MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS

K040790 · Pulmonetic Systems, Inc. · CBK · Jun 3, 2004 · Anesthesiology

Device Facts

• Record ID: K040790
• Device Name: MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
• Applicant: Pulmonetic Systems, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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. - 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 continuous ventilator providing mechanical ventilatory support; supports adult and pediatric patients (≥5 kg). Device delivers positive pressure ventilation (invasive/non-invasive) using Assist/Control, SIMV, or CPAP modes; supports Volume, Pressure Control, and Pressure Support breath types. Modification adds commercially available heated wire breathing circuit limbs (Allegiance Healthcare) to provide heated/humidified air under physician order. Used in institutional, home, and transport settings by trained clinicians. Output is mechanical ventilation; healthcare providers monitor patient status and ventilator settings to adjust therapy. Benefits include reliable respiratory support across diverse clinical environments.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of the modified breathing circuit components to predicate devices.

Technological Characteristics

Continuous ventilator; supports adult/pediatric patients ≥5 kg. Features heated wire breathing circuit limbs (Allegiance Healthcare) for heated/humidified air. Modes: Assist/Control, SIMV, CPAP. Breath types: Volume, Pressure Control, Pressure Support. Connectivity: compatible with external humidifiers (e.g., Fisher & Paykel MR 730/850).

Indications for Use

Indicated for adult and pediatric patients weighing at least 5 kg (11 lbs.) requiring continuous or intermittent mechanical ventilatory support via invasive (ET tube) or non-invasive (mask) positive pressure ventilation. Modes include Assist/Control, SIMV, or CPAP. Restricted to use by qualified, 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 1000 Ventilator (K981371, K984056, K002881, K010608, K032226)
• Allegiance Airlife Heated Ventilator Breathing Circuits (K000697)

Reference Devices

• Fisher & Paykel MR 730 (K913368)
• Fisher & Paykel MR 850 (K020332)

Submission Summary (Full Text)

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JUN - 3 2004

K040790

### 510(K) SUMMARY 1.

#### SUBMITTER 1.1

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

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

#### 1.2 DEVICE / TRADE NAME

LTV 1000 Ventilator/Breathing circuits Trade Name:

Common Name: Ventilator

Classification Name: Ventilator, Continuous (Respirator) 868.5895

#### 1.3 SUBMISSION DATE

Submission Date: March 26, 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 modification intended to be cleared by this submission is:

The addition of commercially available heated wire breathing circuit inspiratory/expiratory limbs manufactured and distributed by Allegiance Healthcare Corporation (K000697), as an option to the ventilator breathing circuits specified for use

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commercially available humidifier with heated wire controller* to provide heated and humidified air under a physicians order/supervision.

*Fisher & Paykel Models: MR 730 (K913368) MR 850 (K020332)

#### 1.5 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,

#### 1.6 EQUIVALENCE TO PREDICATE DEVICE(S)

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

| Predicate Device | 510(k) Clearance | Manufacturer |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| LTV 1000 Ventilator<br>with breathing<br>circuits. | 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 |
| Allegiance Airlife<br>Heated Ventilator<br>Breathing Circuits | K000697 | Allegiance Healthcare<br>Corporation |

The LTV 1000 Ventilator with breathing circuits, 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 page compares the modification of the LTV 1000 breathing circuits to the previously cleared LTV 1000 ventilator/breathing circuits and the Allegiance Airlife Heated Wire Breathing Circuits. Allegiance Healthcare Corporation, the manufacturer of the Airlife Heated Wire

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Breathing Circuits is the selected supplier for the Heated Wire Breathing Circuit inspiratory/expiratory limbs to be utilized with the LTV 1000 ventilator.

The LTV 1000 ventilator/breathing circuits with the modification listed are substantially equivalent to the EP 1000 ventilator/breathing circuits (K981371) and the Allegiance Airlife Heated the products = r = 1000 (K000697), intended for use with commercially available ventilators.

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# SUBSTANTIAL EQUIVALENCE SUMMARY TABLE

| LTV 1000 with Modification | LTV 1000<br>(Predicate Device)<br>(K981371) | Allegiance Airlife Heated Wire<br>Breathing Circuit Limb(s)<br>(K000697) Predicate Device | Discussion of Differences and<br>Similarities |
|-------------------------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model 15090-001 Heated Circuit<br>Assy., 6', SPU, Adult w/PEEP | Model 10820 Circuit Assy., 6', SPU,<br>Adult w/PEEP | RT600-850 Adult Inspiratory Limb,<br>Heated, 6'. | Airlife Adult Heated Wire Inspiratory<br>Limb replaces PSI Adult Inspiratory<br>Limb. |
| Model 15090-002 Heated Circuit<br>Assy., 6', SPU, Adult PEEPless | Model 10822 Circuit Assy., 6', SPU,<br>Adult PEEPless | RT600-850 Adult Inspiratory Limb,<br>Heated, 6'. | Airlife Adult Heated Wire Inspiratory<br>Limb replaces PSI Adult Inspiratory<br>Limb. |
| Model 15090-003 Heated Circuit<br>Assy., 6', SPU, Pediatric w/PEEP | Model 10821 Circuit Assy., 6', SPU.<br>Pediatric w/PEEP | RT609-856 Pediatric Inspiratory Limb,<br>Heated, 6'. | Airlife Pediatric Heated Wire<br>Inspiratory Limb replaces PSI Pediatric<br>Inspiratory Limb. |
| Model 15090-004 Heated Circuit<br>Assy., 6' SPU, Pediatric PEEPless | Model 10823 Circuit Assy., 6', SPU,<br>Pediatric PEEPless | RT609-856 Pediatric Inspiratory Limb,<br>Heated, 6'. | Airlife Pediatric Heated Wire<br>Inspiratory Limb replaces PSI Pediatric<br>Inspiratory Limb. |
| Model 15091-001 Heated Circuit<br>Assy., 5', SPU, Adult w/ PEEP | Model 10820 Circuit Assy., 6', SPU,<br>Adult w/PEEP | RT500-853 Adult<br>Inspiratoty/Expiratory Limbs, Heated,<br>5'. | Airlife Adult Heated Wire<br>Inspiratory/Expiratory Limb replaces<br>PSI Adult Inspiratory/Expiratory Limb.<br>Length reduced from 6' to 5'. |
| | | | Airlife Adult Heated Wire<br>Inspiratory/Expiratory Limb replaces<br>PSI Adult Inspiratory/Expiratory Limb.<br>Length reduced from 6' to 5'. |
| | | | Airlife Pediatric Heated Wire<br>Inspiratory/Expiratory Limb replaces<br>PSI Pediatric Inspiratory/Expiratory<br>Limb. Length reduced from 6' to 5'. |
| Model 15091-004 Heated Circuit<br>Assy., 5', SPU, Pediatric PEEPless | Model 10823 Circuit Assy., 6', SPU,<br>Pediatric PEEPless | RT509-852 Pediatric<br>Inspiratoty/Expiratory Limbs, Heated,<br>5'. | Airlife Pediatric Heated Wire<br>Inspiratory/Expiratory Limb replaces<br>PSI Pediatric Inspiratory/Expiratory<br>Limb. Length reduced from 6' to 5'. |
| Model 15092-001 Assy. Heated<br>Inspiratory Limb Assy., 6', SPU,<br>Pediatric | Model 10823 Circuit Assy., 6', SPU,<br>Pediatric PEEPless | RT609-856 Pediatric Inspiratory Limb,<br>Heated, 6'. | Airlife Pediatric Heated Wire<br>Inspiratory Limb replaces PSI Pediatric<br>Inspiratory Limb. |
| Model 15092- 002 Assy. Heated<br>Inspiratory Limb Assy., 6', SPU, Adult | Model 10820 Circuit Assy., 6', SPU,<br>Adult w/PEEP | RT600-850 Adult Inspiratory Limb,<br>Heated, 6'. | Airlife Adult Heated Wire Inspiratory<br>Limb replaces PSI Adult Inspiratory<br>Limb. |

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UN - 3 2004

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

Re: K040790

K040770
Trade/Device Name: Modification to LTV 1000 Ventilator/Breathing Circuits Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Il Product Code: CBK Dated: May 24, 2004 Received: May 25, 2004

Dear Mr. Samec:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectoris in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tise stated in the encrosure) to regally management date of the Medical Device American's on to commerce prior to May 26, 1970, the enated with the provisions of the Federal Food, Drug, devices that have been recuire in assee approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Y ou may, ulciently, market the devices, obly of the courements for annual registration, listing of general controls provisions of the fice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it If your device is classified (secure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations liDA m may be subject to such additional controls. Extremgions be found in the Code of Pouchal Ingerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1127 s issuates or our device complies with other requirements of the Act that FIA has made a decemmances and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Robert C. Samec

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,

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

510(k) Number (if known):

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

Over-The-Counter Use AND/OR

(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)

Aung Suulum

these sintray, General Hospital. Infection Control, Dental Devices 510(k) Number:

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