LTV 1200 VENTILATOR

K060647 · Pulmonetic Systems, Inc. · CBK · May 25, 2006 · Anesthesiology

Device Facts

• Record ID: K060647
• Device Name: LTV 1200 VENTILATOR
• Applicant: Pulmonetic Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• 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, CPAP, or NPPV 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 1200 is a portable, continuous ventilator for institutional, home, and transport use. It provides positive pressure ventilation (invasive/non-invasive) via Assist/Control, SIMV, CPAP, or NPPV modes. Modifications from the predicate LTV 1000 include internal PEEP control, a Low PEEP alarm, patient setting control presets, NPPV mode enhancements, and external battery access. Operated by trained personnel under physician direction; provides ventilatory support to patients weighing ≥5 kg. Clinicians use the device interface to set parameters and monitor ventilation; output assists in maintaining patient respiration. Benefits include flexible, portable respiratory support across various clinical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and design verification of the modified features.

Technological Characteristics

Continuous ventilator; supports Volume, Pressure Control, and Pressure Support breath types. Features internal PEEP control, Low PEEP alarm, and user-accessible battery. Designed for adult/pediatric use (≥5 kg). Operates in institutional, home, and transport settings.

Indications for Use

Indicated for adult and pediatric patients weighing at least 5 kg (11 lbs.) requiring continuous or intermittent mechanical ventilatory support (invasive or non-invasive).

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

• iVent 201 Portable Ventilator (K011957)
• AVEA Ventilator (K022674)
• LTV 1000 Ventilator (K051767)

Submission Summary (Full Text)

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Ko60647

### 510(K) SUMMARY

#### SUBMITTER

MAY 2 5 2006

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

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

#### DEVICE / TRADE NAME

Trade Name: LTV 1200 Ventilator

Common Name: Ventilator

Ventilator, Continuous (Respirator) 868.5895 Classification Name:

#### SUBMISSION DATE

Submission Date: March 9, 2006

#### DESCRIPTION

The LTV 1200 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, CPAP, or NPPV modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. .

The modifications intended to be cleared by this submission are:

- Incorporation of optional internal PEEP control, replacing the optional external 록 mechanical PEEP valve used with the previously cleared LTV 1000 Ventilator.
- 해 The addition of a Low PEEP alarm.

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- The addition of optional Patient Setting Control Presets to assist clinicians in initially setting patient ventilation set parameters.
- I The addition of NPPV mode setting enhancements to assist the clinician in setting up NPPV mode ventilation.
- I The addition of externally accessibility to the device internal battery for trained service personnel battery replacement.
- g The designation of the modified LTV 1000 Ventilator as the VIASYS LTV 1200 Ventilator. (Note: The previously cleared Pulmonetic Systems LTV 1000 will continue to be marketed without the modifications listed in this submission).

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

#### 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,CPAP, or NPPV 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)

The modified LTV 1000 with the modifications listed is substantially equivalent to the predicate device(s) listed.

| Predicate Device | 510(k) Clearance | Manufacturer |
|----------------------------------|------------------|-----------------------------------------------------------------------------------|
| iVent 201 Portable<br>Ventilator | K011957 | Versamed Corporation<br>2 Blue Hill Plaza<br>Pearl River, NY 10965 |
| AVEA Ventilator | K022674 | Bird Products Corporation<br>1100 Bird Center Drive<br>Palm Springs, CA 92262 |
| LTV 1000 Ventilator | K051767 | Pulmonetic Systems, Inc.<br>17400 Medina Road, Suite 100<br>Minneapolis, MN 55447 |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

Mr. Robert C. Samec Vice President-Product Assurance Pulmonetic Systems, Incorporated 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341

Re: K060647

Trade/Device Name: Ventilator, Continuous (Respirator), Model LTV 1200 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 9, 2006 Received: May 10, 2006

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.

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

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## Indications for Use

510(k) Number (if known):

Device Name: Ventilator, Continuous (Respirator)

Indications for Use:

The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilation is a restricted medical device intension of individuals who require incomment venture direction of a physician. Specifically, the ventilator is applicable for adult and petiative weighing at least 5 kg (1 1 lbs), who require the following types of ventilatory support:

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

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Aunselum

Anesthesiology, General Hospital,
Control, Dental Devices

K060647

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