Page 1 of

510(k) Number: K040540