LTV-1000 VENTILATOR

K032226 · Pulmonetic Systems, Inc. · CBK · Oct 16, 2003 · Anesthesiology

Device Facts

• Record ID: K032226
• Device Name: LTV-1000 VENTILATOR
• Applicant: Pulmonetic Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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

Device Story

LTV 1000 is a continuous ventilator providing positive pressure respiratory support. Device delivers invasive or non-invasive ventilation via ET tube or mask. Supports Assist/Control, SIMV, and CPAP modes. Intended for use in institutional, home, or transport settings by qualified, trained personnel under physician direction. Device provides mechanical ventilation to patients weighing ≥ 5 kg. Output assists patient breathing, maintaining adequate gas exchange. Clinical decision-making relies on provider assessment of patient respiratory needs and ventilator settings.

Clinical Evidence

No clinical data provided. Substantial equivalence determination based on bench testing and regulatory review.

Technological Characteristics

Continuous ventilator; provides positive pressure ventilation; supports Assist/Control, SIMV, and CPAP modes; suitable for adult and pediatric patients ≥ 5 kg; portable form factor for institutional, home, or transport use.

Indications for Use

Indicated for adult and pediatric patients weighing ≥ 5 kg (11 lbs) requiring continuous or intermittent mechanical ventilatory support via invasive (ET tube) or non-invasive (mask) positive pressure ventilation, including Assist/Control, SIMV, or CPAP modes.

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.

Submission Summary (Full Text)

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OCT 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert C. Samec Vice President, Regulatory Affairs/Quality Assurance Pulmonetic Systems, Inc. 17400 Medina Road, Suite 100 Minneapolis, MN 55447

Re: K032226

Trade/Device Name: LTV 1000 Ventilator Regulation Number: 868,5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 15, 2003 Received: July 21, 2003

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. Robert C. 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/dsma/dsmamain.html.

Sincerely vours.

Susan Runnells

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 Statement

| 510(k) Number (if known) | K032226 |
|--------------------------|-------------------------------------|
| 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 (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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <span style="text-decoration: overline;">✓</span> (Per 21 CFR 801. 109) | OR | Over-The-Counter Use <span style="text-decoration: overline;">________</span> |
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(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

| 510(k) Number: | K032226 |
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