PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR

K083688 · Pulmonetic Systems, Inc. · CBK · Mar 18, 2009 · Anesthesiology

Device Facts

• Record ID: K083688
• Device Name: PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
• Applicant: Pulmonetic Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Mar 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The LTV® 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation 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 5kg (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via endotrach tube or trach tube) . or non-invasively (via mask or nasal prongs). - Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. . The ventilator is suitable for use in institutional, home, or transport settings. The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners. CAUTION: Federal law restricts this device to sale by or on the order of a physician

Device Story

LTV 1200 ventilator provides mechanical ventilatory support; supports adult/pediatric patients ≥5kg; invasive/non-invasive delivery. Modification adds MR Conditional labeling for use in 1.5T and 3.0T shielded magnetic scanners. Operated by qualified personnel in institutional, home, or transport settings. Device maintains ventilatory function within MR environment; ensures patient safety during imaging. Clinical decision-making supported by continuous monitoring of ventilation parameters.

Clinical Evidence

Bench testing only. Testing conducted in the MR environment to validate performance and safety of the LTV 1200 ventilator within 1.5T and 3.0T shielded magnetic scanners.

Technological Characteristics

Continuous ventilator; supports invasive/non-invasive ventilation; modes: Assist/Control, SIMV, CPAP, NPPV. MR Conditional for 1.5T and 3.0T static magnetic fields. No changes to core mechanical ventilation technology; modification limited to MR compatibility labeling and testing.

Indications for Use

Indicated for adult and pediatric patients (≥5kg) requiring continuous or intermittent mechanical ventilatory support (invasive or non-invasive). Modes include Assist/Control, SIMV, CPAP, and NPPV. Suitable for institutional, home, and transport settings. MR Conditional for use in 1.5T and 3.0T shielded magnetic scanners.

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 MR Conditional Portable Ventilator (K073694)

Submission Summary (Full Text)

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# 510(K) SUMMARY

K083688

## SUBMITTER

Cardinal Health 203, Inc. 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341

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

### DEVICE / TRADE NAME

| Trade Name: | LTV 1200 MR Conditional Ventilator |
|----------------------|----------------------------------------------|
| Common Name: | Ventilator |
| Classification Name: | Ventilator, Continuous (Respirator) 868.5895 |
| SUBMISSION DATE: | |

Submission Date: December 11, 2008

#### 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 modification intended to be cleared by this submission is:

The "Indications for Use" is being expanded to label the LTV 1200 as MR Conditional.

The LTV 1200 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modification.

5-i

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## INTENDED USE

The LTV® 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation 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 5kg (11 lbs.), who require the following types of ventilatory support:

- Positive Pressure Ventilation, delivered invasively (via endotrach tube or trach tube) . or non-invasively (via mask or nasal prongs).
- Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. .

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

The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners.

CAUTION: Federal law restricts this device to sale by or on the order of a physician

# EQUIVALENCE TO PREDICATE DEVICE(S)

Testing conducted in the MR environment has demonstrated that the LTV 1200 MR Conditional ventilator is substantially equivalent to the predicate device listed below.

The LTV 1200 with the modification listed is substantially equivalent to the predicate device(s) listed.

| Predicate Device | 510(k) Clearance | Manufacturer |
|----------------------------------------------------|------------------|--------------------------------------------------------------------|
| iVent 201 MR<br>Conditional<br>Portable Ventilator | K073694 | Versamed Corporation<br>2 Blue Hill Plaza<br>Pearl River, NY 10965 |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

MAR 1 8 2009

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert C. Samec Vice President, ORA Cardinal Health 203, Incorporated 17400 Medina Road Suite 100 Minneapolis, Minnesota 55447

K083688 Re:

> Trade/Device Name: Ventilator, Continuous (Respirator) Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 11, 2008 Received: December 22, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Sutte H. Mckinions

Ginette Y. Michaud, M.D. Acting 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 Statement

| 510(k) Number (if known) | 15083688 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 the 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 5kg (11 lbs.), who require the following types of ventilatory support: <ul><li>Positive Pressure Ventilation, delivered invasively (via endotrach tube or trach tube) or non-invasively (via mask or nasal prongs).</li><li>Assist/Control, SIMV, CPAP, or NPPV modes of ventilation.</li></ul> The ventilator is suitable for use in institutional, home, or transport settings. The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners. CAUTION: Federal law restricts this device to sale by or on the order of a physician. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801. 109) | OR | Over-The-Counter Use |
|----------------------------------------|----------------------------------------------------------------------------------------------------|----------------------|
| | <img alt="Signature" src="signature.png"/> | |
| | (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K083688 4-1 | |

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